0A4F4F9BD490A749D5437F821CF06DF1
Medicinal Products in Human Medicine Act, Chapter 4 (2018)
https://www.lex.bg/laws/ldoc/2135549536
http://leaux.net/URLS/ConvertAPI Text Files/43A02D3C0E8742592BB306FDEC930D63.en.txt
Examining the file media/Synopses/43A02D3C0E8742592BB306FDEC930D63.html:
This file was generated: 2020-07-14 08:05:06
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator crime:
(return to top)
p.002007: has obtained a retail authorization for medicinal products under the conditions and in the order specified by
p.002007: the ordinance under Art. 219, para. 2.
p.002007: (6) (Repealed, previous para. 4 - SG, iss. 71 in 2008, effective from 26.07.2008, previous para.
p.002007: 2011, in force since 05/08/2011) Pharmacies of outpatient medical establishments at
p.002007: The Ministry of Defense and the Ministry of Interior may be managed by an Assistant-
p.002007: pharmacist at the proposal of the relevant department and after the permission of the executive
p.002007: director of the BDA.
p.002007: Art. 223. (1) A master pharmacist or an assistant pharmacist may be the head of only one pharmacy and
p.002007: necessarily work in it.
p.002007: (2) (amend. - SG 12/11, in force from 08.02.2011) Master pharmacist or assistant pharmacist,
p.002007: who runs a pharmacy cannot be hired under a sole proprietorship or
p.002007: a business company manufacturing, importing, wholesaling or retailing medicinal products
p.002007: products.
p.002007: (3) The person under para. 1, authorized to trade in medicinal products, no
p.002007: may own or participate in manufacturing, importing or trading companies
p.002007: wholesale of medicinal products, including in affiliated companies within the meaning of
p.002007: Trade Law.
p.002007: Art. 224. The pharmacy manager must:
p.002007: 1. is a master pharmacist, respectively assistant pharmacist, in the cases provided for by law;
p.002007: 2. is not deprived of the right to practice the profession;
p.002007: 3. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crime against the individual;
p.002007: 4. has at least one year of experience as a master pharmacist.
p.002007: Art. 225. (amend. - SG 71/08, in force from 26.07.2008) (1) In a settlement on whose territory there is no
p.002007: opened a pharmacy, the right to carry out retail trade in medicinal products has a person under Art. 222, para. 1,
p.002007: who has entered into an employment or pharmacy management contract with an assistant pharmacist or with
p.002007: Master of Pharmacy with less than one year of work experience.
p.002007: (2) The assistant pharmacist or the master pharmacist under para. 1 is a pharmacy manager and a must
p.002007: works in it.
p.002007: (3) (New, SG No. 60/2011, effective 05.08.2011) Assistant Pharmacist - Head of Pharmacy
p.002007: para. 1 may perform the following activities: preservation and release without a prescription of
p.002007: medicinal products, medical devices and dietary products authorized for use in the Republic of Bulgaria
p.002007: special-purpose foods and infant formulas and follow-on formulas,
p.002007: cosmetic and sanitary products.
p.002007: Art. 226. (1) Pharmacies may be opened on the territory of outpatient medical establishments
p.002007: sale of medicinal products to citizens.
p.002007: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, medical establishments for
p.002007: hospital care and medical establishments under art. 10 of the Medical Establishments Act cannot be found
p.002007: pharmacies to sell medicinal products to citizens.
p.002007: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009) The requirements for
p.002007: the location and the premises of the pharmacy shall be determined in the ordinance under Art. 219, para. 2.
...
p.002007: respectively to the manufacturer or importer.
p.002007: (2) The orders under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 280. (1) In establishing violations of the provisions, head eleven, respectively, of the ordinance
p.002007: under Art. 249, the Executive Director of the BDA orders the suspension of the distribution of
p.002007: advertising.
p.002007: (2) With the order under para. 1, the BDA Director may oblige the advertiser to publish or to publish
p.002007: disseminate, in agreement with the BDA, the allegations in advertising by the same means and in the same
p.002007: format and volume.
p.002007: (3) The order under para. 2 shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002007: Chapter fourteen.
p.002007: ADMINISTRATIVE PENALTY PROVISIONS
p.002007: Art. 281. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG, No. 102 of 2012)
p.002007: 01/02/2013) Who manufactures, imports, sells, stores or makes available for use in the Republic of Bulgaria
p.002007: medicinal products that are not authorized for use, except in cases under Art. 8, 9 and 10, as well as those with
p.002007: non-established origin, if not subject to more severe punishment, shall be punished by a fine of BGN 25,000 to BGN 50,000.
p.002007: (2) The same punishment shall be imposed on the persons who produce, import, sell or allow
p.002007: use in the Republic of Bulgaria medicinal products that do not meet the requirements of the active one
p.002007: pharmacopoeia and the conditions of their authorization.
p.002007: (3) When the violations under para. 1 and 2 relate to unauthorized medicinal products containing
p.002007: narcotics, or when they are repeated if the acts do not constitute a crime,
p.002007: the permit issued under this law shall be revoked.
p.002007: (4) Medical professionals who manufacture, sell or supply unauthorized uses
p.002007: medicinal products are deprived of the right to practice their profession for a period of 6 months to two years.
p.002007: (5) The punishment under para. 4 shall be imposed by order of the Minister of Health on the proposal of
p.002007: the BDA Executive Director.
p.002007: Art. 282. (1) Who sells medicinal products in packages or leaflets for a patient who does not meet
p.002007: the requirements of this law shall be punished by a fine of 750 to 1500 levs, and in case of repeated performance of the same
p.002007: violation - with a fine from 1500 to 3000 BGN.
p.002007: (2) A person who sells medicinal products without leaflets to the patient shall be punished by a fine of BGN 750 up to 1500,
p.002007: repeated infringement - with a fine from 1500 to 3000 BGN.
p.002007: Art. 283. (1) Who imports, trades or makes available medicinal products which have expired,
p.002007: shall be liable to a fine of from BGN 10,000 to BGN 20,000.
p.002007: (2) Who breaks the primary / secondary packaging or sells / supplies the offending medicinal products
p.002007: primary / secondary packaging, punishable by a fine of 750 to 1500 levs, and for repeated violation - a fine of 1500
p.002007: up to 3000 BGN
p.002007: Art. 284. (1) Who manufactures, imports or wholesale medicinal products or sells medicinal products
p.002007: products, without permission, are fined BGN 50,000.
p.002007: (2) (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 02.01.2013)
p.002007: Who manufactures, imports or wholesale medicinal products or sells medicinal products in
p.002007: breach of the authorization or sell, store or supply medicinal products that are
p.002007: of unidentified origin shall be liable to a fine of BGN 25,000 to BGN 50,000.
...
p.002007: BGN 000
p.002007: Art. 285. (1) Whoever trades in medicinal products without a batch release certificate shall be punished with
p.002007: a fine of BGN 5,000 to 10,000 and, in the case of a repeated infringement, a fine of 10,000 to 20,000 BGN
p.002007: (2) (Amended, SG No. 60/2011, effective 05.08.2011) Wholesale wholesaler supplying drugstores
p.002007: prescription medicinal products are punishable by a financial penalty of 2500
p.002007: up to BGN 5,000, and in the case of a repeated violation - with a fine of between BGN 5,000 and 10,000.
p.002007: (3) Qualified person allowed to sell lots of medicinal products without
p.002007: certificate for release of each individual batch, is punished with a fine from 2500 to 5000 levs.
p.002007: Art. 285a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102 of 2012)
p.002007: 12/21/2012) Marketing Authorization Holder who did not notify the Minister of Health of
p.002007: suspension of sales under Art. 264, shall be punished by a pecuniary sanction of from 25,000 to 50,000 BGN.
p.002007: Art. 285b. (New, SG No. 102/2012, effective 21.12.2012) Who produces, imports, exports, sells, or
p.002007: stores active substances in violation of the requirements of this law, shall be punished by a fine from 10,000 to 20
p.002007: BGN 000
p.002007: Art. 285c. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018)
p.002007: medicinal products in quantities greater than the quantities under Art. 207, para. 1, item 15, letter "d" shall be punished by Art
p.002007: a fine of BGN 50,000 to BGN 100,000, and in the case of a repeated infringement, a fine of BGN 50,000
p.002007: from 100,000 to 150,000 BGN
p.002007: Art. 286. (1) (Supplemented, SG No. 84/2018) (*) For clinical trials conducted in violation of this Act, or
p.002007: of Regulation (EU) No 536/2014, if committed does not constitute a crime, of the perpetrators
p.002007: or who have committed this violation, will be fined $ 5,000 to $ 10,000, and upon re-admission or
p.002007: committing the same offense - a fine of 10,000 to 20,000 BGN.
p.002007: (2) To medical specialists who have admitted or committed violations under para. 1 may also be required
p.002007: punishment "deprivation of the right to exercise their profession" from 6 months to two years.
p.002007: (3) The measure under para. 2 shall be imposed by the Minister of Health upon proposal of the Executive Director
p.002007: of the BDA.
p.002007: Art. 287. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 60/2011, effective 05.08.2011
p.002007: (d) Who is retailing medicinal products without a marketing authorization / certificate
p.002007: this, or works in violation of his issued permit / certificate, shall be punished with a fine of 5000 to 10
p.002007: BGN 000
p.002007: (2) (New, SG No. 84/2018, effective 12.10.2018) Retailer who supplies medicinal products
p.002007: products from the list under Art. 217c, para. 1 wholesaler or other person in violation of the requirements of
p.002007: this law, or the by-laws implementing it, shall be punished by a fine, as appropriate
p.002007: property sanction from 10,000 to 20,000 BGN, and in the case of repeated violation - from 25,000 to 35,000 BGN.
p.002007: (3) (Renumbered from Paragraph (2), SG No. 84/2018) Effective from 12.10.2018. 1 shall also be imposed on the persons,
p.002007: who are retailing a pharmacy or drugstore after the termination of the business
p.002007: the permit / certificate.
p.002007: (4) (amend. - SG 71/08, in force from 12.08.2008, suppl. - SG, iss. 60 in 2011, in force since 05.08.2011,
p.002007: previous para. 3 - SG, iss. 84 of 2018, effective 12/10/2018) Who sells or stores in a drugstore
...
Searching for indicator illegal:
(return to top)
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) use only active substances which are manufactured
p.002007: in accordance with the requirements of Good Manufacturing Practice for Active Substances;
p.002007: 2a. (new - SG 102/2012, in force from 02.01.2013) make sure that the auxiliary substances used in
p.002007: the medicinal products are manufactured in accordance with the relevant good manufacturing practices for
p.002007: excipients determined on the basis of a formal risk assessment in accordance with the applicable ones
p.002007: guidelines adopted by the European Commission;
p.002007: 3. provide permanently qualified production and control personnel as required by
p.002007: the ordinance under Art. 152;
p.002007: 4. (amend. - SG 12/11, in force from 08.02.2011) has only medicinal products which have
p.002007: authorization for use, subject to the requirements of this law;
p.002007: 5. (repealed, SG No. 12/2011, effective 08.02.2011)
p.002007: 6. notify immediately the control bodies in case of change of qualified person post. 148, Vol. 2;
p.002007: 7. provide access to the premises and documentation at all times to the control bodies;
p.002007: 8. provide to the qualified person under Art. 148, item 2 the necessary conditions for fulfilling the obligations
p.002007: his;
p.002007: 9. (New - SG, iss. 102 in 2012) shall inform immediately the BDA and the holder of
p.002007: the marketing authorization if it receives information that the medicinal products covered by the
p.002007: its manufacturing authorization, are falsified or there are suspected falsifications,
p.002007: whether or not these medicinal products were distributed within the legal chain
p.002007: delivery or in an illegal manner, including through illegal sale through the services of
p.002007: the information society;
p.002007: 10. (new - SG 102/2012, in force from 02.01.2013) check whether the manufacturers, importers or
p.002007: traders from whom it receives active substances are registered by the competent authority of the Member State,
p.002007: in which they are established;
p.002007: 11. (new - SG 102/2012, in force from 02.01.2013) shall check the authenticity and quality of the active and
p.002007: of excipients.
p.002007: (2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
p.002007: performs audits at the sites for the production and marketing of active substances in order to comply with the Good
p.002007: manufacturing practice and Good distribution practice. The holder of the manufacturing authorization
p.002007: may contract with a third party to perform the audit on his behalf and on his behalf.
p.002007: (3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
p.002007: documents the undertakings under para. 1, items 2 and 2a measures.
p.002007: (4) (Renumbered from Paragraph (2) - SG, No. 102 of 2012, in force since 02.01.2013, amend. - SG, iss. 84 in 2018. (*))
p.002007: of a manufacturing authorization shall keep the samples and the documentation of the medicinal products manufactured by him
p.002007: products and active substances under the conditions and in the order specified in the ordinance under Art. 152, para. 1.
p.002007: (5) (Renumbered from Paragraph (3), SG No. 102/2012, effective as of 02/01/2013, repealed - SG, iss. 84 in 2018 (*))
p.002007: (6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013) The documentation for each concluded transaction
...
p.002007: Marketing Authorization / Registration Certificate, Modification of the Marketing Authorization or
p.002007: its renewal.
p.002007: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002007: 1. medicinal products with restricted medical prescription, intended for use in certain medicinal products only
p.002007: specialized areas;
p.002007: 2. medicinal products - subject to special medical prescription;
p.002007: 3. medicinal products for multiple or single dispensing under the same medical prescription.
p.002007: Art. 173. Medicinal products that meet the following requirements are prescribed on medical prescription:
p.002007: 1. may present a direct or indirect danger to human health, even if used correctly, if
p.002007: apply without medical supervision;
p.002007: 2. they are frequently and very widely applied incorrectly and as a result can be a danger to
p.002007: human health;
p.002007: 3. contain substances the activity and / or side effects of which subsequently require
p.002007: additional study;
p.002007: 4. usually prescribed by a doctor for parenteral administration.
p.002007: Art. 174. Medicinal products are subject to special medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. contain narcotic substances within the meaning of the Drug Control Act; and
p.002007: precursors in permissible quantities;
p.002007: 2. if used improperly, they can create a significant risk of abuse, lead to a medicinal product
p.002007: dependency or use for illegal purposes;
p.002007: 3. contain new medicinal substances whose characteristics are not sufficiently known for this reason
p.002007: a preventive cause may be attributed to the group of medicinal products under item 2.
p.002007: Art. 175. Medicinal products are subject to limited medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. restricted to hospital use only because of limited experience in use or in the interest of
p.002007: public health;
p.002007: 2. intended for the treatment of conditions which can only be diagnosed in
p.002007: medical institutions, although their implementation and monitoring of the course of treatment may be
p.002007: carry out in other health establishments;
p.002007: 3. they are intended for the treatment of outpatients, but their use can be serious
p.002007: side effects requiring specialist prescription and monitoring during treatment.
p.002007: Art. 176. (1) The Executive Agency for Medicines may not approve the mail requested by the applicant. 26, para.
p.002007: 1 medication delivery regimen based on an assessment of:
p.002007: 1. the maximum single dose, the maximum daily dose, the amount of active substance in a single dose
p.002007: unit, dosage form, specific type of immediate packaging of the product, and / or
p.002007: 2. other specific conditions of use.
p.002007: (2) The Medicines Executive Agency may not specify the exact category of medicinal product under
p.002007: Art. 172, but according to the criteria of Art. 174 and 175 determine whether the medicinal product is to be classified as
p.002007: product available only on prescription.
...
p.002007: the main documentation of the holder 's pharmacovigilance monitoring system
p.002007: the marketing authorization or persons entrusted with the activities of Chapter Eight;
p.002007: 6. (new - SG 102/2012, in force since 21.12.2012) to carry out an inspection on compliance with
p.002007: approved prices, marginal prices or registered prices for the sale of medicinal products;
p.002007: 7. (Renumbered from Item 6, SG No. 102/2012, effective 21.12.2012) to draw up acts for establishing
p.002007: administrative violations.
p.002007: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002007: (3) (amend. - SG 98/10, in force from 01.01.2011) The Executive Director of the BDA or the respective
p.002007: the Director of the SIC is entitled, depending on the submission of the offending official,
p.002007: Yes:
p.002007: 1. order in writing the offender to suspend the violation under para. 1, Vol. 1;
p.002007: 2. requires the offender to declare that he will cease the violation under para. 1, item 1 and, if necessary, yes
p.002007: obliged him to make the declaration public;
p.002007: 3. order the termination or prohibition of any violation under para. 1, item 1 and if necessary to do
p.002007: the order for termination or prohibition of the public domain infringement.
p.002007: (4) (New, SG No. 102/2012, effective 21.12.2012) The Chairman of the Council shall mail. 258, para. 1 is right
p.002007: to order in writing the offender to suspend the violation found during the inspection under para. 1, v. 6.
p.002007: Art. 271. (1) (amend. - SG 98/10, in force from 01.01.2011) Regional health inspections shall be entitled
p.002007: Yes:
p.002007: 1. stop construction and issue prescriptions when they find violations of hygiene standards and
p.002007: requirements in the construction execution process; illegal construction of sites and facilities
p.002007: for the production, storage and sale of medicinal products shall notify the National Directorate
p.002007: building control or technical service of the municipality;
p.002007: 2. prohibit the commissioning and stop the operation of sites and facilities in case of violation
p.002007: the requirements and hygiene standards for the production, storage and sale of medicines
p.002007: products - until the elimination of the infringements;
p.002007: 3. (amend. - SG 71/08, in force from 12.08.2008) block medicinal products in the presence of
p.002007: documented information on: non-compliance with quality requirements; medicinal products imported
p.002007: or produced in violation of this law; medicinal products that are available in packs of leaflets,
p.002007: who do not meet the requirements of this law; and send samples of them to the BDA;
p.002007: 4. give conclusions about the compliance of the objects of control with the statutory requirements;
p.002007: 5. issue orders, prescriptions and instructions within their competence, which are obligatory
p.002007: for all persons in the territory of the area concerned.
p.002007: (2) (amend. - SG 98/10, in force from 01.01.2011) The compulsory administrative measures under para. 1 or more
p.002007: Art. 270, para. 3 shall be imposed by an order of the director of the RII.
p.002007: (3) The orders under para. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 272. (1) The Executive Agency for Medicines shall:
p.002007: 1. (suppl. - SG 102/2012, in force from 02.01.2013) prohibits the commissioning and stops
p.002007: the operation of sites and facilities in violation of the rules of Good Manufacturing Practice of
...
p.002007: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and
p.002007: the extent to which the active substance or the therapeutically significant portion of the investigational medicinal product is tested
p.002007: reach from the dosage form into the systemic circulation.
p.002007: 20. (amend. - SG 84/2018) (*) "Tested medicinal product" is a tested medicinal product within the meaning of
p.002007: of Art. 2 (2) (5) of Regulation (EU) No 536/2014.
p.002007: 21. (Amended, SG No. 84/2018) (*) "Researcher" shall be a researcher within the meaning of Art. 2 (2) (15)
p.002007: Regulation (EU) No 536/2014.
p.002007: 22. (amended, SG No. 84/2018) (*) "Informed consent" is informed consent within the meaning of Art. 2,
p.002007: paragraph 2, point 21 of Regulation (EU) No 536/2014.
p.002007: 23. "Kit" means any substance which is usually dissolved, suspended, diluted or diluted before use
p.002007: combines with radionuclides, resulting in the finished radioactive medicinal product.
p.002007: 24. (amended, SG No. 84/2018) (*) "Clinical trial of a medicinal product" is a clinical trial of
p.002007: the meaning of Art. 2 (2) (2) of Regulation (EU) No 536/2014.
p.002007: 25. "Clinical advantage" is a significant therapeutic or diagnostic benefit of a drug
p.002007: product compared to a medicinal product that has already been authorized.
p.002007: 25a. (new, SG No. 84/2018, effective 12.10.2018) Conflict
p.002007: "interests" is a conflict of interests under
p.002007: within the meaning of Chapter Eight, Section I of the Anti-Corruption and Removal of Illegal Act
p.002007: the property acquired.
p.002007: 26. (Repealed, SG No. 84/2018)
p.002007: 27. "Patient leaflet" is a leaflet containing user information to accompany
p.002007: the medicinal product.
p.002007: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002007: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No
p.002007: Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on medicinal products for
p.002007: advanced therapy and amending Directive 2001/83 / EC and Regulation (EC) No 726/2004.
p.002007: 27b. (new - SG 84 2018, in force from 12.10.2018) Medicinal
p.002007: "product for compassionate use" is
p.002007: medicinal product for palliative use within the meaning of Art. 83 (2) of Regulation (EC) No 726/2004
p.002007: of the European Parliament and of the Council.
p.002007: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product manufactured
p.002007: from human blood components and by a method involving an industrial process. These include albumin,
p.002007: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, other plasma
p.002007: fractions or combinations thereof.
p.002007: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare diseases" is
p.002007: a product that:
p.002007: (a) is intended for the diagnosis, prophylaxis or treatment of life - threatening diseases; or
p.002007: progressively chronic diseases affecting no more than 5 in 10,000 people in the territory
p.002007: on the side, or
p.002007: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.002007: Art. 148. To obtain a manufacturing authorization, the person mailed. 146 must have:
p.002007: 1. with personnel with appropriate qualification, depending on the specificity of the species produced
p.002007: medicines and dosage forms;
p.002007: 2. at any time with at least one qualified person eligible for post. 159;
p.002007: 3. premises for production, control and storage of the medicinal products, provided with the necessary
p.002007: technical equipment and control laboratories.
p.002007: Art. 149. Heads of production and quality control of medicinal products in
p.002007: manufacturing enterprises are persons:
p.002007: 1. who have a master's degree in pharmacy, chemistry
p.002007: or "biology" and at least two years of practical experience in pharmaceutical manufacturing;
p.002007: 2. which meet the requirements of item 1 and have an additional recognized specialty in radiobiology or
p.002007: radiochemistry - for radiopharmaceuticals or for medicinal products subject to ionizing radiation;
p.002007: 3. with recognized specialty in clinical hematology, medical microbiology, virology or immunology
p.002007: - for the production of immunological medicinal products - vaccines, toxins, serums, for biotechnological products
p.002007: products and for medicinal products derived from human plasma or from human blood.
p.002007: Art. 150. (1) The person under art. 146 shall submit to the BDA an application in accordance with a model approved by the Director of the Agency.
p.002007: (2) Together with the application under para. 1 the applicant shall also submit:
p.002007: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002007: specialty, work record, criminal record or similar person document, if not
p.002007: is a Bulgarian citizen, and an employment contract for the persons under Art. 148, item 2 and art. 149;
p.002007: 2. copies of contracts for the assignment of production and / or control of the products declared for production - in
p.002007: the cases under Art. 151;
p.002007: 3. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
p.002007: for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
p.002007: registered in a Member State of the European Union, or in a State Party to the
p.002007: European Economic Area - a document for current national registration
p.002007: legislation issued by a competent authority of the country concerned;
p.002007: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: a list of the manufacturing activities and the dosage forms to be manufactured;
p.002007: 5. schemes of the premises for production, control and storage and file of the production capacity;
p.002007: 6. assessment of the environmental impact of the manufacture of medicinal products in accordance with the provisions of Art
p.002007: Environmental Protection Act cases;
p.002007: 7. permission from the Nuclear Regulatory Agency when the application concerns the production of
p.002007: radiopharmaceuticals or medicinal products subject to ionizing radiation during manufacture
p.002007: them;
p.002007: 8. permission to use the premises for production, control and storage, issued in accordance with the procedure of
p.002007: The Spatial Planning Act, or any other substitute document;
p.002007: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 10. a document for payment of a fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) In the manufacture of narcotic substances and dosage forms containing such substances,
p.002007: also comply with the requirements of the Narcotic Drugs and Precursors Control Act.
p.002007: (4) (New - SG 103 2017, in force from 01.01.2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the persons under para. 2, item 1, when they are Bulgarian citizens.
p.002007: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
p.002007: carry out by contract in another object on the territory of the Republic of Bulgaria or outside it, the persons under art. 146 are
p.002007: shall indicate the location of this site and a copy of the contract in which they are determined
p.002007: the responsibilities of each Party in respect of compliance with the requirements of Good Manufacturing
p.002007: practice of medicinal products and the obligations of the qualified person under art. 148, Vol. 2.
p.002007: Art. 152. (amend. - SG 102/2012, in force from 02.01.2013) (1) The principles and requirements for Good
p.002007: manufacturing practice for all types of medicinal products, clinical medicinal products
p.002007: testing and of active substances shall be determined by an ordinance of the Minister of Health and by acts and
p.002007: guidelines adopted by the European Commission.
p.002007: (2) Principles and requirements for official risk assessment to establish Good Manufacturing
p.002007: practice for excipients shall be determined by the ordinance under para. 1 and with guidelines adopted by the European
p.002007: commission.
p.002007: Art. 153. (1) Upon receipt of an application under Art. 150 BDA evaluates the submitted documentation and performs
p.002007: on-site inspection of the production, control and storage sites, including in the cases under Art. 151,
p.002007: to establish the correspondence between the submitted documentation and the conditions of production, control
p.002007: and storage of manufacturing starting materials and finished medicinal products and conformity
p.002007: them with the requirements of Good Manufacturing Practice.
...
p.002007: (3) When the holder of the marketing authorization for a medicinal product meets the requirements of
p.002007: para. 2, it may fulfill the obligation of a qualified person.
p.002007: (4) (New, SG No. 102/2012, effective 21.12.2012) The qualified person shall be responsible for
p.002007: the packaging of the medicinal product the safety indicators according to art. 168, para. 8.
p.002007: (5) (Renumbered from Paragraph (4), SG No. 102/2012, effective 21.12.2012) The qualified person shall issue a certificate
p.002007: to release any batch certifying that the batch of medicinal product is manufactured and
p.002007: controlled in accordance with the requirements of the marketing authorization under this Act.
p.002007: (6) (Renumbered from Paragraph 5, SG No. 102/2012, effective 21.12.2012, amended - SG No. 84/2018 (*))
p.002007: The qualified person shall issue a certificate of release to each lot, certifying that the lot
p.002007: medicinal product intended for clinical trial is manufactured and controlled in accordance with
p.002007: the requirements of Good Manufacturing Practice, with the manufacturing file of the product and with the documentation
p.002007: for the investigational medicinal product under Regulation (EU) No 536/2014.
p.002007: (7) (Renumbered from Paragraph 6, SG No. 102/2012, effective 21.12.2012) The Qualified Person shall keep a register of
p.002007: certificates issued for the release of each batch of the medicinal product.
p.002007: (8) (Prev. Para 7, amend. - SG 102/02, in force from 21.12.2012) The data from the register under para. 7 se
p.002007: kept for at least 5 years after the last entry and shall be submitted to the inspection bodies at
p.002007: request.
p.002007: (9) (Renumbered from Paragraph 8, SG No. 102/2012, effective 21.12.2012)
p.002007: administrative criminal proceedings for violations committed in the performance of the duties of
p.002007: the qualified person, the BDA orders the holder of the manufacturing authorization to remove
p.002007: on a temporary basis by a qualified person.
p.002007: (10) (Renumbered from Paragraph 9, SG No. 102/2012, effective 21.12.2012) Criteria and requirements for
p.002007: the qualification and training of the persons under art. 148, item 2 shall be determined in the ordinance under Art. 152.
p.002007: Art. 160. (1) The holder of a manufacturing authorization shall:
p.002007: 1. (amended, SG No. 84/2018) (*) ensure the production operations in accordance with
p.002007: the requirements of the Good Manufacturing Practice and in accordance with the information approved by the BDA under Art.
p.002007: 27, para. 1, items 7 and 8, and in the case of medicinal products for clinical trial, in accordance with
p.002007: the documentation for the tested medicinal product in accordance with Regulation (EU) No 536/2014;
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) use only active substances which are manufactured
p.002007: in accordance with the requirements of Good Manufacturing Practice for Active Substances;
p.002007: 2a. (new - SG 102/2012, in force from 02.01.2013) make sure that the auxiliary substances used in
p.002007: the medicinal products are manufactured in accordance with the relevant good manufacturing practices for
p.002007: excipients determined on the basis of a formal risk assessment in accordance with the applicable ones
p.002007: guidelines adopted by the European Commission;
p.002007: 3. provide permanently qualified production and control personnel as required by
p.002007: the ordinance under Art. 152;
p.002007: 4. (amend. - SG 12/11, in force from 08.02.2011) has only medicinal products which have
...
p.002007: Bulgaria.
p.002007: (3) Where a batch of a medicinal product is imported from a third country with which the European Community is present
p.002007: signed agreement on mutual recognition of the certificate of good manufacturing practice,
p.002007: the qualified person issues a batch release certificate based on the accompanying person
p.002007: the batch of documentation without having to carry out control tests on the territory of the Republic
p.002007: Bulgaria.
p.002007: (4) (Repealed, SG No. 84/2018)
p.002007: (5) (Repealed, SG No. 84/2018)
p.002007: (6) (Am. - SG, iss. 71 in 2008, effective from 12.08.2008, repealed - SG, iss. 84 of 2018 (*))
p.002007: (7) The qualified person under para. 1 shall keep records of each batch of medicinal product imported
p.002007: for at least 5 years and submit it to the control authorities upon request.
p.002007: (8) The holder of an import authorization provides and maintains a system for blocking and withdrawing from the market
p.002007: medicinal products that have shown non-compliance with quality requirements.
p.002007: (9) The holder of the import authorization is obliged to block and withdraw the medicinal products which have shown
p.002007: non-compliance with the requirements for safety and efficacy according to the ordinance under Art. 274, para. 1.
p.002007: (10) (amend. - SG 12/11, in force from 08.02.2011) The provisions of Art. 160, para. 1, items 4 and 7 shall also apply
p.002007: as regards the holders of the import authorization.
p.002007: (11) The holder of the import authorization shall provide the qualified person with a post. 161, para. 2, Vol. 1
p.002007: the conditions necessary for the performance of his duties and shall notify the inspection bodies immediately
p.002007: its change.
p.002007: (12) When instituting administrative criminal proceedings for infringements committed under
p.002007: the fulfillment of the obligations of the qualified person, the BDA shall order the authorization holder
p.002007: to remove temporarily qualified person from office.
p.002007: Art. 163a. (New, SG No. 12/2011, effective 08.02.2011) (1) When the BDA establishes incompleteness and deficiencies
p.002007: in the documentation submitted, it shall notify the applicant in writing and give written instructions.
p.002007: (2) In the cases of para. 1 the term under Art. 164, para. 1 stops running until documentation in
p.002007: compliance with requirements.
p.002007: Art. 164. (1) The BDA Executive Director shall issue an import permit within 30 days from the date of submission
p.002007: of the application under Art. 162 or reasonably refused.
p.002007: (2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002007: (3) The import permit shall be issued only for the medicinal products specified in the application, their forms
p.002007: active substances for both the specified medicinal products for clinical trial and for
p.002007: the premises where the control and storage will be carried out.
p.002007: (4) The import authorization is open-ended.
p.002007: Art. 165. (1) The holder of an import permit from a third country shall submit to the BDA an application upon change of:
p.002007: 1. the person under art. 161, para. 2, Vol. 1;
p.002007: 2. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and the forms for which it was issued
p.002007: the import authorization;
p.002007: 3. the address of the laboratory under Art. 161, para. 2, Vol. 2;
p.002007: 4. the court registration of the trader.
p.002007: (2) To the application under para. 1, the documents related to the change set out in the ordinance post shall apply.
p.002007: 152.
p.002007: Art. Article 166. (1) The provisions of Art.
...
p.002007: Art. 197. The persons under art. 195 must have:
p.002007: 1. suitable premises, equipment and facilities and suitable means of transport providing
p.002007: the proper storage, distribution and transport of medicinal products in accordance with
p.002007: the requirements of Good Distribution Practice;
p.002007: 2. Qualified staff and responsible Master of Pharmacy with at least two years of work experience
p.002007: the specialty whose obligations are defined in the ordinance under Art. 198.
p.002007: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.002007: the distribution practices of medicinal products and active substances are adopted by an ordinance of the Minister
p.002007: health and with guidelines adopted by the European Commission.
p.002007: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002007: 1. an application containing the name, registered office and address of management of the trader; address and description
p.002007: premises and facilities for storage of medicinal products;
p.002007: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: country;
p.002007: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar
p.002007: document of the person, if not a Bulgarian citizen, diploma for higher education and document for work experience
p.002007: of the responsible master pharmacist under Art. 197, item 2 and a copy of his employment contract;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 6. a document certifying the legal basis for the use of the premises;
p.002007: 7. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 84 of 2018, effective from 12.10.2018)
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002007: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a Member State;
p.002007: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002007: 3. the address of the premises for the storage of medicinal products in the territory of the Member States.
p.002007: (3) In the wholesale trade in narcotic substances and in dosage forms containing such substances,
p.002007: the requirements of the Narcotic Drugs and Precursors Control Act also apply.
p.002007: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Nuclear Regulatory Agency.
p.002007: (5) (New, SG No. 103/2017, effective 01/01/2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the person under para. 1, item 3, when he is a Bulgarian citizen.
p.002007: Art. 200. The Executive Agency for Medicines shall evaluate the documentation and carry out an on-the-spot check
p.002007: the sites mentioned in the application to establish their compliance with the requirements for the Good
p.002007: distribution practice.
p.002007: Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing when it finds out
p.002007: incompleteness in the documentation submitted.
p.002007: (2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
p.002007: Art. 202. (1) (amend. - SG 84/08, in force from 12.10.2018) Within 60 days from the date of submission of
p.002007: the application under Art. 199, para. 1, the Executive Director of the BDA shall issue a permit for wholesale or
p.002007: makes a reasoned refusal.
p.002007: (2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002007: Art. 203. Within 15 days from the date of submission of the documentation 199, para. 2 the Executive Director
p.002007: of the BDA issues a certificate of registration for wholesale trade in the territory of the Republic of Bulgaria on
p.002007: the person under Art. 195, para. 1.
p.002007: Art. 204. (1) The permit for wholesale of medicinal products shall be indefinite.
p.002007: (2) The authorization under Art. 202 or the certificate under Art. 203 shall be terminated if the holder so requests
p.002007: in writing by the BDA Executive Director.
p.002007: (3) The person under art. 195 is obliged to notify the BDA in writing within 7 days after termination of its activity under
p.002007: wholesale of medicines. In such cases, the BDA Executive Director shall terminate
p.002007: licenses / certificates issued for wholesale of medicinal products.
...
p.002007: the location and the premises of the pharmacy shall be determined in the ordinance under Art. 219, para. 2.
p.002007: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in force since 05.08.2011)
p.002007: Requirements for the device and premises of pharmacies under Art. 228, para. 5 shall be determined in the ordinance under para.
p.002007: 1.
p.002007: Art. 228. (Amended, SG No. 71/2008, effective 26.07.2008) (1) (Amended, SG No. 60/2011)
p.002007: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002007: Director of the BDA on the basis of an application form to which shall be attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 222, para. 1;
p.002007: 2. employment contract or contract for management of the pharmacy, concluded with a master pharmacist or an assistant;
p.002007: pharmacist;
p.002007: 3. a copy of the act of creation of the persons of the post. 222, para. 4;
p.002007: 4. documents certifying that the requirements of Art. 224 Hours;
p.002007: 5. (suppl. - SG 103/07, in force from 01.01.2018) certificate of criminal record of the master pharmacist,
p.002007: respectively to the assistant pharmacist appointed as the head of the pharmacy, if they are not Bulgarian citizens;
p.002007: 6. the medical certificate of the master pharmacist, respectively of the assistant pharmacist appointed for
p.002007: pharmacy manager;
p.002007: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002007: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued by the respective Health Insurance Fund;
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002007: medicinal products are checked to see if the diploma of the master-
p.002007: the pharmacist / pharmacist assistant is issued by the relevant competent institution.
p.002007: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies no. 222, para. 4 and 6 are
p.002007: open and close at the request of the person representing the medical establishment.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 60/2011, effective 05.08.2011) Opening of a pharmacy in which they are available
p.002007: medicinal products containing narcotic substances are also subject to the requirements of the Control Act
p.002007: on drugs and precursors.
p.002007: (5) (New - SG, iss. 102 in 2009, in force since 22.12.2009, previous para 4 - SG, iss. 60 in 2011, in force since
p.002007: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy which is opened in
p.002007: a settlement with a population of less than 10,000 inhabitants shall be issued on the basis of an application in accordance with a specimen to which
p.002007: apply:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 84 of 2018, effective from 12.10.2018)
...
p.002007: (6) (Renumbered from Paragraph (4), Suppl. - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 98 in 2010, in force since
p.002007: 01.01.2011, previous para. 5, amend. - SG, issue. 60 of 2011, effective 05.08.2011) The application and the documents under
p.002007: para. 1 and 5 shall be submitted to the BDA.
p.002007: (7) (Renumbered from Paragraph (5), amend. - SG 102/09, in force from 22.12.2009, amended - SG, issue 98 from 2010, in force from
p.002007: 01.01.2011, previous para. 6, amend. - SG, issue. 60 of 2011, effective 05.08.2011) Regional Health
p.002007: inspections shall issue a hygienic conclusion within 14 days of the date of application.
p.002007: (8) (New, SG No. 48/2015; Supplemented, SG No. 91/2018) On the day the application under para. 1 and 5
p.002007: The BDA sends an official request to the Governing Board of the Bulgarian Pharmaceutical Union for issuance
p.002007: of a certificate for entry in the national electronic register of the members of the Bulgarian
p.002007: pharmaceutical union - for the master pharmacist, pharmacy manager, and to the board of directors of
p.002007: Bulgarian Association of Assistant Pharmacists - Assistant Pharmacist, Pharmacy Manager at
p.002007: cases stipulated by law, as well as providing information on penalties imposed in the order
p.002007: of the Professional Organization of Master Pharmacists and the Health Act.
p.002007: (9) (New, SG No. 48/2015) The Managing Board shall submit the documents under para. 8 within 5 working days of
p.002007: receipt of the request.
p.002007: (10) (New - SG 103 2017, in force from 01.01.2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the persons under para. 1, item 5, when they are Bulgarian citizens.
p.002007: Art. 229. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, repealed - SG No. 60/2011, effective 05.08.2011
p.002007: d)
p.002007: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 102/2009, effective 22.12.2009, amended -
p.002007: SG, issue 60 of 2011, in force since 05.08.2011, suppl. - SG, issue. 18 of 2014) Within one month of receipt of the
p.002007: the documentation under Art. 228, para. 6, the Executive Director of the BDA, following the opinion of the Expert Council on
p.002007: retail trade of medicinal products, issues a permit for retail trade with
p.002007: medicinal products at a pharmacy or make a reasoned refusal to grant an authorization. The permission or
p.002007: the refusal shall be served on the applicant.
p.002007: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation on
p.002007: Art. 228, para. 6 The BDA verifies the documents submitted and notifies the applicant in writing
p.002007: identified inconsistencies or incompleteness. In these cases, the term under para. 2 stops running from the day of
p.002007: notification until the deficiencies are rectified.
p.002007: (4) (New - SG 71/08, in force from 12.08.2008) In case within 60 days from the date of
p.002007: the notification under para. 3 the applicant has not remedied any inconsistencies or incompleteness found,
p.002007: the procedure for granting a marketing authorization for a medicinal product or for modifying it
p.002007: the authorization granted shall be terminated.
p.002007: (5) (Renumbered from Paragraph 4, SG No. 71/2008, effective 12.08.2008, amended - SG No. 60/2011)
p.002007: 08/08/2011) The refusal of the BDA Executive Director to issue a permit is subject to appeal
...
p.002007: products, opening a drugstore, have all natural and legal persons registered under the Commercial
p.002007: law or under the law of a Member State.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore shall be medical
p.002007: specialist who:
p.002007: 1. is not deprived of the right to practice his profession;
p.002007: 2. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crimes against the individual;
p.002007: 3. have at least one year of experience in the specialty.
p.002007: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened upon registration in
p.002007: the relevant REI.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) 238, para. 2 shall be submitted to the relevant RHI
p.002007: application for registration, to which the following documents are attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 238, para. 1;
p.002007: 2. (suppl. - SG 103/07, in force from 01.01.2018) document for education and criminal record of
p.002007: the person designated as the head of the drugstore, if not a Bulgarian citizen;
p.002007: 3. the medical certificate of the person under item 2;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 6. document for paid state fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para.
p.002007: 2 The Regional Inspectorate shall carry out an inspection on compliance with the requirements of the ordinance under Art. 243. Where
p.002007: establish that the requirements of the ordinance under Art. 243, within 7 days from the completion of the inspection
p.002007: The RII prescribes and sets a time limit for their removal.
p.002007: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application and
p.002007: the documents under para. 2, the Director of the RII shall notify the person in writing of the incompleteness found therein and
p.002007: sets a time limit for their removal.
p.002007: (5) (New, SG No. 60/2011, effective 05.08.2011) For filing an application for registration of a drugstore
p.002007: or to effect a change under Art. 242 the respective SIC collects fees in the amount determined by the tariff under
p.002007: Art. 21, para. 2.
p.002007: (6) (New - SG 103 2017, in force from 01.01.2018) The Bulgarian Food Safety Agency
p.002007: establish ex officio the circumstances regarding the criminal record of the person under para. 2, item 2, when it is Bulgarian
p.002007: citizen.
p.002007: Art. 240. (amend. - SG 60/11, in force from 05.08.2011) (1) Within 14 days from carrying out the inspection
p.002007: under Art. 239, para. 3 or by eliminating incomplete mail. 239, para. 4, the Director of the SIC issues
p.002007: a drugstore registration certificate or a reasoned refusal to issue a drugstore.
p.002007: (2) (New, SG No. 102/2012, effective 21.12.2012) The Director of the RZI shall reasonably refuse to issue
p.002007: certificate of registration of the person under art. 238, para. 2 when:
p.002007: 1. none of the documents under Art. 239, para. 2;
p.002007: 2. within the term of art. 239, para. 4 the applicant did not remove the incompleteness found.
p.002007: (3) (New, SG No. 102/2012, effective 21.12.2012) When, within the term of para. 1 the director of the RZI has not issued
p.002007: drugstore registration certificate or did not make a reasoned refusal, it is considered to be available
p.002007: silent agreement.
p.002007: (4) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 3 the applicant can start
p.002007: performing the requested activities in compliance with Art. 29 of the Administrative Restriction Act
p.002007: regulation and administrative control over the economic activity.
p.002007: (5) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21 December 2012) 1
p.002007: it is subject to appeal under the Administrative Procedure Code.
p.002007: Art. 240a. (New, SG No. 102/2012, effective 21.12.2012) (1) The Director of the respective SIC shall terminate
p.002007: with order registration of drugstore:
p.002007: 1. at the request of the person who has received a certificate for registration of a drugstore;
p.002007: 2. by termination of the activity of the person under art. 238, para. 2, of which it notifies the relevant RIC.
...
p.002007: the activity of the holder of a marketing authorization for a medicinal product
p.002007: The Executive Director of the BDA issues an order revoking the authorization.
p.002007: (6) (Renumbered from Paragraph (5), amend. - SG 84/08, in force from 12.10.2018). 1 - 5 are subject to
p.002007: appeal in accordance with the Administrative Procedure Code, and the appeal does not suspend their enforcement.
p.002007: Art. 294. Who violates the provisions of this law or the regulations on its implementation, except in cases of post.
p.002007: 281 - 293, shall be punished by a fine of from 1000 to 3000 levs, and in the case of repeated commission of the same violation - by a fine of
p.002007: 3000 to 5000 BGN
p.002007: Art. 295. (1) (amend. - SG 98/10, in force from 01.01.2011, amended - SG, issue 102 of 2018)
p.002007: 01.01.2019) The violations under this law shall be established by acts drawn up by officials under Art. 267,
p.002007: para. 3.
p.002007: (2) (Supplemented, SG No. 84/2018, effective 12.10.2018, repealed - SG No. 102/2018)
p.002007: (3) (amend. - SG 98/10, in force from 01.01.2011, amended - SG, issue 102 of 2018, effective from 01.01.2019)
p.002007: The penal decrees are issued by the Minister of Health, by the Chief State Health
p.002007: inspector, by the chairman of the council under Art. 258, para. 1, by the BDA Executive Director and the Directors
p.002007: of the RHI, depending on the submission of the offending official.
p.002007: (4) (new - SG 102/08, in force from 01.01.2019) The penal decrees may also be issued by
p.002007: other officials authorized by the persons under para. 3, as the chairman of the council under Art. 258, para. 1
p.002007: may authorize another committee member.
p.002007: Art. 296. Drafting acts, issuing, appealing and executing criminal decrees
p.002007: are carried out in accordance with the Law on Administrative Offenses and Penalties.
p.002007: Art. 297. (Amended, SG No. 84/2018, effective 12.10.2018) (1) In the cases of Art. 281, 282, 283, 284, 285 and 287
p.002007: the penal authority also orders the withdrawal in favor of the State of the medicinal products subject to the
p.002007: the committed offense, under the conditions and in the order specified in the Administrative Offenses Act and
p.002007: penalties and in accordance with Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 February
p.002007: October 2013 establishing the Union Customs Code (OJ, L 269/1 of 10 October 2013) and
p.002007: Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed implementing rules
p.002007: rules for the implementation of certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the
p.002007: Of the Council establishing the Union Customs Code (OJ, L 343/558 of 29 December 2015).
p.002007: (2) The medicinal products under para. 1 shall be destroyed under the conditions and in the order of the ordinance post. 274, para. 2.
p.002007: Additional provisions
p.002007: § 1. For the purposes of this Act:
p.002007: 1. (amend. - SG 102/02, in force from 02.01.2013) А
p.002007: "substance" means any substance or mixture of
p.002007: substances intended for use in the manufacture of a medicinal product which when used
p.002007: in its manufacture, they become the active ingredient of this product, intended for the exercise of
...
p.002011: ...................................
p.002011: § 84. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of § 65, which
p.002011: shall enter into force on 30 September 2011.
p.002011: Transitional and Final Provisions
p.002011: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002011: DRUGS AND PRECURSORS
p.002011: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002011: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002011: Transitional and Final Provisions
p.002011: TO THE LAW AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.002011: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002011: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in the State Gazette:
p.002011: 1. The Council of Ministers shall bring the Classifier of posts in administration in line with that
p.002011: law;
p.002011: 2. the competent authorities shall bring the statutory acts of the respective administration in accordance with
p.002011: this law.
p.002011: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002011: the Independent Financial Audit Act, the Electronic Communications Act, the Financial Supervision Commission Act,
p.002011: Law on Access and Disclosure of Documents and Declaration of Affiliation of Bulgarian Citizens to
p.002011: State Security and Intelligence Services of the Bulgarian People's Army, Forfeiture Act
p.002011: of the State of property acquired through criminal activity, the Prevention and Establishment Act
p.002011: conflict of interest, Social Security Code, Health Insurance Act,
p.002011: support to farmers and the Roads Act are governed by the terms and procedures of §
p.002011: 36 of the transitional and final provisions of the Act amending the State Act
p.002011: employee (SG, issue 24 of 2006).
p.002011: (2) The act of appointment of the civil servant shall:
p.002011: 1. assigns a minimum rank for the position assigned to the posts in the administration in the administration
p.002011: post, unless the employee holds a higher rank;
p.002011: 2. determines the individual basic monthly salary.
p.002011: (3) The additional necessary funds for social security contributions of the persons under para. 2 shall be provided within
p.002011: the cost of wages, salaries and social security contributions to the budgets of the authorizing officers concerned
p.002011: with appropriations.
p.002011: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account of the State Fund
p.002011: "Agriculture" arising from this law.
p.002011: (5) The governing bodies of the National Social Security Institute and the National Health Insurance Fund
p.002011: to make necessary changes to the respective budgets arising from this law.
p.002011: (6) Unused employment leave shall be maintained and shall not be offset by cash benefits.
p.002011: benefits.
p.002011: § 86. (1) Within one month from the entry into force of this Act, the individual basic monthly salary of
p.002011: the employee shall be determined in such a way that the same is reduced by the tax due and the mandatory social security contributions
p.002011: at the expense of the insured person, if they were due, should not be lower than the gross received so far
p.002011: monthly salary, reduced by the obligatory mandatory social security contributions at the expense of the insured person,
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.002007: or "biology" and at least two years of practical experience in pharmaceutical manufacturing;
p.002007: 2. which meet the requirements of item 1 and have an additional recognized specialty in radiobiology or
p.002007: radiochemistry - for radiopharmaceuticals or for medicinal products subject to ionizing radiation;
p.002007: 3. with recognized specialty in clinical hematology, medical microbiology, virology or immunology
p.002007: - for the production of immunological medicinal products - vaccines, toxins, serums, for biotechnological products
p.002007: products and for medicinal products derived from human plasma or from human blood.
p.002007: Art. 150. (1) The person under art. 146 shall submit to the BDA an application in accordance with a model approved by the Director of the Agency.
p.002007: (2) Together with the application under para. 1 the applicant shall also submit:
p.002007: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002007: specialty, work record, criminal record or similar person document, if not
p.002007: is a Bulgarian citizen, and an employment contract for the persons under Art. 148, item 2 and art. 149;
p.002007: 2. copies of contracts for the assignment of production and / or control of the products declared for production - in
p.002007: the cases under Art. 151;
p.002007: 3. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
p.002007: for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
p.002007: registered in a Member State of the European Union, or in a State Party to the
p.002007: European Economic Area - a document for current national registration
p.002007: legislation issued by a competent authority of the country concerned;
p.002007: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: a list of the manufacturing activities and the dosage forms to be manufactured;
p.002007: 5. schemes of the premises for production, control and storage and file of the production capacity;
p.002007: 6. assessment of the environmental impact of the manufacture of medicinal products in accordance with the provisions of Art
p.002007: Environmental Protection Act cases;
p.002007: 7. permission from the Nuclear Regulatory Agency when the application concerns the production of
p.002007: radiopharmaceuticals or medicinal products subject to ionizing radiation during manufacture
p.002007: them;
p.002007: 8. permission to use the premises for production, control and storage, issued in accordance with the procedure of
p.002007: The Spatial Planning Act, or any other substitute document;
p.002007: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 10. a document for payment of a fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) In the manufacture of narcotic substances and dosage forms containing such substances,
p.002007: also comply with the requirements of the Narcotic Drugs and Precursors Control Act.
p.002007: (4) (New - SG 103 2017, in force from 01.01.2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the persons under para. 2, item 1, when they are Bulgarian citizens.
p.002007: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
p.002007: carry out by contract in another object on the territory of the Republic of Bulgaria or outside it, the persons under art. 146 are
p.002007: shall indicate the location of this site and a copy of the contract in which they are determined
p.002007: the responsibilities of each Party in respect of compliance with the requirements of Good Manufacturing
p.002007: practice of medicinal products and the obligations of the qualified person under art. 148, Vol. 2.
p.002007: Art. 152. (amend. - SG 102/2012, in force from 02.01.2013) (1) The principles and requirements for Good
p.002007: manufacturing practice for all types of medicinal products, clinical medicinal products
p.002007: testing and of active substances shall be determined by an ordinance of the Minister of Health and by acts and
p.002007: guidelines adopted by the European Commission.
p.002007: (2) Principles and requirements for official risk assessment to establish Good Manufacturing
p.002007: practice for excipients shall be determined by the ordinance under para. 1 and with guidelines adopted by the European
p.002007: commission.
p.002007: Art. 153. (1) Upon receipt of an application under Art. 150 BDA evaluates the submitted documentation and performs
p.002007: on-site inspection of the production, control and storage sites, including in the cases under Art. 151,
p.002007: to establish the correspondence between the submitted documentation and the conditions of production, control
p.002007: and storage of manufacturing starting materials and finished medicinal products and conformity
p.002007: them with the requirements of Good Manufacturing Practice.
p.002007: (2) The costs of carrying out on-site inspections under para. 1 shall be at the expense of the applicant.
p.002007: (3) For carrying out on-site inspections under para. 1, the applicant shall pay a fee in the amount specified in the tariff
p.002007: under Art. 21, para. 2.
p.002007: Art. 154. (1) When the BDA establishes incompleteness in the submitted documentation and / or inconsistency between
p.002007: the content of the documentation submitted and the status of the site or the qualification requirements
...
p.002007: 6. notify immediately the control bodies in case of change of qualified person post. 148, Vol. 2;
p.002007: 7. provide access to the premises and documentation at all times to the control bodies;
p.002007: 8. provide to the qualified person under Art. 148, item 2 the necessary conditions for fulfilling the obligations
p.002007: his;
p.002007: 9. (New - SG, iss. 102 in 2012) shall inform immediately the BDA and the holder of
p.002007: the marketing authorization if it receives information that the medicinal products covered by the
p.002007: its manufacturing authorization, are falsified or there are suspected falsifications,
p.002007: whether or not these medicinal products were distributed within the legal chain
p.002007: delivery or in an illegal manner, including through illegal sale through the services of
p.002007: the information society;
p.002007: 10. (new - SG 102/2012, in force from 02.01.2013) check whether the manufacturers, importers or
p.002007: traders from whom it receives active substances are registered by the competent authority of the Member State,
p.002007: in which they are established;
p.002007: 11. (new - SG 102/2012, in force from 02.01.2013) shall check the authenticity and quality of the active and
p.002007: of excipients.
p.002007: (2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
p.002007: performs audits at the sites for the production and marketing of active substances in order to comply with the Good
p.002007: manufacturing practice and Good distribution practice. The holder of the manufacturing authorization
p.002007: may contract with a third party to perform the audit on his behalf and on his behalf.
p.002007: (3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
p.002007: documents the undertakings under para. 1, items 2 and 2a measures.
p.002007: (4) (Renumbered from Paragraph (2) - SG, No. 102 of 2012, in force since 02.01.2013, amend. - SG, iss. 84 in 2018. (*))
p.002007: of a manufacturing authorization shall keep the samples and the documentation of the medicinal products manufactured by him
p.002007: products and active substances under the conditions and in the order specified in the ordinance under Art. 152, para. 1.
p.002007: (5) (Renumbered from Paragraph (3), SG No. 102/2012, effective as of 02/01/2013, repealed - SG, iss. 84 in 2018 (*))
p.002007: (6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013) The documentation for each concluded transaction
p.002007: is stored for 5 years and contains the date, the name of the medicinal product, the quantity delivered, the name and
p.002007: recipient address and batch number.
p.002007: (7) (Renumbered from Paragraph 5, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
p.002007: production provides and maintains a system for blocking and withdrawal of medicinal products from the market,
p.002007: showed non-compliance with quality requirements.
p.002007: (8) (Renumbered from Paragraph 6, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
p.002007: the production is obliged to block and withdraw the medicinal products which have shown non-compliance with
p.002007: the requirements for quality, efficiency and safety, in accordance with the ordinance under Art. 274, para. 1.
p.002007: (9) (Renumbered from Paragraph 7, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
p.002007: production is obliged to update production methods in accordance with the development of new ones
...
p.002007: Section II.
p.002007: Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
p.002007: Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria
p.002007: from a third country of all types of medicinal products and medicinal products intended for
p.002007: clinical trial may only be performed by natural or legal persons registered as traders
p.002007: under the law of a Member State which has been granted an import authorization by the executive
p.002007: director of the BDA.
p.002007: (2) In order to obtain an import permit, the person under para. 1 must have:
p.002007: 1. (amend. - SG 102/2012, in force from 02.01.2013) at any time with at least one qualified person,
p.002007: which meets the requirements of Art. 159, para. 2 and 10;
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) with a laboratory for quality control in compliance
p.002007: with the requirements of the ordinance under Art. 152 and storage facilities for medicinal products, and
p.002007: clinical trial medicinal products with the necessary technical equipment, c
p.002007: compliance with the requirements of the ordinance under Art. 198.
p.002007: Art. 162. (1) For obtaining a permit for import the person shall mail. 161, para. 1 submits an application to the BDA on
p.002007: model approved by the Executive Director of the Agency.
p.002007: (2) To the application under para. 1 shall apply:
p.002007: 1. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
p.002007: for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
p.002007: registered in a Member State of the European Union, or in a State Party to the
p.002007: European Economic Area - a document for current national registration
p.002007: legislation issued by a competent authority of the country concerned;
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) list of the medicinal products and the forms which will
p.002007: are imported;
p.002007: 3. (suppl. - SG 71/08, in force from 12.08.2008) a copy of the production permit issued by
p.002007: the regulatory authority of the exporting country and a certificate attesting the eligibility of the exporting country
p.002007: production, control and storage with standards at least equivalent to Good standards
p.002007: manufacturing practice;
p.002007: 4. documents certifying the circumstances under Art. 159, para. 1 and 2 for the qualified person;
p.002007: 5. data on the address of a laboratory on the territory of the Republic of Bulgaria for completion of a complete
p.002007: quantitative and qualitative analysis of at least the active substances and of all other tests and tests for
p.002007: demonstration of the quality of each imported batch of medicinal product in accordance with the requirements of
p.002007: the marketing authorization under this law and the address of the storage premises;
p.002007: 6. a contract which defines the responsibilities of each party in respect of compliance with
p.002007: the principles of Good Manufacturing Practice by the contractor and the way in which the qualified person
p.002007: under Art. 161, para. 2, item 1 shall perform its duties when the person sends. 161, para. 1 does not have
p.002007: with its own laboratory;
p.002007: 7. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (3) (New, SG No. 71/2008, effective 12.08.2008) Upon receipt of an application under para. 1 BDA evaluates
p.002007: the documentation submitted and perform an on-site inspection of the control laboratory and premises
p.002007: storage of medicinal products and medicinal products intended for clinical trial for
p.002007: establishing their compliance with the requirements of Good Manufacturing Practice and Good
p.002007: distribution practice.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 71/2008, effective 12.08.2008) Where the premises for production are
p.002007: located in a third country with which the European Community has a mutual agreement signed
p.002007: recognition of certificates of good manufacturing practice, the persons under art. 161, para. 1 apply to
p.002007: the application address of any premises for the production of medicinal products, active substances or
p.002007: medicinal products intended for clinical trial, name, headquarters and management address
p.002007: of the person who has obtained the manufacturing authorization, a certificate certifying compliance with the conditions
p.002007: for production, control and storage with standards equivalent to those approved by
p.002007: the requirements of Good Manufacturing Practice, and the name of the qualified person.
p.002007: (5) (Renumbered from Paragraph (4), amend. - SG 71/08, in force from 12.08.2008) In cases other than para. 4, BDA
...
p.002007: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may trade on
p.002007: wholesale only of medicinal products for which a manufacturing authorization has been granted.
p.002007: (2) An importer of medicinal products within the meaning of this Law may only wholesale trade with
p.002007: medicinal products for which import authorization has been granted.
p.002007: Art. 197. The persons under art. 195 must have:
p.002007: 1. suitable premises, equipment and facilities and suitable means of transport providing
p.002007: the proper storage, distribution and transport of medicinal products in accordance with
p.002007: the requirements of Good Distribution Practice;
p.002007: 2. Qualified staff and responsible Master of Pharmacy with at least two years of work experience
p.002007: the specialty whose obligations are defined in the ordinance under Art. 198.
p.002007: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.002007: the distribution practices of medicinal products and active substances are adopted by an ordinance of the Minister
p.002007: health and with guidelines adopted by the European Commission.
p.002007: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002007: 1. an application containing the name, registered office and address of management of the trader; address and description
p.002007: premises and facilities for storage of medicinal products;
p.002007: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: country;
p.002007: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar
p.002007: document of the person, if not a Bulgarian citizen, diploma for higher education and document for work experience
p.002007: of the responsible master pharmacist under Art. 197, item 2 and a copy of his employment contract;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 6. a document certifying the legal basis for the use of the premises;
p.002007: 7. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 84 of 2018, effective from 12.10.2018)
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002007: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a Member State;
p.002007: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002007: 3. the address of the premises for the storage of medicinal products in the territory of the Member States.
p.002007: (3) In the wholesale trade in narcotic substances and in dosage forms containing such substances,
p.002007: the requirements of the Narcotic Drugs and Precursors Control Act also apply.
...
p.002007: special-purpose foods and infant formulas and follow-on formulas,
p.002007: cosmetic and sanitary products.
p.002007: Art. 226. (1) Pharmacies may be opened on the territory of outpatient medical establishments
p.002007: sale of medicinal products to citizens.
p.002007: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, medical establishments for
p.002007: hospital care and medical establishments under art. 10 of the Medical Establishments Act cannot be found
p.002007: pharmacies to sell medicinal products to citizens.
p.002007: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009) The requirements for
p.002007: the location and the premises of the pharmacy shall be determined in the ordinance under Art. 219, para. 2.
p.002007: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in force since 05.08.2011)
p.002007: Requirements for the device and premises of pharmacies under Art. 228, para. 5 shall be determined in the ordinance under para.
p.002007: 1.
p.002007: Art. 228. (Amended, SG No. 71/2008, effective 26.07.2008) (1) (Amended, SG No. 60/2011)
p.002007: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002007: Director of the BDA on the basis of an application form to which shall be attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 222, para. 1;
p.002007: 2. employment contract or contract for management of the pharmacy, concluded with a master pharmacist or an assistant;
p.002007: pharmacist;
p.002007: 3. a copy of the act of creation of the persons of the post. 222, para. 4;
p.002007: 4. documents certifying that the requirements of Art. 224 Hours;
p.002007: 5. (suppl. - SG 103/07, in force from 01.01.2018) certificate of criminal record of the master pharmacist,
p.002007: respectively to the assistant pharmacist appointed as the head of the pharmacy, if they are not Bulgarian citizens;
p.002007: 6. the medical certificate of the master pharmacist, respectively of the assistant pharmacist appointed for
p.002007: pharmacy manager;
p.002007: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002007: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued by the respective Health Insurance Fund;
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002007: medicinal products are checked to see if the diploma of the master-
p.002007: the pharmacist / pharmacist assistant is issued by the relevant competent institution.
p.002007: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies no. 222, para. 4 and 6 are
p.002007: open and close at the request of the person representing the medical establishment.
...
p.002007: products.
p.002007: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002007: prescription, can be sold in a drugstore. Drugstores can also sell products and goods
p.002007: relevant to human health as defined in the ordinance under Art. 243, and medical devices.
p.002007: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to carry out retail trade in medicinal products
p.002007: products, opening a drugstore, have all natural and legal persons registered under the Commercial
p.002007: law or under the law of a Member State.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore shall be medical
p.002007: specialist who:
p.002007: 1. is not deprived of the right to practice his profession;
p.002007: 2. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crimes against the individual;
p.002007: 3. have at least one year of experience in the specialty.
p.002007: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened upon registration in
p.002007: the relevant REI.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) 238, para. 2 shall be submitted to the relevant RHI
p.002007: application for registration, to which the following documents are attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 238, para. 1;
p.002007: 2. (suppl. - SG 103/07, in force from 01.01.2018) document for education and criminal record of
p.002007: the person designated as the head of the drugstore, if not a Bulgarian citizen;
p.002007: 3. the medical certificate of the person under item 2;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 6. document for paid state fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para.
p.002007: 2 The Regional Inspectorate shall carry out an inspection on compliance with the requirements of the ordinance under Art. 243. Where
p.002007: establish that the requirements of the ordinance under Art. 243, within 7 days from the completion of the inspection
p.002007: The RII prescribes and sets a time limit for their removal.
p.002007: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application and
p.002007: the documents under para. 2, the Director of the RII shall notify the person in writing of the incompleteness found therein and
p.002007: sets a time limit for their removal.
p.002007: (5) (New, SG No. 60/2011, effective 05.08.2011) For filing an application for registration of a drugstore
p.002007: or to effect a change under Art. 242 the respective SIC collects fees in the amount determined by the tariff under
...
p.002007: 12/10/2018) Donations of medicinal products from marketing authorization holders, manufacturers,
p.002007: wholesalers and retailers and the Bulgarian Red Cross can only be made after filing
p.002007: notification from the donor to the BDA following a model approved by the Minister of Health on proposal
p.002007: of the BDA Executive Director.
p.002007: (2) Donations shall be made in accordance with the World Health Donation Good Practice Rules
p.002007: organization.
p.002007: (3) (Repealed, SG No. 84/2018, effective 12.10.2018)
p.002007: (4) The medical establishments and the Bulgarian Red Cross shall notify the BDA of the received donations of medicinal products.
p.002007: products within 7 days of receipt.
p.002007: (5) At the end of each quarter, the BDA sends information to the Ministry of Health about
p.002007: the donations made under para. 4.
p.002007: (6) To make a donation of a medicinal product at the request of a medical establishment intended for
p.002007: treatment of a particular patient in a life-threatening condition, the donor notifies the BDA within 7 days
p.002007: since its implementation.
p.002007: (7) The donations under para. 6 may not exceed the amount required for a single course of treatment.
p.002007: Art. 269. (1) The control under art. 267 is performed through inspections and laboratory tests.
p.002007: (2) The inspections and laboratory tests under para. 1 shall be carried out:
p.002007: 1. in connection with the issuance of authorizations for use, production, import and certificates under the procedure of this law;
p.002007: 2. in connection with the supervision of the market of medicinal products;
p.002007: 3. upon request by the European Commission, the European Medicines Agency or by a party
p.002007: to the competent authority of another Member State;
p.002007: 4. upon application by a manufacturer, importer or holder of a marketing authorization outside
p.002007: the cases under item 1.
p.002007: (3) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall carry out
p.002007: Inspections:
p.002007: 1. to manufacturers of medicinal products located on the territory of the Republic of Bulgaria;
p.002007: Member State or in third countries;
p.002007: 2. to importers and wholesalers of medicinal products;
p.002007: 3. on the premises of manufacturers, importers and wholesalers of active substances located
p.002007: on the territory of the Republic of Bulgaria;
p.002007: 4. at the premises of manufacturers or wholesalers of active substances located in third places
p.002007: countries as well as manufacturers or importers of excipients;
p.002007: 5. at the premises of the marketing authorization holders and the intermediaries
p.002007: in the field of medicinal products, registered in accordance with Art. 212a;
p.002007: 6. as part of a certification procedure relating to monographs of the European Pharmacopoeia;
p.002007: 7. to manufacturers of starting materials at the written request of the manufacturer.
p.002007: (4) The Medicines Executive Agency shall carry out inspections of manufacturers of medicinal products,
p.002007: established in a third country in connection with an application for a marketing authorization or
p.002007: import.
p.002007: (5) (Amended, SG No. 102/2012, effective 21.12.2012) The inspections under para. 3 and 4 are performed in accordance
p.002007: with guidelines adopted by the European Commission.
p.002007: (6) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall participate in
...
p.002007: of the BDA.
p.002007: (3) The orders under para. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 272a. (New, SG No. 102/2012, effective 02.01.2013) (1) By delegated acts, no. 52b, paragraph 2
p.002007: Directive 2001/83 / EC lays down the necessary measures to prevent the placing on the market of
p.002007: medicinal products introduced into the European Union but not intended for the marketing of
p.002007: The European Union, for which there are sufficient grounds for suspecting that they have been falsified.
p.002007: (2) The Medicines Executive Agency shall take the necessary measures in accordance with the delegated ones
p.002007: acts under para. 1 to prevent the release of medicinal products introduced into the European Union
p.002007: Union, but not intended to be placed on the European Union market for which there are sufficient grounds for
p.002007: suspected of being counterfeit.
p.002007: (3) The customs authorities shall notify the BDA of the introduction on the territory of the Republic of Bulgaria of
p.002007: medicinal products under para. 1 with a view to taking measures under para. 2.
p.002007: Art. 273. (1) The conditions and the order for taking the samples, performing the tests and paying for them shall be
p.002007: determined in an ordinance of the Minister of Health.
p.002007: (2) When challenging the results of laboratory tests, repeated tests shall be made. They
p.002007: shall be made upon written request from the interested party made within 7 days from the date of
p.002007: obtaining the result of the original test.
p.002007: (3) The repeated tests under para. 2 shall be carried out by experts designated by the BDA Executive Director,
p.002007: who did not participate in the original test in the presence of an authorized representative of
p.002007: the interested party.
p.002007: Art. 274. (1) The conditions and the order for blocking and withdrawal of medicinal products which have shown non-compliance with
p.002007: the requirements for quality, safety and efficiency shall be laid down in an ordinance of the Minister of Agriculture and Forestry
p.002007: healthcare.
p.002007: (2) The conditions and procedure for the destruction, processing or use for other purposes of medicinal products
p.002007: products are defined in an ordinance of the Minister of Health.
p.002007: Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure
p.002007: proper validation of the processes of production and purification of medicinal products obtained from
p.002007: human blood or human plasma, consistency in batch quality and guarantee as far as possible
p.002007: the technology allows for the absence of specific viral contamination.
p.002007: (2) Manufacturers shall notify the BDA of the method used to reduce or eliminate pathogens
p.002007: viruses that can be transmitted through medicinal products derived from human blood or human
p.002007: plasma.
p.002007: (3) The Executive Agency for Medicines shall test or send for testing to another official agency
p.002007: laboratory for the control of medicinal products in the Republic of Bulgaria or in another Member State samples from
p.002007: bulk / non - spilled product and / or medicinal product for testing or in the course of evaluating an application for
p.002007: authorization for use under Art. 46, para. 1, item 2 or after issuing a marketing authorization.
p.002007: Art. 276. The Executive Director of the BDA shall, by order, suspend, revoke, suspend or amend
p.002007: the authorization to use the medicinal product / registration when it is established that:
p.002007: 1. there is an unacceptable side effect when used properly, or
...
p.002007: same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or
p.002007: active substance derivatives are considered to be the same active substance unless they differ significantly
p.002007: for its safety and / or efficacy.
p.002007: 10. (Amended, SG No. 84/2018) (*) "Principal Investigator" is a Principal Investigator within the meaning of Art. 2,
p.002007: paragraph 2, point 16 of Regulation (EU) No 536/2014.
p.002007: 11. "Defined daily dose" is an average daily maintenance dose of a medicinal product that is
p.002007: administered to adults according to the primary indication of the medicinal product.
p.002007: 12. (Amended, SG No. 84/2018) (*) "Good clinical practice" is a good clinical practice within the meaning of Art. 2,
p.002007: paragraph 2, point 30 of Regulation (EU) No 536/2014.
p.002007: 13. "Good laboratory practice" is a system of internationally recognized rules regarding conditions
p.002007: for the planning, processes of organizing, executing, tracking and documenting the laboratory
p.002007: tests.
p.002007: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers
p.002007: all sides of production - personnel, premises, facilities, materials, documentation, quality
p.002007: control, and aims to ensure safety, efficiency and compliance with the specification.
p.002007: 15. (Supplemented, SG No. 71/2008, effective 12.08.2008) State
p.002007: "Member" means a Member State of the European Union
p.002007: union or country party to the Agreement on the European Economic Area.
p.002007: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002007: 17. "Immunological medicinal product" means a medicinal product containing vaccines, toxins, sera or
p.002007: allergens. The scope of vaccines, toxins and serums includes agents used to create
p.002007: active immunity, or to establish a state of immunity, or to induce passive immunity. Allergens
p.002007: are medicinal products that are intended to identify or stimulate a specific
p.002007: targeted change in the immunological response to the allergic agent.
p.002007: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002007: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically equivalent
p.002007: alternative, and when their bioavailability after administration at the same molar dose is similar to the extent that
p.002007: is a requirement for equivalent efficacy and safety.
p.002007: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and
p.002007: the extent to which the active substance or the therapeutically significant portion of the investigational medicinal product is tested
p.002007: reach from the dosage form into the systemic circulation.
p.002007: 20. (amend. - SG 84/2018) (*) "Tested medicinal product" is a tested medicinal product within the meaning of
p.002007: of Art. 2 (2) (5) of Regulation (EU) No 536/2014.
p.002007: 21. (Amended, SG No. 84/2018) (*) "Researcher" shall be a researcher within the meaning of Art. 2 (2) (15)
p.002007: Regulation (EU) No 536/2014.
p.002007: 22. (amended, SG No. 84/2018) (*) "Informed consent" is informed consent within the meaning of Art. 2,
...
p.002007: a product that:
p.002007: (a) is intended for the diagnosis, prophylaxis or treatment of life - threatening diseases; or
p.002007: progressively chronic diseases affecting no more than 5 in 10,000 people in the territory
p.002007: on the side, or
p.002007: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002007: chronic health conditions (diseases with a high rate of disease - related illnesses)
p.002007: disability and disability) and evidence is provided that the sale of the product does not provide
p.002007: satisfactory returns to justify the necessary investment for research and development
p.002007: development without incentives for the product creator, and
p.002007: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of the condition, or
p.002007: if there is such a method, the proposed medicinal product has significantly more advantages than it and the benefit to
p.002007: affected by this condition.
p.002007: 30. "Dosage form" is an acceptable structure containing the active substance (s),
p.002007: which may or may not include excipients obtained by the administration of certain
p.002007: technological operations, providing the desired healing effect and storage stability over the shelf life.
p.002007: 31. (amend. - SG 71/08, in force from 12.08.2008) L.
p.002007: "located within the territory of a Member State" means
p.002007: a legal entity registered under the civil or commercial law of a Member State or
p.002007: established by a regulation having its registered office and registered office in a Member State or in
p.002007: State party to the Agreement on the European Economic Area.
p.002007: 32. "Highway formulation" is a prescription for a medicinal product prepared in a pharmacy prescribed by
p.002007: a medical specialist or an approved prescription for a particular patient.
p.002007: 33. "International non-patent name" means the recommended name of the active substance,
p.002007: approved and published by WHO.
p.002007: 34. "Medical specialists" are doctors, dentists, masters-pharmacists, medical
p.002007: nurses, midwives, medical assistants, paramedics and pharmacy assistants.
p.002007: 35. "Medical sales representative" is a person who has received special training and possesses scientific
p.002007: knowledge of providing accurate and complete information about the medicinal product it is advertising.
p.002007: 35a. (new - SG 1/2014, in force from 03.01.2014) Medical
p.002007: "prescription" is a prescription of
p.002007: medicinal product or medical device issued by a person practicing regulated medical
p.002007: a profession within the meaning of § 1, item 1 of the additional provisions of the Professional Recognition Act
p.002007: qualifications and who has the legal right to do so in the Member State where the medical is issued
p.002007: prescription.
p.002007: 36. (Repealed, SG No. 84/2018)
p.002007: 36a. (New, SG No. 84/2018, effective 12.10.2018) Network
p.002007: "and information security" is the protection of
p.002007: information from unauthorized or accidental access, use, disclosure to third parties, change
p.002007: or destruction.
p.002007: 37. "Medicinal product name" means the name given to the product, which may be:
p.002007: a) freely chosen name (trade name);
...
p.002007: "an appropriate herbal medicinal product
p.002007: "medicinal product" is a product which contains the same active substances, regardless of the composition of
p.002007: excipients intended for the same purpose with an equivalent amount of the medicinal product
p.002007: substance / substances, with the same dosage and with the same or similar route of administration as the product, for
p.002007: who has applied.
p.002007: 74. An "adverse reaction message" is documented information about one or more
p.002007: suspected adverse reactions associated with the use of one or more medicinal products by one
p.002007: patient. For the validity of the adverse reaction message, they are required
p.002007: minimum identifier identifier data (initials or address or profession / specialty) of
p.002007: the patient (initials or age, or date of birth or gender), the adverse reaction / event, and
p.002007: the suspected medicinal product.
p.002007: 75. (Amended, SG No. 84/2018) (*) "Substantial change in the protocol of the clinical trial" is significant
p.002007: change within the meaning of Art. 2 (2) (13) of Regulation (EU) No 536/2014.
p.002007: 75a. (new, SG No. 102/2012, effective 21.12.2012) Substantial
p.002007: "changes to the
p.002007: non-interventional post-marketing research "are changes that affect safety,
p.002007: the physical or mental integrity of the patients or the results of the study and theirs
p.002007: interpretation.
p.002007: 76. (amend. - SG 71/08, in force from 12.08.2008)
p.002007: "reta country" is a non-state country -
p.002007: Member State of the European Union or not a State Party to the Agreement on the European Economic
p.002007: space.
p.002007: 77. "Wholesale" means all activities for the acquisition, storage, supply, import or export of
p.002007: medicinal products, except in the case of the supply of medicinal products directly to
p.002007: the population.
p.002007: 78. (Amended, SG No. 84/2018) (*) "Participant" shall be a participant within the meaning of Art. 2 (2) (17)
p.002007: Regulation (EU) No 536/2014.
p.002007: 79. (Repealed, SG No. 84/2018)
p.002007: 80. "Pharmacopoeia" is a collection of approved specifications and related production requirements,
p.002007: testing, storage and labeling of active substances, excipients, dosage forms,
p.002007: materials for packaging and components of the medicinal product.
p.002007: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product prepared in a pharmacy by a formulation
p.002007: operating pharmacopoeia and intended for delivery to patients at the same pharmacy.
p.002007: 81a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: "Counterfeit medicinal product" means any medicinal product in which it is misrepresented:
p.002007: (a) its identity, including particulars of the immediate packaging or its immediate packaging, its name or
p.002007: content with respect to any of its constituents, including excipients, and
p.002007: the amount of active substance per unit dose;
p.002007: (b) its source, including its manufacturer, the country in which it is manufactured, the country in which it is produced
p.002007: placed on the market, or the holder of his marketing authorization, or
p.002007: (c) the timing, including records and documents, of the supply chain used.
p.002007: It is not considered to be a counterfeit medicinal product with inadvertent tolerance in
...
p.002007: para. 1, according to the model approved by the Minister of Health;
p.002007: 2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration of
p.002007: the person under Art. 222, para. 1;
p.002007: 3. copy of the Law on Medicines and Pharmacies in the Human Medicine issued under the repealed order
p.002007: permission to open a pharmacy;
p.002007: 4. a certified copy of the employment contract or contract for the management of the pharmacy manager -
p.002007: in cases where such is required;
p.002007: 5. declaration by the persons under art. 222, para. 1 that the conditions under which the authorization was granted were maintained
p.002007: retail trade in medicinal products of the persons under para. 2;
p.002007: 6. document for a one-time fee of BGN 100
p.002007: § 67. Persons who have submitted prior to the entry into force of this law applications for re-registration under the procedure of revoked §
p.002007: 16 of the transitional and final provisions that will carry out their activities as required
p.002007: of this law shall be submitted to the Ministry of Health within three months of its entry into force
p.002007: the following documents:
p.002007: 1. an application in accordance with a model approved by the Minister of Health;
p.002007: 2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration
p.002007: or a certified copy of a similar document under the national law of a Member State of the European Union
p.002007: union, or under the law of another country party to the EEA Agreement
p.002007: space, according to Art. 222, para. 1;
p.002007: 3. an employment contract or a pharmacy management contract concluded with a master pharmacist or assistant;
p.002007: pharmacist.
p.002007: § 68. (1) Master pharmacist or assistant pharmacist who has received a permit for opening a pharmacy in accordance with the procedure
p.002007: to the repealed § 16 of the transitional and final provisions, may transpose the one issued
p.002007: permission of a person under art. 222, para. 1.
p.002007: (2) For carrying out the transfer the persons under para. 1 filed with the Ministry of Health
p.002007: application to which they attach:
p.002007: 1. application for authorization of retail sale of medicinal products by the persons of origin. 222,
p.002007: para. 1, according to the model approved by the Minister of Health;
p.002007: 2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration of
p.002007: the person under Art. 222, para. 1;
p.002007: 3. copy of the Law on Medicines and Pharmacies in the Human Medicine issued under the repealed order
p.002007: pharmacy permit or re-registration permit pursuant to the repealed § 16 of the
p.002007: transitional and final provisions;
p.002007: 4. a certified copy of the employment contract or management contract of the pharmacy manager;
p.002007: 5. declaration by the persons under art. 222, para. 1 that the conditions under which the authorization was granted were maintained
p.002007: retail trade in medicinal products of the persons under para. 1.
p.002007: (3) The transfer under para. 1 may be completed within one year from the entry into force of this Act.
p.002007: § 69. The drugstores welded upon the entry into force of this Act shall continue to operate
p.002007: on the basis of their registration certificates.
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.002007: compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3. When one parent is unknown,
p.002007: died or deprived of parental rights, or not granted such rights in cases of divorce,
p.002007: written informed consent is given by the minor and the parent who exercises
p.002007: parental rights.
p.002007: (5) The consent of the minor, the parents or the guardian may be withdrawn at any time
p.002007: time without negative consequences for the minor.
p.002007: (6) The express wish of the minor to withdraw at any time from the clinical trial must
p.002007: to be taken into account by the researcher and, if necessary, by the principal investigator.
p.002007: (7) The information of the minor or the minor shall be provided to the juvenile or minor
p.002007: risks and benefits in a way that is understandable to him by a doctor who has experience with minors.
p.002007: Art. 98. (Repealed, SG No. 84/2018)
p.002007: Art. 99. (Repealed, SG No. 84/2018)
p.002007: Section II.
p.002007: Clinical trial with vulnerable patient groups (Repealed, SG No. 84/2018)
p.002007: Section II.
p.002007: A clinical trial with vulnerable patient groups
p.002007: Art. 100. (Repealed, SG No. 84/2018)
p.002007: Art. 101. (Repealed, SG No. 84/2018)
p.002007: Art. 102. (Repealed, SG No. 84/2018)
p.002007: Section III.
p.002007: Ethical Committee for Clinical Trials (Title Amended, SG No. 84/2018)
p.002007: 12/10/2018)
p.002007: Section III.
p.002007: Ethics Committees
p.002007: Art. 103. (amend. - SG 84/08, in force from 12.10.2018) (1) To the Minister of Health shall be
p.002007: establish an Ethical Committee for Clinical Trials, the composition of which is determined by an order of the Minister of
p.002007: and includes regular and reserve members. The reserve members shall attend the meetings of the
p.002007: commission and have the right to vote in the absence of regular members.
p.002007: (2) The commission under para. 1 consists of 7 to 12 regular members, including the Chair and the Deputy
p.002007: a chairman with the qualifications and experience to review and evaluate scientific, medical and ethical
p.002007: aspects of the proposed clinical trial. Requirements for the qualification of members of the Commission
p.002007: under para. 1, as well as the terms and procedure for determining the composition of the commission shall be settled by
p.002007: the rules of art. 106, para. 1.
p.002007: (3) The commission under para. 1 includes at least two full-time non-medical members -
p.002007: representatives of both sexes.
p.002007: (4) For the needs of its work, the commission under para. 1 can attract external specialists.
p.002007: (5) Only the members of the commission under para. 1, which are not in conflict of interest, are not specifically involved
p.002007: testing and are independent of the client, the medical establishment where the clinical trial is being conducted,
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.002007: The Council of Ministers.
p.002007: (5) The Medicines Executive Agency shall:
p.002007: 1. issues authorizations for the manufacture of medicinal products;
p.002007: 2. issues marketing authorizations and certificates for registration of medicinal products;
p.002007: 3. (suppl. - SG 71/08, in force from 12.08.2008) issue licenses and certificates for wholesale trade
p.002007: with medicinal products;
p.002007: 4. issue permits for parallel import of medicinal products;
p.002007: 5. (amend. - SG 60/11, in force from 05.08.2011) issue, refuse or terminate marketing authorizations
p.002007: retail of medicinal products;
p.002007: 5a. (new - SG 102/2012, in force from 21.12.2012) shall enter the manufacturers, importers and traders of
p.002007: wholesale of active substances;
p.002007: 5b. (new - SG 102/2012, in force from 21.12.2012) keep a register of the persons, carrying out
p.002007: mediation in the field of medicinal products;
p.002007: 6. issue permits for conducting clinical trials of medicinal products;
p.002007: 7. assess the quality, efficacy and safety of medicinal products in connection with
p.002007: authorizing them for use;
p.002007: 8. issue marketing authorizations for medicinal products;
p.002007: 9. control production, import, storage, wholesale and retail, clinical
p.002007: testing, safety and advertising of medicinal products;
p.002007: 10. perform laboratory analysis on suspected deviation in the quality, efficiency and safety of
p.002007: medicinal products and take the measures provided for by law;
p.002007: 10a. (new - SG 102/2012, effective 21.12.2012) performs the functions of a competent body for
p.002007: pharmacovigilance monitoring;
p.002007: 11. (amend. - SG 102/02, in force from 21.12.2012) organize and maintain a system for tracking of
p.002007: drug safety;
p.002007: 12. issue certificates under the WHO certification scheme;
p.002007: 12a. (new, SG No. 18/2014) issue certificates of Good Distribution Practice;
p.002007: 13. issue certificates of Good Manufacturing Practice;
p.002007: 14. (amend. - SG 18/04) advise investment projects for construction of new and / or
p.002007: reconstruction of existing facilities related to the manufacture of medicinal products in accordance
p.002007: with the rules of Good Manufacturing Practice;
p.002007: 15. performs the functions of coordinator and advisory body on quality issues,
p.002007: the efficacy and safety of medicinal products;
p.002007: 16. performs consulting, scientific, information and publishing activities in the field of pharmaceuticals
p.002007: sector;
p.002007: 17. coordinates and participates in activities related to the European Pharmacopoeia and in the development of
p.002007: The Bulgarian Pharmacopoeia;
p.002007: 18. participate in activities in the field of medicinal products related to the work of the European Agency
p.002007: on Medicines, European Directorate for Quality of Medicines and Health, international
p.002007: bodies and organizations, as well as with the implementation of international treaties to which the Republic of Bulgaria is
p.002007: country;
p.002007: 18a. (new - SG 102/2012, in force since 21.12.2012) participate in the international harmonization and
p.002007: standardization of technical measures regarding pharmacovigilance monitoring, sub
p.002007: the coordination of the European Medicines Agency;
p.002007: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain a national Internet portal for
p.002007: medical products;
p.002007: 19. performs other activities specified by law.
p.002007: (6) (amend. - SG 98/10, in force from 01.01.2011) The Executive Agency for Medicines shall coordinate
p.002007: its activities with the Regional Health Inspectorates (RICs) in the field of drug control.
p.002007: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under this Act related to
p.002007: preventing the entry and distribution of counterfeit medicinal products,
p.002007: carries out in cooperation between the BDA and the customs authorities.
p.002007: (8) (New, SG No. 84/2018, effective 12.10.2018) The Executive Agency for Medicines may
p.002007: carries out joint checks with the National Revenue Agency, the Customs Agency, the National Revenue Agency
p.002007: Health Insurance Fund, the Ministry of Health and the National Board of Prices and
p.002007: reimbursement of medicinal products in the exercise of their control functions
p.002007: on medicinal products.
p.002007: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health Inspectorates shall issue
p.002007: drugstore registration certificates.
p.002007: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002007: retail of medicinal products, which includes three representatives of the Bulgarian
p.002007: pharmaceutical union, one representative of the faculties of pharmacy at medical colleges
p.002007: and four BDA representatives. The composition of the Board shall be determined by order of the Executive Director
p.002007: of the BDA, coordinated with the Minister of Health.
p.002007: (2) The council under para. 1 is an advisory unit which:
p.002007: 1. prepares opinions on applications and documents submitted to the BDA. 228, para. 1 and 5, which he presents to
p.002007: the Executive Director of the BDA;
p.002007: 2. make motivated proposals to the Minister of Health through the BDA Executive Director for
p.002007: improving public access to medicines.
...
p.002007: 2, Vol. 1;
p.002007: 2. (amend. - SG 102/02, in force from 21.12.2012) manufacturers, importers and wholesalers of
p.002007: active substances;
p.002007: 3. the authorized and registered medicinal products on the territory of the Republic of Bulgaria;
p.002007: 4. wholesalers of medicinal products on the territory of the Republic of Bulgaria;
p.002007: 4a. (new - SG 102/2012, in force from 21.12.2012) intermediaries in the field of medicinal products;
p.002007: 5. (amend. - SG 60/11, in force from 05.08.2011) the issued licenses for retail trade with
p.002007: medical products;
p.002007: 6. approved clinical trials;
p.002007: 7. the licenses issued for parallel import.
p.002007: 8. (New, SG No. 18/2014, repealed, SG No. 84/2018, effective 12.10.2018)
p.002007: (2) (amend. - SG 84/08, in force from 12.10.2018) The data from the registers under para. 1, items 1 - 7 are published in
p.002007: 14 days from the issuance of the relevant authorization on the BDA website on the Internet.
p.002007: (3) The Executive Agency for Medicines shall maintain systems for the electronic exchange of data with the regulatory authorities
p.002007: authorities of other Member States, the European Commission and the European Medicines Agency.
p.002007: Art. 19a. (New, SG No. 60/2011, effective 05.08.2011) (1) The respective SICs shall keep and maintain public
p.002007: registers for their drugstore registration certificates.
p.002007: (2) Within 7 days from the issuance of a certificate for registration of a drugstore, the respective RHI shall send to
p.002007: Ministry of Health information about the issued act.
p.002007: (3) The Ministry of Health shall maintain and maintain on its website a public national
p.002007: register of issued drug registration certificates.
p.002007: Section III.
p.002007: Financing
p.002007: Art. 20. (1) The activity of the BDA shall be financed by budgetary funds and income from own activity.
p.002007: (2) (Amended, SG No. 15/2013, in force from 01.01.2014) The budgetary funds shall be provided by a subsidy from
p.002007: the state budget through the budget of the Ministry of Health.
p.002007: Art. 21. (1) The Executive Agency for Medicines shall be the administrator of own-source revenues which
p.002007: are formed by:
p.002007: 1. chemical-pharmaceutical expertise;
p.002007: 2. laboratory analyzes and tests;
p.002007: 3. evaluation of documentation and issuance of permits, certificates, certificates and other documents,
p.002007: referred to in this Act;
p.002007: 4. evaluation of the renewal, modification and deletion of the marketing authorization and the certificate of use
p.002007: registration of a medicinal product;
p.002007: 5. maintenance of the marketing authorizations or the registration certificates of a medicinal product;
p.002007: 6. fines and pecuniary sanctions imposed by penal decrees issued for violations of this
p.002007: law;
p.002007: 7. consulting, publishing and research activities in the field of the pharmaceutical sector;
p.002007: 8. coordination of investment projects for construction of new ones and / or reconstruction of existing ones
p.002007: facilities related to the manufacture of medicinal products;
p.002007: 9. carrying out inspections in relation to conformity assessment of the production conditions with
p.002007: the requirements of Good Manufacturing Practice;
p.002007: 10. (new - SG 84 2018, in force from 12.10.2018) carrying out inspections of authorized for conducting
p.002007: clinical trials;
p.002007: 11. (new, SG No. 84/2018) effective inspections related to the issuance of
p.002007: Certificate of Good Manufacturing Practice or Good Distributor Practice at the request of
...
p.002007: 5. (amend. - SG 71/08, in force from 12.08.2008) dosage, dosage form, method of administration and
p.002007: route of administration and proposed shelf life;
p.002007: 6. precautions and safety measures for the storage of the product, for its administration to patients and
p.002007: in the event of disposal of the product waste, accompanied by an indication of the potential risks of
p.002007: the medicinal product for the environment;
p.002007: 7. description of the production method;
p.002007: 8. description of the control methods used by the manufacturer;
p.002007: 8a. (new - SG 102/2012, in force from 02.01.2013) declaration that the results of the audit are 160, para. 2,
p.002007: conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
p.002007: compliance with the principles and guidelines for Good Manufacturing Practice; the declaration shall state
p.002007: the date on which the audit was conducted;
p.002007: 9. assessment of the potential risk of the medicinal product for the environment on a case-by-case basis and measures,
p.002007: intended to limit it;
p.002007: 10. results from:
p.002007: (a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.002007: (b) preclinical (toxicological and pharmacological) studies;
p.002007: (c) clinical trials;
p.002007: 11. a statement that they have been complied with in clinical trials conducted outside the territory of the Member States
p.002007: ethical principles of Good Clinical Practice;
p.002007: 12. (amend. - SG 102/2012, in force from 21.12.2012) summary of the traceability system
p.002007: drug safety, which includes the following elements:
p.002007: a) the name of the qualified person under Art. 191, Curriculum Vitae - Education acquired by professional experience in
p.002007: the field of pharmacovigilance monitoring and the qualification for fulfilling his duties
p.002007: in the order of Chapter Eight;
p.002007: (b) any Member State in which the qualified person fulfills his duties;
p.002007: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002007: (d) the address at which the basic document of the medication traceability system is stored
p.002007: safety;
p.002007: 12a. (new - SG 102/2012, in force since 21.12.2012) declaration by the applicant that he has at his disposal
p.002007: the necessary means to fulfill the obligations of Chapter Eight;
p.002007: 13. (amend. - SG 102/2012, in force from 21.12.2012) risk management plan with description of the system
p.002007: for risk management to be introduced by the applicant for the medicinal product concerned, together with a summary of
p.002007: the plan;
p.002007: 14. a brief description of the product according to Art. 34;
p.002007: 15. layout of the primary and secondary packaging of the product and a leaflet in accordance with
p.002007: the requirements of Chapter Six;
p.002007: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country in which it is located
p.002007: carry out the production accompanied by a certificate of good manufacturing practice or a certificate,
p.002007: certifying that the manufacture of the medicinal product and of its active substances is
...
p.002007: implementation of the procedure under Art. 74.
p.002007: (2) Where an application for marketing authorization or registration of a medicinal product has been submitted to the BDA,
p.002007: for which in accordance with the data under Art. 27, para. 1, item 19, there is information that in a Member State the dossier of
p.002007: the same medicinal product is under evaluation; the BDA does not review the documentation under Art. 27 - 32 or Art.
p.002007: 35, para. 3, or under Art. 38 and shall notify the applicant in writing of the application of the postal procedure. 75.
p.002007: (3) For the implementation of the provisions of para. 1 and 2 the medicinal product is defined as the same authorized in
p.002007: another Member State, or as a product under evaluation in another Member State,
p.002007: when both medicinal products:
p.002007: 1. have the same qualitative and quantitative composition as regards the active substance (s);
p.002007: they are available in the same dosage form, with differences in excipients being allowed, if not
p.002007: affects safety and efficacy, and when
p.002007: 2. belong to one company, or apply for medicinal products by persons belonging to one
p.002007: to the same company or associations of companies, or where they apply for medicinal products
p.002007: application by persons who have entered into a license or other agreement or are acting together,
p.002007: related to the marketing of the medicinal product concerned in the various Member States.
p.002007: Art. 46. (1) When evaluating the BDA documentation:
p.002007: 1. may test the finished product, the intermediate, or the starting materials for
p.002007: the medicinal product, and send them for testing in a laboratory by the official system
p.002007: drug control laboratories in a Member State to determine whether the control methods of analysis,
p.002007: used by the manufacturer and described in the dossier satisfy the requirements;
p.002007: 2. confirm, after on-the-spot verification or on the basis of documents, that the manufacturers of medicinal products from
p.002007: third countries shall carry out the production in accordance with the data described in Art. 27, para. 1, item 7, and / or
p.002007: carry out the control in accordance with the methods described in Art. 27, para. 1, Vol. 8;
p.002007: 3. checks the production establishment specified in the application when the manufacturer (s) of
p.002007: medicines from third countries were, by way of exception, assigned to another manufacturer
p.002007: certain stages of the manufacture or control of the medicinal product.
p.002007: (2) When the BDA carries out an on-site inspection of a production site, the term shall begin. 44 stops running until
p.002007: drawing up a report with the results of the verification.
p.002007: (3) In the cases of para. 1, items 2 and 3 the manufacturers shall pay a fee in the amount specified in the tariff mail. 21, para.
p.002007: 2.
p.002007: Art. 47. (1) The following shall be created to the Executive Director of the BDA as consultative bodies
p.002007: specialized committees:
p.002007: 1. Committee for Medicinal Products;
p.002007: 2. Committee on Immunological Medicinal Products;
p.002007: 3. Committee for Homeopathic Medicinal Products;
p.002007: 4. Committee for Herbal Medicinal Products;
p.002007: 5. Radiopharmaceuticals Commission;
p.002007: 6. (new - SG 71/08, in force from 12.08.2008) Committee for Medicinal Products with Annex to
p.002007: pediatrics;
p.002007: 7. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002007: Committee for Medicinal Products for Advanced Therapies;
p.002007: 8. (new - SG 102/2012, in force since 21.12.2012)
p.002007: drug safety.
p.002007: (2) If necessary, the Executive Director of the BDA may establish other specialized committees
p.002007: beyond the ones specified in para. 1.
p.002007: (3) Specialist committees shall include specialists with scientific achievements and practical experience in the
p.002007: the relevant fields of application of medicinal products.
p.002007: (4) External experts with scientific knowledge and expertise may also be attracted to the permanent composition of the committees.
p.002007: hands-on experience in the specific drug group.
p.002007: (5) The Executive Director of the BDA shall determine by an order the composition of the committees for a term of three years, the amount
p.002007: of their remuneration and approves rules of procedure for their work.
p.002007: (6) By 30 January each year, the Executive Director of the BDA shall approve the lists of experts outside
p.002007: the composition of the commissions under para. 1 after approval by the Minister of Health.
p.002007: (7) The Executive Director of the BDA may release a member of a specialized commission for early termination
p.002007: his request for failure to fulfill his obligations for more than three months or in bad faith
p.002007: performing its functions.
p.002007: (8) The composition of the commissions and the list of experts under para. 6 are announced on the BDA website on the Internet.
p.002007: Art. 48. (1) The members of the specialized commissions under Art. 47, para. 1 and the experts under Art. 47, para. 4 sign
p.002007: a declaration obliging them not to:
p.002007: 1. disclose data and circumstances that became known to them in the course of or in connection with the performance of their activity;
p.002007: 2. participate in activities related to the production or wholesale and retail of medicines
p.002007: products.
p.002007: (2) In case the persons under para. 1 have participated in any of the stages of preparation of the documentation required
p.002007: to authorize the use of the medicinal product, they may not participate in the meetings of the medicinal product
p.002007: specialized commission under art. 47.
p.002007: (3) The persons under para. 1 shall not vote in decisions on matters which they or the members of
p.002007: their family has commercial, financial or other interests.
p.002007: Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
...
p.002007: para. 1 with the reasons for the decision, deleting the data constituting a trade secret.
p.002007: (3) The report under para. 2 shall be accompanied by a summary of a language comprehensible to the public. The summary contains
p.002007: section on the conditions of use of the medicinal product.
p.002007: Art. 54. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of the permit for
p.002007: use / the registration certificate of the medicinal product shall notify the BDA in writing of the date of
p.002007: the actual marketing of the medicinal product in the Republic of Bulgaria.
p.002007: (2) (Amended, SG No. 18/2014) The holder of the marketing authorization / registration certificate
p.002007: of the medicinal product shall be notified in writing to the BDA at least two months before the sale ceases
p.002007: of a medicinal product, whether temporary or permanent.
p.002007: (3) (Amended, SG No. 18/2014) The holder of the marketing authorization / registration certificate
p.002007: of medicinal product shall indicate the reasons for discontinuation of sales in accordance with Art. 68, para. 1, vol.
p.002007: 6 and declares whether the actions taken by him under para. 2 are due to any of the grounds of post. 276 or
p.002007: under Art. 277.
p.002007: (4) (Amended, SG No. 18/2014) Upon termination of the sales of the medicinal product as a result of
p.002007: unforeseen circumstances the holder of the marketing authorization / registration certificate for
p.002007: medicinal product shall notify the BDA in writing within 7 days of the establishment of the circumstances.
p.002007: Art. 54a. (New, SG No. 60/2011, effective 05.08.2011) (1) (amend. - SG 18/04) Upon receipt of
p.002007: a signal to the Drug Enforcement Agency to suspend the sale of a medicinal product, p
p.002007: except for the cases under art. 54, para. 2 and 4, the Agency shall carry out the check within 30 days of receipt of
p.002007: signal.
p.002007: (2) When performing the inspection under para. 1 The BDA may request information from the authorization holder
p.002007: for use and / or by the person under Art. 26, para. 2 on the suspension of sales of the particular
p.002007: medicinal product as well as the wholesalers of medicinal products regarding the available quantities of
p.002007: product.
p.002007: (3) The Medicines Executive Agency shall publish its page on the Internet of the results of
p.002007: the check carried out.
p.002007: Art. 55. (1) The authorization for use / the registration certificate of a medicinal product shall be issued by
p.002007: the Executive Director of the BDA for a period of 5 years.
p.002007: (2) (suppl. - SG 71/08, in force from 12.08.2008) After the expiration of the term under para. 1 permission for
p.002007: the use / registration certificate of the medicinal product may be renewed by the BDA on the basis of
p.002007: of assessment of the benefit / risk ratio in accordance with Art. 59a.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) The authorization for use / the certificate for
p.002007: registration may be terminated before the expiry of the term under para. 1 if the owner requests it
p.002007: in writing by the BDA Executive Director, stating the reasons.
p.002007: (4) (suppl. - SG 71/08, in force from 12.08.2008) The marketing authorization / the certificate for use
p.002007: registration shall be held indefinitely after its renewal, except in the cases of para. 5.
p.002007: (5) (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 21.12.2012)
...
p.002007: the notification.
p.002007: (5) Within 10 days of receipt of the evaluation report under para. 3 the BDA Executive Director issues
p.002007: authorization for renewal of the Marketing Authorization / Marketing Authorization
p.002007: product or reasoned refusal.
p.002007: Art. 59b. (New, SG No. 71/2008, effective 12.08.2008) (1) The Executive Director of the BDA shall refuse
p.002007: renewal of the marketing authorization / marketing authorization of the medicinal product when
p.002007: after evaluation of the file under Art. 59a, para. 1 found that:
p.002007: 1. the medicinal product is harmful when used correctly, or
p.002007: 2. lack of therapeutic efficacy, or
p.002007: 3. the benefit / risk balance is unfavorable when used correctly, or
p.002007: 4. the quantitative and qualitative composition of the medicinal product does not correspond to that described in the dossier, or
p.002007: 5. the data in the file under art. 59a, para. 1 are incorrect, or
p.002007: 6. the control of the medicinal product and / or the ingredients and the intermediate stages of the manufacturing process
p.002007: no other requirement or the fulfillment of which the manufacturing authorization was granted has been fulfilled,
p.002007: or
p.002007: 7. some of the data in the file do not meet the requirements of Art. 59a, para. 1 and 2.
p.002007: (2) Refusal of the BDA Executive Director to renew the Marketing Authorization / Certificate for use
p.002007: registration of a medicinal product may be appealed in accordance with the Administrative Procedure Code.
p.002007: (3) The refusal of the BDA Executive Director and the reasons shall be published on the BDA website.
p.002007: Art. 59c. (New, SG No. 60/2011, effective 05.08.2011; amend. - SG 102/2012, effective 01.04.2013)
p.002007: The Drug Enforcement Agency notifies the National Board of Pricing and Reimbursement
p.002007: the medicinal products for the withdrawn and revoked marketing authorizations, and for the refusals made for
p.002007: Renewal of marketing authorizations for medicinal products within 7 days of the granting of a marketing authorization
p.002007: the relevant act.
p.002007: Section VI.
p.002007: Changes to the marketing authorization issued
p.002007: Art. 60. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of a permit for use of
p.002007: a medicinal product is obliged to notify the BDA of any change in the conditions under which it is issued
p.002007: the permission.
p.002007: (2) (amend. - SG 12/11, in force from 08.02.2011) The changes may be of type IA, type IB, type II,
p.002007: extension of the marketing authorization and emergency restrictive safety measures.
p.002007: (3) (amend. - SG 12/11, in force from 08.02.2011) Conditions and criteria for classification of changes
p.002007: shall be determined by the ordinance under Art. 42.
p.002007: (4) (amend. - SG 12/11, in force from 08.02.2011) Change, which is not an extension of the scope and
p.002007: the classification of which remains uncertain after the application of the conditions and criteria of the ordinance under Art. 42,
p.002007: is considered to be a type IB change by default.
p.002007: (5) (New, SG No. 12/2011, effective 08.02.2011) As an exception to para. 4 a change that does not occur
p.002007: extension and the classification of which remains uncertain after the application of the conditions and
p.002007: the criteria of the ordinance under Art. 42 shall be considered a Type II change in the following cases:
p.002007: 1. at the request of the holder of the marketing authorization, reflected in the application for change;
...
p.002007: tasks in accordance with the Good Clinical Practice rules under Regulation (EU) No 536/2014.
p.002007: (2) A clinical trial of a medicinal product shall be carried out under the supervision of a physician or physician
p.002007: dental medicine with recognized medical specialty in the relevant field, which is familiar with the available
p.002007: preclinical and / or clinical data on the product and the risks and procedures of the study.
p.002007: (3) During the clinical trial, the medical care provided to the trial participant and
p.002007: medical decision-making is the responsibility of a physician with an appropriate qualification or a dentist
p.002007: medicine.
p.002007: Art. 87. (1) (amend. - SG 59/10, in force from 31.07.2010, amended - SG, issue 60 of 2011, in force since 05.08.2011
p.002007: g., add. - SG, issue. 84 of 2018, effective 12.10.2018) Clinical trial may be conducted in therapeutic
p.002007: hospitals, mental health centers, venereal disease centers,
p.002007: complex oncology centers, dialysis centers, diagnostic and consulting centers, medical centers
p.002007: centers, dental centers and medical-dental centers, as well as in individual and group practices for
p.002007: primary and specialized medical care, licensed for activity / certificate of
p.002007: registration according to the procedure of the Medical Institutions Act.
p.002007: (2) (New, SG No. 84/2018, effective 12.10.2018) Clinical trial of medicinal products,
p.002007: containing narcotic substances can only be carried out in hospitals,
p.002007: mental health centers, centers for skin and venereal diseases and complex oncology
p.002007: centers, in the structure of which a pharmacy, licensed under Art. 33, para. 1 of the Law on
p.002007: control of narcotic drugs and precursors, or who have contracted with another drug
p.002007: an establishment in the structure of which a pharmacy has been opened, holding a license under Art. 33, para. 1 of the Law
p.002007: for drug and precursor control.
p.002007: (3) (Renumbered from Paragraph (2), amend. - SG 84/08, in force from 12.10.2018) Clinical trial may be
p.002007: conducts only in a medical establishment in which there is a designated contact person under Art. 107a, para. 1.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 84/2018, effective 12.10.2018)
p.002007: the clinical trial of a medicinal product will be agreed to the participation of the principal
p.002007: researcher and for conducting the test.
p.002007: Art. 88. (1) Clinical trial on humans shall be performed with:
p.002007: 1. medicinal products not authorized for use in the Republic of Bulgaria;
p.002007: 2. medicinal products authorized for use in the Republic of Bulgaria when tested for unauthorized use
p.002007: indication for a dosage form other than the authorized one in a group of patients not previously studied or
p.002007: for more information.
p.002007: (2) Authorized for use in the Republic of Bulgaria within the meaning of para. 1, item 2 are medicinal products received
p.002007: authorization for use under this Act or under Regulation (EC) No 726/2004 of the European Union
p.002007: Parliament and Council.
p.002007: Art. 89. (Repealed, SG No. 84/2018)
p.002007: Art. 90. (Repealed, SG No. 84/2018) (Amended, SG No. 17/2019)
p.002007: Art. 91. The contracting authority and the principal investigator take out insurance covering their liability for
p.002007: non-material and property damage caused during or in the course of the clinical trial
p.002007: of the participants.
p.002007: Art. 92. (1) (Amended, SG No. 84/2018) (*) The contracting authority shall be liable in case of health damage.
...
p.002007: documents the undertakings under para. 1, items 2 and 2a measures.
p.002007: (4) (Renumbered from Paragraph (2) - SG, No. 102 of 2012, in force since 02.01.2013, amend. - SG, iss. 84 in 2018. (*))
p.002007: of a manufacturing authorization shall keep the samples and the documentation of the medicinal products manufactured by him
p.002007: products and active substances under the conditions and in the order specified in the ordinance under Art. 152, para. 1.
p.002007: (5) (Renumbered from Paragraph (3), SG No. 102/2012, effective as of 02/01/2013, repealed - SG, iss. 84 in 2018 (*))
p.002007: (6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013) The documentation for each concluded transaction
p.002007: is stored for 5 years and contains the date, the name of the medicinal product, the quantity delivered, the name and
p.002007: recipient address and batch number.
p.002007: (7) (Renumbered from Paragraph 5, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
p.002007: production provides and maintains a system for blocking and withdrawal of medicinal products from the market,
p.002007: showed non-compliance with quality requirements.
p.002007: (8) (Renumbered from Paragraph 6, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
p.002007: the production is obliged to block and withdraw the medicinal products which have shown non-compliance with
p.002007: the requirements for quality, efficiency and safety, in accordance with the ordinance under Art. 274, para. 1.
p.002007: (9) (Renumbered from Paragraph 7, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
p.002007: production is obliged to update production methods in accordance with the development of new ones
p.002007: technologies and the development of test drug products.
p.002007: (10) (New - SG, iss. 12 in 2011, in force since 08.02.2011, previous para 8, amended - SG, iss. 102 in 2012, in force since
p.002007: 02.01.2013) Based on the manufacturing authorization issued pursuant to this section, the holder
p.002007: it may import the excipients necessary for the manufacture of the medicinal products
p.002007: products specified in the manufacturing authorization.
p.002007: Art. 160a. (New, SG No. 60/2011, effective 05.08.2011) (1) The Executive Director of the BDA with an order
p.002007: withdraw the issued production permit when the conditions under Art. 148 and were not observed
p.002007: the requirements of Good Manufacturing Practice, determined in accordance with Art. 152.
p.002007: (2) The Executive Director of the BDA shall, with an order, terminate the manufacturing authorization:
p.002007: 1. at the written request of its holder;
p.002007: 2. upon termination of the activities for which it was issued;
p.002007: 3. upon deletion of the registration of the trader;
p.002007: 4. at the death of the individual - sole trader.
p.002007: (3) The order under para. 1 may be appealed in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend enforcement.
p.002007: Section II.
p.002007: Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
p.002007: Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria
p.002007: from a third country of all types of medicinal products and medicinal products intended for
p.002007: clinical trial may only be performed by natural or legal persons registered as traders
p.002007: under the law of a Member State which has been granted an import authorization by the executive
p.002007: director of the BDA.
p.002007: (2) In order to obtain an import permit, the person under para. 1 must have:
...
p.002007: Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
p.002007: ensure the availability of medicinal products, the importer may import the active substance without the written request
p.002007: confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
p.002007: manufacturing practice where the manufacturing site of the active substance in the exporting country was
p.002007: inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines for
p.002007: Good manufacturing practice.
p.002007: (2) In the cases of para. 1 The BDA shall notify the European Commission.
p.002007: Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of manufacturing authorizations,
p.002007: including those who perform the activities of art. 168b, para. 2 shall be considered as producers within the meaning of
p.002007: § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002007: caused by a defect in the goods provided for therein.
p.002007: Chapter Six.
p.002007: PACKAGING AND PACKAGE LEAFLET
p.002007: Art. 168. (1) The packaging of a medicinal product shall consist of a primary and / or secondary packaging and a leaflet for
p.002007: patient.
p.002007: (2) (amend. - SG 61/11, in force from 10.11.2011) The secondary packaging of medicinal products,
p.002007: containing substances specified in the list under Art. 3, para. 2, item 2 of the Drug Control Act
p.002007: substances and precursors, is marked diagonally with two red strips, and the outer packaging of medicinal
p.002007: products containing substances from the list under Art. 3, para. 2, item 3 of the Drug Control Act
p.002007: substances and precursors - with two blue bands. The package must contain an indication that the medicinal product
p.002007: the product is only available on special medical prescription.
p.002007: (3) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products included in
p.002007: the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains
p.002007: information with the following text: "This medicinal product is subject to additional monitoring". In front of
p.002007: the text shall be marked in black in accordance with Article 23 (5) of Regulation (EC) No 726/2004
p.002007: The European Parliament and the Council, accompanied by an explanatory note.
p.002007: (4) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products shall include
p.002007: a standard text asking patients to report to healthcare professionals or directly
p.002007: of the BDA any suspected adverse reaction according to the models of Art. 185, para. 2, Vol. 4.
p.002007: (5) When the medicinal product is authorized for use on the territory of the Republic of Bulgaria, on
p.002007: its secondary packaging is labeled for separate collection and recycling in accordance with the Law on
p.002007: waste management and implementing acts.
p.002007: (6) Where the medicinal product is authorized, its name shall be given on the outer carton,
p.002007: the dosage form and the content of the active substance in the dosage unit are also indicated with Braille
p.002007: alphabet.
p.002007: (7) The requirements of para. 6 shall not apply to vaccines and medicinal products in hospital packaging.
p.002007: (8) (New, SG No. 102/2012, in force since 21.12.2012) On the outer packaging, or, if there is none, on
...
p.002007: (c) specific characteristics of the medicinal products concerned;
p.002007: (d) the severity of the disease to be treated;
p.002007: (e) other potential risks to public health.
p.002007: Art. 168b. (New, SG No. 102/2012, effective 21.12.2012) (1) The rules on indicators for
p.002007: safety under Art. 168, para. 8 shall be determined by the European Commission by means of delegated acts of Article 54a,
p.002007: paragraph 2 of Directive 2001/83 / EC.
p.002007: (2) The safety indicators shall not be eliminated or partially or completely closed, unless they are
p.002007: the following conditions are met:
p.002007: 1. the holder of the manufacturing authorization before partially or completely removing or closing it
p.002007: safety, checks that the medicinal product concerned is authentic and has not been
p.002007: forged;
p.002007: 2. the holder of a production permit in compliance with the requirements of Art. 168, para. 8 can replace
p.002007: safety indicators with their equivalent in terms of the ability to guarantee
p.002007: authentication, identification and provision of evidence of tampering with the medicinal product
p.002007: product.
p.002007: (3) Safety indicators shall be considered equivalent if:
p.002007: 1. satisfy the requirements laid down in the delegated acts referred to in Article 54a (2) of the Directive
p.002007: 2001/83 / EC, and
p.002007: 2. are equally effective in allowing authentication and identification of
p.002007: medicinal products and providing evidence of counterfeiting.
p.002007: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of the medicinal product and in
p.002007: compliance with Good Manufacturing Practice for Medicinal Products.
p.002007: (5) The Drug Enforcement Agency oversees the replacement of the
p.002007: safety.
p.002007: Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
p.002007: compliance with the data in the summary of product characteristics approved by the BDA at the time of the issuance of the BDA
p.002007: the marketing authorization and meet the requirements set out in the ordinance under Art. 170.
p.002007: (2) The information on the packaging and the leaflet may be in several languages, but necessarily one
p.002007: should be Bulgarian. The content of the information in different languages must be identical.
p.002007: (3) The name of the medicinal product shall be written in Bulgarian and the international name
p.002007: non-patent name of the medicinal substance is given in accordance with the Anatomical Therapeutic
p.002007: the chemical classification of WHO. The name and address of the marketing authorization holder may be
p.002007: written in Latin.
p.002007: (4) The information on the packaging and the package leaflet must be in a patient-friendly language, legible and
p.002007: be indelible.
p.002007: (5) (New, SG No. 18/2014) The leaflet must be designed in such a way that it is clear and comprehensible,
p.002007: allowing the patient to take appropriate action, medically as needed
p.002007: specialists.
p.002007: Art. 170. (1) (Former text of Art. 170 - SG, issue 102 of 2012, effective 21.12.2012) Requirements to
p.002007: the packaging and leaflets of the medicinal products shall be laid down in an ordinance of the Minister of Health
p.002007: healthcare.
p.002007: (2) (New - SG, iss. 102 in 2012; effective from 21.12.2012, supplemented - SG, iss. 18 of 2014) Where a medicinal product,
...
p.002007: determined by the BDA in the Marketing Authorization / Registration Certificate or the Marketing Authorization
p.002007: parallel import of the medicinal product into the territory of the Republic of Bulgaria.
p.002007: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in the application for
p.002007: Marketing Authorization / Registration Certificate, Modification of the Marketing Authorization or
p.002007: its renewal.
p.002007: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002007: 1. medicinal products with restricted medical prescription, intended for use in certain medicinal products only
p.002007: specialized areas;
p.002007: 2. medicinal products - subject to special medical prescription;
p.002007: 3. medicinal products for multiple or single dispensing under the same medical prescription.
p.002007: Art. 173. Medicinal products that meet the following requirements are prescribed on medical prescription:
p.002007: 1. may present a direct or indirect danger to human health, even if used correctly, if
p.002007: apply without medical supervision;
p.002007: 2. they are frequently and very widely applied incorrectly and as a result can be a danger to
p.002007: human health;
p.002007: 3. contain substances the activity and / or side effects of which subsequently require
p.002007: additional study;
p.002007: 4. usually prescribed by a doctor for parenteral administration.
p.002007: Art. 174. Medicinal products are subject to special medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. contain narcotic substances within the meaning of the Drug Control Act; and
p.002007: precursors in permissible quantities;
p.002007: 2. if used improperly, they can create a significant risk of abuse, lead to a medicinal product
p.002007: dependency or use for illegal purposes;
p.002007: 3. contain new medicinal substances whose characteristics are not sufficiently known for this reason
p.002007: a preventive cause may be attributed to the group of medicinal products under item 2.
p.002007: Art. 175. Medicinal products are subject to limited medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. restricted to hospital use only because of limited experience in use or in the interest of
p.002007: public health;
p.002007: 2. intended for the treatment of conditions which can only be diagnosed in
p.002007: medical institutions, although their implementation and monitoring of the course of treatment may be
p.002007: carry out in other health establishments;
p.002007: 3. they are intended for the treatment of outpatients, but their use can be serious
p.002007: side effects requiring specialist prescription and monitoring during treatment.
p.002007: Art. 176. (1) The Executive Agency for Medicines may not approve the mail requested by the applicant. 26, para.
p.002007: 1 medication delivery regimen based on an assessment of:
p.002007: 1. the maximum single dose, the maximum daily dose, the amount of active substance in a single dose
...
p.002007: Bulgaria.
p.002007: (2) The list under para. 1 is updated annually.
p.002007: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002007: or a certificate of registration, the BDA shall review and, where necessary, amend the classification
p.002007: according to the requirements of Art. 173 and the criteria specified in the ordinance post. 178.
p.002007: Art. 181. Where a change in the classification of a medicinal product is authorized
p.002007: significant preclinical or clinical trials, following applicant or marketing authorization holder
p.002007: use may not be invoked within one year from the date of the variation authorization issued by
p.002007: a regulatory authority of a Member State, when applying for a change in the classification of the same
p.002007: substance.
p.002007: Art. 182. The Medicines Executive Agency shall inform the European Commission and the regulatory authorities on an annual basis
p.002007: authorities of other Member States for changes in the list under Art. 179.
p.002007: Chapter Eight.
p.002007: PHARMACEUTICAL SAFETY TRACKING
p.002007: Section I.
p.002007: General Provisions (New, SG No. 102/2012, effective 21.12.2012)
p.002007: Art. 183. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: organizes and maintains a pharmacovigilance monitoring system for the implementation of the
p.002007: the obligations under this Chapter.
p.002007: (2) The system of para. 1 is used to gather information on the risks of medicinal products
p.002007: for patients' health and public health. The information covers unwanted messages
p.002007: drug reactions when using a medicinal product in accordance with the approved summary
p.002007: characteristics, as well as misuse and use information that is not in accordance with the approved one
p.002007: summary of product characteristics, including information on the side effects observed
p.002007: in the performance of professional duties.
p.002007: (3) The Executive Agency for Medicines shall validate, process and classify the information under para. 2,
p.002007: makes a scientific analysis of the data collected with a view to assessing the options for reduction and prevention
p.002007: risk and take the necessary action with regard to the marketing authorization
p.002007: product.
p.002007: (4) The Executive Agency for Medicines shall carry out audits of the system under para. 1 and every two years
p.002007: sends a report to the European Commission on the results thereof.
p.002007: (5) The Medicines Executive Agency shall implement an adequate and effective quality system in order
p.002007: ensure compliance of the system under para. 1 with the requirements of this law. The minimum requirements for
p.002007: the quality system is defined by Implementing Regulation (EU) No 520/2012.
p.002007: Art. 184. (Amended, SG No. 102/2012, effective 21.12.2012) (1) Medical specialists shall be obliged to
p.002007: notify immediately the holder of the marketing authorization or the BDA of any suspected serious
p.002007: adverse reaction and provide additional follow-up information upon request
p.002007: of the case.
p.002007: (2) Patients may report undesirable effects at any time on medical grounds
p.002007: specialists or the BDA.
p.002007: (3) In the cases of para. 1 and 2, where the communication concerns a biological medicinal product prescribed,
p.002007: distributed or sold on the territory of the Republic of Bulgaria, it must be clearly identified
...
p.002007: (2) In the cases of para. 1 The BDA informed the European Commission, the European Medicines Agency and the European Medicines Agency
p.002007: the regulatory authorities of the other Member States for the delegation of powers and publish a communication
p.002007: on the Internet portal under Art. 185, para. 1 or on your website.
p.002007: Art. 190. (amend. - SG 102/02, in force from 21.12.2012) (1) The holder of the marketing authorization is
p.002007: obliged to have a pharmacovigilance monitoring system to fulfill the
p.002007: your obligations under this chapter.
p.002007: (2) The holder of a marketing authorization through the system of para. 1 makes a scientific assessment of the collected
p.002007: information on the safety of medicinal products, assesses the potential for
p.002007: minimize or prevent risk and take the necessary measures.
p.002007: (3) The marketing authorization holder shall implement an adequate and effective quality system in order to
p.002007: ensure compliance of the system under para. 1 with the requirements of this law. The minimum requirements for
p.002007: the quality system is defined by Implementing Regulation (EU) No 520/2012.
p.002007: (4) The marketing authorization holder shall regularly audit the system under para. 1. Information about
p.002007: the main findings of the audit shall be noted in the main documentation of the system and shall be used to prepare
p.002007: a plan for the implementation of appropriate corrective actions. This information may be deleted after
p.002007: overall implementation of corrective actions.
p.002007: Art. 191. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
p.002007: designates a qualified person with an appropriate qualification responsible for drug monitoring
p.002007: safety.
p.002007: (2) The person under para. 1 is established in the territory of a Member State and is permanent and continuous on
p.002007: placement of the Marketing Authorization Holder.
p.002007: (3) To support the activity of the qualified person, the holder of the marketing authorization shall designate
p.002007: a person established in the territory of the Republic of Bulgaria. The appointment of such person shall not relieve him
p.002007: the qualified person under para. 1 of his responsibilities under this chapter.
p.002007: (4) The Marketing Authorization Holder shall submit the data to the BDA. 27, para. 1, item 12, letters "a" - "c"
p.002007: for the persons under para. 1 and 3.
p.002007: (5) The holder of the marketing authorization shall notify the BDA of any change in the data under para. 4.
p.002007: (6) The holder of the marketing authorization shall submit the data under para. 4 for the qualified person of
p.002007: European Medicines Agency.
p.002007: Art. 192. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization shall be
p.002007: shall:
p.002007: 1. maintains and makes available on request from the BDA the basic document of the traceability system
p.002007: drug safety;
p.002007: 2. apply a risk management system for each medicinal product;
p.002007: 3. monitor the outcome of the measures contained in the risk management plan, or
p.002007: 4. monitors the result of the fulfillment of the terms of the post. 55a, 56 or 56a;
p.002007: 5. update the risk management system;
p.002007: 6. monitors the data from the system under Art. 190, para. 1 to identify new risks or
p.002007: change the identified risks, and determine if changes in the ratio have occurred
p.002007: benefit / risk for the monitored medicinal product.
p.002007: (2) The content and procedure for maintaining the basic documentation of the traceability system
p.002007: pharmacovigilance is determined by Implementing Regulation (EU) No 520/2012.
p.002007: Art. 193. (amend. - SG 102/2012, in force from 21.12.2012) The holder of the marketing authorization
p.002007: inform the BDA and the European Medicines Agency of any new signals identified
p.002007: risks, or to change the identified risks, or to change the benefit / risk ratio of
p.002007: medicine.
p.002007: Art. 194. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
p.002007: at the same time or before providing the public with new information on concerns related to
p.002007: monitoring the safety of a medicinal product authorized in the territory of
p.002007: The Republic of Bulgaria, informs the BDA, the European Medicines Agency and the European Commission.
p.002007: (2) The information under para. 1 must be objective and not misleading.
p.002007: (3) Before disseminating information relating to pharmacovigilance,
...
p.002007: except for suspected adverse reactions from active medicinal products
p.002007: substances listed in Article 27 of Regulation (EC) No 726/2004 of the European Parliament and of the
p.002007: Council and described in literature, monitored by the European Medicines Agency.
p.002007: (4) The marketing authorization holder establishes procedures for the collection of accurate and reliable data,
p.002007: allowing the scientific evaluation of reports of suspected adverse reactions. The owner of
p.002007: the marketing authorization collects follow-up information regarding these communications and provides
p.002007: updated data in "EudraVigilance".
p.002007: (5) The form and content of the reports under para. 1 - 3 are laid down in Implementing Regulation (EU) No
p.002007: 520/2012.
p.002007: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: register in the system under art. 183 all reports of suspected adverse reactions,
p.002007: occurred on the territory of the Republic of Bulgaria by medical specialists and patients, and requires, at
p.002007: need, additional information from case tracking.
p.002007: (2) Where reports of suspected adverse reactions occurring within the territory of
p.002007: The Republic of Bulgaria has been submitted by the Marketing Authorization Holder, which he provides
p.002007: additional information from case tracking upon request from the BDA.
p.002007: Art. 194d. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: submits to the EudraVigilance database electronically all serious suspects
p.002007: undesirable effects occurring on the territory of the Republic of Bulgaria within 15 days from the date
p.002007: on receipt.
p.002007: (2) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002007: reports of all suspected adverse reactions other than those specified in para. 1, occurred
p.002007: within the territory of the Republic of Bulgaria, within 90 days from the date of receipt of the notification.
p.002007: (3) The Drug Enforcement Agency submits reports electronically to the EudraVigilance database
p.002007: suspected adverse reactions occurring on the territory of the Republic of Bulgaria as a result of
p.002007: misuse of a medicinal product. The Medicines Executive Agency shall inform thereof
p.002007: Ministry of Health and professional organizations of medical specialists.
p.002007: (4) Any body or institution to which information about a suspected adverse drug has been received
p.002007: a reaction occurring on the territory of the Republic of Bulgaria informs the BDA about this.
p.002007: (5) The content and format of the communications and reports under para. 1 - 3 are determined by the Regulation for
p.002007: Implementation (EU) No 520/2012.
p.002007: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: receives the information submitted by the Marketing Authorization Holder for serious suspects
p.002007: adverse reactions occurring within the European Union or in a third country through
p.002007: the EudraVigilance database.
p.002007: (2) The requirements for monitoring information in the EudraVigilance database are laid down in a Regulation.
p.002007: Implementing Regulation (EU) No 520/2012.
p.002007: Art. 194g. (New - SG 102/2012, in force since 21.12.2012) In the process of exchange of information of the BDA,
p.002007: the Marketing Authorization Holders and the European Medicines Agency are cooperating with the European Medicines Agency
p.002007: detecting duplicate reports of suspected adverse reactions.
p.002007: Section III.
p.002007: Periodic Safety Update Reports (New, SG No. 102/2012, in force)
p.002007: from 21.12.2012)
p.002007: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization is
p.002007: obliged to provide the European Medicines Agency electronically with periodic updates
p.002007: safety reports containing:
p.002007: 1. summaries of data on the benefit / risk balance of the medicinal product, including
p.002007: the results of all studies, with a view to their potential impact on the Marketing Authorization;
...
p.002007: or the termination of the relevant marketing authorizations, including a timetable for
p.002007: implementation of the opinion.
p.002007: (2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
p.002007: of the Marketing Authorizations, European Commission:
p.002007: 1. adopt a decision to change, suspend or terminate the marketing authorizations issued in accordance with
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002007: 2. adopt a decision recommending the change, suspension or termination of the marketing authorizations,
p.002007: issued by the relevant regulatory authorities of the Member States.
p.002007: (3) The Executive Agency for Medicinal Products shall apply the provisional and / or definitive measures of the decision on
p.002007: para. 2, Vol. 2.
p.002007: Section IV.
p.002007: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002007: 12/21/2012)
p.002007: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure at European Union level
p.002007: can be initiated by the European Commission, the European Medicines Agency or a country
p.002007: state.
p.002007: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under the procedure
p.002007: of this section by informing the regulatory authorities of the other Member States the European Agency
p.002007: on medicines and the European Commission, when for reasons related to drug monitoring
p.002007: safety, consider that a medicinal product placed on the Bulgarian market is necessary
p.002007: take any of the following measures:
p.002007: 1. suspension or termination of the marketing authorization;
p.002007: 2. prohibition of distribution of a medicinal product;
p.002007: 3. issuing a refusal to renew the marketing authorization.
p.002007: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para. 2 when
p.002007: has been informed by the Marketing Authorization Holder that for traceability reasons
p.002007: drug safety, suspends the distribution of the medicinal product or has taken, or
p.002007: intends to take action to withdraw it from the market or not to take action on
p.002007: renewal of the marketing authorization.
p.002007: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure under para.
p.002007: 2 and where it considers that for reasons of pharmacovigilance,
p.002007: new contraindications must be added or reduced for a medicinal product
p.002007: the recommended dose or indication should be limited.
p.002007: (5) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall submit to the European Agency
p.002007: on medicines and regulatory authorities of other Member States all scientific information with which
p.002007: it shall have, as well as the data evaluation carried out, the reasons for initiating the procedure in accordance with this
p.002007: section.
p.002007: (6) (Amended, SG No. 18/2014) In the cases of para. 2 - 4 The European Medicines Agency notifies the BDA of
p.002007: initiation of the procedure when safety concerns also apply to other medicinal products
p.002007: products that belong to the same therapeutic group or that contain the same active substance
p.002007: substance with the product specified in the information under para. 5, or where this medicinal product is authorized for
p.002007: use in another or in other Member States.
p.002007: (7) (amend. - SG 18/04) In the cases of para. 4, when no emergency measures are required, BDA
p.002007: apply the procedure under Art. 77 or 79b.
...
p.002007: Art. 194f within 30 days from the date of receipt and issue an opinion on the retention, change,
p.002007: suspension, termination of the relevant marketing authorizations or refusal of
p.002007: their renewal, including a timetable for the implementation of the opinion.
p.002007: (2) Where the opinion recommends the taking of postal measures. 194ts, para. 3, item 5, the executive
p.002007: the BDA Director shall by order suspend or terminate the Marketing Authorization or refuse
p.002007: its renewal.
p.002007: (3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued,
p.002007: the marketing authorization holder submits to the BDA an application for change including an updated one
p.002007: a summary of the product characteristics and a leaflet, within the specified implementation schedule.
p.002007: (4) Where in the opinion under para. 1 it is recommended to take post measures. 194ts, para. 3, Vol. 2 - 4,
p.002007: the holder of the marketing authorization takes the necessary action and informs the BDA and
p.002007: the regulatory authorities of the other Member States.
p.002007: (5) Where within the coordination group under Art. 77, para. 2 cannot be reached,
p.002007: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002007: decision recommending change, suspension or termination of the marketing authorization granted by
p.002007: the relevant regulatory authorities of the Member States.
p.002007: (6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5 temporary and / or
p.002007: final measures.
p.002007: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where, within the scope of the procedure, Art. 194y
p.002007: a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002007: Parliament and the Council, the Committee on Medicinal Products for Human Use, on the basis of the recommendation
p.002007: under Art. 194ts, para. 3 within 30 days from the date of receipt and issue an opinion on retention,
p.002007: modification, suspension, termination of the relevant marketing authorizations or refusal
p.002007: their renewal, including a timetable for the implementation of the opinion.
p.002007: (2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
p.002007: of the Marketing Authorizations, European Commission:
p.002007: 1. Decides to change, suspend or terminate the validity of the marketing authorizations,
p.002007: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002007: 2. adopt a decision recommending the change, suspension or termination of the validity of the permissions for
p.002007: use issued by the relevant regulatory authorities of the Member States.
p.002007: (3) The Medicines Executive Agency implements the recommendations made in the European Commission decision on
p.002007: para. 2, item 2 provisional and / or final measures.
p.002007: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) 194ts, para. 1, the opinion of
...
p.002007: (5) (New, SG No. 102/2012, effective 02.01.2013) Upon request by the European Commission or by
p.002007: the BDA Member State shall provide information on the marketing authorization for medicinal products
p.002007: products.
p.002007: Art. 206. (1) In case of change of the circumstances, related to the issued permit for wholesale trade,
p.002007: the holder submits an application to the BDA pursuant to Art. 199, to which the change related
p.002007: documentation.
p.002007: (2) The permit for change shall be issued under the conditions and by the order of art. 200 - 202. When changing
p.002007: the storage premises the term under Art. 202, and in other cases the deadline is 14 days.
p.002007: Art. 207. (1) The holder of a wholesale trade permit who conducts his business in the territory
p.002007: of the Republic of Bulgaria shall be obliged to:
p.002007: 1. provides access at all times to the control bodies to the premises for storage of medicinal products
p.002007: products;
p.002007: 2. trade only in medicinal products authorized under this Law;
p.002007: 3. trade in medicinal products whose packaging and leaflets are in accordance with the authorization granted
p.002007: use, under the terms and procedure of this law and their expiry date;
p.002007: 4. obtains medicinal products only from manufacturers, importers or wholesalers of medicinal products
p.002007: products authorized to carry out this activity under this law;
p.002007: 4a. (new - SG 102/2012, in force from 02.01.2013) check whether the received medicinal products from
p.002007: the persons under item 4 are not falsified by checking the safety indicators on the secondary
p.002007: package;
p.002007: 5. supply medicinal products to other holders of a wholesale, pharmacy and drug store authorization,
p.002007: opened in accordance with this law;
p.002007: 5a. (new - SG 71/08, in force from 12.08.2008, amended - SG, iss. 84 from 2018, in force since 12.10.2018)
p.002007: supplies medicinal products to meet their own needs:
p.002007: a) medical establishments;
p.002007: b) higher schools, which carry out medical activity according to Art. 2a of the Medical Institutions Act;
p.002007: c) the institutions of art. 26, para. 1, items 1 and 3 of the Health Act for the health offices established therein;
p.002007: (d) shipowners for the purpose of supplying medicinal products on board ships in accordance with
p.002007: The Merchant Shipping Code;
p.002007: 6. supply doctors and dentists with medicinal products when there is no place in the settlement
p.002007: a pharmacy, under the conditions and in the order laid down in an ordinance of the Minister of Health;
p.002007: 6a. (new - SG, issue 102 of 2012, in force since 02.01.2013, suppl. - SG, iss. 84 of 2018, in force since 12.10.2018)
p.002007: shall enter in the delivery documents the batch number of the medicinal products delivered as well as the address of
p.002007: delivery of medicinal products;
p.002007: 6b. (new - SG 102/2012, in force from 02.01.2013) has an emergency plan, which
p.002007: contains effective measures to withdraw a medicinal product from the market by order of the BDA or
p.002007: an initiative of the manufacturer or the holder of the marketing authorization for the medicinal product concerned
p.002007: product;
p.002007: 6c. (new - SG 18/2014) ensure the supply of sufficient quantities of medicinal products for
p.002007: meeting the health needs of the population of the Republic of Bulgaria;
p.002007: 7. (amend. - SG 102/2012, in force from 02.01.2013) store data for each transaction with received, delivered
...
p.002007: suspicion that the mediation product is counterfeit;
p.002007: 7. check that the trader holds a license for wholesale of medicinal products;
p.002007: 8. verify that the manufacturer or importer holds a manufacturing / import permit;
p.002007: 9. to keep the data under item 3 for a period of at least 5 years and to provide them at the request of the control bodies
p.002007: organs.
p.002007: (2) The requirements for mediation activities in the field of medicinal products shall be determined by
p.002007: the ordinance under Art. 198 and in European Commission guidance.
p.002007: Chapter Nine "a".
p.002007: PARALLEL IMPORTS OF MEDICINAL PRODUCTS (PREVIOUS SECTION II - SG 71/00)
p.002007: 2008, IN EFFECT OF 12/08/2008)
p.002007: Art. 213. (amend. - SG 71/08, in force from 12.08.2008) Parallel import of medicinal products of
p.002007: the territory of the Republic of Bulgaria may be exercised by a natural or legal person registered under
p.002007: Commercial law, under the law of a Member State, after obtaining a parallel permit
p.002007: imports issued by the BDA Executive Director.
p.002007: Art. 214. (1) A medicinal product authorized for use in another Member State may be imported in parallel
p.002007: in the territory of the Republic of Bulgaria, when it is identical or similar to a medicinal product authorized for
p.002007: use in the Republic of Bulgaria by the order of this law.
p.002007: (2) (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 12/2011, in force from 08.02.2011)
p.002007: the meaning of para. 1 identical or similar medicinal product is one which has the same qualitative and quantitative value
p.002007: composition with respect to the active substance (s) available in the same drug
p.002007: form, available in the same primary packaging, with a similar graphic design to the packaging.
p.002007: Art. 215. (1) (amend. - SG 71/08, in force from 12.08.2008) For obtaining a permit for
p.002007: parallel import of a medicinal product into the territory of the Republic of Bulgaria by the person under Art. 213 lodges
p.002007: an application to the BDA Executive Director stating the Member State from which it will perform
p.002007: parallel import of a medicinal product.
p.002007: (2) The following data and documents shall be attached to the application:
p.002007: 1. name, dosage form, quantity of active substance per unit dose of authorizations
p.002007: use in the Republic of Bulgaria of a medicinal product;
p.002007: 2. name, dosage form, amount of active substance per unit dose of the medicinal product
p.002007: product intended for parallel import;
p.002007: 3. (suppl. - SG 12/11, in force from 08.02.2011) the name of the holder of the marketing authorization and of
p.002007: the manufacturer, if he is a person other than the holder of the marketing authorization, of the medicinal product,
p.002007: intended for parallel imports;
p.002007: 4. the number of the marketing authorization for the medicinal product in the Republic of Bulgaria and the number of
p.002007: the authorization to use the medicinal product in the parallel Member State
p.002007: import;
p.002007: 5. statement on establishing the circumstances under art. 217, v. 1;
p.002007: 6. a copy of the leaflet for the patient and a sample of the medicinal product as sold in the country
p.002007: Member from which parallel importation is made, translation of the contents of the leaflet into Bulgarian,
...
p.002007: medicinal products under letter "a";
p.002007: (d) the date on which the importation / delivery was made under letters "a" and "b";
p.002007: (e) the quantities available in the stores indicated by medicinal products included in the Positive Medicinal Product
p.002007: a list of holders of the parallel import authorization.
p.002007: Chapter Nine "b".
p.002007: EXPORTS OF MEDICINAL PRODUCTS. SPECIALIZED ELECTRONIC SYSTEM FOR
p.002007: FOLLOW-UP AND ANALYSIS OF THE MEDICINAL PRODUCTS (NEW, SG 18/14
p.002007: G., TITLE. AMENDED. - DV, BR. 84 FROM 2018, IN EFFECT ON 12/10/2018)
p.002007: Chapter Nine "b".
p.002007: EXPORT OF MEDICINAL PRODUCTS (NEW, SG No. 18/2014)
p.002007: Art. 217a. (New, SG No. 18/2014) (1) Export of medicinal products from the territory of the Republic
p.002007: Bulgaria may be a natural or legal person holding a wholesale marketing authorization
p.002007: with medicinal products or a manufacturing authorization holder.
p.002007: (2) The holder of a manufacturing authorization may export only the ones produced by him
p.002007: medical products.
p.002007: (3) For the purposes of this Chapter, exports are also intra-Community supplies within the European Union.
p.002007: (4) (amend. - SG 84/08, in force from 12.10.2018) Medicinal products included in the Positive
p.002007: medicinal list for which a shortage has been established in accordance with Art. 217b, cannot be exported for the term
p.002007: contained in the list under Art. 217c, para. 1.
p.002007: Art. 217b. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018) (1)
p.002007: Specialized electronic system for tracking and analyzing the medicinal products included in
p.002007: The positive drug list, administered and maintained by the Executive Agency
p.002007: medicines.
p.002007: (2) The creation and maintenance of the specialized electronic system under para. 1 is done on the basis of
p.002007: on the following principles:
p.002007: 1. ensuring the accuracy and accuracy of the data submitted and stored;
p.002007: 2. providing an appropriate data exchange environment;
p.002007: 3. ensuring regulated access to the data in the electronic information system in compliance
p.002007: the requirements of the law;
p.002007: 4. ensuring interoperability and information security.
p.002007: (3) The specialized electronic system of para. 1 contains:
p.002007: 1. the information under art. 54, Art. 54a, Art. 68, para. 1, Vol. 10, Art. 207, para. 1, Vol. 15, Art. 217, item 5 and art. 232a provided
p.002007: by the persons concerned;
p.002007: 2. information provided by the National Health Insurance Fund about the quantities indicated
p.002007: on paid medicinal products included in the Positive Medicinal List for the previous one month;
p.002007: 3. information provided by the Ministry of Health about the quantities indicated under
p.002007: paid medicinal products included in the Positive Medicinal List for the previous one month.
p.002007: (4) On the basis of the information under para. 3 through the specialized electronic system of para. 1 is performed
p.002007: shortage analysis of medicinal products included in the Positive Medicinal List, of
p.002007: the territory of the Republic of Bulgaria under the conditions and in the order specified in the ordinance under para. 8.
p.002007: (5) The shortage under para. 4 of the medicinal products included in the Positive Medicinal List are established,
p.002007: when performing the analysis under par. 4 was found to be available on the territory of the Republic of Bulgaria
...
p.002007: and for the administration, maintenance and access to the specialized electronic system under para. 1 se
p.002007: determined by an ordinance of the Minister of Health.
p.002007: (9) The Medicines Executive Agency is obliged to provide the network and information
p.002007: security of the specialized electronic system under para. 1 subject to the obligation of secrecy
p.002007: of the information received under para. 3.
p.002007: Art. 217c. (New, SG No. 18/2014, declared as unconstitutional SRKS No. 1 of 2015 - SG, issue 12 of
p.002007: 2015, as amended. - SG, issue. 84 of 2018, effective 12.10.2018) (1) A list of medicinal products is hereby established,
p.002007: included in the Positive Medicinal List for which there is a shortage in the territory of the Republic
p.002007: Bulgaria, which is being prepared, updated and maintained by the Bulgarian Medicines Executive Agency.
p.002007: (2) The list under para. 1 shall be prepared on the basis of the analysis performed in accordance with Art. 217b, para. 4 and is published on
p.002007: the website of the Executive Agency for Medicinal Products.
p.002007: (3) The list of medicinal products for which a shortage has been established pursuant to Art. 217b, para. 5, is prepared
p.002007: by name of the medicinal product included in the Positive Medicinal List, internationally
p.002007: non-patent name, amount of active substance, dosage form and quantity in pack.
p.002007: (4) The list under para. 1 is being updated:
p.002007: 1. weekly;
p.002007: 2. in case of change of circumstances related to the import and / or export of medicinal products included in
p.002007: Positive drug list.
p.002007: (5) Upon updating the list in the order of para. 4, item 1, as well as in the cases when the circumstances under
p.002007: para. 4, item 2, based on the information provided under Art. 68, para. 1, Vol. 10, Art. 207, para. 1, item 15 and art. 217, v. 5,
p.002007: through the specialized electronic system of art. 217b, para. 1 a message shall be sent to the persons under Art. 68, para.
p.002007: 1, Art. 207, para. 1, Art. 217 and Art. 232a for the updated list. The list shall be published immediately on the Internet
p.002007: the page of the Executive Agency for Medicines.
p.002007: (6) In the cases of para. 4 the list under para. 1 shall be forwarded by the BDA and the Customs Agency by official order.
p.002007: (7) After the inclusion of medicinal products in the list under para. 1 they may not be exported for the period for which they are
p.002007: contain in the list.
p.002007: Art. 217g. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018)
p.002007: the medicines agency checks the persons who are obliged to provide information on
p.002007: the order of this chapter.
p.002007: Chapter Ten.
p.002007: RETAIL TRADE OF MEDICINAL PRODUCTS
p.002007: Art. 218. Retail trade in medicinal products shall be carried out only in pharmacies and drug stores in accordance with this
p.002007: law, except in cases under Art. 232, para. 2.
p.002007: Art. 219. (1) (amend. - SG 71/08, in force from 12.08.2008, suppl. - SG, iss. 23 in 2009, in force since 30.03.2009
p.002007: g., add. - SG, issue. 41 of 2009, in force since 02.06.2009, as amended. - SG, issue. 60 of 2011, effective 05.08.2011)
p.002007: The pharmacy is a health establishment that performs the following activities: storage, preparation, packaging,
p.002007: controlling, consulting, prescribing, and prescribing, non-prescribing
p.002007: use in the Republic of Bulgaria of medicinal products, medical devices, dietary foods for
p.002007: special medical purposes and infant formulas and follow-on formulas and nutritional supplements, cosmetic and
p.002007: hygiene products.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) The structure, the order and the organization of the work of
p.002007: pharmacies, the nomenclature of medicinal products, are laid down in an ordinance of the Minister of Health
p.002007: healthcare.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008, repealed - SG, iss. 23 of 2009, in force from 30.03.2009)
p.002007: Art. 220. (1) The activities under art. 219, para. 1 are performed by the Master of Pharmacy.
p.002007: (2) (suppl. - SG 71/08, in force from 12.08.2008) The master pharmacist shall be obliged to fulfill the issued
p.002007: prescription, including for the formulations of the trunk and pharmacopoeial form
p.002007: formulation, according to the procedure specified in the ordinance under Art. 221, para. 1.
p.002007: (3) (amend. - SG 102/2012, in force from 02.01.2013) The assistant-pharmacist may perform all
p.002007: activities under art. 219, para. 1 under the control of a pharmacist, except for: dispensing a medicinal product
...
p.002007: 4. name of the head of the drugstore;
p.002007: 5. address of the drugstore;
p.002007: 6. date of termination of the registration and the reason for it.
p.002007: Art. 242. In case of change of address of the drugstore or the head, the person, who has received a certificate for
p.002007: opening and submits an application in accordance with Art. 239, para. 2 and the documents related to the change.
p.002007: Art. 243. The terms and conditions for the organization of work in the drugstore shall be laid down in an ordinance of the Minister of Medicine.
p.002007: healthcare.
p.002007: Chapter eleven.
p.002007: ADVERTISING OF MEDICINAL PRODUCTS
p.002007: Art. Article 244. (1) Advertising of medicinal products shall be any form of information, presentation, promotion or
p.002007: proposals to promote the prescription, sale or use of the medicinal product; and
p.002007: includes:
p.002007: 1. advertising aimed at the population;
p.002007: 2. advertising intended for medical specialists;
p.002007: 3. visit of medical sales representatives to medical specialists;
p.002007: 4. providing samples of medicinal products;
p.002007: 5. sponsorship of promotional meetings and scientific congresses attended by medical professionals,
p.002007: including the reimbursement of their travel and stay expenses in the country in which they are located
p.002007: conducts the event.
p.002007: (2) Does not constitute advertising of medicinal products:
p.002007: 1. text on the immediate packaging and in the package leaflet approved in the authorization procedure for
p.002007: use;
p.002007: 2. correspondence regarding a specific issue or problem related to a medicinal product;
p.002007: 3. information messages and instructions on changes in packaging, warnings for unwanted ones
p.002007: drug reactions as part of general product safety measures, commercial catalogs
p.002007: and price lists, provided that they do not include drug-related advertising data
p.002007: product;
p.002007: 4. statements relating to human health or diseases where they do not directly or indirectly
p.002007: direct treatment, prevention or diagnosis with medicinal products;
p.002007: 5. vaccination campaigns conducted by the Ministry of Health of the population when
p.002007: related materials do not contain data for a specific medicinal product.
p.002007: Art. 245. (1) The holder of the marketing authorization shall be obliged to establish a scientific unit for
p.002007: dissemination of information on medicinal products for which it has been authorized
p.002007: the order of this law.
p.002007: (2) The marketing authorization holder shall be obliged to:
p.002007: 1. ensure that the advertising of the medicinal product is presented to the general public or the medical community
p.002007: specialists in a form that complies with the requirements of this Chapter and in accordance with the authorization issued
p.002007: for advertising by the BDA;
p.002007: 2. has data and materials from all advertising campaigns undertaken in the course of his activity,
p.002007: including information about the ad groups they are targeted for, how they should be implemented,
p.002007: as well as the start date of the ad campaign
p.002007: 3. ensure the training of medical sales representatives;
p.002007: 4. Execute exactly and in due time the instructions of the advertising control officials.
p.002007: (3) The medical sales representatives shall report to the scientific units under para. 1 any information
p.002007: about the use of the medicinal products they advertise, especially with regard to information on
p.002007: side effects reported to them by healthcare professionals.
p.002007: Art. 245a. (New - SG 71/08, in force from 12.08.2008) Advertising is allowed only on medicinal products
p.002007: products for which a marketing authorization has been granted under this Act.
...
p.002007: (2) The activity of the council shall be financed from the state budget through the budget of the Ministry of Public Administration
p.002007: healthcare.
p.002007: (3) The Council is a collegial body and consists of a chairman and six members, three of whom are doctors or
p.002007: Master of Pharmacy, two lawyers and two economists, all with a minimum of 5 years of experience
p.002007: years. The Chairman and the members of the Council are elected and dismissed by a decision of the Council of Ministers
p.002007: at the proposal of the Minister of Health. The chairman directs the activity of the council and it
p.002007: represents.
p.002007: (4) The members of the council may not occupy a position or carry on business post. 19, para. 6 of the Law on
p.002007: the administration.
p.002007: (5) The activity of the council shall be assisted by an administration whose structure and organization of work are
p.002007: determine by regulation, adopted by the Council of Ministers.
p.002007: Art. 259. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: (1) The Council:
p.002007: 1. approve, refuse to approve, amend or delete the price of medicinal products by mail. 261a, para. 1;
p.002007: 2. approve, refuse to approve, amend or delete the marginal price of medicinal products by mail. 261a,
p.002007: para. 2;
p.002007: 3. register, refuse to register, amend or delete the prices of medicinal products without
p.002007: medical prescription under Art. 261a, para. 3;
p.002007: 4. (Am. - SG, iss. 48 in 2015; amend. - SG, iss. 102 from 2018, effective from 01.01.2019, amended and supplemented - SG, iss. 64 from
p.002007: 2019) adopt, revoke or amend pharmacotherapeutic guidelines that include assessment criteria
p.002007: of the result of the therapy applied and algorithms for drug treatment in agreement with
p.002007: the relevant expert council on medical specialty or medical activity under art. 6a, para. 1, item 1 of
p.002007: Health Law. Pharmacotherapeutic guidelines are adopted by regulations and promulgated in the State
p.002007: newspaper ";
p.002007: 5. include, modify or exclude medicinal products from the Positive Medicinal List;
p.002007: 6. (New - SG, iss. 102 in 2018) effective assessment of the health technologies of
p.002007: medical products;
p.002007: 7. (prev. Item 6 - SG, iss. 102 in 2018, effective from 01.01.2019) maintains and updates the Positive
p.002007: medication list;
p.002007: 8. (new, SG No. 48/2015, prev. Item 7 - SG, issue 102 of 2018, effective from 01.01.2019)
p.002007: the reimbursement status of the medicinal products every three years after their inclusion in the Positive
p.002007: medication list;
p.002007: 9. (new, SG No. 48/2015, prev. Item 8, amended - SG, No. 102/2018, in force from 01.01.2019)
p.002007: assistance in negotiating discounts in the cases under Art. 45, para. 10, 13 and 21 of the Health Act
p.002007: insurance for medicinal products for which applications for inclusion in the Positive Medicinal Product have been submitted
p.002007: list;
p.002007: 10. (new - SG 102 2018, in force from 01.01.2019) determine the medicinal products for which
p.002007: traces the effect of the therapy, the term, as well as the medical establishments in which it is performed, under conditions, according to
p.002007: order and criteria set out in the ordinance under Art. 261a, para. 5;
p.002007: 11. (New, SG No. 102/2018) effect information, publishing and
p.002007: research, research related to pricing, reimbursement and drug policy.
p.002007: (2) The Council shall keep public registers of:
p.002007: 1. the approved prices of the medicinal products shall be sent. 261a, para. 1;
p.002007: 2. the approved marginal prices of the medicinal products shall be sent. 261a, para. 2;
p.002007: 3. the registered prices of the medicinal products shall be sent. 261a, para. 3.
p.002007: (3) The Council shall exercise control over the sale of approved medicinal products, the marginal price
p.002007: price and registered price.
p.002007: (4) The Council accepts the written applications for approval or price registration or for inclusion,
p.002007: exclusion and alteration of medicinal products from the Positive Medicinal List under this Chapter shall be carried out
p.002007: inspections and studies on them and make informed decisions.
p.002007: (5) The Council shall collect fees in the amounts specified in the postal tariff. 21, para. 2, to submit applications for:
p.002007: 1. approval, registration or change in the approved or registered price of a medicinal product;
p.002007: 2. (amend. - SG 48/2015) inclusion, change or maintenance of the reimbursement status of a person included in
p.002007: the list under Art. 262, para. 1 medicinal product;
p.002007: 3. (new, SG No. 102/2018) effective assessment of health technologies.
p.002007: Art. 259a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG No. 102/2012, effective 21.12.2012
p.002007: (d) (1) The meetings of the Council shall be regular if they are attended by more than half of the total number of
p.002007: its members.
p.002007: (2) The Council shall act by a majority of more than half of its total members.
p.002007: (3) (New, SG No. 102/2018, in force from 01.01.2019)
p.002007: representative / representatives of NHIF, Ministry of Health and BDA when performed
p.002007: health technology assessment.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 102/2018) Effective on 01.01.2019
p.002007: interested parties to be notified of the date and time of the meeting at which
p.002007: the request made will be considered.
p.002007: Art. 259b. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102 of 2012, effective 21.12.2012
p.002007: (d) (1) The Council shall act within:
p.002007: 1. sixty days, when an application for price approval under Art. 261a, para. 1 and turn on
p.002007: the medicinal product in the Positive Medicinal List;
p.002007: 2. thirty days, when an application for change or deletion of a positive drug is submitted
p.002007: product list;
p.002007: 3. thirty days when the application for approval, change or deletion of a postage price is submitted. 261a,
p.002007: para. 2;
p.002007: 4. thirty days, when an application for registration, change or deletion of a post price has been submitted. 261a,
p.002007: para. 3;
p.002007: 5. thirty days for approval / registration of the price of the medicinal products for which it has been received
p.002007: parallel import authorization;
p.002007: 6. (new - SG 48/15, amend. - SG 102/2018) one hundred and eighty days when
p.002007: an application for inclusion in the Positive Medicines List of a new medicinal product has been submitted
p.002007: an international non-proprietary name that is subject to health technology assessment;
p.002007: 7. (new, SG No. 48/2015) sixty days when an application for maintaining the reimbursement has been submitted
p.002007: status of included medicinal product in the Positive Medicinal List;
p.002007: 8. (new - SG 102/2018) ninety days when the application for
p.002007: expanding the indications for a product that is not currently on the Positive Medicinal List
p.002007: paid;
p.002007: 9. (new - SG 102/2018) ninety days when an application for assessment has been submitted
p.002007: of health technology.
p.002007: (2) For the medicinal products under Art. 262, para. 5 the council shall act within thirty days, when it is
p.002007: application for price approval under art. 261a, para. 1 and including the product in the Positive
p.002007: medication list.
p.002007: (3) The time limits under para. 1 and 2 shall commence on the date of submission of an application in accordance with the procedure of the postal order.
p.002007: 261a, para. 5.
p.002007: Art. 259c. (New, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 102/2012, effective 21.12.2012
p.002007: d)
...
p.002007: the budget of the NHIF, from the state budget outside the scope of compulsory health insurance, from the budget
p.002007: of the medical establishments under art. 5 of the Medical Institutions Act and the budget of the medical establishments with
p.002007: state and / or municipal participation under Art. 9 and 10 of the Medical Institutions Act.
p.002007: (2) (amend. - SG 102/08, in force from 01.01.2019) The positive medical list includes medicinal
p.002007: products classified by pharmacological groups according to the anatomical-therapeutic-chemical code
p.002007: classification, with the corresponding international non-patent names belonging to them
p.002007: names, with the corresponding defined daily dose / therapeutic course, price under Art. 261a, para. 1, limit
p.002007: price of medicinal products at retail sale, reference value for defined daily use
p.002007: dose / therapeutic course, packing value calculated on the basis of reference / therapeutic
p.002007: a defined daily dose course, pay level, therapeutic indications, and an international
p.002007: diseases (ICD). For medicinal products, the reference value is established on the basis of
p.002007: a defined defined daily dose or therapeutic course, or concentration or volume.
p.002007: (3) (amend. - SG 102/08, in force from 01.01.2019) The Positive medicinal list shall include
p.002007: medicinal products to which the international non-patent name to which it belongs
p.002007: the medicinal product / combination (for combined medicinal products) is to be paid by the public
p.002007: health insurance fund with the same therapeutic indications in at least 5 countries specified in the Ordinance on
p.002007: Art. 261a, para. 5.
p.002007: (4) (Supplemented, SG No. 48/2015, amended, SG No. 102/2018) Effective January 1, 2019
p.002007: The positive drug list is selected according to evidence of efficacy, therapeutic
p.002007: efficacy, safety and analysis of pharmacoeconomic indicators such as for medicinal products with
p.002007: a new international non-proprietary designation also evaluates healthcare technology. The assessment of
p.002007: Health technologies shall be carried out under the conditions and in the order determined by the ordinance under Art. 261a, para. 5.
p.002007: (5) (amend. - SG 102/08, in force from 01.01.2019) Where one or more medicinal products with
p.002007: the same international non-patent name, dosage form and concentration of the active substance,
p.002007: already included in the relevant part of the Positive Medicinal List, no assessment under para. 4.
p.002007: (6) The positive medical list includes:
p.002007: 1. medicinal products intended for the treatment of diseases, which are paid in accordance with the Law on
p.002007: health insurance;
p.002007: 2. medicinal products paid from the budget of the medical establishments under art. 5 of the Law on Healing
p.002007: establishments and from the budget of medical establishments with state and / or municipal participation 9 and 10 of the Law on
p.002007: medical establishments;
p.002007: 3. medicinal products intended for the treatment of AIDS, infectious diseases, diseases
p.002007: outside the scope of the Health Insurance Act, paid in accordance with Art. 82, para. 1, item 8 of the Law on
p.002007: health as well as vaccines for compulsory immunizations and immunizations, vaccines for special indications and
p.002007: in exceptional circumstances, specific sera, immunoglobulins;
p.002007: 4. the marginal price of the medicinal products under Art. 261a, para. 4 by elements.
p.002007: (7) The Ministry of Health and the NHIF may submit proposals to the council by post. 258, para. 1 for
p.002007: review of included medicinal products in the Positive Medicinal List under conditions and in order,
p.002007: defined in the ordinance under art. 261a, para. 5.
p.002007: (8) The National Health Insurance Fund shall pay for the medicinal products under para. 6, item 1 under the conditions and under
p.002007: the order of the ordinance under art. 45, para. 9 of the Health Insurance Act.
p.002007: (9) (New, SG No. 18/2014, Supplemented, SG No. 48/2015) Conditions, rules and criteria for inclusion,
p.002007: changes and / or exclusion of medicinal products from the Positive Medication List and to maintain
p.002007: the reimbursement status of the medicinal products shall be determined in the ordinance under Art. 261a, para. 5.
p.002007: (10) (New, SG No. 48/2015, amend. - SG 102/08, in force from 01.01.2019) Medicinal Products
p.002007: under Art. 45, para. 10, 13 and 21 of the Health Insurance Act, for which no discounts have been agreed, do not
p.002007: are included in the Positive Medication List. Discount contracts come to the board of
p.002007: the order specified in the ordinance under Art. 261a, para. 5.
p.002007: (11) (New, SG No. 48/2015, amend. - SG 102/2018) Medicinal Products,
p.002007: for which in the procedure under Art. 259, para. 1, item 8 does not prove a positive assessment upon their inclusion, does
p.002007: are excluded from the Positive Medication List.
p.002007: (12) (New, SG No. 84/2018, effective 12.10.2018, amended - SG No. 102/2018, effective 01/01/2019)
p.002007: The Ministry of Health pays the medicinal products under para. 6, item 3 with a new international
p.002007: a non-patent name, if it has been concluded before being included in the Positive Drug List
p.002007: preliminary framework agreement between the Ministry of Health and the holder of the
p.002007: the marketing authorization / authorized representative of the maximum value to which
p.002007: the relevant medicinal product may be delivered to the Ministry of Health in the order of
p.002007: Public Procurement Law. The agreement is binding on the parties. The agreements
p.002007: act in the council in the order determined by the ordinance of art. 261a, para. 5.
p.002007: (13) (New, SG No. 102/2018) The medicinal products under para. 6, item 3 with a new one
p.002007: international non-patent name for which no prior framework agreement has been concluded under para.
p.002007: 12 are not included in the Positive Medication List.
p.002007: Art. 262a. (New, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 102/2012, effective 21.12.2012,
p.002007: new - SG, iss. 102 of 2018, effective January 1, 2019) (1) Assessment of health technologies under Art. 262, para. 4 do not
p.002007: performs for generic medicinal products and for medicinal products containing active / active
p.002007: substance / substances with well-established use in medical practice.
p.002007: (2) Health products shall be evaluated for medicinal products included in the Positive Medicinal List
p.002007: technologies where an extension of therapeutic indications has been requested and has not yet been paid for
p.002007: by public funds, under conditions and in the order determined by the ordinance under Art. 261a, para. 5.
p.002007: (3) The Ministry of Health and the NHIF may reasonably request an assessment of the
p.002007: the health technologies of medicinal products included in the Positive Medicinal List under conditions and conditions
p.002007: order determined by the ordinance under art. 261a, para. 5.
...
p.002007: Art. 259, para. 1, item 10 shall be carried out by medical establishments, determined by the National Council for prices and
p.002007: reimbursement of medicinal products.
p.002007: (2) The National Health Insurance Fund and the Ministry of Health shall carry out an analysis of
p.002007: the information collected by the medical establishments under para. 1 under the conditions and according to the procedure specified in the ordinance under Art.
p.002007: 261a, para. 5.
p.002007: Art. 263. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 15 in 2013, in force since 01.01.2014)
p.002007: With state budget funds outside the scope of compulsory health insurance can be
p.002007: pay for prescription medicines not included in the list under Art.
p.002007: 262, para. 1 required for the prevention or treatment of epidemic outbreaks, epidemics, pandemics, and
p.002007: in the presence of suspected or confirmed distribution of chemical or biological agents; or
p.002007: nuclear radiation.
p.002007: Art. 264. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: (1) (Supplemented, SG No. 18/2014) Upon termination of the sales under Art. 54, para. 3 per medicinal product,
p.002007: which is included in the Positive Medicinal List and, where relevant, internationally
p.002007: non - patent name is not authorized by this law for any other medicinal product the proprietor of
p.002007: the marketing authorization is notified in writing to the Ministry of Health and the National Council for Health
p.002007: prices and reimbursement of medicinal products.
p.002007: (2) (Supplemented, SG No. 18/2014) The holder of the marketing authorization shall notify in writing
p.002007: The Ministry of Health and the National Council on Drug Price and Reimbursement
p.002007: products and in the event of discontinuation of sales of a medicinal product for which the price is for
p.002007: setting a benchmark within the relevant international non - patent name; and
p.002007: dosage form.
p.002007: (3) Where the product under para. 1 and 2 is intended for the treatment of diseases payable in the order of
p.002007: The Health Insurance Act, the marketing authorization holder also informs the NHIF in
p.002007: the terms under para. 4.
p.002007: (4) The holder of the marketing authorization shall be obliged to make the notification under para. 1 not later than
p.002007: 18 months before the date of cessation of sales, and in the cases under par. 2 - no later than three months
p.002007: before the date of discontinuation of sales.
p.002007: (5) (Supplemented, SG No. 18/2014) Until the termination of the sales under para. 1 and 2 of the authorization holder
p.002007: is obliged to provide sufficient quantities of the relevant medicinal product for use in order to satisfy
p.002007: health needs, except in cases where the suspension is due to any of the grounds under Art.
p.002007: 276 or under Art. 277.
p.002007: (6) After the expiry of the terms under para. 4, the Marketing Authorization Holder submits an application and
p.002007: the relevant documents to exclude the medicinal product from the Positive Medicinal List.
p.002007: (7) Where, following the cessation of sales of the medicinal product, the holder of the authorization for
p.002007: use has not fulfilled its obligation under par. 6, the council under art. 258, para. 1 ex officio excludes him from
p.002007: Positive drug list.
p.002007: Art. 265. (1) The Council of Ministers shall establish a Transparency Committee.
p.002007: (2) (Supplemented, SG No. 60/2011, effective 05.08.2011) The composition of the Transparency Committee shall be determined by
p.002007: The Council of Ministers on a proposal from the Minister of Health. It is mandatory to include
p.002007: representatives of the Ministry of Health, the Ministry of Labor and Social Policy,
p.002007: of the BDA, the NHIF, the Bulgarian Medical Association, the Bulgarian Dental Union, the Bulgarian
p.002007: pharmaceutical union and patient organizations and the pharmaceutical industry.
p.002007: (3) (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: A person who is a member of the Transparency Committee cannot also be a member of the National Board of Prices and
p.002007: reimbursement of medicinal products.
p.002007: (4) The Council of Ministers shall determine by rules the terms and conditions for the work of the Transparency Commission.
p.002007: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012)
p.002007: 12/21/2012) The Transparency Committee is an authority against which decisions of the National can be appealed
p.002007: advice on prices and reimbursement of medicinal products.
p.002007: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority of the panel and.
p.002007: (3) The decisions under par. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a relevant disease is
...
p.002007: or medical activity under Art. 6a, para. 1, item 1 of the Health Act the Minister of Health
p.002007: approve the list of medicinal products under para. 1, which contains the following information:
p.002007: 1. anatomical-therapeutic-chemical classification code;
p.002007: 2. an international non-patent name to which the product belongs;
p.002007: 3. disease according to the international disease code;
p.002007: 4. the dosage form and the amount of active substance;
p.002007: 5. additional information.
p.002007: (3) The list under para. 2 is published on the website of the Ministry of Health on the Internet.
p.002007: (4) The conditions and the order for inclusion, change or exclusion of medicinal products in the list under para. 2 se
p.002007: determine with the ordinance under art. 9, para. 1.
p.002007: (5) The medicinal product under para. 1 shall be delivered by special order to a hospital establishment for hospital care
p.002007: under the conditions and in the order determined by the ordinance of art. 9, para. 1.
p.002007: (6) The head of the medical establishment under para. 5 shall be responsible for the implementation of the treatment under para. 1.
p.002007: Chapter thirteen.
p.002007: STATE CONTROLS ON MEDICINAL PRODUCTS
p.002007: Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
p.002007: 12/21/2012) The Ministry of Health manages the state control over the medicinal products
p.002007: products. Immediate guidance is provided by the Chief State Health Inspector, from
p.002007: the chairman of the council under Art. 258, para. 1, by the Executive Director of the BDA and by the Directors of the Health Insurance Fund, who
p.002007: are state drug control inspectors.
p.002007: (2) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, in force since 21.12.2012)
p.002007: Bodies for state control over medicinal products are the council under Art. 258, para. 1, BDA and RZI.
p.002007: (3) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, in force since 21.12.2012)
p.002007: The direct control is exercised by officials - inspectors and experts designated by
p.002007: orders of the chairman of the council under art. 258, para. 1, to the director of the BDA or to the director of the respective
p.002007: RZI.
p.002007: (4) In exercising their control functions, the bodies under para. 1 may request the assistance of
p.002007: the bodies of the Ministry of Interior.
p.002007: Art. 267a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102 of 2012, effective 21.12.2012,
p.002007: ed. - SG, issue. 102 of 2018, effective as of 01.01.2019) Medical Supervision Executive Agency implements
p.002007: monitoring compliance with approved pharmacotherapeutic guidelines and evaluating
p.002007: the effectiveness of the therapy in accordance with the criteria of Art. 259, para. 1, Vol. 4.
p.002007: Art. 268. (1) The Executive Agency for Medicines shall exercise control over:
p.002007: 1. (suppl. - SG 102/2012, in force from 02.01.2013) the conformity of the premises, facilities and
p.002007: the conditions for the manufacture, control, storage and marketing of medicinal products and active substances, and for
p.002007: compliance with the requirements of Good Manufacturing Practice of Medicinal Products and Good
p.002007: distribution practice;
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) the activity of the holders of a permit for
p.002007: use by manufacturers, importers, wholesalers of medicinal products and active substances,
...
p.002007: rules for the implementation of certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the
p.002007: Of the Council establishing the Union Customs Code (OJ, L 343/558 of 29 December 2015).
p.002007: (2) The medicinal products under para. 1 shall be destroyed under the conditions and in the order of the ordinance post. 274, para. 2.
p.002007: Additional provisions
p.002007: § 1. For the purposes of this Act:
p.002007: 1. (amend. - SG 102/02, in force from 02.01.2013) А
p.002007: "substance" means any substance or mixture of
p.002007: substances intended for use in the manufacture of a medicinal product which when used
p.002007: in its manufacture, they become the active ingredient of this product, intended for the exercise of
p.002007: pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
p.002007: physiological functions or for medical diagnosis.
p.002007: 2. "Bioequivalence" is present when the medicinal products are pharmaceutically equivalent or
p.002007: pharmaceutical alternatives, and if their bioavailability after administration at the same molar dose are
p.002007: similar to such an extent that their efficacy and safety effects are significant
p.002007: similar.
p.002007: 3. "Bioavailability" means the speed and degree at which the active substance or the therapeutically active part thereof
p.002007: absorb from the dosage form and become available at the site of action. When the drug substance is
p.002007: intended to exert a systemic therapeutic effect, bioavailability means speed and degree, c
p.002007: which the drug substance or the therapeutically active part thereof is released from the dosage form and
p.002007: goes into general circulation.
p.002007: 4. (Amended, SG No. 84/2018) (*) "Researcher's Brochure" is a Researcher's Brochure within the meaning of Art.
p.002007: 2 (2), point 23 of Regulation (EU) No 536/2014.
p.002007: 5. "Valid documentation" shall mean documentation that in content and completeness meets the requirements,
p.002007: provided for in a particular procedure under this Act.
p.002007: 6. "Substance with well established use in medical practice" is a substance for which it can be used
p.002007: apply the following criteria:
p.002007: (a) the period of proof of well-established use in medical practice shall be not less than 10
p.002007: years from the date of the first systematic and documented use of the substance as a medicinal product
p.002007: product in the European Union or in the European Economic Area;
p.002007: (b) quantitative aspects of the use of the substance, taking into account the extent of use in the substance
p.002007: medical practice, the extent of geographical use and the degree of traceability through
p.002007: the safety system, including studies carried out before and afterwards and
...
p.002007: alternative, and when their bioavailability after administration at the same molar dose is similar to the extent that
p.002007: is a requirement for equivalent efficacy and safety.
p.002007: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and
p.002007: the extent to which the active substance or the therapeutically significant portion of the investigational medicinal product is tested
p.002007: reach from the dosage form into the systemic circulation.
p.002007: 20. (amend. - SG 84/2018) (*) "Tested medicinal product" is a tested medicinal product within the meaning of
p.002007: of Art. 2 (2) (5) of Regulation (EU) No 536/2014.
p.002007: 21. (Amended, SG No. 84/2018) (*) "Researcher" shall be a researcher within the meaning of Art. 2 (2) (15)
p.002007: Regulation (EU) No 536/2014.
p.002007: 22. (amended, SG No. 84/2018) (*) "Informed consent" is informed consent within the meaning of Art. 2,
p.002007: paragraph 2, point 21 of Regulation (EU) No 536/2014.
p.002007: 23. "Kit" means any substance which is usually dissolved, suspended, diluted or diluted before use
p.002007: combines with radionuclides, resulting in the finished radioactive medicinal product.
p.002007: 24. (amended, SG No. 84/2018) (*) "Clinical trial of a medicinal product" is a clinical trial of
p.002007: the meaning of Art. 2 (2) (2) of Regulation (EU) No 536/2014.
p.002007: 25. "Clinical advantage" is a significant therapeutic or diagnostic benefit of a drug
p.002007: product compared to a medicinal product that has already been authorized.
p.002007: 25a. (new, SG No. 84/2018, effective 12.10.2018) Conflict
p.002007: "interests" is a conflict of interests under
p.002007: within the meaning of Chapter Eight, Section I of the Anti-Corruption and Removal of Illegal Act
p.002007: the property acquired.
p.002007: 26. (Repealed, SG No. 84/2018)
p.002007: 27. "Patient leaflet" is a leaflet containing user information to accompany
p.002007: the medicinal product.
p.002007: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002007: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No
p.002007: Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on medicinal products for
p.002007: advanced therapy and amending Directive 2001/83 / EC and Regulation (EC) No 726/2004.
p.002007: 27b. (new - SG 84 2018, in force from 12.10.2018) Medicinal
p.002007: "product for compassionate use" is
p.002007: medicinal product for palliative use within the meaning of Art. 83 (2) of Regulation (EC) No 726/2004
p.002007: of the European Parliament and of the Council.
p.002007: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product manufactured
p.002007: from human blood components and by a method involving an industrial process. These include albumin,
p.002007: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, other plasma
p.002007: fractions or combinations thereof.
p.002007: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare diseases" is
p.002007: a product that:
...
p.002007: knowledge of providing accurate and complete information about the medicinal product it is advertising.
p.002007: 35a. (new - SG 1/2014, in force from 03.01.2014) Medical
p.002007: "prescription" is a prescription of
p.002007: medicinal product or medical device issued by a person practicing regulated medical
p.002007: a profession within the meaning of § 1, item 1 of the additional provisions of the Professional Recognition Act
p.002007: qualifications and who has the legal right to do so in the Member State where the medical is issued
p.002007: prescription.
p.002007: 36. (Repealed, SG No. 84/2018)
p.002007: 36a. (New, SG No. 84/2018, effective 12.10.2018) Network
p.002007: "and information security" is the protection of
p.002007: information from unauthorized or accidental access, use, disclosure to third parties, change
p.002007: or destruction.
p.002007: 37. "Medicinal product name" means the name given to the product, which may be:
p.002007: a) freely chosen name (trade name);
p.002007: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the trademark or name of
p.002007: the holder of the marketing authorization;
p.002007: c) (amend. - SG 12/11, in force from 08.02.2011) scientific name together with the trademark or the name of
p.002007: the holder of the marketing authorization.
p.002007: 38. "Scientific literature" is a publication / publications of research results in specialized
p.002007: international scientific publications.
p.002007: 38a. (new, SG No. 84/2018, effective 12.10.2018) Shortage
p.002007: "the medicinal product" is the shortage of
p.002007: medicinal products included in the Positive Medicinal List established by the specialized drug
p.002007: electronic system in accordance with Art. 217b.
p.002007: 39. "New active substance" is:
p.002007: (a) a chemical, biological or radiopharmaceutical substance which has not been authorized for use as
p.002007: medicinal product in the European Union;
p.002007: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that has been authorized for
p.002007: use as a medicinal product in the European Union but differs in safety and health
p.002007: its efficacy from a previously authorized substance;
p.002007: (c) a biological substance that has been authorized for use as a medicinal product in the European Union, but
p.002007: is of different molecular structure, of different origin with respect to the starting material or is obtained
p.002007: through a different production process;
p.002007: d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which are not
p.002007: have been authorized as a medicinal product in the European Union, or the pairing mechanism of
p.002007: molecules and radionuclides has not been authorized in the European Union.
p.002007: 40. (amended, SG No. 84/2018) (*) "Adverse event" is any adverse change in the health status.
p.002007: a condition observed when administering a medicinal product to a patient which is not necessarily causative
p.002007: related to this treatment.
p.002007: 41. (Am. - SG, iss. 102 in 2012, in force since 21.12.2012, amended - SG, iss. 84 of 2018. (*))
p.002007: reaction "is any adverse and unintended response to a medicinal product. The types of adverse drug reactions
p.002007: reactions are:
p.002007: a) (amended, SG No. 84/2018) (*) "unexpected" - adverse reaction not mentioned in the summary
p.002007: a characteristic of the product or whose character, weight or output does not correspond to those specified in the summary
p.002007: product characteristics;
p.002007: (b) "suspected" - an adverse reaction for which the notifier or marketing authorization holder
p.002007: use implies a possible cause and effect relationship with the medicinal product being administered;
p.002007: c) "serious" - any adverse effect on a health condition that has caused the death
p.002007: exit, immediate danger to life, hospitalization or prolongation of hospitalization,
p.002007: significant or permanent damage, disability and congenital anomalies;
p.002007: (d) combinations of reactions under letters "a", "b" and "c".
p.002007: 42. "Common name" means the international non-patent name of a medicinal or ancillary medicinal product
p.002007: substance (INN) recommended by the WHO; if not, the name in the European Pharmacopoeia is used, if and
p.002007: there is no other pharmacopoeial name; when there is no pharmacopoeial name, the usual accepted name is used.
p.002007: 42a. (new - SG 102/02, in force from 21.12.2012) Main
p.002007: "system documentation for
p.002007: Drug Safety Tracking "is a detailed description of the drug tracking system
p.002007: the pharmacovigilance used by the holder of the marketing authorization in respect of one or
p.002007: more authorized medicinal products.
p.002007: 42b. (new - SG 48/2015) "Assessment of health technologies" is:
p.002007: (a) a form of research policy examining the short and long term
p.002007: results related to the implementation of health technologies and aims to provide information on
p.002007: alternative health strategies;
p.002007: (b) a multidisciplinary activity that systematically assesses technical characteristics, safety,
p.002007: clinical efficacy and effectiveness, cost, value effectiveness, organizational, social,
p.002007: the legal and ethical implications of the administration of medicinal products in health care and focus
p.002007: on the value - clinical and economic, the analysis being comparable to existing or most
p.002007: the good alternative at the moment.
p.002007: 43. "Batch" means the specified quantity of the drug produced according to established reproducible
p.002007: technological scheme providing the necessary batch homogeneity with respect to the required ones
p.002007: benchmarks.
p.002007: 43a. (New, SG No. 102/2012, effective 21.12.2012) Plan
p.002007: "risk management" is a detailed description
p.002007: of the risk management system.
p.002007: 44. "Maintenance of a marketing authorization for a medicinal product" includes all necessary activities with
p.002007: in order to maintain the current registration status of the medicinal product, including
p.002007: drug safety monitoring.
p.002007: 44a. (new - SG 48/2015) "Maintenance of reimbursement status" is an evaluation of a medicinal product on the basis of
p.002007: Based on evidence of efficacy, therapeutic efficacy, safety and pharmacovigilance analysis
p.002007: Economic Indicators.
p.002007: 45. "Benefit" is the positive result / therapeutic efficacy of the medicinal product for the individual patient,
p.002007: a group of patients or the public. The quantified estimate of expected benefit includes an estimate
p.002007: calculating the probability of this positive result.
p.002007: 46. (amend. - SG 102/02, in force from 02.01.2013)
p.002007: "excipient" means any constituent of a medicinal product
p.002007: product other than the active substance and the packaging material.
p.002007: 47. "Post-marketing study" means any study conducted with the use of the medicinal product in
p.002007: within the approved summary of product characteristics after authorization.
p.002007: 47a. (new - SG 102/2012, in force from 02.01.2013) Mediation
p.002007: "in the field of medicines
p.002007: "products" are all activities aimed at concluding a contract for the purchase or sale of "
p.002007: medicinal products, other than wholesale, which do not include physical holding and which do
p.002007: express in negotiation independently and on behalf of another legal or natural person.
p.002007: 48. (Amended, SG No. 102/2012, effective 21.12.2012)
p.002007: "ostmarketing safety study" is anyone
p.002007: a study relating to an authorized medicinal product conducted in order to identify itself,
p.002007: characterize or determine the degree of safety risk, confirm the profile of
...
p.002007: the safety or efficacy of the medicinal product;
p.002007: (b) the risk of adverse effects on the environment.
p.002007: 67. "Serious adverse event" is any adverse change in health status that has occurred
p.002007: cause of death, imminent danger of life, hospitalization or prolongation of life expectancy
p.002007: hospitalization, significant or permanent disability, disability and congenital anomalies.
p.002007: 68. "Batch Release Certificate" is a document that is issued by a qualified person to
p.002007: manufacturer or importer for each individual batch and include requirements in accordance with
p.002007: the specification, as well as all the results of the batch release tests.
p.002007: 69. "Supplemental protection certificate" is a document which provides additional patent protection to
p.002007: medicinal product not more than 5 years after the date of expiry of the basic patent.
p.002007: 69a. (new, SG No. 102/2012, effective 21.12.2012) System
p.002007: "risk management" is a system of measures
p.002007: and pharmacovigilance monitoring activities for identification,
p.002007: characterizing, preventing or minimizing the risks associated with a medicinal product,
p.002007: including an assessment of the effectiveness of these activities and measures.
p.002007: 69b. (new, SG No. 102/2012, effective 21.12.2012) System
p.002007: "to track the drug
p.002007: safety "is a system used by the Marketing Authorization Holder and the BDA for the implementation of the
p.002007: the tasks and responsibilities of Chapter Eight to monitor the safety of
p.002007: the authorized medicinal products and the detection of any change in the benefit / risk ratio.
p.002007: 69c. (new, SG No. 84/2018, effective 12.10.2018)
p.002007: "is a violation committed three or more
p.002007: times within one year of the entry into force of the first penal decree whereby the offender
p.002007: the same type of offense is punished.
p.002007: 70. "Emergency restrictive safety measures" are temporary changes to product information under
p.002007: relation to one or more parts of the summary of product characteristics, indications, manner of
p.002007: application, contraindications and warnings resulting from new information related to
p.002007: safe use of the medicinal product.
p.002007: 71. "Spontaneous message" is a voluntarily sent message for a suspected adverse reaction to
p.002007: the use of the medicinal product by the Marketing Authorization Holder, the market surveillance authorities
p.002007: medicinal products or other organizations not derived from research or other organized
p.002007: information collection system.
p.002007: 72. "Shelf life of a medicinal product" is the interval of time when, if stored
p.002007: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002007: the basis of stability studies of several batches of finished form.
p.002007: 73. (amend. - SG 71/08, in force from 12.08.2008) p
p.002007: "an appropriate herbal medicinal product
p.002007: "medicinal product" is a product which contains the same active substances, regardless of the composition of
...
p.002007: 87. (new - SG 41/09, in force from 02.06.2009) Food
p.002007: "infant formulas" means foods intended for infants
p.002007: specific nutritional use of infants during their first months, which alone are sufficient
p.002007: satisfy the nutritional needs of these infants until the introduction of a suitable supplement
p.002007: food.
p.002007: 88. (new - SG 41/09, in force from 02.06.2009) Transitional
p.002007: "food" means food intended for
p.002007: specific nutritional use of infants in the introduction of appropriate supplemental food and which
p.002007: are the staple liquid food from the progressively increasing variety of foods in these
p.002007: infants.
p.002007: 89. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "Type IA" is a change with minimal impact
p.002007: or without affecting the quality, safety or efficacy of the medicinal product concerned.
p.002007: 90. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "type IB" is a change that is neither type IA,
p.002007: neither a change of type II nor an extension of the marketing authorization.
p.002007: 91. (New, SG No. 12/2011, effective 08.02.2011) Change
p.002007: "type II" is a change that does not occur
p.002007: extending the scope of the marketing authorization and which may have a significant impact on
p.002007: the quality, safety or efficacy of the medicinal product concerned.
p.002007: 92. (new, SG No. 102/2012, effective 21.12.2012) Delegated
p.002007: "act" is an act within the meaning of Art. 290 of
p.002007: Treaty on the Functioning of the European Union.
p.002007: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
p.002007: § 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and updating of
p.002007: medicinal products stored by the State Agency for State Reserves and Wartime Stocks.
p.002007: § 4. (Supplemented, SG No. 18/2014) This Act introduces the provisions of Directive 2001/83 / EC of the European Union.
p.002007: Parliament and the Council on the approval of the Community code relating to medicinal products for human use,
p.002007: as last amended by Directive 2004/27 / EC of the European Parliament and of the Council and Directive 2012/26 / EU
p.002007: of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83 / EC
p.002007: on pharmacovigilance (OJ L 299/1 of 27 October 2012).
p.002007: § 5. The data protection periods for the reference medicinal products shall be applied in accordance with the provisions
p.002007: of Art. 89 of Regulation (EC) No 726/2004 of the European Parliament and of the Council and Art. 2 of Directive 2004/27 / EC
p.002007: of the European Parliament and of the Council.
p.002007: § 5a. (New, SG No. 60/2011, effective 30.09.2011) (1) (Amended, SG No. 102/2012, effective 01.04.2013,
p.002007: ed. - SG, issue. 85 of 2017) Ministry of Health, National Price Council and
p.002007: reimbursement of medicinal products, the Executive Agency for Medicines and Regional Health
p.002007: inspections shall provide an opportunity for the submission of information and the acceptance of applications and documents
p.002007: this Act electronically under the terms and conditions of the Electronic Document and Electronic Act
p.002007: certification services and the eGovernment Act.
p.002007: (2) The provision of information and the acceptance of applications and documents electronically shall be carried out
...
p.002007: Positive Medication List is the Positive Medicinal List adopted by the Ordinance on the definition of
p.002007: positive medical list in the Republic of Bulgaria (promulgated, SG No. 113/2003; amended, No. 18/2004; issue 4 of
p.002007: 2005 and issue. 8, 107 and 112 of 2007).
p.002007: (3) (New, SG No. 71/2008, effective 14.04.2008; amend. - SG 23/09, in force from 30.03.2009)
p.002007: two months after the entry into force of the list under para. 1 medical care providers prescribe
p.002007: and the NHIF pays the medicinal products according to the medicinal list of the NHIF adopted by Decision No. RD-CC-
p.002007: 04-127 of 27 December 2007 laying down the conditions to be fulfilled by the contractors of
p.002007: medical assistance, the procedure for concluding contracts with them and other conditions under Art. 55, para. 2, items 2, 4, 6 and 7 of
p.002007: The Health Insurance Act.
p.002007: § 19. (1) Within three months from the entry into force of this Act:
p.002007: 1. The Council of Ministers shall amend the Rules of Procedure of the Executive Agency for
p.002007: medicines in accordance with this law;
p.002007: 2. the Minister of Health issues the ordinance under Art. 82, para. 3.
p.002007: (2) Within 6 months from the entry into force of this Act, the Council of Ministers shall also adopt the Minister of
p.002007: Health issues other legislative acts.
p.002007: § 20. After the expiry of the first two years of the term of office of the members of the committees, the post. 103, 107, 259 and 261, respectively
p.002007: lots shall be determined by half of the members whose term of office is terminated.
p.002007: § 21. (amend. - SG 71/08, in force from 14.04.2008) Within two years from the entry into force of this law
p.002007: The BDA is taking the necessary steps to accredit its drug control laboratory
p.002007: products and active substances from the European Directorate for Quality of Medicines and Health.
p.002007: § 22. (Effective 14.04.2008) In the Health Insurance Act (promulgated, SG No. 70/1998; amended, Nos. 93 and 153
p.002007: from 1998, issue. 62, 65, 67, 69, 110 and 113 of 1999, issue. 1, 31 and 64 of 2000; 41 of 2001, issue. 1, 54, 74, 107, 112,
p.002007: 119 and 120 of 2002; 8, 50, 107 and 114 of 2003 28, 38, 49, 70, 85 and 111 of 2004; 39 45 45 76 99 99
p.002007: 103 and 105 of 2005; 17, 18, 30, 33, 34, 59, 95 and 105 of 2006; 11 of 2007, issue. 26 of 2007 - Decision No
p.002007: 3 of the Constitutional Court of 2007) the following amendments are made:
p.002007: 1. In Art. 45:
p.002007: (a) paragraphs 4, 5, 6 and 7 are repealed;
p.002007: (b) paragraph 8 is amended as follows:
p.002007: "(8) The conditions and procedure for payment of medicinal products included in the Positive Medicinal List under
p.002007: Art. 262 of the Law on Medicinal Products in Human Medicine, Medical Devices and Dietary Products
p.002007: foods for special medical purposes shall be governed by an ordinance of the Minister of Health. "
p.002007: 2. In Art. 55, para. 2, item 7 shall be amended as follows:
p.002007: "7. the lists of medical devices and dietary foods for special medical purposes and the prices to which the NHIF
p.002007: fully or partially pays them; conditions for prescribing and receiving medicines, medical
p.002007: articles and dietetic foods for special medical purposes. "
p.002007: § 23. In the Law on Medical Institutions (promulgated, SG No. 62/1999; Amended, SG No. 88 and 113, 1999; Amendments No. 114/1999)
p.002007: 1999; amend. 36, 65 and 108 of 2000; pcs. 51 of 2001 - Decision No. 11 of the Constitutional Court of 2001;
p.002007: amend. 28 and 62 of 2002, issue. 83, 102 and 114 of 2003; 70 of 2004, issue. 46, 76, 85, 88 and 105 of 2005; 30,
...
p.002011: a permit for production under this law after:
p.002011: 1. submission of an application and documentation under Art. 150 and 151, and
p.002011: 2. presentation of a document for a paid fee of 1500 BGN.
p.002011: (7) When, within one month from the completion of the inspection under para. 2 the person under para. 6 has not submitted an application
p.002011: and documentation under Art. 150 and 151, the production permit issued pursuant to the repealed Law on
p.002011: medicines and pharmacies in human medicine are being discontinued.
p.002011: § 67. (1) Issuance or amendment proceedings opened and not completed before the entry into force of this Act
p.002011: of marketing authorizations for medicinal products are reviewed and completed in the past
p.002011: without submitting a proposal by the High Pharmacy Council.
p.002011: (2) Within two months of the entry into force of this Act, the Ministry of Health shall provide
p.002011: of the Executive Agency for Medicinal Products with the Receiving and Transmission Protocol of the completed files
p.002011: production.
p.002011: (3) Within two months of the entry into force of this Act, the Ministry of Health shall provide
p.002011: of the Executive Agency for Medicinal Products with the protocol of acceptance kept by the Ministry of Health
p.002011: register of authorizations for retail trade of medicinal products in the
p.002011: pharmacy.
p.002011: (4) After issuing a permit in accordance with the procedure of para. 1 The Ministry of Health sends in three days
p.002011: term ex officio to the Executive Agency for Medicinal Products a copy of it for entry in the register of
p.002011: the authorizations for retail trade of medicinal products.
p.002011: (5) Upon completion of the proceedings under para. 1 The Ministry of Health provides to
p.002011: The Drug Enforcement Agency has a transcript of their records.
p.002011: § 68. (1) Applications for issuance or change of certificates for registration of drugstores submitted by
p.002011: the entry into force of this Act shall be considered under the conditions and in the order provided for therein.
p.002011: (2) Within one month of the entry into force of this Act, the Executive Agency for Medicines
p.002011: submit to the relevant Regional Health Inspectorate, with an acceptance protocol, the applications and
p.002011: the documents submitted for the proceedings for the issue of certificates for registration of drugstores, and
p.002011: archive of completed proceedings.
p.002011: (3) Within one month of the entry into force of this Act, the Executive Agency for Medicines
p.002011: provides the Ministry of Health with a protocol of reception and transmission, guided by the BDA
p.002011: register of issued drug registration certificates.
p.002011: (4) Within one month of the submission of the register under para. 3 Ministry of Health
p.002011: draws up and publishes on its page the national register of the issued before this law enters into force
p.002011: drugstore registration certificates.
p.002011: § 69. (1) Within three months of the entry into force of this Act, the procedures for approval or
p.002011: the registration of prices of medicinal products is carried out so far by the Price Committee
p.002011: of medicinal products.
p.002011: (2) After the expiration of the term under para. 1 The Committee on Medicinal Products Prices shall submit to
p.002011: Committee on Prices and Reimbursement with Receipt Protocol of the applications and documents submitted
p.002011: for the procedures under para. 1, as well as the archive of the completed procedures for approval or registration of
p.002011: prices of medicinal products.
p.002011: (3) After the expiration of the term under para. 1 The Committee on Medicinal Products Prices shall submit to
p.002011: Committee on Pricing and Reimbursement with the Transmission Protocol kept by the Commission registers of
p.002011: the issued decisions for approval or registration of prices of medicinal products.
p.002011: § 70. (1) Within three months of the entry into force of this Act, the procedures for inclusion, exclusion and / or
p.002011: Changes to the Positive Drug List medicinal products are made to date by
p.002011: Positive Drug List Committee.
p.002011: (2) After the expiration of the term under para. 1 The Committee on the Positive Medicinal List shall submit it to the Commission
p.002011: on prices and reimbursement with the transceiver protocol, the applications and documents submitted for
p.002011: the procedures under para. 1, as well as an archive of completed procedures for turning on, off and / or changes to
p.002011: Medicinal products from the Positive Medicinal List.
p.002011: § 71. State fees paid under the procedures under § 69, para. 1 and § 70, para. 1 shall be spent to secure
p.002011: relevant administrative proceedings as well as the activities of the Transparency Committee.
p.002011: § 72. (1) The prices determined in accordance with Art. 258, para. 1, of medicinal products which, upon entry into force
p.002011: of this law are included in the Positive Medicinal List and are considered as their marginal prices at
p.002011: their retail sale in accordance with Art. 258, para. 3.
p.002011: (2) Within three months of the entry into force of this Act, the Committee on Medicinal Products Prices
p.002011: ex officio deletes the established marginal prices of medicinal products from the register of marginal prices
p.002011: under para. 1.
p.002011: (3) Until 31 December 2012, marketing authorization holders may not change the price of
p.002011: medicinal product with the exception of the reduction and for products which, by the time this law enters into force
p.002011: had a certain price but were not included in the Positive Medicinal List.
p.002011: § 73. (1) With the entry into force of this Act, the established marginal prices of the medicinal products granted
p.002011: on prescription, and the registered prices of non-medical medicinal products
p.002011: prescription, shall be considered their registered prices under Art. 258, para. 2.
...
p.002011: Transitional and Final Provisions
p.002011: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002011: PRODUCTS IN HUMAN MEDICINE
p.002011: (Official Gazette of the Republic of Bulgaria, issue 102 of 2012, effective 21.12.2012)
p.002011: § 119. (1) After 2 January 2013, manufacturers, importers and wholesalers of active substances
p.002011: submit to the BDA until March 2, 2013 an application and documents for entry in accordance with Art. 167b.
p.002011: (2) Manufacturers and importers who manufactured or imported active substances on the basis of
p.002011: Production / import licenses issued before 2 January 2013 do not pay a fee for their entry in
p.002011: the register under Art. 167g.
p.002011: (3) Until 2 March 2013, the persons under para. 2 shall carry out activities for the production and import of active substances at
p.002011: basis of production / import licenses issued to them.
p.002011: § 120. The persons who mediate in the field of medicinal products and have started
p.002011: their activity before January 2, 2013, shall be registered under the conditions and in accordance with Art. 212a by 2 March
p.002013: 2013
p.002013: § 121. Authorization procedures for use before the law has entered into force shall be completed
p.002013: under the conditions and in the manner provided therein.
p.002013: § 122. (1) Holders of marketing authorizations shall not apply a risk management system for mail. 192,
p.002013: para. 1, item 2 for medicinal products which were authorized before 21 July 2012, except
p.002013: in the cases of para. 2.
p.002013: (2) The Executive Agency for Medicinal Products may impose an obligation on the marketing authorization holder
p.002013: use to create and implement a risk management system when it deems it for a drug
p.002013: product has concerns that may affect the benefit / risk ratio. In this case, the BDA
p.002013: requires the marketing authorization holder to also provide a detailed description of the system for
p.002013: risk management that it intends to introduce for the respective medicinal product.
p.002013: (3) In the cases of para. 2 The BDA shall inform the marketing authorization holder in writing, stating
p.002013: the reasons for imposing the obligation and the time limit for submitting the detailed description of the system
p.002013: Risk Management.
p.002013: (4) Within 30 days from receipt of the notification under para. 3 the Marketing Authorization Holder
p.002013: may ask the BDA to provide information on what has been imposed
p.002013: obligation under para. 2.
p.002013: (5) Upon receipt of the request under para. 4 The BDA sets a deadline for submitting the information from
p.002013: the holder of the marketing authorization.
p.002013: (6) On the basis of the information provided, the BDA may confirm the imposed obligation under para. 2 or yes
p.002013: cancel it.
p.002013: (7) The Executive Agency for Medicinal Products shall notify the holder of the decision taken under para. 6.
p.002013: (8) When the BDA confirms the obligation, the Executive Director officially issues a change in the authorization.
p.002013: for use, including in it as a condition the imposed obligation under para. 2.
p.002013: § 123. Holders of marketing authorizations for medicinal products issued before 21 July 2012,
p.002013: fulfill the obligation under Art. 192, para. 1, item 1 with effect from 21 July 2015 or from the date of renewal of
p.002013: the authorization to use the respective medicinal product, whichever is the date
p.002013: occurred earlier.
...
Searching for indicator substance:
(return to top)
p.002007: substances;
p.002007: 3. authorization and conduct of clinical trials;
p.002007: 4. wholesale and retail trade in medicinal products; Job: Legal Counsel / Senior Legal Counsel
p.002007: 5. parallel import of medicinal products;
p.002007: Sofia, DSK Bank EAD, 01/27/2020
p.002007: 5a. (new - SG 102/2012, in force since 21.12.2012) mediation in the field of medicinal
p.002007: products;
p.002007: 5b. (new, SG No. 18/2014) export of medicinal products under the order of heading nine "b"; View All Post More
p.002007: 6. advertising of medicinal products;
p.002007: 7. monitoring the safety of medicinal products placed on the market;
p.002007: 8. the classification of the manner of prescribing and dispensing of medicinal products;
p.002007: 9. control of production and import, wholesale and retail, conducting clinical
p.002007: tests, advertising and the safety monitoring system for commercially available medicinal products
p.002007: Forum
p.002007: products;
p.002007: Renovation of a farm building in
p.002007: 10. the pricing of medicinal products;
p.002007: 11. drawing up a positive medical list. residential
p.002007: by probcho at 2/1 14:21 3 posts
p.002007: I am asking for advice! Complex Case Study on Ex. business
p.002007: by propensity at 1 Feb 13:45 6 posts
p.002007: Fenced part of a foreign property
p.002007: Art. 2. This law aims to create conditions that ensure the marketing of medicinal products
p.002007: products that meet the requirements of quality, safety and efficiency. by milen73 on Jan 31 20:11 2 posts
p.002007: Visit the forum
p.002007: Art. 3. (1) (amend. - SG 71/08, in force from 12.08.2008) A medicinal product in human medicine shall be:
p.002007: 1. any substance or combination of substances presented as having properties for treatment or
p.002007: prevention of human diseases, or
p.002007: 2. any substance or combination of substances that may be used or administered to humans for the purpose of:
p.002007: (a) restoration, correction or alteration of physiological functions through pharmacological, immunological
p.002007: or metabolic action, or
p.002007: b) making a medical diagnosis.
p.002007: (2) A substance is any substance the origin of which may be:
p.002007: 1. human (human blood, human blood products and others);
p.002007: 2. animal (microorganisms, animal organs, extracts, secretions, toxins, blood products, etc.);
p.002007: 3. plant (microorganisms, plants, parts of plants, plant extracts, secretions, etc.);
p.002007: 4. chemical (elements, natural chemical materials, synthetic or semi-synthetic substances, etc.).
p.002007: Art. 4. Where a product meets both the characteristics of a medicinal product and a product,
p.002007: regulated by another law, the requirements of that law shall apply.
p.002007: Art. 5. Medicinal products shall be classified according to the anatomical-therapeutic-chemical classification in
p.002007: compliance with World Health Organization (WHO) requirements.
p.002007: Art. 6. This law shall not apply to:
p.002007: 1. hermetically sealed radionuclides;
p.002007: 2. blood, plasma or blood cells of human origin, with the exception of plasma obtained by method,
p.002007: involving an industrial process.
p.002007: Art. 7. (1) Production, import, wholesale and retail trade, advertising and medical treatment are allowed,
p.002007: prevention and diagnosis only with medicinal products authorized
p.002007: The order of:
p.002007: 1. this law, or
p.002007: 2. Regulation (EC) No 726/2004 of the European Parliament and of the Council.
p.002007: (2) It is prohibited to import, trade, treat, prevent and diagnose medicinal products with
p.002007: expired.
p.002007: (3) Holding a permit or certificate of use, production and clinical trials of
p.002007: medicinal products issued pursuant to this Act shall not be grounds for discharge
p.002007: in accordance with applicable law.
p.002007: Art. 8. No marketing authorization is required under this Act for:
p.002007: 1. a medicinal product prepared according to a prescription in a pharmacy;
...
p.002007: (3) (Supplemented, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines shall be obliged to
p.002007: Ensure compliance with the label, patient package leaflet, classification, advertising and tracking
p.002007: the safety of the marketed medicinal product under para. 1 with the requirements of this law.
p.002007: The information on the packaging and the package leaflet of the medicinal product under para. 1 does not have to be
p.002007: in Bulgarian.
p.002007: (4) The BDA Executive Director shall inform the European Commission of the permits issued under para. 1 for
p.002007: the name and address of the authorization holder as well as the date of their termination.
p.002007: Art. 12. (1) The official pharmacopoeia in the Republic of Bulgaria is the European Pharmacopoeia.
p.002007: (2) The official pharmacopoeia may be supplemented by the requirements of the Bulgarian Pharmacopoeia.
p.002007: (3) The Minister of Health shall determine with an order the dates of entry into force of the current edition
p.002007: of the official pharmacopoeia and its supplements.
p.002007: (4) The order under para. 3 shall be published in the State Gazette and published on the Internet site of the BDA.
p.002007: Art. 13. (1) Monographs of the European Pharmacopoeia are obligatory for all substances, preparations and
p.002007: dosage forms contained therein. In cases where there are no monographs in the European
p.002007: pharmacopoeia, the requirements of the current editions of the pharmacopoeia of the Member States, the USA and
p.002007: Japan, if they comply with the general rules of the European Pharmacopoeia.
p.002007: (2) Where the specification contained in a monograph of the European Pharmacopoeia or in another
p.002007: national pharmacopoeia is insufficient to ensure the quality of the substance or dosage form,
p.002007: The BDA may require supplementation of the specification by the applicant / holder of the marketing authorization.
p.002007: Chapter Two.
p.002007: MANAGEMENT AND FINANCING BODIES
p.002007: Section I.
p.002007: Authorities
p.002007: Art. 14. (1) Medicinal policy is a part of the state health policy in the Republic of Bulgaria and is
p.002007: carried out by the Minister of Health.
p.002007: (2) The Minister of Health shall:
p.002007: 1. is a national coordinator for the problems of medicinal products;
p.002007: 2. participate in international bodies and organizations performing activities in the field of pharmaceuticals
p.002007: products;
p.002007: 3. (repealed, SG No. 60/2011, effective 05.08.2011, new - SG No. 102/2012, effective 21.12.2012)
p.002007: organizes the provision of public information to patients' organizations and organizations
p.002007: consumers about actions taken against counterfeiting of medicinal products;
p.002007: 4. performs other activities specified by law.
p.002007: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: Art. 15. (1) A Pharmacopoeial Committee shall be established with the Minister of Health as an advisory body on
p.002007: the issues of the current pharmacopoeia.
p.002007: (2) On the proposal of the BDA Executive Director, the Minister of Health shall designate with
p.002007: order of the composition of the Pharmacopoeia Committee and of the expert groups attached thereto, and approves the regulations for
p.002007: their activity.
p.002007: (3) The activities of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
p.002007: Art. 16. (1) (Supplemented, SG No. 91/2018) A Supreme Council shall be established at the Minister of Health.
p.002007: pharmacy, which includes five representatives appointed by the Minister of Health, five
...
p.002007: liability under the legislation in force in the Republic of Bulgaria.
p.002007: Section II.
p.002007: Requirements to the marketing authorization documentation
p.002007: Art. 27. (1) (amend. - SG 71/08, in force from 12.08.2008) For issuance of a permit for use of
p.002007: medicinal product the person under Art. 26, para. 1 shall submit to the BDA an application in the form, accompanied by a file in
p.002007: electronic common technical document format, containing:
p.002007: 1. name and address of management / permanent address of the applicant and the postal representative. 26, para. 2; when
p.002007: the applicant is a person other than the manufacturer or manufacturers - the address of the production sites;
p.002007: 2. name of the medicinal product;
p.002007: 3. data on the qualitative and quantitative composition of the medicinal product, indicating the international
p.002007: a non-patent name recommended by the WHO, if any, or the corresponding chemical
p.002007: name;
p.002007: 4. therapeutic indications, contraindications and side effects;
p.002007: 5. (amend. - SG 71/08, in force from 12.08.2008) dosage, dosage form, method of administration and
p.002007: route of administration and proposed shelf life;
p.002007: 6. precautions and safety measures for the storage of the product, for its administration to patients and
p.002007: in the event of disposal of the product waste, accompanied by an indication of the potential risks of
p.002007: the medicinal product for the environment;
p.002007: 7. description of the production method;
p.002007: 8. description of the control methods used by the manufacturer;
p.002007: 8a. (new - SG 102/2012, in force from 02.01.2013) declaration that the results of the audit are 160, para. 2,
p.002007: conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
p.002007: compliance with the principles and guidelines for Good Manufacturing Practice; the declaration shall state
p.002007: the date on which the audit was conducted;
p.002007: 9. assessment of the potential risk of the medicinal product for the environment on a case-by-case basis and measures,
p.002007: intended to limit it;
p.002007: 10. results from:
p.002007: (a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.002007: (b) preclinical (toxicological and pharmacological) studies;
p.002007: (c) clinical trials;
p.002007: 11. a statement that they have been complied with in clinical trials conducted outside the territory of the Member States
p.002007: ethical principles of Good Clinical Practice;
p.002007: 12. (amend. - SG 102/2012, in force from 21.12.2012) summary of the traceability system
p.002007: drug safety, which includes the following elements:
p.002007: a) the name of the qualified person under Art. 191, Curriculum Vitae - Education acquired by professional experience in
p.002007: the field of pharmacovigilance monitoring and the qualification for fulfilling his duties
p.002007: in the order of Chapter Eight;
p.002007: (b) any Member State in which the qualified person fulfills his duties;
p.002007: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002007: (d) the address at which the basic document of the medication traceability system is stored
p.002007: safety;
p.002007: 12a. (new - SG 102/2012, in force since 21.12.2012) declaration by the applicant that he has at his disposal
p.002007: the necessary means to fulfill the obligations of Chapter Eight;
...
p.002007: was granted marketing authorization in the territory of the Republic of Bulgaria
p.002007: (4) In the cases of para. 3 the person under art. 26, para. 1 shall indicate in the application under Art. 27, para. 1 the Member State in which
p.002007: the reference product is authorized or has been authorized.
p.002007: (5) In the cases of para. 3 The BDA requires the regulatory authority of the Member State referred to in the application under
p.002007: Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and qualitative composition of the reference
p.002007: product and, if necessary, additional documentation.
p.002007: (6) The Executive Agency for Medicines shall make available to a regulatory authority of a State upon request
p.002007: Member State in which the application for a generic reference product has been authorized
p.002007: or has been authorized for use on the territory of the Republic of Bulgaria, the necessary information under para. 5th c
p.002007: within one month from the date of request.
p.002007: (7) The ten-year period under par. 2 may be extended by up to one year at the request of the holder
p.002007: of the marketing authorization of the reference medicinal product, if during the first 8 years of its granting
p.002007: the marketing authorization was granted to the holder of the reference medicinal product for the same product
p.002007: authorization of a new therapeutic indication with significant clinical advantages over existing ones
p.002007: healing options are scientifically sound.
p.002007: (8) (New - SG 12/11, in force from 08.02.2011) When originally issued for a medicinal product
p.002007: marketing authorization in accordance with Art. 23, for any change in the amount of active substance, c
p.002007: the dosage form, in the amount in the package, in the route of administration of the medicinal product, and for
p.002007: any other modification or extension of the marketing authorization shall also be granted
p.002007: as required by this Act or the original marketing authorization is supplemented. All these
p.002007: authorizations are considered to belong to a single global marketing authorization
p.002007: product for the purposes of applying this Article.
p.002007: Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary preclinical and / or clinical
p.002007: tests where the medicinal product referred to in the application:
p.002007: 1. cannot be defined as generic, or
p.002007: 2. bioavailability tests do not prove bioequivalence, or
p.002007: 3. (suppl. - SG 71/08, in force from 12.08.2008) there is a change in the active substance or substances in
p.002007: the amount of active substance or substances per dosage unit, the therapeutic indication, of
p.002007: the dosage form, the route of administration relative to the reference medicinal product.
p.002007: 4. (repealed, SG No. 71/2008, effective 12.08.2008)
p.002007: (2) Where the biological medicinal product referred to in the application is similar to a reference biological
p.002007: medicinal product does not qualify as a generic medicinal product
p.002007: due to a different production method or different starting materials compared to the reference or
p.002007: other reasons, the applicant submits to the BDA the results of the required preclinical and / or clinical
p.002007: tests related to these conditions.
p.002007: (3) In the cases of para. 1 and 2 the documentation specified in the ordinance post shall also be submitted. 42.
p.002007: Art. 30. (1) The person under art. 26, para. 1, in so far as it does not infringe industrial or commercial property rights,
p.002007: does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b" or "c", if he can prove, under the conditions,
p.002007: defined in the ordinance under art. 42 that the active substance included in the proposed authorization
p.002007: for use a medicinal product is well established in medical practice, is recognized
p.002007: efficiency and an acceptable level of safety. In these cases, the test results and tests may
p.002007: to be replaced by the relevant scientific publications.
p.002007: (2) The person under para. 1 presents the results of the necessary preclinical and clinical trials in the case of
p.002007: a medicinal product containing active substances with well-established use that has not been used
p.002007: in the proposed combination for therapeutic purposes. In this case, no documentation is provided regarding
p.002007: of each individual active substance.
p.002007: (3) When an active substance within the meaning of para. 1 has a proven new therapeutic indication based on
p.002007: significant preclinical or clinical data related to the new indication, once a year
p.002007: a subsequent applicant cannot rely on the data for the new indication of the active substance.
p.002007: Art. 31. In the case where a medicinal product contains active substances used in the authorized composition
p.002007: for use medicinal products but not used in the proposed combination for therapeutic purposes, the person
p.002007: under Art. 26, para. 1 presents the results of the preclinical and clinical trials related to this
p.002007: combination. In this case, the applicant does not provide documentation on the safety and efficacy of
p.002007: each individual active substance.
p.002007: Art. 32. The marketing authorization holder may authorize the use of a medicinal product
p.002007: the pharmaceutical, preclinical and clinical records contained in the dossier
p.002007: product, when evaluating subsequent applications for medicinal products of the same quality and quality
p.002007: a quantitative composition in terms of the active substances and of the same dosage form.
p.002007: Art. 33. Conducting the necessary studies and tests to prepare documentation for
p.002007: marketing authorization and the subsequent practical requirements for marketing authorization
p.002007: medicinal products under Art. 28 and 29 is not a violation of the patent or of the supplementary protection certificate
p.002007: of a medicinal product.
p.002007: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002007: 1. name of the medicinal product, quantity of active substance per unit dose, medicinal product
p.002007: form;
p.002007: 2. quantitative and qualitative composition with respect to the active substances and those of the excipients,
p.002007: information for which it is essential for the correct application of the product; the common name is used
p.002007: or the chemical description;
p.002007: 3. dosage form;
p.002007: 4. clinical data:
p.002007: (a) therapeutic indications;
p.002007: (b) dosage and route of administration for adults and children;
p.002007: c) contraindications;
p.002007: (d) special warnings and precautions for use; for immunological medicinal products -
p.002007: precautions for those who work with them and apply them to patients, and precautions that
p.002007: should be taken by the patient;
p.002007: (e) interactions with other medicinal products or other forms of interaction;
p.002007: (f) use in pregnancy or lactation;
p.002007: (g) effects on the ability to drive and use machines;
p.002007: h) side effects;
p.002007: i) overdose (symptoms, antidotes, emergency measures);
p.002007: 5. pharmacological data:
p.002007: a) pharmacodynamic properties;
p.002007: b) pharmacokinetic properties;
p.002007: (c) preclinical safety data;
p.002007: 6. pharmaceutical data:
p.002007: (a) a list of excipients;
p.002007: (b) major incompatibilities;
p.002007: c) shelf life; shelf life after reconstitution of the medicinal product (if necessary) or after
p.002007: opening the primary packaging for the first time;
p.002007: (d) special storage instructions;
p.002007: (e) the nature and composition of the packages;
p.002007: (f) specific instructions for the disposal of the remainder of the medicinal product or of waste material from
p.002007: him;
p.002007: 7. the holder of the marketing authorization;
p.002007: 8. registration number;
...
p.002007: manufacturing practice;
p.002007: 5. copies of authorizations or marketing authorizations obtained for the same products in other Member States;
p.002007: 6. layout of the primary and / or secondary packaging of the product;
p.002007: 7. product stability data.
p.002007: (4) The data requirements under para. 3 shall be determined in the ordinance of the post. 42.
p.002007: Art. 36. (1) For homeopathic medicinal products other than those specified in Art. 35, para. 1, apply
p.002007: the provisions of Art. 27 - 32.
p.002007: (2) For homeopathic medicinal products under para. 1 person posted 26, para. 1 does not present results from
p.002007: pre-clinical and clinical trials, where it can demonstrate bibliographic data from the scientific literature,
p.002007: that the homeopathic use of the medicinal product or homeopathic constituents
p.002007: his, have been established safety.
p.002007: (3) In the cases of para. 2 of the bibliographic data must be established:
p.002007: 1. the homeopathic nature of the raw materials used and their traditional use in the application
p.002007: testimony;
p.002007: 2. the harmlessness of the homeopathic medicinal product with respect to the degree of dilution of each
p.002007: the ingredients.
p.002007: Section IV.
p.002007: Specific requirements for traditional herbal medicinal products
p.002007: Art. 37. (1) A certificate for registration of a traditional herbal medicinal product shall be issued under
p.002007: simplified procedure if it fulfills the following conditions:
p.002007: 1. there are therapeutic indications inherent in the use of traditional herbal medicinal products; and
p.002007: according to its composition and purpose, it is intended for use without medical prescription and monitoring;
p.002007: 2. is administered only in a fixed quantity of the medicinal substance in unit dose and at
p.002007: a certain dosage;
p.002007: 3. is administered orally, by inhalation (inhalation) or intended for external use;
p.002007: 4. the period of traditional use according to art. 38, para. 1, item 5 has expired;
p.002007: 5. the data on the traditional use of the medicinal product prove that it is not harmful for the determined ones
p.002007: conditions of use and the pharmacological effect or efficacy of the medicinal product have been established
p.002007: through its many years of use and experience.
p.002007: (2) The Executive Agency for Medicines may apply the procedure under para. 1 versus vegetable
p.002007: a medicinal product containing vitamins or minerals, the safety of which has been documented and
p.002007: whose action against the herbal medicinal products in the product in relation to its specific
p.002007: indications is ancillary.
p.002007: Art. 38. (1) To issue a certificate of registration of a traditional herbal medicinal product
p.002007: the person under Art. 26, para. 1 shall submit an application to the BDA, accompanied by the following documentation:
p.002007: 1. the data referred to in Art. 27, para. 1, items 1 - 9 and item 10, letter "a";
p.002007: 2. (amend. - SG 71/08, in force from 12.08.2008) a brief description of the product, except for
p.002007: the data under Art. 34, para. 1, Vol. 5;
p.002007: 3. in the case of a herbal medicinal product within the meaning of Art. 37, para. 2 or the combined vegetable
p.002007: medicinal product - the information under art. 37, para. 1, item 5 for the combination; when the individual active substances
p.002007: the combined product is not sufficiently known, data on the traditional use of each is provided
p.002007: from them;
p.002007: 4. a copy of the marketing authorization or the registration certificate of the herbal medicinal product,
...
p.002007: (4) The submitted data under para. 1, item 5 shall also be valid in cases where during the 30-year period of use in
p.002007: medical practice:
p.002007: 1. the relevant medicinal product of the product for which the application for registration was submitted was on
p.002007: the market without authorization or registration for use, or
p.002007: 2. where the number of ingredients in the medicinal product for which an application for registration is submitted is
p.002007: reduced or reduced in unit dosage.
p.002007: Art. 39. (1) Where the herbal medicinal product has been on the Community market for less than 15 years, but
p.002007: meets the conditions of Art. 37, para. 1, the BDA shall submit for the opinion the documentation under Art. 38, para. 1 on
p.002007: Committee for Herbal Medicinal Products of the European Medicines Agency.
p.002007: (2) The Executive Agency for Medicines shall take a final decision after the publication of the monograph
p.002007: by the committee under para. 1 for compliance of the product with the registration criteria for traditional use.
p.002007: (3) In the cases of para. 1 the term under Art. 44 stops running.
p.002007: Art. 40. The Medicines Executive Agency may require the applicant for a herbal medicinal product
p.002007: product to submit documentation under Art. 27 - 32 or under Art. 35.
p.002007: Art. 41. (1) (amend. - SG 71/08, in force from 12.08.2008) The Executive Agency for Medicines
p.002007: publish on its website a list of herbal substances, preparations or combinations thereof,
p.002007: used in traditional herbal medicinal products prepared by the Committee on Herbs
p.002007: medicinal products to the European Medicines Agency. The list contains for each plant
p.002007: substance therapeutic indications, active ingredient content per unit dose and dosage route of
p.002007: introduction and other information necessary for the safe use of the herbal substance such as
p.002007: traditional medicinal product.
p.002007: (2) Where the product for registration in the application for registration for traditional use contains a vegetable
p.002007: substance, preparation or combination thereof listed in para. 1, the applicant does not provide the data,
p.002007: referred to in Art. 38, para. 1, Vols 4 - 6.
p.002007: (3) When the herbal substance, the preparation or the combination thereof are excluded from the list under para. 1,
p.002007: the holder of the registration certificate of the herbal medicinal product must submit to
p.002007: BDA full documentation under Art. 38 within three months of the change.
p.002007: (4) In case the holder of the registration certificate of the herbal medicinal product does not
p.002007: fulfilled the obligation under para. 3, the BDA shall terminate the product registration certificate.
p.002007: Section V.
p.002007: Authorization procedure for medicinal products and
p.002007: registration of homeopathic and traditional herbal products
p.002007: Art. 42. The requirements for the data and documents from the file under Art. 27 - 32, Art. 35, para. 3, Art. 36, para. 2 and Art. 38
p.002007: shall be determined in an ordinance of the Minister of Health.
p.002007: Art. 43. (1) Within 30 days from the date of submission of the documentation, mail. 27 - 32, Art. 35, para. 3 or under Art. 38
p.002007: The BDA shall verify the completeness of the parts of the dossier accompanying the application and their compliance with
p.002007: the requirements for granting the marketing authorization or the registration certificate under this Act.
p.002007: (2) In case it does not identify incompleteness or inconsistencies in the submitted documentation, the BDA shall notify in writing
p.002007: of the applicant, within the period under par. 1 that the documentation is valid. The notification shall indicate the date from which
p.002007: the term under Art. 44.
p.002007: (3) When establishing incompleteness and / or inconsistencies in the documentation under para. 1, the BDA shall notify in writing
p.002007: submit additional information and / or provide an oral or written explanation to the applicant
p.002007: incompleteness and non-compliance found within 14 days from the date of notification.
...
p.002007: (5) When the requirements of para. 3 have been fulfilled within the set deadline, the BDA informs the applicant in writing that
p.002007: the documentation is valid, indicating in the notification the date from which the term under Art. 44.
p.002007: Art. 44. The procedure for granting a marketing authorization or registration for a medicinal product begins
p.002007: from the date specified in the notification under Art. 43, para. 2, respectively under Art. 43, para. 5, and ends by 210
p.002007: days.
p.002007: Art. 45. (1) When an application for authorization for use or registration of a medicinal product is submitted to the BDA
p.002007: a product for which, in accordance with the data under Art. 27, para. 1, item 18, there is information that there is in a Member State
p.002007: the marketing authorization was granted for the same medicinal product, the BDA would notify the applicant in writing
p.002007: implementation of the procedure under Art. 74.
p.002007: (2) Where an application for marketing authorization or registration of a medicinal product has been submitted to the BDA,
p.002007: for which in accordance with the data under Art. 27, para. 1, item 19, there is information that in a Member State the dossier of
p.002007: the same medicinal product is under evaluation; the BDA does not review the documentation under Art. 27 - 32 or Art.
p.002007: 35, para. 3, or under Art. 38 and shall notify the applicant in writing of the application of the postal procedure. 75.
p.002007: (3) For the implementation of the provisions of para. 1 and 2 the medicinal product is defined as the same authorized in
p.002007: another Member State, or as a product under evaluation in another Member State,
p.002007: when both medicinal products:
p.002007: 1. have the same qualitative and quantitative composition as regards the active substance (s);
p.002007: they are available in the same dosage form, with differences in excipients being allowed, if not
p.002007: affects safety and efficacy, and when
p.002007: 2. belong to one company, or apply for medicinal products by persons belonging to one
p.002007: to the same company or associations of companies, or where they apply for medicinal products
p.002007: application by persons who have entered into a license or other agreement or are acting together,
p.002007: related to the marketing of the medicinal product concerned in the various Member States.
p.002007: Art. 46. (1) When evaluating the BDA documentation:
p.002007: 1. may test the finished product, the intermediate, or the starting materials for
p.002007: the medicinal product, and send them for testing in a laboratory by the official system
p.002007: drug control laboratories in a Member State to determine whether the control methods of analysis,
p.002007: used by the manufacturer and described in the dossier satisfy the requirements;
p.002007: 2. confirm, after on-the-spot verification or on the basis of documents, that the manufacturers of medicinal products from
p.002007: third countries shall carry out the production in accordance with the data described in Art. 27, para. 1, item 7, and / or
p.002007: carry out the control in accordance with the methods described in Art. 27, para. 1, Vol. 8;
p.002007: 3. checks the production establishment specified in the application when the manufacturer (s) of
p.002007: medicines from third countries were, by way of exception, assigned to another manufacturer
p.002007: certain stages of the manufacture or control of the medicinal product.
p.002007: (2) When the BDA carries out an on-site inspection of a production site, the term shall begin. 44 stops running until
...
p.002007: Art. 50. (1) When the BDA establishes discrepancies in the file with the requirements for issuing a permit for
p.002007: use or certificate of registration under this Act shall notify the applicant in writing to submit
p.002007: additional information related to the documentation under Art. 27 - 32 or under Art. 35, para. 3, or under Art. 38, and / or
p.002007: to provide an oral or written explanation of the incompleteness and non-compliance found within 180 days of
p.002007: the date of notification.
p.002007: (2) In the cases of para. 1 the term under Art. 44 ceases to run from the date of notification until the submission of the
p.002007: the information requested.
p.002007: (3) The BDA Executive Director shall terminate the procedure for granting a marketing authorization or
p.002007: certificate of registration of a medicinal product where:
p.002007: 1. the applicant has not provided the information under para. 1 within the specified period;
p.002007: 2. the persons under art. 26, para. 1 request termination in writing and.
p.002007: Art. 51. Within 10 days of the preparation of the evaluation report, mail. 49, para. 1 Executive Director of the BDA
p.002007: issues a marketing authorization / registration certificate or makes a motivated one
p.002007: refusal.
p.002007: Art. 52. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 5 days from the date of issue of
p.002007: the marketing authorization / registration certificate in the register of art. 19, para. 1, item 3 shall be entered
p.002007: the following permit / certificate information:
p.002007: 1. registration number;
p.002007: 2. number and date of the marketing authorization / registration certificate of the medicinal product;
p.002007: 3. name of the medicinal product;
p.002007: 4. the international non-patent name of each active substance;
p.002007: 5. name and address of the holder of the marketing authorization / registration certificate;
p.002007: 5a. (new, SG No. 102/2012, effective 21.12.2012) 55a, 56 and 56a, recorded in
p.002007: the marketing authorization / registration certificate;
p.002007: 6. date of change of the Marketing Authorization / Registration Certificate;
p.002007: 7. date of termination of the marketing authorization / registration certificate;
p.002007: 8. other data.
p.002007: (2) The authorization for use / the registration certificate of the medicinal product shall be served on the person
p.002007: under Art. 26, para. 1 and shall enter into force on the date of its entry in the register mail. 19, para. 1, Vol. 3.
p.002007: Art. 53. (amend. - SG 102/2012, in force from 21.12.2012) (1) The Executive Agency for Medicines
p.002007: shall publish on its website within 14 days of the granting of the authorization
p.002007: use / certificate for registration of the data under art. 52, para. 1, the approved summary of the
p.002007: product and leaflet information.
p.002007: (2) The Executive Agency for Medicines shall publish on its website the assessment report under Art. 49,
p.002007: para. 1 with the reasons for the decision, deleting the data constituting a trade secret.
p.002007: (3) The report under para. 2 shall be accompanied by a summary of a language comprehensible to the public. The summary contains
p.002007: section on the conditions of use of the medicinal product.
p.002007: Art. 54. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of the permit for
p.002007: use / the registration certificate of the medicinal product shall notify the BDA in writing of the date of
p.002007: the actual marketing of the medicinal product in the Republic of Bulgaria.
...
p.002007: significant impact on the quality, safety or efficacy of the medicinal product.
p.002007: Art. 61. (amend. - SG 12/11, in force from 08.02.2011) (1) For any change of type IA, type IB, type II or
p.002007: The marketing authorization holder submits the extension to the BDA
p.002007: separate notification, respectively application.
p.002007: (2) When a change leads to a change in the summary of product characteristics of the packaging
p.002007: and / or in the package leaflet, these changes are accepted as part of the requested change and are not filed separately
p.002007: application.
p.002007: (3) The Marketing Authorization Holder may group the changes when:
p.002007: 1. notifies simultaneously the same type IA changes under the conditions of one or more authorizations for
p.002007: use;
p.002007: 2. declares at the same time several changes to the terms of the marketing authorizations belonging to
p.002007: the global marketing authorization under Art. 28, para. 8 of the medicinal product, provided that the relevant
p.002007: changes occur in one of the following cases:
p.002007: (a) one of the changes in the group is the extension of the marketing authorization;
p.002007: (b) one of the changes in the group is a type II change, and all other changes in the group are changes that are
p.002007: a consequence of the Type II change;
p.002007: c) one of the changes in the group is a change type IB, and all other changes in the group are changes that are
p.002007: a consequence of the type IB change;
p.002007: (d) any changes to the group shall relate only to changes of an administrative nature in the brief
p.002007: product characteristics, patient package leaflet or packaging;
p.002007: (e) all changes in the group are changes in the active substance master documentation, the main one
p.002007: vaccine antigen documentation or plasma basic documentation;
p.002007: (f) all changes to the group are in relation to a project designed to refine the production process
p.002007: and the quality of the medicinal product concerned or its active substance (s);
p.002007: (g) all changes in the group are changes affecting the quality of the pandemic influenza vaccine;
p.002007: h) all changes in the group are changes in the pharmacovigilance system heading eight;
p.002007: (i) any changes to the group are the result of a specific emergency safety measure and are filed with
p.002007: in accordance with Art. 66;
p.002007: (k) all changes in the group are related to the inclusion of information on a particular pharmacotherapeutic class;
p.002007: (l) all changes in the group result from the evaluation of the periodic safety report;
p.002007: (m) any changes to the group are the result of a post-authorization study,
p.002007: conducted under the supervision of the Marketing Authorization Holder;
p.002007: n) all changes in the group are due to the fulfillment of a condition in the authorization for use of mail. 56;
p.002007: 3. the requested changes in the conditions of the same marketing authorization do not fall in the cases under item 2, at
p.002007: provided that the BDA agrees to apply the same procedure to these changes.
p.002007: (4) When grouping changes under para. 3, items 2 and 3 the holder of the marketing authorization shall submit to the BDA:
p.002007: 1. a single notification where at least one of the changes is type IB and all others are type IA or type IB;
p.002007: 2. a single application where the major change is type II and none of the other changes is an extension of
p.002007: the scope of the marketing authorization;
p.002007: 3. a single application where the major change is the extension of the marketing authorization.
...
p.002007: (6) Within 15 days of preparation of the evaluation report, the BDA Executive Director shall:
p.002007: 1. approve the change or give a reasoned refusal and notify the authorization holder thereof
p.002007: use;
p.002007: 2. inform the holder of the marketing authorization whether the approved change leads to a change of the
p.002007: the data in the marketing authorization issued; when it is necessary to change the issued permit for
p.002007: use, Art. 64a.
p.002007: (7) The holder of the marketing authorization may apply the type II variation approved only after
p.002007: the issuance of a change permit under Art. 64a.
p.002007: Art. 64a. (New, SG No. 12/2011, effective 08.02.2011) The Executive Director of the BDA shall issue
p.002007: authorization to change the marketing authorization in time:
p.002007: 1. thirty days from the date of notification. 62, para. 4, Vol. 2, Art. 63, para. 2, item 2, respectively Art. 63, para. 6, vol.
p.002007: 2 or Art. 64, para. 6, item 2, when the respective change leads to an extension by 6 months of the term specified by the member
p.002007: 13 (1) and (2) of Council Regulation (EEC) No 1768/92 of 18 June 1992 establishing a
p.002007: additional certificate for protection of medicinal products, in accordance with Art. 36 of Regulation (EC) No
p.002007: 1901/2006;
p.002007: 2. sixty days from the issuance of the notification under Art. 62, para. 4, item 2 - for type IA changes, which do not require
p.002007: immediate notification;
p.002007: 3. sixty days from the issuance of the notification under Art. 64, para. 6, item 2 - for type II changes;
p.002007: 4. one hundred and eighty days - in all other cases.
p.002007: Art. 64b. (New - SG 12/2011, in force from 08.02.2011) (1) In case of changes related to changes in
p.002007: the active substance for the purpose of the annual update of influenza vaccines, the holder of
p.002007: the marketing authorization shall be submitted to the BDA by an application accompanied by the documentation specified in the Ordinance on
p.002007: Art. 42. Within 7 days the BDA shall check the completeness of the submitted documentation.
p.002007: (2) When the application meets the requirements of para. 1, the BDA shall notify the holder of the authorization for
p.002007: use that the application is valid, indicating the date from which the period under par. 3 starts to flow.
p.002007: (3) Within 45 days of receipt of a valid application, the BDA evaluates the documentation and prepares an evaluation report.
p.002007: report.
p.002007: (4) The Executive Agency for Medicinal Products may require the marketing authorization holder to
p.002007: provided clinical and stability data for the medicinal product. The owner of
p.002007: the marketing authorization shall submit the requested data to the BDA within 12 days from the expiry of the term under para. 3.
p.002007: (5) The Executive Agency for Medicines shall evaluate the documentation and take a final decision within 10 days
p.002007: days from receipt of the data under para. 4, by granting permission for change or refusal.
p.002007: Art. 65. (1) When the holder of the marketing authorization establishes a health risk in the use of
p.002007: the medicinal product, it shall take urgent restrictive measures and immediately notify the BDA in writing.
p.002007: (2) The Executive Agency for Medicines shall decide on the measures within 24 hours from the notification.
p.002007: (3) When the BDA does not make its decision within the term under para. 2, the measures are considered to be approved.
p.002007: (4) When the BDA determines that there is a risk to human health from the use of the medicinal product,
p.002007: orders the marketing authorization holder to take immediate restrictive measures.
p.002007: (5) In the cases of para. 1 and 4, the marketing authorization holder agrees with
p.002007: BDA manner and time limits for implementation of the measures taken.
p.002007: (6) The marketing authorization holder shall submit it to the Executive Director
p.002007: of BDA application for change in accordance with Art. 64 not later than 15 days after the date of taking over
p.002007: measures.
p.002007: Art. 66. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of a permit for use of
p.002007: the medicinal product is applying for an extension of the marketing authorization
p.002007: at:
p.002007: 1. change of active substance (s):
p.002007: (a) replacement of a chemically active substance with a different complex / derivative including salt / ester with the same
p.002007: the therapeutic part, wherein the efficacy / safety characteristics do not differ significantly;
p.002007: b) replacement with different isomer, different mixture of isomers, replacement of mixture with isolated isomer (e.g.
p.002007: single enantiomer racemate), whereby the efficacy / safety characteristics are not
p.002007: differ significantly;
p.002007: (c) replacement of a biologically active substance with one having a slightly different molecular structure when
p.002007: which does not differ significantly in performance / safety characteristics, except
p.002007: changes in the active substance of a seasonal, pre-pandemic or pandemic influenza vaccine
p.002007: human use;
p.002007: (d) modification of the vector used to produce the antigen or starting material, including a new one
p.002007: a major cell bank from another source, with no performance / safety features
p.002007: differ significantly;
p.002007: (e) a new radiopharmaceutical ligand or binding mechanism in which the characteristics of
p.002007: efficiency / safety do not differ significantly;
p.002007: (f) a change in the extraction solvent or in the ratio of plant matter / plant preparation,
p.002007: in which the efficacy / safety characteristics do not differ significantly;
p.002007: 2. change in the amount of active substance, dosage form and route of administration:
p.002007: (a) change in bioavailability;
p.002007: (b) a change in pharmacokinetics, such as a change in the rate of release;
p.002007: (c) modification or addition of a new amount of the active substance / activity;
p.002007: (d) modifying or adding a new dosage form;
p.002007: (e) Modification or addition of a new route of administration - parenteral administration should be done
p.002007: differentiation between intraarterial, intravenous, intramuscular, subcutaneous and other routes of
p.002007: introduction.
p.002007: (2) The application under para. 1 shall be submitted together with the documentation under Art. 27, para. 1, item 10, related to the changes under para.
p.002007: 1.
p.002007: (3) The requirements to the documentation under para. 2 shall be specified in the ordinance of the post. 42.
p.002007: (4) The name of the medicinal product in the extended marketing authorization
p.002007: the original marketing authorization does not change.
p.002007: (5) The granting of an authorization to extend the scope of an already granted marketing authorization to
p.002007: medicinal product is carried out under the conditions and in accordance with Art. 49 - 51.
p.002007: Art. 67. (1) The holder of the marketing authorization for the medicinal product shall submit an application for issuance
p.002007: of a new marketing authorization for:
p.002007: 1. the addition or removal of one or more active substances, including antigenic components, for
p.002007: vaccines;
p.002007: 2. a change in the quality of the active substance indicated in the dossier which changes substantially
p.002007: the safety and efficacy characteristics of the medicinal product, and the modified substance is determined
p.002007: as new;
p.002007: 3. adding a new one or changing the existing indication for treatment, prophylaxis or diagnosis in
p.002007: another therapeutic area.
p.002007: (2) (New, SG No. 71/2008, effective 12.08.2008) The holder of the marketing authorization for
p.002007: the medicinal product applies for a new marketing authorization when the application is made
p.002007: Renewal of the marketing authorization was not filed within the time limit under Art. 59a, para. 1.
p.002007: (3) (Renumbered from Paragraph (2), SG No. 71/2008, effective 12.08.2008) The application shall be accompanied by
p.002007: documentation specified in the ordinance under Art. 42.
p.002007: (4) (Renumbered from Paragraph (3), Supplemented, SG No. 71/2008, effective 12.08.2008). 1 and 2 shall apply
p.002007: the procedure under Art. 49 - 51.
p.002007: Art. 68. (amend. - SG 102/2012, in force from 21.12.2012) (1) The holder of a permit for
p.002007: the use / registration certificate of the medicinal product is obliged to:
p.002007: 1. take into account the achievements of scientific and technical progress and make any necessary changes in
p.002007: the documentation under Art. 27, para. 1, items 7 and 8 in order to manufacture and control the medicinal product according to
p.002007: conventional scientific methods; the changes are made in the order of chapters three and five;
p.002007: 2. immediately submit to the BDA any new information that may require a change in the data and documents
p.002007: under Art. 27 - 32 and in the summary of product characteristics;
p.002007: 3. immediately inform the BDA of any prohibition or restriction imposed by regulatory authorities on others
p.002007: countries where the medicinal product is placed on the market for the reasons why it was imposed
...
p.002007: for active substances.
p.002007: (2) Importers may import active substances only if the following conditions are met:
p.002007: 1. the active substances have been manufactured in accordance with Good Manufacturing Practice standards,
p.002007: which are at least equivalent to those established by the European Union, and
p.002007: 2. (In force from 02.07.2013) The active substances shall be accompanied by a written confirmation from the competent person
p.002007: authority of the exporting country that:
p.002007: (a) Good manufacturing practice standards applicable to the exported production site
p.002007: active substances are at least equivalent to those established by the European Union;
p.002007: (b) the production site concerned is subject to regular control and is effectively implemented by the Good
p.002007: manufacturing practices, including repeated and unannounced inspections, to ensure the protection of
p.002007: public health at least equivalent to that of the European Union, and
p.002007: (c) in the event of non-compliance, the exporting country will immediately inform the BDA.
p.002007: (3) (In force from 02.07.2013) The requirement of para. 2, item 2 shall not apply if the exporting country is included in
p.002007: the list under Art. 111b of Directive 2001/83 / EC.
p.002007: Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
p.002007: ensure the availability of medicinal products, the importer may import the active substance without the written request
p.002007: confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
p.002007: manufacturing practice where the manufacturing site of the active substance in the exporting country was
p.002007: inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines for
p.002007: Good manufacturing practice.
p.002007: (2) In the cases of para. 1 The BDA shall notify the European Commission.
p.002007: Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of manufacturing authorizations,
p.002007: including those who perform the activities of art. 168b, para. 2 shall be considered as producers within the meaning of
p.002007: § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002007: caused by a defect in the goods provided for therein.
p.002007: Chapter Six.
p.002007: PACKAGING AND PACKAGE LEAFLET
p.002007: Art. 168. (1) The packaging of a medicinal product shall consist of a primary and / or secondary packaging and a leaflet for
p.002007: patient.
p.002007: (2) (amend. - SG 61/11, in force from 10.11.2011) The secondary packaging of medicinal products,
p.002007: containing substances specified in the list under Art. 3, para. 2, item 2 of the Drug Control Act
p.002007: substances and precursors, is marked diagonally with two red strips, and the outer packaging of medicinal
p.002007: products containing substances from the list under Art. 3, para. 2, item 3 of the Drug Control Act
p.002007: substances and precursors - with two blue bands. The package must contain an indication that the medicinal product
p.002007: the product is only available on special medical prescription.
p.002007: (3) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products included in
p.002007: the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains
p.002007: information with the following text: "This medicinal product is subject to additional monitoring". In front of
p.002007: the text shall be marked in black in accordance with Article 23 (5) of Regulation (EC) No 726/2004
p.002007: The European Parliament and the Council, accompanied by an explanatory note.
p.002007: (4) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products shall include
p.002007: a standard text asking patients to report to healthcare professionals or directly
p.002007: of the BDA any suspected adverse reaction according to the models of Art. 185, para. 2, Vol. 4.
p.002007: (5) When the medicinal product is authorized for use on the territory of the Republic of Bulgaria, on
p.002007: its secondary packaging is labeled for separate collection and recycling in accordance with the Law on
p.002007: waste management and implementing acts.
p.002007: (6) Where the medicinal product is authorized, its name shall be given on the outer carton,
p.002007: the dosage form and the content of the active substance in the dosage unit are also indicated with Braille
p.002007: alphabet.
p.002007: (7) The requirements of para. 6 shall not apply to vaccines and medicinal products in hospital packaging.
p.002007: (8) (New, SG No. 102/2012, in force since 21.12.2012) On the outer packaging, or, if there is none, on
p.002007: The primary packaging of medicinal products, with the exception of radiopharmaceuticals, shall include:
p.002007: 1. an individual identifier for safety features that enables traders
p.002007: wholesale and retail:
p.002007: (a) verify the authenticity of the medicinal product;
p.002007: (b) identify the individual packaging;
p.002007: 2. a means of checking whether the medicinal product has been tampered with.
p.002007: Art. 168a. (New, SG No. 102/2012, effective 21.12.2012) (1) On the packaging of a medicinal product,
p.002007: which is granted on medical prescription, safety indicators according to art. 168, para. 8, p
p.002007: except where the medicinal product is included in the list established by the European Union
p.002007: commission with delegated act under art. 168b.
p.002007: (2) The packaging of a medicinal product, which is available without a prescription, shall not be affixed
p.002007: safety indicators under art. 168, para. 8, except where the medicinal product is
p.002007: included in the list determined by the European Commission by a delegated act under art. 168b, after being judged to be
p.002007: at risk of counterfeiting.
p.002007: (3) The Medicines Executive Agency shall notify the European Commission of:
p.002007: 1. for medicinal products which are available without a prescription for which it has been established
p.002007: risk of counterfeiting;
...
p.002007: forged;
p.002007: 2. the holder of a production permit in compliance with the requirements of Art. 168, para. 8 can replace
p.002007: safety indicators with their equivalent in terms of the ability to guarantee
p.002007: authentication, identification and provision of evidence of tampering with the medicinal product
p.002007: product.
p.002007: (3) Safety indicators shall be considered equivalent if:
p.002007: 1. satisfy the requirements laid down in the delegated acts referred to in Article 54a (2) of the Directive
p.002007: 2001/83 / EC, and
p.002007: 2. are equally effective in allowing authentication and identification of
p.002007: medicinal products and providing evidence of counterfeiting.
p.002007: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of the medicinal product and in
p.002007: compliance with Good Manufacturing Practice for Medicinal Products.
p.002007: (5) The Drug Enforcement Agency oversees the replacement of the
p.002007: safety.
p.002007: Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
p.002007: compliance with the data in the summary of product characteristics approved by the BDA at the time of the issuance of the BDA
p.002007: the marketing authorization and meet the requirements set out in the ordinance under Art. 170.
p.002007: (2) The information on the packaging and the leaflet may be in several languages, but necessarily one
p.002007: should be Bulgarian. The content of the information in different languages must be identical.
p.002007: (3) The name of the medicinal product shall be written in Bulgarian and the international name
p.002007: non-patent name of the medicinal substance is given in accordance with the Anatomical Therapeutic
p.002007: the chemical classification of WHO. The name and address of the marketing authorization holder may be
p.002007: written in Latin.
p.002007: (4) The information on the packaging and the package leaflet must be in a patient-friendly language, legible and
p.002007: be indelible.
p.002007: (5) (New, SG No. 18/2014) The leaflet must be designed in such a way that it is clear and comprehensible,
p.002007: allowing the patient to take appropriate action, medically as needed
p.002007: specialists.
p.002007: Art. 170. (1) (Former text of Art. 170 - SG, issue 102 of 2012, effective 21.12.2012) Requirements to
p.002007: the packaging and leaflets of the medicinal products shall be laid down in an ordinance of the Minister of Health
p.002007: healthcare.
p.002007: (2) (New - SG, iss. 102 in 2012; effective from 21.12.2012, supplemented - SG, iss. 18 of 2014) Where a medicinal product,
p.002007: authorized for use under this Act, is not intended for direct delivery to the patient or is not
p.002007: available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data,
p.002007: defined in the ordinance under para. 1 are not affixed to the package or package leaflet.
p.002007: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2 information on the packaging and
p.002007: the leaflet may not be provided in Bulgarian.
p.002007: (4) (New, SG No. 102/2012, effective 21.12.2012) The terms and procedure for delivery of medicinal products
p.002007: products under para. 2 shall be determined by the ordinance under art. 198.
p.002007: Chapter seven.
p.002007: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002007: Art. 171. (1) Depending on the method of dispensing, medicinal products shall be classified as:
p.002007: 1. prescription medicinal products;
...
p.002007: 1. contain narcotic substances within the meaning of the Drug Control Act; and
p.002007: precursors in permissible quantities;
p.002007: 2. if used improperly, they can create a significant risk of abuse, lead to a medicinal product
p.002007: dependency or use for illegal purposes;
p.002007: 3. contain new medicinal substances whose characteristics are not sufficiently known for this reason
p.002007: a preventive cause may be attributed to the group of medicinal products under item 2.
p.002007: Art. 175. Medicinal products are subject to limited medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. restricted to hospital use only because of limited experience in use or in the interest of
p.002007: public health;
p.002007: 2. intended for the treatment of conditions which can only be diagnosed in
p.002007: medical institutions, although their implementation and monitoring of the course of treatment may be
p.002007: carry out in other health establishments;
p.002007: 3. they are intended for the treatment of outpatients, but their use can be serious
p.002007: side effects requiring specialist prescription and monitoring during treatment.
p.002007: Art. 176. (1) The Executive Agency for Medicines may not approve the mail requested by the applicant. 26, para.
p.002007: 1 medication delivery regimen based on an assessment of:
p.002007: 1. the maximum single dose, the maximum daily dose, the amount of active substance in a single dose
p.002007: unit, dosage form, specific type of immediate packaging of the product, and / or
p.002007: 2. other specific conditions of use.
p.002007: (2) The Medicines Executive Agency may not specify the exact category of medicinal product under
p.002007: Art. 172, but according to the criteria of Art. 174 and 175 determine whether the medicinal product is to be classified as
p.002007: product available only on prescription.
p.002007: Art. 177. Medicinal products which do not meet the requirements of the EMA. 173, 174 and 175 and the criteria,
p.002007: defined in the ordinance under art. 178, are granted without medical prescription.
p.002007: Art. 178. The classification criteria for medicinal products and the requirements for the dossier
p.002007: making changes in the classification shall be determined in an ordinance of the Minister of Health.
p.002007: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish its page on an internet list
p.002007: of medicinal products subject to medical prescription on the territory of the Republic
p.002007: Bulgaria.
p.002007: (2) The list under para. 1 is updated annually.
p.002007: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002007: or a certificate of registration, the BDA shall review and, where necessary, amend the classification
p.002007: according to the requirements of Art. 173 and the criteria specified in the ordinance post. 178.
p.002007: Art. 181. Where a change in the classification of a medicinal product is authorized
p.002007: significant preclinical or clinical trials, following applicant or marketing authorization holder
p.002007: use may not be invoked within one year from the date of the variation authorization issued by
p.002007: a regulatory authority of a Member State, when applying for a change in the classification of the same
p.002007: substance.
p.002007: Art. 182. The Medicines Executive Agency shall inform the European Commission and the regulatory authorities on an annual basis
p.002007: authorities of other Member States for changes in the list under Art. 179.
p.002007: Chapter Eight.
p.002007: PHARMACEUTICAL SAFETY TRACKING
p.002007: Section I.
p.002007: General Provisions (New, SG No. 102/2012, effective 21.12.2012)
p.002007: Art. 183. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: organizes and maintains a pharmacovigilance monitoring system for the implementation of the
p.002007: the obligations under this Chapter.
p.002007: (2) The system of para. 1 is used to gather information on the risks of medicinal products
p.002007: for patients' health and public health. The information covers unwanted messages
p.002007: drug reactions when using a medicinal product in accordance with the approved summary
p.002007: characteristics, as well as misuse and use information that is not in accordance with the approved one
p.002007: summary of product characteristics, including information on the side effects observed
p.002007: in the performance of professional duties.
p.002007: (3) The Executive Agency for Medicines shall validate, process and classify the information under para. 2,
p.002007: makes a scientific analysis of the data collected with a view to assessing the options for reduction and prevention
p.002007: risk and take the necessary action with regard to the marketing authorization
p.002007: product.
p.002007: (4) The Executive Agency for Medicines shall carry out audits of the system under para. 1 and every two years
p.002007: sends a report to the European Commission on the results thereof.
...
p.002007: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002007: available data, including clinical trial data for unauthorized indications and target groups,
p.002007: not included in the summary of product characteristics;
p.002007: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002007: the holder of the marketing authorization is in possession of the volume of prescriptions, including
p.002007: approximate number of persons who have used or are exposed to the medicinal product
p.002007: another reason.
p.002007: (2) The content and format of the electronic periodic safety update reports shall be
p.002007: set out in Implementing Regulation (EU) No 520/2012.
p.002007: (3) The information under para. 1 shall be collected and stored in a register established pursuant to Article 25a of the Regulation
p.002007: (EC) No 726/2004 of the European Parliament and of the Council, and is available to the BDA.
p.002007: Art. 194i. (New, SG No. 102/2012, effective 21.12.2012) Holders of authorizations for
p.002007: use / certificates for registration of medicinal products under Art. 28, 30, 35 and 37 submit periodically
p.002007: updated safety reports only in cases where:
p.002007: 1. submission of a report is a condition under Art. 55a or 56, entered in the Marketing Authorization / Certificate
p.002007: registration, or
p.002007: 2. The Executive Agency for Medicinal Products or a regulatory authority of another Member State shall so request
p.002007: based on safety considerations for the medicinal product or due to lack of periodic medicines
p.002007: updated safety reports for the active substance contained in the medicinal product at
p.002007: who has been granted marketing authorization / registration certificate.
p.002007: Art. 194k. (New, SG No. 102/2012, effective 21.12.2012) (1) In the marketing authorization / certificate
p.002007: the frequency of submission of periodic safety update reports shall be determined for registration.
p.002007: (2) The filing dates of the reports depending on the frequency under para. 1 shall be calculated from the date of issue
p.002007: of the Marketing Authorization / Registration Certificate.
p.002007: (3) Periodic safety update reports shall be submitted at the following time intervals, p
p.002007: except where the frequency of submission of reports is a condition for authorization
p.002007: for use / registration certificate or determined in accordance with Art. 194l, 194m and 194h:
p.002007: 1. every 6 months from the date of issue of the marketing authorization / registration certificate
p.002007: medicinal product by the date of its placing on the market;
p.002007: 2. every 6 months during the first two years from the date of placing on the market of the medicinal product;
p.002007: 3. once a year for the next two years;
p.002007: 4. once every three years after the fourth year from the date on which the medicinal product is placed on the market.
p.002007: (4) Outside the cases under para. 3, periodic safety update reports shall be submitted immediately to
p.002007: a request from the BDA or a regulatory authority of a Member State.
p.002007: (5) Paragraphs 3 and 4 shall also apply to medicinal products authorized only in the territory of
p.002007: Republic of Bulgaria, which are not covered by Art. 194l.
p.002007: Art. 194l. (New, SG No. 102/2012, effective 21.12.2012) Where medicinal products containing
p.002007: the same active substance, or combination of the same active substances, have been obtained separately
p.002007: marketing authorizations / registration certificate, frequency and filing dates for periodic applications
p.002007: updated safety reports may be modified and harmonized in order to carry out
p.002007: uniform evaluation of these reports.
p.002007: Art. 194m. (New, SG No. 102/2012, effective 21.12.2012) (1) The filing dates of the periodicals
p.002007: updated safety reports for the medicinal products under Art. 194l are calculated according to
p.002007: European Union reference date.
p.002007: (2) The European Union reference date under para. 1 is:
p.002007: 1. the date of the first authorization for use in the European Union of the medicinal product containing
p.002007: the active substance concerned or the corresponding combination of active substances, or
p.002007: 2. the earliest known date of the marketing authorizations for the medicinal product containing
p.002007: the relevant active substance or the corresponding combination of active substances, if the date referred to in point 1,
p.002007: could not be determined.
p.002007: Art. 194n. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
p.002007: of medicinal products under Art. 194l may submit a reasoned request to the Committee for Medicinal Products
p.002007: products for human use, respectively to the coordination group under Art. 77, para. 2 to determine
p.002007: reference date of the European Union or change of frequency of submission of periodicals
p.002007: updated safety reports on one of the following grounds:
p.002007: 1. reasons for public health;
p.002007: 2. to avoid duplicate assessment;
p.002007: 3. to achieve international harmonization.
p.002007: (2) The Committee for Medicinal Products for Human Use, or the Coordination Group of Post Offices. 77,
p.002007: para. 2 after consultation with the committee under Art. 56a, para. 1, item 1 approves the request or makes a reasoned refusal.
p.002007: (3) The filing frequency and the reference date of the European Union shall be determined in consultation with
p.002007: the committee under Art. 56a, para. 1, item 1 of:
p.002007: 1. The Committee for Medicinal Products for Human Use - where at least one of the Marketing Authorizations
p.002007: for medicinal products containing the active substance concerned, is granted in accordance with
p.002007: the centralized procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.002007: Parliament and the Council, or
p.002007: 2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
p.002007: (4) The list of European Union reference dates for medicinal products has been sent. 194l and
p.002007: the harmonized frequency for submitting their periodic safety update reports
p.002007: publish on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002007: (5) The holder of the marketing authorization after the publication of the data under para. 4 presents in the BDA
p.002007: application for a change of the marketing authorization for the medicinal product concerned. Any change to
p.002007: filing dates and frequency of submission of periodic safety update reports,
p.002007: specified in the marketing authorizations shall take effect 6 months after the date of their publication.
p.002007: Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: evaluates periodic safety update reports for medicinal products to determine whether
p.002007: there are new risks, or a change in the identified risks, or a change in the benefit / risk balance.
p.002007: (2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic updated reports
p.002007: on the safety of medicinal products for which the Republic of Bulgaria has fulfilled the functions of
p.002007: reference country within the meaning of Art. 76, and is designated by the coordination group under Art. 77, para. 2.
...
p.002007: take any of the following measures:
p.002007: 1. suspension or termination of the marketing authorization;
p.002007: 2. prohibition of distribution of a medicinal product;
p.002007: 3. issuing a refusal to renew the marketing authorization.
p.002007: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para. 2 when
p.002007: has been informed by the Marketing Authorization Holder that for traceability reasons
p.002007: drug safety, suspends the distribution of the medicinal product or has taken, or
p.002007: intends to take action to withdraw it from the market or not to take action on
p.002007: renewal of the marketing authorization.
p.002007: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure under para.
p.002007: 2 and where it considers that for reasons of pharmacovigilance,
p.002007: new contraindications must be added or reduced for a medicinal product
p.002007: the recommended dose or indication should be limited.
p.002007: (5) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall submit to the European Agency
p.002007: on medicines and regulatory authorities of other Member States all scientific information with which
p.002007: it shall have, as well as the data evaluation carried out, the reasons for initiating the procedure in accordance with this
p.002007: section.
p.002007: (6) (Amended, SG No. 18/2014) In the cases of para. 2 - 4 The European Medicines Agency notifies the BDA of
p.002007: initiation of the procedure when safety concerns also apply to other medicinal products
p.002007: products that belong to the same therapeutic group or that contain the same active substance
p.002007: substance with the product specified in the information under para. 5, or where this medicinal product is authorized for
p.002007: use in another or in other Member States.
p.002007: (7) (amend. - SG 18/04) In the cases of para. 4, when no emergency measures are required, BDA
p.002007: apply the procedure under Art. 77 or 79b.
p.002007: (8) (New, SG No. 18/2014) The Executive Agency for Medicines shall inform the holder of the
p.002007: the marketing authorization for initiating the procedure under this section.
p.002007: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases of no. 194y, para. 2, when judged,
p.002007: that urgent public health measures need to be taken, the BDA may temporarily
p.002007: suspend the marketing authorization and prohibit the use of the medicinal product in the territory of
p.002007: Until the adoption of a final decision under Art. 194h or 194h.
p.002007: (2) The Medicines Executive Agency shall notify the European Medicines Agency, the European Medicines Agency
p.002007: the Commission and the regulatory authorities of the other Member States for the measures taken under para. 1 within one
p.002007: working day from their implementation and state the reasons for this.
p.002007: (3) Where the Medicines Executive Agency participates in the procedure under this section, at the request of the
p.002007: The European Commission BDA takes the recommended provisional measures with regard to the authorization of
p.002007: use of the medicinal product, or where the medicinal product is authorized for use in the order of
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council - as regards the product itself,
p.002007: completion of the procedure.
p.002007: Art. 194x. (New, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines
...
p.002007: the risks associated with its activities;
p.002007: 6. to immediately inform the BDA and the Marketing Authorization Holder when it has established or has
p.002007: suspicion that the mediation product is counterfeit;
p.002007: 7. check that the trader holds a license for wholesale of medicinal products;
p.002007: 8. verify that the manufacturer or importer holds a manufacturing / import permit;
p.002007: 9. to keep the data under item 3 for a period of at least 5 years and to provide them at the request of the control bodies
p.002007: organs.
p.002007: (2) The requirements for mediation activities in the field of medicinal products shall be determined by
p.002007: the ordinance under Art. 198 and in European Commission guidance.
p.002007: Chapter Nine "a".
p.002007: PARALLEL IMPORTS OF MEDICINAL PRODUCTS (PREVIOUS SECTION II - SG 71/00)
p.002007: 2008, IN EFFECT OF 12/08/2008)
p.002007: Art. 213. (amend. - SG 71/08, in force from 12.08.2008) Parallel import of medicinal products of
p.002007: the territory of the Republic of Bulgaria may be exercised by a natural or legal person registered under
p.002007: Commercial law, under the law of a Member State, after obtaining a parallel permit
p.002007: imports issued by the BDA Executive Director.
p.002007: Art. 214. (1) A medicinal product authorized for use in another Member State may be imported in parallel
p.002007: in the territory of the Republic of Bulgaria, when it is identical or similar to a medicinal product authorized for
p.002007: use in the Republic of Bulgaria by the order of this law.
p.002007: (2) (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 12/2011, in force from 08.02.2011)
p.002007: the meaning of para. 1 identical or similar medicinal product is one which has the same qualitative and quantitative value
p.002007: composition with respect to the active substance (s) available in the same drug
p.002007: form, available in the same primary packaging, with a similar graphic design to the packaging.
p.002007: Art. 215. (1) (amend. - SG 71/08, in force from 12.08.2008) For obtaining a permit for
p.002007: parallel import of a medicinal product into the territory of the Republic of Bulgaria by the person under Art. 213 lodges
p.002007: an application to the BDA Executive Director stating the Member State from which it will perform
p.002007: parallel import of a medicinal product.
p.002007: (2) The following data and documents shall be attached to the application:
p.002007: 1. name, dosage form, quantity of active substance per unit dose of authorizations
p.002007: use in the Republic of Bulgaria of a medicinal product;
p.002007: 2. name, dosage form, amount of active substance per unit dose of the medicinal product
p.002007: product intended for parallel import;
p.002007: 3. (suppl. - SG 12/11, in force from 08.02.2011) the name of the holder of the marketing authorization and of
p.002007: the manufacturer, if he is a person other than the holder of the marketing authorization, of the medicinal product,
p.002007: intended for parallel imports;
p.002007: 4. the number of the marketing authorization for the medicinal product in the Republic of Bulgaria and the number of
p.002007: the authorization to use the medicinal product in the parallel Member State
p.002007: import;
p.002007: 5. statement on establishing the circumstances under art. 217, v. 1;
p.002007: 6. a copy of the leaflet for the patient and a sample of the medicinal product as sold in the country
p.002007: Member from which parallel importation is made, translation of the contents of the leaflet into Bulgarian,
p.002007: accompanied by a declaration that the translation is in accordance with the original of the leaflet;
p.002007: 7. a proposal for a leaflet for the patient of the parallel medicinal product, accompanied by
p.002007: a statement that the contents of the package leaflet are identical to the contents of the product leaflet,
p.002007: authorized for use in the Republic of Bulgaria, except for the following:
p.002007: (a) the name and management address of the parallel importer;
p.002007: (b) the name of the manufacturer, where different for the two products;
p.002007: (c) a period of stability when different for the two products;
p.002007: (d) excipients, where different in the two products;
p.002007: 8. in the case of repackaging:
p.002007: a) (amend. - SG 71/08, in force from 12.08.2008) a sample of the medicinal product as it will be
p.002007: launches on the market in Bulgaria;
p.002007: (b) a copy of the contract between the parallel importer and the partial importer
...
p.002007: solely for the purpose of providing information specified by this Act and are responsible for
p.002007: the accuracy of the information provided, as well as its timely delivery.
p.002007: (8) The conditions and procedure for providing, storing and performing analysis of the information under para. 3, as
p.002007: and for the administration, maintenance and access to the specialized electronic system under para. 1 se
p.002007: determined by an ordinance of the Minister of Health.
p.002007: (9) The Medicines Executive Agency is obliged to provide the network and information
p.002007: security of the specialized electronic system under para. 1 subject to the obligation of secrecy
p.002007: of the information received under para. 3.
p.002007: Art. 217c. (New, SG No. 18/2014, declared as unconstitutional SRKS No. 1 of 2015 - SG, issue 12 of
p.002007: 2015, as amended. - SG, issue. 84 of 2018, effective 12.10.2018) (1) A list of medicinal products is hereby established,
p.002007: included in the Positive Medicinal List for which there is a shortage in the territory of the Republic
p.002007: Bulgaria, which is being prepared, updated and maintained by the Bulgarian Medicines Executive Agency.
p.002007: (2) The list under para. 1 shall be prepared on the basis of the analysis performed in accordance with Art. 217b, para. 4 and is published on
p.002007: the website of the Executive Agency for Medicinal Products.
p.002007: (3) The list of medicinal products for which a shortage has been established pursuant to Art. 217b, para. 5, is prepared
p.002007: by name of the medicinal product included in the Positive Medicinal List, internationally
p.002007: non-patent name, amount of active substance, dosage form and quantity in pack.
p.002007: (4) The list under para. 1 is being updated:
p.002007: 1. weekly;
p.002007: 2. in case of change of circumstances related to the import and / or export of medicinal products included in
p.002007: Positive drug list.
p.002007: (5) Upon updating the list in the order of para. 4, item 1, as well as in the cases when the circumstances under
p.002007: para. 4, item 2, based on the information provided under Art. 68, para. 1, Vol. 10, Art. 207, para. 1, item 15 and art. 217, v. 5,
p.002007: through the specialized electronic system of art. 217b, para. 1 a message shall be sent to the persons under Art. 68, para.
p.002007: 1, Art. 207, para. 1, Art. 217 and Art. 232a for the updated list. The list shall be published immediately on the Internet
p.002007: the page of the Executive Agency for Medicines.
p.002007: (6) In the cases of para. 4 the list under para. 1 shall be forwarded by the BDA and the Customs Agency by official order.
p.002007: (7) After the inclusion of medicinal products in the list under para. 1 they may not be exported for the period for which they are
p.002007: contain in the list.
p.002007: Art. 217g. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018)
p.002007: the medicines agency checks the persons who are obliged to provide information on
p.002007: the order of this chapter.
p.002007: Chapter Ten.
p.002007: RETAIL TRADE OF MEDICINAL PRODUCTS
p.002007: Art. 218. Retail trade in medicinal products shall be carried out only in pharmacies and drug stores in accordance with this
p.002007: law, except in cases under Art. 232, para. 2.
...
p.002007: price of medicinal products at retail sale, reference value for defined daily use
p.002007: dose / therapeutic course, packing value calculated on the basis of reference / therapeutic
p.002007: a defined daily dose course, pay level, therapeutic indications, and an international
p.002007: diseases (ICD). For medicinal products, the reference value is established on the basis of
p.002007: a defined defined daily dose or therapeutic course, or concentration or volume.
p.002007: (3) (amend. - SG 102/08, in force from 01.01.2019) The Positive medicinal list shall include
p.002007: medicinal products to which the international non-patent name to which it belongs
p.002007: the medicinal product / combination (for combined medicinal products) is to be paid by the public
p.002007: health insurance fund with the same therapeutic indications in at least 5 countries specified in the Ordinance on
p.002007: Art. 261a, para. 5.
p.002007: (4) (Supplemented, SG No. 48/2015, amended, SG No. 102/2018) Effective January 1, 2019
p.002007: The positive drug list is selected according to evidence of efficacy, therapeutic
p.002007: efficacy, safety and analysis of pharmacoeconomic indicators such as for medicinal products with
p.002007: a new international non-proprietary designation also evaluates healthcare technology. The assessment of
p.002007: Health technologies shall be carried out under the conditions and in the order determined by the ordinance under Art. 261a, para. 5.
p.002007: (5) (amend. - SG 102/08, in force from 01.01.2019) Where one or more medicinal products with
p.002007: the same international non-patent name, dosage form and concentration of the active substance,
p.002007: already included in the relevant part of the Positive Medicinal List, no assessment under para. 4.
p.002007: (6) The positive medical list includes:
p.002007: 1. medicinal products intended for the treatment of diseases, which are paid in accordance with the Law on
p.002007: health insurance;
p.002007: 2. medicinal products paid from the budget of the medical establishments under art. 5 of the Law on Healing
p.002007: establishments and from the budget of medical establishments with state and / or municipal participation 9 and 10 of the Law on
p.002007: medical establishments;
p.002007: 3. medicinal products intended for the treatment of AIDS, infectious diseases, diseases
p.002007: outside the scope of the Health Insurance Act, paid in accordance with Art. 82, para. 1, item 8 of the Law on
p.002007: health as well as vaccines for compulsory immunizations and immunizations, vaccines for special indications and
p.002007: in exceptional circumstances, specific sera, immunoglobulins;
p.002007: 4. the marginal price of the medicinal products under Art. 261a, para. 4 by elements.
p.002007: (7) The Ministry of Health and the NHIF may submit proposals to the council by post. 258, para. 1 for
p.002007: review of included medicinal products in the Positive Medicinal List under conditions and in order,
p.002007: defined in the ordinance under art. 261a, para. 5.
p.002007: (8) The National Health Insurance Fund shall pay for the medicinal products under para. 6, item 1 under the conditions and under
p.002007: the order of the ordinance under art. 45, para. 9 of the Health Insurance Act.
p.002007: (9) (New, SG No. 18/2014, Supplemented, SG No. 48/2015) Conditions, rules and criteria for inclusion,
p.002007: changes and / or exclusion of medicinal products from the Positive Medication List and to maintain
...
p.002007: the order specified in the ordinance under Art. 261a, para. 5.
p.002007: (11) (New, SG No. 48/2015, amend. - SG 102/2018) Medicinal Products,
p.002007: for which in the procedure under Art. 259, para. 1, item 8 does not prove a positive assessment upon their inclusion, does
p.002007: are excluded from the Positive Medication List.
p.002007: (12) (New, SG No. 84/2018, effective 12.10.2018, amended - SG No. 102/2018, effective 01/01/2019)
p.002007: The Ministry of Health pays the medicinal products under para. 6, item 3 with a new international
p.002007: a non-patent name, if it has been concluded before being included in the Positive Drug List
p.002007: preliminary framework agreement between the Ministry of Health and the holder of the
p.002007: the marketing authorization / authorized representative of the maximum value to which
p.002007: the relevant medicinal product may be delivered to the Ministry of Health in the order of
p.002007: Public Procurement Law. The agreement is binding on the parties. The agreements
p.002007: act in the council in the order determined by the ordinance of art. 261a, para. 5.
p.002007: (13) (New, SG No. 102/2018) The medicinal products under para. 6, item 3 with a new one
p.002007: international non-patent name for which no prior framework agreement has been concluded under para.
p.002007: 12 are not included in the Positive Medication List.
p.002007: Art. 262a. (New, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 102/2012, effective 21.12.2012,
p.002007: new - SG, iss. 102 of 2018, effective January 1, 2019) (1) Assessment of health technologies under Art. 262, para. 4 do not
p.002007: performs for generic medicinal products and for medicinal products containing active / active
p.002007: substance / substances with well-established use in medical practice.
p.002007: (2) Health products shall be evaluated for medicinal products included in the Positive Medicinal List
p.002007: technologies where an extension of therapeutic indications has been requested and has not yet been paid for
p.002007: by public funds, under conditions and in the order determined by the ordinance under Art. 261a, para. 5.
p.002007: (3) The Ministry of Health and the NHIF may reasonably request an assessment of the
p.002007: the health technologies of medicinal products included in the Positive Medicinal List under conditions and conditions
p.002007: order determined by the ordinance under art. 261a, para. 5.
p.002007: Art. 262b. (New, SG No. 102/2018, effective 01/01/2019) (1) The assessment of health technologies shall include:
p.002007: 1. analysis of the health problem;
p.002007: 2. comparative analysis of the therapeutic efficacy, efficacy and safety of the medicinal product;
p.002007: 3. analysis of pharmaco-economic indicators;
p.002007: 4. analysis of budgetary impact.
p.002007: (2) The assessment of health technologies shall be carried out according to the following criteria:
p.002007: 1. presence or absence of alternative treatment of the disease;
p.002007: 2. presence or absence of a medicinal alternative for the treatment of the disease;
p.002007: 3. efficacy and therapeutic efficacy of treatment - evaluation of therapeutic benefit, extension
p.002007: life expectancy and improving the quality of life, reducing complications from the basic
p.002007: illness;
p.002007: 4. number of potential patients;
p.002007: 5. safety of the medicinal product - frequency and severity of adverse reactions, need for administration of
p.002007: additional prophylactic or therapeutic measures to prevent side effects;
p.002007: 6. Pharmaco-economic indicators - costs for therapy with the medicinal product and comparison of costs
...
p.002007: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012)
p.002007: 12/21/2012) The Transparency Committee is an authority against which decisions of the National can be appealed
p.002007: advice on prices and reimbursement of medicinal products.
p.002007: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority of the panel and.
p.002007: (3) The decisions under par. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a relevant disease is
p.002007: without an alternative in the country, an authorized medicinal product may be administered to a particular patient
p.002007: for use in a Member State of the European Union, authorized for use under this Act, but not
p.002007: distributes on the Bulgarian market.
p.002007: (2) (amend. - SG 102/08, in force from 01.01.2019) Annually at the proposal of the medical establishments for
p.002007: hospital care and after the opinion of the relevant expert council in the relevant medical specialty
p.002007: or medical activity under Art. 6a, para. 1, item 1 of the Health Act the Minister of Health
p.002007: approve the list of medicinal products under para. 1, which contains the following information:
p.002007: 1. anatomical-therapeutic-chemical classification code;
p.002007: 2. an international non-patent name to which the product belongs;
p.002007: 3. disease according to the international disease code;
p.002007: 4. the dosage form and the amount of active substance;
p.002007: 5. additional information.
p.002007: (3) The list under para. 2 is published on the website of the Ministry of Health on the Internet.
p.002007: (4) The conditions and the order for inclusion, change or exclusion of medicinal products in the list under para. 2 se
p.002007: determine with the ordinance under art. 9, para. 1.
p.002007: (5) The medicinal product under para. 1 shall be delivered by special order to a hospital establishment for hospital care
p.002007: under the conditions and in the order determined by the ordinance of art. 9, para. 1.
p.002007: (6) The head of the medical establishment under para. 5 shall be responsible for the implementation of the treatment under para. 1.
p.002007: Chapter thirteen.
p.002007: STATE CONTROLS ON MEDICINAL PRODUCTS
p.002007: Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
p.002007: 12/21/2012) The Ministry of Health manages the state control over the medicinal products
p.002007: products. Immediate guidance is provided by the Chief State Health Inspector, from
p.002007: the chairman of the council under Art. 258, para. 1, by the Executive Director of the BDA and by the Directors of the Health Insurance Fund, who
p.002007: are state drug control inspectors.
p.002007: (2) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, in force since 21.12.2012)
p.002007: Bodies for state control over medicinal products are the council under Art. 258, para. 1, BDA and RZI.
p.002007: (3) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, in force since 21.12.2012)
p.002007: The direct control is exercised by officials - inspectors and experts designated by
...
p.002007: and exchanges information with the European Medicines Agency when planning and carrying out inspections
p.002007: para. 3.
p.002007: (8) (New, SG No. 102/2012, effective 21.12.2012) The Executive Agency for its Medicines
p.002007: cooperates with the European Medicines Agency in coordinating inspections in third countries.
p.002007: Art. 269a. (New, SG No. 102/2012, effective 21.12.2012) (1) 267, para. 3 draw up
p.002007: report on each inspection carried out under Art. 269, para. 3 and 4 on compliance with the principles and guidelines for
p.002007: Good manufacturing practice, either for Good Distributor Practices or for compliance with the requirements of
p.002007: Chapter Eight, as well as the requirements of this law.
p.002007: (2) The report under para. 1 shall be provided to the verified person, who may submit observations thereon.
p.002007: (3) Upon receiving a substantiated request, the BDA shall electronically send the reports under para. 1 on
p.002007: the competent authority of another Member State or of the European Medicines Agency.
p.002007: Art. 269b. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002007: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good
p.002007: distributor practices, where applicable, are issued by the BDA to the manufacturer, importer or trader.
p.002007: wholesale Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice
p.002007: within 90 days of the inspection.
p.002007: (2) When, as a result of an inspection, 269, para. 3 it was found that the manufacturer, the importer
p.002007: or the wholesaler of the medicinal product or the active substance does not comply with the law
p.002007: and / or the principles and guidelines for Good Manufacturing Practice and / or Good Distribution
p.002007: practices, the BDA issues a non-compliance statement.
p.002007: (3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued certificates under para.
p.002007: 1 and information under para. 2.
p.002007: Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002007: Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of the head
p.002007: eighth, the BDA provides prescriptions for the correction of inconsistencies.
p.002007: (2) In the cases of para. 1 The BDA shall notify the Member States, the European Medicines Agency and the European Medicines Agency
p.002007: The European Commission.
p.002007: Art. 270. (1) Within the limits of their competence, officials shall send. 267, para. 3 have the right:
p.002007: 1. (amend. - SG 102/2012, in force from 02.01.2013) access to all documents related to the subject of
p.002007: inspection, as well as documents related directly or indirectly to a violation of this Act or of
p.002007: the legislation of the Member States implementing the requirements of Directive 2001/83 / EC, regardless of
p.002007: the format of the document;
p.002007: 2. order each person to provide information on violations under item 1, which are known to him;
p.002007: 2a. (new - SG 102/2012, in force from 02.01.2013) to inspect the production and commercial
p.002007: facilities of manufacturers of medicinal products, active or auxiliary substances, as well as laboratories,
p.002007: used by the holders of a manufacturing or import license;
p.002007: 3. to inspect at any time the sites to be inspected and to request, verify and make copies
...
p.002007: other officials authorized by the persons under para. 3, as the chairman of the council under Art. 258, para. 1
p.002007: may authorize another committee member.
p.002007: Art. 296. Drafting acts, issuing, appealing and executing criminal decrees
p.002007: are carried out in accordance with the Law on Administrative Offenses and Penalties.
p.002007: Art. 297. (Amended, SG No. 84/2018, effective 12.10.2018) (1) In the cases of Art. 281, 282, 283, 284, 285 and 287
p.002007: the penal authority also orders the withdrawal in favor of the State of the medicinal products subject to the
p.002007: the committed offense, under the conditions and in the order specified in the Administrative Offenses Act and
p.002007: penalties and in accordance with Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 February
p.002007: October 2013 establishing the Union Customs Code (OJ, L 269/1 of 10 October 2013) and
p.002007: Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed implementing rules
p.002007: rules for the implementation of certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the
p.002007: Of the Council establishing the Union Customs Code (OJ, L 343/558 of 29 December 2015).
p.002007: (2) The medicinal products under para. 1 shall be destroyed under the conditions and in the order of the ordinance post. 274, para. 2.
p.002007: Additional provisions
p.002007: § 1. For the purposes of this Act:
p.002007: 1. (amend. - SG 102/02, in force from 02.01.2013) А
p.002007: "substance" means any substance or mixture of
p.002007: substances intended for use in the manufacture of a medicinal product which when used
p.002007: in its manufacture, they become the active ingredient of this product, intended for the exercise of
p.002007: pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
p.002007: physiological functions or for medical diagnosis.
p.002007: 2. "Bioequivalence" is present when the medicinal products are pharmaceutically equivalent or
p.002007: pharmaceutical alternatives, and if their bioavailability after administration at the same molar dose are
p.002007: similar to such an extent that their efficacy and safety effects are significant
p.002007: similar.
p.002007: 3. "Bioavailability" means the speed and degree at which the active substance or the therapeutically active part thereof
p.002007: absorb from the dosage form and become available at the site of action. When the drug substance is
p.002007: intended to exert a systemic therapeutic effect, bioavailability means speed and degree, c
p.002007: which the drug substance or the therapeutically active part thereof is released from the dosage form and
p.002007: goes into general circulation.
p.002007: 4. (Amended, SG No. 84/2018) (*) "Researcher's Brochure" is a Researcher's Brochure within the meaning of Art.
p.002007: 2 (2), point 23 of Regulation (EU) No 536/2014.
p.002007: 5. "Valid documentation" shall mean documentation that in content and completeness meets the requirements,
p.002007: provided for in a particular procedure under this Act.
p.002007: 6. "Substance with well established use in medical practice" is a substance for which it can be used
p.002007: apply the following criteria:
p.002007: (a) the period of proof of well-established use in medical practice shall be not less than 10
p.002007: years from the date of the first systematic and documented use of the substance as a medicinal product
p.002007: product in the European Union or in the European Economic Area;
p.002007: (b) quantitative aspects of the use of the substance, taking into account the extent of use in the substance
p.002007: medical practice, the extent of geographical use and the degree of traceability through
p.002007: the safety system, including studies carried out before and afterwards and
p.002007: published scientific literature on epidemiological studies and in particular comparative epidemiological studies
p.002007: studies;
p.002007: (c) a high level of scientific interest in the use of the substance (number of scientific publications) and unity in
p.002007: scientific circles in scientific evaluations.
p.002007: 7. "Secondary packaging" is a packaging which does not come into direct contact with the medicinal product.
p.002007: 8. (Amended, SG No. 84/2018) (*) "Assignor" shall be a sponsor within the meaning of Art. 2 (2) (14)
p.002007: Regulation (EU) No 536/2014.
p.002007: 9. "Generic medicinal product" is a medicinal product which has the same qualitative and quantitative value
p.002007: composition with respect to the active substances and the same dosage form as the reference dosage form
p.002007: product, and its bioequivalence with the reference medicinal product has been demonstrated by appropriate tests for
p.002007: bioavailability. The various immediate-release oral dosage forms are considered to be one and the same
p.002007: same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or
p.002007: active substance derivatives are considered to be the same active substance unless they differ significantly
p.002007: for its safety and / or efficacy.
p.002007: 10. (Amended, SG No. 84/2018) (*) "Principal Investigator" is a Principal Investigator within the meaning of Art. 2,
p.002007: paragraph 2, point 16 of Regulation (EU) No 536/2014.
p.002007: 11. "Defined daily dose" is an average daily maintenance dose of a medicinal product that is
p.002007: administered to adults according to the primary indication of the medicinal product.
p.002007: 12. (Amended, SG No. 84/2018) (*) "Good clinical practice" is a good clinical practice within the meaning of Art. 2,
p.002007: paragraph 2, point 30 of Regulation (EU) No 536/2014.
p.002007: 13. "Good laboratory practice" is a system of internationally recognized rules regarding conditions
p.002007: for the planning, processes of organizing, executing, tracking and documenting the laboratory
p.002007: tests.
p.002007: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers
p.002007: all sides of production - personnel, premises, facilities, materials, documentation, quality
p.002007: control, and aims to ensure safety, efficiency and compliance with the specification.
p.002007: 15. (Supplemented, SG No. 71/2008, effective 12.08.2008) State
p.002007: "Member" means a Member State of the European Union
p.002007: union or country party to the Agreement on the European Economic Area.
p.002007: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002007: 17. "Immunological medicinal product" means a medicinal product containing vaccines, toxins, sera or
p.002007: allergens. The scope of vaccines, toxins and serums includes agents used to create
p.002007: active immunity, or to establish a state of immunity, or to induce passive immunity. Allergens
p.002007: are medicinal products that are intended to identify or stimulate a specific
p.002007: targeted change in the immunological response to the allergic agent.
p.002007: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002007: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically equivalent
p.002007: alternative, and when their bioavailability after administration at the same molar dose is similar to the extent that
p.002007: is a requirement for equivalent efficacy and safety.
p.002007: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and
p.002007: the extent to which the active substance or the therapeutically significant portion of the investigational medicinal product is tested
p.002007: reach from the dosage form into the systemic circulation.
p.002007: 20. (amend. - SG 84/2018) (*) "Tested medicinal product" is a tested medicinal product within the meaning of
p.002007: of Art. 2 (2) (5) of Regulation (EU) No 536/2014.
p.002007: 21. (Amended, SG No. 84/2018) (*) "Researcher" shall be a researcher within the meaning of Art. 2 (2) (15)
p.002007: Regulation (EU) No 536/2014.
p.002007: 22. (amended, SG No. 84/2018) (*) "Informed consent" is informed consent within the meaning of Art. 2,
p.002007: paragraph 2, point 21 of Regulation (EU) No 536/2014.
p.002007: 23. "Kit" means any substance which is usually dissolved, suspended, diluted or diluted before use
p.002007: combines with radionuclides, resulting in the finished radioactive medicinal product.
p.002007: 24. (amended, SG No. 84/2018) (*) "Clinical trial of a medicinal product" is a clinical trial of
p.002007: the meaning of Art. 2 (2) (2) of Regulation (EU) No 536/2014.
p.002007: 25. "Clinical advantage" is a significant therapeutic or diagnostic benefit of a drug
p.002007: product compared to a medicinal product that has already been authorized.
p.002007: 25a. (new, SG No. 84/2018, effective 12.10.2018) Conflict
p.002007: "interests" is a conflict of interests under
p.002007: within the meaning of Chapter Eight, Section I of the Anti-Corruption and Removal of Illegal Act
p.002007: the property acquired.
p.002007: 26. (Repealed, SG No. 84/2018)
p.002007: 27. "Patient leaflet" is a leaflet containing user information to accompany
p.002007: the medicinal product.
p.002007: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002007: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No
p.002007: Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on medicinal products for
p.002007: advanced therapy and amending Directive 2001/83 / EC and Regulation (EC) No 726/2004.
p.002007: 27b. (new - SG 84 2018, in force from 12.10.2018) Medicinal
p.002007: "product for compassionate use" is
p.002007: medicinal product for palliative use within the meaning of Art. 83 (2) of Regulation (EC) No 726/2004
p.002007: of the European Parliament and of the Council.
p.002007: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product manufactured
p.002007: from human blood components and by a method involving an industrial process. These include albumin,
p.002007: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, other plasma
p.002007: fractions or combinations thereof.
p.002007: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare diseases" is
p.002007: a product that:
p.002007: (a) is intended for the diagnosis, prophylaxis or treatment of life - threatening diseases; or
p.002007: progressively chronic diseases affecting no more than 5 in 10,000 people in the territory
p.002007: on the side, or
p.002007: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002007: chronic health conditions (diseases with a high rate of disease - related illnesses)
p.002007: disability and disability) and evidence is provided that the sale of the product does not provide
p.002007: satisfactory returns to justify the necessary investment for research and development
p.002007: development without incentives for the product creator, and
p.002007: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of the condition, or
p.002007: if there is such a method, the proposed medicinal product has significantly more advantages than it and the benefit to
p.002007: affected by this condition.
p.002007: 30. "Dosage form" is an acceptable structure containing the active substance (s),
p.002007: which may or may not include excipients obtained by the administration of certain
p.002007: technological operations, providing the desired healing effect and storage stability over the shelf life.
p.002007: 31. (amend. - SG 71/08, in force from 12.08.2008) L.
p.002007: "located within the territory of a Member State" means
p.002007: a legal entity registered under the civil or commercial law of a Member State or
p.002007: established by a regulation having its registered office and registered office in a Member State or in
p.002007: State party to the Agreement on the European Economic Area.
p.002007: 32. "Highway formulation" is a prescription for a medicinal product prepared in a pharmacy prescribed by
p.002007: a medical specialist or an approved prescription for a particular patient.
p.002007: 33. "International non-patent name" means the recommended name of the active substance,
p.002007: approved and published by WHO.
p.002007: 34. "Medical specialists" are doctors, dentists, masters-pharmacists, medical
p.002007: nurses, midwives, medical assistants, paramedics and pharmacy assistants.
p.002007: 35. "Medical sales representative" is a person who has received special training and possesses scientific
p.002007: knowledge of providing accurate and complete information about the medicinal product it is advertising.
p.002007: 35a. (new - SG 1/2014, in force from 03.01.2014) Medical
p.002007: "prescription" is a prescription of
p.002007: medicinal product or medical device issued by a person practicing regulated medical
p.002007: a profession within the meaning of § 1, item 1 of the additional provisions of the Professional Recognition Act
p.002007: qualifications and who has the legal right to do so in the Member State where the medical is issued
p.002007: prescription.
p.002007: 36. (Repealed, SG No. 84/2018)
p.002007: 36a. (New, SG No. 84/2018, effective 12.10.2018) Network
p.002007: "and information security" is the protection of
p.002007: information from unauthorized or accidental access, use, disclosure to third parties, change
p.002007: or destruction.
p.002007: 37. "Medicinal product name" means the name given to the product, which may be:
p.002007: a) freely chosen name (trade name);
p.002007: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the trademark or name of
p.002007: the holder of the marketing authorization;
p.002007: c) (amend. - SG 12/11, in force from 08.02.2011) scientific name together with the trademark or the name of
p.002007: the holder of the marketing authorization.
p.002007: 38. "Scientific literature" is a publication / publications of research results in specialized
p.002007: international scientific publications.
p.002007: 38a. (new, SG No. 84/2018, effective 12.10.2018) Shortage
p.002007: "the medicinal product" is the shortage of
p.002007: medicinal products included in the Positive Medicinal List established by the specialized drug
p.002007: electronic system in accordance with Art. 217b.
p.002007: 39. "New active substance" is:
p.002007: (a) a chemical, biological or radiopharmaceutical substance which has not been authorized for use as
p.002007: medicinal product in the European Union;
p.002007: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that has been authorized for
p.002007: use as a medicinal product in the European Union but differs in safety and health
p.002007: its efficacy from a previously authorized substance;
p.002007: (c) a biological substance that has been authorized for use as a medicinal product in the European Union, but
p.002007: is of different molecular structure, of different origin with respect to the starting material or is obtained
p.002007: through a different production process;
p.002007: d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which are not
p.002007: have been authorized as a medicinal product in the European Union, or the pairing mechanism of
p.002007: molecules and radionuclides has not been authorized in the European Union.
p.002007: 40. (amended, SG No. 84/2018) (*) "Adverse event" is any adverse change in the health status.
p.002007: a condition observed when administering a medicinal product to a patient which is not necessarily causative
p.002007: related to this treatment.
p.002007: 41. (Am. - SG, iss. 102 in 2012, in force since 21.12.2012, amended - SG, iss. 84 of 2018. (*))
p.002007: reaction "is any adverse and unintended response to a medicinal product. The types of adverse drug reactions
p.002007: reactions are:
p.002007: a) (amended, SG No. 84/2018) (*) "unexpected" - adverse reaction not mentioned in the summary
p.002007: a characteristic of the product or whose character, weight or output does not correspond to those specified in the summary
p.002007: product characteristics;
p.002007: (b) "suspected" - an adverse reaction for which the notifier or marketing authorization holder
p.002007: use implies a possible cause and effect relationship with the medicinal product being administered;
p.002007: c) "serious" - any adverse effect on a health condition that has caused the death
p.002007: exit, immediate danger to life, hospitalization or prolongation of hospitalization,
p.002007: significant or permanent damage, disability and congenital anomalies;
p.002007: (d) combinations of reactions under letters "a", "b" and "c".
p.002007: 42. "Common name" means the international non-patent name of a medicinal or ancillary medicinal product
p.002007: substance (INN) recommended by the WHO; if not, the name in the European Pharmacopoeia is used, if and
p.002007: there is no other pharmacopoeial name; when there is no pharmacopoeial name, the usual accepted name is used.
p.002007: 42a. (new - SG 102/02, in force from 21.12.2012) Main
p.002007: "system documentation for
p.002007: Drug Safety Tracking "is a detailed description of the drug tracking system
p.002007: the pharmacovigilance used by the holder of the marketing authorization in respect of one or
p.002007: more authorized medicinal products.
p.002007: 42b. (new - SG 48/2015) "Assessment of health technologies" is:
p.002007: (a) a form of research policy examining the short and long term
p.002007: results related to the implementation of health technologies and aims to provide information on
p.002007: alternative health strategies;
p.002007: (b) a multidisciplinary activity that systematically assesses technical characteristics, safety,
p.002007: clinical efficacy and effectiveness, cost, value effectiveness, organizational, social,
p.002007: the legal and ethical implications of the administration of medicinal products in health care and focus
p.002007: on the value - clinical and economic, the analysis being comparable to existing or most
p.002007: the good alternative at the moment.
p.002007: 43. "Batch" means the specified quantity of the drug produced according to established reproducible
p.002007: technological scheme providing the necessary batch homogeneity with respect to the required ones
p.002007: benchmarks.
p.002007: 43a. (New, SG No. 102/2012, effective 21.12.2012) Plan
p.002007: "risk management" is a detailed description
p.002007: of the risk management system.
p.002007: 44. "Maintenance of a marketing authorization for a medicinal product" includes all necessary activities with
p.002007: in order to maintain the current registration status of the medicinal product, including
p.002007: drug safety monitoring.
p.002007: 44a. (new - SG 48/2015) "Maintenance of reimbursement status" is an evaluation of a medicinal product on the basis of
p.002007: Based on evidence of efficacy, therapeutic efficacy, safety and pharmacovigilance analysis
p.002007: Economic Indicators.
p.002007: 45. "Benefit" is the positive result / therapeutic efficacy of the medicinal product for the individual patient,
p.002007: a group of patients or the public. The quantified estimate of expected benefit includes an estimate
p.002007: calculating the probability of this positive result.
p.002007: 46. (amend. - SG 102/02, in force from 02.01.2013)
p.002007: "excipient" means any constituent of a medicinal product
p.002007: product other than the active substance and the packaging material.
p.002007: 47. "Post-marketing study" means any study conducted with the use of the medicinal product in
p.002007: within the approved summary of product characteristics after authorization.
p.002007: 47a. (new - SG 102/2012, in force from 02.01.2013) Mediation
p.002007: "in the field of medicines
p.002007: "products" are all activities aimed at concluding a contract for the purchase or sale of "
p.002007: medicinal products, other than wholesale, which do not include physical holding and which do
p.002007: express in negotiation independently and on behalf of another legal or natural person.
p.002007: 48. (Amended, SG No. 102/2012, effective 21.12.2012)
p.002007: "ostmarketing safety study" is anyone
p.002007: a study relating to an authorized medicinal product conducted in order to identify itself,
p.002007: characterize or determine the degree of safety risk, confirm the profile of
p.002007: the safety of the medicinal product or to evaluate the effectiveness of the risk management measures.
p.002007: 49. A "potential serious risk to public health" exists when there is a high degree of
p.002007: the likelihood that the use of a medicinal product will cause irreversible, irreversible and irreversible
p.002007: negative consequences. The evaluation process identifies the risk of causing harm to
p.002007: population health and actual exposure and wide exposure to the product. The serious one
p.002007: health risk in the context of the use of a particular medicinal product may be assessed at
p.002007: the following conditions:
...
p.002007: established on the territory of the Republic of Bulgaria, determined by the person under Art. 26, para. 1 or by the holder
p.002007: of the marketing authorization to represent it before the regulatory authorities in the territory of the Republic
p.002007: Bulgaria.
p.002007: 51. An "acceptable level of safety" is present when the data presented is accepted statistically
p.002007: reliable safety according to clinical trials conducted in accordance with Good Clinical Practice.
p.002007: 52. "Manufacture of a medicinal product" means all operations related to the procurement of materials,
p.002007: their processing in the production process, including packaging and labeling, quality
p.002007: control, batch release, storage, shipping and related operations.
p.002007: 53. (Amended, SG No. 84/2018) (*) "Clinical Trial Protocol" is a protocol within the meaning of Art. 2, paragraph
p.002007: 2, point 22 of Regulation (EU) No 536/2014.
p.002007: 54. "Placing on the market" means the distribution of a medicinal product on the market in the territory of
p.002007: Republic of Bulgaria beyond the direct control of the marketing authorization holder.
p.002007: 55. "Primary packaging" means packaging that comes into direct contact with the medicinal product.
p.002007: 56. "Radiopharmaceutical" is a medicinal product which, when ready for use, contains one or more
p.002007: radionuclides (radioactive isotopes) included for medical purposes.
p.002007: 57. "Radionuclide generator" means any system that includes a fixed mother radionuclide from which
p.002007: obtains a daughter radionuclide which is recovered by elution or other methods and used in
p.002007: radiopharmaceuticals.
p.002007: 58. "radionuclide precursor" means any other radionuclide produced for the radioactive labeling of another
p.002007: substance just before its introduction into the patient's body.
p.002007: 59. "Herbal medicinal product" is a medicinal product which contains as medicinal substances one
p.002007: or more herbal substances or one or more herbal preparations or one or more herbal preparations
p.002007: substances in combination with one or more herbal preparations.
p.002007: 60. "Vegetable substances" are mainly plants or parts of plants, algae, fungi, lichens, which are whole,
p.002007: broken or cut, and used in the raw state, usually in the dried state, but sometimes also
p.002007: fresh. Some exudates which have not undergone specific treatment also apply to
p.002007: plant substances. The plant matter must be of a specific botanical science
p.002007: name of the plants from which they originate according to the binominal system (genus, species, variety and
p.002007: author).
p.002007: 61. "Herbal preparation" is the product obtained after extraction, distillation, squeezing,
p.002007: fractionation, purification, concentration or fermentation of the plant substance. The vegetable
p.002007: preparation can also be ground or powdered vegetable substances, tinctures, extracts, ethereal
p.002007: oils, processed vegetable fluids / juices.
p.002007: 62. "Rare diseases" are diseases that are characterized by a frequency of spread of
p.002007: high from 5 in 10,000 people.
p.002007: 63. "Reference medicinal product" is a medicinal product authorized under Art. 23 in accordance with
p.002007: the requirements of Art. 27.
p.002007: 64. "Defined daily dose reference value" for an international non-patent name with
p.002007: the corresponding dosage form of the anatomic therapeutic classification of the drugs is the lowest
p.002007: a defined daily dose value based on the defined daily dose values for
p.002007: different medicinal products for the relevant international non-patent name with the corresponding
p.002007: dosage form according to the anatomic therapeutic classification of medicines.
p.002007: 65. "Therapeutic course reference value" is the lowest therapeutic course value set at
p.002007: base on the values of the therapeutic course of medicines under the international non - patent name with
p.002007: appropriate dosage form.
p.002007: 66. "Risk in use of a medicinal product" is:
p.002007: (a) patient's health risk or quality-related population health risk,
p.002007: the safety or efficacy of the medicinal product;
p.002007: (b) the risk of adverse effects on the environment.
p.002007: 67. "Serious adverse event" is any adverse change in health status that has occurred
p.002007: cause of death, imminent danger of life, hospitalization or prolongation of life expectancy
...
p.002007: the authorized medicinal products and the detection of any change in the benefit / risk ratio.
p.002007: 69c. (new, SG No. 84/2018, effective 12.10.2018)
p.002007: "is a violation committed three or more
p.002007: times within one year of the entry into force of the first penal decree whereby the offender
p.002007: the same type of offense is punished.
p.002007: 70. "Emergency restrictive safety measures" are temporary changes to product information under
p.002007: relation to one or more parts of the summary of product characteristics, indications, manner of
p.002007: application, contraindications and warnings resulting from new information related to
p.002007: safe use of the medicinal product.
p.002007: 71. "Spontaneous message" is a voluntarily sent message for a suspected adverse reaction to
p.002007: the use of the medicinal product by the Marketing Authorization Holder, the market surveillance authorities
p.002007: medicinal products or other organizations not derived from research or other organized
p.002007: information collection system.
p.002007: 72. "Shelf life of a medicinal product" is the interval of time when, if stored
p.002007: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002007: the basis of stability studies of several batches of finished form.
p.002007: 73. (amend. - SG 71/08, in force from 12.08.2008) p
p.002007: "an appropriate herbal medicinal product
p.002007: "medicinal product" is a product which contains the same active substances, regardless of the composition of
p.002007: excipients intended for the same purpose with an equivalent amount of the medicinal product
p.002007: substance / substances, with the same dosage and with the same or similar route of administration as the product, for
p.002007: who has applied.
p.002007: 74. An "adverse reaction message" is documented information about one or more
p.002007: suspected adverse reactions associated with the use of one or more medicinal products by one
p.002007: patient. For the validity of the adverse reaction message, they are required
p.002007: minimum identifier identifier data (initials or address or profession / specialty) of
p.002007: the patient (initials or age, or date of birth or gender), the adverse reaction / event, and
p.002007: the suspected medicinal product.
p.002007: 75. (Amended, SG No. 84/2018) (*) "Substantial change in the protocol of the clinical trial" is significant
p.002007: change within the meaning of Art. 2 (2) (13) of Regulation (EU) No 536/2014.
p.002007: 75a. (new, SG No. 102/2012, effective 21.12.2012) Substantial
p.002007: "changes to the
p.002007: non-interventional post-marketing research "are changes that affect safety,
p.002007: the physical or mental integrity of the patients or the results of the study and theirs
p.002007: interpretation.
p.002007: 76. (amend. - SG 71/08, in force from 12.08.2008)
p.002007: "reta country" is a non-state country -
p.002007: Member State of the European Union or not a State Party to the Agreement on the European Economic
p.002007: space.
p.002007: 77. "Wholesale" means all activities for the acquisition, storage, supply, import or export of
p.002007: medicinal products, except in the case of the supply of medicinal products directly to
p.002007: the population.
p.002007: 78. (Amended, SG No. 84/2018) (*) "Participant" shall be a participant within the meaning of Art. 2 (2) (17)
p.002007: Regulation (EU) No 536/2014.
p.002007: 79. (Repealed, SG No. 84/2018)
p.002007: 80. "Pharmacopoeia" is a collection of approved specifications and related production requirements,
p.002007: testing, storage and labeling of active substances, excipients, dosage forms,
p.002007: materials for packaging and components of the medicinal product.
p.002007: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product prepared in a pharmacy by a formulation
p.002007: operating pharmacopoeia and intended for delivery to patients at the same pharmacy.
p.002007: 81a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: "Counterfeit medicinal product" means any medicinal product in which it is misrepresented:
p.002007: (a) its identity, including particulars of the immediate packaging or its immediate packaging, its name or
p.002007: content with respect to any of its constituents, including excipients, and
p.002007: the amount of active substance per unit dose;
p.002007: (b) its source, including its manufacturer, the country in which it is manufactured, the country in which it is produced
p.002007: placed on the market, or the holder of his marketing authorization, or
p.002007: (c) the timing, including records and documents, of the supply chain used.
p.002007: It is not considered to be a counterfeit medicinal product with inadvertent tolerance in
p.002007: quality as well as a medicinal product placed on the market in violation of intellectual property rights
p.002007: property.
p.002007: 82. "Homeopathic medicinal product" is a medicinal product made from substances called homeopathic
p.002007: source, according to the European Pharmacopoeia manufacturing procedures, and in the absence thereof -
p.002007: according to the national pharmacopoeia of a Member State.
p.002007: 83. "Price calculated on the basis of a benchmark" is the price established for each medicinal product,
p.002007: included in the Positive Medicinal List calculated on the basis of the established reference value for
p.002007: defined daily dose or therapeutic course.
p.002007: 84. (Repealed, SG No. 84/2018)
p.002007: 85. "Misuse of medicinal products" is a persistent or occasional intentional overuse of
p.002007: medicinal products accompanied by harmful physical or psychological effects.
p.002007: 86. (new - SG 41/09, in force from 02.06.2009)
p.002007: "are children under 12 months of age.
p.002007: 87. (new - SG 41/09, in force from 02.06.2009) Food
p.002007: "infant formulas" means foods intended for infants
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.002019: 1. paragraph 29, item 13, letter "b", items 14 and 15, § 30 and § 42, item 2, which come into force on the day of promulgation of
p.002019: the law in the State Gazette;
p.002019: 2. paragraph 28, items 6 - 12 and items 14 - 19, § 35, item 3, with the exception of Art. 7a, para. 4 and Art. 7c, para. 4, items 5 and 6, items 8 - 22 and so on.
p.002019: 36 - 40, § 41, items 2 - 8, item 9, letters "a" and "c" and item 10, which come into force on April 1, 2019;
p.002019: 3. paragraph 29, item 5, letter "a" on words "and through the budget of the Ministry of Health for
p.002019: payment for medical devices, aids, gadgets and equipment for people with
p.002019: 9, letter "a" on words "as well as medical devices, accessories, devices
p.002019: and facilities for people with disabilities ", item 9, letter" d "on words" and accessories,
p.002019: facilities and facilities for persons with disabilities "and for words" as well as persons,
p.002019: carrying out activities for provision and repair of medical devices, auxiliaries,
p.002019: facilities and equipment for persons with disabilities registered as traders and entered in the register of
p.002019: persons carrying out activities for provision and repair of auxiliaries, devices,
p.002019: facilities and medical devices for persons with disabilities "and item 9, letter" e "regarding paragraph 15, item 3 and paragraph 16
p.002019: on the words "as well as persons engaged in the provision and repair of auxiliaries,
p.002019: devices, equipment and medical devices for persons with disabilities registered as dealers and
p.002019: entered in the register of persons performing activities for providing and repairing auxiliaries,
p.002019: facilities, equipment and medical devices for people with disabilities - to pay for medical
p.002019: articles, aids, appliances and facilities for disabled people ", item 25, letter" a "- paragraph 1, item 13
p.002019: on the words "aids, devices and equipment for the disabled" and item 25 (b)
p.002019: regarding para. 4 on the words "and persons engaged in the activities of providing and repairing medical
p.002019: Merchant-registered items, accessories, gadgets and equipment for disabled people
p.002019: and entered in the register of persons performing activities for provision and repair of auxiliary means,
p.002019: devices, equipment and medical devices for people with disabilities "i" and accessories,
p.002019: facilities and facilities for persons with disabilities ", § 36 and § 37 regarding Article 14, paragraph 8, item 2, letter" b ", which
p.002019: shall enter into force on 1 January 2020.
p.002019: Relevant European legislation
p.002019: Directives:
p.002019: COMMISSION DIRECTIVE 2017/1572 of 15 September 2017 supplementing the Directive
p.002019: 2001/83 / EC of the European Parliament and of the Council as regards the principles and guidelines for good
p.002019: manufacturing practice for medicinal products for human use
p.002019: DIRECTIVE 2012/26 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012
p.002019: amendment of Directive 2001/83 / EC as regards pharmacovigilance
p.002019: DIRECTIVE 2011/62 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending
p.002019: of Directive 2001/83 / EC on the Community code relating to medicinal products for human use
p.002019: use with regard to the prevention of entry of counterfeit medicinal products into
p.002019: legal supply chain
p.002019: DIRECTIVE 2010/84 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010
p.002019: amendment concerning the pharmacovigilance of Directive 2001/83 / EC on the approval of
p.002019: Community code on medicinal products for human use
p.002019: DIRECTIVE 2005/36 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 on the
p.002019: recognition of professional qualifications
p.002019: COMMISSION DIRECTIVE 2005/28 / EC of 8 April 2005 laying down the principles
p.002019: detailed guidelines for good clinical practice with regard to medicinal products for human use,
...
Searching for indicator disability:
(return to top)
p.002007: 26. (Repealed, SG No. 84/2018)
p.002007: 27. "Patient leaflet" is a leaflet containing user information to accompany
p.002007: the medicinal product.
p.002007: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002007: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No
p.002007: Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on medicinal products for
p.002007: advanced therapy and amending Directive 2001/83 / EC and Regulation (EC) No 726/2004.
p.002007: 27b. (new - SG 84 2018, in force from 12.10.2018) Medicinal
p.002007: "product for compassionate use" is
p.002007: medicinal product for palliative use within the meaning of Art. 83 (2) of Regulation (EC) No 726/2004
p.002007: of the European Parliament and of the Council.
p.002007: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product manufactured
p.002007: from human blood components and by a method involving an industrial process. These include albumin,
p.002007: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, other plasma
p.002007: fractions or combinations thereof.
p.002007: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare diseases" is
p.002007: a product that:
p.002007: (a) is intended for the diagnosis, prophylaxis or treatment of life - threatening diseases; or
p.002007: progressively chronic diseases affecting no more than 5 in 10,000 people in the territory
p.002007: on the side, or
p.002007: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002007: chronic health conditions (diseases with a high rate of disease - related illnesses)
p.002007: disability and disability) and evidence is provided that the sale of the product does not provide
p.002007: satisfactory returns to justify the necessary investment for research and development
p.002007: development without incentives for the product creator, and
p.002007: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of the condition, or
p.002007: if there is such a method, the proposed medicinal product has significantly more advantages than it and the benefit to
p.002007: affected by this condition.
p.002007: 30. "Dosage form" is an acceptable structure containing the active substance (s),
p.002007: which may or may not include excipients obtained by the administration of certain
p.002007: technological operations, providing the desired healing effect and storage stability over the shelf life.
p.002007: 31. (amend. - SG 71/08, in force from 12.08.2008) L.
p.002007: "located within the territory of a Member State" means
p.002007: a legal entity registered under the civil or commercial law of a Member State or
p.002007: established by a regulation having its registered office and registered office in a Member State or in
p.002007: State party to the Agreement on the European Economic Area.
p.002007: 32. "Highway formulation" is a prescription for a medicinal product prepared in a pharmacy prescribed by
p.002007: a medical specialist or an approved prescription for a particular patient.
p.002007: 33. "International non-patent name" means the recommended name of the active substance,
p.002007: approved and published by WHO.
p.002007: 34. "Medical specialists" are doctors, dentists, masters-pharmacists, medical
p.002007: nurses, midwives, medical assistants, paramedics and pharmacy assistants.
...
p.002007: through a different production process;
p.002007: d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which are not
p.002007: have been authorized as a medicinal product in the European Union, or the pairing mechanism of
p.002007: molecules and radionuclides has not been authorized in the European Union.
p.002007: 40. (amended, SG No. 84/2018) (*) "Adverse event" is any adverse change in the health status.
p.002007: a condition observed when administering a medicinal product to a patient which is not necessarily causative
p.002007: related to this treatment.
p.002007: 41. (Am. - SG, iss. 102 in 2012, in force since 21.12.2012, amended - SG, iss. 84 of 2018. (*))
p.002007: reaction "is any adverse and unintended response to a medicinal product. The types of adverse drug reactions
p.002007: reactions are:
p.002007: a) (amended, SG No. 84/2018) (*) "unexpected" - adverse reaction not mentioned in the summary
p.002007: a characteristic of the product or whose character, weight or output does not correspond to those specified in the summary
p.002007: product characteristics;
p.002007: (b) "suspected" - an adverse reaction for which the notifier or marketing authorization holder
p.002007: use implies a possible cause and effect relationship with the medicinal product being administered;
p.002007: c) "serious" - any adverse effect on a health condition that has caused the death
p.002007: exit, immediate danger to life, hospitalization or prolongation of hospitalization,
p.002007: significant or permanent damage, disability and congenital anomalies;
p.002007: (d) combinations of reactions under letters "a", "b" and "c".
p.002007: 42. "Common name" means the international non-patent name of a medicinal or ancillary medicinal product
p.002007: substance (INN) recommended by the WHO; if not, the name in the European Pharmacopoeia is used, if and
p.002007: there is no other pharmacopoeial name; when there is no pharmacopoeial name, the usual accepted name is used.
p.002007: 42a. (new - SG 102/02, in force from 21.12.2012) Main
p.002007: "system documentation for
p.002007: Drug Safety Tracking "is a detailed description of the drug tracking system
p.002007: the pharmacovigilance used by the holder of the marketing authorization in respect of one or
p.002007: more authorized medicinal products.
p.002007: 42b. (new - SG 48/2015) "Assessment of health technologies" is:
p.002007: (a) a form of research policy examining the short and long term
p.002007: results related to the implementation of health technologies and aims to provide information on
p.002007: alternative health strategies;
p.002007: (b) a multidisciplinary activity that systematically assesses technical characteristics, safety,
p.002007: clinical efficacy and effectiveness, cost, value effectiveness, organizational, social,
p.002007: the legal and ethical implications of the administration of medicinal products in health care and focus
p.002007: on the value - clinical and economic, the analysis being comparable to existing or most
p.002007: the good alternative at the moment.
p.002007: 43. "Batch" means the specified quantity of the drug produced according to established reproducible
...
p.002007: oils, processed vegetable fluids / juices.
p.002007: 62. "Rare diseases" are diseases that are characterized by a frequency of spread of
p.002007: high from 5 in 10,000 people.
p.002007: 63. "Reference medicinal product" is a medicinal product authorized under Art. 23 in accordance with
p.002007: the requirements of Art. 27.
p.002007: 64. "Defined daily dose reference value" for an international non-patent name with
p.002007: the corresponding dosage form of the anatomic therapeutic classification of the drugs is the lowest
p.002007: a defined daily dose value based on the defined daily dose values for
p.002007: different medicinal products for the relevant international non-patent name with the corresponding
p.002007: dosage form according to the anatomic therapeutic classification of medicines.
p.002007: 65. "Therapeutic course reference value" is the lowest therapeutic course value set at
p.002007: base on the values of the therapeutic course of medicines under the international non - patent name with
p.002007: appropriate dosage form.
p.002007: 66. "Risk in use of a medicinal product" is:
p.002007: (a) patient's health risk or quality-related population health risk,
p.002007: the safety or efficacy of the medicinal product;
p.002007: (b) the risk of adverse effects on the environment.
p.002007: 67. "Serious adverse event" is any adverse change in health status that has occurred
p.002007: cause of death, imminent danger of life, hospitalization or prolongation of life expectancy
p.002007: hospitalization, significant or permanent disability, disability and congenital anomalies.
p.002007: 68. "Batch Release Certificate" is a document that is issued by a qualified person to
p.002007: manufacturer or importer for each individual batch and include requirements in accordance with
p.002007: the specification, as well as all the results of the batch release tests.
p.002007: 69. "Supplemental protection certificate" is a document which provides additional patent protection to
p.002007: medicinal product not more than 5 years after the date of expiry of the basic patent.
p.002007: 69a. (new, SG No. 102/2012, effective 21.12.2012) System
p.002007: "risk management" is a system of measures
p.002007: and pharmacovigilance monitoring activities for identification,
p.002007: characterizing, preventing or minimizing the risks associated with a medicinal product,
p.002007: including an assessment of the effectiveness of these activities and measures.
p.002007: 69b. (new, SG No. 102/2012, effective 21.12.2012) System
p.002007: "to track the drug
p.002007: safety "is a system used by the Marketing Authorization Holder and the BDA for the implementation of the
p.002007: the tasks and responsibilities of Chapter Eight to monitor the safety of
p.002007: the authorized medicinal products and the detection of any change in the benefit / risk ratio.
p.002007: 69c. (new, SG No. 84/2018, effective 12.10.2018)
p.002007: "is a violation committed three or more
p.002007: times within one year of the entry into force of the first penal decree whereby the offender
p.002007: the same type of offense is punished.
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.002007: testing.
p.002007: (2) The person under para. 1 is the addressee of the communication with the contracting authority provided for in Regulation (EU) No 536/2014.
p.002007: Art. 94. The sponsor shall provide free of charge the tested medicinal product / products and each device,
p.002007: necessary for its implementation.
p.002007: Art. 95. (Repealed, SG No. 84/2018)
p.002007: Art. 96. (1) (Amended, SG No. 84/2018) (*) Clinical testing of medicinal products shall be allowed only on
p.002007: a person who has given his or her written informed consent.
p.002007: (2) (Repealed, SG No. 84/2018)
p.002007: (3) (Amended, SG No. 84/2018) (*) Informed consent under Chapter V of Regulation (EU) No 536/2014 may
p.002007: gives only a capable person who understands the nature, significance, scope and potential risks of
p.002007: the clinical trial. Informed consent to participate in a clinical trial may be withdrawn at
p.002007: anytime.
p.002007: (4) (Amended, SG No. 84/2018) (*) Informed consent under Chapter V of Regulation (EU) No 536/2014 for
p.002007: an invalid adult is given by his legal representative. The consent of the legal representative
p.002007: must represent the intended will of the participant and may be withdrawn at any time without
p.002007: negative consequences for the participant.
p.002007: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent is given by the court-appointed person.
p.002007: (6) The incapable adult shall be provided with information about the test, the possible risks and
p.002007: benefits in accordance with his ability to understand.
p.002007: (7) The explicit desire of the incapable adult to refuse to participate or to withdraw at any time
p.002007: the time of the clinical trial should be taken into account by the investigator and, if necessary, by the investigator
p.002007: the principal investigator.
p.002007: Art. 97. (1) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
p.002007: obtaining the written informed consent of both parents or guardians of the person at
p.002007: compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3.
p.002007: (2) The consent of the parents and guardians must represent the presumed will of the minor
p.002007: and may be withdrawn at any time without negative consequences for the minor.
p.002007: (3) The express wish of the minor to refuse to participate or to withdraw at any time from
p.002007: the clinical trial should be considered by the investigator and, if necessary, by the principal
p.002007: Explorer.
p.002007: (4) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
p.002007: obtaining written informed consent from the person or both parents or the guardian of
p.002007: compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3. When one parent is unknown,
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.002007: hands-on experience in the specific drug group.
p.002007: (5) The Executive Director of the BDA shall determine by an order the composition of the committees for a term of three years, the amount
p.002007: of their remuneration and approves rules of procedure for their work.
p.002007: (6) By 30 January each year, the Executive Director of the BDA shall approve the lists of experts outside
p.002007: the composition of the commissions under para. 1 after approval by the Minister of Health.
p.002007: (7) The Executive Director of the BDA may release a member of a specialized commission for early termination
p.002007: his request for failure to fulfill his obligations for more than three months or in bad faith
p.002007: performing its functions.
p.002007: (8) The composition of the commissions and the list of experts under para. 6 are announced on the BDA website on the Internet.
p.002007: Art. 48. (1) The members of the specialized commissions under Art. 47, para. 1 and the experts under Art. 47, para. 4 sign
p.002007: a declaration obliging them not to:
p.002007: 1. disclose data and circumstances that became known to them in the course of or in connection with the performance of their activity;
p.002007: 2. participate in activities related to the production or wholesale and retail of medicines
p.002007: products.
p.002007: (2) In case the persons under para. 1 have participated in any of the stages of preparation of the documentation required
p.002007: to authorize the use of the medicinal product, they may not participate in the meetings of the medicinal product
p.002007: specialized commission under art. 47.
p.002007: (3) The persons under para. 1 shall not vote in decisions on matters which they or the members of
p.002007: their family has commercial, financial or other interests.
p.002007: Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
p.002007: valid documentation of the BDA together with the relevant commission under Art. 47, para. 1 evaluates the quality,
p.002007: the safety and efficacy of the medicinal product and produces an evaluation report with comments from
p.002007: the results of the pharmaceutical and preclinical tests, clinical trials, of the
p.002007: risk management and the safety monitoring system for the medicinal product concerned.
p.002007: The evaluation report prepared shall be submitted to the BDA Executive Director.
p.002007: (2) (New, SG No. 102/2012, effective 21.12.2012) The report under para. 1 is updated when new
p.002007: information relevant to the evaluation of the quality, safety and efficacy of the medicinal product.
p.002007: (3) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012) Where the medicinal product contains
p.002007: genetically modified organisms, the BDA provides the Ministry of Environment and Water
p.002007: the necessary documentation from the dossier of the medicinal product and requires an opinion within 60 days
p.002007: relation to the potential environmental risk. The sixty-day period is within the term of para. 1.
p.002007: (4) (Renumbered from Paragraph 3, SG No. 102/2012, effective 21.12.2012) In the cases of radiopharmaceuticals, the BDA
p.002007: provide the necessary documentation from the dossier of the medicinal product and request an opinion within 60 days
p.002007: days from the Nuclear Regulatory Agency regarding product quality and safety.
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.002007: websites;
p.002007: 4. general information about the risks associated with medicinal products delivered to consumers through
p.002007: Internet in violation of the ordinance under Art. 234, para. 5.
p.002007: (2) The website of the BDA under para. 1 is linked to the European Agency for Europe website
p.002007: medicines.
p.002007: Art. 234b. (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines shall participate
p.002007: in information campaigns conducted by the European Commission and the European Medicines Agency
p.002007: on the risk of counterfeit medicinal products.
p.002007: Art. 235. (1) The permit for carrying out retail trade in medicinal products shall be mailed. 229, para. 2 se
p.002007: terminate with termination of the activity of the persons under art. 222 and 225.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) The Executive Director of the BDA shall terminate
p.002007: authorization to trade in medicinal products:
p.002007: 1. at the request of the person who has received a permit for retail trade;
p.002007: 2. when it is established that the head of the pharmacy does not meet the requirements specified in Art. 224 and 225.
p.002007: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 14 days termination of the activity under para. 1
p.002007: the persons under art. 222 and 225 shall notify the BDA in writing.
p.002007: Art. 236. (1) The pharmacy may not be closed for more than 30 days within one calendar year
p.002007: due to the absence of the manager and.
p.002007: (2) (Suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 12 of 2011, in force since 08.02.2011, amended -
p.002007: SG, issue 60 of 2011, effective 05.08.2011) When the pharmacy manager is unable to perform
p.002007: obligations due to sick leave, sickness and pregnancy
p.002007: birth or adoption and parental leave in accordance with the Labor Code, the pharmacy may
p.002007: work for no more than two years under the direction of another Master of Pharmacy, respectively
p.002007: assistant pharmacist, in the cases of art. 225, which meets the requirements of post. 224. In these cases, yes
p.002007: issues permission from the BDA Executive Director.
p.002007: (3) The permit under para. 2 shall be issued within 30 days.
p.002007: Art. 237. In case of termination of the activity of the person who has been authorized to open a pharmacy, the medicines
p.002007: the products may be sold to persons who have been authorized to wholesale medicinal products
p.002007: products.
p.002007: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002007: prescription, can be sold in a drugstore. Drugstores can also sell products and goods
p.002007: relevant to human health as defined in the ordinance under Art. 243, and medical devices.
p.002007: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to carry out retail trade in medicinal products
p.002007: products, opening a drugstore, have all natural and legal persons registered under the Commercial
p.002007: law or under the law of a Member State.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore shall be medical
p.002007: specialist who:
p.002007: 1. is not deprived of the right to practice his profession;
p.002007: 2. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crimes against the individual;
p.002007: 3. have at least one year of experience in the specialty.
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.002007: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under this Act related to
p.002007: preventing the entry and distribution of counterfeit medicinal products,
p.002007: carries out in cooperation between the BDA and the customs authorities.
p.002007: (8) (New, SG No. 84/2018, effective 12.10.2018) The Executive Agency for Medicines may
p.002007: carries out joint checks with the National Revenue Agency, the Customs Agency, the National Revenue Agency
p.002007: Health Insurance Fund, the Ministry of Health and the National Board of Prices and
p.002007: reimbursement of medicinal products in the exercise of their control functions
p.002007: on medicinal products.
p.002007: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health Inspectorates shall issue
p.002007: drugstore registration certificates.
p.002007: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002007: retail of medicinal products, which includes three representatives of the Bulgarian
p.002007: pharmaceutical union, one representative of the faculties of pharmacy at medical colleges
p.002007: and four BDA representatives. The composition of the Board shall be determined by order of the Executive Director
p.002007: of the BDA, coordinated with the Minister of Health.
p.002007: (2) The council under para. 1 is an advisory unit which:
p.002007: 1. prepares opinions on applications and documents submitted to the BDA. 228, para. 1 and 5, which he presents to
p.002007: the Executive Director of the BDA;
p.002007: 2. make motivated proposals to the Minister of Health through the BDA Executive Director for
p.002007: improving public access to medicines.
p.002007: (3) The organization and activity of the expert council under para. 1 shall be governed by a regulation issued by
p.002007: the Executive Director of the BDA at the proposal of the Board.
p.002007: (4) The members of the expert council under para. 1 shall not receive remuneration for attending council meetings.
p.002007: (5) The expert council under para. 1 shall be reported annually to the Minister of Health.
p.002007: Art. 17c. (New, SG No. 18/2014) May not be members of the expert council. 17b, para. 1 person,
p.002007: which:
p.002007: 1. owners, members of management and controlling bodies of commercial companies or sole traders with
p.002007: subject of activity manufacture, import, wholesale or retail of medicinal products;
p.002007: 2. partners or shareholders holding more than 5 per cent of the capital of commercial companies with the object of
p.002007: activity manufacturing, importing, wholesaling or retailing of medicinal products or working in labor
p.002007: contract in these companies.
p.002007: Section II.
p.002007: Registers
p.002007: Art. 18. (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: Art. 19. (1) The Executive Agency for Medicines shall keep and keep registers of:
p.002007: 1. (amend. - SG 102/12, in force from 21.12.2012) manufacturers and importers of medicinal products
p.002007: products on the territory of the Republic of Bulgaria and the qualified persons under art. 148, item 2 and under Art. 161, para.
p.002007: 2, Vol. 1;
p.002007: 2. (amend. - SG 102/02, in force from 21.12.2012) manufacturers, importers and wholesalers of
p.002007: active substances;
p.002007: 3. the authorized and registered medicinal products on the territory of the Republic of Bulgaria;
p.002007: 4. wholesalers of medicinal products on the territory of the Republic of Bulgaria;
...
p.002007: for granting authorization for a substantial change to an authorized clinical trial, the sponsor shall submit
p.002007: application and dossier pursuant to Chapter IV of Regulation (EU) No 536/2014 through the European Union (EU) Portal on
p.002007: Art. 80 of Regulation (EU) No 536/2014.
p.002007: (2) To submit an application under para. 1 and for evaluation of the documentation attached to it, the assignor
p.002007: shall pay a fee in the amount determined by the tariff under Art. 21, para. 2.
p.002007: Art. 83. (Amended, SG No. 84/2018) (*) The Commission under Art. 103, para. 1 assesses the ethical aspects of
p.002007: the clinical trial and the substantial modification of the clinical trial under the terms and conditions of
p.002007: Regulation (EU) No 536/2014 and prepares a reasoned opinion which it submits to the BDA.
p.002007: Art. 84. (Amended, SG No. 84/2018) (1) (1) The Executive Agency for Medicines shall issue a permit for
p.002007: clinical trial, authorization of clinical trial under certain conditions, authorization of substantial
p.002007: change of clinical trial, permission to substantially change clinical trial in certain
p.002007: conditions or refuses authorization under the terms and conditions of Regulation (EU) No 536/2014.
p.002007: (2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002007: Art. 85. (Amended, SG No. 84/2018) (*) By an ordinance of the Minister of Health shall determine:
p.002007: 1. the conditions and procedure for submission of data and information by the BDA and the Ethical Commission for Clinical
p.002007: tests in the EU Portal under Art. 80 of Regulation (EU) No 536/2014;
p.002007: 2. the access of the BDA and the Ethical Committee for Clinical Trials to the EU Database. 81 of
p.002007: Regulation (EU) No 536/2014;
p.002007: 3. the terms and procedure for submitting the opinions by post. 83 and the order of interaction between the BDA and
p.002007: Ethics Committee for Clinical Trials;
p.002007: 4. the documents and particulars of Annex I and Annex II to Regulation (EU) No 536/2014, to be evaluated by
p.002007: BDA and the Ethical Committee for Clinical Trials, as well as the language in which they are presented.
p.002007: Art. 86. (1) (Supplemented, SG No. 84/2018) (*) All persons conducting a clinical trial must have
p.002007: relevant professional qualifications, training and experience to fulfill the test-related requirements
p.002007: tasks in accordance with the Good Clinical Practice rules under Regulation (EU) No 536/2014.
p.002007: (2) A clinical trial of a medicinal product shall be carried out under the supervision of a physician or physician
p.002007: dental medicine with recognized medical specialty in the relevant field, which is familiar with the available
p.002007: preclinical and / or clinical data on the product and the risks and procedures of the study.
p.002007: (3) During the clinical trial, the medical care provided to the trial participant and
p.002007: medical decision-making is the responsibility of a physician with an appropriate qualification or a dentist
p.002007: medicine.
p.002007: Art. 87. (1) (amend. - SG 59/10, in force from 31.07.2010, amended - SG, issue 60 of 2011, in force since 05.08.2011
p.002007: g., add. - SG, issue. 84 of 2018, effective 12.10.2018) Clinical trial may be conducted in therapeutic
p.002007: hospitals, mental health centers, venereal disease centers,
...
p.002007: the qualification and training of the persons under art. 148, item 2 shall be determined in the ordinance under Art. 152.
p.002007: Art. 160. (1) The holder of a manufacturing authorization shall:
p.002007: 1. (amended, SG No. 84/2018) (*) ensure the production operations in accordance with
p.002007: the requirements of the Good Manufacturing Practice and in accordance with the information approved by the BDA under Art.
p.002007: 27, para. 1, items 7 and 8, and in the case of medicinal products for clinical trial, in accordance with
p.002007: the documentation for the tested medicinal product in accordance with Regulation (EU) No 536/2014;
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) use only active substances which are manufactured
p.002007: in accordance with the requirements of Good Manufacturing Practice for Active Substances;
p.002007: 2a. (new - SG 102/2012, in force from 02.01.2013) make sure that the auxiliary substances used in
p.002007: the medicinal products are manufactured in accordance with the relevant good manufacturing practices for
p.002007: excipients determined on the basis of a formal risk assessment in accordance with the applicable ones
p.002007: guidelines adopted by the European Commission;
p.002007: 3. provide permanently qualified production and control personnel as required by
p.002007: the ordinance under Art. 152;
p.002007: 4. (amend. - SG 12/11, in force from 08.02.2011) has only medicinal products which have
p.002007: authorization for use, subject to the requirements of this law;
p.002007: 5. (repealed, SG No. 12/2011, effective 08.02.2011)
p.002007: 6. notify immediately the control bodies in case of change of qualified person post. 148, Vol. 2;
p.002007: 7. provide access to the premises and documentation at all times to the control bodies;
p.002007: 8. provide to the qualified person under Art. 148, item 2 the necessary conditions for fulfilling the obligations
p.002007: his;
p.002007: 9. (New - SG, iss. 102 in 2012) shall inform immediately the BDA and the holder of
p.002007: the marketing authorization if it receives information that the medicinal products covered by the
p.002007: its manufacturing authorization, are falsified or there are suspected falsifications,
p.002007: whether or not these medicinal products were distributed within the legal chain
p.002007: delivery or in an illegal manner, including through illegal sale through the services of
p.002007: the information society;
p.002007: 10. (new - SG 102/2012, in force from 02.01.2013) check whether the manufacturers, importers or
p.002007: traders from whom it receives active substances are registered by the competent authority of the Member State,
p.002007: in which they are established;
p.002007: 11. (new - SG 102/2012, in force from 02.01.2013) shall check the authenticity and quality of the active and
p.002007: of excipients.
p.002007: (2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
p.002007: performs audits at the sites for the production and marketing of active substances in order to comply with the Good
p.002007: manufacturing practice and Good distribution practice. The holder of the manufacturing authorization
p.002007: may contract with a third party to perform the audit on his behalf and on his behalf.
p.002007: (3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
...
p.002007: 7. remarks on the entered circumstances.
p.002007: (2) The Executive Agency for Medicines shall keep a register of the issued certified mail. 203 for
p.002007: wholesale of medicinal products, which contains:
p.002007: 1. number and date of the certificate;
p.002007: 2. the number of the marketing authorization for medicinal products and the body which issued it;
p.002007: 3. name, seat and address of management of the person receiving the certificate;
p.002007: 4. details of the person under art. 199, para. 2, Vol. 2;
p.002007: 5. date of deletion of the certificate from the register and the reason for it;
p.002007: 6. notes on the entered circumstances.
p.002007: (3) Data from the registers shall be published on the BDA website on the Internet.
p.002007: (4) (New - SG 102/2012, in force from 02.01.2013) The Executive Agency for Medicines shall introduce in
p.002007: the database under Art. 147 information on marketing authorizations for medicinal products.
p.002007: (5) (New, SG No. 102/2012, effective 02.01.2013) Upon request by the European Commission or by
p.002007: the BDA Member State shall provide information on the marketing authorization for medicinal products
p.002007: products.
p.002007: Art. 206. (1) In case of change of the circumstances, related to the issued permit for wholesale trade,
p.002007: the holder submits an application to the BDA pursuant to Art. 199, to which the change related
p.002007: documentation.
p.002007: (2) The permit for change shall be issued under the conditions and by the order of art. 200 - 202. When changing
p.002007: the storage premises the term under Art. 202, and in other cases the deadline is 14 days.
p.002007: Art. 207. (1) The holder of a wholesale trade permit who conducts his business in the territory
p.002007: of the Republic of Bulgaria shall be obliged to:
p.002007: 1. provides access at all times to the control bodies to the premises for storage of medicinal products
p.002007: products;
p.002007: 2. trade only in medicinal products authorized under this Law;
p.002007: 3. trade in medicinal products whose packaging and leaflets are in accordance with the authorization granted
p.002007: use, under the terms and procedure of this law and their expiry date;
p.002007: 4. obtains medicinal products only from manufacturers, importers or wholesalers of medicinal products
p.002007: products authorized to carry out this activity under this law;
p.002007: 4a. (new - SG 102/2012, in force from 02.01.2013) check whether the received medicinal products from
p.002007: the persons under item 4 are not falsified by checking the safety indicators on the secondary
p.002007: package;
p.002007: 5. supply medicinal products to other holders of a wholesale, pharmacy and drug store authorization,
p.002007: opened in accordance with this law;
p.002007: 5a. (new - SG 71/08, in force from 12.08.2008, amended - SG, iss. 84 from 2018, in force since 12.10.2018)
p.002007: supplies medicinal products to meet their own needs:
p.002007: a) medical establishments;
p.002007: b) higher schools, which carry out medical activity according to Art. 2a of the Medical Institutions Act;
p.002007: c) the institutions of art. 26, para. 1, items 1 and 3 of the Health Act for the health offices established therein;
p.002007: (d) shipowners for the purpose of supplying medicinal products on board ships in accordance with
p.002007: The Merchant Shipping Code;
p.002007: 6. supply doctors and dentists with medicinal products when there is no place in the settlement
p.002007: a pharmacy, under the conditions and in the order laid down in an ordinance of the Minister of Health;
...
p.002007: EXPORTS OF MEDICINAL PRODUCTS. SPECIALIZED ELECTRONIC SYSTEM FOR
p.002007: FOLLOW-UP AND ANALYSIS OF THE MEDICINAL PRODUCTS (NEW, SG 18/14
p.002007: G., TITLE. AMENDED. - DV, BR. 84 FROM 2018, IN EFFECT ON 12/10/2018)
p.002007: Chapter Nine "b".
p.002007: EXPORT OF MEDICINAL PRODUCTS (NEW, SG No. 18/2014)
p.002007: Art. 217a. (New, SG No. 18/2014) (1) Export of medicinal products from the territory of the Republic
p.002007: Bulgaria may be a natural or legal person holding a wholesale marketing authorization
p.002007: with medicinal products or a manufacturing authorization holder.
p.002007: (2) The holder of a manufacturing authorization may export only the ones produced by him
p.002007: medical products.
p.002007: (3) For the purposes of this Chapter, exports are also intra-Community supplies within the European Union.
p.002007: (4) (amend. - SG 84/08, in force from 12.10.2018) Medicinal products included in the Positive
p.002007: medicinal list for which a shortage has been established in accordance with Art. 217b, cannot be exported for the term
p.002007: contained in the list under Art. 217c, para. 1.
p.002007: Art. 217b. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018) (1)
p.002007: Specialized electronic system for tracking and analyzing the medicinal products included in
p.002007: The positive drug list, administered and maintained by the Executive Agency
p.002007: medicines.
p.002007: (2) The creation and maintenance of the specialized electronic system under para. 1 is done on the basis of
p.002007: on the following principles:
p.002007: 1. ensuring the accuracy and accuracy of the data submitted and stored;
p.002007: 2. providing an appropriate data exchange environment;
p.002007: 3. ensuring regulated access to the data in the electronic information system in compliance
p.002007: the requirements of the law;
p.002007: 4. ensuring interoperability and information security.
p.002007: (3) The specialized electronic system of para. 1 contains:
p.002007: 1. the information under art. 54, Art. 54a, Art. 68, para. 1, Vol. 10, Art. 207, para. 1, Vol. 15, Art. 217, item 5 and art. 232a provided
p.002007: by the persons concerned;
p.002007: 2. information provided by the National Health Insurance Fund about the quantities indicated
p.002007: on paid medicinal products included in the Positive Medicinal List for the previous one month;
p.002007: 3. information provided by the Ministry of Health about the quantities indicated under
p.002007: paid medicinal products included in the Positive Medicinal List for the previous one month.
p.002007: (4) On the basis of the information under para. 3 through the specialized electronic system of para. 1 is performed
p.002007: shortage analysis of medicinal products included in the Positive Medicinal List, of
p.002007: the territory of the Republic of Bulgaria under the conditions and in the order specified in the ordinance under para. 8.
p.002007: (5) The shortage under para. 4 of the medicinal products included in the Positive Medicinal List are established,
p.002007: when performing the analysis under par. 4 was found to be available on the territory of the Republic of Bulgaria
p.002007: the quantities of the medicinal product concerned are less than 65 per cent of the quantities required for
p.002007: meeting the health needs of the population for a period of one month, calculated on the basis of
p.002007: the average monthly consumption of the respective medicinal product for the previous 6 months.
p.002007: (6) The specialized electronic system under para. 1 supports an automated interface for providing
p.002007: the information under para. 3 and to send messages.
p.002007: (7) The right of access to the specialized electronic system under para. 1 have the institutions and persons under para. 3
p.002007: solely for the purpose of providing information specified by this Act and are responsible for
p.002007: the accuracy of the information provided, as well as its timely delivery.
p.002007: (8) The conditions and procedure for providing, storing and performing analysis of the information under para. 3, as
p.002007: and for the administration, maintenance and access to the specialized electronic system under para. 1 se
p.002007: determined by an ordinance of the Minister of Health.
p.002007: (9) The Medicines Executive Agency is obliged to provide the network and information
p.002007: security of the specialized electronic system under para. 1 subject to the obligation of secrecy
p.002007: of the information received under para. 3.
p.002007: Art. 217c. (New, SG No. 18/2014, declared as unconstitutional SRKS No. 1 of 2015 - SG, issue 12 of
p.002007: 2015, as amended. - SG, issue. 84 of 2018, effective 12.10.2018) (1) A list of medicinal products is hereby established,
p.002007: included in the Positive Medicinal List for which there is a shortage in the territory of the Republic
p.002007: Bulgaria, which is being prepared, updated and maintained by the Bulgarian Medicines Executive Agency.
p.002007: (2) The list under para. 1 shall be prepared on the basis of the analysis performed in accordance with Art. 217b, para. 4 and is published on
p.002007: the website of the Executive Agency for Medicinal Products.
p.002007: (3) The list of medicinal products for which a shortage has been established pursuant to Art. 217b, para. 5, is prepared
p.002007: by name of the medicinal product included in the Positive Medicinal List, internationally
p.002007: non-patent name, amount of active substance, dosage form and quantity in pack.
p.002007: (4) The list under para. 1 is being updated:
p.002007: 1. weekly;
p.002007: 2. in case of change of circumstances related to the import and / or export of medicinal products included in
p.002007: Positive drug list.
p.002007: (5) Upon updating the list in the order of para. 4, item 1, as well as in the cases when the circumstances under
...
p.002007: Art. 269b. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002007: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good
p.002007: distributor practices, where applicable, are issued by the BDA to the manufacturer, importer or trader.
p.002007: wholesale Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice
p.002007: within 90 days of the inspection.
p.002007: (2) When, as a result of an inspection, 269, para. 3 it was found that the manufacturer, the importer
p.002007: or the wholesaler of the medicinal product or the active substance does not comply with the law
p.002007: and / or the principles and guidelines for Good Manufacturing Practice and / or Good Distribution
p.002007: practices, the BDA issues a non-compliance statement.
p.002007: (3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued certificates under para.
p.002007: 1 and information under para. 2.
p.002007: Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002007: Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of the head
p.002007: eighth, the BDA provides prescriptions for the correction of inconsistencies.
p.002007: (2) In the cases of para. 1 The BDA shall notify the Member States, the European Medicines Agency and the European Medicines Agency
p.002007: The European Commission.
p.002007: Art. 270. (1) Within the limits of their competence, officials shall send. 267, para. 3 have the right:
p.002007: 1. (amend. - SG 102/2012, in force from 02.01.2013) access to all documents related to the subject of
p.002007: inspection, as well as documents related directly or indirectly to a violation of this Act or of
p.002007: the legislation of the Member States implementing the requirements of Directive 2001/83 / EC, regardless of
p.002007: the format of the document;
p.002007: 2. order each person to provide information on violations under item 1, which are known to him;
p.002007: 2a. (new - SG 102/2012, in force from 02.01.2013) to inspect the production and commercial
p.002007: facilities of manufacturers of medicinal products, active or auxiliary substances, as well as laboratories,
p.002007: used by the holders of a manufacturing or import license;
p.002007: 3. to inspect at any time the sites to be inspected and to request, verify and make copies
p.002007: from all documents related to the overall activity of the controlled site;
p.002007: 4. take samples of medicinal products, active substances and excipients for laboratory testing;
p.002007: 5. (amend. - SG 102/02, in force from 21.12.2012) to inspect the premises, archives, documents and
p.002007: the main documentation of the holder 's pharmacovigilance monitoring system
p.002007: the marketing authorization or persons entrusted with the activities of Chapter Eight;
p.002007: 6. (new - SG 102/2012, in force since 21.12.2012) to carry out an inspection on compliance with
p.002007: approved prices, marginal prices or registered prices for the sale of medicinal products;
p.002007: 7. (Renumbered from Item 6, SG No. 102/2012, effective 21.12.2012) to draw up acts for establishing
p.002007: administrative violations.
p.002007: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002007: (3) (amend. - SG 98/10, in force from 01.01.2011) The Executive Director of the BDA or the respective
p.002007: the Director of the SIC is entitled, depending on the submission of the offending official,
p.002007: Yes:
...
p.002007: a legal entity registered under the civil or commercial law of a Member State or
p.002007: established by a regulation having its registered office and registered office in a Member State or in
p.002007: State party to the Agreement on the European Economic Area.
p.002007: 32. "Highway formulation" is a prescription for a medicinal product prepared in a pharmacy prescribed by
p.002007: a medical specialist or an approved prescription for a particular patient.
p.002007: 33. "International non-patent name" means the recommended name of the active substance,
p.002007: approved and published by WHO.
p.002007: 34. "Medical specialists" are doctors, dentists, masters-pharmacists, medical
p.002007: nurses, midwives, medical assistants, paramedics and pharmacy assistants.
p.002007: 35. "Medical sales representative" is a person who has received special training and possesses scientific
p.002007: knowledge of providing accurate and complete information about the medicinal product it is advertising.
p.002007: 35a. (new - SG 1/2014, in force from 03.01.2014) Medical
p.002007: "prescription" is a prescription of
p.002007: medicinal product or medical device issued by a person practicing regulated medical
p.002007: a profession within the meaning of § 1, item 1 of the additional provisions of the Professional Recognition Act
p.002007: qualifications and who has the legal right to do so in the Member State where the medical is issued
p.002007: prescription.
p.002007: 36. (Repealed, SG No. 84/2018)
p.002007: 36a. (New, SG No. 84/2018, effective 12.10.2018) Network
p.002007: "and information security" is the protection of
p.002007: information from unauthorized or accidental access, use, disclosure to third parties, change
p.002007: or destruction.
p.002007: 37. "Medicinal product name" means the name given to the product, which may be:
p.002007: a) freely chosen name (trade name);
p.002007: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the trademark or name of
p.002007: the holder of the marketing authorization;
p.002007: c) (amend. - SG 12/11, in force from 08.02.2011) scientific name together with the trademark or the name of
p.002007: the holder of the marketing authorization.
p.002007: 38. "Scientific literature" is a publication / publications of research results in specialized
p.002007: international scientific publications.
p.002007: 38a. (new, SG No. 84/2018, effective 12.10.2018) Shortage
p.002007: "the medicinal product" is the shortage of
p.002007: medicinal products included in the Positive Medicinal List established by the specialized drug
p.002007: electronic system in accordance with Art. 217b.
p.002007: 39. "New active substance" is:
p.002007: (a) a chemical, biological or radiopharmaceutical substance which has not been authorized for use as
p.002007: medicinal product in the European Union;
p.002007: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that has been authorized for
p.002007: use as a medicinal product in the European Union but differs in safety and health
p.002007: its efficacy from a previously authorized substance;
...
p.002011: 1. The Minister of Health shall amend and supplement the ordinances under Art. 82, para. 3, Art. 219, para. 2 and Art. 243 c
p.002011: compliance with this law.
p.002011: 2. The Council of Ministers shall adopt the ordinance under Art. 258, para. 5 and amend the tariff under Art. 21, para. 2 and Device
p.002011: regulations of the Ministry of Health in accordance with this law.
p.002011: ...................................
p.002011: § 84. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of § 65, which
p.002011: shall enter into force on 30 September 2011.
p.002011: Transitional and Final Provisions
p.002011: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002011: DRUGS AND PRECURSORS
p.002011: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002011: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002011: Transitional and Final Provisions
p.002011: TO THE LAW AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.002011: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002011: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in the State Gazette:
p.002011: 1. The Council of Ministers shall bring the Classifier of posts in administration in line with that
p.002011: law;
p.002011: 2. the competent authorities shall bring the statutory acts of the respective administration in accordance with
p.002011: this law.
p.002011: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002011: the Independent Financial Audit Act, the Electronic Communications Act, the Financial Supervision Commission Act,
p.002011: Law on Access and Disclosure of Documents and Declaration of Affiliation of Bulgarian Citizens to
p.002011: State Security and Intelligence Services of the Bulgarian People's Army, Forfeiture Act
p.002011: of the State of property acquired through criminal activity, the Prevention and Establishment Act
p.002011: conflict of interest, Social Security Code, Health Insurance Act,
p.002011: support to farmers and the Roads Act are governed by the terms and procedures of §
p.002011: 36 of the transitional and final provisions of the Act amending the State Act
p.002011: employee (SG, issue 24 of 2006).
p.002011: (2) The act of appointment of the civil servant shall:
p.002011: 1. assigns a minimum rank for the position assigned to the posts in the administration in the administration
p.002011: post, unless the employee holds a higher rank;
p.002011: 2. determines the individual basic monthly salary.
p.002011: (3) The additional necessary funds for social security contributions of the persons under para. 2 shall be provided within
p.002011: the cost of wages, salaries and social security contributions to the budgets of the authorizing officers concerned
p.002011: with appropriations.
p.002011: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account of the State Fund
p.002011: "Agriculture" arising from this law.
p.002011: (5) The governing bodies of the National Social Security Institute and the National Health Insurance Fund
p.002011: to make necessary changes to the respective budgets arising from this law.
p.002011: (6) Unused employment leave shall be maintained and shall not be offset by cash benefits.
p.002011: benefits.
...
Social / Age
Searching for indicator age:
(return to top)
p.002007: relation to one or more parts of the summary of product characteristics, indications, manner of
p.002007: application, contraindications and warnings resulting from new information related to
p.002007: safe use of the medicinal product.
p.002007: 71. "Spontaneous message" is a voluntarily sent message for a suspected adverse reaction to
p.002007: the use of the medicinal product by the Marketing Authorization Holder, the market surveillance authorities
p.002007: medicinal products or other organizations not derived from research or other organized
p.002007: information collection system.
p.002007: 72. "Shelf life of a medicinal product" is the interval of time when, if stored
p.002007: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002007: the basis of stability studies of several batches of finished form.
p.002007: 73. (amend. - SG 71/08, in force from 12.08.2008) p
p.002007: "an appropriate herbal medicinal product
p.002007: "medicinal product" is a product which contains the same active substances, regardless of the composition of
p.002007: excipients intended for the same purpose with an equivalent amount of the medicinal product
p.002007: substance / substances, with the same dosage and with the same or similar route of administration as the product, for
p.002007: who has applied.
p.002007: 74. An "adverse reaction message" is documented information about one or more
p.002007: suspected adverse reactions associated with the use of one or more medicinal products by one
p.002007: patient. For the validity of the adverse reaction message, they are required
p.002007: minimum identifier identifier data (initials or address or profession / specialty) of
p.002007: the patient (initials or age, or date of birth or gender), the adverse reaction / event, and
p.002007: the suspected medicinal product.
p.002007: 75. (Amended, SG No. 84/2018) (*) "Substantial change in the protocol of the clinical trial" is significant
p.002007: change within the meaning of Art. 2 (2) (13) of Regulation (EU) No 536/2014.
p.002007: 75a. (new, SG No. 102/2012, effective 21.12.2012) Substantial
p.002007: "changes to the
p.002007: non-interventional post-marketing research "are changes that affect safety,
p.002007: the physical or mental integrity of the patients or the results of the study and theirs
p.002007: interpretation.
p.002007: 76. (amend. - SG 71/08, in force from 12.08.2008)
p.002007: "reta country" is a non-state country -
p.002007: Member State of the European Union or not a State Party to the Agreement on the European Economic
p.002007: space.
p.002007: 77. "Wholesale" means all activities for the acquisition, storage, supply, import or export of
p.002007: medicinal products, except in the case of the supply of medicinal products directly to
p.002007: the population.
p.002007: 78. (Amended, SG No. 84/2018) (*) "Participant" shall be a participant within the meaning of Art. 2 (2) (17)
p.002007: Regulation (EU) No 536/2014.
p.002007: 79. (Repealed, SG No. 84/2018)
p.002007: 80. "Pharmacopoeia" is a collection of approved specifications and related production requirements,
p.002007: testing, storage and labeling of active substances, excipients, dosage forms,
p.002007: materials for packaging and components of the medicinal product.
p.002007: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product prepared in a pharmacy by a formulation
p.002007: operating pharmacopoeia and intended for delivery to patients at the same pharmacy.
...
p.002007: content with respect to any of its constituents, including excipients, and
p.002007: the amount of active substance per unit dose;
p.002007: (b) its source, including its manufacturer, the country in which it is manufactured, the country in which it is produced
p.002007: placed on the market, or the holder of his marketing authorization, or
p.002007: (c) the timing, including records and documents, of the supply chain used.
p.002007: It is not considered to be a counterfeit medicinal product with inadvertent tolerance in
p.002007: quality as well as a medicinal product placed on the market in violation of intellectual property rights
p.002007: property.
p.002007: 82. "Homeopathic medicinal product" is a medicinal product made from substances called homeopathic
p.002007: source, according to the European Pharmacopoeia manufacturing procedures, and in the absence thereof -
p.002007: according to the national pharmacopoeia of a Member State.
p.002007: 83. "Price calculated on the basis of a benchmark" is the price established for each medicinal product,
p.002007: included in the Positive Medicinal List calculated on the basis of the established reference value for
p.002007: defined daily dose or therapeutic course.
p.002007: 84. (Repealed, SG No. 84/2018)
p.002007: 85. "Misuse of medicinal products" is a persistent or occasional intentional overuse of
p.002007: medicinal products accompanied by harmful physical or psychological effects.
p.002007: 86. (new - SG 41/09, in force from 02.06.2009)
p.002007: "are children under 12 months of age.
p.002007: 87. (new - SG 41/09, in force from 02.06.2009) Food
p.002007: "infant formulas" means foods intended for infants
p.002007: specific nutritional use of infants during their first months, which alone are sufficient
p.002007: satisfy the nutritional needs of these infants until the introduction of a suitable supplement
p.002007: food.
p.002007: 88. (new - SG 41/09, in force from 02.06.2009) Transitional
p.002007: "food" means food intended for
p.002007: specific nutritional use of infants in the introduction of appropriate supplemental food and which
p.002007: are the staple liquid food from the progressively increasing variety of foods in these
p.002007: infants.
p.002007: 89. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "Type IA" is a change with minimal impact
p.002007: or without affecting the quality, safety or efficacy of the medicinal product concerned.
p.002007: 90. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "type IB" is a change that is neither type IA,
p.002007: neither a change of type II nor an extension of the marketing authorization.
p.002007: 91. (New, SG No. 12/2011, effective 08.02.2011) Change
p.002007: "type II" is a change that does not occur
p.002007: extending the scope of the marketing authorization and which may have a significant impact on
p.002007: the quality, safety or efficacy of the medicinal product concerned.
p.002007: 92. (new, SG No. 102/2012, effective 21.12.2012) Delegated
p.002007: "act" is an act within the meaning of Art. 290 of
p.002007: Treaty on the Functioning of the European Union.
p.002007: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
...
Social / Child
Searching for indicator children:
(return to top)
p.002007: under Art. 26, para. 1 presents the results of the preclinical and clinical trials related to this
p.002007: combination. In this case, the applicant does not provide documentation on the safety and efficacy of
p.002007: each individual active substance.
p.002007: Art. 32. The marketing authorization holder may authorize the use of a medicinal product
p.002007: the pharmaceutical, preclinical and clinical records contained in the dossier
p.002007: product, when evaluating subsequent applications for medicinal products of the same quality and quality
p.002007: a quantitative composition in terms of the active substances and of the same dosage form.
p.002007: Art. 33. Conducting the necessary studies and tests to prepare documentation for
p.002007: marketing authorization and the subsequent practical requirements for marketing authorization
p.002007: medicinal products under Art. 28 and 29 is not a violation of the patent or of the supplementary protection certificate
p.002007: of a medicinal product.
p.002007: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002007: 1. name of the medicinal product, quantity of active substance per unit dose, medicinal product
p.002007: form;
p.002007: 2. quantitative and qualitative composition with respect to the active substances and those of the excipients,
p.002007: information for which it is essential for the correct application of the product; the common name is used
p.002007: or the chemical description;
p.002007: 3. dosage form;
p.002007: 4. clinical data:
p.002007: (a) therapeutic indications;
p.002007: (b) dosage and route of administration for adults and children;
p.002007: c) contraindications;
p.002007: (d) special warnings and precautions for use; for immunological medicinal products -
p.002007: precautions for those who work with them and apply them to patients, and precautions that
p.002007: should be taken by the patient;
p.002007: (e) interactions with other medicinal products or other forms of interaction;
p.002007: (f) use in pregnancy or lactation;
p.002007: (g) effects on the ability to drive and use machines;
p.002007: h) side effects;
p.002007: i) overdose (symptoms, antidotes, emergency measures);
p.002007: 5. pharmacological data:
p.002007: a) pharmacodynamic properties;
p.002007: b) pharmacokinetic properties;
p.002007: (c) preclinical safety data;
p.002007: 6. pharmaceutical data:
p.002007: (a) a list of excipients;
p.002007: (b) major incompatibilities;
p.002007: c) shelf life; shelf life after reconstitution of the medicinal product (if necessary) or after
p.002007: opening the primary packaging for the first time;
p.002007: (d) special storage instructions;
p.002007: (e) the nature and composition of the packages;
p.002007: (f) specific instructions for the disposal of the remainder of the medicinal product or of waste material from
p.002007: him;
p.002007: 7. the holder of the marketing authorization;
p.002007: 8. registration number;
p.002007: 9. date of first authorization or renewal of the authorization;
p.002007: 10. date on which the content of the summary of product characteristics was changed;
p.002007: 11. for radiopharmaceuticals - comprehensive information on internal radiation dosimetry;
p.002007: 12. for radiopharmaceuticals - detailed instructions for extemporaneous preparation and quality control and, where applicable
p.002007: applicable, the maximum storage time during which the relevant intermediate such as eluate or
...
p.002007: (a) its identity, including particulars of the immediate packaging or its immediate packaging, its name or
p.002007: content with respect to any of its constituents, including excipients, and
p.002007: the amount of active substance per unit dose;
p.002007: (b) its source, including its manufacturer, the country in which it is manufactured, the country in which it is produced
p.002007: placed on the market, or the holder of his marketing authorization, or
p.002007: (c) the timing, including records and documents, of the supply chain used.
p.002007: It is not considered to be a counterfeit medicinal product with inadvertent tolerance in
p.002007: quality as well as a medicinal product placed on the market in violation of intellectual property rights
p.002007: property.
p.002007: 82. "Homeopathic medicinal product" is a medicinal product made from substances called homeopathic
p.002007: source, according to the European Pharmacopoeia manufacturing procedures, and in the absence thereof -
p.002007: according to the national pharmacopoeia of a Member State.
p.002007: 83. "Price calculated on the basis of a benchmark" is the price established for each medicinal product,
p.002007: included in the Positive Medicinal List calculated on the basis of the established reference value for
p.002007: defined daily dose or therapeutic course.
p.002007: 84. (Repealed, SG No. 84/2018)
p.002007: 85. "Misuse of medicinal products" is a persistent or occasional intentional overuse of
p.002007: medicinal products accompanied by harmful physical or psychological effects.
p.002007: 86. (new - SG 41/09, in force from 02.06.2009)
p.002007: "are children under 12 months of age.
p.002007: 87. (new - SG 41/09, in force from 02.06.2009) Food
p.002007: "infant formulas" means foods intended for infants
p.002007: specific nutritional use of infants during their first months, which alone are sufficient
p.002007: satisfy the nutritional needs of these infants until the introduction of a suitable supplement
p.002007: food.
p.002007: 88. (new - SG 41/09, in force from 02.06.2009) Transitional
p.002007: "food" means food intended for
p.002007: specific nutritional use of infants in the introduction of appropriate supplemental food and which
p.002007: are the staple liquid food from the progressively increasing variety of foods in these
p.002007: infants.
p.002007: 89. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "Type IA" is a change with minimal impact
p.002007: or without affecting the quality, safety or efficacy of the medicinal product concerned.
p.002007: 90. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "type IB" is a change that is neither type IA,
p.002007: neither a change of type II nor an extension of the marketing authorization.
p.002007: 91. (New, SG No. 12/2011, effective 08.02.2011) Change
p.002007: "type II" is a change that does not occur
p.002007: extending the scope of the marketing authorization and which may have a significant impact on
p.002007: the quality, safety or efficacy of the medicinal product concerned.
p.002007: 92. (new, SG No. 102/2012, effective 21.12.2012) Delegated
p.002007: "act" is an act within the meaning of Art. 290 of
p.002007: Treaty on the Functioning of the European Union.
p.002007: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.002007: healthcare.
p.002007: (2) (New - SG, iss. 102 in 2012; effective from 21.12.2012, supplemented - SG, iss. 18 of 2014) Where a medicinal product,
p.002007: authorized for use under this Act, is not intended for direct delivery to the patient or is not
p.002007: available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data,
p.002007: defined in the ordinance under para. 1 are not affixed to the package or package leaflet.
p.002007: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2 information on the packaging and
p.002007: the leaflet may not be provided in Bulgarian.
p.002007: (4) (New, SG No. 102/2012, effective 21.12.2012) The terms and procedure for delivery of medicinal products
p.002007: products under para. 2 shall be determined by the ordinance under art. 198.
p.002007: Chapter seven.
p.002007: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002007: Art. 171. (1) Depending on the method of dispensing, medicinal products shall be classified as:
p.002007: 1. prescription medicinal products;
p.002007: 2. medicinal products dispensed without a prescription.
p.002007: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002007: determined by the BDA in the Marketing Authorization / Registration Certificate or the Marketing Authorization
p.002007: parallel import of the medicinal product into the territory of the Republic of Bulgaria.
p.002007: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in the application for
p.002007: Marketing Authorization / Registration Certificate, Modification of the Marketing Authorization or
p.002007: its renewal.
p.002007: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002007: 1. medicinal products with restricted medical prescription, intended for use in certain medicinal products only
p.002007: specialized areas;
p.002007: 2. medicinal products - subject to special medical prescription;
p.002007: 3. medicinal products for multiple or single dispensing under the same medical prescription.
p.002007: Art. 173. Medicinal products that meet the following requirements are prescribed on medical prescription:
p.002007: 1. may present a direct or indirect danger to human health, even if used correctly, if
p.002007: apply without medical supervision;
p.002007: 2. they are frequently and very widely applied incorrectly and as a result can be a danger to
p.002007: human health;
p.002007: 3. contain substances the activity and / or side effects of which subsequently require
p.002007: additional study;
p.002007: 4. usually prescribed by a doctor for parenteral administration.
p.002007: Art. 174. Medicinal products are subject to special medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. contain narcotic substances within the meaning of the Drug Control Act; and
p.002007: precursors in permissible quantities;
p.002007: 2. if used improperly, they can create a significant risk of abuse, lead to a medicinal product
p.002007: dependency or use for illegal purposes;
p.002007: 3. contain new medicinal substances whose characteristics are not sufficiently known for this reason
p.002007: a preventive cause may be attributed to the group of medicinal products under item 2.
p.002007: Art. 175. Medicinal products are subject to limited medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. restricted to hospital use only because of limited experience in use or in the interest of
p.002007: public health;
p.002007: 2. intended for the treatment of conditions which can only be diagnosed in
p.002007: medical institutions, although their implementation and monitoring of the course of treatment may be
p.002007: carry out in other health establishments;
p.002007: 3. they are intended for the treatment of outpatients, but their use can be serious
p.002007: side effects requiring specialist prescription and monitoring during treatment.
p.002007: Art. 176. (1) The Executive Agency for Medicines may not approve the mail requested by the applicant. 26, para.
p.002007: 1 medication delivery regimen based on an assessment of:
p.002007: 1. the maximum single dose, the maximum daily dose, the amount of active substance in a single dose
p.002007: unit, dosage form, specific type of immediate packaging of the product, and / or
p.002007: 2. other specific conditions of use.
p.002007: (2) The Medicines Executive Agency may not specify the exact category of medicinal product under
p.002007: Art. 172, but according to the criteria of Art. 174 and 175 determine whether the medicinal product is to be classified as
p.002007: product available only on prescription.
p.002007: Art. 177. Medicinal products which do not meet the requirements of the EMA. 173, 174 and 175 and the criteria,
p.002007: defined in the ordinance under art. 178, are granted without medical prescription.
p.002007: Art. 178. The classification criteria for medicinal products and the requirements for the dossier
p.002007: making changes in the classification shall be determined in an ordinance of the Minister of Health.
...
Social / Infant
Searching for indicator infant:
(return to top)
p.002007: through the specialized electronic system of art. 217b, para. 1 a message shall be sent to the persons under Art. 68, para.
p.002007: 1, Art. 207, para. 1, Art. 217 and Art. 232a for the updated list. The list shall be published immediately on the Internet
p.002007: the page of the Executive Agency for Medicines.
p.002007: (6) In the cases of para. 4 the list under para. 1 shall be forwarded by the BDA and the Customs Agency by official order.
p.002007: (7) After the inclusion of medicinal products in the list under para. 1 they may not be exported for the period for which they are
p.002007: contain in the list.
p.002007: Art. 217g. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018)
p.002007: the medicines agency checks the persons who are obliged to provide information on
p.002007: the order of this chapter.
p.002007: Chapter Ten.
p.002007: RETAIL TRADE OF MEDICINAL PRODUCTS
p.002007: Art. 218. Retail trade in medicinal products shall be carried out only in pharmacies and drug stores in accordance with this
p.002007: law, except in cases under Art. 232, para. 2.
p.002007: Art. 219. (1) (amend. - SG 71/08, in force from 12.08.2008, suppl. - SG, iss. 23 in 2009, in force since 30.03.2009
p.002007: g., add. - SG, issue. 41 of 2009, in force since 02.06.2009, as amended. - SG, issue. 60 of 2011, effective 05.08.2011)
p.002007: The pharmacy is a health establishment that performs the following activities: storage, preparation, packaging,
p.002007: controlling, consulting, prescribing, and prescribing, non-prescribing
p.002007: use in the Republic of Bulgaria of medicinal products, medical devices, dietary foods for
p.002007: special medical purposes and infant formulas and follow-on formulas and nutritional supplements, cosmetic and
p.002007: hygiene products.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) The structure, the order and the organization of the work of
p.002007: pharmacies, the nomenclature of medicinal products, are laid down in an ordinance of the Minister of Health
p.002007: healthcare.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008, repealed - SG, iss. 23 of 2009, in force from 30.03.2009)
p.002007: Art. 220. (1) The activities under art. 219, para. 1 are performed by the Master of Pharmacy.
p.002007: (2) (suppl. - SG 71/08, in force from 12.08.2008) The master pharmacist shall be obliged to fulfill the issued
p.002007: prescription, including for the formulations of the trunk and pharmacopoeial form
p.002007: formulation, according to the procedure specified in the ordinance under Art. 221, para. 1.
p.002007: (3) (amend. - SG 102/2012, in force from 02.01.2013) The assistant-pharmacist may perform all
p.002007: activities under art. 219, para. 1 under the control of a pharmacist, except for: dispensing a medicinal product
p.002007: prescribing, monitoring and consulting products related to medicinal products.
p.002007: Art. 221. (1) (Former text of Art. 221 - SG 71/08, in force from 12.08.2008)
p.002007: Health determines in an ordinance the medical professionals who can issue prescriptions, the order for
p.002007: prescribing medicinal products, the time limit for implementation, as well as the cases and the order in which the master-
p.002007: the pharmacist may refuse to comply with a prescription.
p.002007: (2) (New, SG No. 71/2008, effective 12.08.2008, amended, SG No. 9/2011) Bulgarian citizens and
p.002007: foreigners who are allowed to reside in the country when traveling outside the Republic of Bulgaria
p.002007: to carry or export medicinal products intended for their treatment, on terms and conditions,
...
p.002007: products.
p.002007: (3) The person under para. 1, authorized to trade in medicinal products, no
p.002007: may own or participate in manufacturing, importing or trading companies
p.002007: wholesale of medicinal products, including in affiliated companies within the meaning of
p.002007: Trade Law.
p.002007: Art. 224. The pharmacy manager must:
p.002007: 1. is a master pharmacist, respectively assistant pharmacist, in the cases provided for by law;
p.002007: 2. is not deprived of the right to practice the profession;
p.002007: 3. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crime against the individual;
p.002007: 4. has at least one year of experience as a master pharmacist.
p.002007: Art. 225. (amend. - SG 71/08, in force from 26.07.2008) (1) In a settlement on whose territory there is no
p.002007: opened a pharmacy, the right to carry out retail trade in medicinal products has a person under Art. 222, para. 1,
p.002007: who has entered into an employment or pharmacy management contract with an assistant pharmacist or with
p.002007: Master of Pharmacy with less than one year of work experience.
p.002007: (2) The assistant pharmacist or the master pharmacist under para. 1 is a pharmacy manager and a must
p.002007: works in it.
p.002007: (3) (New, SG No. 60/2011, effective 05.08.2011) Assistant Pharmacist - Head of Pharmacy
p.002007: para. 1 may perform the following activities: preservation and release without a prescription of
p.002007: medicinal products, medical devices and dietary products authorized for use in the Republic of Bulgaria
p.002007: special-purpose foods and infant formulas and follow-on formulas,
p.002007: cosmetic and sanitary products.
p.002007: Art. 226. (1) Pharmacies may be opened on the territory of outpatient medical establishments
p.002007: sale of medicinal products to citizens.
p.002007: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, medical establishments for
p.002007: hospital care and medical establishments under art. 10 of the Medical Establishments Act cannot be found
p.002007: pharmacies to sell medicinal products to citizens.
p.002007: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009) The requirements for
p.002007: the location and the premises of the pharmacy shall be determined in the ordinance under Art. 219, para. 2.
p.002007: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in force since 05.08.2011)
p.002007: Requirements for the device and premises of pharmacies under Art. 228, para. 5 shall be determined in the ordinance under para.
p.002007: 1.
p.002007: Art. 228. (Amended, SG No. 71/2008, effective 26.07.2008) (1) (Amended, SG No. 60/2011)
p.002007: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002007: Director of the BDA on the basis of an application form to which shall be attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
...
p.002007: retail trade of medicinal products, issues a permit for retail trade with
p.002007: medicinal products at a pharmacy or make a reasoned refusal to grant an authorization. The permission or
p.002007: the refusal shall be served on the applicant.
p.002007: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation on
p.002007: Art. 228, para. 6 The BDA verifies the documents submitted and notifies the applicant in writing
p.002007: identified inconsistencies or incompleteness. In these cases, the term under para. 2 stops running from the day of
p.002007: notification until the deficiencies are rectified.
p.002007: (4) (New - SG 71/08, in force from 12.08.2008) In case within 60 days from the date of
p.002007: the notification under para. 3 the applicant has not remedied any inconsistencies or incompleteness found,
p.002007: the procedure for granting a marketing authorization for a medicinal product or for modifying it
p.002007: the authorization granted shall be terminated.
p.002007: (5) (Renumbered from Paragraph 4, SG No. 71/2008, effective 12.08.2008, amended - SG No. 60/2011)
p.002007: 08/08/2011) The refusal of the BDA Executive Director to issue a permit is subject to appeal
p.002007: in accordance with the Administrative Procedure Code.
p.002007: Art. 229a. (New, SG No. 23/2009, effective 30.03.2009) (1) (amend. - SG 41/09, in force from 30.03.2009)
p.002007: 02.06.2009, amend. - SG, issue. 98 of 2010, effective January 1, 2011, as amended. - SG, issue. 60 of 2011, effective 05.08.2011
p.002007: d) The Executive Agency for Medicinal Products shall ex officio send to the Health Insurance Fund at the location of the respective
p.002007: pharmacy with issued permit under art. 229, para. 2, which includes the retail trade of food
p.002007: supplements, dietary foods for special medical purposes, infant formulas and follow-on foods, copy of
p.002007: the permission for entry in the register of art. 14, para. 1 of the Food Act.
p.002007: (2) (amend. - SG 41/09, in force from 02.06.2009) Pharmacies engaged in retail trade with
p.002007: nutritional supplements, dietary foods for special medical purposes, infant formulas and follow-on foods,
p.002007: are subject to control under the Food Act.
p.002007: Art. 230. (1) (amend. - SG 60/11, in force from 05.08.2011) The Executive Agency for Medicines shall keep
p.002007: register of licenses issued for retail trade in medicinal products under Art. 229, para. 2 which
p.002007: contains:
p.002007: 1. number and date of authorization;
p.002007: 2. (suppl. - SG 71/08, in force from 12.08.2008) name, type of the trader, seat and address of
p.002007: management of the authorized person;
p.002007: 3. (amend. - SG 12/11, in force from 08.02.2011) name, unique civil number of the head of
p.002007: pharmacy;
p.002007: 4. pharmacy address;
p.002007: 5. the activities to be performed in the pharmacy;
p.002007: 6. the date of termination of the permit and deletion from the register and the reason for it;
p.002007: 7. remarks on entered circumstances.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) Data from the register shall be published on the page of
p.002007: Executive Agency for Medicines on the Internet.
p.002007: Art. 231. (1) Upon change of the entries in the register under Art. 230, para. 1, items 2 - 5 circumstances of the person receiving
p.002007: permit for retail trade in medicinal products, submits an application in accordance with Art.
p.002007: 228, para. 1, to which the documents related to the change are attached.
p.002007: (2) (New, SG No. 60/2011, effective 05.08.2011) In the case of a change of the name and
p.002007: type of the trader, address of the pharmacy and manager of the pharmacy a new application shall be submitted in accordance with Art. 228,
p.002007: para. 1 and pay the fee for the authorization of retail sale of medicinal products in a pharmacy,
p.002007: determined in the tariff under Art. 21, para. 2.
p.002007: (3) (New - SG 60/11, in force from 05.08.2011) A person who has received a permit for retail trade with
...
p.002007: the amount of active substance per unit dose;
p.002007: (b) its source, including its manufacturer, the country in which it is manufactured, the country in which it is produced
p.002007: placed on the market, or the holder of his marketing authorization, or
p.002007: (c) the timing, including records and documents, of the supply chain used.
p.002007: It is not considered to be a counterfeit medicinal product with inadvertent tolerance in
p.002007: quality as well as a medicinal product placed on the market in violation of intellectual property rights
p.002007: property.
p.002007: 82. "Homeopathic medicinal product" is a medicinal product made from substances called homeopathic
p.002007: source, according to the European Pharmacopoeia manufacturing procedures, and in the absence thereof -
p.002007: according to the national pharmacopoeia of a Member State.
p.002007: 83. "Price calculated on the basis of a benchmark" is the price established for each medicinal product,
p.002007: included in the Positive Medicinal List calculated on the basis of the established reference value for
p.002007: defined daily dose or therapeutic course.
p.002007: 84. (Repealed, SG No. 84/2018)
p.002007: 85. "Misuse of medicinal products" is a persistent or occasional intentional overuse of
p.002007: medicinal products accompanied by harmful physical or psychological effects.
p.002007: 86. (new - SG 41/09, in force from 02.06.2009)
p.002007: "are children under 12 months of age.
p.002007: 87. (new - SG 41/09, in force from 02.06.2009) Food
p.002007: "infant formulas" means foods intended for infants
p.002007: specific nutritional use of infants during their first months, which alone are sufficient
p.002007: satisfy the nutritional needs of these infants until the introduction of a suitable supplement
p.002007: food.
p.002007: 88. (new - SG 41/09, in force from 02.06.2009) Transitional
p.002007: "food" means food intended for
p.002007: specific nutritional use of infants in the introduction of appropriate supplemental food and which
p.002007: are the staple liquid food from the progressively increasing variety of foods in these
p.002007: infants.
p.002007: 89. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "Type IA" is a change with minimal impact
p.002007: or without affecting the quality, safety or efficacy of the medicinal product concerned.
p.002007: 90. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "type IB" is a change that is neither type IA,
p.002007: neither a change of type II nor an extension of the marketing authorization.
p.002007: 91. (New, SG No. 12/2011, effective 08.02.2011) Change
p.002007: "type II" is a change that does not occur
p.002007: extending the scope of the marketing authorization and which may have a significant impact on
p.002007: the quality, safety or efficacy of the medicinal product concerned.
p.002007: 92. (new, SG No. 102/2012, effective 21.12.2012) Delegated
p.002007: "act" is an act within the meaning of Art. 290 of
p.002007: Treaty on the Functioning of the European Union.
p.002007: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
p.002007: § 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and updating of
p.002007: medicinal products stored by the State Agency for State Reserves and Wartime Stocks.
...
p.002007: § 75. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of the provision
p.002007: of § 64, item 2, effective April 14, 2008, and the provisions of § 9, item 4, §§ 41, 42 and 43, which enter into force.
p.002007: effective from 26 July 2008.
p.002007: Final provisions
p.002007: TO AMENDING LAW ON THE MEDICINAL PRODUCTS ACT IN HUMAN
p.002007: MEDICINE
p.002007: (Official Gazette of the Republic of Bulgaria, Issue 10 of 2009, Effective 29.01.2009)
p.002007: § 2. The law shall enter into force on January 29, 2009.
p.002007: Transitional and Final Provisions
p.002007: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002007: PRODUCTS IN HUMAN MEDICINE
p.002007: (Official Gazette of the Republic of Bulgaria, Issue 23 of 2009, Effective 30.03.2009)
p.002007: § 4. The persons who have received a permit under Art. 229, para. 2, including performing
p.002007: nutritional supplements can also retail diet foods for special
p.002007: medical purposes.
p.002007: § 5. Within two months of the entry into force of this law, the Ministry of Health ex officio
p.002007: sends to the respective RIPCPH by location of pharmacies for entry in the register under Art. 14, para. 1 of
p.002007: Food Act a copy of the authorizations under Art. 229, para. 2 issued prior to the entry into force of this Act.
p.002007: ...................................
p.002007: § 7. The law shall enter into force on March 30, 2009.
p.002007: Transitional and Final Provisions
p.002007: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002007: (Promulgated - SG, issue 41 of 2009, effective 02.06.2009)
p.002007: § 92. (1) The persons who have received a permit under Art. 229, para. 2 of the Law on
p.002007: medicinal products in human medicine, including the marketing of food supplements,
p.002007: they can also trade in infant formulas and follow-on foods.
p.002007: (2) Within two months of the entry into force of this Act the Ministry of Health ex officio
p.002007: sends to the respective RIPCPH at the location of pharmacies operating and retailing
p.002007: infant formulas and follow-on formulas 1, for entry in the register under Art. 14, para. 1 of the Food Act
p.002007: copy of the permits under art. 229, para. 2 of the Law on Medicinal Products in Human Medicine, issued
p.002007: until this law enters into force. "
p.002007: ...................................
p.002007: § 96. The law shall enter into force on the day of its promulgation in the State Gazette, except for:
p.002007: 1. paragraphs 3, 5, 6 and 9, which shall take effect from 1 January 2009;
p.002007: 2. Paragraphs 26, 36, 38, 39, 40, 41, 42, 43, 44, 65, 66, 69, 70, 73, 77, 78, 79, 80, 81, 82, 83, 88, 89 and 90 that go into
p.002007: with effect from 1 July 2009;
p.002007: 3. paragraph 21, which shall take effect from 1 June 2010.
p.002007: Final provisions
p.002007: TO THE LAW FOR SUPPLEMENTATION OF THE MEDICINAL PRODUCTS ACT
p.002007: HUMAN MEDICINE
p.002007: (Official Gazette of the Republic of Bulgaria, issue 88 of 2009, effective 06.11.2009)
p.002007: § 2. The law shall enter into force on the day of its promulgation in the State Gazette.
p.002007: Transitional and Final Provisions
p.002007: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002007: PRODUCTS IN HUMAN MEDICINE
p.002007: (Official Gazette, issue 102 of 2009, effective 22.12.2009)
p.002007: § 4. (1) Master-pharmacists and assistant-pharmacists who were welded until the law came into force
p.002007: received a permit for opening a pharmacy in the settlements under Art. 228, para. 4 in the order of the repealed Law
p.002007: on medicines and pharmacies in human medicine (promulgated, SG No. 36/1995; Decision No. 10 of
p.002007: The Constitutional Court of 1996 - no. 61 of 1996; amend. 38 of 1998, issue. 30 of 1999, issue. 10 of 2000;
p.002007: Decision No. 3 of the Constitutional Court of 2000 - issue no. 37 of 2000; amend. 59 of 2000; Decision # 7 of
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.002007: the marketing authorization / registration certificate in the register of art. 19, para. 1, item 3 shall be entered
p.002007: the following permit / certificate information:
p.002007: 1. registration number;
p.002007: 2. number and date of the marketing authorization / registration certificate of the medicinal product;
p.002007: 3. name of the medicinal product;
p.002007: 4. the international non-patent name of each active substance;
p.002007: 5. name and address of the holder of the marketing authorization / registration certificate;
p.002007: 5a. (new, SG No. 102/2012, effective 21.12.2012) 55a, 56 and 56a, recorded in
p.002007: the marketing authorization / registration certificate;
p.002007: 6. date of change of the Marketing Authorization / Registration Certificate;
p.002007: 7. date of termination of the marketing authorization / registration certificate;
p.002007: 8. other data.
p.002007: (2) The authorization for use / the registration certificate of the medicinal product shall be served on the person
p.002007: under Art. 26, para. 1 and shall enter into force on the date of its entry in the register mail. 19, para. 1, Vol. 3.
p.002007: Art. 53. (amend. - SG 102/2012, in force from 21.12.2012) (1) The Executive Agency for Medicines
p.002007: shall publish on its website within 14 days of the granting of the authorization
p.002007: use / certificate for registration of the data under art. 52, para. 1, the approved summary of the
p.002007: product and leaflet information.
p.002007: (2) The Executive Agency for Medicines shall publish on its website the assessment report under Art. 49,
p.002007: para. 1 with the reasons for the decision, deleting the data constituting a trade secret.
p.002007: (3) The report under para. 2 shall be accompanied by a summary of a language comprehensible to the public. The summary contains
p.002007: section on the conditions of use of the medicinal product.
p.002007: Art. 54. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of the permit for
p.002007: use / the registration certificate of the medicinal product shall notify the BDA in writing of the date of
p.002007: the actual marketing of the medicinal product in the Republic of Bulgaria.
p.002007: (2) (Amended, SG No. 18/2014) The holder of the marketing authorization / registration certificate
p.002007: of the medicinal product shall be notified in writing to the BDA at least two months before the sale ceases
p.002007: of a medicinal product, whether temporary or permanent.
p.002007: (3) (Amended, SG No. 18/2014) The holder of the marketing authorization / registration certificate
p.002007: of medicinal product shall indicate the reasons for discontinuation of sales in accordance with Art. 68, para. 1, vol.
p.002007: 6 and declares whether the actions taken by him under para. 2 are due to any of the grounds of post. 276 or
p.002007: under Art. 277.
p.002007: (4) (Amended, SG No. 18/2014) Upon termination of the sales of the medicinal product as a result of
p.002007: unforeseen circumstances the holder of the marketing authorization / registration certificate for
p.002007: medicinal product shall notify the BDA in writing within 7 days of the establishment of the circumstances.
p.002007: Art. 54a. (New, SG No. 60/2011, effective 05.08.2011) (1) (amend. - SG 18/04) Upon receipt of
p.002007: a signal to the Drug Enforcement Agency to suspend the sale of a medicinal product, p
p.002007: except for the cases under art. 54, para. 2 and 4, the Agency shall carry out the check within 30 days of receipt of
p.002007: signal.
...
p.002007: Art. 83. (Amended, SG No. 84/2018) (*) The Commission under Art. 103, para. 1 assesses the ethical aspects of
p.002007: the clinical trial and the substantial modification of the clinical trial under the terms and conditions of
p.002007: Regulation (EU) No 536/2014 and prepares a reasoned opinion which it submits to the BDA.
p.002007: Art. 84. (Amended, SG No. 84/2018) (1) (1) The Executive Agency for Medicines shall issue a permit for
p.002007: clinical trial, authorization of clinical trial under certain conditions, authorization of substantial
p.002007: change of clinical trial, permission to substantially change clinical trial in certain
p.002007: conditions or refuses authorization under the terms and conditions of Regulation (EU) No 536/2014.
p.002007: (2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002007: Art. 85. (Amended, SG No. 84/2018) (*) By an ordinance of the Minister of Health shall determine:
p.002007: 1. the conditions and procedure for submission of data and information by the BDA and the Ethical Commission for Clinical
p.002007: tests in the EU Portal under Art. 80 of Regulation (EU) No 536/2014;
p.002007: 2. the access of the BDA and the Ethical Committee for Clinical Trials to the EU Database. 81 of
p.002007: Regulation (EU) No 536/2014;
p.002007: 3. the terms and procedure for submitting the opinions by post. 83 and the order of interaction between the BDA and
p.002007: Ethics Committee for Clinical Trials;
p.002007: 4. the documents and particulars of Annex I and Annex II to Regulation (EU) No 536/2014, to be evaluated by
p.002007: BDA and the Ethical Committee for Clinical Trials, as well as the language in which they are presented.
p.002007: Art. 86. (1) (Supplemented, SG No. 84/2018) (*) All persons conducting a clinical trial must have
p.002007: relevant professional qualifications, training and experience to fulfill the test-related requirements
p.002007: tasks in accordance with the Good Clinical Practice rules under Regulation (EU) No 536/2014.
p.002007: (2) A clinical trial of a medicinal product shall be carried out under the supervision of a physician or physician
p.002007: dental medicine with recognized medical specialty in the relevant field, which is familiar with the available
p.002007: preclinical and / or clinical data on the product and the risks and procedures of the study.
p.002007: (3) During the clinical trial, the medical care provided to the trial participant and
p.002007: medical decision-making is the responsibility of a physician with an appropriate qualification or a dentist
p.002007: medicine.
p.002007: Art. 87. (1) (amend. - SG 59/10, in force from 31.07.2010, amended - SG, issue 60 of 2011, in force since 05.08.2011
p.002007: g., add. - SG, issue. 84 of 2018, effective 12.10.2018) Clinical trial may be conducted in therapeutic
p.002007: hospitals, mental health centers, venereal disease centers,
p.002007: complex oncology centers, dialysis centers, diagnostic and consulting centers, medical centers
p.002007: centers, dental centers and medical-dental centers, as well as in individual and group practices for
p.002007: primary and specialized medical care, licensed for activity / certificate of
p.002007: registration according to the procedure of the Medical Institutions Act.
p.002007: (2) (New, SG No. 84/2018, effective 12.10.2018) Clinical trial of medicinal products,
p.002007: containing narcotic substances can only be carried out in hospitals,
p.002007: mental health centers, centers for skin and venereal diseases and complex oncology
...
p.002007: product.
p.002007: (3) Safety indicators shall be considered equivalent if:
p.002007: 1. satisfy the requirements laid down in the delegated acts referred to in Article 54a (2) of the Directive
p.002007: 2001/83 / EC, and
p.002007: 2. are equally effective in allowing authentication and identification of
p.002007: medicinal products and providing evidence of counterfeiting.
p.002007: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of the medicinal product and in
p.002007: compliance with Good Manufacturing Practice for Medicinal Products.
p.002007: (5) The Drug Enforcement Agency oversees the replacement of the
p.002007: safety.
p.002007: Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
p.002007: compliance with the data in the summary of product characteristics approved by the BDA at the time of the issuance of the BDA
p.002007: the marketing authorization and meet the requirements set out in the ordinance under Art. 170.
p.002007: (2) The information on the packaging and the leaflet may be in several languages, but necessarily one
p.002007: should be Bulgarian. The content of the information in different languages must be identical.
p.002007: (3) The name of the medicinal product shall be written in Bulgarian and the international name
p.002007: non-patent name of the medicinal substance is given in accordance with the Anatomical Therapeutic
p.002007: the chemical classification of WHO. The name and address of the marketing authorization holder may be
p.002007: written in Latin.
p.002007: (4) The information on the packaging and the package leaflet must be in a patient-friendly language, legible and
p.002007: be indelible.
p.002007: (5) (New, SG No. 18/2014) The leaflet must be designed in such a way that it is clear and comprehensible,
p.002007: allowing the patient to take appropriate action, medically as needed
p.002007: specialists.
p.002007: Art. 170. (1) (Former text of Art. 170 - SG, issue 102 of 2012, effective 21.12.2012) Requirements to
p.002007: the packaging and leaflets of the medicinal products shall be laid down in an ordinance of the Minister of Health
p.002007: healthcare.
p.002007: (2) (New - SG, iss. 102 in 2012; effective from 21.12.2012, supplemented - SG, iss. 18 of 2014) Where a medicinal product,
p.002007: authorized for use under this Act, is not intended for direct delivery to the patient or is not
p.002007: available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data,
p.002007: defined in the ordinance under para. 1 are not affixed to the package or package leaflet.
p.002007: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2 information on the packaging and
p.002007: the leaflet may not be provided in Bulgarian.
p.002007: (4) (New, SG No. 102/2012, effective 21.12.2012) The terms and procedure for delivery of medicinal products
p.002007: products under para. 2 shall be determined by the ordinance under art. 198.
p.002007: Chapter seven.
p.002007: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002007: Art. 171. (1) Depending on the method of dispensing, medicinal products shall be classified as:
p.002007: 1. prescription medicinal products;
p.002007: 2. medicinal products dispensed without a prescription.
p.002007: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002007: determined by the BDA in the Marketing Authorization / Registration Certificate or the Marketing Authorization
p.002007: parallel import of the medicinal product into the territory of the Republic of Bulgaria.
...
p.002007: (c) a period of stability when different for the two products;
p.002007: (d) excipients, where different in the two products;
p.002007: 8. in the case of repackaging:
p.002007: a) (amend. - SG 71/08, in force from 12.08.2008) a sample of the medicinal product as it will be
p.002007: launches on the market in Bulgaria;
p.002007: (b) a copy of the contract between the parallel importer and the partial importer
p.002007: manufacturing activity - packaging, labeling;
p.002007: (c) a certificate of good manufacturing practice when the repackaging processes are carried out outside
p.002007: the territory of the Republic of Bulgaria;
p.002007: d) when performed by the person mailing. 213 - copy of the manufacturing authorization issued by the regulatory authority
p.002007: the authority of the Member State where the repackaging takes place;
p.002007: 9. a document for payment of a fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) Where between the medicinal product for parallel import
p.002007: and the product authorized for use on the territory of the Republic of Bulgaria, there are differences (in the composition of
p.002007: excipients, etc.), the person under para. 1 presents evidence that they do not affect
p.002007: the therapeutic qualities of the parallel import medicinal product.
p.002007: (4) In the cases of para. 3 the person under para. 1 indicates on the package and in the package leaflet the patient in parallel
p.002007: the imported medicinal product differences.
p.002007: (5) Where the person under Art. 213 carries out repackaging and / or labeling of the medicinal product in Bulgarian
p.002007: language in the territory of the Republic of Bulgaria, it must have a production permit issued
p.002007: by the BDA Executive Director.
p.002007: (6) The parallel imported product is used under the conditions of the marketing authorization issued
p.002007: the medicinal product on the territory of the Republic of Bulgaria.
p.002007: Art. 216. (1) The permit for carrying out parallel import on the territory of the Republic of Bulgaria shall be
p.002007: issues within 45 days from the date of submission of the documentation to the BDA.
p.002007: (2) When the BDA requests additional documentation from the applicant, the term under para. 1 stops running until received
p.002007: of the information requested.
p.002007: (3) Where the BDA requires the regulatory authority of the Member State from which parallel imports are made,
p.002007: information related to the granting of the marketing authorization for the imported medicinal product
p.002007: para. 1 is extended by 45 days.
p.002007: (4) If, within the term of para. 3 The BDA did not receive the requested documentation, the authorization procedure for
p.002007: parallel import into the territory of the Republic of Bulgaria shall be terminated.
p.002007: (5) Licenses issued for parallel import into the territory of the Republic of Bulgaria shall be issued
p.002007: posted on the BDA's website.
p.002007: (6) The authorization for parallel importation shall be for a period of 5 years. A new permit is issued in the order
p.002007: of Art. 215.
p.002007: (7) The authorization for parallel importation shall not be automatically terminated when the holder of the
p.002007: the marketing authorization for the medicinal product placed on the market in the Republic of Bulgaria,
p.002007: withdraw it for reasons unrelated to the danger to the health of the population.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.002007: Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and qualitative composition of the reference
p.002007: product and, if necessary, additional documentation.
p.002007: (6) The Executive Agency for Medicines shall make available to a regulatory authority of a State upon request
p.002007: Member State in which the application for a generic reference product has been authorized
p.002007: or has been authorized for use on the territory of the Republic of Bulgaria, the necessary information under para. 5th c
p.002007: within one month from the date of request.
p.002007: (7) The ten-year period under par. 2 may be extended by up to one year at the request of the holder
p.002007: of the marketing authorization of the reference medicinal product, if during the first 8 years of its granting
p.002007: the marketing authorization was granted to the holder of the reference medicinal product for the same product
p.002007: authorization of a new therapeutic indication with significant clinical advantages over existing ones
p.002007: healing options are scientifically sound.
p.002007: (8) (New - SG 12/11, in force from 08.02.2011) When originally issued for a medicinal product
p.002007: marketing authorization in accordance with Art. 23, for any change in the amount of active substance, c
p.002007: the dosage form, in the amount in the package, in the route of administration of the medicinal product, and for
p.002007: any other modification or extension of the marketing authorization shall also be granted
p.002007: as required by this Act or the original marketing authorization is supplemented. All these
p.002007: authorizations are considered to belong to a single global marketing authorization
p.002007: product for the purposes of applying this Article.
p.002007: Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary preclinical and / or clinical
p.002007: tests where the medicinal product referred to in the application:
p.002007: 1. cannot be defined as generic, or
p.002007: 2. bioavailability tests do not prove bioequivalence, or
p.002007: 3. (suppl. - SG 71/08, in force from 12.08.2008) there is a change in the active substance or substances in
p.002007: the amount of active substance or substances per dosage unit, the therapeutic indication, of
p.002007: the dosage form, the route of administration relative to the reference medicinal product.
p.002007: 4. (repealed, SG No. 71/2008, effective 12.08.2008)
p.002007: (2) Where the biological medicinal product referred to in the application is similar to a reference biological
p.002007: medicinal product does not qualify as a generic medicinal product
p.002007: due to a different production method or different starting materials compared to the reference or
p.002007: other reasons, the applicant submits to the BDA the results of the required preclinical and / or clinical
p.002007: tests related to these conditions.
p.002007: (3) In the cases of para. 1 and 2 the documentation specified in the ordinance post shall also be submitted. 42.
p.002007: Art. 30. (1) The person under art. 26, para. 1, in so far as it does not infringe industrial or commercial property rights,
p.002007: does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b" or "c", if he can prove, under the conditions,
...
p.002007: product characteristics, patient package leaflet or packaging;
p.002007: (e) all changes in the group are changes in the active substance master documentation, the main one
p.002007: vaccine antigen documentation or plasma basic documentation;
p.002007: (f) all changes to the group are in relation to a project designed to refine the production process
p.002007: and the quality of the medicinal product concerned or its active substance (s);
p.002007: (g) all changes in the group are changes affecting the quality of the pandemic influenza vaccine;
p.002007: h) all changes in the group are changes in the pharmacovigilance system heading eight;
p.002007: (i) any changes to the group are the result of a specific emergency safety measure and are filed with
p.002007: in accordance with Art. 66;
p.002007: (k) all changes in the group are related to the inclusion of information on a particular pharmacotherapeutic class;
p.002007: (l) all changes in the group result from the evaluation of the periodic safety report;
p.002007: (m) any changes to the group are the result of a post-authorization study,
p.002007: conducted under the supervision of the Marketing Authorization Holder;
p.002007: n) all changes in the group are due to the fulfillment of a condition in the authorization for use of mail. 56;
p.002007: 3. the requested changes in the conditions of the same marketing authorization do not fall in the cases under item 2, at
p.002007: provided that the BDA agrees to apply the same procedure to these changes.
p.002007: (4) When grouping changes under para. 3, items 2 and 3 the holder of the marketing authorization shall submit to the BDA:
p.002007: 1. a single notification where at least one of the changes is type IB and all others are type IA or type IB;
p.002007: 2. a single application where the major change is type II and none of the other changes is an extension of
p.002007: the scope of the marketing authorization;
p.002007: 3. a single application where the major change is the extension of the marketing authorization.
p.002007: (5) Along with the application, respectively, the notification under para. 1 or 4, the holder of the authorization for
p.002007: use feeds:
p.002007: 1. documentation related to the changes, determined by the ordinance post. 42;
p.002007: 2. a document for payment of a fee in the amount determined by the postal tariff. 21, para. 2.
p.002007: (6) The Executive Director of the BDA shall approve the models of application, respectively notification under para. 1 and
p.002007: 4, which are published on the BDA website.
p.002007: Art. 62. (amend. - SG 12/11, in force from 08.02.2011) (1) The holder of the marketing authorization
p.002007: may notify type IA changes within 12 months after their application except for
p.002007: changes that require immediate notification.
p.002007: (2) The type IA changes, which require immediate notification, shall be determined by the ordinance under Art. 42.
p.002007: (3) In the cases of para. 2, the Marketing Authorization Holder notifies the Type IA change
p.002007: immediately after administration and.
p.002007: (4) Within 30 days from receipt of the notification under para. 1, respectively under para. 3, the BDA informs
p.002007: of the marketing authorization holder:
p.002007: 1. whether the change (s) are accepted / accepted or not; when the change / changes are not accepted / accepted,
p.002007: state the reasons for this, and
p.002007: 2. whether the change (s) lead to a change in the data in the issued marketing authorization; when
p.002007: a change in the issued marketing authorization is required; Art. 64a.
p.002007: (5) The Marketing Authorization Holder shall immediately suspend the application of
p.002007: the relevant change (s) type IA upon receipt of the notification under para. 4, item 1 for
p.002007: rejection.
...
p.002007: the medicinal product, it shall take urgent restrictive measures and immediately notify the BDA in writing.
p.002007: (2) The Executive Agency for Medicines shall decide on the measures within 24 hours from the notification.
p.002007: (3) When the BDA does not make its decision within the term under para. 2, the measures are considered to be approved.
p.002007: (4) When the BDA determines that there is a risk to human health from the use of the medicinal product,
p.002007: orders the marketing authorization holder to take immediate restrictive measures.
p.002007: (5) In the cases of para. 1 and 4, the marketing authorization holder agrees with
p.002007: BDA manner and time limits for implementation of the measures taken.
p.002007: (6) The marketing authorization holder shall submit it to the Executive Director
p.002007: of BDA application for change in accordance with Art. 64 not later than 15 days after the date of taking over
p.002007: measures.
p.002007: Art. 66. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of a permit for use of
p.002007: the medicinal product is applying for an extension of the marketing authorization
p.002007: at:
p.002007: 1. change of active substance (s):
p.002007: (a) replacement of a chemically active substance with a different complex / derivative including salt / ester with the same
p.002007: the therapeutic part, wherein the efficacy / safety characteristics do not differ significantly;
p.002007: b) replacement with different isomer, different mixture of isomers, replacement of mixture with isolated isomer (e.g.
p.002007: single enantiomer racemate), whereby the efficacy / safety characteristics are not
p.002007: differ significantly;
p.002007: (c) replacement of a biologically active substance with one having a slightly different molecular structure when
p.002007: which does not differ significantly in performance / safety characteristics, except
p.002007: changes in the active substance of a seasonal, pre-pandemic or pandemic influenza vaccine
p.002007: human use;
p.002007: (d) modification of the vector used to produce the antigen or starting material, including a new one
p.002007: a major cell bank from another source, with no performance / safety features
p.002007: differ significantly;
p.002007: (e) a new radiopharmaceutical ligand or binding mechanism in which the characteristics of
p.002007: efficiency / safety do not differ significantly;
p.002007: (f) a change in the extraction solvent or in the ratio of plant matter / plant preparation,
p.002007: in which the efficacy / safety characteristics do not differ significantly;
p.002007: 2. change in the amount of active substance, dosage form and route of administration:
p.002007: (a) change in bioavailability;
p.002007: (b) a change in pharmacokinetics, such as a change in the rate of release;
p.002007: (c) modification or addition of a new amount of the active substance / activity;
p.002007: (d) modifying or adding a new dosage form;
p.002007: (e) Modification or addition of a new route of administration - parenteral administration should be done
p.002007: differentiation between intraarterial, intravenous, intramuscular, subcutaneous and other routes of
p.002007: introduction.
...
p.002007: available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data,
p.002007: defined in the ordinance under para. 1 are not affixed to the package or package leaflet.
p.002007: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2 information on the packaging and
p.002007: the leaflet may not be provided in Bulgarian.
p.002007: (4) (New, SG No. 102/2012, effective 21.12.2012) The terms and procedure for delivery of medicinal products
p.002007: products under para. 2 shall be determined by the ordinance under art. 198.
p.002007: Chapter seven.
p.002007: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002007: Art. 171. (1) Depending on the method of dispensing, medicinal products shall be classified as:
p.002007: 1. prescription medicinal products;
p.002007: 2. medicinal products dispensed without a prescription.
p.002007: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002007: determined by the BDA in the Marketing Authorization / Registration Certificate or the Marketing Authorization
p.002007: parallel import of the medicinal product into the territory of the Republic of Bulgaria.
p.002007: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in the application for
p.002007: Marketing Authorization / Registration Certificate, Modification of the Marketing Authorization or
p.002007: its renewal.
p.002007: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002007: 1. medicinal products with restricted medical prescription, intended for use in certain medicinal products only
p.002007: specialized areas;
p.002007: 2. medicinal products - subject to special medical prescription;
p.002007: 3. medicinal products for multiple or single dispensing under the same medical prescription.
p.002007: Art. 173. Medicinal products that meet the following requirements are prescribed on medical prescription:
p.002007: 1. may present a direct or indirect danger to human health, even if used correctly, if
p.002007: apply without medical supervision;
p.002007: 2. they are frequently and very widely applied incorrectly and as a result can be a danger to
p.002007: human health;
p.002007: 3. contain substances the activity and / or side effects of which subsequently require
p.002007: additional study;
p.002007: 4. usually prescribed by a doctor for parenteral administration.
p.002007: Art. 174. Medicinal products are subject to special medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. contain narcotic substances within the meaning of the Drug Control Act; and
p.002007: precursors in permissible quantities;
p.002007: 2. if used improperly, they can create a significant risk of abuse, lead to a medicinal product
p.002007: dependency or use for illegal purposes;
p.002007: 3. contain new medicinal substances whose characteristics are not sufficiently known for this reason
p.002007: a preventive cause may be attributed to the group of medicinal products under item 2.
p.002007: Art. 175. Medicinal products are subject to limited medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. restricted to hospital use only because of limited experience in use or in the interest of
p.002007: public health;
p.002007: 2. intended for the treatment of conditions which can only be diagnosed in
p.002007: medical institutions, although their implementation and monitoring of the course of treatment may be
p.002007: carry out in other health establishments;
p.002007: 3. they are intended for the treatment of outpatients, but their use can be serious
p.002007: side effects requiring specialist prescription and monitoring during treatment.
p.002007: Art. 176. (1) The Executive Agency for Medicines may not approve the mail requested by the applicant. 26, para.
p.002007: 1 medication delivery regimen based on an assessment of:
p.002007: 1. the maximum single dose, the maximum daily dose, the amount of active substance in a single dose
p.002007: unit, dosage form, specific type of immediate packaging of the product, and / or
p.002007: 2. other specific conditions of use.
p.002007: (2) The Medicines Executive Agency may not specify the exact category of medicinal product under
p.002007: Art. 172, but according to the criteria of Art. 174 and 175 determine whether the medicinal product is to be classified as
p.002007: product available only on prescription.
p.002007: Art. 177. Medicinal products which do not meet the requirements of the EMA. 173, 174 and 175 and the criteria,
p.002007: defined in the ordinance under art. 178, are granted without medical prescription.
p.002007: Art. 178. The classification criteria for medicinal products and the requirements for the dossier
p.002007: making changes in the classification shall be determined in an ordinance of the Minister of Health.
p.002007: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish its page on an internet list
p.002007: of medicinal products subject to medical prescription on the territory of the Republic
p.002007: Bulgaria.
p.002007: (2) The list under para. 1 is updated annually.
p.002007: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002007: or a certificate of registration, the BDA shall review and, where necessary, amend the classification
p.002007: according to the requirements of Art. 173 and the criteria specified in the ordinance post. 178.
p.002007: Art. 181. Where a change in the classification of a medicinal product is authorized
p.002007: significant preclinical or clinical trials, following applicant or marketing authorization holder
p.002007: use may not be invoked within one year from the date of the variation authorization issued by
...
p.002007: the centralized procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.002007: Parliament and the Council, or
p.002007: 2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
p.002007: (4) The list of European Union reference dates for medicinal products has been sent. 194l and
p.002007: the harmonized frequency for submitting their periodic safety update reports
p.002007: publish on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002007: (5) The holder of the marketing authorization after the publication of the data under para. 4 presents in the BDA
p.002007: application for a change of the marketing authorization for the medicinal product concerned. Any change to
p.002007: filing dates and frequency of submission of periodic safety update reports,
p.002007: specified in the marketing authorizations shall take effect 6 months after the date of their publication.
p.002007: Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: evaluates periodic safety update reports for medicinal products to determine whether
p.002007: there are new risks, or a change in the identified risks, or a change in the benefit / risk balance.
p.002007: (2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic updated reports
p.002007: on the safety of medicinal products for which the Republic of Bulgaria has fulfilled the functions of
p.002007: reference country within the meaning of Art. 76, and is designated by the coordination group under Art. 77, para. 2.
p.002007: (3) A rapporteur from the Republic of Bulgaria shall participate in the single evaluation of the periodic up-to-date reports
p.002007: safety for medicinal products where at least one of the products is authorized for use in the order of
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council, and has been designated as such by the Committee.
p.002007: 56a, para. 1, v. 1.
p.002007: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases of no. 194o, para. 2 and 3 BDA,
p.002007: respectively, the rapporteur from the Republic of Bulgaria within 60 days from the date of receipt of the periodic
p.002007: an updated safety report shall prepare an evaluation report and send it electronically to
p.002007: The European Medicines Agency and the regulatory authorities of the Member States. The owner of
p.002007: the marketing authorization was received by the European Medicines Agency.
p.002007: (2) Within 30 days of receipt of the report under para. 1 the holder of the marketing authorization or
p.002007: Member States' regulatory authorities may submit their comments to the European Agency
p.002007: on medicines and to the BDA.
p.002007: (3) Within 15 days from the date of receipt of the comments under para. 2 The BDA updates the evaluation report, such as
p.002007: takes into account all the objections presented, and sends it to the committee under Art. 56a, para. 1, item 1 for approval and
p.002007: recommendation.
p.002007: (4) The European Medicines Agency shall include the evaluation report adopted and the committee recommendation.
p.002007: 56a, para. 1, item 1 in the register under Art. 194h, para. 3 and send it to the Marketing Authorization Holder.
p.002007: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) Where the Republic of Bulgaria is not a rapporteur in
p.002007: the procedure under Art. 194o, para. 2, the BDA may submit comments within the deadline. 194p, para. 2 to the European
p.002007: the Medicines Agency and the regulatory authority of the Member State that prepared the assessment report.
p.002007: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002007: updated reports on the safety of medicinal products under Art. 194l and when none of
p.002007: the marketing authorizations for these products were not granted under Regulation (EC) No 726/2004
p.002007: The European Parliament and the Council, the coordination group under Art. 77, para. 2 within 30 days from the date of
p.002007: receiving the recommendation from the committee under Art. 56a, para. 1, item 1 issues an opinion on conservation,
p.002007: modification, suspension or termination of relevant marketing authorizations, including a schedule for
p.002007: implementation of the opinion.
p.002007: (2) Where the Member States represented in the coordination group have 77, para. 2 agreed
p.002007: on the actions to be taken, the BDA implements the decision taken.
p.002007: (3) When the opinion under para. 1 is for suspension or termination of the marketing authorization, the executive
p.002007: the BDA director issues an order.
p.002007: (4) Where in the opinion under para. 1 recommended changes to the marketing authorization issued,
p.002007: the marketing authorization holder submits to the BDA an application for change including an updated one
p.002007: a summary of the product characteristics and a leaflet, within the specified implementation schedule.
p.002007: (5) Where agreement cannot be reached within the postal coordination group. 77, para. 2,
p.002007: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002007: a decision to modify, suspend or terminate the marketing authorizations granted by them
p.002007: Member States' regulatory authorities.
p.002007: (6) The Executive Agency for Medicinal Products shall apply the provisional and / or definitive measures of the Decision on Medicinal Products
p.002007: para. 5.
p.002007: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002007: updated reports on the safety of medicinal products under Art. 194l and when at least one of
p.002007: the marketing authorizations were granted under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
p.002007: The Council, the Committee for Medicinal Products for Human Use, within 30 days of receipt of the
p.002007: the recommendation of the committee under Art. 56a, para. 1, item 1 issues an opinion on the retention, amendment, suspension
p.002007: or the termination of the relevant marketing authorizations, including a timetable for
p.002007: implementation of the opinion.
p.002007: (2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
p.002007: of the Marketing Authorizations, European Commission:
p.002007: 1. adopt a decision to change, suspend or terminate the marketing authorizations issued in accordance with
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002007: 2. adopt a decision recommending the change, suspension or termination of the marketing authorizations,
p.002007: issued by the relevant regulatory authorities of the Member States.
p.002007: (3) The Executive Agency for Medicinal Products shall apply the provisional and / or definitive measures of the decision on
p.002007: para. 2, Vol. 2.
p.002007: Section IV.
p.002007: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002007: 12/21/2012)
...
p.002007: 2. on the activity of the holders of the marketing authorization for medicinal products regarding compliance
p.002007: of their obligations determined by the ordinance under Art. 261a, para. 5.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 102/2018, effective from 01.01.2019)
p.002007: projects for the construction of new and / or remodeling of existing sites related to the production of
p.002007: medicinal products in accordance with the rules of good manufacturing practice for medicinal products.
p.002007: Art. 268a. (New, SG No. 60/2011, effective 05.08.2011) (1) (Amended, SG No. 84/2018)
p.002007: 12/10/2018) Donations of medicinal products from marketing authorization holders, manufacturers,
p.002007: wholesalers and retailers and the Bulgarian Red Cross can only be made after filing
p.002007: notification from the donor to the BDA following a model approved by the Minister of Health on proposal
p.002007: of the BDA Executive Director.
p.002007: (2) Donations shall be made in accordance with the World Health Donation Good Practice Rules
p.002007: organization.
p.002007: (3) (Repealed, SG No. 84/2018, effective 12.10.2018)
p.002007: (4) The medical establishments and the Bulgarian Red Cross shall notify the BDA of the received donations of medicinal products.
p.002007: products within 7 days of receipt.
p.002007: (5) At the end of each quarter, the BDA sends information to the Ministry of Health about
p.002007: the donations made under para. 4.
p.002007: (6) To make a donation of a medicinal product at the request of a medical establishment intended for
p.002007: treatment of a particular patient in a life-threatening condition, the donor notifies the BDA within 7 days
p.002007: since its implementation.
p.002007: (7) The donations under para. 6 may not exceed the amount required for a single course of treatment.
p.002007: Art. 269. (1) The control under art. 267 is performed through inspections and laboratory tests.
p.002007: (2) The inspections and laboratory tests under para. 1 shall be carried out:
p.002007: 1. in connection with the issuance of authorizations for use, production, import and certificates under the procedure of this law;
p.002007: 2. in connection with the supervision of the market of medicinal products;
p.002007: 3. upon request by the European Commission, the European Medicines Agency or by a party
p.002007: to the competent authority of another Member State;
p.002007: 4. upon application by a manufacturer, importer or holder of a marketing authorization outside
p.002007: the cases under item 1.
p.002007: (3) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall carry out
p.002007: Inspections:
p.002007: 1. to manufacturers of medicinal products located on the territory of the Republic of Bulgaria;
p.002007: Member State or in third countries;
p.002007: 2. to importers and wholesalers of medicinal products;
p.002007: 3. on the premises of manufacturers, importers and wholesalers of active substances located
p.002007: on the territory of the Republic of Bulgaria;
p.002007: 4. at the premises of manufacturers or wholesalers of active substances located in third places
p.002007: countries as well as manufacturers or importers of excipients;
p.002007: 5. at the premises of the marketing authorization holders and the intermediaries
p.002007: in the field of medicinal products, registered in accordance with Art. 212a;
p.002007: 6. as part of a certification procedure relating to monographs of the European Pharmacopoeia;
p.002007: 7. to manufacturers of starting materials at the written request of the manufacturer.
...
Social / Occupation
Searching for indicator job:
(return to top)
p.002007: Issue 59 of July 31, 2010, amend. DV. No.98 of December 14, 2010, amend. DV. Issue 9 of January 28, 2011, amend. DV. issue 12
p.002007: of February 8, 2011, as amended. DV. Issue 60 of August 5, 2011, amend. DV. No. 61 of 9 August 2011, amended. DV. Issue 38 of 18 01/02/2020 08:46
p.002007: May 2012, ed. and ext. DV. Issue 60 of August 7, 2012, amend. and ext. DV. Issue 102 of 21 December 2012, amend. DV.
p.002007: issue 15 of February 15, 2013, suppl. DV. Issue 1 of 3 January 2014, amended. and ext. DV. 18 of March 4, 2014, amend. DV.
p.002007: Issue 12 of February 13, 2015, amend. and ext. DV. Issue 48 of 27 June 2015, amend. DV. 43, dated 7 June 2016, amend. DV. Lighter penalties for
p.002007: Issue 85 of 24 October 2017, Suppl. DV. 103 of December 28, 2017, amend. and ext. DV. Issue 84 of 12 October
p.002007: 2018, Suppl. DV. Issue 91 of November 2, 2018, amend. and ext. DV. Issue 102 of December 11, 2018, amend. DV. 17 of 26 minors to be more
p.002007: February 2019, ed. and ext. DV. issue 64 of 13 August 2019 heavy and not be
p.002007: mandatory
p.002007: In order to view this page you need Adobe Flash Player 9 (or higher) equivalent support!
p.002007: 01/31/2020 13:21
p.002007: Spectrum
p.002007: Laurence Van Den Acker:
p.002007: "Personalization as
p.002007: form of expression "
p.002007: Project: 602-01-67 / 07/27/2006 2020-01-31
p.002007: Chapter One.
p.002007: GENERAL
p.002007: Section I.
p.002007: general provisions
p.002007: Art. 1. This Act regulates the terms and conditions for:
p.002007: 1. authorizing the use or registration of industrially produced or manufactured methods,
p.002007: involving an industrial process, medicinal products intended for human use;
p.002007: Work
p.002007: 2. (amend. - SG 102/2012, in force from 21.12.2012) authorizing the production and import of medicinal products
p.002007: products; Job: Trainee
p.002007: 2a. (new - SG 102/02, in force from 21.12.2012) production, import and wholesale trade with active Sofia, Law Firm, 01/28/2020
p.002007: substances;
p.002007: 3. authorization and conduct of clinical trials;
p.002007: 4. wholesale and retail trade in medicinal products; Job: Legal Counsel / Senior Legal Counsel
p.002007: 5. parallel import of medicinal products;
p.002007: Sofia, DSK Bank EAD, 01/27/2020
p.002007: 5a. (new - SG 102/2012, in force since 21.12.2012) mediation in the field of medicinal
p.002007: products;
p.002007: 5b. (new, SG No. 18/2014) export of medicinal products under the order of heading nine "b"; View All Post More
p.002007: 6. advertising of medicinal products;
p.002007: 7. monitoring the safety of medicinal products placed on the market;
p.002007: 8. the classification of the manner of prescribing and dispensing of medicinal products;
p.002007: 9. control of production and import, wholesale and retail, conducting clinical
p.002007: tests, advertising and the safety monitoring system for commercially available medicinal products
p.002007: Forum
p.002007: products;
p.002007: Renovation of a farm building in
p.002007: 10. the pricing of medicinal products;
p.002007: 11. drawing up a positive medical list. residential
p.002007: by probcho at 2/1 14:21 3 posts
p.002007: I am asking for advice! Complex Case Study on Ex. business
p.002007: by propensity at 1 Feb 13:45 6 posts
p.002007: Fenced part of a foreign property
p.002007: Art. 2. This law aims to create conditions that ensure the marketing of medicinal products
p.002007: products that meet the requirements of quality, safety and efficiency. by milen73 on Jan 31 20:11 2 posts
p.002007: Visit the forum
p.002007: Art. 3. (1) (amend. - SG 71/08, in force from 12.08.2008) A medicinal product in human medicine shall be:
p.002007: 1. any substance or combination of substances presented as having properties for treatment or
p.002007: prevention of human diseases, or
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.002007: involving an industrial process, medicinal products intended for human use;
p.002007: Work
p.002007: 2. (amend. - SG 102/2012, in force from 21.12.2012) authorizing the production and import of medicinal products
p.002007: products; Job: Trainee
p.002007: 2a. (new - SG 102/02, in force from 21.12.2012) production, import and wholesale trade with active Sofia, Law Firm, 01/28/2020
p.002007: substances;
p.002007: 3. authorization and conduct of clinical trials;
p.002007: 4. wholesale and retail trade in medicinal products; Job: Legal Counsel / Senior Legal Counsel
p.002007: 5. parallel import of medicinal products;
p.002007: Sofia, DSK Bank EAD, 01/27/2020
p.002007: 5a. (new - SG 102/2012, in force since 21.12.2012) mediation in the field of medicinal
p.002007: products;
p.002007: 5b. (new, SG No. 18/2014) export of medicinal products under the order of heading nine "b"; View All Post More
p.002007: 6. advertising of medicinal products;
p.002007: 7. monitoring the safety of medicinal products placed on the market;
p.002007: 8. the classification of the manner of prescribing and dispensing of medicinal products;
p.002007: 9. control of production and import, wholesale and retail, conducting clinical
p.002007: tests, advertising and the safety monitoring system for commercially available medicinal products
p.002007: Forum
p.002007: products;
p.002007: Renovation of a farm building in
p.002007: 10. the pricing of medicinal products;
p.002007: 11. drawing up a positive medical list. residential
p.002007: by probcho at 2/1 14:21 3 posts
p.002007: I am asking for advice! Complex Case Study on Ex. business
p.002007: by propensity at 1 Feb 13:45 6 posts
p.002007: Fenced part of a foreign property
p.002007: Art. 2. This law aims to create conditions that ensure the marketing of medicinal products
p.002007: products that meet the requirements of quality, safety and efficiency. by milen73 on Jan 31 20:11 2 posts
p.002007: Visit the forum
p.002007: Art. 3. (1) (amend. - SG 71/08, in force from 12.08.2008) A medicinal product in human medicine shall be:
p.002007: 1. any substance or combination of substances presented as having properties for treatment or
p.002007: prevention of human diseases, or
p.002007: 2. any substance or combination of substances that may be used or administered to humans for the purpose of:
p.002007: (a) restoration, correction or alteration of physiological functions through pharmacological, immunological
p.002007: or metabolic action, or
p.002007: b) making a medical diagnosis.
p.002007: (2) A substance is any substance the origin of which may be:
p.002007: 1. human (human blood, human blood products and others);
p.002007: 2. animal (microorganisms, animal organs, extracts, secretions, toxins, blood products, etc.);
p.002007: 3. plant (microorganisms, plants, parts of plants, plant extracts, secretions, etc.);
p.002007: 4. chemical (elements, natural chemical materials, synthetic or semi-synthetic substances, etc.).
p.002007: Art. 4. Where a product meets both the characteristics of a medicinal product and a product,
p.002007: regulated by another law, the requirements of that law shall apply.
p.002007: Art. 5. Medicinal products shall be classified according to the anatomical-therapeutic-chemical classification in
p.002007: compliance with World Health Organization (WHO) requirements.
p.002007: Art. 6. This law shall not apply to:
...
p.002007: (2) (Supplemented, SG No. 18/2014) The documents under para. 1, items 18 and 18a with respect to the Member States, respectively
p.002007: under item 19, shall be submitted only in the procedures under section VII.
p.002007: (3) For radionuclide generators to the data of para. 1 the following documents shall be submitted additionally:
p.002007: 1. a description of the system together with a detailed description of the components and which may affect the composition
p.002007: or the quality of daughter radionuclides;
p.002007: 2. the qualitative and quantitative characteristics of the eluate or sublimate.
p.002007: (4) Documents and data from pharmaceutical, preclinical and clinical trials shall be accompanied by
p.002007: summary reports prepared by experts with the necessary technical and professional qualifications. To
p.002007: the reports shall be accompanied by a CV of the experts who produced the report.
p.002007: (5) The dossier of the medicinal product shall be submitted in Bulgarian and / or English.
p.002007: (6) (New, SG No. 102/2012, effective 21.12.2012) The risk management system of para. 1, v. 13
p.002007: should be proportionate to the identified and potential risks of the medicinal product and of
p.002007: the need to collect safety data from post-marketing studies.
p.002007: (7) (New, SG No. 102/2012, in force since 21.12.2012) The holder of the marketing authorization
p.002007: updates the data from the file under para. 1. The order of Chapter Three, Section 1, shall apply to any change to the dossier
p.002007: VI, where applicable.
p.002007: Art. 28. (1) (amend. - SG 71/08, in force from 12.08.2008) 26, para. 1 insofar as it does not violate
p.002007: industrial and commercial property rights, does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b"
p.002007: and "c" if it can prove that the medicinal product referred to in the application is generic of the reference
p.002007: a medicinal product which has been authorized or has been authorized for use in a Member State, not less than
p.002007: for 8 years.
p.002007: (2) The holder of the authorization for use of the generic product under para. 1 can't put it on the market,
p.002007: before the expiry of 10 years from the date of the first authorization to use the reference medicinal product.
p.002007: (3) The person under art. 26, para. 1, subject to the conditions of para. 1 and 2 may apply to the BDA for
p.002007: authorization to use a generic reference product and when the reference product is not
p.002007: was granted marketing authorization in the territory of the Republic of Bulgaria
p.002007: (4) In the cases of para. 3 the person under art. 26, para. 1 shall indicate in the application under Art. 27, para. 1 the Member State in which
p.002007: the reference product is authorized or has been authorized.
p.002007: (5) In the cases of para. 3 The BDA requires the regulatory authority of the Member State referred to in the application under
p.002007: Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and qualitative composition of the reference
p.002007: product and, if necessary, additional documentation.
p.002007: (6) The Executive Agency for Medicines shall make available to a regulatory authority of a State upon request
p.002007: Member State in which the application for a generic reference product has been authorized
p.002007: or has been authorized for use on the territory of the Republic of Bulgaria, the necessary information under para. 5th c
...
p.002007: as required by this Act or the original marketing authorization is supplemented. All these
p.002007: authorizations are considered to belong to a single global marketing authorization
p.002007: product for the purposes of applying this Article.
p.002007: Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary preclinical and / or clinical
p.002007: tests where the medicinal product referred to in the application:
p.002007: 1. cannot be defined as generic, or
p.002007: 2. bioavailability tests do not prove bioequivalence, or
p.002007: 3. (suppl. - SG 71/08, in force from 12.08.2008) there is a change in the active substance or substances in
p.002007: the amount of active substance or substances per dosage unit, the therapeutic indication, of
p.002007: the dosage form, the route of administration relative to the reference medicinal product.
p.002007: 4. (repealed, SG No. 71/2008, effective 12.08.2008)
p.002007: (2) Where the biological medicinal product referred to in the application is similar to a reference biological
p.002007: medicinal product does not qualify as a generic medicinal product
p.002007: due to a different production method or different starting materials compared to the reference or
p.002007: other reasons, the applicant submits to the BDA the results of the required preclinical and / or clinical
p.002007: tests related to these conditions.
p.002007: (3) In the cases of para. 1 and 2 the documentation specified in the ordinance post shall also be submitted. 42.
p.002007: Art. 30. (1) The person under art. 26, para. 1, in so far as it does not infringe industrial or commercial property rights,
p.002007: does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b" or "c", if he can prove, under the conditions,
p.002007: defined in the ordinance under art. 42 that the active substance included in the proposed authorization
p.002007: for use a medicinal product is well established in medical practice, is recognized
p.002007: efficiency and an acceptable level of safety. In these cases, the test results and tests may
p.002007: to be replaced by the relevant scientific publications.
p.002007: (2) The person under para. 1 presents the results of the necessary preclinical and clinical trials in the case of
p.002007: a medicinal product containing active substances with well-established use that has not been used
p.002007: in the proposed combination for therapeutic purposes. In this case, no documentation is provided regarding
p.002007: of each individual active substance.
p.002007: (3) When an active substance within the meaning of para. 1 has a proven new therapeutic indication based on
p.002007: significant preclinical or clinical data related to the new indication, once a year
p.002007: a subsequent applicant cannot rely on the data for the new indication of the active substance.
p.002007: Art. 31. In the case where a medicinal product contains active substances used in the authorized composition
p.002007: for use medicinal products but not used in the proposed combination for therapeutic purposes, the person
p.002007: under Art. 26, para. 1 presents the results of the preclinical and clinical trials related to this
p.002007: combination. In this case, the applicant does not provide documentation on the safety and efficacy of
...
p.002007: an establishment in the structure of which a pharmacy has been opened, holding a license under Art. 33, para. 1 of the Law
p.002007: for drug and precursor control.
p.002007: (3) (Renumbered from Paragraph (2), amend. - SG 84/08, in force from 12.10.2018) Clinical trial may be
p.002007: conducts only in a medical establishment in which there is a designated contact person under Art. 107a, para. 1.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 84/2018, effective 12.10.2018)
p.002007: the clinical trial of a medicinal product will be agreed to the participation of the principal
p.002007: researcher and for conducting the test.
p.002007: Art. 88. (1) Clinical trial on humans shall be performed with:
p.002007: 1. medicinal products not authorized for use in the Republic of Bulgaria;
p.002007: 2. medicinal products authorized for use in the Republic of Bulgaria when tested for unauthorized use
p.002007: indication for a dosage form other than the authorized one in a group of patients not previously studied or
p.002007: for more information.
p.002007: (2) Authorized for use in the Republic of Bulgaria within the meaning of para. 1, item 2 are medicinal products received
p.002007: authorization for use under this Act or under Regulation (EC) No 726/2004 of the European Union
p.002007: Parliament and Council.
p.002007: Art. 89. (Repealed, SG No. 84/2018)
p.002007: Art. 90. (Repealed, SG No. 84/2018) (Amended, SG No. 17/2019)
p.002007: Art. 91. The contracting authority and the principal investigator take out insurance covering their liability for
p.002007: non-material and property damage caused during or in the course of the clinical trial
p.002007: of the participants.
p.002007: Art. 92. (1) (Amended, SG No. 84/2018) (*) The contracting authority shall be liable in case of health damage.
p.002007: or death caused during or on the occasion of the clinical trial when the trial is
p.002007: carried out in accordance with the requirements and procedures of the approved protocol.
p.002007: (2) (Amended, SG No. 84/2018) (*) The Principal Investigator shall be liable in the event of damage to
p.002007: health or death caused during or in connection with the conduct of a clinical trial when not
p.002007: the requirements and procedures of the approved protocol are complied with.
p.002007: Art. 93. (Am. - SG, iss. 84 in 2018. (*)) (1) When the clinical trial is conducted only in the territory of
p.002007: The Republic of Bulgaria or on the territory of the Republic of Bulgaria and on the territory of a third country,
p.002007: the contracting authority appoints a representative on the territory of the Republic of Bulgaria for the specific clinical
p.002007: testing.
p.002007: (2) The person under para. 1 is the addressee of the communication with the contracting authority provided for in Regulation (EU) No 536/2014.
p.002007: Art. 94. The sponsor shall provide free of charge the tested medicinal product / products and each device,
p.002007: necessary for its implementation.
p.002007: Art. 95. (Repealed, SG No. 84/2018)
p.002007: Art. 96. (1) (Amended, SG No. 84/2018) (*) Clinical testing of medicinal products shall be allowed only on
p.002007: a person who has given his or her written informed consent.
p.002007: (2) (Repealed, SG No. 84/2018)
...
p.002007: establishments under para. 4, which do not have an open pharmacy, can be obtained from a pharmacy at a medical establishment,
p.002007: has obtained a retail authorization for medicinal products under the conditions and in the order specified by
p.002007: the ordinance under Art. 219, para. 2.
p.002007: (6) (Repealed, previous para. 4 - SG, iss. 71 in 2008, effective from 26.07.2008, previous para.
p.002007: 2011, in force since 05/08/2011) Pharmacies of outpatient medical establishments at
p.002007: The Ministry of Defense and the Ministry of Interior may be managed by an Assistant-
p.002007: pharmacist at the proposal of the relevant department and after the permission of the executive
p.002007: director of the BDA.
p.002007: Art. 223. (1) A master pharmacist or an assistant pharmacist may be the head of only one pharmacy and
p.002007: necessarily work in it.
p.002007: (2) (amend. - SG 12/11, in force from 08.02.2011) Master pharmacist or assistant pharmacist,
p.002007: who runs a pharmacy cannot be hired under a sole proprietorship or
p.002007: a business company manufacturing, importing, wholesaling or retailing medicinal products
p.002007: products.
p.002007: (3) The person under para. 1, authorized to trade in medicinal products, no
p.002007: may own or participate in manufacturing, importing or trading companies
p.002007: wholesale of medicinal products, including in affiliated companies within the meaning of
p.002007: Trade Law.
p.002007: Art. 224. The pharmacy manager must:
p.002007: 1. is a master pharmacist, respectively assistant pharmacist, in the cases provided for by law;
p.002007: 2. is not deprived of the right to practice the profession;
p.002007: 3. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crime against the individual;
p.002007: 4. has at least one year of experience as a master pharmacist.
p.002007: Art. 225. (amend. - SG 71/08, in force from 26.07.2008) (1) In a settlement on whose territory there is no
p.002007: opened a pharmacy, the right to carry out retail trade in medicinal products has a person under Art. 222, para. 1,
p.002007: who has entered into an employment or pharmacy management contract with an assistant pharmacist or with
p.002007: Master of Pharmacy with less than one year of work experience.
p.002007: (2) The assistant pharmacist or the master pharmacist under para. 1 is a pharmacy manager and a must
p.002007: works in it.
p.002007: (3) (New, SG No. 60/2011, effective 05.08.2011) Assistant Pharmacist - Head of Pharmacy
p.002007: para. 1 may perform the following activities: preservation and release without a prescription of
p.002007: medicinal products, medical devices and dietary products authorized for use in the Republic of Bulgaria
p.002007: special-purpose foods and infant formulas and follow-on formulas,
p.002007: cosmetic and sanitary products.
p.002007: Art. 226. (1) Pharmacies may be opened on the territory of outpatient medical establishments
p.002007: sale of medicinal products to citizens.
p.002007: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, medical establishments for
p.002007: hospital care and medical establishments under art. 10 of the Medical Establishments Act cannot be found
p.002007: pharmacies to sell medicinal products to citizens.
p.002007: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009) The requirements for
p.002007: the location and the premises of the pharmacy shall be determined in the ordinance under Art. 219, para. 2.
...
p.002007: SG, issue 60 of 2011, effective 05.08.2011) When the pharmacy manager is unable to perform
p.002007: obligations due to sick leave, sickness and pregnancy
p.002007: birth or adoption and parental leave in accordance with the Labor Code, the pharmacy may
p.002007: work for no more than two years under the direction of another Master of Pharmacy, respectively
p.002007: assistant pharmacist, in the cases of art. 225, which meets the requirements of post. 224. In these cases, yes
p.002007: issues permission from the BDA Executive Director.
p.002007: (3) The permit under para. 2 shall be issued within 30 days.
p.002007: Art. 237. In case of termination of the activity of the person who has been authorized to open a pharmacy, the medicines
p.002007: the products may be sold to persons who have been authorized to wholesale medicinal products
p.002007: products.
p.002007: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002007: prescription, can be sold in a drugstore. Drugstores can also sell products and goods
p.002007: relevant to human health as defined in the ordinance under Art. 243, and medical devices.
p.002007: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to carry out retail trade in medicinal products
p.002007: products, opening a drugstore, have all natural and legal persons registered under the Commercial
p.002007: law or under the law of a Member State.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore shall be medical
p.002007: specialist who:
p.002007: 1. is not deprived of the right to practice his profession;
p.002007: 2. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crimes against the individual;
p.002007: 3. have at least one year of experience in the specialty.
p.002007: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened upon registration in
p.002007: the relevant REI.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) 238, para. 2 shall be submitted to the relevant RHI
p.002007: application for registration, to which the following documents are attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 238, para. 1;
p.002007: 2. (suppl. - SG 103/07, in force from 01.01.2018) document for education and criminal record of
p.002007: the person designated as the head of the drugstore, if not a Bulgarian citizen;
p.002007: 3. the medical certificate of the person under item 2;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 6. document for paid state fee in the amount specified in the tariff mail. 21, para. 2.
...
p.002007: (2) (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 02.01.2013)
p.002007: Who manufactures, imports or wholesale medicinal products or sells medicinal products in
p.002007: breach of the authorization or sell, store or supply medicinal products that are
p.002007: of unidentified origin shall be liable to a fine of BGN 25,000 to BGN 50,000.
p.002007: (3) (suppl. - SG 71/08, in force from 12.08.2008) In the cases of para. 1 and 2 the bodies of state control
p.002007: stop the operation of the site by order.
p.002007: (4) The order under para. 3 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal shall not suspend its execution.
p.002007: Art. 284a. (New, SG No. 102/2012, effective 02.01.2013) Who produces, imports, exports, stores,
p.002007: sells or provides counterfeit medicinal products, and mediates the purchase and sale
p.002007: falsified medicinal products shall be liable to a fine of BGN 25,000 to BGN 50,000.
p.002007: Art. 284b. (New, SG No. 102/2012, effective 02.01.2013) Holder of a production permit,
p.002007: who does not fulfill his obligations under Art. 160, shall be punished by a pecuniary sanction from 5000 to 10 000 levs, a
p.002007: for repeated infringement - with a pecuniary sanction from BGN 10,000 to BGN 20,000.
p.002007: Art. 284c. (1) (New - SG, iss. 102 in 2012, in force since 02.01.2013, previous text Art. 284c, suppl. - SG, iss. 84 from
p.002007: 2018, effective 12.10.2018) The holder of a wholesale marketing authorization for medicinal products which
p.002007: does not fulfill its obligations under Art. 207, para. 1, items 1 - 3, items 4a - 14 and para. 2, shall be punished by a pecuniary sanction of
p.002007: 2000 to 5000 levs, and in case of repeated infringement - with a property sanction from 5000 to 10
p.002007: BGN 000
p.002007: (2) (New, SG No. 84/2018, effective 12.10.2018) Holder of a wholesale trading permit
p.002007: medicinal products, which is supplied with medicinal products by persons other than those specified in Art. 207,
p.002007: para. 1, item 4, shall be punished by a pecuniary sanction of BGN 25,000 to BGN 50,000, and in the case of a repeated execution of the same
p.002007: violation - with a property sanction from BGN 50,000 to BGN 100,000
p.002007: Art. 284g. (New, SG No. 84/2018, effective 12.10.2018) Who fails to fulfill his / her obligations 68,
p.002007: para. 1, items 9 and 10, shall be punished by a fine in the amount of BGN 50,000 to BGN 100,000, and in the case of repeated commission of the same
p.002007: violation - with a fine of BGN 100,000 to BGN 150,000.
p.002007: Art. 284d. (New, SG No. 84/2018, effective 12.10.2018) Who carries out the export of medicinal products,
p.002007: included in the list under Art. 217c, para. 1, shall be punished by a fine in the amount of BGN 50,000 to BGN 100,000, and for a repeated fine
p.002007: committing the same offense - with a fine of BGN 100,000 to BGN 150,000.
p.002007: Art. 284f. (New, SG 84/2018, effective 12.10.2018) Who does not fulfill or does not fulfill in the specified
p.002007: within the time limits, the obligation to provide information under Art. 217b, para. 3, item 1, shall be punished by a fine in Art
p.002007: amount from BGN 50,000 to BGN 100,000, and in the case of repeated infringement - with a fine of BGN 100
p.002007: 000 to 150 000 BGN
p.002007: Art. 284g. (New, SG No. 84/2018, effective 12.10.2018) Who provided information 217b, para. 3,
p.002007: item 1 with incomplete and / or inaccurate content shall be punished with a fine in the amount of 5000 to 10 000 BGN, and in case of repeated
p.002007: committing the same offense - with a fine of BGN 10,000 to BGN 15,000.
p.002007: Art. 284s. (New, SG No. 84/2018, effective 12.10.2018) For failure to fulfill the obligations, mail. 217b,
p.002007: para. 9 of the Executive Director of the BDA, respectively an official of the BDA, shall be fined
p.002007: 50,000 to 100,000 BGN, and in the case of repeated infringement - a fine of 100,000 to 150
p.002007: BGN 000
p.002007: Art. 285. (1) Whoever trades in medicinal products without a batch release certificate shall be punished with
...
p.002007: Art. 285c. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018)
p.002007: medicinal products in quantities greater than the quantities under Art. 207, para. 1, item 15, letter "d" shall be punished by Art
p.002007: a fine of BGN 50,000 to BGN 100,000, and in the case of a repeated infringement, a fine of BGN 50,000
p.002007: from 100,000 to 150,000 BGN
p.002007: Art. 286. (1) (Supplemented, SG No. 84/2018) (*) For clinical trials conducted in violation of this Act, or
p.002007: of Regulation (EU) No 536/2014, if committed does not constitute a crime, of the perpetrators
p.002007: or who have committed this violation, will be fined $ 5,000 to $ 10,000, and upon re-admission or
p.002007: committing the same offense - a fine of 10,000 to 20,000 BGN.
p.002007: (2) To medical specialists who have admitted or committed violations under para. 1 may also be required
p.002007: punishment "deprivation of the right to exercise their profession" from 6 months to two years.
p.002007: (3) The measure under para. 2 shall be imposed by the Minister of Health upon proposal of the Executive Director
p.002007: of the BDA.
p.002007: Art. 287. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 60/2011, effective 05.08.2011
p.002007: (d) Who is retailing medicinal products without a marketing authorization / certificate
p.002007: this, or works in violation of his issued permit / certificate, shall be punished with a fine of 5000 to 10
p.002007: BGN 000
p.002007: (2) (New, SG No. 84/2018, effective 12.10.2018) Retailer who supplies medicinal products
p.002007: products from the list under Art. 217c, para. 1 wholesaler or other person in violation of the requirements of
p.002007: this law, or the by-laws implementing it, shall be punished by a fine, as appropriate
p.002007: property sanction from 10,000 to 20,000 BGN, and in the case of repeated violation - from 25,000 to 35,000 BGN.
p.002007: (3) (Renumbered from Paragraph (2), SG No. 84/2018) Effective from 12.10.2018. 1 shall also be imposed on the persons,
p.002007: who are retailing a pharmacy or drugstore after the termination of the business
p.002007: the permit / certificate.
p.002007: (4) (amend. - SG 71/08, in force from 12.08.2008, suppl. - SG, iss. 60 in 2011, in force since 05.08.2011,
p.002007: previous para. 3 - SG, iss. 84 of 2018, effective 12/10/2018) Who sells or stores in a drugstore
p.002007: medicinal products subject to medical prescription or products and goods relevant to
p.002007: human health beyond those specified in the ordinance under Art. 243, shall be punished by the fine under para. 1, and when re
p.002007: committing the same infringement shall be revoked the issued certificate for registration of a drugstore.
p.002007: (5) (Renumbered from Paragraph (4), amend. - SG 84/08, in force from 12.10.2018). 1, 2 and 3 bodies of
p.002007: state control over medicinal products shall stop the operation of the facility by order.
p.002007: (6) (repealed - SG 71/08, in force from 12.08.2008, previous para 5, amended - SG, iss. 84 of 2018, in force from
p.002007: 12.10.2018) The order under par. 5 shall be subject to appeal in accordance with the Administrative Procedure Code,
p.002007: and the appeal does not suspend its execution.
p.002007: Art. 287a. (New - SG 71/08, in force from 12.08.2008) (1) Medical specialist working at
p.002007: retailers of medicinal products without a permit / certificate
p.002007: this is fined from 2500 to 5000 BGN.
p.002007: (2) The punishment under para. 1 shall also be imposed on a person under para. 1 that works in a pharmacy or drugstore after discontinuation
p.002007: the validity of the permit / certificate and.
p.002007: (3) In case of more than two violations under para. 1 and 2, the Minister of Health may deprive
p.002007: the relevant healthcare professional entitled to practice for up to two years.
p.002007: Art. 287b. (New, SG No. 102/2012, effective 02.01.2013) Who conducts trade in medicinal products
p.002007: products on the Internet in violation of the requirements of this law and the ordinance under Art. 234, para. 5, shall be punished by
p.002007: fine from $ 5,000 to $ 10,000
p.002007: Art. 288. (1) A retailer of medicinal products who has authorized the activities specified in Art. 219, yes
p.002007: are carried out by an incapacitated person, punishable by a pecuniary sanction of BGN 5,000 to 10,000;
p.002007: repeated infringement shall be revoked the issued authorization for retail trade.
p.002007: (2) In the cases of para. 1, the state control bodies shall stop the operation of the site with an order.
p.002007: Art. 289. (1) (Previous text of Art. 289 - SG, iss. 60 in 2012, in force since 07.08.2012, amended - SG, iss. 102 in 2018)
p.002007: who sells medicinal products at no established or registered price or at
p.002007: prices, other than those established by the order of this law, shall be punished with a fine from 1500 to 3000 levs, and in case of repeated
p.002007: committing the same offense - with a fine from 2500 to 4000 BGN.
p.002007: (2) (New - SG, iss. 60 in 2012, in force since 07.08.2012, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: Holder of a marketing authorization that fails to fulfill an obligation specified in the ordinance under Art. 261a,
p.002007: para. 5, shall be punished by a pecuniary sanction from 5000 to 10 000 levs, and in the case of repeated commission of the same
p.002007: violation - with a property sanction from BGN 10,000 to BGN 20,000
p.002007: (3) (New, SG No. 102/2012, effective 21.12.2012, repealed - SG No. 102/2018, effective 01/01/2019)
p.002007: Art. 289a. (New, SG No. 60/2011, effective 05.08.2011) (1) (Amended, SG No. 102/2012, effective from
p.002007: 21.12.2012, amend. - SG, issue. 102 of 2018, effective January 1, 2019) Who works in violation of the approved
p.002007: pharmacotherapeutic guidelines or evaluates the outcome of therapy in deviation from
p.002007: the criteria under Art. 259, para. 1, item 4, shall be punished by a fine of from 1000 to 2000 levs, and in case of repeated commission of the same
p.002007: violation - with a fine from 2000 to 3000 BGN.
p.002007: (2) (amend. - SG 102/08, in force from 01.01.2019) The violations under para. 1 shall be established by acts,
p.002007: made up of officials designated by the Executive Director of the Executive Agency
p.002007: Medical Supervision, and penal orders are issued by the Executive Director of the Executive
p.002007: Medical Supervision Agency.
p.002007: Art. 290. (1) (amend. - SG 71/08, in force from 12.08.2008) Who advertises medicinal products which
p.002007: are not authorized for use under this law, shall be liable to a fine of BGN 10,000 to BGN 20,000.
p.002007: (2) (New, SG No. 71/2008, effective 12.08.2008) Who advertises a product by attributing it and / or
p.002007: directs to the properties related to the prevention, diagnosis or treatment of human diseases, punishable by
p.002007: fine from BGN 10,000 to BGN 20,000
p.002007: (3) (Renumbered from Paragraph (2), SG No. 71/2008, effective 12.08.2008) Who advertises medicinal products in
p.002007: violation of this law, shall be punished by a fine of BGN 10,000 to BGN 20,000.
p.002007: (4) (Renumbered from Paragraph (3), Amended, SG No. 71/2008, effective 12.08.2008). 1 - 3 is also imposed on
p.002007: the persons who allowed the broadcast, publication and distribution of the advertisement.
p.002007: Art. 290a. (New, SG No. 71/2008, effective 12.08.2008) Medical specialist or person presenting
p.002007: is a healthcare professional who directly or indirectly advertises medicinal products in
p.002007: the printed and / or electronic media, as well as on the Internet, are fined from 1000 to 5000 BGN,
p.002007: repeated violation - from 3,000 to 10,000 BGN
p.002007: Art. 290b. (New, SG No. 60/2011, effective 05.08.2011) Who makes a donation of medicinal products
p.002007: in violation of Art. 268a, para. 1, shall be punished by a fine of from 1000 to 3000 levs, and in case of repeated performance of the same
p.002007: violation - with a fine from 3000 to 5000 BGN.
p.002007: Art. 290c. (New - SG 102/2012, in force since 21.12.2012) The holder of a marketing authorization which
p.002007: conducts non-interventional studies in violation of this law, is punished by a property sanction of
p.002007: BGN 5,000 to 10,000, and in the case of repeated infringement - with a property sanction of 10,000 to 20
p.002007: BGN 000
p.002007: Art. 290g. (New, SG No. 102/2012, effective 21.12.2012) Holder of a marketing authorization which does not
p.002007: fulfills the conditions of art. 55a, 56a and 56b shall be punishable by a pecuniary sanction of from BGN 5,000 to BGN 10,000, and for
p.002007: re-committing the same offense - with a property sanction of BGN 10,000 to BGN 20,000.
p.002007: Art. 290d. (New - SG 102/2012, in force since 21.12.2012) The holder of a marketing authorization which
p.002007: does not fulfill the obligations under Art. 190 - 192, 194b, 194c, 194h and 194i, shall be punished by a pecuniary sanction of
p.002007: BGN 5,000 to 10,000, and in the case of repeated infringement - with a property sanction of 10,000 to 20
p.002007: BGN 000
p.002007: Art. 290s. (New, SG No. 102/2012, effective 21.12.2012) Holder of a marketing authorization that does not
p.002007: fulfills the obligations under Art. 193 and 194, shall be punished by a pecuniary sanction from 2000 to 5000 levs, and at
p.002007: re-committing the same offense - with a property sanction from 5000 to 10 000 BGN.
p.002007: Art. 291. (1) (Supplemented, SG No. 60/2011, effective 05.08.2011, Supplemented, SG No. 60/2012, effective 07.08.2012
p.002007: , amended - SG, issue. 102 of 2012, in force since 21.12.2012, suppl. - SG, issue. 84 of 2018, effective 12.10.2018) Where
p.002007: the violations under Art. 281 - 284a, Art. 284g - 284z, 285, 285b, art. 286, para. 1, Art. 287 and 287b, Art. 289, para. 1, Art. 289a,
p.002007: Art. 290, Art. 290b, Art. 292 and Art. 294 are made by legal persons or sole traders, are imposed
p.002007: property penalties of not less than three times the estimated minimum size of
p.002007: the respective fines and not exceeding the triple the size of the respective maximum amounts of the respective fines
p.002007: fines.
p.002007: (2) (suppl. - SG 60/2012, in force from 07.08.2012) For violations of post. 289, para. 1 the property sanction
p.002007: shall be in nine-fold amount of the excess amount if it exceeds the maximum amount of the sanction under para. 1.
p.002007: (3) The imposition of a pecuniary sanction shall not preclude the imposition of a fine on the guilty officials.
p.002007: (4) The imposition of pecuniary sanctions does not preclude the imposition of measures provided for
p.002007: legal capacity of medical specialists and qualified persons.
p.002007: Art. 292. (1) Who does not comply with the order, prescription or instruction of the state control bodies under Art
p.002007: this law, except in cases under Art. 270, para. 1, item 2 and para. 3, shall be punished by a fine from 1500 to 3000 levs.
p.002007: (2) For failure to comply with an order under Art. 270, para. 1, item 2 and para. 3 guilty persons are liable to a fine of 500
p.002007: up to 1000 BGN
p.002007: Art. 293. (1) (amend. - SG 102/02, in force from 02.01.2013, amended - SG, issue 84 of 2018)
p.002007: 12.10.2018) Failure to comply with the conditions under which the permits / certificates for
p.002007: manufacture, import, parallel import, wholesale and retail of medicines in a pharmacy,
p.002007: as well as in the cases under Art. 281, para. 1 - 3, Art. 283, para. 1, Art. 284c, para. 2 and Art. 287, para. 2 the Executive Director
p.002007: The BDA issues an order for their withdrawal.
p.002007: (2) (Am. - SG, iss. 102 in 2012, in force since 02.01.2013, amended - SG, iss. 84 of 2018, in force since 12.10.2018).
p.002007: non-compliance with the conditions under which a drugstore registration certificate was issued, as well as in cases
p.002007: under Art. 287, para. 4, the director of the respective RIC issues an order for revocation of the certificate.
p.002007: (3) In case of non-fulfillment of the obligation for notification under Art. 204, para. 3 for termination of activity by
...
p.002007: the extent to which the active substance or the therapeutically significant portion of the investigational medicinal product is tested
p.002007: reach from the dosage form into the systemic circulation.
p.002007: 20. (amend. - SG 84/2018) (*) "Tested medicinal product" is a tested medicinal product within the meaning of
p.002007: of Art. 2 (2) (5) of Regulation (EU) No 536/2014.
p.002007: 21. (Amended, SG No. 84/2018) (*) "Researcher" shall be a researcher within the meaning of Art. 2 (2) (15)
p.002007: Regulation (EU) No 536/2014.
p.002007: 22. (amended, SG No. 84/2018) (*) "Informed consent" is informed consent within the meaning of Art. 2,
p.002007: paragraph 2, point 21 of Regulation (EU) No 536/2014.
p.002007: 23. "Kit" means any substance which is usually dissolved, suspended, diluted or diluted before use
p.002007: combines with radionuclides, resulting in the finished radioactive medicinal product.
p.002007: 24. (amended, SG No. 84/2018) (*) "Clinical trial of a medicinal product" is a clinical trial of
p.002007: the meaning of Art. 2 (2) (2) of Regulation (EU) No 536/2014.
p.002007: 25. "Clinical advantage" is a significant therapeutic or diagnostic benefit of a drug
p.002007: product compared to a medicinal product that has already been authorized.
p.002007: 25a. (new, SG No. 84/2018, effective 12.10.2018) Conflict
p.002007: "interests" is a conflict of interests under
p.002007: within the meaning of Chapter Eight, Section I of the Anti-Corruption and Removal of Illegal Act
p.002007: the property acquired.
p.002007: 26. (Repealed, SG No. 84/2018)
p.002007: 27. "Patient leaflet" is a leaflet containing user information to accompany
p.002007: the medicinal product.
p.002007: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002007: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No
p.002007: Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on medicinal products for
p.002007: advanced therapy and amending Directive 2001/83 / EC and Regulation (EC) No 726/2004.
p.002007: 27b. (new - SG 84 2018, in force from 12.10.2018) Medicinal
p.002007: "product for compassionate use" is
p.002007: medicinal product for palliative use within the meaning of Art. 83 (2) of Regulation (EC) No 726/2004
p.002007: of the European Parliament and of the Council.
p.002007: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product manufactured
p.002007: from human blood components and by a method involving an industrial process. These include albumin,
p.002007: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, other plasma
p.002007: fractions or combinations thereof.
p.002007: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare diseases" is
p.002007: a product that:
p.002007: (a) is intended for the diagnosis, prophylaxis or treatment of life - threatening diseases; or
p.002007: progressively chronic diseases affecting no more than 5 in 10,000 people in the territory
p.002007: on the side, or
p.002007: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002007: chronic health conditions (diseases with a high rate of disease - related illnesses)
...
p.002007: medicinal products, except in the case of the supply of medicinal products directly to
p.002007: the population.
p.002007: 78. (Amended, SG No. 84/2018) (*) "Participant" shall be a participant within the meaning of Art. 2 (2) (17)
p.002007: Regulation (EU) No 536/2014.
p.002007: 79. (Repealed, SG No. 84/2018)
p.002007: 80. "Pharmacopoeia" is a collection of approved specifications and related production requirements,
p.002007: testing, storage and labeling of active substances, excipients, dosage forms,
p.002007: materials for packaging and components of the medicinal product.
p.002007: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product prepared in a pharmacy by a formulation
p.002007: operating pharmacopoeia and intended for delivery to patients at the same pharmacy.
p.002007: 81a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: "Counterfeit medicinal product" means any medicinal product in which it is misrepresented:
p.002007: (a) its identity, including particulars of the immediate packaging or its immediate packaging, its name or
p.002007: content with respect to any of its constituents, including excipients, and
p.002007: the amount of active substance per unit dose;
p.002007: (b) its source, including its manufacturer, the country in which it is manufactured, the country in which it is produced
p.002007: placed on the market, or the holder of his marketing authorization, or
p.002007: (c) the timing, including records and documents, of the supply chain used.
p.002007: It is not considered to be a counterfeit medicinal product with inadvertent tolerance in
p.002007: quality as well as a medicinal product placed on the market in violation of intellectual property rights
p.002007: property.
p.002007: 82. "Homeopathic medicinal product" is a medicinal product made from substances called homeopathic
p.002007: source, according to the European Pharmacopoeia manufacturing procedures, and in the absence thereof -
p.002007: according to the national pharmacopoeia of a Member State.
p.002007: 83. "Price calculated on the basis of a benchmark" is the price established for each medicinal product,
p.002007: included in the Positive Medicinal List calculated on the basis of the established reference value for
p.002007: defined daily dose or therapeutic course.
p.002007: 84. (Repealed, SG No. 84/2018)
p.002007: 85. "Misuse of medicinal products" is a persistent or occasional intentional overuse of
p.002007: medicinal products accompanied by harmful physical or psychological effects.
p.002007: 86. (new - SG 41/09, in force from 02.06.2009)
p.002007: "are children under 12 months of age.
p.002007: 87. (new - SG 41/09, in force from 02.06.2009) Food
p.002007: "infant formulas" means foods intended for infants
p.002007: specific nutritional use of infants during their first months, which alone are sufficient
p.002007: satisfy the nutritional needs of these infants until the introduction of a suitable supplement
p.002007: food.
p.002007: 88. (new - SG 41/09, in force from 02.06.2009) Transitional
p.002007: "food" means food intended for
p.002007: specific nutritional use of infants in the introduction of appropriate supplemental food and which
p.002007: are the staple liquid food from the progressively increasing variety of foods in these
p.002007: infants.
p.002007: 89. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "Type IA" is a change with minimal impact
...
p.002011: regulations of the Ministry of Health in accordance with this law.
p.002011: ...................................
p.002011: § 84. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of § 65, which
p.002011: shall enter into force on 30 September 2011.
p.002011: Transitional and Final Provisions
p.002011: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002011: DRUGS AND PRECURSORS
p.002011: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002011: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002011: Transitional and Final Provisions
p.002011: TO THE LAW AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.002011: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002011: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in the State Gazette:
p.002011: 1. The Council of Ministers shall bring the Classifier of posts in administration in line with that
p.002011: law;
p.002011: 2. the competent authorities shall bring the statutory acts of the respective administration in accordance with
p.002011: this law.
p.002011: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002011: the Independent Financial Audit Act, the Electronic Communications Act, the Financial Supervision Commission Act,
p.002011: Law on Access and Disclosure of Documents and Declaration of Affiliation of Bulgarian Citizens to
p.002011: State Security and Intelligence Services of the Bulgarian People's Army, Forfeiture Act
p.002011: of the State of property acquired through criminal activity, the Prevention and Establishment Act
p.002011: conflict of interest, Social Security Code, Health Insurance Act,
p.002011: support to farmers and the Roads Act are governed by the terms and procedures of §
p.002011: 36 of the transitional and final provisions of the Act amending the State Act
p.002011: employee (SG, issue 24 of 2006).
p.002011: (2) The act of appointment of the civil servant shall:
p.002011: 1. assigns a minimum rank for the position assigned to the posts in the administration in the administration
p.002011: post, unless the employee holds a higher rank;
p.002011: 2. determines the individual basic monthly salary.
p.002011: (3) The additional necessary funds for social security contributions of the persons under para. 2 shall be provided within
p.002011: the cost of wages, salaries and social security contributions to the budgets of the authorizing officers concerned
p.002011: with appropriations.
p.002011: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account of the State Fund
p.002011: "Agriculture" arising from this law.
p.002011: (5) The governing bodies of the National Social Security Institute and the National Health Insurance Fund
p.002011: to make necessary changes to the respective budgets arising from this law.
p.002011: (6) Unused employment leave shall be maintained and shall not be offset by cash benefits.
p.002011: benefits.
p.002011: § 86. (1) Within one month from the entry into force of this Act, the individual basic monthly salary of
p.002011: the employee shall be determined in such a way that the same is reduced by the tax due and the mandatory social security contributions
p.002011: at the expense of the insured person, if they were due, should not be lower than the gross received so far
...
Social / Soldier
Searching for indicator army:
(return to top)
p.002011: 2. The Council of Ministers shall adopt the ordinance under Art. 258, para. 5 and amend the tariff under Art. 21, para. 2 and Device
p.002011: regulations of the Ministry of Health in accordance with this law.
p.002011: ...................................
p.002011: § 84. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of § 65, which
p.002011: shall enter into force on 30 September 2011.
p.002011: Transitional and Final Provisions
p.002011: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002011: DRUGS AND PRECURSORS
p.002011: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002011: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002011: Transitional and Final Provisions
p.002011: TO THE LAW AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.002011: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002011: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in the State Gazette:
p.002011: 1. The Council of Ministers shall bring the Classifier of posts in administration in line with that
p.002011: law;
p.002011: 2. the competent authorities shall bring the statutory acts of the respective administration in accordance with
p.002011: this law.
p.002011: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002011: the Independent Financial Audit Act, the Electronic Communications Act, the Financial Supervision Commission Act,
p.002011: Law on Access and Disclosure of Documents and Declaration of Affiliation of Bulgarian Citizens to
p.002011: State Security and Intelligence Services of the Bulgarian People's Army, Forfeiture Act
p.002011: of the State of property acquired through criminal activity, the Prevention and Establishment Act
p.002011: conflict of interest, Social Security Code, Health Insurance Act,
p.002011: support to farmers and the Roads Act are governed by the terms and procedures of §
p.002011: 36 of the transitional and final provisions of the Act amending the State Act
p.002011: employee (SG, issue 24 of 2006).
p.002011: (2) The act of appointment of the civil servant shall:
p.002011: 1. assigns a minimum rank for the position assigned to the posts in the administration in the administration
p.002011: post, unless the employee holds a higher rank;
p.002011: 2. determines the individual basic monthly salary.
p.002011: (3) The additional necessary funds for social security contributions of the persons under para. 2 shall be provided within
p.002011: the cost of wages, salaries and social security contributions to the budgets of the authorizing officers concerned
p.002011: with appropriations.
p.002011: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account of the State Fund
p.002011: "Agriculture" arising from this law.
p.002011: (5) The governing bodies of the National Social Security Institute and the National Health Insurance Fund
p.002011: to make necessary changes to the respective budgets arising from this law.
p.002011: (6) Unused employment leave shall be maintained and shall not be offset by cash benefits.
p.002011: benefits.
p.002011: § 86. (1) Within one month from the entry into force of this Act, the individual basic monthly salary of
p.002011: the employee shall be determined in such a way that the same is reduced by the tax due and the mandatory social security contributions
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.002007: Chapter Two.
p.002007: MANAGEMENT AND FINANCING BODIES
p.002007: Section I.
p.002007: Authorities
p.002007: Art. 14. (1) Medicinal policy is a part of the state health policy in the Republic of Bulgaria and is
p.002007: carried out by the Minister of Health.
p.002007: (2) The Minister of Health shall:
p.002007: 1. is a national coordinator for the problems of medicinal products;
p.002007: 2. participate in international bodies and organizations performing activities in the field of pharmaceuticals
p.002007: products;
p.002007: 3. (repealed, SG No. 60/2011, effective 05.08.2011, new - SG No. 102/2012, effective 21.12.2012)
p.002007: organizes the provision of public information to patients' organizations and organizations
p.002007: consumers about actions taken against counterfeiting of medicinal products;
p.002007: 4. performs other activities specified by law.
p.002007: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: Art. 15. (1) A Pharmacopoeial Committee shall be established with the Minister of Health as an advisory body on
p.002007: the issues of the current pharmacopoeia.
p.002007: (2) On the proposal of the BDA Executive Director, the Minister of Health shall designate with
p.002007: order of the composition of the Pharmacopoeia Committee and of the expert groups attached thereto, and approves the regulations for
p.002007: their activity.
p.002007: (3) The activities of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
p.002007: Art. 16. (1) (Supplemented, SG No. 91/2018) A Supreme Council shall be established at the Minister of Health.
p.002007: pharmacy, which includes five representatives appointed by the Minister of Health, five
p.002007: representatives of the Bulgarian Pharmaceutical Union, one representative of the Bulgarian Association of Pharmaceuticals
p.002007: Assistant Pharmacists, two representatives of the National Health Insurance Fund (NHIF) and one each
p.002007: representative of the faculties of pharmacy at medical colleges. The Minister of
p.002007: healthcare is chairman of the non-voting council.
p.002007: (2) The High Pharmacy Council is an advisory body that deliberates and gives opinions on:
p.002007: 1. the main directions and priorities in the field of pharmacy;
p.002007: 2. ethical problems of pharmacy;
p.002007: 3. draft legislative acts related to pharmacy;
p.002007: 4. scientific priorities in the field of pharmacy;
p.002007: 5. programs for organizing public educational campaigns in the field of medicinal products.
p.002007: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: (4) The organization and activities of the Supreme Pharmacy Council shall be governed by regulations issued by the Minister.
p.002007: of Health at the proposal of the High Pharmacy Council.
p.002007: Art. 17. (1) The Executive Agency for Medicines shall be a specialized body to the Minister of Health
p.002007: healthcare to oversee the quality, safety and efficacy of medicines.
p.002007: (2) (Amended, SG No. 15/2013, effective 01/01/2014) The Executive Agency for Medicines shall be legally
p.002007: budget support person based in Sofia to the Minister of Health.
p.002007: (3) The Executive Agency for Medicines shall be managed and represented by an Executive Director, who shall
p.002007: appoint by the order of the Law on Administration.
p.002007: (4) The structure, functions and organization of work of the BDA shall be laid down in the Rules of Procedure adopted by
p.002007: The Council of Ministers.
p.002007: (5) The Medicines Executive Agency shall:
p.002007: 1. issues authorizations for the manufacture of medicinal products;
...
p.002007: country;
p.002007: 18a. (new - SG 102/2012, in force since 21.12.2012) participate in the international harmonization and
p.002007: standardization of technical measures regarding pharmacovigilance monitoring, sub
p.002007: the coordination of the European Medicines Agency;
p.002007: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain a national Internet portal for
p.002007: medical products;
p.002007: 19. performs other activities specified by law.
p.002007: (6) (amend. - SG 98/10, in force from 01.01.2011) The Executive Agency for Medicines shall coordinate
p.002007: its activities with the Regional Health Inspectorates (RICs) in the field of drug control.
p.002007: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under this Act related to
p.002007: preventing the entry and distribution of counterfeit medicinal products,
p.002007: carries out in cooperation between the BDA and the customs authorities.
p.002007: (8) (New, SG No. 84/2018, effective 12.10.2018) The Executive Agency for Medicines may
p.002007: carries out joint checks with the National Revenue Agency, the Customs Agency, the National Revenue Agency
p.002007: Health Insurance Fund, the Ministry of Health and the National Board of Prices and
p.002007: reimbursement of medicinal products in the exercise of their control functions
p.002007: on medicinal products.
p.002007: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health Inspectorates shall issue
p.002007: drugstore registration certificates.
p.002007: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002007: retail of medicinal products, which includes three representatives of the Bulgarian
p.002007: pharmaceutical union, one representative of the faculties of pharmacy at medical colleges
p.002007: and four BDA representatives. The composition of the Board shall be determined by order of the Executive Director
p.002007: of the BDA, coordinated with the Minister of Health.
p.002007: (2) The council under para. 1 is an advisory unit which:
p.002007: 1. prepares opinions on applications and documents submitted to the BDA. 228, para. 1 and 5, which he presents to
p.002007: the Executive Director of the BDA;
p.002007: 2. make motivated proposals to the Minister of Health through the BDA Executive Director for
p.002007: improving public access to medicines.
p.002007: (3) The organization and activity of the expert council under para. 1 shall be governed by a regulation issued by
p.002007: the Executive Director of the BDA at the proposal of the Board.
p.002007: (4) The members of the expert council under para. 1 shall not receive remuneration for attending council meetings.
p.002007: (5) The expert council under para. 1 shall be reported annually to the Minister of Health.
p.002007: Art. 17c. (New, SG No. 18/2014) May not be members of the expert council. 17b, para. 1 person,
p.002007: which:
p.002007: 1. owners, members of management and controlling bodies of commercial companies or sole traders with
p.002007: subject of activity manufacture, import, wholesale or retail of medicinal products;
p.002007: 2. partners or shareholders holding more than 5 per cent of the capital of commercial companies with the object of
p.002007: activity manufacturing, importing, wholesaling or retailing of medicinal products or working in labor
p.002007: contract in these companies.
p.002007: Section II.
p.002007: Registers
p.002007: Art. 18. (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: Art. 19. (1) The Executive Agency for Medicines shall keep and keep registers of:
...
p.002007: Art. 79. (1) Where the regulatory authorities of one or more Member States have adopted different decisions
p.002007: with regard to the marketing authorization or the same medicinal product
p.002007: suspending or withdrawing it, the BDA referred the matter to the Committee for Medicinal Products for
p.002007: human use by the European Medicines Agency for arbitration.
p.002007: The applicant or the holder of the Marketing Authorization may refer the matter to the Committee
p.002007: medicinal products for human use by the European Medicines Agency for the administration of
p.002007: arbitration at its discretion.
p.002007: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002007: (3) (amend. - SG 102/2012, in force from 21.12.2012) In the cases of para. 1 BDA or the applicant / holder
p.002007: of the Marketing Authorization is granted to the European Medicines Agency
p.002007: all available information on the relevant matter.
p.002007: (4) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: (5) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: Art. 79a. (New, SG No. 60/2011, effective 05.08.2011) (1) Subject to the decision of the European
p.002007: Commission after the completion of the BDA arbitration procedure within 30 days of receipt of the notification:
p.002007: 1. issues, suspends or suspends a marketing authorization, or
p.002007: 2. Requests that changes be made to the permit issued to comply with the decision of
p.002007: The European Commission.
p.002007: (2) The Medicines Executive Agency shall notify the European Commission and the European Medicines Agency
p.002007: the medicines for the issued act under para. 1.
p.002007: Art. 79b. (New, SG No. 102/2012, effective 21.12.2012) (1) In cases where the interests of
p.002007: The European Union and before deciding on the authorization of a medicinal product
p.002007: product, its suspension, termination or change, BDA, applicant or
p.002007: the holder of the marketing authorization may refer the matter to the committee referred to in Art. 79, para. 1 for implementation
p.002007: to arbitration.
p.002007: (2) In the cases of para. 1 where referral is the result of an evaluation of tracking data
p.002007: the safety of an authorized medicinal product, the matter is referred to the
p.002007: Art. 56a, para. 1, item 1 and the procedure of art. 194h or 194h.
p.002007: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall apply the procedure Chapter Eight,
p.002007: Section IV, when it is necessary to implement one of the measures referred to in Art. 194y, para. 2 and 3.
p.002007: (4) (New, SG No. 18/2014) Notwithstanding para. 1 - 3, when emergency action is needed to protect
p.002007: public health at some stage of the arbitration procedure, the BDA may suspend the action of
p.002007: the marketing authorization and prohibit the use of the relevant medicinal product within the territory of
p.002007: The Republic of Bulgaria pending the adoption of the final decision.
p.002007: (5) (New, SG No. 18/2014) In the cases of para. 4 The BDA informs the European Commission, the European Commission
p.002007: the Medicines Agency and the other Member States for the reasons for their decision no later than the next
p.002007: working day.
p.002007: Art. 80. (amend. - SG 12/11, in force from 08.02.2011) The conditions and the procedure for making changes in
p.002007: the authorizations granted under this section shall be governed by Regulation (EC) No 1234/2008 of the European Commission
p.002007: 24 November 2008 on the examination of changes in the conditions of marketing authorizations for
p.002007: medicinal products for human use and veterinary medicinal products (OJ, L 334/7 of 12 December
p.002007: 2008).
p.002007: Chapter Four.
p.002007: CLINICAL TESTS
p.002007: Section I.
p.002007: general provisions
p.002007: Art. 81. (Amended, SG No. 84/2018) (1) (1) A clinical trial on the territory of the Republic of Bulgaria may
p.002007: shall be held after obtaining a permit issued under the terms and conditions of Regulation (EU) No
p.002007: 536/2014 of the European Parliament and of the Council of 16 April 2014 on the clinical trials of
p.002007: medicinal products for human use and repealing Directive 2001/20 / EC (OJ L 158/1 of 27 May 2014
p.002007: d.), hereinafter referred to as "Regulation (EU) No 536/2014", and this Act.
p.002007: (2) The Executive Agency for Medicinal Products shall carry out the activities of reporting, respectively affected
p.002007: country and additionally affected country within the meaning of Regulation (EU) No 536/2014, and is national
p.002007: contact point of art. 83 of Regulation (EU) No 536/2014.
p.002007: Art. 82. (Amended, SG No. 84/2018) (1) (1) For issuing a permit for conducting a clinical trial and
p.002007: for granting authorization for a substantial change to an authorized clinical trial, the sponsor shall submit
p.002007: application and dossier pursuant to Chapter IV of Regulation (EU) No 536/2014 through the European Union (EU) Portal on
p.002007: Art. 80 of Regulation (EU) No 536/2014.
p.002007: (2) To submit an application under para. 1 and for evaluation of the documentation attached to it, the assignor
p.002007: shall pay a fee in the amount determined by the tariff under Art. 21, para. 2.
p.002007: Art. 83. (Amended, SG No. 84/2018) (*) The Commission under Art. 103, para. 1 assesses the ethical aspects of
p.002007: the clinical trial and the substantial modification of the clinical trial under the terms and conditions of
p.002007: Regulation (EU) No 536/2014 and prepares a reasoned opinion which it submits to the BDA.
p.002007: Art. 84. (Amended, SG No. 84/2018) (1) (1) The Executive Agency for Medicines shall issue a permit for
p.002007: clinical trial, authorization of clinical trial under certain conditions, authorization of substantial
p.002007: change of clinical trial, permission to substantially change clinical trial in certain
p.002007: conditions or refuses authorization under the terms and conditions of Regulation (EU) No 536/2014.
p.002007: (2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002007: Art. 85. (Amended, SG No. 84/2018) (*) By an ordinance of the Minister of Health shall determine:
p.002007: 1. the conditions and procedure for submission of data and information by the BDA and the Ethical Commission for Clinical
p.002007: tests in the EU Portal under Art. 80 of Regulation (EU) No 536/2014;
p.002007: 2. the access of the BDA and the Ethical Committee for Clinical Trials to the EU Database. 81 of
p.002007: Regulation (EU) No 536/2014;
p.002007: 3. the terms and procedure for submitting the opinions by post. 83 and the order of interaction between the BDA and
...
p.002007: (2) (New, SG No. 84/2018, effective 12.10.2018) Clinical trial of medicinal products,
p.002007: containing narcotic substances can only be carried out in hospitals,
p.002007: mental health centers, centers for skin and venereal diseases and complex oncology
p.002007: centers, in the structure of which a pharmacy, licensed under Art. 33, para. 1 of the Law on
p.002007: control of narcotic drugs and precursors, or who have contracted with another drug
p.002007: an establishment in the structure of which a pharmacy has been opened, holding a license under Art. 33, para. 1 of the Law
p.002007: for drug and precursor control.
p.002007: (3) (Renumbered from Paragraph (2), amend. - SG 84/08, in force from 12.10.2018) Clinical trial may be
p.002007: conducts only in a medical establishment in which there is a designated contact person under Art. 107a, para. 1.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 84/2018, effective 12.10.2018)
p.002007: the clinical trial of a medicinal product will be agreed to the participation of the principal
p.002007: researcher and for conducting the test.
p.002007: Art. 88. (1) Clinical trial on humans shall be performed with:
p.002007: 1. medicinal products not authorized for use in the Republic of Bulgaria;
p.002007: 2. medicinal products authorized for use in the Republic of Bulgaria when tested for unauthorized use
p.002007: indication for a dosage form other than the authorized one in a group of patients not previously studied or
p.002007: for more information.
p.002007: (2) Authorized for use in the Republic of Bulgaria within the meaning of para. 1, item 2 are medicinal products received
p.002007: authorization for use under this Act or under Regulation (EC) No 726/2004 of the European Union
p.002007: Parliament and Council.
p.002007: Art. 89. (Repealed, SG No. 84/2018)
p.002007: Art. 90. (Repealed, SG No. 84/2018) (Amended, SG No. 17/2019)
p.002007: Art. 91. The contracting authority and the principal investigator take out insurance covering their liability for
p.002007: non-material and property damage caused during or in the course of the clinical trial
p.002007: of the participants.
p.002007: Art. 92. (1) (Amended, SG No. 84/2018) (*) The contracting authority shall be liable in case of health damage.
p.002007: or death caused during or on the occasion of the clinical trial when the trial is
p.002007: carried out in accordance with the requirements and procedures of the approved protocol.
p.002007: (2) (Amended, SG No. 84/2018) (*) The Principal Investigator shall be liable in the event of damage to
p.002007: health or death caused during or in connection with the conduct of a clinical trial when not
p.002007: the requirements and procedures of the approved protocol are complied with.
p.002007: Art. 93. (Am. - SG, iss. 84 in 2018. (*)) (1) When the clinical trial is conducted only in the territory of
p.002007: The Republic of Bulgaria or on the territory of the Republic of Bulgaria and on the territory of a third country,
p.002007: the contracting authority appoints a representative on the territory of the Republic of Bulgaria for the specific clinical
p.002007: testing.
p.002007: (2) The person under para. 1 is the addressee of the communication with the contracting authority provided for in Regulation (EU) No 536/2014.
...
p.002007: the majority of the Member States are referred to the European Commission, which decides on
p.002007: modification, suspension or revocation of the marketing authorization granted by the relevant regulatory authority
p.002007: Member State authorities.
p.002007: (7) The decision under para. 6 is published on the European Medicines Portal. 68, para.
p.002007: 1, item 4 and shall be sent to the holder of the marketing authorization.
p.002007: (8) The Executive Agency for Medicinal Products applies the provisional and / or definitive measures of the Decision on Medicinal Products
p.002007: para. 6 and inform the European Medicines Agency and the European Commission.
p.002007: (9) In the cases of para. 1, item 1 The Committee for Medicinal Products for Human Use, in accordance with
p.002007: the recommendation of the committee under art. 56a, para. 1, item 1 issues an opinion on the retention, amendment,
p.002007: suspension or termination of the marketing authorization, including a timetable for
p.002007: implementation of the opinion. The opinion shall be published on the European Medicines Portal
p.002007: products of art. 68, para. 1, item 4 and shall be sent to the holder of the marketing authorization.
p.002007: (10) Where in the opinion under para. 9 is a position for regulatory action under
p.002007: as regards marketing authorizations, the European Commission shall decide to amend, suspend or
p.002007: suspension of the marketing authorizations granted under Regulation (EC) No 726/2004 of the European Union
p.002007: Parliament and the Council.
p.002007: Art. 145k. (New, SG No. 102/2012, effective 21.12.2012) (1) (Amended, SG No. 84/2018)
p.002007: 12.10.2018) Non-interventional studies in the territory of the Republic of Bulgaria are conducted at
p.002007: conditions and in the order determined by an ordinance of the Minister of Health.
p.002007: (2) When conducting non-interventional studies under para. 1 indicates the source of funding.
p.002007: Chapter Five.
p.002007: MANUFACTURE AND IMPORTATION OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES (TITLE I).
p.002007: AMENDED. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002007: Section I.
p.002007: Production
p.002007: Art. 146. (1) (amend. - SG 102/02, in force from 02.01.2013) The production of all kinds of medicinal
p.002007: products within the meaning of this Act and of medicinal products intended for clinical trial may
p.002007: to carry out on the territory of the Republic of Bulgaria only natural or legal persons registered
p.002007: as traders in the territory of a Member State who have been granted a manufacturing authorization granted by
p.002007: the Director of the Executive Agency for Medicines.
p.002007: (2) A production permit shall also be required in the cases where the products under para. 1 are intended for
p.002007: wear.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) Production permit is also required for persons,
p.002007: who simultaneously or individually perform one of the following activities: full or partial production,
p.002007: various processes of packaging, packaging, repackaging, labeling, quality control and
p.002007: release of batches of medicinal products and medicinal products intended for clinical use
p.002007: testing.
p.002007: (4) (Repealed, SG No. 71/2008, effective 12.08.2008)
p.002007: (5) No manufacturing authorization is required when the processes of packaging, mixing or packaging are carried out
p.002007: they carry out a prescription or pharmacopoeial prescription at a pharmacy.
p.002007: Art. 147. (amend. - SG 102/2012, in force from 02.01.2013) The Executive Agency for Medicines shall introduce
p.002007: information on marketing authorizations for medicinal products and certificates of Good
p.002007: manufacturing practice in the European Union database.
p.002007: Art. 148. To obtain a manufacturing authorization, the person mailed. 146 must have:
p.002007: 1. with personnel with appropriate qualification, depending on the specificity of the species produced
p.002007: medicines and dosage forms;
p.002007: 2. at any time with at least one qualified person eligible for post. 159;
p.002007: 3. premises for production, control and storage of the medicinal products, provided with the necessary
p.002007: technical equipment and control laboratories.
p.002007: Art. 149. Heads of production and quality control of medicinal products in
p.002007: manufacturing enterprises are persons:
p.002007: 1. who have a master's degree in pharmacy, chemistry
p.002007: or "biology" and at least two years of practical experience in pharmaceutical manufacturing;
p.002007: 2. which meet the requirements of item 1 and have an additional recognized specialty in radiobiology or
p.002007: radiochemistry - for radiopharmaceuticals or for medicinal products subject to ionizing radiation;
p.002007: 3. with recognized specialty in clinical hematology, medical microbiology, virology or immunology
p.002007: - for the production of immunological medicinal products - vaccines, toxins, serums, for biotechnological products
p.002007: products and for medicinal products derived from human plasma or from human blood.
p.002007: Art. 150. (1) The person under art. 146 shall submit to the BDA an application in accordance with a model approved by the Director of the Agency.
p.002007: (2) Together with the application under para. 1 the applicant shall also submit:
p.002007: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002007: specialty, work record, criminal record or similar person document, if not
p.002007: is a Bulgarian citizen, and an employment contract for the persons under Art. 148, item 2 and art. 149;
p.002007: 2. copies of contracts for the assignment of production and / or control of the products declared for production - in
p.002007: the cases under Art. 151;
p.002007: 3. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
p.002007: for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
p.002007: registered in a Member State of the European Union, or in a State Party to the
p.002007: European Economic Area - a document for current national registration
p.002007: legislation issued by a competent authority of the country concerned;
p.002007: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: a list of the manufacturing activities and the dosage forms to be manufactured;
p.002007: 5. schemes of the premises for production, control and storage and file of the production capacity;
p.002007: 6. assessment of the environmental impact of the manufacture of medicinal products in accordance with the provisions of Art
p.002007: Environmental Protection Act cases;
p.002007: 7. permission from the Nuclear Regulatory Agency when the application concerns the production of
p.002007: radiopharmaceuticals or medicinal products subject to ionizing radiation during manufacture
p.002007: them;
p.002007: 8. permission to use the premises for production, control and storage, issued in accordance with the procedure of
p.002007: The Spatial Planning Act, or any other substitute document;
p.002007: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 10. a document for payment of a fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) In the manufacture of narcotic substances and dosage forms containing such substances,
p.002007: also comply with the requirements of the Narcotic Drugs and Precursors Control Act.
p.002007: (4) (New - SG 103 2017, in force from 01.01.2018) The Executive Agency for Medicines shall establish
...
p.002007: the appeal does not suspend enforcement.
p.002007: Section II.
p.002007: Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
p.002007: Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria
p.002007: from a third country of all types of medicinal products and medicinal products intended for
p.002007: clinical trial may only be performed by natural or legal persons registered as traders
p.002007: under the law of a Member State which has been granted an import authorization by the executive
p.002007: director of the BDA.
p.002007: (2) In order to obtain an import permit, the person under para. 1 must have:
p.002007: 1. (amend. - SG 102/2012, in force from 02.01.2013) at any time with at least one qualified person,
p.002007: which meets the requirements of Art. 159, para. 2 and 10;
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) with a laboratory for quality control in compliance
p.002007: with the requirements of the ordinance under Art. 152 and storage facilities for medicinal products, and
p.002007: clinical trial medicinal products with the necessary technical equipment, c
p.002007: compliance with the requirements of the ordinance under Art. 198.
p.002007: Art. 162. (1) For obtaining a permit for import the person shall mail. 161, para. 1 submits an application to the BDA on
p.002007: model approved by the Executive Director of the Agency.
p.002007: (2) To the application under para. 1 shall apply:
p.002007: 1. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
p.002007: for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
p.002007: registered in a Member State of the European Union, or in a State Party to the
p.002007: European Economic Area - a document for current national registration
p.002007: legislation issued by a competent authority of the country concerned;
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) list of the medicinal products and the forms which will
p.002007: are imported;
p.002007: 3. (suppl. - SG 71/08, in force from 12.08.2008) a copy of the production permit issued by
p.002007: the regulatory authority of the exporting country and a certificate attesting the eligibility of the exporting country
p.002007: production, control and storage with standards at least equivalent to Good standards
p.002007: manufacturing practice;
p.002007: 4. documents certifying the circumstances under Art. 159, para. 1 and 2 for the qualified person;
p.002007: 5. data on the address of a laboratory on the territory of the Republic of Bulgaria for completion of a complete
p.002007: quantitative and qualitative analysis of at least the active substances and of all other tests and tests for
p.002007: demonstration of the quality of each imported batch of medicinal product in accordance with the requirements of
p.002007: the marketing authorization under this law and the address of the storage premises;
p.002007: 6. a contract which defines the responsibilities of each party in respect of compliance with
p.002007: the principles of Good Manufacturing Practice by the contractor and the way in which the qualified person
p.002007: under Art. 161, para. 2, item 1 shall perform its duties when the person sends. 161, para. 1 does not have
p.002007: with its own laboratory;
...
p.002007: Art. 167g. (New - SG 102/2012, in force from 02.01.2013) (1) The Executive Agency for Medicines shall lead
p.002007: a public register of importers, manufacturers and wholesalers of active substances containing:
p.002007: 1. Name, registered office and address of management of the person mailed. 167a;
p.002007: 2. a list of the active substances that are imported, manufactured or marketed;
p.002007: 3. the activities that the person under art. 167a will perform;
p.002007: 4. address of the premises where the activities are carried out;
p.002007: 5. notes on the entered circumstances.
p.002007: (2) The Executive Agency for Medicines shall enter into the database under Art. 147 registered information
p.002007: importers, manufacturers and wholesalers of active substances.
p.002007: Art. 167d. (New, SG No. 102/2012, effective 02/01/2013) (1) 167a submits to the BDA annually by
p.002007: 31 January notification of changes in the information entered in the register under Art. 167g.
p.002007: (2) When changes occur that may affect the quality or safety of the active
p.002007: substances produced, imported or distributed, the person under Art. 167a shall notify the BDA immediately.
p.002007: Art. 167f. (1) (New, SG No. 102/2012, in force from 02.01.2013) Production, import and wholesale trade
p.002007: with active substances on the territory of the Republic of Bulgaria, including active substances intended for use
p.002007: for export, is carried out in accordance with Good Manufacturing Practice and Good Distribution Practices
p.002007: for active substances.
p.002007: (2) Importers may import active substances only if the following conditions are met:
p.002007: 1. the active substances have been manufactured in accordance with Good Manufacturing Practice standards,
p.002007: which are at least equivalent to those established by the European Union, and
p.002007: 2. (In force from 02.07.2013) The active substances shall be accompanied by a written confirmation from the competent person
p.002007: authority of the exporting country that:
p.002007: (a) Good manufacturing practice standards applicable to the exported production site
p.002007: active substances are at least equivalent to those established by the European Union;
p.002007: (b) the production site concerned is subject to regular control and is effectively implemented by the Good
p.002007: manufacturing practices, including repeated and unannounced inspections, to ensure the protection of
p.002007: public health at least equivalent to that of the European Union, and
p.002007: (c) in the event of non-compliance, the exporting country will immediately inform the BDA.
p.002007: (3) (In force from 02.07.2013) The requirement of para. 2, item 2 shall not apply if the exporting country is included in
p.002007: the list under Art. 111b of Directive 2001/83 / EC.
p.002007: Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
p.002007: ensure the availability of medicinal products, the importer may import the active substance without the written request
p.002007: confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
p.002007: manufacturing practice where the manufacturing site of the active substance in the exporting country was
p.002007: inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines for
p.002007: Good manufacturing practice.
p.002007: (2) In the cases of para. 1 The BDA shall notify the European Commission.
p.002007: Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of manufacturing authorizations,
p.002007: including those who perform the activities of art. 168b, para. 2 shall be considered as producers within the meaning of
p.002007: § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002007: caused by a defect in the goods provided for therein.
p.002007: Chapter Six.
p.002007: PACKAGING AND PACKAGE LEAFLET
p.002007: Art. 168. (1) The packaging of a medicinal product shall consist of a primary and / or secondary packaging and a leaflet for
p.002007: patient.
...
p.002007: (4) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products shall include
p.002007: a standard text asking patients to report to healthcare professionals or directly
p.002007: of the BDA any suspected adverse reaction according to the models of Art. 185, para. 2, Vol. 4.
p.002007: (5) When the medicinal product is authorized for use on the territory of the Republic of Bulgaria, on
p.002007: its secondary packaging is labeled for separate collection and recycling in accordance with the Law on
p.002007: waste management and implementing acts.
p.002007: (6) Where the medicinal product is authorized, its name shall be given on the outer carton,
p.002007: the dosage form and the content of the active substance in the dosage unit are also indicated with Braille
p.002007: alphabet.
p.002007: (7) The requirements of para. 6 shall not apply to vaccines and medicinal products in hospital packaging.
p.002007: (8) (New, SG No. 102/2012, in force since 21.12.2012) On the outer packaging, or, if there is none, on
p.002007: The primary packaging of medicinal products, with the exception of radiopharmaceuticals, shall include:
p.002007: 1. an individual identifier for safety features that enables traders
p.002007: wholesale and retail:
p.002007: (a) verify the authenticity of the medicinal product;
p.002007: (b) identify the individual packaging;
p.002007: 2. a means of checking whether the medicinal product has been tampered with.
p.002007: Art. 168a. (New, SG No. 102/2012, effective 21.12.2012) (1) On the packaging of a medicinal product,
p.002007: which is granted on medical prescription, safety indicators according to art. 168, para. 8, p
p.002007: except where the medicinal product is included in the list established by the European Union
p.002007: commission with delegated act under art. 168b.
p.002007: (2) The packaging of a medicinal product, which is available without a prescription, shall not be affixed
p.002007: safety indicators under art. 168, para. 8, except where the medicinal product is
p.002007: included in the list determined by the European Commission by a delegated act under art. 168b, after being judged to be
p.002007: at risk of counterfeiting.
p.002007: (3) The Medicines Executive Agency shall notify the European Commission of:
p.002007: 1. for medicinal products which are available without a prescription for which it has been established
p.002007: risk of counterfeiting;
p.002007: 2. for medicinal products for which it has been established that there is no risk of counterfeiting, taking into account
p.002007: the following criteria:
p.002007: (a) the price and sales volume of the medicinal product;
p.002007: (b) the number and incidence of cases of counterfeit medicinal products registered within the
p.002007: The European Union and in third countries, and a change in the number and frequency of such cases historically;
p.002007: (c) specific characteristics of the medicinal products concerned;
p.002007: (d) the severity of the disease to be treated;
p.002007: (e) other potential risks to public health.
p.002007: Art. 168b. (New, SG No. 102/2012, effective 21.12.2012) (1) The rules on indicators for
p.002007: safety under Art. 168, para. 8 shall be determined by the European Commission by means of delegated acts of Article 54a,
p.002007: paragraph 2 of Directive 2001/83 / EC.
p.002007: (2) The safety indicators shall not be eliminated or partially or completely closed, unless they are
p.002007: the following conditions are met:
p.002007: 1. the holder of the manufacturing authorization before partially or completely removing or closing it
p.002007: safety, checks that the medicinal product concerned is authentic and has not been
p.002007: forged;
p.002007: 2. the holder of a production permit in compliance with the requirements of Art. 168, para. 8 can replace
p.002007: safety indicators with their equivalent in terms of the ability to guarantee
p.002007: authentication, identification and provision of evidence of tampering with the medicinal product
p.002007: product.
p.002007: (3) Safety indicators shall be considered equivalent if:
p.002007: 1. satisfy the requirements laid down in the delegated acts referred to in Article 54a (2) of the Directive
p.002007: 2001/83 / EC, and
p.002007: 2. are equally effective in allowing authentication and identification of
p.002007: medicinal products and providing evidence of counterfeiting.
p.002007: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of the medicinal product and in
p.002007: compliance with Good Manufacturing Practice for Medicinal Products.
...
p.002007: notify immediately the holder of the marketing authorization or the BDA of any suspected serious
p.002007: adverse reaction and provide additional follow-up information upon request
p.002007: of the case.
p.002007: (2) Patients may report undesirable effects at any time on medical grounds
p.002007: specialists or the BDA.
p.002007: (3) In the cases of para. 1 and 2, where the communication concerns a biological medicinal product prescribed,
p.002007: distributed or sold on the territory of the Republic of Bulgaria, it must be clearly identified
p.002007: from the notifier with his trade name and batch number or this information to be provided at
p.002007: additional tracking.
p.002007: Art. 185. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: maintains a national medicines portal linked to the European Medicines Portal
p.002007: the medicinal products under Art. 68, para. 1, Vol. 4.
p.002007: (2) The Executive Agency for Medicines shall make available through the portal under para. 1 at least the following
p.002007: information:
p.002007: 1. the public evaluation reports under art. 53, para. 2 and their summaries;
p.002007: 2. the summary of product characteristics and leaflets;
p.002007: 3. a summary of the risk management plans for the medicinal products authorized for use
p.002007: the territory of the Republic of Bulgaria;
p.002007: 4. specimens of standardized forms for reporting suspected adverse reactions from
p.002007: medical professionals and patients drawn up in accordance with the requirements of Article 25 of Regulation (EC)
p.002007: No 726/2004 of the European Parliament and of the Council;
p.002007: 5. an updated list of medicinal products referred to in Article 23 of Regulation (EC) No 726/2004 of the European Union
p.002007: Parliament and the Council;
p.002007: 6. communications providing information to the general public about safety concerns from
p.002007: the use of a medicinal product;
p.002007: 7. instructions for all ways and forms for reporting suspected adverse reactions from
p.002007: medical professionals and patients.
p.002007: Art. 186. (Amended, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines
p.002007: carries out the following activities for medicinal products placed on the market of the Republic of Bulgaria:
p.002007: 1. monitoring the outcome of the risk reduction measures for the medicinal product contained in the plan
p.002007: risk management;
p.002007: 2. monitoring of the result of the fulfillment of conditions specified in Art. 55a, 56 or 56a;
p.002007: 3. evaluation of the update of the risk management system;
p.002007: 4. monitoring of the "EudraVigilance" database established in accordance with Article 24 of Regulation (EC) No
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council on new risks or changes to those already identified and on
p.002007: change in benefit / risk ratio.
p.002007: Art. 187. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: inform the European Medicines Agency and the Marketing Authorization Holder
p.002007: identifying signals for new risks or for changing identified risks, or when changing
p.002007: the benefit / risk ratio of the medicinal product.
p.002007: (2) The Committee under Art. 56a, para. 1, item 1 analyzes and prioritizes validated alerts for new risks or for
...
p.002007: risks, or to change the identified risks, or to change the benefit / risk ratio of
p.002007: medicine.
p.002007: Art. 194. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
p.002007: at the same time or before providing the public with new information on concerns related to
p.002007: monitoring the safety of a medicinal product authorized in the territory of
p.002007: The Republic of Bulgaria, informs the BDA, the European Medicines Agency and the European Commission.
p.002007: (2) The information under para. 1 must be objective and not misleading.
p.002007: (3) Before disseminating information relating to pharmacovigilance,
p.002007: the holder of the marketing authorization shall coordinate it in advance with the BDA, except in the cases under para.
p.002007: 1.
p.002007: (4) For carrying out the evaluation of the information under para. 3 a fee shall be paid in the amount specified in the tariff
p.002007: under Art. 21, para. 2.
p.002007: Art. 194a. (New, SG No. 102/2012, effective 21.12.2012) (1) The principles and requirements of the Good
p.002007: pharmacovigilance practices are defined in a guidance document issued by
p.002007: European Medicines Agency.
p.002007: (2) In carrying out pharmacovigilance monitoring activities, the holder of
p.002007: the marketing authorization complies with the good practice under para. 1.
p.002007: Section II.
p.002007: Collection and reporting of information on suspected adverse reactions
p.002007: (New, SG No. 102/2012, effective 21.12.2012)
p.002007: Art. 194b. (New, SG No. 102/2012, effective 21.12.2012) The holder of the marketing authorization in
p.002007: fulfillment of its obligations under Art. 190 is required to document all suspected reports
p.002007: adverse reactions observed within the European Union or in third countries,
p.002007: reported spontaneously by medical professionals or by patients or arising from the process
p.002007: conducting post-marketing studies.
p.002007: Art. 194c. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
p.002007: submit electronically to the "EudraVigilance" database under Art. 24 of Regulation (EC) No
p.002007: Serious suspected adverse reactions reported to the European Parliament and the Council,
p.002007: occurred within the territory of the European Union and in third countries, within 15 days of the date of receipt
p.002007: of the message.
p.002007: (2) The Marketing Authorization Holder submits to the EudraVigilance database electronically
p.002007: reports of all suspected adverse reactions other than those specified in para. 1, occurred
p.002007: within the territory of the European Union, within 90 days of the date of receipt of the communication.
p.002007: (3) The Marketing Authorization Holder monitors publications in specialized medical literature
p.002007: and report to the EudraVigilance database any suspected adverse reaction described in the
p.002007: except for suspected adverse reactions from active medicinal products
p.002007: substances listed in Article 27 of Regulation (EC) No 726/2004 of the European Parliament and of the
p.002007: Council and described in literature, monitored by the European Medicines Agency.
p.002007: (4) The marketing authorization holder establishes procedures for the collection of accurate and reliable data,
p.002007: allowing the scientific evaluation of reports of suspected adverse reactions. The owner of
p.002007: the marketing authorization collects follow-up information regarding these communications and provides
p.002007: updated data in "EudraVigilance".
p.002007: (5) The form and content of the reports under para. 1 - 3 are laid down in Implementing Regulation (EU) No
p.002007: 520/2012.
p.002007: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: register in the system under art. 183 all reports of suspected adverse reactions,
p.002007: occurred on the territory of the Republic of Bulgaria by medical specialists and patients, and requires, at
p.002007: need, additional information from case tracking.
p.002007: (2) Where reports of suspected adverse reactions occurring within the territory of
p.002007: The Republic of Bulgaria has been submitted by the Marketing Authorization Holder, which he provides
p.002007: additional information from case tracking upon request from the BDA.
p.002007: Art. 194d. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: submits to the EudraVigilance database electronically all serious suspects
p.002007: undesirable effects occurring on the territory of the Republic of Bulgaria within 15 days from the date
p.002007: on receipt.
p.002007: (2) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002007: reports of all suspected adverse reactions other than those specified in para. 1, occurred
p.002007: within the territory of the Republic of Bulgaria, within 90 days from the date of receipt of the notification.
p.002007: (3) The Drug Enforcement Agency submits reports electronically to the EudraVigilance database
p.002007: suspected adverse reactions occurring on the territory of the Republic of Bulgaria as a result of
p.002007: misuse of a medicinal product. The Medicines Executive Agency shall inform thereof
p.002007: Ministry of Health and professional organizations of medical specialists.
p.002007: (4) Any body or institution to which information about a suspected adverse drug has been received
p.002007: a reaction occurring on the territory of the Republic of Bulgaria informs the BDA about this.
p.002007: (5) The content and format of the communications and reports under para. 1 - 3 are determined by the Regulation for
p.002007: Implementation (EU) No 520/2012.
p.002007: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: receives the information submitted by the Marketing Authorization Holder for serious suspects
p.002007: adverse reactions occurring within the European Union or in a third country through
p.002007: the EudraVigilance database.
p.002007: (2) The requirements for monitoring information in the EudraVigilance database are laid down in a Regulation.
p.002007: Implementing Regulation (EU) No 520/2012.
p.002007: Art. 194g. (New - SG 102/2012, in force since 21.12.2012) In the process of exchange of information of the BDA,
p.002007: the Marketing Authorization Holders and the European Medicines Agency are cooperating with the European Medicines Agency
p.002007: detecting duplicate reports of suspected adverse reactions.
p.002007: Section III.
p.002007: Periodic Safety Update Reports (New, SG No. 102/2012, in force)
p.002007: from 21.12.2012)
p.002007: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization is
p.002007: obliged to provide the European Medicines Agency electronically with periodic updates
p.002007: safety reports containing:
p.002007: 1. summaries of data on the benefit / risk balance of the medicinal product, including
p.002007: the results of all studies, with a view to their potential impact on the Marketing Authorization;
p.002007: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002007: available data, including clinical trial data for unauthorized indications and target groups,
p.002007: not included in the summary of product characteristics;
p.002007: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002007: the holder of the marketing authorization is in possession of the volume of prescriptions, including
p.002007: approximate number of persons who have used or are exposed to the medicinal product
p.002007: another reason.
...
p.002007: except where the frequency of submission of reports is a condition for authorization
p.002007: for use / registration certificate or determined in accordance with Art. 194l, 194m and 194h:
p.002007: 1. every 6 months from the date of issue of the marketing authorization / registration certificate
p.002007: medicinal product by the date of its placing on the market;
p.002007: 2. every 6 months during the first two years from the date of placing on the market of the medicinal product;
p.002007: 3. once a year for the next two years;
p.002007: 4. once every three years after the fourth year from the date on which the medicinal product is placed on the market.
p.002007: (4) Outside the cases under para. 3, periodic safety update reports shall be submitted immediately to
p.002007: a request from the BDA or a regulatory authority of a Member State.
p.002007: (5) Paragraphs 3 and 4 shall also apply to medicinal products authorized only in the territory of
p.002007: Republic of Bulgaria, which are not covered by Art. 194l.
p.002007: Art. 194l. (New, SG No. 102/2012, effective 21.12.2012) Where medicinal products containing
p.002007: the same active substance, or combination of the same active substances, have been obtained separately
p.002007: marketing authorizations / registration certificate, frequency and filing dates for periodic applications
p.002007: updated safety reports may be modified and harmonized in order to carry out
p.002007: uniform evaluation of these reports.
p.002007: Art. 194m. (New, SG No. 102/2012, effective 21.12.2012) (1) The filing dates of the periodicals
p.002007: updated safety reports for the medicinal products under Art. 194l are calculated according to
p.002007: European Union reference date.
p.002007: (2) The European Union reference date under para. 1 is:
p.002007: 1. the date of the first authorization for use in the European Union of the medicinal product containing
p.002007: the active substance concerned or the corresponding combination of active substances, or
p.002007: 2. the earliest known date of the marketing authorizations for the medicinal product containing
p.002007: the relevant active substance or the corresponding combination of active substances, if the date referred to in point 1,
p.002007: could not be determined.
p.002007: Art. 194n. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
p.002007: of medicinal products under Art. 194l may submit a reasoned request to the Committee for Medicinal Products
p.002007: products for human use, respectively to the coordination group under Art. 77, para. 2 to determine
p.002007: reference date of the European Union or change of frequency of submission of periodicals
p.002007: updated safety reports on one of the following grounds:
p.002007: 1. reasons for public health;
p.002007: 2. to avoid duplicate assessment;
p.002007: 3. to achieve international harmonization.
p.002007: (2) The Committee for Medicinal Products for Human Use, or the Coordination Group of Post Offices. 77,
p.002007: para. 2 after consultation with the committee under Art. 56a, para. 1, item 1 approves the request or makes a reasoned refusal.
p.002007: (3) The filing frequency and the reference date of the European Union shall be determined in consultation with
p.002007: the committee under Art. 56a, para. 1, item 1 of:
p.002007: 1. The Committee for Medicinal Products for Human Use - where at least one of the Marketing Authorizations
p.002007: for medicinal products containing the active substance concerned, is granted in accordance with
p.002007: the centralized procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council
p.002007: Parliament and the Council, or
p.002007: 2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
p.002007: (4) The list of European Union reference dates for medicinal products has been sent. 194l and
p.002007: the harmonized frequency for submitting their periodic safety update reports
p.002007: publish on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002007: (5) The holder of the marketing authorization after the publication of the data under para. 4 presents in the BDA
p.002007: application for a change of the marketing authorization for the medicinal product concerned. Any change to
p.002007: filing dates and frequency of submission of periodic safety update reports,
p.002007: specified in the marketing authorizations shall take effect 6 months after the date of their publication.
p.002007: Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: evaluates periodic safety update reports for medicinal products to determine whether
p.002007: there are new risks, or a change in the identified risks, or a change in the benefit / risk balance.
p.002007: (2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic updated reports
p.002007: on the safety of medicinal products for which the Republic of Bulgaria has fulfilled the functions of
p.002007: reference country within the meaning of Art. 76, and is designated by the coordination group under Art. 77, para. 2.
p.002007: (3) A rapporteur from the Republic of Bulgaria shall participate in the single evaluation of the periodic up-to-date reports
p.002007: safety for medicinal products where at least one of the products is authorized for use in the order of
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council, and has been designated as such by the Committee.
p.002007: 56a, para. 1, v. 1.
...
p.002007: para. 5.
p.002007: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002007: updated reports on the safety of medicinal products under Art. 194l and when at least one of
p.002007: the marketing authorizations were granted under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
p.002007: The Council, the Committee for Medicinal Products for Human Use, within 30 days of receipt of the
p.002007: the recommendation of the committee under Art. 56a, para. 1, item 1 issues an opinion on the retention, amendment, suspension
p.002007: or the termination of the relevant marketing authorizations, including a timetable for
p.002007: implementation of the opinion.
p.002007: (2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
p.002007: of the Marketing Authorizations, European Commission:
p.002007: 1. adopt a decision to change, suspend or terminate the marketing authorizations issued in accordance with
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002007: 2. adopt a decision recommending the change, suspension or termination of the marketing authorizations,
p.002007: issued by the relevant regulatory authorities of the Member States.
p.002007: (3) The Executive Agency for Medicinal Products shall apply the provisional and / or definitive measures of the decision on
p.002007: para. 2, Vol. 2.
p.002007: Section IV.
p.002007: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002007: 12/21/2012)
p.002007: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure at European Union level
p.002007: can be initiated by the European Commission, the European Medicines Agency or a country
p.002007: state.
p.002007: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under the procedure
p.002007: of this section by informing the regulatory authorities of the other Member States the European Agency
p.002007: on medicines and the European Commission, when for reasons related to drug monitoring
p.002007: safety, consider that a medicinal product placed on the Bulgarian market is necessary
p.002007: take any of the following measures:
p.002007: 1. suspension or termination of the marketing authorization;
p.002007: 2. prohibition of distribution of a medicinal product;
p.002007: 3. issuing a refusal to renew the marketing authorization.
p.002007: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para. 2 when
p.002007: has been informed by the Marketing Authorization Holder that for traceability reasons
p.002007: drug safety, suspends the distribution of the medicinal product or has taken, or
p.002007: intends to take action to withdraw it from the market or not to take action on
p.002007: renewal of the marketing authorization.
p.002007: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure under para.
p.002007: 2 and where it considers that for reasons of pharmacovigilance,
p.002007: new contraindications must be added or reduced for a medicinal product
p.002007: the recommended dose or indication should be limited.
p.002007: (5) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall submit to the European Agency
p.002007: on medicines and regulatory authorities of other Member States all scientific information with which
...
p.002007: (2) Where the opinion recommends the taking of postal measures. 194ts, para. 3, item 5, the executive
p.002007: the BDA Director shall by order suspend or terminate the Marketing Authorization or refuse
p.002007: its renewal.
p.002007: (3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued,
p.002007: the marketing authorization holder submits to the BDA an application for change including an updated one
p.002007: a summary of the product characteristics and a leaflet, within the specified implementation schedule.
p.002007: (4) Where in the opinion under para. 1 it is recommended to take post measures. 194ts, para. 3, Vol. 2 - 4,
p.002007: the holder of the marketing authorization takes the necessary action and informs the BDA and
p.002007: the regulatory authorities of the other Member States.
p.002007: (5) Where within the coordination group under Art. 77, para. 2 cannot be reached,
p.002007: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002007: decision recommending change, suspension or termination of the marketing authorization granted by
p.002007: the relevant regulatory authorities of the Member States.
p.002007: (6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5 temporary and / or
p.002007: final measures.
p.002007: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where, within the scope of the procedure, Art. 194y
p.002007: a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002007: Parliament and the Council, the Committee on Medicinal Products for Human Use, on the basis of the recommendation
p.002007: under Art. 194ts, para. 3 within 30 days from the date of receipt and issue an opinion on retention,
p.002007: modification, suspension, termination of the relevant marketing authorizations or refusal
p.002007: their renewal, including a timetable for the implementation of the opinion.
p.002007: (2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
p.002007: of the Marketing Authorizations, European Commission:
p.002007: 1. Decides to change, suspend or terminate the validity of the marketing authorizations,
p.002007: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002007: 2. adopt a decision recommending the change, suspension or termination of the validity of the permissions for
p.002007: use issued by the relevant regulatory authorities of the Member States.
p.002007: (3) The Medicines Executive Agency implements the recommendations made in the European Commission decision on
p.002007: para. 2, item 2 provisional and / or final measures.
p.002007: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) 194ts, para. 1, the opinion of
p.002007: Art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and Art. 194h, para. 2 are published on
p.002007: The European Internet Portal under Art. 68, para. 1, Vol. 4.
p.002007: Chapter Nine.
p.002007: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN THE AREA OF
p.002007: MEDICINAL PRODUCTS (TITLE AMENDED - SG 71/08, IN EFFECT OF 12.08.2008,
...
p.002007: Wholesale trade in medicinal products after obtaining authorization from the executive
p.002007: director of the BDA.
p.002007: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may trade on
p.002007: wholesale only of medicinal products for which a manufacturing authorization has been granted.
p.002007: (2) An importer of medicinal products within the meaning of this Law may only wholesale trade with
p.002007: medicinal products for which import authorization has been granted.
p.002007: Art. 197. The persons under art. 195 must have:
p.002007: 1. suitable premises, equipment and facilities and suitable means of transport providing
p.002007: the proper storage, distribution and transport of medicinal products in accordance with
p.002007: the requirements of Good Distribution Practice;
p.002007: 2. Qualified staff and responsible Master of Pharmacy with at least two years of work experience
p.002007: the specialty whose obligations are defined in the ordinance under Art. 198.
p.002007: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.002007: the distribution practices of medicinal products and active substances are adopted by an ordinance of the Minister
p.002007: health and with guidelines adopted by the European Commission.
p.002007: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002007: 1. an application containing the name, registered office and address of management of the trader; address and description
p.002007: premises and facilities for storage of medicinal products;
p.002007: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: country;
p.002007: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar
p.002007: document of the person, if not a Bulgarian citizen, diploma for higher education and document for work experience
p.002007: of the responsible master pharmacist under Art. 197, item 2 and a copy of his employment contract;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 6. a document certifying the legal basis for the use of the premises;
p.002007: 7. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 84 of 2018, effective from 12.10.2018)
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002007: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a Member State;
p.002007: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002007: 3. the address of the premises for the storage of medicinal products in the territory of the Member States.
p.002007: (3) In the wholesale trade in narcotic substances and in dosage forms containing such substances,
p.002007: the requirements of the Narcotic Drugs and Precursors Control Act also apply.
...
p.002007: the circumstances through the specialized electronic system of art. 217b, para. 1 information for:
p.002007: a) the quantities imported in the territory of the Republic of Bulgaria in parallel indicated by medicinal products
p.002007: products on the Positive Medicinal List that are the holder of the parallel authorization
p.002007: import;
p.002007: b) the mail delivered to individuals and legal entities. 207, para. 1, items 5, 5a and 6 the quantities indicated under
p.002007: medicinal products included in the Positive Medicinal List;
p.002007: c) the natural and legal persons under Art. 207, para. 1, items 5, 5a and 6, to which the quantities have been delivered
p.002007: medicinal products under letter "a";
p.002007: (d) the date on which the importation / delivery was made under letters "a" and "b";
p.002007: (e) the quantities available in the stores indicated by medicinal products included in the Positive Medicinal Product
p.002007: a list of holders of the parallel import authorization.
p.002007: Chapter Nine "b".
p.002007: EXPORTS OF MEDICINAL PRODUCTS. SPECIALIZED ELECTRONIC SYSTEM FOR
p.002007: FOLLOW-UP AND ANALYSIS OF THE MEDICINAL PRODUCTS (NEW, SG 18/14
p.002007: G., TITLE. AMENDED. - DV, BR. 84 FROM 2018, IN EFFECT ON 12/10/2018)
p.002007: Chapter Nine "b".
p.002007: EXPORT OF MEDICINAL PRODUCTS (NEW, SG No. 18/2014)
p.002007: Art. 217a. (New, SG No. 18/2014) (1) Export of medicinal products from the territory of the Republic
p.002007: Bulgaria may be a natural or legal person holding a wholesale marketing authorization
p.002007: with medicinal products or a manufacturing authorization holder.
p.002007: (2) The holder of a manufacturing authorization may export only the ones produced by him
p.002007: medical products.
p.002007: (3) For the purposes of this Chapter, exports are also intra-Community supplies within the European Union.
p.002007: (4) (amend. - SG 84/08, in force from 12.10.2018) Medicinal products included in the Positive
p.002007: medicinal list for which a shortage has been established in accordance with Art. 217b, cannot be exported for the term
p.002007: contained in the list under Art. 217c, para. 1.
p.002007: Art. 217b. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018) (1)
p.002007: Specialized electronic system for tracking and analyzing the medicinal products included in
p.002007: The positive drug list, administered and maintained by the Executive Agency
p.002007: medicines.
p.002007: (2) The creation and maintenance of the specialized electronic system under para. 1 is done on the basis of
p.002007: on the following principles:
p.002007: 1. ensuring the accuracy and accuracy of the data submitted and stored;
p.002007: 2. providing an appropriate data exchange environment;
p.002007: 3. ensuring regulated access to the data in the electronic information system in compliance
p.002007: the requirements of the law;
p.002007: 4. ensuring interoperability and information security.
p.002007: (3) The specialized electronic system of para. 1 contains:
p.002007: 1. the information under art. 54, Art. 54a, Art. 68, para. 1, Vol. 10, Art. 207, para. 1, Vol. 15, Art. 217, item 5 and art. 232a provided
p.002007: by the persons concerned;
p.002007: 2. information provided by the National Health Insurance Fund about the quantities indicated
p.002007: on paid medicinal products included in the Positive Medicinal List for the previous one month;
p.002007: 3. information provided by the Ministry of Health about the quantities indicated under
p.002007: paid medicinal products included in the Positive Medicinal List for the previous one month.
...
p.002007: medicinal products, medical devices and dietary products authorized for use in the Republic of Bulgaria
p.002007: special-purpose foods and infant formulas and follow-on formulas,
p.002007: cosmetic and sanitary products.
p.002007: Art. 226. (1) Pharmacies may be opened on the territory of outpatient medical establishments
p.002007: sale of medicinal products to citizens.
p.002007: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, medical establishments for
p.002007: hospital care and medical establishments under art. 10 of the Medical Establishments Act cannot be found
p.002007: pharmacies to sell medicinal products to citizens.
p.002007: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009) The requirements for
p.002007: the location and the premises of the pharmacy shall be determined in the ordinance under Art. 219, para. 2.
p.002007: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in force since 05.08.2011)
p.002007: Requirements for the device and premises of pharmacies under Art. 228, para. 5 shall be determined in the ordinance under para.
p.002007: 1.
p.002007: Art. 228. (Amended, SG No. 71/2008, effective 26.07.2008) (1) (Amended, SG No. 60/2011)
p.002007: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002007: Director of the BDA on the basis of an application form to which shall be attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 222, para. 1;
p.002007: 2. employment contract or contract for management of the pharmacy, concluded with a master pharmacist or an assistant;
p.002007: pharmacist;
p.002007: 3. a copy of the act of creation of the persons of the post. 222, para. 4;
p.002007: 4. documents certifying that the requirements of Art. 224 Hours;
p.002007: 5. (suppl. - SG 103/07, in force from 01.01.2018) certificate of criminal record of the master pharmacist,
p.002007: respectively to the assistant pharmacist appointed as the head of the pharmacy, if they are not Bulgarian citizens;
p.002007: 6. the medical certificate of the master pharmacist, respectively of the assistant pharmacist appointed for
p.002007: pharmacy manager;
p.002007: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002007: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued by the respective Health Insurance Fund;
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002007: medicinal products are checked to see if the diploma of the master-
p.002007: the pharmacist / pharmacist assistant is issued by the relevant competent institution.
p.002007: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies no. 222, para. 4 and 6 are
p.002007: open and close at the request of the person representing the medical establishment.
...
p.002007: on drugs and precursors.
p.002007: (5) (New - SG, iss. 102 in 2009, in force since 22.12.2009, previous para 4 - SG, iss. 60 in 2011, in force since
p.002007: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy which is opened in
p.002007: a settlement with a population of less than 10,000 inhabitants shall be issued on the basis of an application in accordance with a specimen to which
p.002007: apply:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 84 of 2018, effective from 12.10.2018)
p.002007: the documents under para. 1, Vol. 1 - 7a;
p.002007: 2. (amend. - SG 102/02, in force from 02.01.2013) document for paid fee in the amount of 50 percent of
p.002007: the fee determined in the tariff under Art. 21, para. 2 for the granting of a permit for retail trade with
p.002007: medicinal products under Art. 222, para. 1.
p.002007: (6) (Renumbered from Paragraph (4), Suppl. - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 98 in 2010, in force since
p.002007: 01.01.2011, previous para. 5, amend. - SG, issue. 60 of 2011, effective 05.08.2011) The application and the documents under
p.002007: para. 1 and 5 shall be submitted to the BDA.
p.002007: (7) (Renumbered from Paragraph (5), amend. - SG 102/09, in force from 22.12.2009, amended - SG, issue 98 from 2010, in force from
p.002007: 01.01.2011, previous para. 6, amend. - SG, issue. 60 of 2011, effective 05.08.2011) Regional Health
p.002007: inspections shall issue a hygienic conclusion within 14 days of the date of application.
p.002007: (8) (New, SG No. 48/2015; Supplemented, SG No. 91/2018) On the day the application under para. 1 and 5
p.002007: The BDA sends an official request to the Governing Board of the Bulgarian Pharmaceutical Union for issuance
p.002007: of a certificate for entry in the national electronic register of the members of the Bulgarian
p.002007: pharmaceutical union - for the master pharmacist, pharmacy manager, and to the board of directors of
p.002007: Bulgarian Association of Assistant Pharmacists - Assistant Pharmacist, Pharmacy Manager at
p.002007: cases stipulated by law, as well as providing information on penalties imposed in the order
p.002007: of the Professional Organization of Master Pharmacists and the Health Act.
p.002007: (9) (New, SG No. 48/2015) The Managing Board shall submit the documents under para. 8 within 5 working days of
p.002007: receipt of the request.
p.002007: (10) (New - SG 103 2017, in force from 01.01.2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the persons under para. 1, item 5, when they are Bulgarian citizens.
p.002007: Art. 229. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, repealed - SG No. 60/2011, effective 05.08.2011
p.002007: d)
p.002007: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 102/2009, effective 22.12.2009, amended -
p.002007: SG, issue 60 of 2011, in force since 05.08.2011, suppl. - SG, issue. 18 of 2014) Within one month of receipt of the
p.002007: the documentation under Art. 228, para. 6, the Executive Director of the BDA, following the opinion of the Expert Council on
p.002007: retail trade of medicinal products, issues a permit for retail trade with
p.002007: medicinal products at a pharmacy or make a reasoned refusal to grant an authorization. The permission or
p.002007: the refusal shall be served on the applicant.
p.002007: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation on
p.002007: Art. 228, para. 6 The BDA verifies the documents submitted and notifies the applicant in writing
...
p.002007: Art. 232a. (New, SG No. 84/2018, effective 12.10.2018) Holders of a marketing authorization for
p.002007: retail with medicinal products and persons under art. 207, para. 1, items 5a and 6 shall be provided daily to the BDA through
p.002007: the specialized electronic system of art. 217b, para. 1 information for:
p.002007: 1. the quantities delivered to them indicated by medicinal products included in the Positive Medicinal List;
p.002007: 2. the quantities awarded / sold indicated by the medicinal products included in the Positive
p.002007: medication list;
p.002007: 3. their available quantities indicated by medicinal products included in the Positive Medicinal List.
p.002007: Art. 233. The pharmacy manager is responsible for the activities referred to in Art. 219, para. 1.
p.002007: Art. 234. (1) It shall be prohibited to sell medicinal products through vending machines other than medicinal ones
p.002007: products listed in the list specified in the ordinance under Art. 219, para. 2.
p.002007: (2) The automatic machines under para. 1 may be owned only by the postmen. 222 and Art. 238, para. 2.
p.002007: (3) The sale of medicinal products shall be prohibited.
p.002007: (4) It shall be prohibited to sell on the Internet medicinal products subject to medical prescription.
p.002007: (5) (New, SG No. 60/2011, effective 05.08.2011) Medicinal products without medical prescription may
p.002007: to be sold online only by a pharmacy or drugstore authorized under the terms and conditions of
p.002007: this law and the ordinance under art. 219, para. 2, respectively under Art. 243.
p.002007: (6) (New, SG No. 102/2012, effective 02.01.2013) The pharmacies and drugstores of para. 5 posted on
p.002007: the website through which they trade medicinal products without a prescription,
p.002007: a common logo that is recognizable throughout the European Union.
p.002007: (7) (New, SG No. 102/2012, effective 02.01.2013) The requirements to the general logo under para. 6 are determined by
p.002007: delegated act of art. 85c (3) of Directive 2001/83 / EC.
p.002007: Art. 234a. (New - SG 102/2012, in force from 02.01.2013) (1) The Executive Agency for Medicines
p.002007: publish and maintain on its website:
p.002007: 1. information on national legislation applicable to the marketing of medicinal products for
p.002007: Internet sales, including information that there may be differences between
p.002007: Member States as regards the classification of medicinal products and the conditions for
p.002007: their delivery;
p.002007: 2. information on the purpose of the common logo;
p.002007: 3. a list of persons offering medicinal products for sale on the Internet, as well as their addresses
p.002007: websites;
p.002007: 4. general information about the risks associated with medicinal products delivered to consumers through
p.002007: Internet in violation of the ordinance under Art. 234, para. 5.
p.002007: (2) The website of the BDA under para. 1 is linked to the European Agency for Europe website
p.002007: medicines.
p.002007: Art. 234b. (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines shall participate
p.002007: in information campaigns conducted by the European Commission and the European Medicines Agency
p.002007: on the risk of counterfeit medicinal products.
p.002007: Art. 235. (1) The permit for carrying out retail trade in medicinal products shall be mailed. 229, para. 2 se
p.002007: terminate with termination of the activity of the persons under art. 222 and 225.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) The Executive Director of the BDA shall terminate
p.002007: authorization to trade in medicinal products:
...
p.002007: the products may be sold to persons who have been authorized to wholesale medicinal products
p.002007: products.
p.002007: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002007: prescription, can be sold in a drugstore. Drugstores can also sell products and goods
p.002007: relevant to human health as defined in the ordinance under Art. 243, and medical devices.
p.002007: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to carry out retail trade in medicinal products
p.002007: products, opening a drugstore, have all natural and legal persons registered under the Commercial
p.002007: law or under the law of a Member State.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore shall be medical
p.002007: specialist who:
p.002007: 1. is not deprived of the right to practice his profession;
p.002007: 2. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crimes against the individual;
p.002007: 3. have at least one year of experience in the specialty.
p.002007: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened upon registration in
p.002007: the relevant REI.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) 238, para. 2 shall be submitted to the relevant RHI
p.002007: application for registration, to which the following documents are attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 238, para. 1;
p.002007: 2. (suppl. - SG 103/07, in force from 01.01.2018) document for education and criminal record of
p.002007: the person designated as the head of the drugstore, if not a Bulgarian citizen;
p.002007: 3. the medical certificate of the person under item 2;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 6. document for paid state fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para.
p.002007: 2 The Regional Inspectorate shall carry out an inspection on compliance with the requirements of the ordinance under Art. 243. Where
p.002007: establish that the requirements of the ordinance under Art. 243, within 7 days from the completion of the inspection
p.002007: The RII prescribes and sets a time limit for their removal.
p.002007: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application and
p.002007: the documents under para. 2, the Director of the RII shall notify the person in writing of the incompleteness found therein and
p.002007: sets a time limit for their removal.
p.002007: (5) (New, SG No. 60/2011, effective 05.08.2011) For filing an application for registration of a drugstore
...
p.002007: prescription drugs, with the exception of ad campaigns
p.002007: vaccination, carried out in accordance with Art. 248 and approved by the competent authorities.
p.002007: Art. 249. Requirements for advertising of medicinal products shall be determined by an ordinance of the Minister of Health
p.002007: healthcare.
p.002007: Art. 250. An application for marketing authorization for a medicinal product shall be submitted by the holder of the medicinal product
p.002007: the marketing authorization for the medicinal product or its authorized person.
p.002007: Art. 251. (1) To authorize the advertisement, the person shall send. 250 shall submit to the BDA an application in accordance with a model approved by
p.002007: the Executive Director of the Agency, accompanied by:
p.002007: 1. advertising project;
p.002007: 2. a notarized power of attorney from the holder of the marketing authorization when the application is submitted
p.002007: filed by another person;
p.002007: 3. the literary sources of the quotations, tables or other materials used, if any;
p.002007: 4. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The advertising projects under para. 1, item 1 must be clear, with comprehensible text, in cases where there is one, and yes
p.002007: they allow all elements and text and illustrations to be evaluated.
p.002007: (3) An Expert Council on Advertising shall be established at the BDA. It includes doctors and specialists with
p.002007: hands-on experience in advertising. The Executive Director of the BDA shall determine the composition of the Board with an order
p.002007: of the Council, to which one representative of the Committee on Professional Ethics of the Bulgarian shall be included
p.002007: medical union, the Bulgarian Dental Union and the Bulgarian Pharmaceutical Union, the size of
p.002007: the remuneration of its members and approves rules of procedure for its work. In the composition of
p.002007: counseling may also include representatives of patient organizations.
p.002007: (4) The council under para. 3 prepares expertise on the advertising project and prepares an opinion to the executive
p.002007: director of the BDA.
p.002007: (5) In case of finding inconsistencies of the advertising with the requirements of this law within 7 days from the date
p.002007: of filing the application under para. 1 The BDA gives written instructions for their removal within one month from
p.002007: the date of the notification. The time limit for ruling ceases to run from the date of notification to
p.002007: eliminate inconsistencies.
p.002007: (6) In case the applicant fails to comply with the instructions within one month from the date of notification under para. 5,
p.002007: the authorization procedure is terminated.
p.002007: Art. 252. (1) Within one month from the submission of the documentation, mail. 251, para. 1 based on
p.002007: the opinion under Art. 251, para. 4, the BDA Executive Director authorizes the advertisement or does it by order
p.002007: a reasoned refusal to notify the Marketing Authorization Holder.
p.002007: (2) (New, SG No. 60/2011, effective 05.08.2011) When, within the term of para. 1 Executive Director of
p.002007: The BDA did not authorize the advertisement or did not make a reasoned refusal, it is assumed that it is silent
p.002007: consent to the project of advertising under Art. 251, para. 1, item 1 and it may be distributed.
p.002007: (3) (Renumbered from Paragraph (2), SG No. 60/2011, effective 05.08.2011) The refusal of the Executive Director
...
p.002007: The Health Insurance Act, the marketing authorization holder also informs the NHIF in
p.002007: the terms under para. 4.
p.002007: (4) The holder of the marketing authorization shall be obliged to make the notification under para. 1 not later than
p.002007: 18 months before the date of cessation of sales, and in the cases under par. 2 - no later than three months
p.002007: before the date of discontinuation of sales.
p.002007: (5) (Supplemented, SG No. 18/2014) Until the termination of the sales under para. 1 and 2 of the authorization holder
p.002007: is obliged to provide sufficient quantities of the relevant medicinal product for use in order to satisfy
p.002007: health needs, except in cases where the suspension is due to any of the grounds under Art.
p.002007: 276 or under Art. 277.
p.002007: (6) After the expiry of the terms under para. 4, the Marketing Authorization Holder submits an application and
p.002007: the relevant documents to exclude the medicinal product from the Positive Medicinal List.
p.002007: (7) Where, following the cessation of sales of the medicinal product, the holder of the authorization for
p.002007: use has not fulfilled its obligation under par. 6, the council under art. 258, para. 1 ex officio excludes him from
p.002007: Positive drug list.
p.002007: Art. 265. (1) The Council of Ministers shall establish a Transparency Committee.
p.002007: (2) (Supplemented, SG No. 60/2011, effective 05.08.2011) The composition of the Transparency Committee shall be determined by
p.002007: The Council of Ministers on a proposal from the Minister of Health. It is mandatory to include
p.002007: representatives of the Ministry of Health, the Ministry of Labor and Social Policy,
p.002007: of the BDA, the NHIF, the Bulgarian Medical Association, the Bulgarian Dental Union, the Bulgarian
p.002007: pharmaceutical union and patient organizations and the pharmaceutical industry.
p.002007: (3) (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: A person who is a member of the Transparency Committee cannot also be a member of the National Board of Prices and
p.002007: reimbursement of medicinal products.
p.002007: (4) The Council of Ministers shall determine by rules the terms and conditions for the work of the Transparency Commission.
p.002007: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012)
p.002007: 12/21/2012) The Transparency Committee is an authority against which decisions of the National can be appealed
p.002007: advice on prices and reimbursement of medicinal products.
p.002007: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority of the panel and.
p.002007: (3) The decisions under par. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a relevant disease is
p.002007: without an alternative in the country, an authorized medicinal product may be administered to a particular patient
p.002007: for use in a Member State of the European Union, authorized for use under this Act, but not
p.002007: distributes on the Bulgarian market.
p.002007: (2) (amend. - SG 102/08, in force from 01.01.2019) Annually at the proposal of the medical establishments for
p.002007: hospital care and after the opinion of the relevant expert council in the relevant medical specialty
p.002007: or medical activity under Art. 6a, para. 1, item 1 of the Health Act the Minister of Health
p.002007: approve the list of medicinal products under para. 1, which contains the following information:
p.002007: 1. anatomical-therapeutic-chemical classification code;
p.002007: 2. an international non-patent name to which the product belongs;
p.002007: 3. disease according to the international disease code;
p.002007: 4. the dosage form and the amount of active substance;
p.002007: 5. additional information.
p.002007: (3) The list under para. 2 is published on the website of the Ministry of Health on the Internet.
p.002007: (4) The conditions and the order for inclusion, change or exclusion of medicinal products in the list under para. 2 se
p.002007: determine with the ordinance under art. 9, para. 1.
p.002007: (5) The medicinal product under para. 1 shall be delivered by special order to a hospital establishment for hospital care
p.002007: under the conditions and in the order determined by the ordinance of art. 9, para. 1.
p.002007: (6) The head of the medical establishment under para. 5 shall be responsible for the implementation of the treatment under para. 1.
p.002007: Chapter thirteen.
p.002007: STATE CONTROLS ON MEDICINAL PRODUCTS
p.002007: Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
p.002007: 12/21/2012) The Ministry of Health manages the state control over the medicinal products
...
p.002007: the cases under item 1.
p.002007: (3) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall carry out
p.002007: Inspections:
p.002007: 1. to manufacturers of medicinal products located on the territory of the Republic of Bulgaria;
p.002007: Member State or in third countries;
p.002007: 2. to importers and wholesalers of medicinal products;
p.002007: 3. on the premises of manufacturers, importers and wholesalers of active substances located
p.002007: on the territory of the Republic of Bulgaria;
p.002007: 4. at the premises of manufacturers or wholesalers of active substances located in third places
p.002007: countries as well as manufacturers or importers of excipients;
p.002007: 5. at the premises of the marketing authorization holders and the intermediaries
p.002007: in the field of medicinal products, registered in accordance with Art. 212a;
p.002007: 6. as part of a certification procedure relating to monographs of the European Pharmacopoeia;
p.002007: 7. to manufacturers of starting materials at the written request of the manufacturer.
p.002007: (4) The Medicines Executive Agency shall carry out inspections of manufacturers of medicinal products,
p.002007: established in a third country in connection with an application for a marketing authorization or
p.002007: import.
p.002007: (5) (Amended, SG No. 102/2012, effective 21.12.2012) The inspections under para. 3 and 4 are performed in accordance
p.002007: with guidelines adopted by the European Commission.
p.002007: (6) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall participate in
p.002007: a request from the European Commission, the European Medicines Agency or a Member State to perform
p.002007: of inspections under para. 3 in the European Union or in third countries.
p.002007: (7) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall cooperate
p.002007: and exchanges information with the European Medicines Agency when planning and carrying out inspections
p.002007: para. 3.
p.002007: (8) (New, SG No. 102/2012, effective 21.12.2012) The Executive Agency for its Medicines
p.002007: cooperates with the European Medicines Agency in coordinating inspections in third countries.
p.002007: Art. 269a. (New, SG No. 102/2012, effective 21.12.2012) (1) 267, para. 3 draw up
p.002007: report on each inspection carried out under Art. 269, para. 3 and 4 on compliance with the principles and guidelines for
p.002007: Good manufacturing practice, either for Good Distributor Practices or for compliance with the requirements of
p.002007: Chapter Eight, as well as the requirements of this law.
p.002007: (2) The report under para. 1 shall be provided to the verified person, who may submit observations thereon.
p.002007: (3) Upon receiving a substantiated request, the BDA shall electronically send the reports under para. 1 on
p.002007: the competent authority of another Member State or of the European Medicines Agency.
p.002007: Art. 269b. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002007: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good
p.002007: distributor practices, where applicable, are issued by the BDA to the manufacturer, importer or trader.
p.002007: wholesale Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice
p.002007: within 90 days of the inspection.
p.002007: (2) When, as a result of an inspection, 269, para. 3 it was found that the manufacturer, the importer
...
p.002007: The Ministry of Health;
p.002007: 5. (amend. - SG 84/2018) (*) revoke the issued clinical trial permit, suspend the holding
p.002007: of the clinical trial or obliges the contracting authority to submit a substantive change to
p.002007: the clinical trial of established infringements of Regulation (EU) No 536/2014 under the terms and procedures,
p.002007: provided for therein;
p.002007: 5a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: orders the blocking, withdrawal and destruction of counterfeit medicinal products and medicinal products
p.002007: products of unknown origin;
p.002007: 5b. (new - SG 60/11, in force from 05.08.2011) carries out checks on the donations made.
p.002007: 268a, para. 1;
p.002007: 6. issue orders, instructions and instructions within its competence, which are obligatory
p.002007: for all persons;
p.002007: 7. (new - SG 60/11, in force from 05.08.2011) place medicinal products and active medicinal products under prohibition
p.002007: substances in doubt in the deviation of their quality by affixing signs in the sites
p.002007: for production.
p.002007: (2) The compulsory administrative measures under para. 1 or under Art. 270, para. 3 shall be imposed by order of the director
p.002007: of the BDA.
p.002007: (3) The orders under para. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 272a. (New, SG No. 102/2012, effective 02.01.2013) (1) By delegated acts, no. 52b, paragraph 2
p.002007: Directive 2001/83 / EC lays down the necessary measures to prevent the placing on the market of
p.002007: medicinal products introduced into the European Union but not intended for the marketing of
p.002007: The European Union, for which there are sufficient grounds for suspecting that they have been falsified.
p.002007: (2) The Medicines Executive Agency shall take the necessary measures in accordance with the delegated ones
p.002007: acts under para. 1 to prevent the release of medicinal products introduced into the European Union
p.002007: Union, but not intended to be placed on the European Union market for which there are sufficient grounds for
p.002007: suspected of being counterfeit.
p.002007: (3) The customs authorities shall notify the BDA of the introduction on the territory of the Republic of Bulgaria of
p.002007: medicinal products under para. 1 with a view to taking measures under para. 2.
p.002007: Art. 273. (1) The conditions and the order for taking the samples, performing the tests and paying for them shall be
p.002007: determined in an ordinance of the Minister of Health.
p.002007: (2) When challenging the results of laboratory tests, repeated tests shall be made. They
p.002007: shall be made upon written request from the interested party made within 7 days from the date of
p.002007: obtaining the result of the original test.
p.002007: (3) The repeated tests under para. 2 shall be carried out by experts designated by the BDA Executive Director,
p.002007: who did not participate in the original test in the presence of an authorized representative of
p.002007: the interested party.
p.002007: Art. 274. (1) The conditions and the order for blocking and withdrawal of medicinal products which have shown non-compliance with
p.002007: the requirements for quality, safety and efficiency shall be laid down in an ordinance of the Minister of Agriculture and Forestry
p.002007: healthcare.
p.002007: (2) The conditions and procedure for the destruction, processing or use for other purposes of medicinal products
p.002007: products are defined in an ordinance of the Minister of Health.
p.002007: Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure
p.002007: proper validation of the processes of production and purification of medicinal products obtained from
...
p.002007: 3000 to 5000 BGN
p.002007: Art. 295. (1) (amend. - SG 98/10, in force from 01.01.2011, amended - SG, issue 102 of 2018)
p.002007: 01.01.2019) The violations under this law shall be established by acts drawn up by officials under Art. 267,
p.002007: para. 3.
p.002007: (2) (Supplemented, SG No. 84/2018, effective 12.10.2018, repealed - SG No. 102/2018)
p.002007: (3) (amend. - SG 98/10, in force from 01.01.2011, amended - SG, issue 102 of 2018, effective from 01.01.2019)
p.002007: The penal decrees are issued by the Minister of Health, by the Chief State Health
p.002007: inspector, by the chairman of the council under Art. 258, para. 1, by the BDA Executive Director and the Directors
p.002007: of the RHI, depending on the submission of the offending official.
p.002007: (4) (new - SG 102/08, in force from 01.01.2019) The penal decrees may also be issued by
p.002007: other officials authorized by the persons under para. 3, as the chairman of the council under Art. 258, para. 1
p.002007: may authorize another committee member.
p.002007: Art. 296. Drafting acts, issuing, appealing and executing criminal decrees
p.002007: are carried out in accordance with the Law on Administrative Offenses and Penalties.
p.002007: Art. 297. (Amended, SG No. 84/2018, effective 12.10.2018) (1) In the cases of Art. 281, 282, 283, 284, 285 and 287
p.002007: the penal authority also orders the withdrawal in favor of the State of the medicinal products subject to the
p.002007: the committed offense, under the conditions and in the order specified in the Administrative Offenses Act and
p.002007: penalties and in accordance with Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 February
p.002007: October 2013 establishing the Union Customs Code (OJ, L 269/1 of 10 October 2013) and
p.002007: Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed implementing rules
p.002007: rules for the implementation of certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the
p.002007: Of the Council establishing the Union Customs Code (OJ, L 343/558 of 29 December 2015).
p.002007: (2) The medicinal products under para. 1 shall be destroyed under the conditions and in the order of the ordinance post. 274, para. 2.
p.002007: Additional provisions
p.002007: § 1. For the purposes of this Act:
p.002007: 1. (amend. - SG 102/02, in force from 02.01.2013) А
p.002007: "substance" means any substance or mixture of
p.002007: substances intended for use in the manufacture of a medicinal product which when used
p.002007: in its manufacture, they become the active ingredient of this product, intended for the exercise of
p.002007: pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
p.002007: physiological functions or for medical diagnosis.
p.002007: 2. "Bioequivalence" is present when the medicinal products are pharmaceutically equivalent or
p.002007: pharmaceutical alternatives, and if their bioavailability after administration at the same molar dose are
p.002007: similar to such an extent that their efficacy and safety effects are significant
p.002007: similar.
p.002007: 3. "Bioavailability" means the speed and degree at which the active substance or the therapeutically active part thereof
p.002007: absorb from the dosage form and become available at the site of action. When the drug substance is
p.002007: intended to exert a systemic therapeutic effect, bioavailability means speed and degree, c
p.002007: which the drug substance or the therapeutically active part thereof is released from the dosage form and
p.002007: goes into general circulation.
p.002007: 4. (Amended, SG No. 84/2018) (*) "Researcher's Brochure" is a Researcher's Brochure within the meaning of Art.
p.002007: 2 (2), point 23 of Regulation (EU) No 536/2014.
p.002007: 5. "Valid documentation" shall mean documentation that in content and completeness meets the requirements,
p.002007: provided for in a particular procedure under this Act.
p.002007: 6. "Substance with well established use in medical practice" is a substance for which it can be used
p.002007: apply the following criteria:
p.002007: (a) the period of proof of well-established use in medical practice shall be not less than 10
p.002007: years from the date of the first systematic and documented use of the substance as a medicinal product
p.002007: product in the European Union or in the European Economic Area;
p.002007: (b) quantitative aspects of the use of the substance, taking into account the extent of use in the substance
p.002007: medical practice, the extent of geographical use and the degree of traceability through
p.002007: the safety system, including studies carried out before and afterwards and
p.002007: published scientific literature on epidemiological studies and in particular comparative epidemiological studies
p.002007: studies;
p.002007: (c) a high level of scientific interest in the use of the substance (number of scientific publications) and unity in
p.002007: scientific circles in scientific evaluations.
p.002007: 7. "Secondary packaging" is a packaging which does not come into direct contact with the medicinal product.
p.002007: 8. (Amended, SG No. 84/2018) (*) "Assignor" shall be a sponsor within the meaning of Art. 2 (2) (14)
p.002007: Regulation (EU) No 536/2014.
p.002007: 9. "Generic medicinal product" is a medicinal product which has the same qualitative and quantitative value
p.002007: composition with respect to the active substances and the same dosage form as the reference dosage form
p.002007: product, and its bioequivalence with the reference medicinal product has been demonstrated by appropriate tests for
p.002007: bioavailability. The various immediate-release oral dosage forms are considered to be one and the same
p.002007: same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or
p.002007: active substance derivatives are considered to be the same active substance unless they differ significantly
p.002007: for its safety and / or efficacy.
p.002007: 10. (Amended, SG No. 84/2018) (*) "Principal Investigator" is a Principal Investigator within the meaning of Art. 2,
p.002007: paragraph 2, point 16 of Regulation (EU) No 536/2014.
p.002007: 11. "Defined daily dose" is an average daily maintenance dose of a medicinal product that is
p.002007: administered to adults according to the primary indication of the medicinal product.
p.002007: 12. (Amended, SG No. 84/2018) (*) "Good clinical practice" is a good clinical practice within the meaning of Art. 2,
p.002007: paragraph 2, point 30 of Regulation (EU) No 536/2014.
p.002007: 13. "Good laboratory practice" is a system of internationally recognized rules regarding conditions
p.002007: for the planning, processes of organizing, executing, tracking and documenting the laboratory
p.002007: tests.
p.002007: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers
p.002007: all sides of production - personnel, premises, facilities, materials, documentation, quality
p.002007: control, and aims to ensure safety, efficiency and compliance with the specification.
p.002007: 15. (Supplemented, SG No. 71/2008, effective 12.08.2008) State
p.002007: "Member" means a Member State of the European Union
p.002007: union or country party to the Agreement on the European Economic Area.
p.002007: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002007: 17. "Immunological medicinal product" means a medicinal product containing vaccines, toxins, sera or
p.002007: allergens. The scope of vaccines, toxins and serums includes agents used to create
p.002007: active immunity, or to establish a state of immunity, or to induce passive immunity. Allergens
p.002007: are medicinal products that are intended to identify or stimulate a specific
p.002007: targeted change in the immunological response to the allergic agent.
p.002007: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002007: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically equivalent
p.002007: alternative, and when their bioavailability after administration at the same molar dose is similar to the extent that
p.002007: is a requirement for equivalent efficacy and safety.
p.002007: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and
p.002007: the extent to which the active substance or the therapeutically significant portion of the investigational medicinal product is tested
p.002007: reach from the dosage form into the systemic circulation.
p.002007: 20. (amend. - SG 84/2018) (*) "Tested medicinal product" is a tested medicinal product within the meaning of
p.002007: of Art. 2 (2) (5) of Regulation (EU) No 536/2014.
p.002007: 21. (Amended, SG No. 84/2018) (*) "Researcher" shall be a researcher within the meaning of Art. 2 (2) (15)
p.002007: Regulation (EU) No 536/2014.
...
p.002007: qualifications and who has the legal right to do so in the Member State where the medical is issued
p.002007: prescription.
p.002007: 36. (Repealed, SG No. 84/2018)
p.002007: 36a. (New, SG No. 84/2018, effective 12.10.2018) Network
p.002007: "and information security" is the protection of
p.002007: information from unauthorized or accidental access, use, disclosure to third parties, change
p.002007: or destruction.
p.002007: 37. "Medicinal product name" means the name given to the product, which may be:
p.002007: a) freely chosen name (trade name);
p.002007: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the trademark or name of
p.002007: the holder of the marketing authorization;
p.002007: c) (amend. - SG 12/11, in force from 08.02.2011) scientific name together with the trademark or the name of
p.002007: the holder of the marketing authorization.
p.002007: 38. "Scientific literature" is a publication / publications of research results in specialized
p.002007: international scientific publications.
p.002007: 38a. (new, SG No. 84/2018, effective 12.10.2018) Shortage
p.002007: "the medicinal product" is the shortage of
p.002007: medicinal products included in the Positive Medicinal List established by the specialized drug
p.002007: electronic system in accordance with Art. 217b.
p.002007: 39. "New active substance" is:
p.002007: (a) a chemical, biological or radiopharmaceutical substance which has not been authorized for use as
p.002007: medicinal product in the European Union;
p.002007: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that has been authorized for
p.002007: use as a medicinal product in the European Union but differs in safety and health
p.002007: its efficacy from a previously authorized substance;
p.002007: (c) a biological substance that has been authorized for use as a medicinal product in the European Union, but
p.002007: is of different molecular structure, of different origin with respect to the starting material or is obtained
p.002007: through a different production process;
p.002007: d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which are not
p.002007: have been authorized as a medicinal product in the European Union, or the pairing mechanism of
p.002007: molecules and radionuclides has not been authorized in the European Union.
p.002007: 40. (amended, SG No. 84/2018) (*) "Adverse event" is any adverse change in the health status.
p.002007: a condition observed when administering a medicinal product to a patient which is not necessarily causative
p.002007: related to this treatment.
p.002007: 41. (Am. - SG, iss. 102 in 2012, in force since 21.12.2012, amended - SG, iss. 84 of 2018. (*))
p.002007: reaction "is any adverse and unintended response to a medicinal product. The types of adverse drug reactions
p.002007: reactions are:
p.002007: a) (amended, SG No. 84/2018) (*) "unexpected" - adverse reaction not mentioned in the summary
p.002007: a characteristic of the product or whose character, weight or output does not correspond to those specified in the summary
p.002007: product characteristics;
p.002007: (b) "suspected" - an adverse reaction for which the notifier or marketing authorization holder
p.002007: use implies a possible cause and effect relationship with the medicinal product being administered;
p.002007: c) "serious" - any adverse effect on a health condition that has caused the death
p.002007: exit, immediate danger to life, hospitalization or prolongation of hospitalization,
p.002007: significant or permanent damage, disability and congenital anomalies;
p.002007: (d) combinations of reactions under letters "a", "b" and "c".
p.002007: 42. "Common name" means the international non-patent name of a medicinal or ancillary medicinal product
p.002007: substance (INN) recommended by the WHO; if not, the name in the European Pharmacopoeia is used, if and
p.002007: there is no other pharmacopoeial name; when there is no pharmacopoeial name, the usual accepted name is used.
p.002007: 42a. (new - SG 102/02, in force from 21.12.2012) Main
...
p.002007: 73. (amend. - SG 71/08, in force from 12.08.2008) p
p.002007: "an appropriate herbal medicinal product
p.002007: "medicinal product" is a product which contains the same active substances, regardless of the composition of
p.002007: excipients intended for the same purpose with an equivalent amount of the medicinal product
p.002007: substance / substances, with the same dosage and with the same or similar route of administration as the product, for
p.002007: who has applied.
p.002007: 74. An "adverse reaction message" is documented information about one or more
p.002007: suspected adverse reactions associated with the use of one or more medicinal products by one
p.002007: patient. For the validity of the adverse reaction message, they are required
p.002007: minimum identifier identifier data (initials or address or profession / specialty) of
p.002007: the patient (initials or age, or date of birth or gender), the adverse reaction / event, and
p.002007: the suspected medicinal product.
p.002007: 75. (Amended, SG No. 84/2018) (*) "Substantial change in the protocol of the clinical trial" is significant
p.002007: change within the meaning of Art. 2 (2) (13) of Regulation (EU) No 536/2014.
p.002007: 75a. (new, SG No. 102/2012, effective 21.12.2012) Substantial
p.002007: "changes to the
p.002007: non-interventional post-marketing research "are changes that affect safety,
p.002007: the physical or mental integrity of the patients or the results of the study and theirs
p.002007: interpretation.
p.002007: 76. (amend. - SG 71/08, in force from 12.08.2008)
p.002007: "reta country" is a non-state country -
p.002007: Member State of the European Union or not a State Party to the Agreement on the European Economic
p.002007: space.
p.002007: 77. "Wholesale" means all activities for the acquisition, storage, supply, import or export of
p.002007: medicinal products, except in the case of the supply of medicinal products directly to
p.002007: the population.
p.002007: 78. (Amended, SG No. 84/2018) (*) "Participant" shall be a participant within the meaning of Art. 2 (2) (17)
p.002007: Regulation (EU) No 536/2014.
p.002007: 79. (Repealed, SG No. 84/2018)
p.002007: 80. "Pharmacopoeia" is a collection of approved specifications and related production requirements,
p.002007: testing, storage and labeling of active substances, excipients, dosage forms,
p.002007: materials for packaging and components of the medicinal product.
p.002007: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product prepared in a pharmacy by a formulation
p.002007: operating pharmacopoeia and intended for delivery to patients at the same pharmacy.
p.002007: 81a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: "Counterfeit medicinal product" means any medicinal product in which it is misrepresented:
p.002007: (a) its identity, including particulars of the immediate packaging or its immediate packaging, its name or
p.002007: content with respect to any of its constituents, including excipients, and
p.002007: the amount of active substance per unit dose;
p.002007: (b) its source, including its manufacturer, the country in which it is manufactured, the country in which it is produced
p.002007: placed on the market, or the holder of his marketing authorization, or
p.002007: (c) the timing, including records and documents, of the supply chain used.
...
p.002007: 86. (new - SG 41/09, in force from 02.06.2009)
p.002007: "are children under 12 months of age.
p.002007: 87. (new - SG 41/09, in force from 02.06.2009) Food
p.002007: "infant formulas" means foods intended for infants
p.002007: specific nutritional use of infants during their first months, which alone are sufficient
p.002007: satisfy the nutritional needs of these infants until the introduction of a suitable supplement
p.002007: food.
p.002007: 88. (new - SG 41/09, in force from 02.06.2009) Transitional
p.002007: "food" means food intended for
p.002007: specific nutritional use of infants in the introduction of appropriate supplemental food and which
p.002007: are the staple liquid food from the progressively increasing variety of foods in these
p.002007: infants.
p.002007: 89. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "Type IA" is a change with minimal impact
p.002007: or without affecting the quality, safety or efficacy of the medicinal product concerned.
p.002007: 90. (new - SG 12/11, in force from 08.02.2011) Change
p.002007: "type IB" is a change that is neither type IA,
p.002007: neither a change of type II nor an extension of the marketing authorization.
p.002007: 91. (New, SG No. 12/2011, effective 08.02.2011) Change
p.002007: "type II" is a change that does not occur
p.002007: extending the scope of the marketing authorization and which may have a significant impact on
p.002007: the quality, safety or efficacy of the medicinal product concerned.
p.002007: 92. (new, SG No. 102/2012, effective 21.12.2012) Delegated
p.002007: "act" is an act within the meaning of Art. 290 of
p.002007: Treaty on the Functioning of the European Union.
p.002007: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
p.002007: § 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and updating of
p.002007: medicinal products stored by the State Agency for State Reserves and Wartime Stocks.
p.002007: § 4. (Supplemented, SG No. 18/2014) This Act introduces the provisions of Directive 2001/83 / EC of the European Union.
p.002007: Parliament and the Council on the approval of the Community code relating to medicinal products for human use,
p.002007: as last amended by Directive 2004/27 / EC of the European Parliament and of the Council and Directive 2012/26 / EU
p.002007: of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83 / EC
p.002007: on pharmacovigilance (OJ L 299/1 of 27 October 2012).
p.002007: § 5. The data protection periods for the reference medicinal products shall be applied in accordance with the provisions
p.002007: of Art. 89 of Regulation (EC) No 726/2004 of the European Parliament and of the Council and Art. 2 of Directive 2004/27 / EC
p.002007: of the European Parliament and of the Council.
p.002007: § 5a. (New, SG No. 60/2011, effective 30.09.2011) (1) (Amended, SG No. 102/2012, effective 01.04.2013,
p.002007: ed. - SG, issue. 85 of 2017) Ministry of Health, National Price Council and
p.002007: reimbursement of medicinal products, the Executive Agency for Medicines and Regional Health
p.002007: inspections shall provide an opportunity for the submission of information and the acceptance of applications and documents
p.002007: this Act electronically under the terms and conditions of the Electronic Document and Electronic Act
p.002007: certification services and the eGovernment Act.
p.002007: (2) The provision of information and the acceptance of applications and documents electronically shall be carried out
p.002007: after providing the appropriate technical and organizational conditions, as well as the relevant software
p.002007: products.
p.002007: Transitional and Final Provisions
p.002007: § 6. The Law on Medicines and Pharmacies in Human Medicine (promulgated, SG No. 36/1995; No. 61/1996)
p.002007: Constitutional Court Decision No. 10 of 1996; amend. 38 of 1998, issue. 30 of 1999, issue. 10 of 2000, issue.
p.002007: 37 of 2000 - Decision No. 3 of the Constitutional Court of 2000; amend. 59 of 2000, issue. 78 of 2000 -
p.002007: Constitutional Court Decision No. 7 of 2000; amend. 41 of 2001, issue. 107 and 120 of 2002; ref., issue 2 of
p.002007: 2003; amend. 56, 71 and 112 of 2003; 70 and 111 of 2004, nos. 37, 76, 85, 87, 99 and 105 of 2005; 30, 31,
p.002007: 34, 75 and 105 of 2006) shall be repealed, with the exception of the provision of Art. 10, para. 2, which shall apply until
p.002007: one year from the date of entry into force of this Act.
p.002007: § 7. (1) The marketing authorizations for medicinal products issued prior to the entry into force of this Act under
p.002007: national procedures, which are also authorized in the Member States under a centralized procedure, are
p.002007: shall cease with effect from 1 January 2007.
p.002007: (2) The marketing authorizations for medicinal products issued prior to the entry into force of this Act under
p.002007: national procedure shall be aligned with its requirements at the date of renewal.
p.002007: (3) Authorizations for the use of medicinal products covered by Regulation (EC) No
p.002007: 726/2004 of the European Parliament and of the Council and have been authorized for use under the repealed Act
p.002007: medicines and pharmacies in human medicine as substantially similar products, but are not authorized for
p.002007: use in the European Union under a centralized procedure shall cease.
p.002007: (4) Medicinal products authorized for use in the European Union by a centralized procedure which
p.002007: a national marketing authorization has been terminated in accordance with para. 1, can be sold in the territory
p.002007: of the Republic of Bulgaria in packs and leaflets in accordance with the terminated national authorization for
p.002007: use for a period not exceeding one year from the date of termination.
p.002007: § 8. (1) The approved marginal prices and the registered prices in the order of the repealed Medicines Act and
p.002007: pharmacies in the human medicine of medicinal products authorized for use in the European Union
p.002007: centralized procedure whose national marketing authorization is terminated pursuant to § 7, para. 1,
p.002007: shall remain in force for a period of one year from the date of termination.
p.002007: (2) The approved marginal prices and the registered prices in the order of the repealed Medicines and Pharmacies Act
p.002007: in the human medicine of medicinal products other than those of para. 1 shall remain in force until 31 December
p.002007: 2007
p.002007: § 9. (1) Applications for marketing authorization, renewal, amendment of an authorization granted to
p.002007: the entry into force of this Act shall be considered and concluded under the conditions and in the order provided for therein.
p.002007: (2) The applications and documentation submitted for the authorization of medicinal products which
p.002007: fall within the scope of the procedure under Art. 74, respectively under Art. 75, shall be aligned with the requirements
p.002007: of this law within three months of its entry into force.
p.002007: (3) When, within the term of para. 2 the application and documentation under para. 2 are not aligned with
p.002007: the requirements of this law, the procedure for considering them is terminated.
p.002007: § 10. (1) The clinical trials, approved until the entry into force of this Act, shall be completed according to the present
p.002007: ed.
p.002007: (2) Applications for conducting a clinical trial on the territory of the Republic of Bulgaria shall be submitted,
p.002007: shall be considered and concluded under the conditions and by the order of this law, after the entry into force of the ordinance under Art.
p.002007: 82, para. 3.
p.002007: (3) Applications for changes to authorized clinical trials submitted prior to the entry into force of this Act shall be
p.002007: they shall be considered and concluded under the conditions and in the order provided for therein.
...
p.002007: its entry into force.
p.002007: (4) The persons under para. 3 submit to the Ministry of Health an application for re-registration, to which
p.002007: apply:
p.002007: 1. application for authorization of retail sale of medicinal products by the persons of origin. 222,
p.002007: para. 1, according to the model approved by the Minister of Health;
p.002007: 2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration of
p.002007: the person under Art. 222, para. 1;
p.002007: 3. copy of the Law on Medicines and Pharmacies in the Human Medicine issued under the repealed order
p.002007: permission to open a pharmacy;
p.002007: 4. a certified copy of the employment contract or contract for the management of the pharmacy manager -
p.002007: in cases where such is required;
p.002007: 5. declaration by the persons under art. 222, para. 1 that the conditions under which the authorization was granted were maintained
p.002007: retail trade in medicinal products of the persons under para. 2;
p.002007: 6. document for a one-time fee of BGN 100
p.002007: § 67. Persons who have submitted prior to the entry into force of this law applications for re-registration under the procedure of revoked §
p.002007: 16 of the transitional and final provisions that will carry out their activities as required
p.002007: of this law shall be submitted to the Ministry of Health within three months of its entry into force
p.002007: the following documents:
p.002007: 1. an application in accordance with a model approved by the Minister of Health;
p.002007: 2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration
p.002007: or a certified copy of a similar document under the national law of a Member State of the European Union
p.002007: union, or under the law of another country party to the EEA Agreement
p.002007: space, according to Art. 222, para. 1;
p.002007: 3. an employment contract or a pharmacy management contract concluded with a master pharmacist or assistant;
p.002007: pharmacist.
p.002007: § 68. (1) Master pharmacist or assistant pharmacist who has received a permit for opening a pharmacy in accordance with the procedure
p.002007: to the repealed § 16 of the transitional and final provisions, may transpose the one issued
p.002007: permission of a person under art. 222, para. 1.
p.002007: (2) For carrying out the transfer the persons under para. 1 filed with the Ministry of Health
p.002007: application to which they attach:
p.002007: 1. application for authorization of retail sale of medicinal products by the persons of origin. 222,
p.002007: para. 1, according to the model approved by the Minister of Health;
p.002007: 2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration of
p.002007: the person under Art. 222, para. 1;
p.002007: 3. copy of the Law on Medicines and Pharmacies in the Human Medicine issued under the repealed order
p.002007: pharmacy permit or re-registration permit pursuant to the repealed § 16 of the
p.002007: transitional and final provisions;
p.002007: 4. a certified copy of the employment contract or management contract of the pharmacy manager;
p.002007: 5. declaration by the persons under art. 222, para. 1 that the conditions under which the authorization was granted were maintained
p.002007: retail trade in medicinal products of the persons under para. 1.
p.002007: (3) The transfer under para. 1 may be completed within one year from the entry into force of this Act.
...
p.002013: filed for the procedures under para. 1, as well as the archive of completed procedures.
p.002013: (4) By 31 March 2013, the Price and Reimbursement Commission shall provide the National Price and Reimbursement Committee with
p.002013: reimbursement of medicinal products with a transcript of the records kept by the Commission.
p.002013: § 131. (1) By March 20, 2013, the fees for submitting price confirmation / price caps,
p.002013: registration of prices for medicinal products to include, exclude or change medicinal products
p.002013: products on the Positive Medicinal List are collected by the Ministry of Health in size,
p.002013: determined in the tariff under Art. 21, para. 2.
p.002013: (2) The funds collected by March 20, 2013 under para. 1 shall be expended for the activities of the Commission
p.002013: prices and reimbursement of the Transparency Committee.
p.002013: § 132. Within three months of the entry into force of this Act, the Council of Ministers on a proposal from
p.002013: the Minister of Health:
p.002013: 1. appoints the chairman and members of the National Council for the prices and reimbursement of medicines
p.002013: products;
p.002013: 2. approve the rules of procedure of the National Council for Prices and Reimbursement of Medicinal Products.
p.002013: § 133. (1) Within two months from the entry into force of this law, the Council of Ministers shall amend the tariff under Art.
p.002013: 21, para. 2.
p.002013: (2) By 1 April 2013 the Council of Ministers shall adopt the ordinance under Art. 261a, para. 5.
p.002013: § 134. The obligations under art. 159, para. 4, Art. 168, para. 8, Art. 168a and 168b begin to run three years
p.002013: after the date of publication of the delegated acts under art. 54a of Directive 2001/83 / EC in the Official Journal
p.002013: newspaper "of the European Union.
p.002013: ...................................
p.002013: § 138. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of:
p.002013: 1. paragraph 9, item 1, letter "a", § 29 - 36, § 38 - 43, § 44 regarding Art. 167a, 167b, 167c, 167d, 167d, art. 167f, para. 1 and
p.002013: para. 2, item 1 and art. 167s, § 65 - 76, § 98, Vol. 1 and 2, § 101, Vol. 1, letters "a" and "b", § 102, 103, 106 - 108, 111, 116, § 117, Vol. 1,
p.002013: letters "a", "f", "g" and "l", which shall take effect from 2 January 2013;
p.002013: 2. paragraphs 20 and 117, item 2, which shall enter into force on 1 April 2013;
p.002013: 3. paragraph 44 concerning Art. 167f, para. 2, item 2 and para. 3 and Art. 167g, effective July 2, 2013.
p.002013: Transitional and Final Provisions
p.002013: TO THE PUBLIC FINANCE LAW
p.002013: (Promulgated - SG, issue 15 of 2013, in force since 01.01.2014)
p.002013: § 123. The law shall enter into force on January 1, 2014, with the exception of § 115, which shall enter into force on January 1, 2013, and
p.002013: § 18, § 114, § 120, § 121 and § 122, effective February 1, 2013.
p.002013: Transitional and Final Provisions
p.002013: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002013: (Official Gazette, SG No. 1/2004, IN EFFECT OF 03/01/2014)
p.002013: § 18. Within one month from the entry into force of this law, the Minister of Health shall
p.002013: in accordance with it the ordinance under art. 221, para. 1 of the Law on Medicinal Products in Human Medicine.
p.002013: § 19. The law shall enter into force on the day of its promulgation in the State Gazette.
p.002013: Transitional and Final Provisions
p.002013: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002013: INSURANCE
p.002013: Transitional and Final Provisions
p.002013: (Official Gazette, SG 48/15)
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.002007: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in the application for
p.002007: Marketing Authorization / Registration Certificate, Modification of the Marketing Authorization or
p.002007: its renewal.
p.002007: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002007: 1. medicinal products with restricted medical prescription, intended for use in certain medicinal products only
p.002007: specialized areas;
p.002007: 2. medicinal products - subject to special medical prescription;
p.002007: 3. medicinal products for multiple or single dispensing under the same medical prescription.
p.002007: Art. 173. Medicinal products that meet the following requirements are prescribed on medical prescription:
p.002007: 1. may present a direct or indirect danger to human health, even if used correctly, if
p.002007: apply without medical supervision;
p.002007: 2. they are frequently and very widely applied incorrectly and as a result can be a danger to
p.002007: human health;
p.002007: 3. contain substances the activity and / or side effects of which subsequently require
p.002007: additional study;
p.002007: 4. usually prescribed by a doctor for parenteral administration.
p.002007: Art. 174. Medicinal products are subject to special medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. contain narcotic substances within the meaning of the Drug Control Act; and
p.002007: precursors in permissible quantities;
p.002007: 2. if used improperly, they can create a significant risk of abuse, lead to a medicinal product
p.002007: dependency or use for illegal purposes;
p.002007: 3. contain new medicinal substances whose characteristics are not sufficiently known for this reason
p.002007: a preventive cause may be attributed to the group of medicinal products under item 2.
p.002007: Art. 175. Medicinal products are subject to limited medical prescription when they meet one of the
p.002007: the following conditions:
p.002007: 1. restricted to hospital use only because of limited experience in use or in the interest of
p.002007: public health;
p.002007: 2. intended for the treatment of conditions which can only be diagnosed in
p.002007: medical institutions, although their implementation and monitoring of the course of treatment may be
p.002007: carry out in other health establishments;
p.002007: 3. they are intended for the treatment of outpatients, but their use can be serious
p.002007: side effects requiring specialist prescription and monitoring during treatment.
p.002007: Art. 176. (1) The Executive Agency for Medicines may not approve the mail requested by the applicant. 26, para.
p.002007: 1 medication delivery regimen based on an assessment of:
p.002007: 1. the maximum single dose, the maximum daily dose, the amount of active substance in a single dose
p.002007: unit, dosage form, specific type of immediate packaging of the product, and / or
p.002007: 2. other specific conditions of use.
p.002007: (2) The Medicines Executive Agency may not specify the exact category of medicinal product under
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.002007: (2) (Repealed, SG No. 84/2018)
p.002007: (3) (Amended, SG No. 84/2018) (*) Informed consent under Chapter V of Regulation (EU) No 536/2014 may
p.002007: gives only a capable person who understands the nature, significance, scope and potential risks of
p.002007: the clinical trial. Informed consent to participate in a clinical trial may be withdrawn at
p.002007: anytime.
p.002007: (4) (Amended, SG No. 84/2018) (*) Informed consent under Chapter V of Regulation (EU) No 536/2014 for
p.002007: an invalid adult is given by his legal representative. The consent of the legal representative
p.002007: must represent the intended will of the participant and may be withdrawn at any time without
p.002007: negative consequences for the participant.
p.002007: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent is given by the court-appointed person.
p.002007: (6) The incapable adult shall be provided with information about the test, the possible risks and
p.002007: benefits in accordance with his ability to understand.
p.002007: (7) The explicit desire of the incapable adult to refuse to participate or to withdraw at any time
p.002007: the time of the clinical trial should be taken into account by the investigator and, if necessary, by the investigator
p.002007: the principal investigator.
p.002007: Art. 97. (1) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
p.002007: obtaining the written informed consent of both parents or guardians of the person at
p.002007: compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3.
p.002007: (2) The consent of the parents and guardians must represent the presumed will of the minor
p.002007: and may be withdrawn at any time without negative consequences for the minor.
p.002007: (3) The express wish of the minor to refuse to participate or to withdraw at any time from
p.002007: the clinical trial should be considered by the investigator and, if necessary, by the principal
p.002007: Explorer.
p.002007: (4) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
p.002007: obtaining written informed consent from the person or both parents or the guardian of
p.002007: compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3. When one parent is unknown,
p.002007: died or deprived of parental rights, or not granted such rights in cases of divorce,
p.002007: written informed consent is given by the minor and the parent who exercises
p.002007: parental rights.
p.002007: (5) The consent of the minor, the parents or the guardian may be withdrawn at any time
p.002007: time without negative consequences for the minor.
p.002007: (6) The express wish of the minor to withdraw at any time from the clinical trial must
p.002007: to be taken into account by the researcher and, if necessary, by the principal investigator.
p.002007: (7) The information of the minor or the minor shall be provided to the juvenile or minor
p.002007: risks and benefits in a way that is understandable to him by a doctor who has experience with minors.
p.002007: Art. 98. (Repealed, SG No. 84/2018)
p.002007: Art. 99. (Repealed, SG No. 84/2018)
p.002007: Section II.
p.002007: Clinical trial with vulnerable patient groups (Repealed, SG No. 84/2018)
p.002007: Section II.
p.002007: A clinical trial with vulnerable patient groups
p.002007: Art. 100. (Repealed, SG No. 84/2018)
p.002007: Art. 101. (Repealed, SG No. 84/2018)
p.002007: Art. 102. (Repealed, SG No. 84/2018)
p.002007: Section III.
p.002007: Ethical Committee for Clinical Trials (Title Amended, SG No. 84/2018)
p.002007: 12/10/2018)
p.002007: Section III.
p.002007: Ethics Committees
p.002007: Art. 103. (amend. - SG 84/08, in force from 12.10.2018) (1) To the Minister of Health shall be
p.002007: establish an Ethical Committee for Clinical Trials, the composition of which is determined by an order of the Minister of
p.002007: and includes regular and reserve members. The reserve members shall attend the meetings of the
p.002007: commission and have the right to vote in the absence of regular members.
p.002007: (2) The commission under para. 1 consists of 7 to 12 regular members, including the Chair and the Deputy
p.002007: a chairman with the qualifications and experience to review and evaluate scientific, medical and ethical
p.002007: aspects of the proposed clinical trial. Requirements for the qualification of members of the Commission
p.002007: under para. 1, as well as the terms and procedure for determining the composition of the commission shall be settled by
p.002007: the rules of art. 106, para. 1.
p.002007: (3) The commission under para. 1 includes at least two full-time non-medical members -
...
Social / education
Searching for indicator education:
(return to top)
p.002007: route of administration and proposed shelf life;
p.002007: 6. precautions and safety measures for the storage of the product, for its administration to patients and
p.002007: in the event of disposal of the product waste, accompanied by an indication of the potential risks of
p.002007: the medicinal product for the environment;
p.002007: 7. description of the production method;
p.002007: 8. description of the control methods used by the manufacturer;
p.002007: 8a. (new - SG 102/2012, in force from 02.01.2013) declaration that the results of the audit are 160, para. 2,
p.002007: conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
p.002007: compliance with the principles and guidelines for Good Manufacturing Practice; the declaration shall state
p.002007: the date on which the audit was conducted;
p.002007: 9. assessment of the potential risk of the medicinal product for the environment on a case-by-case basis and measures,
p.002007: intended to limit it;
p.002007: 10. results from:
p.002007: (a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.002007: (b) preclinical (toxicological and pharmacological) studies;
p.002007: (c) clinical trials;
p.002007: 11. a statement that they have been complied with in clinical trials conducted outside the territory of the Member States
p.002007: ethical principles of Good Clinical Practice;
p.002007: 12. (amend. - SG 102/2012, in force from 21.12.2012) summary of the traceability system
p.002007: drug safety, which includes the following elements:
p.002007: a) the name of the qualified person under Art. 191, Curriculum Vitae - Education acquired by professional experience in
p.002007: the field of pharmacovigilance monitoring and the qualification for fulfilling his duties
p.002007: in the order of Chapter Eight;
p.002007: (b) any Member State in which the qualified person fulfills his duties;
p.002007: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002007: (d) the address at which the basic document of the medication traceability system is stored
p.002007: safety;
p.002007: 12a. (new - SG 102/2012, in force since 21.12.2012) declaration by the applicant that he has at his disposal
p.002007: the necessary means to fulfill the obligations of Chapter Eight;
p.002007: 13. (amend. - SG 102/2012, in force from 21.12.2012) risk management plan with description of the system
p.002007: for risk management to be introduced by the applicant for the medicinal product concerned, together with a summary of
p.002007: the plan;
p.002007: 14. a brief description of the product according to Art. 34;
p.002007: 15. layout of the primary and secondary packaging of the product and a leaflet in accordance with
p.002007: the requirements of Chapter Six;
p.002007: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country in which it is located
p.002007: carry out the production accompanied by a certificate of good manufacturing practice or a certificate,
p.002007: certifying that the manufacture of the medicinal product and of its active substances is
p.002007: performed in accordance with standards at least equivalent to Good Manufacturing standards
p.002007: practice;
p.002007: 17. a copy of the document by which the medicinal product is designated for treatment, prophylaxis or diagnosis
...
p.002007: manufacturing practice in the European Union database.
p.002007: Art. 148. To obtain a manufacturing authorization, the person mailed. 146 must have:
p.002007: 1. with personnel with appropriate qualification, depending on the specificity of the species produced
p.002007: medicines and dosage forms;
p.002007: 2. at any time with at least one qualified person eligible for post. 159;
p.002007: 3. premises for production, control and storage of the medicinal products, provided with the necessary
p.002007: technical equipment and control laboratories.
p.002007: Art. 149. Heads of production and quality control of medicinal products in
p.002007: manufacturing enterprises are persons:
p.002007: 1. who have a master's degree in pharmacy, chemistry
p.002007: or "biology" and at least two years of practical experience in pharmaceutical manufacturing;
p.002007: 2. which meet the requirements of item 1 and have an additional recognized specialty in radiobiology or
p.002007: radiochemistry - for radiopharmaceuticals or for medicinal products subject to ionizing radiation;
p.002007: 3. with recognized specialty in clinical hematology, medical microbiology, virology or immunology
p.002007: - for the production of immunological medicinal products - vaccines, toxins, serums, for biotechnological products
p.002007: products and for medicinal products derived from human plasma or from human blood.
p.002007: Art. 150. (1) The person under art. 146 shall submit to the BDA an application in accordance with a model approved by the Director of the Agency.
p.002007: (2) Together with the application under para. 1 the applicant shall also submit:
p.002007: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002007: specialty, work record, criminal record or similar person document, if not
p.002007: is a Bulgarian citizen, and an employment contract for the persons under Art. 148, item 2 and art. 149;
p.002007: 2. copies of contracts for the assignment of production and / or control of the products declared for production - in
p.002007: the cases under Art. 151;
p.002007: 3. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
p.002007: for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
p.002007: registered in a Member State of the European Union, or in a State Party to the
p.002007: European Economic Area - a document for current national registration
p.002007: legislation issued by a competent authority of the country concerned;
p.002007: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: a list of the manufacturing activities and the dosage forms to be manufactured;
p.002007: 5. schemes of the premises for production, control and storage and file of the production capacity;
p.002007: 6. assessment of the environmental impact of the manufacture of medicinal products in accordance with the provisions of Art
p.002007: Environmental Protection Act cases;
p.002007: 7. permission from the Nuclear Regulatory Agency when the application concerns the production of
p.002007: radiopharmaceuticals or medicinal products subject to ionizing radiation during manufacture
p.002007: them;
...
p.002007: the proper storage, distribution and transport of medicinal products in accordance with
p.002007: the requirements of Good Distribution Practice;
p.002007: 2. Qualified staff and responsible Master of Pharmacy with at least two years of work experience
p.002007: the specialty whose obligations are defined in the ordinance under Art. 198.
p.002007: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.002007: the distribution practices of medicinal products and active substances are adopted by an ordinance of the Minister
p.002007: health and with guidelines adopted by the European Commission.
p.002007: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002007: 1. an application containing the name, registered office and address of management of the trader; address and description
p.002007: premises and facilities for storage of medicinal products;
p.002007: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: country;
p.002007: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar
p.002007: document of the person, if not a Bulgarian citizen, diploma for higher education and document for work experience
p.002007: of the responsible master pharmacist under Art. 197, item 2 and a copy of his employment contract;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 6. a document certifying the legal basis for the use of the premises;
p.002007: 7. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 84 of 2018, effective from 12.10.2018)
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002007: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a Member State;
p.002007: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002007: 3. the address of the premises for the storage of medicinal products in the territory of the Member States.
p.002007: (3) In the wholesale trade in narcotic substances and in dosage forms containing such substances,
p.002007: the requirements of the Narcotic Drugs and Precursors Control Act also apply.
p.002007: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Nuclear Regulatory Agency.
p.002007: (5) (New, SG No. 103/2017, effective 01/01/2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the person under para. 1, item 3, when he is a Bulgarian citizen.
p.002007: Art. 200. The Executive Agency for Medicines shall evaluate the documentation and carry out an on-the-spot check
...
p.002007: products, opening a drugstore, have all natural and legal persons registered under the Commercial
p.002007: law or under the law of a Member State.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore shall be medical
p.002007: specialist who:
p.002007: 1. is not deprived of the right to practice his profession;
p.002007: 2. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crimes against the individual;
p.002007: 3. have at least one year of experience in the specialty.
p.002007: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened upon registration in
p.002007: the relevant REI.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) 238, para. 2 shall be submitted to the relevant RHI
p.002007: application for registration, to which the following documents are attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 238, para. 1;
p.002007: 2. (suppl. - SG 103/07, in force from 01.01.2018) document for education and criminal record of
p.002007: the person designated as the head of the drugstore, if not a Bulgarian citizen;
p.002007: 3. the medical certificate of the person under item 2;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 6. document for paid state fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para.
p.002007: 2 The Regional Inspectorate shall carry out an inspection on compliance with the requirements of the ordinance under Art. 243. Where
p.002007: establish that the requirements of the ordinance under Art. 243, within 7 days from the completion of the inspection
p.002007: The RII prescribes and sets a time limit for their removal.
p.002007: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application and
p.002007: the documents under para. 2, the Director of the RII shall notify the person in writing of the incompleteness found therein and
p.002007: sets a time limit for their removal.
p.002007: (5) (New, SG No. 60/2011, effective 05.08.2011) For filing an application for registration of a drugstore
p.002007: or to effect a change under Art. 242 the respective SIC collects fees in the amount determined by the tariff under
p.002007: Art. 21, para. 2.
p.002007: (6) (New - SG 103 2017, in force from 01.01.2018) The Bulgarian Food Safety Agency
p.002007: establish ex officio the circumstances regarding the criminal record of the person under para. 2, item 2, when it is Bulgarian
p.002007: citizen.
...
Searching for indicator educational:
(return to top)
p.002007: consumers about actions taken against counterfeiting of medicinal products;
p.002007: 4. performs other activities specified by law.
p.002007: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: Art. 15. (1) A Pharmacopoeial Committee shall be established with the Minister of Health as an advisory body on
p.002007: the issues of the current pharmacopoeia.
p.002007: (2) On the proposal of the BDA Executive Director, the Minister of Health shall designate with
p.002007: order of the composition of the Pharmacopoeia Committee and of the expert groups attached thereto, and approves the regulations for
p.002007: their activity.
p.002007: (3) The activities of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
p.002007: Art. 16. (1) (Supplemented, SG No. 91/2018) A Supreme Council shall be established at the Minister of Health.
p.002007: pharmacy, which includes five representatives appointed by the Minister of Health, five
p.002007: representatives of the Bulgarian Pharmaceutical Union, one representative of the Bulgarian Association of Pharmaceuticals
p.002007: Assistant Pharmacists, two representatives of the National Health Insurance Fund (NHIF) and one each
p.002007: representative of the faculties of pharmacy at medical colleges. The Minister of
p.002007: healthcare is chairman of the non-voting council.
p.002007: (2) The High Pharmacy Council is an advisory body that deliberates and gives opinions on:
p.002007: 1. the main directions and priorities in the field of pharmacy;
p.002007: 2. ethical problems of pharmacy;
p.002007: 3. draft legislative acts related to pharmacy;
p.002007: 4. scientific priorities in the field of pharmacy;
p.002007: 5. programs for organizing public educational campaigns in the field of medicinal products.
p.002007: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: (4) The organization and activities of the Supreme Pharmacy Council shall be governed by regulations issued by the Minister.
p.002007: of Health at the proposal of the High Pharmacy Council.
p.002007: Art. 17. (1) The Executive Agency for Medicines shall be a specialized body to the Minister of Health
p.002007: healthcare to oversee the quality, safety and efficacy of medicines.
p.002007: (2) (Amended, SG No. 15/2013, effective 01/01/2014) The Executive Agency for Medicines shall be legally
p.002007: budget support person based in Sofia to the Minister of Health.
p.002007: (3) The Executive Agency for Medicines shall be managed and represented by an Executive Director, who shall
p.002007: appoint by the order of the Law on Administration.
p.002007: (4) The structure, functions and organization of work of the BDA shall be laid down in the Rules of Procedure adopted by
p.002007: The Council of Ministers.
p.002007: (5) The Medicines Executive Agency shall:
p.002007: 1. issues authorizations for the manufacture of medicinal products;
p.002007: 2. issues marketing authorizations and certificates for registration of medicinal products;
p.002007: 3. (suppl. - SG 71/08, in force from 12.08.2008) issue licenses and certificates for wholesale trade
p.002007: with medicinal products;
p.002007: 4. issue permits for parallel import of medicinal products;
p.002007: 5. (amend. - SG 60/11, in force from 05.08.2011) issue, refuse or terminate marketing authorizations
p.002007: retail of medicinal products;
p.002007: 5a. (new - SG 102/2012, in force from 21.12.2012) shall enter the manufacturers, importers and traders of
p.002007: wholesale of active substances;
p.002007: 5b. (new - SG 102/2012, in force from 21.12.2012) keep a register of the persons, carrying out
...
Social / employees
Searching for indicator employees:
(return to top)
p.002007: parallel import authorization;
p.002007: 6. (new - SG 48/15, amend. - SG 102/2018) one hundred and eighty days when
p.002007: an application for inclusion in the Positive Medicines List of a new medicinal product has been submitted
p.002007: an international non-proprietary name that is subject to health technology assessment;
p.002007: 7. (new, SG No. 48/2015) sixty days when an application for maintaining the reimbursement has been submitted
p.002007: status of included medicinal product in the Positive Medicinal List;
p.002007: 8. (new - SG 102/2018) ninety days when the application for
p.002007: expanding the indications for a product that is not currently on the Positive Medicinal List
p.002007: paid;
p.002007: 9. (new - SG 102/2018) ninety days when an application for assessment has been submitted
p.002007: of health technology.
p.002007: (2) For the medicinal products under Art. 262, para. 5 the council shall act within thirty days, when it is
p.002007: application for price approval under art. 261a, para. 1 and including the product in the Positive
p.002007: medication list.
p.002007: (3) The time limits under para. 1 and 2 shall commence on the date of submission of an application in accordance with the procedure of the postal order.
p.002007: 261a, para. 5.
p.002007: Art. 259c. (New, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 102/2012, effective 21.12.2012
p.002007: d)
p.002007: Art. 259g. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012, effective 21.12.2012)
p.002007: Art. 260. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: The authorities, officials and applicants under this chapter are obliged to assist the
p.002007: the Board and its employees in the performance of their assigned duties.
p.002007: Art. 261. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: (1) The members of the council and its employees shall be obliged not to disclose circumstances and facts that have occurred.
p.002007: known to them upon or in connection with the performance of their official duties under this Act, except in writing
p.002007: a request from a public authority when provided for by law.
p.002007: (2) In connection with their obligations under para. 1 persons sign a declaration in the form approved by
p.002007: the chairman of the board.
p.002007: Section II.
p.002007: Regulation and registration of the prices of medicinal products. Treatment algorithms
p.002007: with medicinal products. Health Technology Assessment. (New, SG No. 102/2012)
p.002007: force dated 21.12.2012, title ext. - SG, issue. 102 of 2018, effective January 1, 2019)
p.002007: Section II.
p.002007: Regulation and registration of the prices of medicinal products. Treatment algorithms
p.002007: with medicinal products (New, SG No. 102/2012, effective 21.12.2012)
p.002007: Art. 261a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102 of 2012, effective 21.12.2012
p.002007: d. (1) The Council shall regulate the prices of the medicinal products included in the Positive Medicinal List under Art.
p.002007: 262, para. 1 and paid with public funds, in accordance with the lowest country reference prices
p.002007: member states.
p.002007: (2) the Council regulates the marginal prices of medicinal products subject to medical prescription,
p.002007: beyond those of para. 1 according to the lowest reference prices of Member States.
p.002007: (3) The Council registers maximum retail selling prices for medicinal products to be marketed
p.002007: without a prescription.
p.002007: (4) The price determined in accordance with the procedure of para. 1, is also the marginal price of medicinal products when sold to
p.002007: retail.
...
Social / gender
Searching for indicator gender:
(return to top)
p.002007: application, contraindications and warnings resulting from new information related to
p.002007: safe use of the medicinal product.
p.002007: 71. "Spontaneous message" is a voluntarily sent message for a suspected adverse reaction to
p.002007: the use of the medicinal product by the Marketing Authorization Holder, the market surveillance authorities
p.002007: medicinal products or other organizations not derived from research or other organized
p.002007: information collection system.
p.002007: 72. "Shelf life of a medicinal product" is the interval of time when, if stored
p.002007: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002007: the basis of stability studies of several batches of finished form.
p.002007: 73. (amend. - SG 71/08, in force from 12.08.2008) p
p.002007: "an appropriate herbal medicinal product
p.002007: "medicinal product" is a product which contains the same active substances, regardless of the composition of
p.002007: excipients intended for the same purpose with an equivalent amount of the medicinal product
p.002007: substance / substances, with the same dosage and with the same or similar route of administration as the product, for
p.002007: who has applied.
p.002007: 74. An "adverse reaction message" is documented information about one or more
p.002007: suspected adverse reactions associated with the use of one or more medicinal products by one
p.002007: patient. For the validity of the adverse reaction message, they are required
p.002007: minimum identifier identifier data (initials or address or profession / specialty) of
p.002007: the patient (initials or age, or date of birth or gender), the adverse reaction / event, and
p.002007: the suspected medicinal product.
p.002007: 75. (Amended, SG No. 84/2018) (*) "Substantial change in the protocol of the clinical trial" is significant
p.002007: change within the meaning of Art. 2 (2) (13) of Regulation (EU) No 536/2014.
p.002007: 75a. (new, SG No. 102/2012, effective 21.12.2012) Substantial
p.002007: "changes to the
p.002007: non-interventional post-marketing research "are changes that affect safety,
p.002007: the physical or mental integrity of the patients or the results of the study and theirs
p.002007: interpretation.
p.002007: 76. (amend. - SG 71/08, in force from 12.08.2008)
p.002007: "reta country" is a non-state country -
p.002007: Member State of the European Union or not a State Party to the Agreement on the European Economic
p.002007: space.
p.002007: 77. "Wholesale" means all activities for the acquisition, storage, supply, import or export of
p.002007: medicinal products, except in the case of the supply of medicinal products directly to
p.002007: the population.
p.002007: 78. (Amended, SG No. 84/2018) (*) "Participant" shall be a participant within the meaning of Art. 2 (2) (17)
p.002007: Regulation (EU) No 536/2014.
p.002007: 79. (Repealed, SG No. 84/2018)
p.002007: 80. "Pharmacopoeia" is a collection of approved specifications and related production requirements,
p.002007: testing, storage and labeling of active substances, excipients, dosage forms,
p.002007: materials for packaging and components of the medicinal product.
p.002007: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product prepared in a pharmacy by a formulation
p.002007: operating pharmacopoeia and intended for delivery to patients at the same pharmacy.
...
Social / orphan
Searching for indicator orphan:
(return to top)
p.002019: COMMISSION REGULATION (EC) No 1234/2008 of 24 November 2008 on the examination of
p.002019: changes in the terms of marketing authorizations for medicinal products for human use and
p.002019: veterinary medicinal products
p.002019: REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007
p.002019: on advanced therapy medicinal products and amending Directive 2001/83 / EC and Regulation
p.002019: (EC) No 726/2004
p.002019: REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006
p.002019: on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92,
p.002019: Directive 2001/20 / EC, Directive 2001/83 / EC and Regulation (EC) No 726/2004
p.002019: REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004
p.002019: establishing Community procedures for the authorization and control of medicinal products for human and
p.002019: veterinary use and to set up a European Medicines Agency
p.002019: COMMISSION REGULATION (EC) No 1085/2003 of 3 June 2003 examining changes to the
p.002019: the terms of the marketing authorizations for medicinal products for human use and veterinary use
p.002019: medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (repealed)
p.002019: COMMISSION REGULATION (EC) No 1084/2003 of 3 June 2003 examining changes to the
p.002019: the terms of the marketing authorizations for medicinal products for human use and veterinary use
p.002019: medicinal products supplied by a competent authority of a Member State (repealed)
p.002019: COMMISSION REGULATION (EC) No 847/2000 of 27 April 2000 laying down provisions for the
p.002019: application of the criteria for designating a medicinal product as an orphan medicinal product and for
p.002019: defining the terms "similar medicinal product" and "clinical superiority"
p.002019: REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 1999
p.002019: orphan drugs
p.002019: COUNCIL REGULATION (Council of the European Community) No 2309/93 of 22 July 1993 establishing
p.002019: the Community procedure for granting authorizations (licenses) and the supervision of medicinal products
p.002019: used in human and veterinary medicine, and a European Assessment Agency is established
p.002019: Medicines (Repealed)
p.002019: COUNCIL REGULATION (EEC) No 1768/92 of 18 June 1992 establishing a certificate for the
p.002019: additional protection of medicinal products (repealed)
p.002019: This site
p.002019: © Lex.bg Used
p.002019: | terms of cookies
p.002019: | privacy policy. Learn more
...
Social / parents
Searching for indicator parent:
(return to top)
p.002007: the principal investigator.
p.002007: Art. 97. (1) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
p.002007: obtaining the written informed consent of both parents or guardians of the person at
p.002007: compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3.
p.002007: (2) The consent of the parents and guardians must represent the presumed will of the minor
p.002007: and may be withdrawn at any time without negative consequences for the minor.
p.002007: (3) The express wish of the minor to refuse to participate or to withdraw at any time from
p.002007: the clinical trial should be considered by the investigator and, if necessary, by the principal
p.002007: Explorer.
p.002007: (4) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
p.002007: obtaining written informed consent from the person or both parents or the guardian of
p.002007: compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3. When one parent is unknown,
p.002007: died or deprived of parental rights, or not granted such rights in cases of divorce,
p.002007: written informed consent is given by the minor and the parent who exercises
p.002007: parental rights.
p.002007: (5) The consent of the minor, the parents or the guardian may be withdrawn at any time
p.002007: time without negative consequences for the minor.
p.002007: (6) The express wish of the minor to withdraw at any time from the clinical trial must
p.002007: to be taken into account by the researcher and, if necessary, by the principal investigator.
p.002007: (7) The information of the minor or the minor shall be provided to the juvenile or minor
p.002007: risks and benefits in a way that is understandable to him by a doctor who has experience with minors.
p.002007: Art. 98. (Repealed, SG No. 84/2018)
p.002007: Art. 99. (Repealed, SG No. 84/2018)
p.002007: Section II.
p.002007: Clinical trial with vulnerable patient groups (Repealed, SG No. 84/2018)
p.002007: Section II.
p.002007: A clinical trial with vulnerable patient groups
p.002007: Art. 100. (Repealed, SG No. 84/2018)
p.002007: Art. 101. (Repealed, SG No. 84/2018)
p.002007: Art. 102. (Repealed, SG No. 84/2018)
p.002007: Section III.
p.002007: Ethical Committee for Clinical Trials (Title Amended, SG No. 84/2018)
p.002007: 12/10/2018)
p.002007: Section III.
p.002007: Ethics Committees
...
Searching for indicator parents:
(return to top)
p.002007: gives only a capable person who understands the nature, significance, scope and potential risks of
p.002007: the clinical trial. Informed consent to participate in a clinical trial may be withdrawn at
p.002007: anytime.
p.002007: (4) (Amended, SG No. 84/2018) (*) Informed consent under Chapter V of Regulation (EU) No 536/2014 for
p.002007: an invalid adult is given by his legal representative. The consent of the legal representative
p.002007: must represent the intended will of the participant and may be withdrawn at any time without
p.002007: negative consequences for the participant.
p.002007: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent is given by the court-appointed person.
p.002007: (6) The incapable adult shall be provided with information about the test, the possible risks and
p.002007: benefits in accordance with his ability to understand.
p.002007: (7) The explicit desire of the incapable adult to refuse to participate or to withdraw at any time
p.002007: the time of the clinical trial should be taken into account by the investigator and, if necessary, by the investigator
p.002007: the principal investigator.
p.002007: Art. 97. (1) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
p.002007: obtaining the written informed consent of both parents or guardians of the person at
p.002007: compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3.
p.002007: (2) The consent of the parents and guardians must represent the presumed will of the minor
p.002007: and may be withdrawn at any time without negative consequences for the minor.
p.002007: (3) The express wish of the minor to refuse to participate or to withdraw at any time from
p.002007: the clinical trial should be considered by the investigator and, if necessary, by the principal
p.002007: Explorer.
p.002007: (4) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
p.002007: obtaining written informed consent from the person or both parents or the guardian of
p.002007: compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3. When one parent is unknown,
p.002007: died or deprived of parental rights, or not granted such rights in cases of divorce,
p.002007: written informed consent is given by the minor and the parent who exercises
p.002007: parental rights.
p.002007: (5) The consent of the minor, the parents or the guardian may be withdrawn at any time
p.002007: time without negative consequences for the minor.
p.002007: (6) The express wish of the minor to withdraw at any time from the clinical trial must
p.002007: to be taken into account by the researcher and, if necessary, by the principal investigator.
p.002007: (7) The information of the minor or the minor shall be provided to the juvenile or minor
p.002007: risks and benefits in a way that is understandable to him by a doctor who has experience with minors.
p.002007: Art. 98. (Repealed, SG No. 84/2018)
p.002007: Art. 99. (Repealed, SG No. 84/2018)
p.002007: Section II.
p.002007: Clinical trial with vulnerable patient groups (Repealed, SG No. 84/2018)
p.002007: Section II.
p.002007: A clinical trial with vulnerable patient groups
p.002007: Art. 100. (Repealed, SG No. 84/2018)
p.002007: Art. 101. (Repealed, SG No. 84/2018)
p.002007: Art. 102. (Repealed, SG No. 84/2018)
p.002007: Section III.
p.002007: Ethical Committee for Clinical Trials (Title Amended, SG No. 84/2018)
p.002007: 12/10/2018)
p.002007: Section III.
p.002007: Ethics Committees
p.002007: Art. 103. (amend. - SG 84/08, in force from 12.10.2018) (1) To the Minister of Health shall be
p.002007: establish an Ethical Committee for Clinical Trials, the composition of which is determined by an order of the Minister of
p.002007: and includes regular and reserve members. The reserve members shall attend the meetings of the
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.002007: in the order of Chapter Eight;
p.002007: (b) any Member State in which the qualified person fulfills his duties;
p.002007: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002007: (d) the address at which the basic document of the medication traceability system is stored
p.002007: safety;
p.002007: 12a. (new - SG 102/2012, in force since 21.12.2012) declaration by the applicant that he has at his disposal
p.002007: the necessary means to fulfill the obligations of Chapter Eight;
p.002007: 13. (amend. - SG 102/2012, in force from 21.12.2012) risk management plan with description of the system
p.002007: for risk management to be introduced by the applicant for the medicinal product concerned, together with a summary of
p.002007: the plan;
p.002007: 14. a brief description of the product according to Art. 34;
p.002007: 15. layout of the primary and secondary packaging of the product and a leaflet in accordance with
p.002007: the requirements of Chapter Six;
p.002007: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country in which it is located
p.002007: carry out the production accompanied by a certificate of good manufacturing practice or a certificate,
p.002007: certifying that the manufacture of the medicinal product and of its active substances is
p.002007: performed in accordance with standards at least equivalent to Good Manufacturing standards
p.002007: practice;
p.002007: 17. a copy of the document by which the medicinal product is designated for treatment, prophylaxis or diagnosis
p.002007: rare diseases, accompanied by a copy of the opinion of the European Medicines Agency;
p.002007: 18. copies of any marketing authorization issued in another Member State or in a third country for
p.002007: the medicinal product for which authorization is sought;
p.002007: 18a. (new - SG 102/2012, in force since 21.12.2012) copy of the summary of the safety data,
p.002007: including data contained in, and where relevant, periodic safety update reports
p.002007: suspected adverse reactions have been reported;
p.002007: 19. a list of the Member States in which an application for a marketing authorization has been submitted
p.002007: medicine;
p.002007: 20. (amend. - SG 71/08, in force from 12.08.2008) a copy of the summary of product characteristics,
p.002007: proposed by the person under Art. 26, para. 1, or a copy of the summary of product characteristics approved by
p.002007: a regulatory authority of a Member State (s) already authorized;
p.002007: 21. a copy of the refusal of the marketing authorization in a Member State or in a third country,
p.002007: accompanied by motives; information on suspension or termination of the authorization
p.002007: for use;
p.002007: 22. a copy of the proposed leaflet for the patient, accompanied by a summary of the results of the evaluation of
p.002007: the level of readability of the contents of the package leaflet from a patient-selected target group,
p.002007: or a copy of a leaflet approved by a regulatory authority of a Member State which has already granted a marketing authorization;
p.002007: 23. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2;
p.002007: 24. (new - SG 71/08, in force from 26.07.2008) the documents shall be sent. 7 of Regulation (EC) No 1901/2006.
...
p.002007: 2. (amend. - SG 71/08, in force from 12.08.2008) a brief description of the product, except for
p.002007: the data under Art. 34, para. 1, Vol. 5;
p.002007: 3. in the case of a herbal medicinal product within the meaning of Art. 37, para. 2 or the combined vegetable
p.002007: medicinal product - the information under art. 37, para. 1, item 5 for the combination; when the individual active substances
p.002007: the combined product is not sufficiently known, data on the traditional use of each is provided
p.002007: from them;
p.002007: 4. a copy of the marketing authorization or the registration certificate of the herbal medicinal product,
p.002007: issued by a Member State or a third country and / or a copy of the refusal, accompanied by the reasons for the decision;
p.002007: 5. (amend. - SG 71/08, in force from 12.08.2008) bibliographic data or expert opinions which
p.002007: prove that the herbal medicinal product for which application for registration is submitted, or
p.002007: the corresponding product has at least 30 years of use in world medical practice, by
p.002007: which have been in use in the territory of a Member State for at least 15 years before the date on which the application is submitted
p.002007: registration;
p.002007: 6. bibliographic data on product safety, accompanied by an expert report;
p.002007: 7. a copy of the manufacturing authorization, accompanied by a certificate of good manufacturing practice or
p.002007: with a certificate proving that the product was manufactured under conditions equivalent to the Good requirements
p.002007: manufacturing practice.
p.002007: (2) The Executive Agency for Medicinal Products may request from the applicant additional information for evaluation
p.002007: of the safety of the medicinal product under para. 1.
p.002007: (3) The Executive Agency for Medicinal Products may request an opinion from the Committee on Herbs
p.002007: medicinal products to the European Medicines Agency regarding the accuracy of the data under para. 1,
p.002007: item 5 by providing him with the necessary parts of the dossier of the medicinal product.
p.002007: (4) The submitted data under para. 1, item 5 shall also be valid in cases where during the 30-year period of use in
p.002007: medical practice:
p.002007: 1. the relevant medicinal product of the product for which the application for registration was submitted was on
p.002007: the market without authorization or registration for use, or
p.002007: 2. where the number of ingredients in the medicinal product for which an application for registration is submitted is
p.002007: reduced or reduced in unit dosage.
p.002007: Art. 39. (1) Where the herbal medicinal product has been on the Community market for less than 15 years, but
p.002007: meets the conditions of Art. 37, para. 1, the BDA shall submit for the opinion the documentation under Art. 38, para. 1 on
p.002007: Committee for Herbal Medicinal Products of the European Medicines Agency.
p.002007: (2) The Executive Agency for Medicines shall take a final decision after the publication of the monograph
p.002007: by the committee under para. 1 for compliance of the product with the registration criteria for traditional use.
p.002007: (3) In the cases of para. 1 the term under Art. 44 stops running.
p.002007: Art. 40. The Medicines Executive Agency may require the applicant for a herbal medicinal product
p.002007: product to submit documentation under Art. 27 - 32 or under Art. 35.
p.002007: Art. 41. (1) (amend. - SG 71/08, in force from 12.08.2008) The Executive Agency for Medicines
p.002007: publish on its website a list of herbal substances, preparations or combinations thereof,
p.002007: used in traditional herbal medicinal products prepared by the Committee on Herbs
p.002007: medicinal products to the European Medicines Agency. The list contains for each plant
p.002007: substance therapeutic indications, active ingredient content per unit dose and dosage route of
p.002007: introduction and other information necessary for the safe use of the herbal substance such as
p.002007: traditional medicinal product.
p.002007: (2) Where the product for registration in the application for registration for traditional use contains a vegetable
p.002007: substance, preparation or combination thereof listed in para. 1, the applicant does not provide the data,
p.002007: referred to in Art. 38, para. 1, Vols 4 - 6.
p.002007: (3) When the herbal substance, the preparation or the combination thereof are excluded from the list under para. 1,
...
p.002007: 2. participate in activities related to the production or wholesale and retail of medicines
p.002007: products.
p.002007: (2) In case the persons under para. 1 have participated in any of the stages of preparation of the documentation required
p.002007: to authorize the use of the medicinal product, they may not participate in the meetings of the medicinal product
p.002007: specialized commission under art. 47.
p.002007: (3) The persons under para. 1 shall not vote in decisions on matters which they or the members of
p.002007: their family has commercial, financial or other interests.
p.002007: Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
p.002007: valid documentation of the BDA together with the relevant commission under Art. 47, para. 1 evaluates the quality,
p.002007: the safety and efficacy of the medicinal product and produces an evaluation report with comments from
p.002007: the results of the pharmaceutical and preclinical tests, clinical trials, of the
p.002007: risk management and the safety monitoring system for the medicinal product concerned.
p.002007: The evaluation report prepared shall be submitted to the BDA Executive Director.
p.002007: (2) (New, SG No. 102/2012, effective 21.12.2012) The report under para. 1 is updated when new
p.002007: information relevant to the evaluation of the quality, safety and efficacy of the medicinal product.
p.002007: (3) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012) Where the medicinal product contains
p.002007: genetically modified organisms, the BDA provides the Ministry of Environment and Water
p.002007: the necessary documentation from the dossier of the medicinal product and requires an opinion within 60 days
p.002007: relation to the potential environmental risk. The sixty-day period is within the term of para. 1.
p.002007: (4) (Renumbered from Paragraph 3, SG No. 102/2012, effective 21.12.2012) In the cases of radiopharmaceuticals, the BDA
p.002007: provide the necessary documentation from the dossier of the medicinal product and request an opinion within 60 days
p.002007: days from the Nuclear Regulatory Agency regarding product quality and safety.
p.002007: The sixty-day period is within the term of para. 1.
p.002007: (5) (Renumbered from Paragraph (4), amend. - SG 102/02, in force from 21.12.2012) Where the Ministry of Environment
p.002007: environment and waters and the Nuclear Regulatory Agency shall not be pronounced in the established under para. 3 and 4 terms, be
p.002007: considers their opinion to be positive.
p.002007: Art. 50. (1) When the BDA establishes discrepancies in the file with the requirements for issuing a permit for
p.002007: use or certificate of registration under this Act shall notify the applicant in writing to submit
p.002007: additional information related to the documentation under Art. 27 - 32 or under Art. 35, para. 3, or under Art. 38, and / or
p.002007: to provide an oral or written explanation of the incompleteness and non-compliance found within 180 days of
p.002007: the date of notification.
p.002007: (2) In the cases of para. 1 the term under Art. 44 ceases to run from the date of notification until the submission of the
p.002007: the information requested.
p.002007: (3) The BDA Executive Director shall terminate the procedure for granting a marketing authorization or
p.002007: certificate of registration of a medicinal product where:
p.002007: 1. the applicant has not provided the information under para. 1 within the specified period;
p.002007: 2. the persons under art. 26, para. 1 request termination in writing and.
p.002007: Art. 51. Within 10 days of the preparation of the evaluation report, mail. 49, para. 1 Executive Director of the BDA
p.002007: issues a marketing authorization / registration certificate or makes a motivated one
p.002007: refusal.
p.002007: Art. 52. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 5 days from the date of issue of
p.002007: the marketing authorization / registration certificate in the register of art. 19, para. 1, item 3 shall be entered
p.002007: the following permit / certificate information:
p.002007: 1. registration number;
p.002007: 2. number and date of the marketing authorization / registration certificate of the medicinal product;
p.002007: 3. name of the medicinal product;
p.002007: 4. the international non-patent name of each active substance;
...
p.002007: Section I.
p.002007: general provisions
p.002007: Art. 81. (Amended, SG No. 84/2018) (1) (1) A clinical trial on the territory of the Republic of Bulgaria may
p.002007: shall be held after obtaining a permit issued under the terms and conditions of Regulation (EU) No
p.002007: 536/2014 of the European Parliament and of the Council of 16 April 2014 on the clinical trials of
p.002007: medicinal products for human use and repealing Directive 2001/20 / EC (OJ L 158/1 of 27 May 2014
p.002007: d.), hereinafter referred to as "Regulation (EU) No 536/2014", and this Act.
p.002007: (2) The Executive Agency for Medicinal Products shall carry out the activities of reporting, respectively affected
p.002007: country and additionally affected country within the meaning of Regulation (EU) No 536/2014, and is national
p.002007: contact point of art. 83 of Regulation (EU) No 536/2014.
p.002007: Art. 82. (Amended, SG No. 84/2018) (1) (1) For issuing a permit for conducting a clinical trial and
p.002007: for granting authorization for a substantial change to an authorized clinical trial, the sponsor shall submit
p.002007: application and dossier pursuant to Chapter IV of Regulation (EU) No 536/2014 through the European Union (EU) Portal on
p.002007: Art. 80 of Regulation (EU) No 536/2014.
p.002007: (2) To submit an application under para. 1 and for evaluation of the documentation attached to it, the assignor
p.002007: shall pay a fee in the amount determined by the tariff under Art. 21, para. 2.
p.002007: Art. 83. (Amended, SG No. 84/2018) (*) The Commission under Art. 103, para. 1 assesses the ethical aspects of
p.002007: the clinical trial and the substantial modification of the clinical trial under the terms and conditions of
p.002007: Regulation (EU) No 536/2014 and prepares a reasoned opinion which it submits to the BDA.
p.002007: Art. 84. (Amended, SG No. 84/2018) (1) (1) The Executive Agency for Medicines shall issue a permit for
p.002007: clinical trial, authorization of clinical trial under certain conditions, authorization of substantial
p.002007: change of clinical trial, permission to substantially change clinical trial in certain
p.002007: conditions or refuses authorization under the terms and conditions of Regulation (EU) No 536/2014.
p.002007: (2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002007: Art. 85. (Amended, SG No. 84/2018) (*) By an ordinance of the Minister of Health shall determine:
p.002007: 1. the conditions and procedure for submission of data and information by the BDA and the Ethical Commission for Clinical
p.002007: tests in the EU Portal under Art. 80 of Regulation (EU) No 536/2014;
p.002007: 2. the access of the BDA and the Ethical Committee for Clinical Trials to the EU Database. 81 of
p.002007: Regulation (EU) No 536/2014;
p.002007: 3. the terms and procedure for submitting the opinions by post. 83 and the order of interaction between the BDA and
p.002007: Ethics Committee for Clinical Trials;
p.002007: 4. the documents and particulars of Annex I and Annex II to Regulation (EU) No 536/2014, to be evaluated by
p.002007: BDA and the Ethical Committee for Clinical Trials, as well as the language in which they are presented.
p.002007: Art. 86. (1) (Supplemented, SG No. 84/2018) (*) All persons conducting a clinical trial must have
p.002007: relevant professional qualifications, training and experience to fulfill the test-related requirements
p.002007: tasks in accordance with the Good Clinical Practice rules under Regulation (EU) No 536/2014.
...
p.002007: the data obtained and take into account their impact on the benefit / risk balance of the medicinal product.
p.002007: (2) The Marketing Authorization Holder shall notify the BDA of any new information that may
p.002007: affects the benefit / risk ratio of the medicinal product.
p.002007: (3) The obligation under para. 2 shall not exempt the holder of the marketing authorization from the requirement of Art.
p.002007: 194h for providing the information under para. 2 and through periodic safety update reports.
p.002007: Art. 145c. (New, SG No. 102/2012, effective 21.12.2012) (1) (Amended, SG No. 84/2018)
p.002007: 12.10.2018) When the survey is conducted only in the territory of the Republic of Bulgaria in pursuance of
p.002007: obligation under art. 56a, the holder of the marketing authorization shall submit to the BDA a draft of the protocol of
p.002007: the study. The draft protocol, together with the written consent of art. 145a, para. 2, is also presented in
p.002007: the commission under art. 103, para. 1.
p.002007: (2) The Executive Director of the BDA within 60 days from the date of receipt of the documentation under para. 1
p.002007: sends notification of approval of the study to the Marketing Authorization Holder or makes
p.002007: motivated refusal.
p.002007: (3) The BDA Executive Director shall refuse to conduct the study with one or more of the reasons for
p.002007: Art. 145f, para. 2, Vol. 2.
p.002007: (4) (Amended, SG No. 84/2018, effective 12.10.2018) 103, para. 1 within 60 days from the date
p.002007: of receiving the documentation under para. 1 shall send the holder of the marketing authorization
p.002007: positive or negative opinion.
p.002007: (5) (Amended, SG No. 84/2018, effective 12.10.2018) The conduct of the study may commence after
p.002007: obtaining approval from the BDA and a positive opinion from the committee under Art. 103, para. 1.
p.002007: (6) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) (Amended, SG No. 84/2018)
p.002007: 12.10.2018) The Marketing Authorization Holder applies the planned material changes to the
p.002007: in the cases under Art. 145c, para. 1 after their prior approval by the BDA and the Commission.
p.002007: 103, para. 1.
p.002007: (2) (amend. - SG 84/08, in force from 12.10.2018) The holder of the marketing authorization shall submit
p.002007: in the BDA and in the committee under Art. 103, para. 1 the documentation related to the changes and the reasons for it.
p.002007: (3) The Executive Director of the BDA within 30 days from receipt of the documentation under para. 2 approves
p.002007: the amended protocol or issues a reasoned refusal and notifies the marketing authorization holder.
p.002007: (4) (Amended, SG No. 84/2018, effective 12.10.2018) 103, para. 1 within 30 days from the date
p.002007: of receiving the documentation under para. 2 shall send the marketing authorization holder
p.002007: positive or negative opinion.
p.002007: (5) The BDA Executive Director shall refuse the changes under para. 1 with one or more of the reasons given in
p.002007: Art. 145f, para. 2, Vol. 2.
p.002007: (6) (amend. - SG 84/08, in force from 12.10.2018) The holder of the marketing authorization may
p.002007: apply the changes under para. 1 after obtaining the approval of the BDA and a favorable opinion from the Commission on
p.002007: Art. 103, para. 1.
p.002007: (7) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: Art. 145d. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
p.002007: submit a final report of the BDA study within 12 months after the completion of the BDA collection
p.002007: data. A summary of the results of the study shall be attached to the report.
p.002007: (2) The Marketing Authorization Holder may submit a reasoned request to the BDA to postpone
p.002007: term under para. 1 at least three months before the date of submission of the final report referred to in
p.002007: protocol.
p.002007: (3) The Executive Agency for Medicines shall approve or make a reasoned refusal of the request under para. 2 and
p.002007: notifies the marketing authorization holder.
p.002007: (4) When the holder of the marketing authorization based on the report under para. 1 thought it was
p.002007: necessary change of the marketing authorization, he submits to the BDA an application for change in the order of chapter
p.002007: third, section VI.
p.002007: (5) The Executive Director of the BDA shall, by order, suspend or terminate the authorization for
p.002007: use when the BDA based on the report under para. 1 and after consultation with the authorization holder for
p.002007: use shall consider the suspension or termination of the marketing authorization.
p.002007: Art. 145f. (New, SG No. 102/2012, effective 21.12.2012) (1) When the study is conducted as on
p.002007: the territory of the Republic of Bulgaria and of the territory of other Member States for medicinal products
p.002007: products authorized under Regulation (EC) No 726/2004 of the European Parliament and of the Council or
p.002007: the order of Chapter Three, Section VII, in the performance of its duties 55a or under Art. 56a, the holder of
p.002007: the marketing authorization shall be submitted to the committee under art. 56a, para. 1, item 1 of the draft protocol.
p.002007: (2) Within 60 days from the date of receipt of the documentation under para. 1 Committee 56a, para. 1, v. 1
p.002007: prepares an opinion and sends to the marketing authorization holder:
p.002007: 1. notification of approval, or
p.002007: 2. a reasoned refusal when:
p.002007: (a) find that the study promotes the use of the medicinal product, and / or
p.002007: (b) consider that the design of the study will not achieve the objectives of the report, and / or
p.002007: (c) the study is of a clinical trial nature.
p.002007: (3) (amend. - SG 84/08, in force from 12.10.2018) In the cases of para. 2, item 1 the holder of the permit
p.002007: submit a notice to the BDA for use.
p.002007: (4) (Amended, SG No. 84/2018, effective 12.10.2018) 103, para. 1 within 15 days of the date
p.002007: upon receipt of the notification under para. 3 sends the Marketing Authorization Holder positively
p.002007: or negative opinion.
p.002007: (5) (Amended, SG No. 84/2018, effective 12.10.2018) The conduct of the study may commence after
p.002007: receiving a positive opinion from the commission under art. 103, para. 1.
p.002007: (6) The content and format of the protocol under para. 1 are governed by Implementing Regulation (EU) No 520/2012
p.002007: Regulation of 19 June 2012 on the implementation of pharmacological activities
p.002007: vigilance provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and in a Directive
p.002007: 2001/83 / EC of the European Parliament and of the Council (OJ L 159/5 of 20 June 2012), hereinafter referred to as 'the European Parliament and of the Council'
p.002007: "Implementing Regulation (EU) No 520/2012".
p.002007: Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization for
p.002007: the cases under Art. 145f, para. 1 applies planned significant changes to the study protocol after
p.002007: their prior approval by the committee under Art. 56a, para. 1, v. 1.
p.002007: (2) The holder of the marketing authorization shall submit to the committee referred to in Art. 56a, para. 1, item 1 of the documentation,
p.002007: changes, and the reasons for that.
p.002007: (3) (Amended, SG No. 84/2018, effective 12.10.2018) 56a, para. 1, item 1 approved
p.002007: the changes in the protocol, the holder of the marketing authorization shall notify the BDA and the commission under art. 103,
p.002007: para. 1.
p.002007: (4) (amend. - SG 84/08, in force from 12.10.2018) The holder of the marketing authorization may
p.002007: apply the changes under para. 1 after receiving a positive opinion from the commission under Art. 103, para. 1.
p.002007: Art. 145h. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
p.002007: submit electronically to the Committee under Art. 56a, para. 1, item 1 final report, accompanied by a summary of
p.002007: the results of the survey, within 12 months of the completion of data collection.
p.002007: (2) The Marketing Authorization Holder may submit a reasoned request to the Committee. 56a, para.
p.002007: 1, item 1 for postponement of the term under para. 1 at least three months before the final submission date
p.002007: the report referred to in the minutes.
p.002007: (3) The Committee under Art. 56a, para. 1, item 1 approves or makes a reasoned refusal of the request under para. 2 and notify
p.002007: the holder of the marketing authorization.
p.002007: (4) The content and format of the report under para. 1 are governed by Implementing Regulation (EU) No 520/2012.
p.002007: Art. 145i. (New, SG No. 102/2012, effective 21.12.2012) 56a, para. 1, item 1 on the basis of
p.002007: the report under Art. 145h, para. 1 and after consulting the marketing authorization holder issues a reasoned one
p.002007: recommendation on the authorization of the medicinal product and sends it to:
p.002007: 1. The Committee for Medicinal Products for Human Use 5 of Regulation (EC) No 726/2004
p.002007: The European Parliament and the Council, or
p.002007: 2. the coordination group of art. 77, para. 2.
p.002007: (2) In the cases of para. 1, item 2, when the committee under art. 56a, para. 1, item 1 recommended change, suspension or
p.002007: suspension of the marketing authorization, coordination group represented by Member States, c
p.002007: The survey conducted conducted an opinion on the necessary actions to be taken
p.002007: undertake with regard to the marketing authorization, including a timetable for its implementation.
p.002007: (3) When the Member States represented in the coordination group reach consensus on the opinion
p.002007: under para. 2, it shall be published on the European Internet portal for medicinal products under Art. 68, para. 1, item 4 and se
p.002007: sends the marketing authorization holder.
p.002007: (4) The BDA Executive Director in accordance with the opinion under para. 2 stops or
p.002007: terminates the marketing authorization.
p.002007: (5) Where in the opinion under para. 2 recommended changes to the marketing authorization issued,
p.002007: the Marketing Authorization Holder submits to the BDA within the specified implementation schedule
p.002007: an application for change pursuant to Chapter Three, Section VI, incorporating an updated summary of the
p.002007: product and leaflet.
p.002007: (6) Where agreement cannot be reached within the coordination group, the position of
p.002007: the majority of the Member States are referred to the European Commission, which decides on
p.002007: modification, suspension or revocation of the marketing authorization granted by the relevant regulatory authority
p.002007: Member State authorities.
p.002007: (7) The decision under para. 6 is published on the European Medicines Portal. 68, para.
p.002007: 1, item 4 and shall be sent to the holder of the marketing authorization.
p.002007: (8) The Executive Agency for Medicinal Products applies the provisional and / or definitive measures of the Decision on Medicinal Products
p.002007: para. 6 and inform the European Medicines Agency and the European Commission.
p.002007: (9) In the cases of para. 1, item 1 The Committee for Medicinal Products for Human Use, in accordance with
p.002007: the recommendation of the committee under art. 56a, para. 1, item 1 issues an opinion on the retention, amendment,
p.002007: suspension or termination of the marketing authorization, including a timetable for
p.002007: implementation of the opinion. The opinion shall be published on the European Medicines Portal
p.002007: products of art. 68, para. 1, item 4 and shall be sent to the holder of the marketing authorization.
p.002007: (10) Where in the opinion under para. 9 is a position for regulatory action under
p.002007: as regards marketing authorizations, the European Commission shall decide to amend, suspend or
p.002007: suspension of the marketing authorizations granted under Regulation (EC) No 726/2004 of the European Union
p.002007: Parliament and the Council.
p.002007: Art. 145k. (New, SG No. 102/2012, effective 21.12.2012) (1) (Amended, SG No. 84/2018)
p.002007: 12.10.2018) Non-interventional studies in the territory of the Republic of Bulgaria are conducted at
p.002007: conditions and in the order determined by an ordinance of the Minister of Health.
p.002007: (2) When conducting non-interventional studies under para. 1 indicates the source of funding.
p.002007: Chapter Five.
p.002007: MANUFACTURE AND IMPORTATION OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES (TITLE I).
p.002007: AMENDED. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002007: Section I.
p.002007: Production
p.002007: Art. 146. (1) (amend. - SG 102/02, in force from 02.01.2013) The production of all kinds of medicinal
p.002007: products within the meaning of this Act and of medicinal products intended for clinical trial may
p.002007: to carry out on the territory of the Republic of Bulgaria only natural or legal persons registered
p.002007: as traders in the territory of a Member State who have been granted a manufacturing authorization granted by
p.002007: the Director of the Executive Agency for Medicines.
p.002007: (2) A production permit shall also be required in the cases where the products under para. 1 are intended for
p.002007: wear.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) Production permit is also required for persons,
p.002007: who simultaneously or individually perform one of the following activities: full or partial production,
...
p.002007: carries out the following activities for medicinal products placed on the market of the Republic of Bulgaria:
p.002007: 1. monitoring the outcome of the risk reduction measures for the medicinal product contained in the plan
p.002007: risk management;
p.002007: 2. monitoring of the result of the fulfillment of conditions specified in Art. 55a, 56 or 56a;
p.002007: 3. evaluation of the update of the risk management system;
p.002007: 4. monitoring of the "EudraVigilance" database established in accordance with Article 24 of Regulation (EC) No
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council on new risks or changes to those already identified and on
p.002007: change in benefit / risk ratio.
p.002007: Art. 187. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: inform the European Medicines Agency and the Marketing Authorization Holder
p.002007: identifying signals for new risks or for changing identified risks, or when changing
p.002007: the benefit / risk ratio of the medicinal product.
p.002007: (2) The Committee under Art. 56a, para. 1, item 1 analyzes and prioritizes validated alerts for new risks or for
p.002007: change in already established and change in benefit / risk ratio.
p.002007: (3) Where the Committee under Art. 56a, para. 1, item 1 recommends follow-up, the coordination group of art.
p.002007: 77, para. 2 or the Committee for Medicinal Products for Human Use, respectively, draws up an opinion on
p.002007: regulatory actions for the marketing authorization within the timeframe set out in
p.002007: according to the severity and degree of danger.
p.002007: (4) The Medicines Executive Agency shall implement the recommendations recommended in the coordination opinion
p.002007: a group under Art. 77, para. 2 or in the decision of the European Commission provisional and / or definitive measures.
p.002007: Art. 188. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: inform the European Medicines Agency, the regulatory authorities of the other Member States and
p.002007: The European Commission, at least 24 hours before the public disclosure of concerns,
p.002007: related to the monitoring of the safety of a medicinal product, except where the protection of
p.002007: public health requires immediate disclosure.
p.002007: (2) The Executive Agency for Medicinal Products shall publish information relating to active substances containing
p.002007: in medicinal products authorized in other Member States, using harmonized
p.002007: draft communication and timetable for publication proposed by the European Medicines Agency.
p.002007: (3) In the cases of para. 1 and 2 the information containing personal data or constituting a trade secret shall be
p.002007: deleted unless publication of this information is necessary for the protection of public health.
p.002007: Art. 189. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines may
p.002007: delegate some of the rights and obligations under this chapter to a regulatory authority of another Member State
p.002007: by concluding an agreement.
p.002007: (2) In the cases of para. 1 The BDA informed the European Commission, the European Medicines Agency and the European Medicines Agency
p.002007: the regulatory authorities of the other Member States for the delegation of powers and publish a communication
p.002007: on the Internet portal under Art. 185, para. 1 or on your website.
...
p.002007: (2) Within 30 days of receipt of the report under para. 1 the holder of the marketing authorization or
p.002007: Member States' regulatory authorities may submit their comments to the European Agency
p.002007: on medicines and to the BDA.
p.002007: (3) Within 15 days from the date of receipt of the comments under para. 2 The BDA updates the evaluation report, such as
p.002007: takes into account all the objections presented, and sends it to the committee under Art. 56a, para. 1, item 1 for approval and
p.002007: recommendation.
p.002007: (4) The European Medicines Agency shall include the evaluation report adopted and the committee recommendation.
p.002007: 56a, para. 1, item 1 in the register under Art. 194h, para. 3 and send it to the Marketing Authorization Holder.
p.002007: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) Where the Republic of Bulgaria is not a rapporteur in
p.002007: the procedure under Art. 194o, para. 2, the BDA may submit comments within the deadline. 194p, para. 2 to the European
p.002007: the Medicines Agency and the regulatory authority of the Member State that prepared the assessment report.
p.002007: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002007: updated reports on the safety of medicinal products under Art. 194l and when none of
p.002007: the marketing authorizations for these products were not granted under Regulation (EC) No 726/2004
p.002007: The European Parliament and the Council, the coordination group under Art. 77, para. 2 within 30 days from the date of
p.002007: receiving the recommendation from the committee under Art. 56a, para. 1, item 1 issues an opinion on conservation,
p.002007: modification, suspension or termination of relevant marketing authorizations, including a schedule for
p.002007: implementation of the opinion.
p.002007: (2) Where the Member States represented in the coordination group have 77, para. 2 agreed
p.002007: on the actions to be taken, the BDA implements the decision taken.
p.002007: (3) When the opinion under para. 1 is for suspension or termination of the marketing authorization, the executive
p.002007: the BDA director issues an order.
p.002007: (4) Where in the opinion under para. 1 recommended changes to the marketing authorization issued,
p.002007: the marketing authorization holder submits to the BDA an application for change including an updated one
p.002007: a summary of the product characteristics and a leaflet, within the specified implementation schedule.
p.002007: (5) Where agreement cannot be reached within the postal coordination group. 77, para. 2,
p.002007: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002007: a decision to modify, suspend or terminate the marketing authorizations granted by them
p.002007: Member States' regulatory authorities.
p.002007: (6) The Executive Agency for Medicinal Products shall apply the provisional and / or definitive measures of the Decision on Medicinal Products
p.002007: para. 5.
p.002007: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002007: updated reports on the safety of medicinal products under Art. 194l and when at least one of
p.002007: the marketing authorizations were granted under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
p.002007: The Council, the Committee for Medicinal Products for Human Use, within 30 days of receipt of the
p.002007: the recommendation of the committee under Art. 56a, para. 1, item 1 issues an opinion on the retention, amendment, suspension
p.002007: or the termination of the relevant marketing authorizations, including a timetable for
p.002007: implementation of the opinion.
p.002007: (2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
p.002007: of the Marketing Authorizations, European Commission:
p.002007: 1. adopt a decision to change, suspend or terminate the marketing authorizations issued in accordance with
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002007: 2. adopt a decision recommending the change, suspension or termination of the marketing authorizations,
p.002007: issued by the relevant regulatory authorities of the Member States.
p.002007: (3) The Executive Agency for Medicinal Products shall apply the provisional and / or definitive measures of the decision on
p.002007: para. 2, Vol. 2.
p.002007: Section IV.
p.002007: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002007: 12/21/2012)
p.002007: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure at European Union level
p.002007: can be initiated by the European Commission, the European Medicines Agency or a country
p.002007: state.
p.002007: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under the procedure
p.002007: of this section by informing the regulatory authorities of the other Member States the European Agency
p.002007: on medicines and the European Commission, when for reasons related to drug monitoring
p.002007: safety, consider that a medicinal product placed on the Bulgarian market is necessary
p.002007: take any of the following measures:
p.002007: 1. suspension or termination of the marketing authorization;
...
p.002007: (3) The recommendation under para. 1 shall be published on the European Mail Portal. 68, para. 1, item 4 and contains one
p.002007: or more of the following:
p.002007: 1. no further study or action is needed at Community level;
p.002007: 2. the holder of the marketing authorization must carry out further investigation and analysis of
p.002007: the data;
p.002007: 3. the marketing authorization holder must carry out a post-marketing safety study
p.002007: with a subsequent evaluation of its results;
p.002007: 4. the Member State or the Marketing Authorization Holder applies measures to reduce
p.002007: risk;
p.002007: 5. the marketing authorization must be suspended, terminated or a refusal renewed
p.002007: his;
p.002007: 6. the marketing authorization must be modified.
p.002007: (4) The specific measures under para. 3, item 4, as well as the conditions and restrictions that should be included in
p.002007: the marketing authorization is indicated in the recommendation.
p.002007: (5) In the cases of para. 3, item 6, when the changes are related to modification or addition of information in
p.002007: The summary of product characteristics, on the packaging or package leaflet of the medicinal product, is recommended
p.002007: include the wording of the changed or added information and where it should be
p.002007: applied.
p.002007: Art. 194h. (New, SG No. 102/2012, effective 21.12.2012) (1) Where, within the scope of the procedure, Art. 194y
p.002007: does not include a medicinal product authorized under Regulation (EC) No 726/2004
p.002007: The European Parliament and the Council, the coordination group under Art. 77, para. 2 based on the recommendation of
p.002007: Art. 194f within 30 days from the date of receipt and issue an opinion on the retention, change,
p.002007: suspension, termination of the relevant marketing authorizations or refusal of
p.002007: their renewal, including a timetable for the implementation of the opinion.
p.002007: (2) Where the opinion recommends the taking of postal measures. 194ts, para. 3, item 5, the executive
p.002007: the BDA Director shall by order suspend or terminate the Marketing Authorization or refuse
p.002007: its renewal.
p.002007: (3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued,
p.002007: the marketing authorization holder submits to the BDA an application for change including an updated one
p.002007: a summary of the product characteristics and a leaflet, within the specified implementation schedule.
p.002007: (4) Where in the opinion under para. 1 it is recommended to take post measures. 194ts, para. 3, Vol. 2 - 4,
p.002007: the holder of the marketing authorization takes the necessary action and informs the BDA and
p.002007: the regulatory authorities of the other Member States.
p.002007: (5) Where within the coordination group under Art. 77, para. 2 cannot be reached,
p.002007: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002007: decision recommending change, suspension or termination of the marketing authorization granted by
p.002007: the relevant regulatory authorities of the Member States.
p.002007: (6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5 temporary and / or
p.002007: final measures.
p.002007: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where, within the scope of the procedure, Art. 194y
p.002007: a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002007: Parliament and the Council, the Committee on Medicinal Products for Human Use, on the basis of the recommendation
p.002007: under Art. 194ts, para. 3 within 30 days from the date of receipt and issue an opinion on retention,
p.002007: modification, suspension, termination of the relevant marketing authorizations or refusal
p.002007: their renewal, including a timetable for the implementation of the opinion.
p.002007: (2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
p.002007: of the Marketing Authorizations, European Commission:
p.002007: 1. Decides to change, suspend or terminate the validity of the marketing authorizations,
p.002007: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002007: 2. adopt a decision recommending the change, suspension or termination of the validity of the permissions for
p.002007: use issued by the relevant regulatory authorities of the Member States.
p.002007: (3) The Medicines Executive Agency implements the recommendations made in the European Commission decision on
p.002007: para. 2, item 2 provisional and / or final measures.
p.002007: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) 194ts, para. 1, the opinion of
p.002007: Art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and Art. 194h, para. 2 are published on
p.002007: The European Internet Portal under Art. 68, para. 1, Vol. 4.
p.002007: Chapter Nine.
p.002007: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN THE AREA OF
p.002007: MEDICINAL PRODUCTS (TITLE AMENDED - SG 71/08, IN EFFECT OF 12.08.2008,
p.002007: AMENDED. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002007: (Title "Section I. Wholesale trade in medicinal products", SG, issue 71 of 2008, in force since 12.08.2008)
p.002007: Art. 195. (1) Wholesale trade in medicinal products may be carried out by natural and legal persons,
p.002007: holders of an authorization issued by a regulatory authority of the Member State concerned.
p.002007: (2) Where the person under para. 1 has warehouses on the territory of the Republic of Bulgaria, it may
p.002007: Wholesale trade in medicinal products after obtaining authorization from the executive
p.002007: director of the BDA.
p.002007: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may trade on
p.002007: wholesale only of medicinal products for which a manufacturing authorization has been granted.
p.002007: (2) An importer of medicinal products within the meaning of this Law may only wholesale trade with
p.002007: medicinal products for which import authorization has been granted.
p.002007: Art. 197. The persons under art. 195 must have:
p.002007: 1. suitable premises, equipment and facilities and suitable means of transport providing
p.002007: the proper storage, distribution and transport of medicinal products in accordance with
p.002007: the requirements of Good Distribution Practice;
p.002007: 2. Qualified staff and responsible Master of Pharmacy with at least two years of work experience
...
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: country;
p.002007: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar
p.002007: document of the person, if not a Bulgarian citizen, diploma for higher education and document for work experience
p.002007: of the responsible master pharmacist under Art. 197, item 2 and a copy of his employment contract;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 6. a document certifying the legal basis for the use of the premises;
p.002007: 7. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 84 of 2018, effective from 12.10.2018)
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002007: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a Member State;
p.002007: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002007: 3. the address of the premises for the storage of medicinal products in the territory of the Member States.
p.002007: (3) In the wholesale trade in narcotic substances and in dosage forms containing such substances,
p.002007: the requirements of the Narcotic Drugs and Precursors Control Act also apply.
p.002007: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Nuclear Regulatory Agency.
p.002007: (5) (New, SG No. 103/2017, effective 01/01/2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the person under para. 1, item 3, when he is a Bulgarian citizen.
p.002007: Art. 200. The Executive Agency for Medicines shall evaluate the documentation and carry out an on-the-spot check
p.002007: the sites mentioned in the application to establish their compliance with the requirements for the Good
p.002007: distribution practice.
p.002007: Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing when it finds out
p.002007: incompleteness in the documentation submitted.
p.002007: (2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
p.002007: Art. 202. (1) (amend. - SG 84/08, in force from 12.10.2018) Within 60 days from the date of submission of
p.002007: the application under Art. 199, para. 1, the Executive Director of the BDA shall issue a permit for wholesale or
p.002007: makes a reasoned refusal.
p.002007: (2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002007: Art. 203. Within 15 days from the date of submission of the documentation 199, para. 2 the Executive Director
p.002007: of the BDA issues a certificate of registration for wholesale trade in the territory of the Republic of Bulgaria on
p.002007: the person under Art. 195, para. 1.
p.002007: Art. 204. (1) The permit for wholesale of medicinal products shall be indefinite.
p.002007: (2) The authorization under Art. 202 or the certificate under Art. 203 shall be terminated if the holder so requests
p.002007: in writing by the BDA Executive Director.
...
p.002007: (8) (New, SG No. 48/2015; Supplemented, SG No. 91/2018) On the day the application under para. 1 and 5
p.002007: The BDA sends an official request to the Governing Board of the Bulgarian Pharmaceutical Union for issuance
p.002007: of a certificate for entry in the national electronic register of the members of the Bulgarian
p.002007: pharmaceutical union - for the master pharmacist, pharmacy manager, and to the board of directors of
p.002007: Bulgarian Association of Assistant Pharmacists - Assistant Pharmacist, Pharmacy Manager at
p.002007: cases stipulated by law, as well as providing information on penalties imposed in the order
p.002007: of the Professional Organization of Master Pharmacists and the Health Act.
p.002007: (9) (New, SG No. 48/2015) The Managing Board shall submit the documents under para. 8 within 5 working days of
p.002007: receipt of the request.
p.002007: (10) (New - SG 103 2017, in force from 01.01.2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the persons under para. 1, item 5, when they are Bulgarian citizens.
p.002007: Art. 229. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, repealed - SG No. 60/2011, effective 05.08.2011
p.002007: d)
p.002007: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 102/2009, effective 22.12.2009, amended -
p.002007: SG, issue 60 of 2011, in force since 05.08.2011, suppl. - SG, issue. 18 of 2014) Within one month of receipt of the
p.002007: the documentation under Art. 228, para. 6, the Executive Director of the BDA, following the opinion of the Expert Council on
p.002007: retail trade of medicinal products, issues a permit for retail trade with
p.002007: medicinal products at a pharmacy or make a reasoned refusal to grant an authorization. The permission or
p.002007: the refusal shall be served on the applicant.
p.002007: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation on
p.002007: Art. 228, para. 6 The BDA verifies the documents submitted and notifies the applicant in writing
p.002007: identified inconsistencies or incompleteness. In these cases, the term under para. 2 stops running from the day of
p.002007: notification until the deficiencies are rectified.
p.002007: (4) (New - SG 71/08, in force from 12.08.2008) In case within 60 days from the date of
p.002007: the notification under para. 3 the applicant has not remedied any inconsistencies or incompleteness found,
p.002007: the procedure for granting a marketing authorization for a medicinal product or for modifying it
p.002007: the authorization granted shall be terminated.
p.002007: (5) (Renumbered from Paragraph 4, SG No. 71/2008, effective 12.08.2008, amended - SG No. 60/2011)
p.002007: 08/08/2011) The refusal of the BDA Executive Director to issue a permit is subject to appeal
p.002007: in accordance with the Administrative Procedure Code.
p.002007: Art. 229a. (New, SG No. 23/2009, effective 30.03.2009) (1) (amend. - SG 41/09, in force from 30.03.2009)
p.002007: 02.06.2009, amend. - SG, issue. 98 of 2010, effective January 1, 2011, as amended. - SG, issue. 60 of 2011, effective 05.08.2011
p.002007: d) The Executive Agency for Medicinal Products shall ex officio send to the Health Insurance Fund at the location of the respective
p.002007: pharmacy with issued permit under art. 229, para. 2, which includes the retail trade of food
...
p.002007: Art. 251. (1) To authorize the advertisement, the person shall send. 250 shall submit to the BDA an application in accordance with a model approved by
p.002007: the Executive Director of the Agency, accompanied by:
p.002007: 1. advertising project;
p.002007: 2. a notarized power of attorney from the holder of the marketing authorization when the application is submitted
p.002007: filed by another person;
p.002007: 3. the literary sources of the quotations, tables or other materials used, if any;
p.002007: 4. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The advertising projects under para. 1, item 1 must be clear, with comprehensible text, in cases where there is one, and yes
p.002007: they allow all elements and text and illustrations to be evaluated.
p.002007: (3) An Expert Council on Advertising shall be established at the BDA. It includes doctors and specialists with
p.002007: hands-on experience in advertising. The Executive Director of the BDA shall determine the composition of the Board with an order
p.002007: of the Council, to which one representative of the Committee on Professional Ethics of the Bulgarian shall be included
p.002007: medical union, the Bulgarian Dental Union and the Bulgarian Pharmaceutical Union, the size of
p.002007: the remuneration of its members and approves rules of procedure for its work. In the composition of
p.002007: counseling may also include representatives of patient organizations.
p.002007: (4) The council under para. 3 prepares expertise on the advertising project and prepares an opinion to the executive
p.002007: director of the BDA.
p.002007: (5) In case of finding inconsistencies of the advertising with the requirements of this law within 7 days from the date
p.002007: of filing the application under para. 1 The BDA gives written instructions for their removal within one month from
p.002007: the date of the notification. The time limit for ruling ceases to run from the date of notification to
p.002007: eliminate inconsistencies.
p.002007: (6) In case the applicant fails to comply with the instructions within one month from the date of notification under para. 5,
p.002007: the authorization procedure is terminated.
p.002007: Art. 252. (1) Within one month from the submission of the documentation, mail. 251, para. 1 based on
p.002007: the opinion under Art. 251, para. 4, the BDA Executive Director authorizes the advertisement or does it by order
p.002007: a reasoned refusal to notify the Marketing Authorization Holder.
p.002007: (2) (New, SG No. 60/2011, effective 05.08.2011) When, within the term of para. 1 Executive Director of
p.002007: The BDA did not authorize the advertisement or did not make a reasoned refusal, it is assumed that it is silent
p.002007: consent to the project of advertising under Art. 251, para. 1, item 1 and it may be distributed.
p.002007: (3) (Renumbered from Paragraph (2), SG No. 60/2011, effective 05.08.2011) The refusal of the Executive Director
p.002007: it is subject to appeal under the Administrative Procedure Code.
p.002007: Art. 253. (1) The issued permission of the advertisement under Art. 252, para. 1 refers to a specific medicinal product
p.002007: within the period of validity of his marketing authorization.
p.002007: (2) When changes have been made to the marketing authorization for a medicinal product that lead to changes
p.002007: in an authorized advertisement for this product, the Marketing Authorization Holder applies to the BDA
p.002007: change.
p.002007: Art. 254. Upon change of the permitted advertisement the person shall send. 250 shall submit an application in accordance with Art. 251.
p.002007: Art. 254a. (New, SG No. 60/2011, effective 05.08.2011) (1) Advertising intended for medical use
p.002007: specialists, it is not allowed in accordance with Art. 250 - 252.
p.002007: (2) The advertisement under para. 1 shall be distributed upon notification to the BDA to which the project is attached
p.002007: of advertising, and in compliance with the requirements of this chapter and the ordinance under Art. 249.
p.002007: Art. 255. (1) It is prohibited to distribute samples of medicinal products containing narcotic drugs
...
p.002007: pharmaceutical union and patient organizations and the pharmaceutical industry.
p.002007: (3) (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: A person who is a member of the Transparency Committee cannot also be a member of the National Board of Prices and
p.002007: reimbursement of medicinal products.
p.002007: (4) The Council of Ministers shall determine by rules the terms and conditions for the work of the Transparency Commission.
p.002007: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012)
p.002007: 12/21/2012) The Transparency Committee is an authority against which decisions of the National can be appealed
p.002007: advice on prices and reimbursement of medicinal products.
p.002007: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority of the panel and.
p.002007: (3) The decisions under par. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a relevant disease is
p.002007: without an alternative in the country, an authorized medicinal product may be administered to a particular patient
p.002007: for use in a Member State of the European Union, authorized for use under this Act, but not
p.002007: distributes on the Bulgarian market.
p.002007: (2) (amend. - SG 102/08, in force from 01.01.2019) Annually at the proposal of the medical establishments for
p.002007: hospital care and after the opinion of the relevant expert council in the relevant medical specialty
p.002007: or medical activity under Art. 6a, para. 1, item 1 of the Health Act the Minister of Health
p.002007: approve the list of medicinal products under para. 1, which contains the following information:
p.002007: 1. anatomical-therapeutic-chemical classification code;
p.002007: 2. an international non-patent name to which the product belongs;
p.002007: 3. disease according to the international disease code;
p.002007: 4. the dosage form and the amount of active substance;
p.002007: 5. additional information.
p.002007: (3) The list under para. 2 is published on the website of the Ministry of Health on the Internet.
p.002007: (4) The conditions and the order for inclusion, change or exclusion of medicinal products in the list under para. 2 se
p.002007: determine with the ordinance under art. 9, para. 1.
p.002007: (5) The medicinal product under para. 1 shall be delivered by special order to a hospital establishment for hospital care
p.002007: under the conditions and in the order determined by the ordinance of art. 9, para. 1.
p.002007: (6) The head of the medical establishment under para. 5 shall be responsible for the implementation of the treatment under para. 1.
p.002007: Chapter thirteen.
p.002007: STATE CONTROLS ON MEDICINAL PRODUCTS
p.002007: Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
p.002007: 12/21/2012) The Ministry of Health manages the state control over the medicinal products
p.002007: products. Immediate guidance is provided by the Chief State Health Inspector, from
p.002007: the chairman of the council under Art. 258, para. 1, by the Executive Director of the BDA and by the Directors of the Health Insurance Fund, who
...
p.002013: (4) Until the composition of the commission under Art. 103, para. 1 Ethics Committee for Multicenter Testing
p.002013: continues to operate in the past.
p.002013: § 72. (1) The Central Ethics Committee shall cease its activity after all proceedings have been completed,
p.002013: formed before her.
p.002013: (2) The chairman of the Central Ethics Committee shall transmit the archive with a transceiver protocol
p.002013: of the Central Ethics Committee, determined by an order of the Minister of Health
p.002013: person from the Ministry of Health within one month after the termination of the activity of the
p.002013: Central Ethics Committee.
p.002013: § 73. (1) The heads of the medical establishments in which clinical trials are carried out in accordance with this
p.002013: law, designate a contact person in accordance with the requirements of Art. 107a within three months of entry
p.002013: by virtue of Art. 107a.
p.002013: (2) The Ethics Committees set up by the medical establishments in accordance with the previous procedure, continue to
p.002013: carry out their activities until the appointment of a contact person under Art. 107a, para. 1.
p.002013: (3) After designation of a contact person, mail. 107a, para. 1 the functions of the Ethics Committees set up by
p.002013: The medical establishments according to the previous procedure are carried out by the contact person under Art. 107a, para. 1, p
p.002013: except for giving an opinion under art. 83, which is carried out by the commission under art. 103, para. 1.
p.002013: (4) The archives of the ethics committees set up by the medical establishments under the previous procedure shall be transmitted and
p.002013: stored in the respective hospital.
p.002013: § 74. Within 6 months from the publication of the notification under Art. 82 (3) of Regulation (EU) No
p.002013: 536/2014 clinical trials shall be authorized and carried out in accordance with the conditions and procedure in force, except in cases
p.002013: under Art. 98 of Regulation (EU) No 536/2014.
p.002013: § 75. (1) The Executive Agency for Medicines shall establish the specialized electronic mail system. 217b,
p.002013: para. 1 in accordance with the requirements of this law within 4 months after its entry into force.
p.002013: (2) The first List of Medicinal Products included in the Positive Medicinal List for which it is
p.002013: established shortage on the territory of the Republic of Bulgaria, shall be prepared in compliance with the requirements of Art.
p.002013: 217c, determining the shortage of medicinal products on the basis of the quantities required for
p.002013: meeting the health needs of the population for a period of one month, calculated on the basis of
p.002013: the average monthly consumption of the respective medicinal product for the previous 6 months by
p.002013: the specialized electronic system in accordance with Art. 217b.
p.002013: (3) For the preparation of the first list under Art. 217c, para. 1 the information under Art. 217b, para. 3, items 1 - 3 are provided for
p.002013: the previous 6 months from the day of creation of the specialized electronic system under para. 1 which
p.002013: is publicly disclosed on the BDA website. The information shall be provided within two months
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.002007: human health beyond those specified in the ordinance under Art. 243, shall be punished by the fine under para. 1, and when re
p.002007: committing the same infringement shall be revoked the issued certificate for registration of a drugstore.
p.002007: (5) (Renumbered from Paragraph (4), amend. - SG 84/08, in force from 12.10.2018). 1, 2 and 3 bodies of
p.002007: state control over medicinal products shall stop the operation of the facility by order.
p.002007: (6) (repealed - SG 71/08, in force from 12.08.2008, previous para 5, amended - SG, iss. 84 of 2018, in force from
p.002007: 12.10.2018) The order under par. 5 shall be subject to appeal in accordance with the Administrative Procedure Code,
p.002007: and the appeal does not suspend its execution.
p.002007: Art. 287a. (New - SG 71/08, in force from 12.08.2008) (1) Medical specialist working at
p.002007: retailers of medicinal products without a permit / certificate
p.002007: this is fined from 2500 to 5000 BGN.
p.002007: (2) The punishment under para. 1 shall also be imposed on a person under para. 1 that works in a pharmacy or drugstore after discontinuation
p.002007: the validity of the permit / certificate and.
p.002007: (3) In case of more than two violations under para. 1 and 2, the Minister of Health may deprive
p.002007: the relevant healthcare professional entitled to practice for up to two years.
p.002007: Art. 287b. (New, SG No. 102/2012, effective 02.01.2013) Who conducts trade in medicinal products
p.002007: products on the Internet in violation of the requirements of this law and the ordinance under Art. 234, para. 5, shall be punished by
p.002007: fine from $ 5,000 to $ 10,000
p.002007: Art. 288. (1) A retailer of medicinal products who has authorized the activities specified in Art. 219, yes
p.002007: are carried out by an incapacitated person, punishable by a pecuniary sanction of BGN 5,000 to 10,000;
p.002007: repeated infringement shall be revoked the issued authorization for retail trade.
p.002007: (2) In the cases of para. 1, the state control bodies shall stop the operation of the site with an order.
p.002007: Art. 289. (1) (Previous text of Art. 289 - SG, iss. 60 in 2012, in force since 07.08.2012, amended - SG, iss. 102 in 2018)
p.002007: who sells medicinal products at no established or registered price or at
p.002007: prices, other than those established by the order of this law, shall be punished with a fine from 1500 to 3000 levs, and in case of repeated
p.002007: committing the same offense - with a fine from 2500 to 4000 BGN.
p.002007: (2) (New - SG, iss. 60 in 2012, in force since 07.08.2012, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: Holder of a marketing authorization that fails to fulfill an obligation specified in the ordinance under Art. 261a,
p.002007: para. 5, shall be punished by a pecuniary sanction from 5000 to 10 000 levs, and in the case of repeated commission of the same
p.002007: violation - with a property sanction from BGN 10,000 to BGN 20,000
p.002007: (3) (New, SG No. 102/2012, effective 21.12.2012, repealed - SG No. 102/2018, effective 01/01/2019)
p.002007: Art. 289a. (New, SG No. 60/2011, effective 05.08.2011) (1) (Amended, SG No. 102/2012, effective from
p.002007: 21.12.2012, amend. - SG, issue. 102 of 2018, effective January 1, 2019) Who works in violation of the approved
p.002007: pharmacotherapeutic guidelines or evaluates the outcome of therapy in deviation from
p.002007: the criteria under Art. 259, para. 1, item 4, shall be punished by a fine of from 1000 to 2000 levs, and in case of repeated commission of the same
p.002007: violation - with a fine from 2000 to 3000 BGN.
...
General/Other / Other Country
Searching for indicator another country:
(return to top)
p.002007: apply:
p.002007: 1. application for authorization of retail sale of medicinal products by the persons of origin. 222,
p.002007: para. 1, according to the model approved by the Minister of Health;
p.002007: 2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration of
p.002007: the person under Art. 222, para. 1;
p.002007: 3. copy of the Law on Medicines and Pharmacies in the Human Medicine issued under the repealed order
p.002007: permission to open a pharmacy;
p.002007: 4. a certified copy of the employment contract or contract for the management of the pharmacy manager -
p.002007: in cases where such is required;
p.002007: 5. declaration by the persons under art. 222, para. 1 that the conditions under which the authorization was granted were maintained
p.002007: retail trade in medicinal products of the persons under para. 2;
p.002007: 6. document for a one-time fee of BGN 100
p.002007: § 67. Persons who have submitted prior to the entry into force of this law applications for re-registration under the procedure of revoked §
p.002007: 16 of the transitional and final provisions that will carry out their activities as required
p.002007: of this law shall be submitted to the Ministry of Health within three months of its entry into force
p.002007: the following documents:
p.002007: 1. an application in accordance with a model approved by the Minister of Health;
p.002007: 2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration
p.002007: or a certified copy of a similar document under the national law of a Member State of the European Union
p.002007: union, or under the law of another country party to the EEA Agreement
p.002007: space, according to Art. 222, para. 1;
p.002007: 3. an employment contract or a pharmacy management contract concluded with a master pharmacist or assistant;
p.002007: pharmacist.
p.002007: § 68. (1) Master pharmacist or assistant pharmacist who has received a permit for opening a pharmacy in accordance with the procedure
p.002007: to the repealed § 16 of the transitional and final provisions, may transpose the one issued
p.002007: permission of a person under art. 222, para. 1.
p.002007: (2) For carrying out the transfer the persons under para. 1 filed with the Ministry of Health
p.002007: application to which they attach:
p.002007: 1. application for authorization of retail sale of medicinal products by the persons of origin. 222,
p.002007: para. 1, according to the model approved by the Minister of Health;
p.002007: 2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration of
p.002007: the person under Art. 222, para. 1;
p.002007: 3. copy of the Law on Medicines and Pharmacies in the Human Medicine issued under the repealed order
p.002007: pharmacy permit or re-registration permit pursuant to the repealed § 16 of the
p.002007: transitional and final provisions;
p.002007: 4. a certified copy of the employment contract or management contract of the pharmacy manager;
p.002007: 5. declaration by the persons under art. 222, para. 1 that the conditions under which the authorization was granted were maintained
p.002007: retail trade in medicinal products of the persons under para. 1.
p.002007: (3) The transfer under para. 1 may be completed within one year from the entry into force of this Act.
p.002007: § 69. The drugstores welded upon the entry into force of this Act shall continue to operate
p.002007: on the basis of their registration certificates.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.002007: a quantitative composition in terms of the active substances and of the same dosage form.
p.002007: Art. 33. Conducting the necessary studies and tests to prepare documentation for
p.002007: marketing authorization and the subsequent practical requirements for marketing authorization
p.002007: medicinal products under Art. 28 and 29 is not a violation of the patent or of the supplementary protection certificate
p.002007: of a medicinal product.
p.002007: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002007: 1. name of the medicinal product, quantity of active substance per unit dose, medicinal product
p.002007: form;
p.002007: 2. quantitative and qualitative composition with respect to the active substances and those of the excipients,
p.002007: information for which it is essential for the correct application of the product; the common name is used
p.002007: or the chemical description;
p.002007: 3. dosage form;
p.002007: 4. clinical data:
p.002007: (a) therapeutic indications;
p.002007: (b) dosage and route of administration for adults and children;
p.002007: c) contraindications;
p.002007: (d) special warnings and precautions for use; for immunological medicinal products -
p.002007: precautions for those who work with them and apply them to patients, and precautions that
p.002007: should be taken by the patient;
p.002007: (e) interactions with other medicinal products or other forms of interaction;
p.002007: (f) use in pregnancy or lactation;
p.002007: (g) effects on the ability to drive and use machines;
p.002007: h) side effects;
p.002007: i) overdose (symptoms, antidotes, emergency measures);
p.002007: 5. pharmacological data:
p.002007: a) pharmacodynamic properties;
p.002007: b) pharmacokinetic properties;
p.002007: (c) preclinical safety data;
p.002007: 6. pharmaceutical data:
p.002007: (a) a list of excipients;
p.002007: (b) major incompatibilities;
p.002007: c) shelf life; shelf life after reconstitution of the medicinal product (if necessary) or after
p.002007: opening the primary packaging for the first time;
p.002007: (d) special storage instructions;
p.002007: (e) the nature and composition of the packages;
p.002007: (f) specific instructions for the disposal of the remainder of the medicinal product or of waste material from
p.002007: him;
p.002007: 7. the holder of the marketing authorization;
p.002007: 8. registration number;
p.002007: 9. date of first authorization or renewal of the authorization;
p.002007: 10. date on which the content of the summary of product characteristics was changed;
p.002007: 11. for radiopharmaceuticals - comprehensive information on internal radiation dosimetry;
p.002007: 12. for radiopharmaceuticals - detailed instructions for extemporaneous preparation and quality control and, where applicable
p.002007: applicable, the maximum storage time during which the relevant intermediate such as eluate or
p.002007: ready-to-use pharmacist conforms to its specification.
p.002007: (2) In the summary of product characteristics, no. 28 - 33 the parts of
p.002007: the summary of product characteristics of the reference medicinal product for indications and dosage forms,
p.002007: which were under patent protection at the time the generic product was on the market.
p.002007: (3) The requirements for the form and content of the summary of product characteristics are laid down in
p.002007: the ordinance under Art. 42.
...
p.002007: 5. the data in the file under art. 59a, para. 1 are incorrect, or
p.002007: 6. the control of the medicinal product and / or the ingredients and the intermediate stages of the manufacturing process
p.002007: no other requirement or the fulfillment of which the manufacturing authorization was granted has been fulfilled,
p.002007: or
p.002007: 7. some of the data in the file do not meet the requirements of Art. 59a, para. 1 and 2.
p.002007: (2) Refusal of the BDA Executive Director to renew the Marketing Authorization / Certificate for use
p.002007: registration of a medicinal product may be appealed in accordance with the Administrative Procedure Code.
p.002007: (3) The refusal of the BDA Executive Director and the reasons shall be published on the BDA website.
p.002007: Art. 59c. (New, SG No. 60/2011, effective 05.08.2011; amend. - SG 102/2012, effective 01.04.2013)
p.002007: The Drug Enforcement Agency notifies the National Board of Pricing and Reimbursement
p.002007: the medicinal products for the withdrawn and revoked marketing authorizations, and for the refusals made for
p.002007: Renewal of marketing authorizations for medicinal products within 7 days of the granting of a marketing authorization
p.002007: the relevant act.
p.002007: Section VI.
p.002007: Changes to the marketing authorization issued
p.002007: Art. 60. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of a permit for use of
p.002007: a medicinal product is obliged to notify the BDA of any change in the conditions under which it is issued
p.002007: the permission.
p.002007: (2) (amend. - SG 12/11, in force from 08.02.2011) The changes may be of type IA, type IB, type II,
p.002007: extension of the marketing authorization and emergency restrictive safety measures.
p.002007: (3) (amend. - SG 12/11, in force from 08.02.2011) Conditions and criteria for classification of changes
p.002007: shall be determined by the ordinance under Art. 42.
p.002007: (4) (amend. - SG 12/11, in force from 08.02.2011) Change, which is not an extension of the scope and
p.002007: the classification of which remains uncertain after the application of the conditions and criteria of the ordinance under Art. 42,
p.002007: is considered to be a type IB change by default.
p.002007: (5) (New, SG No. 12/2011, effective 08.02.2011) As an exception to para. 4 a change that does not occur
p.002007: extension and the classification of which remains uncertain after the application of the conditions and
p.002007: the criteria of the ordinance under Art. 42 shall be considered a Type II change in the following cases:
p.002007: 1. at the request of the holder of the marketing authorization, reflected in the application for change;
p.002007: 2. when the BDA after assessment of the validity of the notification begins. 63 considered that change might have occurred
p.002007: significant impact on the quality, safety or efficacy of the medicinal product.
p.002007: Art. 61. (amend. - SG 12/11, in force from 08.02.2011) (1) For any change of type IA, type IB, type II or
p.002007: The marketing authorization holder submits the extension to the BDA
p.002007: separate notification, respectively application.
p.002007: (2) When a change leads to a change in the summary of product characteristics of the packaging
p.002007: and / or in the package leaflet, these changes are accepted as part of the requested change and are not filed separately
p.002007: application.
p.002007: (3) The Marketing Authorization Holder may group the changes when:
p.002007: 1. notifies simultaneously the same type IA changes under the conditions of one or more authorizations for
p.002007: use;
p.002007: 2. declares at the same time several changes to the terms of the marketing authorizations belonging to
p.002007: the global marketing authorization under Art. 28, para. 8 of the medicinal product, provided that the relevant
p.002007: changes occur in one of the following cases:
p.002007: (a) one of the changes in the group is the extension of the marketing authorization;
p.002007: (b) one of the changes in the group is a type II change, and all other changes in the group are changes that are
p.002007: a consequence of the Type II change;
p.002007: c) one of the changes in the group is a change type IB, and all other changes in the group are changes that are
p.002007: a consequence of the type IB change;
p.002007: (d) any changes to the group shall relate only to changes of an administrative nature in the brief
p.002007: product characteristics, patient package leaflet or packaging;
p.002007: (e) all changes in the group are changes in the active substance master documentation, the main one
p.002007: vaccine antigen documentation or plasma basic documentation;
p.002007: (f) all changes to the group are in relation to a project designed to refine the production process
p.002007: and the quality of the medicinal product concerned or its active substance (s);
p.002007: (g) all changes in the group are changes affecting the quality of the pandemic influenza vaccine;
p.002007: h) all changes in the group are changes in the pharmacovigilance system heading eight;
p.002007: (i) any changes to the group are the result of a specific emergency safety measure and are filed with
p.002007: in accordance with Art. 66;
p.002007: (k) all changes in the group are related to the inclusion of information on a particular pharmacotherapeutic class;
p.002007: (l) all changes in the group result from the evaluation of the periodic safety report;
p.002007: (m) any changes to the group are the result of a post-authorization study,
p.002007: conducted under the supervision of the Marketing Authorization Holder;
p.002007: n) all changes in the group are due to the fulfillment of a condition in the authorization for use of mail. 56;
p.002007: 3. the requested changes in the conditions of the same marketing authorization do not fall in the cases under item 2, at
p.002007: provided that the BDA agrees to apply the same procedure to these changes.
p.002007: (4) When grouping changes under para. 3, items 2 and 3 the holder of the marketing authorization shall submit to the BDA:
p.002007: 1. a single notification where at least one of the changes is type IB and all others are type IA or type IB;
p.002007: 2. a single application where the major change is type II and none of the other changes is an extension of
p.002007: the scope of the marketing authorization;
p.002007: 3. a single application where the major change is the extension of the marketing authorization.
p.002007: (5) Along with the application, respectively, the notification under para. 1 or 4, the holder of the authorization for
p.002007: use feeds:
p.002007: 1. documentation related to the changes, determined by the ordinance post. 42;
p.002007: 2. a document for payment of a fee in the amount determined by the postal tariff. 21, para. 2.
...
p.002007: (3) When, within the term of para. 2 The BDA found inconsistencies in the submitted documentation with the requirements of the law
p.002007: and the ordinance under Art. 42, it notifies the holder of the marketing authorization.
p.002007: (4) Within 30 days from receipt of the notification under para. 3 the Marketing Authorization Holder
p.002007: may modify or supplement the documentation.
p.002007: (5) When, within the term of para. 4 the Marketing Authorization Holder did not submit an amended or
p.002007: supplementary documentation, the BDA shall terminate the procedure and notify the holder of the authorization for
p.002007: use.
p.002007: (6) Within 30 days from receipt of the changed documentation under para. 4 The BDA notifies the holder of
p.002007: marketing authorization:
p.002007: 1. whether he approves the change or not; where the change is not approved, the reasons shall be given, and
p.002007: 2. whether the change leads to a change in the data in the issued marketing authorization; when needed
p.002007: change in the marketing authorization issued, Art. 64a.
p.002007: (7) The Marketing Authorization Holder applies the approved type IB variation upon receipt of the
p.002007: notification under para. 2, item 1, respectively under para. 6, item 1 for approval of the change.
p.002007: Art. 64. (amend. - SG 12/11, in force from 08.02.2011) (1) When the application for change of type II corresponds
p.002007: of the requirements of Art. 61, the BDA shall notify the holder of the marketing authorization that the application is
p.002007: valid, indicating the date from which the period under par. 2 starts flowing.
p.002007: (2) Within 60 days of receipt of a valid application, the BDA shall prepare an evaluation report on the change.
p.002007: (3) The term under para. 2 can be:
p.002007: 1. reduced in cases of emergency related to the safe use of the medicinal product, or
p.002007: 2. prolonged up to 90 days in case of a change which changes or adds a therapeutic indication.
p.002007: (4) When the BDA establishes inconsistencies in the submitted documentation with the requirements of the law and the ordinance under
p.002007: Art. 42, it notifies the holder of the marketing authorization and sets a time limit for granting it
p.002007: additional information and documentation.
p.002007: (5) In the cases of para. 4 the term under para. 2 stops running until additional information is presented and
p.002007: documentation.
p.002007: (6) Within 15 days of preparation of the evaluation report, the BDA Executive Director shall:
p.002007: 1. approve the change or give a reasoned refusal and notify the authorization holder thereof
p.002007: use;
p.002007: 2. inform the holder of the marketing authorization whether the approved change leads to a change of the
p.002007: the data in the marketing authorization issued; when it is necessary to change the issued permit for
p.002007: use, Art. 64a.
p.002007: (7) The holder of the marketing authorization may apply the type II variation approved only after
p.002007: the issuance of a change permit under Art. 64a.
p.002007: Art. 64a. (New, SG No. 12/2011, effective 08.02.2011) The Executive Director of the BDA shall issue
p.002007: authorization to change the marketing authorization in time:
p.002007: 1. thirty days from the date of notification. 62, para. 4, Vol. 2, Art. 63, para. 2, item 2, respectively Art. 63, para. 6, vol.
p.002007: 2 or Art. 64, para. 6, item 2, when the respective change leads to an extension by 6 months of the term specified by the member
p.002007: 13 (1) and (2) of Council Regulation (EEC) No 1768/92 of 18 June 1992 establishing a
...
p.002007: all available information on the relevant matter.
p.002007: (4) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: (5) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: Art. 79a. (New, SG No. 60/2011, effective 05.08.2011) (1) Subject to the decision of the European
p.002007: Commission after the completion of the BDA arbitration procedure within 30 days of receipt of the notification:
p.002007: 1. issues, suspends or suspends a marketing authorization, or
p.002007: 2. Requests that changes be made to the permit issued to comply with the decision of
p.002007: The European Commission.
p.002007: (2) The Medicines Executive Agency shall notify the European Commission and the European Medicines Agency
p.002007: the medicines for the issued act under para. 1.
p.002007: Art. 79b. (New, SG No. 102/2012, effective 21.12.2012) (1) In cases where the interests of
p.002007: The European Union and before deciding on the authorization of a medicinal product
p.002007: product, its suspension, termination or change, BDA, applicant or
p.002007: the holder of the marketing authorization may refer the matter to the committee referred to in Art. 79, para. 1 for implementation
p.002007: to arbitration.
p.002007: (2) In the cases of para. 1 where referral is the result of an evaluation of tracking data
p.002007: the safety of an authorized medicinal product, the matter is referred to the
p.002007: Art. 56a, para. 1, item 1 and the procedure of art. 194h or 194h.
p.002007: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall apply the procedure Chapter Eight,
p.002007: Section IV, when it is necessary to implement one of the measures referred to in Art. 194y, para. 2 and 3.
p.002007: (4) (New, SG No. 18/2014) Notwithstanding para. 1 - 3, when emergency action is needed to protect
p.002007: public health at some stage of the arbitration procedure, the BDA may suspend the action of
p.002007: the marketing authorization and prohibit the use of the relevant medicinal product within the territory of
p.002007: The Republic of Bulgaria pending the adoption of the final decision.
p.002007: (5) (New, SG No. 18/2014) In the cases of para. 4 The BDA informs the European Commission, the European Commission
p.002007: the Medicines Agency and the other Member States for the reasons for their decision no later than the next
p.002007: working day.
p.002007: Art. 80. (amend. - SG 12/11, in force from 08.02.2011) The conditions and the procedure for making changes in
p.002007: the authorizations granted under this section shall be governed by Regulation (EC) No 1234/2008 of the European Commission
p.002007: 24 November 2008 on the examination of changes in the conditions of marketing authorizations for
p.002007: medicinal products for human use and veterinary medicinal products (OJ, L 334/7 of 12 December
p.002007: 2008).
p.002007: Chapter Four.
p.002007: CLINICAL TESTS
p.002007: Section I.
p.002007: general provisions
p.002007: Art. 81. (Amended, SG No. 84/2018) (1) (1) A clinical trial on the territory of the Republic of Bulgaria may
p.002007: shall be held after obtaining a permit issued under the terms and conditions of Regulation (EU) No
p.002007: 536/2014 of the European Parliament and of the Council of 16 April 2014 on the clinical trials of
p.002007: medicinal products for human use and repealing Directive 2001/20 / EC (OJ L 158/1 of 27 May 2014
p.002007: d.), hereinafter referred to as "Regulation (EU) No 536/2014", and this Act.
p.002007: (2) The Executive Agency for Medicinal Products shall carry out the activities of reporting, respectively affected
...
p.002007: para. 5.
p.002007: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002007: updated reports on the safety of medicinal products under Art. 194l and when at least one of
p.002007: the marketing authorizations were granted under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
p.002007: The Council, the Committee for Medicinal Products for Human Use, within 30 days of receipt of the
p.002007: the recommendation of the committee under Art. 56a, para. 1, item 1 issues an opinion on the retention, amendment, suspension
p.002007: or the termination of the relevant marketing authorizations, including a timetable for
p.002007: implementation of the opinion.
p.002007: (2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
p.002007: of the Marketing Authorizations, European Commission:
p.002007: 1. adopt a decision to change, suspend or terminate the marketing authorizations issued in accordance with
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002007: 2. adopt a decision recommending the change, suspension or termination of the marketing authorizations,
p.002007: issued by the relevant regulatory authorities of the Member States.
p.002007: (3) The Executive Agency for Medicinal Products shall apply the provisional and / or definitive measures of the decision on
p.002007: para. 2, Vol. 2.
p.002007: Section IV.
p.002007: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002007: 12/21/2012)
p.002007: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure at European Union level
p.002007: can be initiated by the European Commission, the European Medicines Agency or a country
p.002007: state.
p.002007: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under the procedure
p.002007: of this section by informing the regulatory authorities of the other Member States the European Agency
p.002007: on medicines and the European Commission, when for reasons related to drug monitoring
p.002007: safety, consider that a medicinal product placed on the Bulgarian market is necessary
p.002007: take any of the following measures:
p.002007: 1. suspension or termination of the marketing authorization;
p.002007: 2. prohibition of distribution of a medicinal product;
p.002007: 3. issuing a refusal to renew the marketing authorization.
p.002007: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para. 2 when
p.002007: has been informed by the Marketing Authorization Holder that for traceability reasons
p.002007: drug safety, suspends the distribution of the medicinal product or has taken, or
p.002007: intends to take action to withdraw it from the market or not to take action on
p.002007: renewal of the marketing authorization.
p.002007: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure under para.
p.002007: 2 and where it considers that for reasons of pharmacovigilance,
p.002007: new contraindications must be added or reduced for a medicinal product
p.002007: the recommended dose or indication should be limited.
p.002007: (5) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall submit to the European Agency
p.002007: on medicines and regulatory authorities of other Member States all scientific information with which
p.002007: it shall have, as well as the data evaluation carried out, the reasons for initiating the procedure in accordance with this
p.002007: section.
p.002007: (6) (Amended, SG No. 18/2014) In the cases of para. 2 - 4 The European Medicines Agency notifies the BDA of
p.002007: initiation of the procedure when safety concerns also apply to other medicinal products
p.002007: products that belong to the same therapeutic group or that contain the same active substance
p.002007: substance with the product specified in the information under para. 5, or where this medicinal product is authorized for
p.002007: use in another or in other Member States.
p.002007: (7) (amend. - SG 18/04) In the cases of para. 4, when no emergency measures are required, BDA
p.002007: apply the procedure under Art. 77 or 79b.
p.002007: (8) (New, SG No. 18/2014) The Executive Agency for Medicines shall inform the holder of the
p.002007: the marketing authorization for initiating the procedure under this section.
p.002007: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases of no. 194y, para. 2, when judged,
p.002007: that urgent public health measures need to be taken, the BDA may temporarily
p.002007: suspend the marketing authorization and prohibit the use of the medicinal product in the territory of
p.002007: Until the adoption of a final decision under Art. 194h or 194h.
p.002007: (2) The Medicines Executive Agency shall notify the European Medicines Agency, the European Medicines Agency
p.002007: the Commission and the regulatory authorities of the other Member States for the measures taken under para. 1 within one
p.002007: working day from their implementation and state the reasons for this.
p.002007: (3) Where the Medicines Executive Agency participates in the procedure under this section, at the request of the
p.002007: The European Commission BDA takes the recommended provisional measures with regard to the authorization of
p.002007: use of the medicinal product, or where the medicinal product is authorized for use in the order of
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council - as regards the product itself,
p.002007: completion of the procedure.
p.002007: Art. 194x. (New, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines
p.002007: publish a message on the national Internet portal under Art. 185, para. 1 for the way you are interested
p.002007: Parties may submit information to the European Internet Portal under Art. 68, para. 1, item 4 for
p.002007: the medicinal product - subject to the procedure under Art. 194y, and for the opportunity to participate in public
...
p.002007: 4. obtains medicinal products only from manufacturers, importers or wholesalers of medicinal products
p.002007: products authorized to carry out this activity under this law;
p.002007: 4a. (new - SG 102/2012, in force from 02.01.2013) check whether the received medicinal products from
p.002007: the persons under item 4 are not falsified by checking the safety indicators on the secondary
p.002007: package;
p.002007: 5. supply medicinal products to other holders of a wholesale, pharmacy and drug store authorization,
p.002007: opened in accordance with this law;
p.002007: 5a. (new - SG 71/08, in force from 12.08.2008, amended - SG, iss. 84 from 2018, in force since 12.10.2018)
p.002007: supplies medicinal products to meet their own needs:
p.002007: a) medical establishments;
p.002007: b) higher schools, which carry out medical activity according to Art. 2a of the Medical Institutions Act;
p.002007: c) the institutions of art. 26, para. 1, items 1 and 3 of the Health Act for the health offices established therein;
p.002007: (d) shipowners for the purpose of supplying medicinal products on board ships in accordance with
p.002007: The Merchant Shipping Code;
p.002007: 6. supply doctors and dentists with medicinal products when there is no place in the settlement
p.002007: a pharmacy, under the conditions and in the order laid down in an ordinance of the Minister of Health;
p.002007: 6a. (new - SG, issue 102 of 2012, in force since 02.01.2013, suppl. - SG, iss. 84 of 2018, in force since 12.10.2018)
p.002007: shall enter in the delivery documents the batch number of the medicinal products delivered as well as the address of
p.002007: delivery of medicinal products;
p.002007: 6b. (new - SG 102/2012, in force from 02.01.2013) has an emergency plan, which
p.002007: contains effective measures to withdraw a medicinal product from the market by order of the BDA or
p.002007: an initiative of the manufacturer or the holder of the marketing authorization for the medicinal product concerned
p.002007: product;
p.002007: 6c. (new - SG 18/2014) ensure the supply of sufficient quantities of medicinal products for
p.002007: meeting the health needs of the population of the Republic of Bulgaria;
p.002007: 7. (amend. - SG 102/2012, in force from 02.01.2013) store data for each transaction with received, delivered
p.002007: or medically sold medicinal products in the form of sales invoices
p.002007: either electronically or in any other form as follows:
p.002007: (a) date of receipt and delivery;
p.002007: (b) the name of the medicinal product;
p.002007: (c) the quantity received, delivered or sold through mediation;
p.002007: (d) the name and address of the person from whom the medicinal product was obtained or delivered;
p.002007: (e) the batch number and the batch exemption certificate number issued by the qualified person
p.002007: person under art. 148, item 2, respectively by the qualified person 161, para. 2, item 1, and certificate number for
p.002007: batch release issued by the BDA - in the cases under Art. 69 and 70;
p.002007: 8. keep records of the purchases and / or sales of all medicinal products;
p.002007: 9. comply with the requirements of Good Distributor Practice as defined in the Ordinance Post. 198;
p.002007: 10. (new - SG 102/2012, in force from 02.01.2013) maintain a quality system defining
p.002007: the responsibilities, processes and risk management measures associated with its business;
p.002007: 11. (new - SG 102/2012, in force from 02.01.2013) inform immediately the BDA and the holder of
...
p.002007: (d) the quantities indicated by medicinal products included in the Positive Medicinal Products List for which
p.002007: plans to export, and countries where exports are planned;
p.002007: e) the quantities indicated by medicinal products included in the Positive Medicinal List of which it is
p.002007: export made, and the country in which the export took place.
p.002007: (2) The documentation under para. 1, items 7 and 8 shall be kept for at least 5 years and shall be made available upon request
p.002007: control bodies.
p.002007: Art. 208. (Supplemented, SG No. 71/2008), effective as of August 12, 2008, amended - SG, issue 102 of 2012, effective as of January 2, 2013,
p.002007: ed. - SG, issue. 84 of 2018, effective 12.10.2018) The provisions of Art. 207, para. 1, items 2 - 15 and para. 2 and Art. 209a
p.002007: apply also to the wholesalers of art. 203 as well as for importers and manufacturers trading with
p.002007: their medicinal products.
p.002007: Art. 209. For the wholesale of medicinal products containing narcotic substances or derived from blood,
p.002007: immunological products and radiopharmaceuticals are subject to the special requirements of other laws.
p.002007: Art. 209a. (New, SG No. 71/2008, effective 12.08.2008) (1) Wholesalers of medicinal products
p.002007: can supply medicinal products:
p.002007: 1. other wholesalers of medicinal products;
p.002007: 2. pharmacies and drugstores;
p.002007: 3. The Ministry of Defense and the Ministry of the Interior, except for their own purposes
p.002007: of their departmental medical establishments, as well as the State Agency of the State Reserve and wartime
p.002007: stocks ";
p.002007: 4. The Ministry of Health with:
p.002007: (a) vaccines, toxins and serums necessary for the implementation of the Immunization Calendar of the Republic
p.002007: Bulgaria, as well as in emergency epidemic situations;
p.002007: b) medicinal products intended for the treatment of diseases, which are paid under the Law on
p.002007: health, as well as ensuring the implementation of national health programs.
p.002007: 5. (new - SG 60/2012, in force from 07.08.2012) medical establishments for outpatient care, concluded
p.002007: contract with the National Health Insurance Fund, with the medicinal products needed to fulfill the
p.002007: the health activities of art. 82, para. 2, item 3 of the Health Act.
p.002007: (2) Physicians and dentists in settlements where there is no pharmacy may be supplied
p.002007: with medicinal products from the wholesalers in accordance with the ordinance under Art. 207, para. 1, v. 6.
p.002007: Art. 209b. (New - SG 102/2012, in force from 02.01.2013) (1) In the wholesale of medicinal products
p.002007: in third countries the requirements of art. 207, para. 1, items 2, 5 and 6, as well as the requirements of Chapter Nine
p.002007: "a".
p.002007: (2) Where the medicinal product is obtained directly from a third country but is not imported into the territory of
p.002007: Republic of Bulgaria, the requirements of Art. 207, para. 1, items 4 and 4a.
p.002007: (3) (New, SG No. 18/2014) In the cases of para. 1 wholesalers certify with the relevant
p.002007: documents that the medicinal products have been obtained from persons authorized or entitled to deliver
p.002007: medicinal products in accordance with the applicable national legislation of the third country.
p.002007: (4) (New, SG No. 18/2014) Where the wholesaler supplies medicinal products to third parties
p.002007: States, it certifies with the relevant documents that the supplies are only for authorized persons
p.002007: or the right to receive medicinal products intended for wholesale or delivery of
p.002007: population in accordance with the applicable national legislation of the third country.
...
p.002007: 68. "Batch Release Certificate" is a document that is issued by a qualified person to
p.002007: manufacturer or importer for each individual batch and include requirements in accordance with
p.002007: the specification, as well as all the results of the batch release tests.
p.002007: 69. "Supplemental protection certificate" is a document which provides additional patent protection to
p.002007: medicinal product not more than 5 years after the date of expiry of the basic patent.
p.002007: 69a. (new, SG No. 102/2012, effective 21.12.2012) System
p.002007: "risk management" is a system of measures
p.002007: and pharmacovigilance monitoring activities for identification,
p.002007: characterizing, preventing or minimizing the risks associated with a medicinal product,
p.002007: including an assessment of the effectiveness of these activities and measures.
p.002007: 69b. (new, SG No. 102/2012, effective 21.12.2012) System
p.002007: "to track the drug
p.002007: safety "is a system used by the Marketing Authorization Holder and the BDA for the implementation of the
p.002007: the tasks and responsibilities of Chapter Eight to monitor the safety of
p.002007: the authorized medicinal products and the detection of any change in the benefit / risk ratio.
p.002007: 69c. (new, SG No. 84/2018, effective 12.10.2018)
p.002007: "is a violation committed three or more
p.002007: times within one year of the entry into force of the first penal decree whereby the offender
p.002007: the same type of offense is punished.
p.002007: 70. "Emergency restrictive safety measures" are temporary changes to product information under
p.002007: relation to one or more parts of the summary of product characteristics, indications, manner of
p.002007: application, contraindications and warnings resulting from new information related to
p.002007: safe use of the medicinal product.
p.002007: 71. "Spontaneous message" is a voluntarily sent message for a suspected adverse reaction to
p.002007: the use of the medicinal product by the Marketing Authorization Holder, the market surveillance authorities
p.002007: medicinal products or other organizations not derived from research or other organized
p.002007: information collection system.
p.002007: 72. "Shelf life of a medicinal product" is the interval of time when, if stored
p.002007: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002007: the basis of stability studies of several batches of finished form.
p.002007: 73. (amend. - SG 71/08, in force from 12.08.2008) p
p.002007: "an appropriate herbal medicinal product
p.002007: "medicinal product" is a product which contains the same active substances, regardless of the composition of
p.002007: excipients intended for the same purpose with an equivalent amount of the medicinal product
p.002007: substance / substances, with the same dosage and with the same or similar route of administration as the product, for
p.002007: who has applied.
p.002007: 74. An "adverse reaction message" is documented information about one or more
p.002007: suspected adverse reactions associated with the use of one or more medicinal products by one
p.002007: patient. For the validity of the adverse reaction message, they are required
p.002007: minimum identifier identifier data (initials or address or profession / specialty) of
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.002007: an order to authorize treatment for a fixed term with a medicinal product not authorized in accordance with Chapter
p.002007: third, when an epidemic caused by pathogenic micro-organisms or toxins is reported in the country, or
p.002007: the alleged or confirmed spread of chemical agents or nuclear radiation and is not appropriate
p.002007: authorized medicinal product.
p.002007: (2) In the cases of para. 1, Marketing Authorization Holders, Manufacturers and Medical
p.002007: professionals are not liable for civil or administrative penalties for the consequences of
p.002007: use of an unauthorized indication of a medicinal product or a medicinal product which is not authorized
p.002007: in the order of Chapter Three.
p.002007: (3) The provision of para. 2 does not exclude liability for defective goods under the Law on Protection of
p.002007: users.
p.002007: Art. 11. (1) The Minister of Health may, for reasons connected with the protection of the health of the population,
p.002007: ordering the BDA Executive Director to authorize a medicinal product for use,
p.002007: which has not been authorized for use on the territory of the Republic of Bulgaria and for which no application has been submitted
p.002007: for authorization but authorized in another Member State.
p.002007: (2) In the cases of para. 1, the Executive Director of the BDA or a person authorized by him:
p.002007: 1. inform the holder of the authorization to use the medicinal product for the initiation of a procedure
p.002007: on the authorization of the product for use;
p.002007: 2. enter as the holder in the issued permit the person under item 1;
p.002007: 3. require from the regulatory authority of the Member State which granted the marketing authorization a copy of the evaluation
p.002007: a report and a copy of the marketing authorization.
p.002007: (3) (Supplemented, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines shall be obliged to
p.002007: Ensure compliance with the label, patient package leaflet, classification, advertising and tracking
p.002007: the safety of the marketed medicinal product under para. 1 with the requirements of this law.
p.002007: The information on the packaging and the package leaflet of the medicinal product under para. 1 does not have to be
p.002007: in Bulgarian.
p.002007: (4) The BDA Executive Director shall inform the European Commission of the permits issued under para. 1 for
p.002007: the name and address of the authorization holder as well as the date of their termination.
p.002007: Art. 12. (1) The official pharmacopoeia in the Republic of Bulgaria is the European Pharmacopoeia.
p.002007: (2) The official pharmacopoeia may be supplemented by the requirements of the Bulgarian Pharmacopoeia.
p.002007: (3) The Minister of Health shall determine with an order the dates of entry into force of the current edition
p.002007: of the official pharmacopoeia and its supplements.
p.002007: (4) The order under para. 3 shall be published in the State Gazette and published on the Internet site of the BDA.
p.002007: Art. 13. (1) Monographs of the European Pharmacopoeia are obligatory for all substances, preparations and
p.002007: dosage forms contained therein. In cases where there are no monographs in the European
p.002007: pharmacopoeia, the requirements of the current editions of the pharmacopoeia of the Member States, the USA and
p.002007: Japan, if they comply with the general rules of the European Pharmacopoeia.
p.002007: (2) Where the specification contained in a monograph of the European Pharmacopoeia or in another
...
p.002007: 11. a statement that they have been complied with in clinical trials conducted outside the territory of the Member States
p.002007: ethical principles of Good Clinical Practice;
p.002007: 12. (amend. - SG 102/2012, in force from 21.12.2012) summary of the traceability system
p.002007: drug safety, which includes the following elements:
p.002007: a) the name of the qualified person under Art. 191, Curriculum Vitae - Education acquired by professional experience in
p.002007: the field of pharmacovigilance monitoring and the qualification for fulfilling his duties
p.002007: in the order of Chapter Eight;
p.002007: (b) any Member State in which the qualified person fulfills his duties;
p.002007: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002007: (d) the address at which the basic document of the medication traceability system is stored
p.002007: safety;
p.002007: 12a. (new - SG 102/2012, in force since 21.12.2012) declaration by the applicant that he has at his disposal
p.002007: the necessary means to fulfill the obligations of Chapter Eight;
p.002007: 13. (amend. - SG 102/2012, in force from 21.12.2012) risk management plan with description of the system
p.002007: for risk management to be introduced by the applicant for the medicinal product concerned, together with a summary of
p.002007: the plan;
p.002007: 14. a brief description of the product according to Art. 34;
p.002007: 15. layout of the primary and secondary packaging of the product and a leaflet in accordance with
p.002007: the requirements of Chapter Six;
p.002007: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country in which it is located
p.002007: carry out the production accompanied by a certificate of good manufacturing practice or a certificate,
p.002007: certifying that the manufacture of the medicinal product and of its active substances is
p.002007: performed in accordance with standards at least equivalent to Good Manufacturing standards
p.002007: practice;
p.002007: 17. a copy of the document by which the medicinal product is designated for treatment, prophylaxis or diagnosis
p.002007: rare diseases, accompanied by a copy of the opinion of the European Medicines Agency;
p.002007: 18. copies of any marketing authorization issued in another Member State or in a third country for
p.002007: the medicinal product for which authorization is sought;
p.002007: 18a. (new - SG 102/2012, in force since 21.12.2012) copy of the summary of the safety data,
p.002007: including data contained in, and where relevant, periodic safety update reports
p.002007: suspected adverse reactions have been reported;
p.002007: 19. a list of the Member States in which an application for a marketing authorization has been submitted
p.002007: medicine;
p.002007: 20. (amend. - SG 71/08, in force from 12.08.2008) a copy of the summary of product characteristics,
p.002007: proposed by the person under Art. 26, para. 1, or a copy of the summary of product characteristics approved by
p.002007: a regulatory authority of a Member State (s) already authorized;
p.002007: 21. a copy of the refusal of the marketing authorization in a Member State or in a third country,
p.002007: accompanied by motives; information on suspension or termination of the authorization
p.002007: for use;
p.002007: 22. a copy of the proposed leaflet for the patient, accompanied by a summary of the results of the evaluation of
p.002007: the level of readability of the contents of the package leaflet from a patient-selected target group,
p.002007: or a copy of a leaflet approved by a regulatory authority of a Member State which has already granted a marketing authorization;
p.002007: 23. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2;
p.002007: 24. (new - SG 71/08, in force from 26.07.2008) the documents shall be sent. 7 of Regulation (EC) No 1901/2006.
p.002007: (2) (Supplemented, SG No. 18/2014) The documents under para. 1, items 18 and 18a with respect to the Member States, respectively
p.002007: under item 19, shall be submitted only in the procedures under section VII.
p.002007: (3) For radionuclide generators to the data of para. 1 the following documents shall be submitted additionally:
p.002007: 1. a description of the system together with a detailed description of the components and which may affect the composition
p.002007: or the quality of daughter radionuclides;
p.002007: 2. the qualitative and quantitative characteristics of the eluate or sublimate.
p.002007: (4) Documents and data from pharmaceutical, preclinical and clinical trials shall be accompanied by
p.002007: summary reports prepared by experts with the necessary technical and professional qualifications. To
p.002007: the reports shall be accompanied by a CV of the experts who produced the report.
p.002007: (5) The dossier of the medicinal product shall be submitted in Bulgarian and / or English.
p.002007: (6) (New, SG No. 102/2012, effective 21.12.2012) The risk management system of para. 1, v. 13
p.002007: should be proportionate to the identified and potential risks of the medicinal product and of
p.002007: the need to collect safety data from post-marketing studies.
p.002007: (7) (New, SG No. 102/2012, in force since 21.12.2012) The holder of the marketing authorization
p.002007: updates the data from the file under para. 1. The order of Chapter Three, Section 1, shall apply to any change to the dossier
p.002007: VI, where applicable.
p.002007: Art. 28. (1) (amend. - SG 71/08, in force from 12.08.2008) 26, para. 1 insofar as it does not violate
p.002007: industrial and commercial property rights, does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b"
p.002007: and "c" if it can prove that the medicinal product referred to in the application is generic of the reference
p.002007: a medicinal product which has been authorized or has been authorized for use in a Member State, not less than
p.002007: for 8 years.
p.002007: (2) The holder of the authorization for use of the generic product under para. 1 can't put it on the market,
p.002007: before the expiry of 10 years from the date of the first authorization to use the reference medicinal product.
p.002007: (3) The person under art. 26, para. 1, subject to the conditions of para. 1 and 2 may apply to the BDA for
p.002007: authorization to use a generic reference product and when the reference product is not
p.002007: was granted marketing authorization in the territory of the Republic of Bulgaria
p.002007: (4) In the cases of para. 3 the person under art. 26, para. 1 shall indicate in the application under Art. 27, para. 1 the Member State in which
p.002007: the reference product is authorized or has been authorized.
p.002007: (5) In the cases of para. 3 The BDA requires the regulatory authority of the Member State referred to in the application under
p.002007: Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and qualitative composition of the reference
p.002007: product and, if necessary, additional documentation.
p.002007: (6) The Executive Agency for Medicines shall make available to a regulatory authority of a State upon request
p.002007: Member State in which the application for a generic reference product has been authorized
p.002007: or has been authorized for use on the territory of the Republic of Bulgaria, the necessary information under para. 5th c
p.002007: within one month from the date of request.
p.002007: (7) The ten-year period under par. 2 may be extended by up to one year at the request of the holder
p.002007: of the marketing authorization of the reference medicinal product, if during the first 8 years of its granting
p.002007: the marketing authorization was granted to the holder of the reference medicinal product for the same product
p.002007: authorization of a new therapeutic indication with significant clinical advantages over existing ones
p.002007: healing options are scientifically sound.
p.002007: (8) (New - SG 12/11, in force from 08.02.2011) When originally issued for a medicinal product
p.002007: marketing authorization in accordance with Art. 23, for any change in the amount of active substance, c
p.002007: the dosage form, in the amount in the package, in the route of administration of the medicinal product, and for
p.002007: any other modification or extension of the marketing authorization shall also be granted
p.002007: as required by this Act or the original marketing authorization is supplemented. All these
p.002007: authorizations are considered to belong to a single global marketing authorization
p.002007: product for the purposes of applying this Article.
p.002007: Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary preclinical and / or clinical
p.002007: tests where the medicinal product referred to in the application:
p.002007: 1. cannot be defined as generic, or
...
p.002007: in the BDA:
p.002007: 1. a sample of the final product and / or a sample of the bulk product / non-spilled product;
p.002007: 2. production and quality control protocols;
p.002007: 3. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The holder of the authorization for the use of new immunological medicinal products or of
p.002007: immunological medicinal products manufactured with new or modified technologies or with technologies new to
p.002007: individual producer, fulfills the obligations under para. 1 for the specific period indicated in the authorization for
p.002007: use.
p.002007: (3) Within 60 days from the date of submission of the complete set of documents, the BDA shall evaluate the
p.002007: the protocols for the production and quality control of live vaccines, immunological and new immunological
p.002007: medicinal products and testing of samples provided at an accredited laboratory to determine
p.002007: whether the medicinal products under para. 1 and 2 are manufactured in accordance with approved specifications.
p.002007: (4) Upon a positive result of the test, the BDA shall issue a batch release certificate.
p.002007: (5) The conditions, procedure and requirements for the documentation for issuing an exemption certificate
p.002007: of the batch for the products of para. 1 and 2 shall be determined in an ordinance of the Minister of Health.
p.002007: (6) When the assessment and testing under para. 3 for the respective batch of medicinal products were made by
p.002007: official laboratory for the control of medicinal products in another Member State, the holder of
p.002007: the marketing authorization provided for in the BDA was the batch release certificate
p.002007: products issued by the regulatory authority of the Member State.
p.002007: (7) In the cases of para. 6 The BDA does not carry out the activities under para. 3 and 4.
p.002007: Art. 70. (1) The holder of a marketing authorization for a medicinal product obtained from human blood or
p.002007: human plasma, prior to placing each batch of the product on the market, is required to submit to the BDA:
p.002007: 1. a sample of the final product and / or a sample of the bulk product / non-spilled product;
p.002007: 2. production and quality control protocols;
p.002007: 3. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) Within 60 days from the date of submission of the complete set of documents, the BDA shall carry out an evaluation of
p.002007: the protocols for the production and quality control of the medicinal product obtained from human blood or
p.002007: human plasma, and testing of the samples provided at an accredited laboratory to determine whether
p.002007: the medicinal product under para. 1 is manufactured in accordance with approved specifications.
p.002007: (3) Upon a positive result of the test, the BDA shall issue a batch release certificate.
p.002007: (4) The conditions, the order, and the requirements for the documentation for issuance of exemption certificate
p.002007: of the batch for the products of para. 1 shall be determined in the ordinance under Art. 69, para. 5.
p.002007: (5) When the assessment and testing under para. 2 for the respective batch of medicinal product were made by
p.002007: official laboratory for the control of medicinal products in another Member State, the holder of
p.002007: the marketing authorization provides for the batch release certificate for the medicinal product,
p.002007: issued by the regulatory authority of the Member State.
p.002007: (6) In the cases of para. 5 BDA does not carry out the activities under para. 2 and 3.
p.002007: Art. 71. (1) The holder of the marketing authorization shall be obliged to maintain a blocking and withdrawal system.
p.002007: from the market for medicinal products that do not meet the quality, safety and quality requirements
p.002007: efficiency.
p.002007: (2) The marketing authorization holder shall be obliged to block and withdraw medicinal products,
p.002007: have shown non-compliance with the requirements for quality, efficiency and safety, in accordance with the ordinance under Art.
p.002007: 274, para. 1.
p.002007: Art. 72. (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002007: Art. 73. (1) The holder of the marketing authorization may transfer the rights to the marketing authorization
p.002007: use of the medicinal product by another legal entity or by non-legal entities
p.002007: persons established in the territory of the Member States.
p.002007: (2) The Marketing Authorization Holder submits an application to the BDA, to which it attaches documentation,
p.002007: defined in the ordinance under Art. 42, indicating a proposal for a transfer date.
p.002007: (3) In case of finding incompleteness in documentation under para. 2 The BDA shall notify in writing the holder of
p.002007: the marketing authorization provided for the additional information required within 30 days. The time limit is
p.002007: para. 5 shall stop running from the date of notification until the requested information has been provided.
p.002007: (4) If, within the term of para. 3 the Marketing Authorization Holder did not complete the documentation, procedure
p.002007: the transfer of the marketing authorization shall cease.
p.002007: (5) Within 30 days from the date of submission of the application under para. 2 the BDA Executive Director issues
p.002007: change permit approving the transfer. The change authorization shall also indicate the date
p.002007: of the transfer of the marketing authorization.
p.002007: (6) The new marketing authorization holder fully assumes the rights and obligations of the previous
p.002007: the marketing authorization holder.
p.002007: (7) When transferring the marketing authorization for a medicinal product under the procedure of para. 1 - 6 his term is not
p.002007: is changing.
p.002007: Section VII.
p.002007: Mutual recognition procedure and decentralized procedure
p.002007: Art. 74. (1) When the person under Art. 26, para. 1 has been granted marketing authorization in another Member State for
p.002007: the same medicinal product within the meaning of Art. 45, para. 3, which has applied for a permit for
p.002007: use to the BDA, it shall submit a request to the regulatory authority of the Member State designated by it in the application,
p.002007: hereinafter referred to as the "reference country", to draw up an evaluation report or to update an existing one.
p.002007: (2) With the application the person under para. 1 submits to the BDA a dossier identical to that submitted in the reference
p.002007: State and in the other Member States referred to in the application, hereinafter referred to as the countries concerned.
p.002007: (3) The Executive Agency for Medicinal Products and the applicant shall receive, ex officio, from the regulatory body of
p.002007: the reference country under para. 1 the evaluation report together with the approved summary of product characteristics and c
p.002007: approved layout of the package and the package leaflet for the patient.
p.002007: (4) The Executive Agency for Medicines shall consider the documents under para. 3 and inform in writing
p.002007: the country of reference for the decision taken within 90 days of the date of receipt.
p.002007: (5) Within 30 days of receipt of notification of completion of the procedure by the reference country
p.002007: the BDA Executive Director issues a marketing authorization for the medicinal product on the territory of
p.002007: Republic of Bulgaria with the approved summary of product characteristics, package layout and package leaflet
p.002007: patient.
p.002007: Art. 75. (1) When the person under Art. 26, para. 1 submits an application simultaneously to the BDA and other Member States
p.002007: of a marketing authorization for a medicinal product for which a marketing authorization has not been granted
p.002007: the territory of a Member State, it shall indicate in the application the regulatory authority of the Member State called
p.002007: hereinafter referred to as the "reference country" to draft the evaluation report, draft summary
p.002007: product characteristics and design of the patient package and package leaflet.
p.002007: (2) With the application the person under para. 1 submits to the BDA a dossier identical to that submitted in all other countries
p.002007: Member States referred to in the application, hereinafter referred to as the countries concerned.
p.002007: (3) The Executive Agency for Medicinal Products and the applicant shall receive, ex officio, from the regulatory body of
p.002007: reference country draft evaluation report, draft summary of product characteristics and design
p.002007: on the mock-up of the package and the package leaflet for the patient.
p.002007: (4) The Executive Agency for Medicines shall consider the documents under para. 3 and inform in writing
p.002007: the country of reference for the decision taken within 90 days of the date of receipt.
p.002007: (5) Within 30 days of receipt of notification of completion of the procedure by the reference country
p.002007: the BDA Executive Director issues a marketing authorization for the medicinal product on the territory of
p.002007: Republic of Bulgaria with the approved summary of product characteristics, package layout and package leaflet
p.002007: patient.
p.002007: Art. 76. (1) When the Republic of Bulgaria is a reference country under Art. 74, BDA:
p.002007: 1. within 90 days from the date of submission of valid documentation, send to the regulatory authorities of
p.002007: the countries concerned and the applicant's assessment report, together with the approved summary of the
p.002007: the product and the approved mock-up of the package and the package leaflet for the patient;
p.002007: 2. closes the procedure and notifies the applicant and the States concerned, if all States concerned are
p.002007: approved.
...
p.002007: centers, in the structure of which a pharmacy, licensed under Art. 33, para. 1 of the Law on
p.002007: control of narcotic drugs and precursors, or who have contracted with another drug
p.002007: an establishment in the structure of which a pharmacy has been opened, holding a license under Art. 33, para. 1 of the Law
p.002007: for drug and precursor control.
p.002007: (3) (Renumbered from Paragraph (2), amend. - SG 84/08, in force from 12.10.2018) Clinical trial may be
p.002007: conducts only in a medical establishment in which there is a designated contact person under Art. 107a, para. 1.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 84/2018, effective 12.10.2018)
p.002007: the clinical trial of a medicinal product will be agreed to the participation of the principal
p.002007: researcher and for conducting the test.
p.002007: Art. 88. (1) Clinical trial on humans shall be performed with:
p.002007: 1. medicinal products not authorized for use in the Republic of Bulgaria;
p.002007: 2. medicinal products authorized for use in the Republic of Bulgaria when tested for unauthorized use
p.002007: indication for a dosage form other than the authorized one in a group of patients not previously studied or
p.002007: for more information.
p.002007: (2) Authorized for use in the Republic of Bulgaria within the meaning of para. 1, item 2 are medicinal products received
p.002007: authorization for use under this Act or under Regulation (EC) No 726/2004 of the European Union
p.002007: Parliament and Council.
p.002007: Art. 89. (Repealed, SG No. 84/2018)
p.002007: Art. 90. (Repealed, SG No. 84/2018) (Amended, SG No. 17/2019)
p.002007: Art. 91. The contracting authority and the principal investigator take out insurance covering their liability for
p.002007: non-material and property damage caused during or in the course of the clinical trial
p.002007: of the participants.
p.002007: Art. 92. (1) (Amended, SG No. 84/2018) (*) The contracting authority shall be liable in case of health damage.
p.002007: or death caused during or on the occasion of the clinical trial when the trial is
p.002007: carried out in accordance with the requirements and procedures of the approved protocol.
p.002007: (2) (Amended, SG No. 84/2018) (*) The Principal Investigator shall be liable in the event of damage to
p.002007: health or death caused during or in connection with the conduct of a clinical trial when not
p.002007: the requirements and procedures of the approved protocol are complied with.
p.002007: Art. 93. (Am. - SG, iss. 84 in 2018. (*)) (1) When the clinical trial is conducted only in the territory of
p.002007: The Republic of Bulgaria or on the territory of the Republic of Bulgaria and on the territory of a third country,
p.002007: the contracting authority appoints a representative on the territory of the Republic of Bulgaria for the specific clinical
p.002007: testing.
p.002007: (2) The person under para. 1 is the addressee of the communication with the contracting authority provided for in Regulation (EU) No 536/2014.
p.002007: Art. 94. The sponsor shall provide free of charge the tested medicinal product / products and each device,
p.002007: necessary for its implementation.
p.002007: Art. 95. (Repealed, SG No. 84/2018)
p.002007: Art. 96. (1) (Amended, SG No. 84/2018) (*) Clinical testing of medicinal products shall be allowed only on
p.002007: a person who has given his or her written informed consent.
p.002007: (2) (Repealed, SG No. 84/2018)
p.002007: (3) (Amended, SG No. 84/2018) (*) Informed consent under Chapter V of Regulation (EU) No 536/2014 may
p.002007: gives only a capable person who understands the nature, significance, scope and potential risks of
p.002007: the clinical trial. Informed consent to participate in a clinical trial may be withdrawn at
p.002007: anytime.
p.002007: (4) (Amended, SG No. 84/2018) (*) Informed consent under Chapter V of Regulation (EU) No 536/2014 for
p.002007: an invalid adult is given by his legal representative. The consent of the legal representative
p.002007: must represent the intended will of the participant and may be withdrawn at any time without
p.002007: negative consequences for the participant.
p.002007: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent is given by the court-appointed person.
p.002007: (6) The incapable adult shall be provided with information about the test, the possible risks and
p.002007: benefits in accordance with his ability to understand.
...
p.002007: The European Parliament and the Council, or
p.002007: 2. the coordination group of art. 77, para. 2.
p.002007: (2) In the cases of para. 1, item 2, when the committee under art. 56a, para. 1, item 1 recommended change, suspension or
p.002007: suspension of the marketing authorization, coordination group represented by Member States, c
p.002007: The survey conducted conducted an opinion on the necessary actions to be taken
p.002007: undertake with regard to the marketing authorization, including a timetable for its implementation.
p.002007: (3) When the Member States represented in the coordination group reach consensus on the opinion
p.002007: under para. 2, it shall be published on the European Internet portal for medicinal products under Art. 68, para. 1, item 4 and se
p.002007: sends the marketing authorization holder.
p.002007: (4) The BDA Executive Director in accordance with the opinion under para. 2 stops or
p.002007: terminates the marketing authorization.
p.002007: (5) Where in the opinion under para. 2 recommended changes to the marketing authorization issued,
p.002007: the Marketing Authorization Holder submits to the BDA within the specified implementation schedule
p.002007: an application for change pursuant to Chapter Three, Section VI, incorporating an updated summary of the
p.002007: product and leaflet.
p.002007: (6) Where agreement cannot be reached within the coordination group, the position of
p.002007: the majority of the Member States are referred to the European Commission, which decides on
p.002007: modification, suspension or revocation of the marketing authorization granted by the relevant regulatory authority
p.002007: Member State authorities.
p.002007: (7) The decision under para. 6 is published on the European Medicines Portal. 68, para.
p.002007: 1, item 4 and shall be sent to the holder of the marketing authorization.
p.002007: (8) The Executive Agency for Medicinal Products applies the provisional and / or definitive measures of the Decision on Medicinal Products
p.002007: para. 6 and inform the European Medicines Agency and the European Commission.
p.002007: (9) In the cases of para. 1, item 1 The Committee for Medicinal Products for Human Use, in accordance with
p.002007: the recommendation of the committee under art. 56a, para. 1, item 1 issues an opinion on the retention, amendment,
p.002007: suspension or termination of the marketing authorization, including a timetable for
p.002007: implementation of the opinion. The opinion shall be published on the European Medicines Portal
p.002007: products of art. 68, para. 1, item 4 and shall be sent to the holder of the marketing authorization.
p.002007: (10) Where in the opinion under para. 9 is a position for regulatory action under
p.002007: as regards marketing authorizations, the European Commission shall decide to amend, suspend or
p.002007: suspension of the marketing authorizations granted under Regulation (EC) No 726/2004 of the European Union
p.002007: Parliament and the Council.
p.002007: Art. 145k. (New, SG No. 102/2012, effective 21.12.2012) (1) (Amended, SG No. 84/2018)
p.002007: 12.10.2018) Non-interventional studies in the territory of the Republic of Bulgaria are conducted at
p.002007: conditions and in the order determined by an ordinance of the Minister of Health.
...
p.002007: radiochemistry - for radiopharmaceuticals or for medicinal products subject to ionizing radiation;
p.002007: 3. with recognized specialty in clinical hematology, medical microbiology, virology or immunology
p.002007: - for the production of immunological medicinal products - vaccines, toxins, serums, for biotechnological products
p.002007: products and for medicinal products derived from human plasma or from human blood.
p.002007: Art. 150. (1) The person under art. 146 shall submit to the BDA an application in accordance with a model approved by the Director of the Agency.
p.002007: (2) Together with the application under para. 1 the applicant shall also submit:
p.002007: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002007: specialty, work record, criminal record or similar person document, if not
p.002007: is a Bulgarian citizen, and an employment contract for the persons under Art. 148, item 2 and art. 149;
p.002007: 2. copies of contracts for the assignment of production and / or control of the products declared for production - in
p.002007: the cases under Art. 151;
p.002007: 3. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
p.002007: for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
p.002007: registered in a Member State of the European Union, or in a State Party to the
p.002007: European Economic Area - a document for current national registration
p.002007: legislation issued by a competent authority of the country concerned;
p.002007: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: a list of the manufacturing activities and the dosage forms to be manufactured;
p.002007: 5. schemes of the premises for production, control and storage and file of the production capacity;
p.002007: 6. assessment of the environmental impact of the manufacture of medicinal products in accordance with the provisions of Art
p.002007: Environmental Protection Act cases;
p.002007: 7. permission from the Nuclear Regulatory Agency when the application concerns the production of
p.002007: radiopharmaceuticals or medicinal products subject to ionizing radiation during manufacture
p.002007: them;
p.002007: 8. permission to use the premises for production, control and storage, issued in accordance with the procedure of
p.002007: The Spatial Planning Act, or any other substitute document;
p.002007: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 10. a document for payment of a fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) In the manufacture of narcotic substances and dosage forms containing such substances,
p.002007: also comply with the requirements of the Narcotic Drugs and Precursors Control Act.
p.002007: (4) (New - SG 103 2017, in force from 01.01.2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the persons under para. 2, item 1, when they are Bulgarian citizens.
p.002007: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
...
p.002007: 150 and 151, with a deadline for issue:
p.002007: 1. 14 days - in cases of post. 156, para. 1, items 1, 2 and 7;
p.002007: 2. (amend. - SG 60/11, in force from 05.08.2011) 30 days - in the cases of post. 156, para. 1, Vols 4 - 6.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) When you change the post. 156, para. 1, items 4 - 6 can not
p.002007: are evaluated by documents, the BDA carries out an on-site inspection. In these cases, the term under para. 1, item 2 stops running until
p.002007: completion of verification.
p.002007: (3) The expenses for carrying out on-site inspections under para. 2 shall be at the expense of the applicant.
p.002007: (4) For carrying out on-site inspections under para. 2, the applicant shall pay a fee in the amount specified in the tariff
p.002007: under Art. 21, para. 2.
p.002007: Art. 158. (1) The Executive Agency for Medicines shall keep a register of mail. 19, para. 1, item 1 of the issued
p.002007: production authorizations containing:
p.002007: 1. number and date of the manufacturing authorization;
p.002007: 2. the name, seat and address of management of the person who has obtained the manufacturing authorization;
p.002007: 3. address of the premises for production, control and storage of the medicines;
p.002007: 4. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and the forms for which it has been received
p.002007: the authorization;
p.002007: 5. name of the person under art. 148, Vol. 2;
p.002007: 6. names of the persons under art. 149;
p.002007: 7. date of deletion from the register of production authorization and the reason for doing so.
p.002007: (2) The data from the register of issued production authorizations shall be published on the BDA website in
p.002007: Internet.
p.002007: (3) Upon request from the European Commission or a regulatory authority of a Member State, the BDA shall provide
p.002007: information on the production authorization issued.
p.002007: Art. 159. (1) The holder of a permit for production of rent under an employment contract at least one
p.002007: Qualified person under Art. 148, item 2, which is permanently at his disposal.
p.002007: (2) The qualified person under para. 1 shall meet the following requirements:
p.002007: 1. have a master's degree in medicine, pharmacy, chemistry, biotechnology or biology;
p.002007: 2. have at least two years of practical experience in pharmaceutical manufacturing and / or manufacturing
p.002007: of qualitative and quantitative analysis of medicinal products and active substances.
p.002007: (3) When the holder of the marketing authorization for a medicinal product meets the requirements of
p.002007: para. 2, it may fulfill the obligation of a qualified person.
p.002007: (4) (New, SG No. 102/2012, effective 21.12.2012) The qualified person shall be responsible for
p.002007: the packaging of the medicinal product the safety indicators according to art. 168, para. 8.
p.002007: (5) (Renumbered from Paragraph (4), SG No. 102/2012, effective 21.12.2012) The qualified person shall issue a certificate
p.002007: to release any batch certifying that the batch of medicinal product is manufactured and
p.002007: controlled in accordance with the requirements of the marketing authorization under this Act.
p.002007: (6) (Renumbered from Paragraph 5, SG No. 102/2012, effective 21.12.2012, amended - SG No. 84/2018 (*))
p.002007: The qualified person shall issue a certificate of release to each lot, certifying that the lot
p.002007: medicinal product intended for clinical trial is manufactured and controlled in accordance with
p.002007: the requirements of Good Manufacturing Practice, with the manufacturing file of the product and with the documentation
...
p.002007: excipients determined on the basis of a formal risk assessment in accordance with the applicable ones
p.002007: guidelines adopted by the European Commission;
p.002007: 3. provide permanently qualified production and control personnel as required by
p.002007: the ordinance under Art. 152;
p.002007: 4. (amend. - SG 12/11, in force from 08.02.2011) has only medicinal products which have
p.002007: authorization for use, subject to the requirements of this law;
p.002007: 5. (repealed, SG No. 12/2011, effective 08.02.2011)
p.002007: 6. notify immediately the control bodies in case of change of qualified person post. 148, Vol. 2;
p.002007: 7. provide access to the premises and documentation at all times to the control bodies;
p.002007: 8. provide to the qualified person under Art. 148, item 2 the necessary conditions for fulfilling the obligations
p.002007: his;
p.002007: 9. (New - SG, iss. 102 in 2012) shall inform immediately the BDA and the holder of
p.002007: the marketing authorization if it receives information that the medicinal products covered by the
p.002007: its manufacturing authorization, are falsified or there are suspected falsifications,
p.002007: whether or not these medicinal products were distributed within the legal chain
p.002007: delivery or in an illegal manner, including through illegal sale through the services of
p.002007: the information society;
p.002007: 10. (new - SG 102/2012, in force from 02.01.2013) check whether the manufacturers, importers or
p.002007: traders from whom it receives active substances are registered by the competent authority of the Member State,
p.002007: in which they are established;
p.002007: 11. (new - SG 102/2012, in force from 02.01.2013) shall check the authenticity and quality of the active and
p.002007: of excipients.
p.002007: (2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
p.002007: performs audits at the sites for the production and marketing of active substances in order to comply with the Good
p.002007: manufacturing practice and Good distribution practice. The holder of the manufacturing authorization
p.002007: may contract with a third party to perform the audit on his behalf and on his behalf.
p.002007: (3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
p.002007: documents the undertakings under para. 1, items 2 and 2a measures.
p.002007: (4) (Renumbered from Paragraph (2) - SG, No. 102 of 2012, in force since 02.01.2013, amend. - SG, iss. 84 in 2018. (*))
p.002007: of a manufacturing authorization shall keep the samples and the documentation of the medicinal products manufactured by him
p.002007: products and active substances under the conditions and in the order specified in the ordinance under Art. 152, para. 1.
p.002007: (5) (Renumbered from Paragraph (3), SG No. 102/2012, effective as of 02/01/2013, repealed - SG, iss. 84 in 2018 (*))
p.002007: (6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013) The documentation for each concluded transaction
p.002007: is stored for 5 years and contains the date, the name of the medicinal product, the quantity delivered, the name and
p.002007: recipient address and batch number.
p.002007: (7) (Renumbered from Paragraph 5, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
p.002007: production provides and maintains a system for blocking and withdrawal of medicinal products from the market,
...
p.002007: from a third country of all types of medicinal products and medicinal products intended for
p.002007: clinical trial may only be performed by natural or legal persons registered as traders
p.002007: under the law of a Member State which has been granted an import authorization by the executive
p.002007: director of the BDA.
p.002007: (2) In order to obtain an import permit, the person under para. 1 must have:
p.002007: 1. (amend. - SG 102/2012, in force from 02.01.2013) at any time with at least one qualified person,
p.002007: which meets the requirements of Art. 159, para. 2 and 10;
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) with a laboratory for quality control in compliance
p.002007: with the requirements of the ordinance under Art. 152 and storage facilities for medicinal products, and
p.002007: clinical trial medicinal products with the necessary technical equipment, c
p.002007: compliance with the requirements of the ordinance under Art. 198.
p.002007: Art. 162. (1) For obtaining a permit for import the person shall mail. 161, para. 1 submits an application to the BDA on
p.002007: model approved by the Executive Director of the Agency.
p.002007: (2) To the application under para. 1 shall apply:
p.002007: 1. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
p.002007: for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
p.002007: registered in a Member State of the European Union, or in a State Party to the
p.002007: European Economic Area - a document for current national registration
p.002007: legislation issued by a competent authority of the country concerned;
p.002007: 2. (amend. - SG 102/2012, in force from 02.01.2013) list of the medicinal products and the forms which will
p.002007: are imported;
p.002007: 3. (suppl. - SG 71/08, in force from 12.08.2008) a copy of the production permit issued by
p.002007: the regulatory authority of the exporting country and a certificate attesting the eligibility of the exporting country
p.002007: production, control and storage with standards at least equivalent to Good standards
p.002007: manufacturing practice;
p.002007: 4. documents certifying the circumstances under Art. 159, para. 1 and 2 for the qualified person;
p.002007: 5. data on the address of a laboratory on the territory of the Republic of Bulgaria for completion of a complete
p.002007: quantitative and qualitative analysis of at least the active substances and of all other tests and tests for
p.002007: demonstration of the quality of each imported batch of medicinal product in accordance with the requirements of
p.002007: the marketing authorization under this law and the address of the storage premises;
p.002007: 6. a contract which defines the responsibilities of each party in respect of compliance with
p.002007: the principles of Good Manufacturing Practice by the contractor and the way in which the qualified person
p.002007: under Art. 161, para. 2, item 1 shall perform its duties when the person sends. 161, para. 1 does not have
p.002007: with its own laboratory;
p.002007: 7. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (3) (New, SG No. 71/2008, effective 12.08.2008) Upon receipt of an application under para. 1 BDA evaluates
p.002007: the documentation submitted and perform an on-site inspection of the control laboratory and premises
p.002007: storage of medicinal products and medicinal products intended for clinical trial for
p.002007: establishing their compliance with the requirements of Good Manufacturing Practice and Good
p.002007: distribution practice.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 71/2008, effective 12.08.2008) Where the premises for production are
...
p.002007: 3. address of the premises for control and storage of the medicinal products;
p.002007: 4. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and the forms for which it has been received
p.002007: the authorization;
p.002007: 5. name of the person under art. 161, para. 2, Vol. 1;
p.002007: 6. date of deletion from the register of the import authorization and the grounds thereof.
p.002007: (2) Data from the register shall be published on the BDA website on the Internet.
p.002007: Section III.
p.002007: Production, import and wholesale of active substances (New, SG No. 102/2012,
p.002007: (effective from 02/01/2013)
p.002007: Art. 167a. (New, SG No. 102/2012, effective 02.01.2013) Manufacture, import or wholesale of
p.002007: active substances may only be carried out by natural or legal persons registered as traders under
p.002007: the legislation of a Member State and entered in the register under Art. 167g.
p.002007: Art. 167b. (New - SG 102/2012, in force from 02.01.2013) (1) For entry in the register no. 167g
p.002007: the applicant submits to the BDA an application in accordance with a model approved by the BDA Executive Director, which contains:
p.002007: 1. Name, registered office and address of management of the person mailed. 167a;
p.002007: 2. a list of the active substances to be imported, manufactured or marketed;
p.002007: 3. the activities that the person under art. 167a will perform;
p.002007: 4. address of the premises and data on the technical equipment for carrying out the activity of the persons under
p.002007: Art. 167a.
p.002007: (2) To the application under para. 1 shall apply:
p.002007: 1. particulars of the trader's unique identification code and of the companies incorporated in a Member State -
p.002007: document for current registration under national law, issued by a competent authority of
p.002007: the country concerned;
p.002007: 2. document for paid fee under Art. 21, para. 2.
p.002007: (3) Within 60 days of receipt of the application and documentation under para. 1 and 2 of the BDA on the basis of an evaluation of
p.002007: risk:
p.002007: 1. enter the person under Art. 167a in the register under Art. 167d, of which he informs him or
p.002007: 2. notify of the date of the inspection of conformity to the conditions for
p.002007: performing the activities under Art. 167a with the requirements of Good manufacturing practice 152, para. 1 and
p.002007: of the Good Distribution Practices of Active Substances under Art. 198.
p.002007: (4) Where, as a result of the inspection under para. 3, item 2 BDA has established compliance with the requirements of the Good
p.002007: production practice under Art. 152, para. 1 and Good Distributive Practices of Active Substances
p.002007: 198, it shall enter the applicant in the register under Art. 167d, of which he informs him.
p.002007: (5) The expenses for carrying out the inspection under para. 3, item 2 shall be at the expense of the applicant.
p.002007: (6) For carrying out the inspection under para. 3, item 2 the applicant shall pay a fee in the amount specified in the tariff under
p.002007: Art. 21, para. 2.
p.002007: (7) In the cases of para. 3, item 1 and para. 4, the applicant may commence its activity after the entry
p.002007: in the register of art. 167g.
p.002007: Art. 167c. (New, SG No. 102/2012, effective 02.01.2013) 167b, para. 3 BDA does not
p.002007: Notify that an inspection will be carried out, the applicant may start the activity.
p.002007: Art. 167g. (New - SG 102/2012, in force from 02.01.2013) (1) The Executive Agency for Medicines shall lead
p.002007: a public register of importers, manufacturers and wholesalers of active substances containing:
p.002007: 1. Name, registered office and address of management of the person mailed. 167a;
p.002007: 2. a list of the active substances that are imported, manufactured or marketed;
p.002007: 3. the activities that the person under art. 167a will perform;
p.002007: 4. address of the premises where the activities are carried out;
p.002007: 5. notes on the entered circumstances.
p.002007: (2) The Executive Agency for Medicines shall enter into the database under Art. 147 registered information
p.002007: importers, manufacturers and wholesalers of active substances.
p.002007: Art. 167d. (New, SG No. 102/2012, effective 02/01/2013) (1) 167a submits to the BDA annually by
p.002007: 31 January notification of changes in the information entered in the register under Art. 167g.
p.002007: (2) When changes occur that may affect the quality or safety of the active
p.002007: substances produced, imported or distributed, the person under Art. 167a shall notify the BDA immediately.
p.002007: Art. 167f. (1) (New, SG No. 102/2012, in force from 02.01.2013) Production, import and wholesale trade
p.002007: with active substances on the territory of the Republic of Bulgaria, including active substances intended for use
p.002007: for export, is carried out in accordance with Good Manufacturing Practice and Good Distribution Practices
p.002007: for active substances.
p.002007: (2) Importers may import active substances only if the following conditions are met:
p.002007: 1. the active substances have been manufactured in accordance with Good Manufacturing Practice standards,
p.002007: which are at least equivalent to those established by the European Union, and
p.002007: 2. (In force from 02.07.2013) The active substances shall be accompanied by a written confirmation from the competent person
p.002007: authority of the exporting country that:
p.002007: (a) Good manufacturing practice standards applicable to the exported production site
p.002007: active substances are at least equivalent to those established by the European Union;
p.002007: (b) the production site concerned is subject to regular control and is effectively implemented by the Good
p.002007: manufacturing practices, including repeated and unannounced inspections, to ensure the protection of
p.002007: public health at least equivalent to that of the European Union, and
p.002007: (c) in the event of non-compliance, the exporting country will immediately inform the BDA.
p.002007: (3) (In force from 02.07.2013) The requirement of para. 2, item 2 shall not apply if the exporting country is included in
p.002007: the list under Art. 111b of Directive 2001/83 / EC.
p.002007: Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
p.002007: ensure the availability of medicinal products, the importer may import the active substance without the written request
p.002007: confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
p.002007: manufacturing practice where the manufacturing site of the active substance in the exporting country was
p.002007: inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines for
p.002007: Good manufacturing practice.
p.002007: (2) In the cases of para. 1 The BDA shall notify the European Commission.
p.002007: Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of manufacturing authorizations,
p.002007: including those who perform the activities of art. 168b, para. 2 shall be considered as producers within the meaning of
p.002007: § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002007: caused by a defect in the goods provided for therein.
p.002007: Chapter Six.
p.002007: PACKAGING AND PACKAGE LEAFLET
p.002007: Art. 168. (1) The packaging of a medicinal product shall consist of a primary and / or secondary packaging and a leaflet for
p.002007: patient.
p.002007: (2) (amend. - SG 61/11, in force from 10.11.2011) The secondary packaging of medicinal products,
p.002007: containing substances specified in the list under Art. 3, para. 2, item 2 of the Drug Control Act
p.002007: substances and precursors, is marked diagonally with two red strips, and the outer packaging of medicinal
p.002007: products containing substances from the list under Art. 3, para. 2, item 3 of the Drug Control Act
p.002007: substances and precursors - with two blue bands. The package must contain an indication that the medicinal product
p.002007: the product is only available on special medical prescription.
p.002007: (3) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products included in
p.002007: the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains
...
p.002007: unit, dosage form, specific type of immediate packaging of the product, and / or
p.002007: 2. other specific conditions of use.
p.002007: (2) The Medicines Executive Agency may not specify the exact category of medicinal product under
p.002007: Art. 172, but according to the criteria of Art. 174 and 175 determine whether the medicinal product is to be classified as
p.002007: product available only on prescription.
p.002007: Art. 177. Medicinal products which do not meet the requirements of the EMA. 173, 174 and 175 and the criteria,
p.002007: defined in the ordinance under art. 178, are granted without medical prescription.
p.002007: Art. 178. The classification criteria for medicinal products and the requirements for the dossier
p.002007: making changes in the classification shall be determined in an ordinance of the Minister of Health.
p.002007: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish its page on an internet list
p.002007: of medicinal products subject to medical prescription on the territory of the Republic
p.002007: Bulgaria.
p.002007: (2) The list under para. 1 is updated annually.
p.002007: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002007: or a certificate of registration, the BDA shall review and, where necessary, amend the classification
p.002007: according to the requirements of Art. 173 and the criteria specified in the ordinance post. 178.
p.002007: Art. 181. Where a change in the classification of a medicinal product is authorized
p.002007: significant preclinical or clinical trials, following applicant or marketing authorization holder
p.002007: use may not be invoked within one year from the date of the variation authorization issued by
p.002007: a regulatory authority of a Member State, when applying for a change in the classification of the same
p.002007: substance.
p.002007: Art. 182. The Medicines Executive Agency shall inform the European Commission and the regulatory authorities on an annual basis
p.002007: authorities of other Member States for changes in the list under Art. 179.
p.002007: Chapter Eight.
p.002007: PHARMACEUTICAL SAFETY TRACKING
p.002007: Section I.
p.002007: General Provisions (New, SG No. 102/2012, effective 21.12.2012)
p.002007: Art. 183. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: organizes and maintains a pharmacovigilance monitoring system for the implementation of the
p.002007: the obligations under this Chapter.
p.002007: (2) The system of para. 1 is used to gather information on the risks of medicinal products
p.002007: for patients' health and public health. The information covers unwanted messages
p.002007: drug reactions when using a medicinal product in accordance with the approved summary
p.002007: characteristics, as well as misuse and use information that is not in accordance with the approved one
p.002007: summary of product characteristics, including information on the side effects observed
p.002007: in the performance of professional duties.
p.002007: (3) The Executive Agency for Medicines shall validate, process and classify the information under para. 2,
p.002007: makes a scientific analysis of the data collected with a view to assessing the options for reduction and prevention
p.002007: risk and take the necessary action with regard to the marketing authorization
p.002007: product.
p.002007: (4) The Executive Agency for Medicines shall carry out audits of the system under para. 1 and every two years
...
p.002007: regulatory actions for the marketing authorization within the timeframe set out in
p.002007: according to the severity and degree of danger.
p.002007: (4) The Medicines Executive Agency shall implement the recommendations recommended in the coordination opinion
p.002007: a group under Art. 77, para. 2 or in the decision of the European Commission provisional and / or definitive measures.
p.002007: Art. 188. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
p.002007: inform the European Medicines Agency, the regulatory authorities of the other Member States and
p.002007: The European Commission, at least 24 hours before the public disclosure of concerns,
p.002007: related to the monitoring of the safety of a medicinal product, except where the protection of
p.002007: public health requires immediate disclosure.
p.002007: (2) The Executive Agency for Medicinal Products shall publish information relating to active substances containing
p.002007: in medicinal products authorized in other Member States, using harmonized
p.002007: draft communication and timetable for publication proposed by the European Medicines Agency.
p.002007: (3) In the cases of para. 1 and 2 the information containing personal data or constituting a trade secret shall be
p.002007: deleted unless publication of this information is necessary for the protection of public health.
p.002007: Art. 189. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines may
p.002007: delegate some of the rights and obligations under this chapter to a regulatory authority of another Member State
p.002007: by concluding an agreement.
p.002007: (2) In the cases of para. 1 The BDA informed the European Commission, the European Medicines Agency and the European Medicines Agency
p.002007: the regulatory authorities of the other Member States for the delegation of powers and publish a communication
p.002007: on the Internet portal under Art. 185, para. 1 or on your website.
p.002007: Art. 190. (amend. - SG 102/02, in force from 21.12.2012) (1) The holder of the marketing authorization is
p.002007: obliged to have a pharmacovigilance monitoring system to fulfill the
p.002007: your obligations under this chapter.
p.002007: (2) The holder of a marketing authorization through the system of para. 1 makes a scientific assessment of the collected
p.002007: information on the safety of medicinal products, assesses the potential for
p.002007: minimize or prevent risk and take the necessary measures.
p.002007: (3) The marketing authorization holder shall implement an adequate and effective quality system in order to
p.002007: ensure compliance of the system under para. 1 with the requirements of this law. The minimum requirements for
p.002007: the quality system is defined by Implementing Regulation (EU) No 520/2012.
p.002007: (4) The marketing authorization holder shall regularly audit the system under para. 1. Information about
p.002007: the main findings of the audit shall be noted in the main documentation of the system and shall be used to prepare
p.002007: a plan for the implementation of appropriate corrective actions. This information may be deleted after
p.002007: overall implementation of corrective actions.
p.002007: Art. 191. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
...
p.002007: safety reports containing:
p.002007: 1. summaries of data on the benefit / risk balance of the medicinal product, including
p.002007: the results of all studies, with a view to their potential impact on the Marketing Authorization;
p.002007: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002007: available data, including clinical trial data for unauthorized indications and target groups,
p.002007: not included in the summary of product characteristics;
p.002007: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002007: the holder of the marketing authorization is in possession of the volume of prescriptions, including
p.002007: approximate number of persons who have used or are exposed to the medicinal product
p.002007: another reason.
p.002007: (2) The content and format of the electronic periodic safety update reports shall be
p.002007: set out in Implementing Regulation (EU) No 520/2012.
p.002007: (3) The information under para. 1 shall be collected and stored in a register established pursuant to Article 25a of the Regulation
p.002007: (EC) No 726/2004 of the European Parliament and of the Council, and is available to the BDA.
p.002007: Art. 194i. (New, SG No. 102/2012, effective 21.12.2012) Holders of authorizations for
p.002007: use / certificates for registration of medicinal products under Art. 28, 30, 35 and 37 submit periodically
p.002007: updated safety reports only in cases where:
p.002007: 1. submission of a report is a condition under Art. 55a or 56, entered in the Marketing Authorization / Certificate
p.002007: registration, or
p.002007: 2. The Executive Agency for Medicinal Products or a regulatory authority of another Member State shall so request
p.002007: based on safety considerations for the medicinal product or due to lack of periodic medicines
p.002007: updated safety reports for the active substance contained in the medicinal product at
p.002007: who has been granted marketing authorization / registration certificate.
p.002007: Art. 194k. (New, SG No. 102/2012, effective 21.12.2012) (1) In the marketing authorization / certificate
p.002007: the frequency of submission of periodic safety update reports shall be determined for registration.
p.002007: (2) The filing dates of the reports depending on the frequency under para. 1 shall be calculated from the date of issue
p.002007: of the Marketing Authorization / Registration Certificate.
p.002007: (3) Periodic safety update reports shall be submitted at the following time intervals, p
p.002007: except where the frequency of submission of reports is a condition for authorization
p.002007: for use / registration certificate or determined in accordance with Art. 194l, 194m and 194h:
p.002007: 1. every 6 months from the date of issue of the marketing authorization / registration certificate
p.002007: medicinal product by the date of its placing on the market;
p.002007: 2. every 6 months during the first two years from the date of placing on the market of the medicinal product;
p.002007: 3. once a year for the next two years;
p.002007: 4. once every three years after the fourth year from the date on which the medicinal product is placed on the market.
p.002007: (4) Outside the cases under para. 3, periodic safety update reports shall be submitted immediately to
p.002007: a request from the BDA or a regulatory authority of a Member State.
p.002007: (5) Paragraphs 3 and 4 shall also apply to medicinal products authorized only in the territory of
p.002007: Republic of Bulgaria, which are not covered by Art. 194l.
p.002007: Art. 194l. (New, SG No. 102/2012, effective 21.12.2012) Where medicinal products containing
p.002007: the same active substance, or combination of the same active substances, have been obtained separately
p.002007: marketing authorizations / registration certificate, frequency and filing dates for periodic applications
p.002007: updated safety reports may be modified and harmonized in order to carry out
p.002007: uniform evaluation of these reports.
p.002007: Art. 194m. (New, SG No. 102/2012, effective 21.12.2012) (1) The filing dates of the periodicals
p.002007: updated safety reports for the medicinal products under Art. 194l are calculated according to
p.002007: European Union reference date.
p.002007: (2) The European Union reference date under para. 1 is:
p.002007: 1. the date of the first authorization for use in the European Union of the medicinal product containing
p.002007: the active substance concerned or the corresponding combination of active substances, or
p.002007: 2. the earliest known date of the marketing authorizations for the medicinal product containing
p.002007: the relevant active substance or the corresponding combination of active substances, if the date referred to in point 1,
p.002007: could not be determined.
p.002007: Art. 194n. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
...
p.002007: Regulation (EC) No 726/2004 of the European Parliament and of the Council, and has been designated as such by the Committee.
p.002007: 56a, para. 1, v. 1.
p.002007: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases of no. 194o, para. 2 and 3 BDA,
p.002007: respectively, the rapporteur from the Republic of Bulgaria within 60 days from the date of receipt of the periodic
p.002007: an updated safety report shall prepare an evaluation report and send it electronically to
p.002007: The European Medicines Agency and the regulatory authorities of the Member States. The owner of
p.002007: the marketing authorization was received by the European Medicines Agency.
p.002007: (2) Within 30 days of receipt of the report under para. 1 the holder of the marketing authorization or
p.002007: Member States' regulatory authorities may submit their comments to the European Agency
p.002007: on medicines and to the BDA.
p.002007: (3) Within 15 days from the date of receipt of the comments under para. 2 The BDA updates the evaluation report, such as
p.002007: takes into account all the objections presented, and sends it to the committee under Art. 56a, para. 1, item 1 for approval and
p.002007: recommendation.
p.002007: (4) The European Medicines Agency shall include the evaluation report adopted and the committee recommendation.
p.002007: 56a, para. 1, item 1 in the register under Art. 194h, para. 3 and send it to the Marketing Authorization Holder.
p.002007: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) Where the Republic of Bulgaria is not a rapporteur in
p.002007: the procedure under Art. 194o, para. 2, the BDA may submit comments within the deadline. 194p, para. 2 to the European
p.002007: the Medicines Agency and the regulatory authority of the Member State that prepared the assessment report.
p.002007: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002007: updated reports on the safety of medicinal products under Art. 194l and when none of
p.002007: the marketing authorizations for these products were not granted under Regulation (EC) No 726/2004
p.002007: The European Parliament and the Council, the coordination group under Art. 77, para. 2 within 30 days from the date of
p.002007: receiving the recommendation from the committee under Art. 56a, para. 1, item 1 issues an opinion on conservation,
p.002007: modification, suspension or termination of relevant marketing authorizations, including a schedule for
p.002007: implementation of the opinion.
p.002007: (2) Where the Member States represented in the coordination group have 77, para. 2 agreed
p.002007: on the actions to be taken, the BDA implements the decision taken.
p.002007: (3) When the opinion under para. 1 is for suspension or termination of the marketing authorization, the executive
p.002007: the BDA director issues an order.
p.002007: (4) Where in the opinion under para. 1 recommended changes to the marketing authorization issued,
p.002007: the marketing authorization holder submits to the BDA an application for change including an updated one
p.002007: a summary of the product characteristics and a leaflet, within the specified implementation schedule.
p.002007: (5) Where agreement cannot be reached within the postal coordination group. 77, para. 2,
...
p.002007: their renewal, including a timetable for the implementation of the opinion.
p.002007: (2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
p.002007: of the Marketing Authorizations, European Commission:
p.002007: 1. Decides to change, suspend or terminate the validity of the marketing authorizations,
p.002007: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002007: 2. adopt a decision recommending the change, suspension or termination of the validity of the permissions for
p.002007: use issued by the relevant regulatory authorities of the Member States.
p.002007: (3) The Medicines Executive Agency implements the recommendations made in the European Commission decision on
p.002007: para. 2, item 2 provisional and / or final measures.
p.002007: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) 194ts, para. 1, the opinion of
p.002007: Art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and Art. 194h, para. 2 are published on
p.002007: The European Internet Portal under Art. 68, para. 1, Vol. 4.
p.002007: Chapter Nine.
p.002007: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN THE AREA OF
p.002007: MEDICINAL PRODUCTS (TITLE AMENDED - SG 71/08, IN EFFECT OF 12.08.2008,
p.002007: AMENDED. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002007: (Title "Section I. Wholesale trade in medicinal products", SG, issue 71 of 2008, in force since 12.08.2008)
p.002007: Art. 195. (1) Wholesale trade in medicinal products may be carried out by natural and legal persons,
p.002007: holders of an authorization issued by a regulatory authority of the Member State concerned.
p.002007: (2) Where the person under para. 1 has warehouses on the territory of the Republic of Bulgaria, it may
p.002007: Wholesale trade in medicinal products after obtaining authorization from the executive
p.002007: director of the BDA.
p.002007: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may trade on
p.002007: wholesale only of medicinal products for which a manufacturing authorization has been granted.
p.002007: (2) An importer of medicinal products within the meaning of this Law may only wholesale trade with
p.002007: medicinal products for which import authorization has been granted.
p.002007: Art. 197. The persons under art. 195 must have:
p.002007: 1. suitable premises, equipment and facilities and suitable means of transport providing
p.002007: the proper storage, distribution and transport of medicinal products in accordance with
p.002007: the requirements of Good Distribution Practice;
p.002007: 2. Qualified staff and responsible Master of Pharmacy with at least two years of work experience
p.002007: the specialty whose obligations are defined in the ordinance under Art. 198.
p.002007: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.002007: the distribution practices of medicinal products and active substances are adopted by an ordinance of the Minister
p.002007: health and with guidelines adopted by the European Commission.
p.002007: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002007: 1. an application containing the name, registered office and address of management of the trader; address and description
p.002007: premises and facilities for storage of medicinal products;
p.002007: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: country;
p.002007: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar
p.002007: document of the person, if not a Bulgarian citizen, diploma for higher education and document for work experience
p.002007: of the responsible master pharmacist under Art. 197, item 2 and a copy of his employment contract;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 6. a document certifying the legal basis for the use of the premises;
p.002007: 7. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 84 of 2018, effective from 12.10.2018)
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002007: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a Member State;
p.002007: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002007: 3. the address of the premises for the storage of medicinal products in the territory of the Member States.
p.002007: (3) In the wholesale trade in narcotic substances and in dosage forms containing such substances,
p.002007: the requirements of the Narcotic Drugs and Precursors Control Act also apply.
p.002007: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Nuclear Regulatory Agency.
p.002007: (5) (New, SG No. 103/2017, effective 01/01/2018) The Executive Agency for Medicines shall establish
p.002007: ex officio the circumstances regarding the criminal record of the person under para. 1, item 3, when he is a Bulgarian citizen.
p.002007: Art. 200. The Executive Agency for Medicines shall evaluate the documentation and carry out an on-the-spot check
p.002007: the sites mentioned in the application to establish their compliance with the requirements for the Good
p.002007: distribution practice.
p.002007: Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing when it finds out
p.002007: incompleteness in the documentation submitted.
p.002007: (2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
p.002007: Art. 202. (1) (amend. - SG 84/08, in force from 12.10.2018) Within 60 days from the date of submission of
p.002007: the application under Art. 199, para. 1, the Executive Director of the BDA shall issue a permit for wholesale or
p.002007: makes a reasoned refusal.
p.002007: (2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
...
p.002007: 2. Higher medical schools and medical colleges.
p.002007: (2) In the cases of para. 1, a sample shall be affixed to the package of medicinal products.
p.002007: (3) To the persons under para. 1, item 1, no more than two samples of the same medicinal product may be delivered
p.002007: form of the medicinal product in one calendar year in the smallest existing packaging of
p.002007: manufacturer, and of medical colleges and colleges only in the quantities required
p.002007: for training purposes.
p.002007: (4) The holder of the marketing authorization and / or the person has sent. 26, para. 2 keep records of all persons on
p.002007: who have supplied samples for the type, quantity and time of delivery and, on request, provide these
p.002007: data from control bodies.
p.002007: Art. 211. (1) Wholesalers must have a system for blocking and withdrawing medicinal products.
p.002007: products that have shown non-compliance with quality, safety and efficacy requirements.
p.002007: (2) The holder of a wholesale marketing authorization shall be obliged to block and withdraw medicinal products.
p.002007: products that have shown non-compliance with the quality, safety and efficacy requirements in the order specified
p.002007: in the ordinance under art. 274, para. 1.
p.002007: Art. 212. (1) The Executive Director of the BDA shall notify the European Commission, the regulatory authorities of
p.002007: the other Member States and the European Medicines Agency for marketing authorizations for
p.002007: wholesale, for the suspended or revoked permits and for the reasons therefor.
p.002007: (2) (amend. - SG 102/2012, in force from 02.01.2013) When the executive director of the BDA establishes that
p.002007: the person under Art. 195, para. 1 does not fulfill the obligations under Art. 207, para. 1, items 2 - 14, he notifies the regulatory body
p.002007: the authority of the Member State which granted the wholesale authorization and the European Commission.
p.002007: (3) Where the regulatory body under para. 2 suspend or revoke the wholesaler 's authorization
p.002007: the person under Art. 195, para. 1, it shall notify the BDA Executive Director and the European Commission.
p.002007: Art. 212a. (New, SG No. 102/2012, effective 2 January 2013) (1) (Amended, SG No. 18/2014) Mediation in
p.002007: the field of medicinal products may be performed by natural and legal persons registered as
p.002007: commercial intermediaries within the meaning of the Commercial Law of the Republic of Bulgaria, which are registered for
p.002007: the performance of this activity by the BDA.
p.002007: (2) The persons under para. 1, who wish to register as intermediaries, shall submit a model notification to the BDA,
p.002007: approved by the BDA Executive Director, which contains:
p.002007: 1. name, seat and address of management;
p.002007: 2. contact details.
p.002007: (3) To the notification under para. 2 shall apply:
p.002007: 1. data on the unique identification code;
p.002007: 2. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002007: (4) The Executive Agency for Medicinal Products shall enter in the public register the persons exercising
p.002007: mediation in the field of medicinal products.
p.002007: (5) The persons under para. 1 may mediate in the field of medicinal products after submission
p.002007: of the notification under para. 2 in the BDA.
p.002007: (6) The persons under para. 1 shall notify the BDA within 7 days from the occurrence of a change in any of the circumstances under
p.002007: para. 2.
p.002007: Art. 212b. (New, SG No. 102/2012, effective 02/01/2013) 212a, para. 1 shall:
p.002007: 1. carry out their activity only with authorized medicinal products;
p.002007: 2. Have a contingency plan that contains effective download measures
...
p.002007: 4. the number of the marketing authorization for the medicinal product in the Republic of Bulgaria and the number of
p.002007: the authorization to use the medicinal product in the parallel Member State
p.002007: import;
p.002007: 5. statement on establishing the circumstances under art. 217, v. 1;
p.002007: 6. a copy of the leaflet for the patient and a sample of the medicinal product as sold in the country
p.002007: Member from which parallel importation is made, translation of the contents of the leaflet into Bulgarian,
p.002007: accompanied by a declaration that the translation is in accordance with the original of the leaflet;
p.002007: 7. a proposal for a leaflet for the patient of the parallel medicinal product, accompanied by
p.002007: a statement that the contents of the package leaflet are identical to the contents of the product leaflet,
p.002007: authorized for use in the Republic of Bulgaria, except for the following:
p.002007: (a) the name and management address of the parallel importer;
p.002007: (b) the name of the manufacturer, where different for the two products;
p.002007: (c) a period of stability when different for the two products;
p.002007: (d) excipients, where different in the two products;
p.002007: 8. in the case of repackaging:
p.002007: a) (amend. - SG 71/08, in force from 12.08.2008) a sample of the medicinal product as it will be
p.002007: launches on the market in Bulgaria;
p.002007: (b) a copy of the contract between the parallel importer and the partial importer
p.002007: manufacturing activity - packaging, labeling;
p.002007: (c) a certificate of good manufacturing practice when the repackaging processes are carried out outside
p.002007: the territory of the Republic of Bulgaria;
p.002007: d) when performed by the person mailing. 213 - copy of the manufacturing authorization issued by the regulatory authority
p.002007: the authority of the Member State where the repackaging takes place;
p.002007: 9. a document for payment of a fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) Where between the medicinal product for parallel import
p.002007: and the product authorized for use on the territory of the Republic of Bulgaria, there are differences (in the composition of
p.002007: excipients, etc.), the person under para. 1 presents evidence that they do not affect
p.002007: the therapeutic qualities of the parallel import medicinal product.
p.002007: (4) In the cases of para. 3 the person under para. 1 indicates on the package and in the package leaflet the patient in parallel
p.002007: the imported medicinal product differences.
p.002007: (5) Where the person under Art. 213 carries out repackaging and / or labeling of the medicinal product in Bulgarian
p.002007: language in the territory of the Republic of Bulgaria, it must have a production permit issued
p.002007: by the BDA Executive Director.
p.002007: (6) The parallel imported product is used under the conditions of the marketing authorization issued
p.002007: the medicinal product on the territory of the Republic of Bulgaria.
p.002007: Art. 216. (1) The permit for carrying out parallel import on the territory of the Republic of Bulgaria shall be
p.002007: issues within 45 days from the date of submission of the documentation to the BDA.
p.002007: (2) When the BDA requests additional documentation from the applicant, the term under para. 1 stops running until received
p.002007: of the information requested.
p.002007: (3) Where the BDA requires the regulatory authority of the Member State from which parallel imports are made,
p.002007: information related to the granting of the marketing authorization for the imported medicinal product
p.002007: para. 1 is extended by 45 days.
p.002007: (4) If, within the term of para. 3 The BDA did not receive the requested documentation, the authorization procedure for
p.002007: parallel import into the territory of the Republic of Bulgaria shall be terminated.
p.002007: (5) Licenses issued for parallel import into the territory of the Republic of Bulgaria shall be issued
p.002007: posted on the BDA's website.
p.002007: (6) The authorization for parallel importation shall be for a period of 5 years. A new permit is issued in the order
p.002007: of Art. 215.
p.002007: (7) The authorization for parallel importation shall not be automatically terminated when the holder of the
p.002007: the marketing authorization for the medicinal product placed on the market in the Republic of Bulgaria,
p.002007: withdraw it for reasons unrelated to the danger to the health of the population.
p.002007: Art. 217. The holder of the parallel import authorization shall be obliged to:
p.002007: 1. notify the holder of the marketing authorization for the medicinal product placed on the market in
p.002007: the territory of the Republic of Bulgaria for its intention to carry out parallel imports upon request
p.002007: provides a sample of the medicinal product in parallel;
p.002007: 2. keep the following documentation for a period of 5 years: name and address of the person to whom it was delivered in parallel
p.002007: the medicinal product imported, the date of delivery, the quantity delivered and the batch number;
p.002007: 3. submit to the BDA:
p.002007: (a) an updated patient leaflet for the parallel imported product, in accordance with changes that have occurred in the
...
p.002007: Art. 226. (1) Pharmacies may be opened on the territory of outpatient medical establishments
p.002007: sale of medicinal products to citizens.
p.002007: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, medical establishments for
p.002007: hospital care and medical establishments under art. 10 of the Medical Establishments Act cannot be found
p.002007: pharmacies to sell medicinal products to citizens.
p.002007: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009) The requirements for
p.002007: the location and the premises of the pharmacy shall be determined in the ordinance under Art. 219, para. 2.
p.002007: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in force since 05.08.2011)
p.002007: Requirements for the device and premises of pharmacies under Art. 228, para. 5 shall be determined in the ordinance under para.
p.002007: 1.
p.002007: Art. 228. (Amended, SG No. 71/2008, effective 26.07.2008) (1) (Amended, SG No. 60/2011)
p.002007: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002007: Director of the BDA on the basis of an application form to which shall be attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 222, para. 1;
p.002007: 2. employment contract or contract for management of the pharmacy, concluded with a master pharmacist or an assistant;
p.002007: pharmacist;
p.002007: 3. a copy of the act of creation of the persons of the post. 222, para. 4;
p.002007: 4. documents certifying that the requirements of Art. 224 Hours;
p.002007: 5. (suppl. - SG 103/07, in force from 01.01.2018) certificate of criminal record of the master pharmacist,
p.002007: respectively to the assistant pharmacist appointed as the head of the pharmacy, if they are not Bulgarian citizens;
p.002007: 6. the medical certificate of the master pharmacist, respectively of the assistant pharmacist appointed for
p.002007: pharmacy manager;
p.002007: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002007: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued by the respective Health Insurance Fund;
p.002007: 8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002007: medicinal products are checked to see if the diploma of the master-
p.002007: the pharmacist / pharmacist assistant is issued by the relevant competent institution.
p.002007: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies no. 222, para. 4 and 6 are
p.002007: open and close at the request of the person representing the medical establishment.
p.002007: (4) (Renumbered from Paragraph (3), SG No. 60/2011, effective 05.08.2011) Opening of a pharmacy in which they are available
p.002007: medicinal products containing narcotic substances are also subject to the requirements of the Control Act
p.002007: on drugs and precursors.
...
p.002007: relevant to human health as defined in the ordinance under Art. 243, and medical devices.
p.002007: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to carry out retail trade in medicinal products
p.002007: products, opening a drugstore, have all natural and legal persons registered under the Commercial
p.002007: law or under the law of a Member State.
p.002007: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore shall be medical
p.002007: specialist who:
p.002007: 1. is not deprived of the right to practice his profession;
p.002007: 2. has not been convicted of crimes related to the exercise of his profession, of crimes against
p.002007: property and economy or intentional crimes against the individual;
p.002007: 3. have at least one year of experience in the specialty.
p.002007: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened upon registration in
p.002007: the relevant REI.
p.002007: (2) (amend. - SG 60/11, in force from 05.08.2011) 238, para. 2 shall be submitted to the relevant RHI
p.002007: application for registration, to which the following documents are attached:
p.002007: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
p.002007: or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
p.002007: Union, or in a State Party to the Agreement on the European Economic Area - Document on
p.002007: up-to-date registration under national law, issued by the competent authority of the relevant
p.002007: the state of the persons under art. 238, para. 1;
p.002007: 2. (suppl. - SG 103/07, in force from 01.01.2018) document for education and criminal record of
p.002007: the person designated as the head of the drugstore, if not a Bulgarian citizen;
p.002007: 3. the medical certificate of the person under item 2;
p.002007: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002007: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
p.002007: 6. document for paid state fee in the amount specified in the tariff mail. 21, para. 2.
p.002007: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para.
p.002007: 2 The Regional Inspectorate shall carry out an inspection on compliance with the requirements of the ordinance under Art. 243. Where
p.002007: establish that the requirements of the ordinance under Art. 243, within 7 days from the completion of the inspection
p.002007: The RII prescribes and sets a time limit for their removal.
p.002007: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application and
p.002007: the documents under para. 2, the Director of the RII shall notify the person in writing of the incompleteness found therein and
p.002007: sets a time limit for their removal.
p.002007: (5) (New, SG No. 60/2011, effective 05.08.2011) For filing an application for registration of a drugstore
p.002007: or to effect a change under Art. 242 the respective SIC collects fees in the amount determined by the tariff under
p.002007: Art. 21, para. 2.
p.002007: (6) (New - SG 103 2017, in force from 01.01.2018) The Bulgarian Food Safety Agency
...
p.002007: 8. (new - SG 102/2018) ninety days when the application for
p.002007: expanding the indications for a product that is not currently on the Positive Medicinal List
p.002007: paid;
p.002007: 9. (new - SG 102/2018) ninety days when an application for assessment has been submitted
p.002007: of health technology.
p.002007: (2) For the medicinal products under Art. 262, para. 5 the council shall act within thirty days, when it is
p.002007: application for price approval under art. 261a, para. 1 and including the product in the Positive
p.002007: medication list.
p.002007: (3) The time limits under para. 1 and 2 shall commence on the date of submission of an application in accordance with the procedure of the postal order.
p.002007: 261a, para. 5.
p.002007: Art. 259c. (New, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 102/2012, effective 21.12.2012
p.002007: d)
p.002007: Art. 259g. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012, effective 21.12.2012)
p.002007: Art. 260. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: The authorities, officials and applicants under this chapter are obliged to assist the
p.002007: the Board and its employees in the performance of their assigned duties.
p.002007: Art. 261. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: (1) The members of the council and its employees shall be obliged not to disclose circumstances and facts that have occurred.
p.002007: known to them upon or in connection with the performance of their official duties under this Act, except in writing
p.002007: a request from a public authority when provided for by law.
p.002007: (2) In connection with their obligations under para. 1 persons sign a declaration in the form approved by
p.002007: the chairman of the board.
p.002007: Section II.
p.002007: Regulation and registration of the prices of medicinal products. Treatment algorithms
p.002007: with medicinal products. Health Technology Assessment. (New, SG No. 102/2012)
p.002007: force dated 21.12.2012, title ext. - SG, issue. 102 of 2018, effective January 1, 2019)
p.002007: Section II.
p.002007: Regulation and registration of the prices of medicinal products. Treatment algorithms
p.002007: with medicinal products (New, SG No. 102/2012, effective 21.12.2012)
p.002007: Art. 261a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102 of 2012, effective 21.12.2012
p.002007: d. (1) The Council shall regulate the prices of the medicinal products included in the Positive Medicinal List under Art.
p.002007: 262, para. 1 and paid with public funds, in accordance with the lowest country reference prices
p.002007: member states.
p.002007: (2) the Council regulates the marginal prices of medicinal products subject to medical prescription,
p.002007: beyond those of para. 1 according to the lowest reference prices of Member States.
p.002007: (3) The Council registers maximum retail selling prices for medicinal products to be marketed
p.002007: without a prescription.
p.002007: (4) The price determined in accordance with the procedure of para. 1, is also the marginal price of medicinal products when sold to
p.002007: retail.
p.002007: (5) The Council of Ministers, upon a proposal by the Minister of Health, shall determine by an ordinance the conditions and
p.002007: the rules for regulating the prices of the medicinal products under para. 1 to regulate the marginal prices of
p.002007: prescribing medicinal products under para. 2 at retail, as well as
...
p.002007: (6) After the expiry of the terms under para. 4, the Marketing Authorization Holder submits an application and
p.002007: the relevant documents to exclude the medicinal product from the Positive Medicinal List.
p.002007: (7) Where, following the cessation of sales of the medicinal product, the holder of the authorization for
p.002007: use has not fulfilled its obligation under par. 6, the council under art. 258, para. 1 ex officio excludes him from
p.002007: Positive drug list.
p.002007: Art. 265. (1) The Council of Ministers shall establish a Transparency Committee.
p.002007: (2) (Supplemented, SG No. 60/2011, effective 05.08.2011) The composition of the Transparency Committee shall be determined by
p.002007: The Council of Ministers on a proposal from the Minister of Health. It is mandatory to include
p.002007: representatives of the Ministry of Health, the Ministry of Labor and Social Policy,
p.002007: of the BDA, the NHIF, the Bulgarian Medical Association, the Bulgarian Dental Union, the Bulgarian
p.002007: pharmaceutical union and patient organizations and the pharmaceutical industry.
p.002007: (3) (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: A person who is a member of the Transparency Committee cannot also be a member of the National Board of Prices and
p.002007: reimbursement of medicinal products.
p.002007: (4) The Council of Ministers shall determine by rules the terms and conditions for the work of the Transparency Commission.
p.002007: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012)
p.002007: 12/21/2012) The Transparency Committee is an authority against which decisions of the National can be appealed
p.002007: advice on prices and reimbursement of medicinal products.
p.002007: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority of the panel and.
p.002007: (3) The decisions under par. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a relevant disease is
p.002007: without an alternative in the country, an authorized medicinal product may be administered to a particular patient
p.002007: for use in a Member State of the European Union, authorized for use under this Act, but not
p.002007: distributes on the Bulgarian market.
p.002007: (2) (amend. - SG 102/08, in force from 01.01.2019) Annually at the proposal of the medical establishments for
p.002007: hospital care and after the opinion of the relevant expert council in the relevant medical specialty
p.002007: or medical activity under Art. 6a, para. 1, item 1 of the Health Act the Minister of Health
p.002007: approve the list of medicinal products under para. 1, which contains the following information:
p.002007: 1. anatomical-therapeutic-chemical classification code;
p.002007: 2. an international non-patent name to which the product belongs;
p.002007: 3. disease according to the international disease code;
p.002007: 4. the dosage form and the amount of active substance;
p.002007: 5. additional information.
p.002007: (3) The list under para. 2 is published on the website of the Ministry of Health on the Internet.
...
p.002007: wholesalers and retailers and the Bulgarian Red Cross can only be made after filing
p.002007: notification from the donor to the BDA following a model approved by the Minister of Health on proposal
p.002007: of the BDA Executive Director.
p.002007: (2) Donations shall be made in accordance with the World Health Donation Good Practice Rules
p.002007: organization.
p.002007: (3) (Repealed, SG No. 84/2018, effective 12.10.2018)
p.002007: (4) The medical establishments and the Bulgarian Red Cross shall notify the BDA of the received donations of medicinal products.
p.002007: products within 7 days of receipt.
p.002007: (5) At the end of each quarter, the BDA sends information to the Ministry of Health about
p.002007: the donations made under para. 4.
p.002007: (6) To make a donation of a medicinal product at the request of a medical establishment intended for
p.002007: treatment of a particular patient in a life-threatening condition, the donor notifies the BDA within 7 days
p.002007: since its implementation.
p.002007: (7) The donations under para. 6 may not exceed the amount required for a single course of treatment.
p.002007: Art. 269. (1) The control under art. 267 is performed through inspections and laboratory tests.
p.002007: (2) The inspections and laboratory tests under para. 1 shall be carried out:
p.002007: 1. in connection with the issuance of authorizations for use, production, import and certificates under the procedure of this law;
p.002007: 2. in connection with the supervision of the market of medicinal products;
p.002007: 3. upon request by the European Commission, the European Medicines Agency or by a party
p.002007: to the competent authority of another Member State;
p.002007: 4. upon application by a manufacturer, importer or holder of a marketing authorization outside
p.002007: the cases under item 1.
p.002007: (3) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall carry out
p.002007: Inspections:
p.002007: 1. to manufacturers of medicinal products located on the territory of the Republic of Bulgaria;
p.002007: Member State or in third countries;
p.002007: 2. to importers and wholesalers of medicinal products;
p.002007: 3. on the premises of manufacturers, importers and wholesalers of active substances located
p.002007: on the territory of the Republic of Bulgaria;
p.002007: 4. at the premises of manufacturers or wholesalers of active substances located in third places
p.002007: countries as well as manufacturers or importers of excipients;
p.002007: 5. at the premises of the marketing authorization holders and the intermediaries
p.002007: in the field of medicinal products, registered in accordance with Art. 212a;
p.002007: 6. as part of a certification procedure relating to monographs of the European Pharmacopoeia;
p.002007: 7. to manufacturers of starting materials at the written request of the manufacturer.
p.002007: (4) The Medicines Executive Agency shall carry out inspections of manufacturers of medicinal products,
p.002007: established in a third country in connection with an application for a marketing authorization or
p.002007: import.
p.002007: (5) (Amended, SG No. 102/2012, effective 21.12.2012) The inspections under para. 3 and 4 are performed in accordance
p.002007: with guidelines adopted by the European Commission.
p.002007: (6) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall participate in
p.002007: a request from the European Commission, the European Medicines Agency or a Member State to perform
p.002007: of inspections under para. 3 in the European Union or in third countries.
p.002007: (7) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall cooperate
p.002007: and exchanges information with the European Medicines Agency when planning and carrying out inspections
p.002007: para. 3.
p.002007: (8) (New, SG No. 102/2012, effective 21.12.2012) The Executive Agency for its Medicines
p.002007: cooperates with the European Medicines Agency in coordinating inspections in third countries.
p.002007: Art. 269a. (New, SG No. 102/2012, effective 21.12.2012) (1) 267, para. 3 draw up
p.002007: report on each inspection carried out under Art. 269, para. 3 and 4 on compliance with the principles and guidelines for
p.002007: Good manufacturing practice, either for Good Distributor Practices or for compliance with the requirements of
p.002007: Chapter Eight, as well as the requirements of this law.
p.002007: (2) The report under para. 1 shall be provided to the verified person, who may submit observations thereon.
p.002007: (3) Upon receiving a substantiated request, the BDA shall electronically send the reports under para. 1 on
p.002007: the competent authority of another Member State or of the European Medicines Agency.
p.002007: Art. 269b. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002007: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good
p.002007: distributor practices, where applicable, are issued by the BDA to the manufacturer, importer or trader.
p.002007: wholesale Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice
p.002007: within 90 days of the inspection.
p.002007: (2) When, as a result of an inspection, 269, para. 3 it was found that the manufacturer, the importer
p.002007: or the wholesaler of the medicinal product or the active substance does not comply with the law
p.002007: and / or the principles and guidelines for Good Manufacturing Practice and / or Good Distribution
p.002007: practices, the BDA issues a non-compliance statement.
p.002007: (3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued certificates under para.
p.002007: 1 and information under para. 2.
p.002007: Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002007: Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of the head
p.002007: eighth, the BDA provides prescriptions for the correction of inconsistencies.
p.002007: (2) In the cases of para. 1 The BDA shall notify the Member States, the European Medicines Agency and the European Medicines Agency
p.002007: The European Commission.
p.002007: Art. 270. (1) Within the limits of their competence, officials shall send. 267, para. 3 have the right:
...
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 272. (1) The Executive Agency for Medicines shall:
p.002007: 1. (suppl. - SG 102/2012, in force from 02.01.2013) prohibits the commissioning and stops
p.002007: the operation of sites and facilities in violation of the rules of Good Manufacturing Practice of
p.002007: medicinal products and active substances as well as good distribution practices until the elimination of
p.002007: violations;
p.002007: 2. prohibit the manufacture, import, export and trade in medicinal products, directly or indirectly
p.002007: threaten human health and order that they be destroyed, recycled or used for others
p.002007: goals;
p.002007: 2a. (new - SG 102/2012, in force from 02.01.2013) shall delete from the register the persons engaged in activity
p.002007: in mediation with medicinal products, in case of non-compliance with the obligations under Art. 212b.
p.002007: 3. temporarily suspend the operation of wholesale and retail outlets for medicinal products when
p.002007: the conditions under which the relevant authorization was granted are not fulfilled;
p.002007: 4. block medicinal products in the presence of documented information about: non-compliance with
p.002007: the requirements for quality, efficiency and safety; medicinal products imported or manufactured in
p.002007: violation of this law, as well as medicinal products that are available in packs of leaflets that do not
p.002007: meet the requirements of this law; order withdrawals from pharmacies and drugstores as needed,
p.002007: from wholesalers, manufacturers and health establishments, and informs
p.002007: The Ministry of Health;
p.002007: 5. (amend. - SG 84/2018) (*) revoke the issued clinical trial permit, suspend the holding
p.002007: of the clinical trial or obliges the contracting authority to submit a substantive change to
p.002007: the clinical trial of established infringements of Regulation (EU) No 536/2014 under the terms and procedures,
p.002007: provided for therein;
p.002007: 5a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 02.01.2013)
p.002007: orders the blocking, withdrawal and destruction of counterfeit medicinal products and medicinal products
p.002007: products of unknown origin;
p.002007: 5b. (new - SG 60/11, in force from 05.08.2011) carries out checks on the donations made.
p.002007: 268a, para. 1;
p.002007: 6. issue orders, instructions and instructions within its competence, which are obligatory
p.002007: for all persons;
p.002007: 7. (new - SG 60/11, in force from 05.08.2011) place medicinal products and active medicinal products under prohibition
p.002007: substances in doubt in the deviation of their quality by affixing signs in the sites
p.002007: for production.
p.002007: (2) The compulsory administrative measures under para. 1 or under Art. 270, para. 3 shall be imposed by order of the director
p.002007: of the BDA.
p.002007: (3) The orders under para. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
p.002007: Art. 272a. (New, SG No. 102/2012, effective 02.01.2013) (1) By delegated acts, no. 52b, paragraph 2
p.002007: Directive 2001/83 / EC lays down the necessary measures to prevent the placing on the market of
p.002007: medicinal products introduced into the European Union but not intended for the marketing of
p.002007: The European Union, for which there are sufficient grounds for suspecting that they have been falsified.
...
p.002007: appeal in accordance with the Administrative Procedure Code, and the appeal does not suspend their enforcement.
p.002007: Art. 294. Who violates the provisions of this law or the regulations on its implementation, except in cases of post.
p.002007: 281 - 293, shall be punished by a fine of from 1000 to 3000 levs, and in the case of repeated commission of the same violation - by a fine of
p.002007: 3000 to 5000 BGN
p.002007: Art. 295. (1) (amend. - SG 98/10, in force from 01.01.2011, amended - SG, issue 102 of 2018)
p.002007: 01.01.2019) The violations under this law shall be established by acts drawn up by officials under Art. 267,
p.002007: para. 3.
p.002007: (2) (Supplemented, SG No. 84/2018, effective 12.10.2018, repealed - SG No. 102/2018)
p.002007: (3) (amend. - SG 98/10, in force from 01.01.2011, amended - SG, issue 102 of 2018, effective from 01.01.2019)
p.002007: The penal decrees are issued by the Minister of Health, by the Chief State Health
p.002007: inspector, by the chairman of the council under Art. 258, para. 1, by the BDA Executive Director and the Directors
p.002007: of the RHI, depending on the submission of the offending official.
p.002007: (4) (new - SG 102/08, in force from 01.01.2019) The penal decrees may also be issued by
p.002007: other officials authorized by the persons under para. 3, as the chairman of the council under Art. 258, para. 1
p.002007: may authorize another committee member.
p.002007: Art. 296. Drafting acts, issuing, appealing and executing criminal decrees
p.002007: are carried out in accordance with the Law on Administrative Offenses and Penalties.
p.002007: Art. 297. (Amended, SG No. 84/2018, effective 12.10.2018) (1) In the cases of Art. 281, 282, 283, 284, 285 and 287
p.002007: the penal authority also orders the withdrawal in favor of the State of the medicinal products subject to the
p.002007: the committed offense, under the conditions and in the order specified in the Administrative Offenses Act and
p.002007: penalties and in accordance with Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 February
p.002007: October 2013 establishing the Union Customs Code (OJ, L 269/1 of 10 October 2013) and
p.002007: Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed implementing rules
p.002007: rules for the implementation of certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the
p.002007: Of the Council establishing the Union Customs Code (OJ, L 343/558 of 29 December 2015).
p.002007: (2) The medicinal products under para. 1 shall be destroyed under the conditions and in the order of the ordinance post. 274, para. 2.
p.002007: Additional provisions
p.002007: § 1. For the purposes of this Act:
p.002007: 1. (amend. - SG 102/02, in force from 02.01.2013) А
p.002007: "substance" means any substance or mixture of
p.002007: substances intended for use in the manufacture of a medicinal product which when used
p.002007: in its manufacture, they become the active ingredient of this product, intended for the exercise of
p.002007: pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
p.002007: physiological functions or for medical diagnosis.
p.002007: 2. "Bioequivalence" is present when the medicinal products are pharmaceutically equivalent or
...
p.002019: Council
p.002019: REGULATION (EC) No 469/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 on the
p.002019: supplementary protection certificate for medicinal products (codified version)
p.002019: COMMISSION REGULATION (EC) No 1234/2008 of 24 November 2008 on the examination of
p.002019: changes in the terms of marketing authorizations for medicinal products for human use and
p.002019: veterinary medicinal products
p.002019: REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007
p.002019: on advanced therapy medicinal products and amending Directive 2001/83 / EC and Regulation
p.002019: (EC) No 726/2004
p.002019: REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006
p.002019: on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92,
p.002019: Directive 2001/20 / EC, Directive 2001/83 / EC and Regulation (EC) No 726/2004
p.002019: REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004
p.002019: establishing Community procedures for the authorization and control of medicinal products for human and
p.002019: veterinary use and to set up a European Medicines Agency
p.002019: COMMISSION REGULATION (EC) No 1085/2003 of 3 June 2003 examining changes to the
p.002019: the terms of the marketing authorizations for medicinal products for human use and veterinary use
p.002019: medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (repealed)
p.002019: COMMISSION REGULATION (EC) No 1084/2003 of 3 June 2003 examining changes to the
p.002019: the terms of the marketing authorizations for medicinal products for human use and veterinary use
p.002019: medicinal products supplied by a competent authority of a Member State (repealed)
p.002019: COMMISSION REGULATION (EC) No 847/2000 of 27 April 2000 laying down provisions for the
p.002019: application of the criteria for designating a medicinal product as an orphan medicinal product and for
p.002019: defining the terms "similar medicinal product" and "clinical superiority"
p.002019: REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 1999
p.002019: orphan drugs
p.002019: COUNCIL REGULATION (Council of the European Community) No 2309/93 of 22 July 1993 establishing
p.002019: the Community procedure for granting authorizations (licenses) and the supervision of medicinal products
p.002019: used in human and veterinary medicine, and a European Assessment Agency is established
p.002019: Medicines (Repealed)
p.002019: COUNCIL REGULATION (EEC) No 1768/92 of 18 June 1992 establishing a certificate for the
p.002019: additional protection of medicinal products (repealed)
p.002019: This site
p.002019: © Lex.bg Used
p.002019: | terms of cookies
p.002019: | privacy policy. Learn more
...
Orphaned Trigger Words
p.002007: of Art. 59a.
p.002007: (6) (amend. - SG 71/08, in force from 12.08.2008) At the expiry of the term of the permit for
p.002007: use / certificate of registration or termination of the medicinal product may be
p.002007: sold until the stock is available in the country, but not more than one year from the date
p.002007: on the expiry or termination, respectively, except where the reasons for termination
p.002007: are related to the safety of the medicinal product.
p.002007: (7) The Executive Director of the BDA withdraws the Marketing Authorization / License
p.002007: registration of a medicinal product when:
p.002007: 1. its holder has not placed the medicinal product on the market within three years from the date of issue of the medicinal product
p.002007: the marketing authorization, or
p.002007: 2. sales of the medicinal product have been discontinued for a period of three consecutive years
p.002007: placing it on the market.
p.002007: (8) The order under para. 7 is subject to appeal in accordance with the Administrative Procedure Code.
p.002007: (9) By way of exception and in the interest of public health, the provision of para. 7 may not apply if
p.002007: the marketing authorization holder gave good reasons. In these
p.002007: cases, the BDA Executive Director gives reasons for his decision.
p.002007: (10) The marketing authorization holder shall pay an annual fee in the amount set out in the postal tariff.
p.002007: 21, para. 2, to maintain the marketing authorization issued.
p.002007: Art. 55a. (New, SG No. 102/2012, effective 21.12.2012) (1) The BDA Executive Director may
p.002007: has granted marketing authorization / marketing authorization for the medicinal product they are in
p.002007: one or more of the following conditions are included:
p.002007: 1. take certain measures to ensure the safe use of the medicinal product which
p.002007: be included in the risk management system;
p.002007: 2. conduct post-marketing safety studies;
p.002007: 3. comply with the obligations for registration or reporting of the obligations specified in Chapter Eight
p.002007: suspected side effects;
p.002007: 4. to comply with any other conditions or restrictions with a view to the safe and efficient use of
p.002007: the medicinal product;
p.002007: 5. existence of an adequate system for monitoring the pharmacovigilance;
p.002007: 6. to conduct post-marketing efficacy studies where there are concerns
p.002007: the efficacy of the medicinal product, which can only be authorized after the medicinal product
p.002007: the product is placed on the market.
p.002007: (2) The marketing authorization / registration certificate shall specify the time limits for the implementation of the
p.002007: the conditions under para. 1, where applicable.
p.002007: (3) The grounds for imposing the condition under para. 1, item 6 shall be determined by a delegated act referred to in Article 22b of the Directive
p.002007: 2001/83 / EC, taking into account the scientific guidelines developed in the guidance document. 194a.
p.002007: (4) The requirements for conducting post-marketing efficacy studies are laid down in a guide,
p.002007: issued by the European Medicines Agency.
p.002007: Art. 56. (amend. - SG 102/2012, in force since 21.12.2012) (1) By way of exception after consultation with
p.002007: the applicant, the BDA's Executive Director may issue a marketing authorization / certificate
p.002007: registration provided that the applicant can demonstrate that he has not provided exhaustive information on
p.002007: the efficacy and safety of the medicinal product under normal conditions of use due to one of the
p.002007: the following reasons:
p.002007: 1. the indications for which the medicinal product is intended are so rare that the applicant does not
p.002007: may submit complete evidence, or
p.002007: 2. the state of scientific knowledge at present is such that no comprehensive data can be provided,
p.002007: or
p.002007: 3. the collection of such data is contrary to the generally accepted principles of medical ethics.
p.002007: (2) The marketing authorization / registration certificate under para. 1 shall be issued in one of the following
p.002007: conditions:
p.002007: 1. the applicant / holder to execute a program of studies for the period under para. 3, taking the results of these
p.002007: studies serve to reassess the benefit-risk balance;
p.002007: 2. the medicinal product is available only on prescription, in certain cases
p.002007: can only be used under strict medical supervision in a hospital care facility, and in
p.002007: case of radiopharmaceutical - only under the control of an authorized person;
p.002007: 3. the package leaflet and any medical information accompanying the medicinal product should be
p.002007: provided text to pay attention to health professionals that some of the available data on
p.002007: the medicinal product is subject to subsequent studies.
p.002007: (3) The marketing authorization / registration certificate under para. 1 shall be issued for one year and for
p.002007: each subsequent year may be extended on the basis of an assessment of the fulfillment of the conditions under par. 2.
p.002007: Art. 56a. (New, SG No. 102/2012, effective 21.12.2012) (1) Upon issuance of the permit for
p.002007: the use / registration certificate of the BDA may oblige the holder of
p.002007: the permit / certificate to hold:
p.002007: 1. post-marketing safety study if there are concerns about identified or potential
p.002007: risks or lack of pharmacovigilance monitoring information for that person
p.002007: medicine; when the same risks apply to other medicinal products, after consultation with
p.002007: The Pharmacovigilance Risk Assessment Committee established by Article 56,
p.002007: paragraph 1 (aa) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, BDA
p.002007: recommends that the relevant Marketing Authorization Holder carry out a joint study on
p.002007: safety with other affected authorization holders;
p.002007: 2. post-marketing efficacy study when knowledge of the disease or clinical use
p.002007: the methodology justifies the revision of the efficacy assessments that are drawn from
p.002007: the date of issue of the authorization.
p.002007: (2) The Executive Agency for Medicinal Products shall notify the holder of the authorization in writing
p.002007: use / registration certificate for the obligation under para. 1, justifying the reasons and indicating
p.002007: the objectives of the study and the time limits for conducting it.
p.002007: (3) Within 30 days from receipt of the notification under para. 2 the holder of the authorization for
p.002007: the use / registration certificate may require the BDA to provide a presentation opportunity
p.002007: of information regarding the obligations under para. 1.
p.002007: (4) Upon receipt of the request under para. 3 The BDA sets a deadline for submitting the information from
p.002007: the holder of the marketing authorization / registration certificate.
p.002007: (5) The Executive Agency for Medicines after analyzing the information under para. 3 can:
p.002007: 1. to confirm the obligation under para. 1, or
p.002007: 2. cancel it.
p.002007: (6) The Executive Agency for Medicinal Products shall notify the holder of the decision taken under para. 5.
p.002007: (7) In the cases of para. 5, item 1, the Executive Director of the BDA officially changes the issued permit for
p.002007: use / registration certificate of the medicinal product, including as a condition
p.002007: the obligation under para. 1.
p.002007: (8) The grounds for imposing the obligations under para. 1, item 2 shall be determined by a delegated act of post. 22b from
p.002007: Directive 2001/83 / EC.
p.002007: Art. 56b. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002007: the use / registration certificate includes all conditions in its risk management system
p.002007: under Art. 55a, 56 and 56a.
p.002007: (2) In the cases of para. 1 the holder of the marketing authorization / registration certificate submits to
p.002007: BDA notification of change in risk management system.
p.002007: Art. 56c. (New, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines shall send
p.002007: information to the European Medicines Agency about the issued authorizations under art. 55a, 56 and 56a.
p.002007: Art. 57. (1) The BDA Executive Director shall refuse to issue a marketing authorization or a certificate.
p.002007: for registration of a medicinal product when, after evaluation of the dossier under Art. 27 - 32 it was found that:
p.002007: 1. the benefit / risk balance is unfavorable, or
p.002007: 2. the efficacy of the medicinal product is not convincingly protected by the applicant, or
p.002007: 3. the quantitative and qualitative composition of the medicinal product does not correspond to those described in the dossier.
p.002007: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008) The Executive Director of the BDA shall refuse to issue
p.002007: of a marketing authorization or a marketing authorization for a medicinal product where some of the particulars in the
p.002007: the file does not meet the requirements of Art. 27 - 32 or the ordinance under Art. 42.
p.002007: (3) The Executive Director of the BDA shall refuse registration of a traditional herbal medicinal product,
p.002007: when, after evaluation of the documentation, it is found that the product does not meet the conditions under Art. 37, para. 1,
p.002007: the data in the file do not correspond to Art. 38 or:
p.002007: 1. the quantitative and qualitative composition does not correspond to those described in the dossier;
p.002007: 2. the medicinal product may be harmful if used correctly;
p.002007: 3. the data on traditional use are insufficient, especially when the pharmacological properties or
p.002007: efficacy has not been demonstrated based on years of use and experience;
p.002007: 4. the pharmaceutical quality of the medicinal product is not sufficiently substantiated.
p.002007: Art. 58. The Marketing Authorization Holder is responsible for the completeness and accuracy of
p.002007: the data in the file.
p.002007: Art. 59. (1) Refusal of the Executive Director of the BDA to issue a Marketing Authorization / Certificate
p.002007: for registration of a medicinal product may be appealed under the procedure of the Administrative Procedure
p.002007: code.
p.002007: (2) The refusal of the BDA Executive Director and the reasons for it shall be published on the Agency's website
p.002007: in Internet.
...
p.002007: as new;
p.002007: 3. adding a new one or changing the existing indication for treatment, prophylaxis or diagnosis in
p.002007: another therapeutic area.
p.002007: (2) (New, SG No. 71/2008, effective 12.08.2008) The holder of the marketing authorization for
p.002007: the medicinal product applies for a new marketing authorization when the application is made
p.002007: Renewal of the marketing authorization was not filed within the time limit under Art. 59a, para. 1.
p.002007: (3) (Renumbered from Paragraph (2), SG No. 71/2008, effective 12.08.2008) The application shall be accompanied by
p.002007: documentation specified in the ordinance under Art. 42.
p.002007: (4) (Renumbered from Paragraph (3), Supplemented, SG No. 71/2008, effective 12.08.2008). 1 and 2 shall apply
p.002007: the procedure under Art. 49 - 51.
p.002007: Art. 68. (amend. - SG 102/2012, in force from 21.12.2012) (1) The holder of a permit for
p.002007: the use / registration certificate of the medicinal product is obliged to:
p.002007: 1. take into account the achievements of scientific and technical progress and make any necessary changes in
p.002007: the documentation under Art. 27, para. 1, items 7 and 8 in order to manufacture and control the medicinal product according to
p.002007: conventional scientific methods; the changes are made in the order of chapters three and five;
p.002007: 2. immediately submit to the BDA any new information that may require a change in the data and documents
p.002007: under Art. 27 - 32 and in the summary of product characteristics;
p.002007: 3. immediately inform the BDA of any prohibition or restriction imposed by regulatory authorities on others
p.002007: countries where the medicinal product is placed on the market for the reasons why it was imposed
p.002007: measures, as well as any other new information that may affect the benefit and risk assessment of
p.002007: the relevant medicinal product; the information includes both positive and negative results
p.002007: from clinical trials or other studies of all indications and populations, whether or not they are
p.002007: included in the marketing authorization, as well as data on the use of the medicinal product where this medicinal product is used
p.002007: use is outside the terms of the Marketing Authorization;
p.002007: 4. store and update the medicinal product information with current scientific knowledge, including
p.002007: the conclusions of the evaluation and the recommendations published on the European Medicines Portal
p.002007: products established in accordance with Article 26 of Regulation (EC) No 726/2004 of the European Parliament and of the
p.002007: The Council;
p.002007: 5. distributes the medicinal product with the last approved summary of product characteristics and package leaflet
p.002007: for the patient;
p.002007: 6. (New, SG No. 18/2014) inform the BDA of any action taken by him in connection with a temporary
p.002007: suspension of the marketing of a particular medicinal product; withdrawal from the market of a specific medicinal product
p.002007: medicinal product, request for termination of the marketing authorization or stated intention for
p.002007: failure to renew the marketing authorization, and indicate the reasons why it was taken
p.002007: action; in such cases, the marketing authorization holder shall declare whether it has been taken by him
p.002007: actions are due to any of the grounds under Art. 276 or under Art. 277;
p.002007: 7. (New, SG No. 18/2014) inform the BDA if the actions under item 6 have been undertaken in a third country and
p.002007: due to any of the grounds under Art. 276 or under Art. 277;
p.002007: 8. (new - SG 18/2014) inform the European Medicines Agency when the actions under items 6 and 7
p.002007: have been undertaken on the basis of Art. 276 and 277;
p.002007: 9. (new, SG No. 18/2014) provide sufficient quantities of the medicinal product to satisfy the
p.002007: the health needs of the population of the Republic of Bulgaria;
p.002007: 10. (new - SG 84 2018, in force from 12.10.2018) submit to the BDA, weekly or at change of
p.002007: the circumstances, through the specialized electronic system of art. 217b, para. 1 information for:
p.002007: a) the quantities delivered on the territory of the Republic of Bulgaria indicated by medicinal products,
p.002007: included in the Positive Medicinal List for which the Marketing Authorization Holder is located;
p.002007: (b) wholesalers to whom the quantities of medicinal products referred to in (a) have been delivered;
p.002007: (c) the date on which the deliveries made under (a) and (b) were made;
p.002007: (d) the quantities available in the stores indicated by medicinal products included in the Positive Medicinal Product
p.002007: a list of which the marketing authorization holder holds.
p.002007: (2) The holder of the marketing authorization / registration certificate is obliged upon request by
p.002007: BDA to submit:
p.002007: 1. data in support of the positive benefit / risk ratio for the medicinal product;
p.002007: 2. (amend. - SG 18/04) data on the volume of sales of the medicinal product and any other
p.002007: information available to the marketing authorization holder regarding the volume of medicinal products
p.002007: product prescriptions;
p.002007: 3. a copy of the basic documentation of the system for monitoring the pharmacovigilance.
p.002007: (3) The holder of the marketing authorization shall submit to the BDA the documentation under para. 2, item 3 in 7-day
p.002007: term of receipt of the request.
p.002007: Art. 69. (1) The holder of the authorization for use of a vaccine or immunological medicinal product,
p.002007: intended for immunization, before the release of each batch of the product on the market is required
p.002007: in the BDA:
p.002007: 1. a sample of the final product and / or a sample of the bulk product / non-spilled product;
p.002007: 2. production and quality control protocols;
p.002007: 3. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
p.002007: (2) The holder of the authorization for the use of new immunological medicinal products or of
p.002007: immunological medicinal products manufactured with new or modified technologies or with technologies new to
p.002007: individual producer, fulfills the obligations under para. 1 for the specific period indicated in the authorization for
p.002007: use.
p.002007: (3) Within 60 days from the date of submission of the complete set of documents, the BDA shall evaluate the
p.002007: the protocols for the production and quality control of live vaccines, immunological and new immunological
p.002007: medicinal products and testing of samples provided at an accredited laboratory to determine
p.002007: whether the medicinal products under para. 1 and 2 are manufactured in accordance with approved specifications.
...
p.002007: 1. within 90 days from the date of submission of valid documentation, send to the regulatory authorities of
p.002007: the countries concerned and the applicant's assessment report, together with the approved summary of the
p.002007: the product and the approved mock-up of the package and the package leaflet for the patient;
p.002007: 2. closes the procedure and notifies the applicant and the States concerned, if all States concerned are
p.002007: approved.
p.002007: (2) Within 30 days of the closing of the procedure under para. 1, item 2 the BDA Executive Director issues
p.002007: marketing authorization for the medicinal product on the territory of the Republic of Bulgaria with the approved summary
p.002007: product characteristics, package layout and package leaflet for the patient.
p.002007: (3) Where the Republic of Bulgaria is a reference country under Art. 75, BDA:
p.002007: 1. send within 120 days from the date of submission of valid documentation to the regulatory authorities of
p.002007: the countries concerned and the applicant draft assessment report, draft summary of the
p.002007: the product and design of the package layout and the package leaflet for the patient;
p.002007: 2. closes the procedure and notifies the applicant and the States concerned, if all States concerned are
p.002007: approved.
p.002007: (4) Within 30 days of the closing of the procedure under para. 3, item 2 the BDA Executive Director issues
p.002007: marketing authorization for the medicinal product on the territory of the Republic of Bulgaria with the approved summary
p.002007: product characteristics, package layout and package leaflet for the patient.
p.002007: Art. 77. (1) When the BDA does not approve the submitted documentation, mail. 74, para. 3 or under Art. 75, para. 3 on
p.002007: Consideration of a potential serious risk to public health, prepares a detailed report with reasons for
p.002007: the Member State of reference, the other countries concerned and the applicant.
p.002007: (2) The disputed issues under para. 1 shall be considered by the Member States Coordination Group. The applicant
p.002007: may submit its position on the issues under consideration in writing or orally.
p.002007: (3) The Executive Agency for Medicines shall participate in the Coordination Group under para. 2 until close of
p.002007: the reference country procedure.
p.002007: (4) Within 30 days of receipt of notification of closure of the procedure by the reference country
p.002007: the BDA Executive Director issues a marketing authorization for the approved medicinal product
p.002007: summary of product characteristics, package layout and package leaflet for the patient.
p.002007: Art. 78. (1) When in a procedure before the Coordination Group under Art. 77, para. 2 Member States did not reach
p.002007: consent, the issues at issue are being considered by the Committee for Medicinal Products for Human Use at
p.002007: European Medicines Agency under arbitration procedure. A copy of the documentation shall be sent to
p.002007: of the applicant.
p.002007: (2) The applicant shall submit to the European Medicines Agency the dossier for the medicinal product and the summary
p.002007: product characteristics.
p.002007: (3) In the cases of para. 1, if the BDA approved the evaluation report, the draft summary of the
p.002007: the product and layout of the package and the package leaflet provided by the reference country,
p.002007: the BDA's Executive Director may, at the request of the applicant, issue a marketing authorization to
p.002007: the medicinal product before completing the arbitration procedure under para. 1.
p.002007: (4) Upon completion of the arbitration procedure, the BDA Executive Director shall bring the issued
p.002007: authorization for use under para. 3 in accordance with the decision of the European Commission.
p.002007: Art. 79. (1) Where the regulatory authorities of one or more Member States have adopted different decisions
p.002007: with regard to the marketing authorization or the same medicinal product
p.002007: suspending or withdrawing it, the BDA referred the matter to the Committee for Medicinal Products for
p.002007: human use by the European Medicines Agency for arbitration.
p.002007: The applicant or the holder of the Marketing Authorization may refer the matter to the Committee
p.002007: medicinal products for human use by the European Medicines Agency for the administration of
p.002007: arbitration at its discretion.
p.002007: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002007: (3) (amend. - SG 102/2012, in force from 21.12.2012) In the cases of para. 1 BDA or the applicant / holder
p.002007: of the Marketing Authorization is granted to the European Medicines Agency
...
p.002007: Art. 144. (Repealed, SG No. 84/2018)
p.002007: Chapter Four "a".
p.002007: NON-INTERVENTIONAL STUDIES (NEW, PREVIOUS SECTION IX
p.002007: "NON-INTERVENTIONAL STUDY" - SG, issue. 12 OF 2011, IN EFFECT OF 08/02/2011)
p.002007: Art. 145. (1) (Supplemented, SG No. 12/2011, effective 08.02.2011) Non-interventional study shall be conducted with
p.002007: medicinal products authorized for use in the Republic of Bulgaria when tested for obtaining
p.002007: additional information on the product, prescribed in the usual manner in accordance with the conditions,
p.002007: set out in the Marketing Authorization. Non-interventional study participants are not administered
p.002007: diagnostic or follow-up procedures other than normal practice, such as for the analysis of results
p.002007: data are used epidemiological methods.
p.002007: (2) (Am. - SG, iss. 12 in 2011, effective as of 08.02.2011, repealed - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: (3) (Am. - SG, iss. 12 in 2011, in force since 08.02.2011, repealed - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002007: (4) (New, SG No. 12/2011, effective 08.02.2011, repealed - SG 102/2012, effective 21.12.2012)
p.002007: (5) (New, SG No. 12/2011, effective 08.02.2011, repealed - SG 102/2012, effective 21.12.2012)
p.002007: (6) (New, SG No. 12/2011, effective 08.02.2011, repealed - SG 102/2012, effective 21.12.2012)
p.002007: Art. 145a. (New, SG No. 102/2012, effective 21.12.2012) (1) Non-interventional post-marketing
p.002007: safety studies shall be carried out at the initiative of the marketing authorization holder or at
p.002007: fulfillment of the conditions of art. 55a and 56a and are related to the collection of pharmacovigilance data from
p.002007: patients and healthcare professionals.
p.002007: (2) (Amended, SG No. 17/2019) Where the collection of patient data is planned in the study,
p.002007: to obtain their consent. Patients' personal data are processed as required
p.002007: for the protection of personal data.
p.002007: (3) Medical professionals do not receive financial or other incentives to participate in
p.002007: non-interventional safety studies other than time and expense compensation.
p.002007: Art. 145b. (New, SG No. 102/2012, effective 21.12.2012) (1) During the conduct of the study on
p.002007: Art. 145c, para. 1 and Art. 145f, para. 1, the marketing authorization holder monitors
p.002007: the data obtained and take into account their impact on the benefit / risk balance of the medicinal product.
p.002007: (2) The Marketing Authorization Holder shall notify the BDA of any new information that may
p.002007: affects the benefit / risk ratio of the medicinal product.
p.002007: (3) The obligation under para. 2 shall not exempt the holder of the marketing authorization from the requirement of Art.
p.002007: 194h for providing the information under para. 2 and through periodic safety update reports.
p.002007: Art. 145c. (New, SG No. 102/2012, effective 21.12.2012) (1) (Amended, SG No. 84/2018)
p.002007: 12.10.2018) When the survey is conducted only in the territory of the Republic of Bulgaria in pursuance of
p.002007: obligation under art. 56a, the holder of the marketing authorization shall submit to the BDA a draft of the protocol of
p.002007: the study. The draft protocol, together with the written consent of art. 145a, para. 2, is also presented in
p.002007: the commission under art. 103, para. 1.
p.002007: (2) The Executive Director of the BDA within 60 days from the date of receipt of the documentation under para. 1
p.002007: sends notification of approval of the study to the Marketing Authorization Holder or makes
p.002007: motivated refusal.
...
p.002007: healthcare.
p.002007: (2) The conditions and procedure for the destruction, processing or use for other purposes of medicinal products
p.002007: products are defined in an ordinance of the Minister of Health.
p.002007: Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure
p.002007: proper validation of the processes of production and purification of medicinal products obtained from
p.002007: human blood or human plasma, consistency in batch quality and guarantee as far as possible
p.002007: the technology allows for the absence of specific viral contamination.
p.002007: (2) Manufacturers shall notify the BDA of the method used to reduce or eliminate pathogens
p.002007: viruses that can be transmitted through medicinal products derived from human blood or human
p.002007: plasma.
p.002007: (3) The Executive Agency for Medicines shall test or send for testing to another official agency
p.002007: laboratory for the control of medicinal products in the Republic of Bulgaria or in another Member State samples from
p.002007: bulk / non - spilled product and / or medicinal product for testing or in the course of evaluating an application for
p.002007: authorization for use under Art. 46, para. 1, item 2 or after issuing a marketing authorization.
p.002007: Art. 276. The Executive Director of the BDA shall, by order, suspend, revoke, suspend or amend
p.002007: the authorization to use the medicinal product / registration when it is established that:
p.002007: 1. there is an unacceptable side effect when used properly, or
p.002007: 2. lack of therapeutic efficacy (therapeutic efficacy is lacking when it is found that they cannot
p.002007: the declared therapeutic results are obtained when authorized), or
p.002007: 3. the benefit / risk balance is unfavorable when used correctly, or
p.002007: 4. the quantitative and qualitative composition of the medicinal product does not correspond to the one declared at
p.002007: the marketing authorization, or
p.002007: 5. the data from the file under art. 27 - 32 are incorrect, or
p.002007: 6. (amend. - SG 71/08, in force from 12.08.2008) the data from the file 27 - 32 are not completed or not
p.002007: have been modified in accordance with the requirements of Chapter Three, Section VI, or
p.002007: 6a. (new - SG 102/2012, in force since 21.12.2012) the conditions of posting are not fulfilled. 55a, 56 or 56a,
p.002007: or
p.002007: 6b. (new - SG 102/2012, in force since 21.12.2012) the manufacture of the medicinal product is not
p.002007: performed in accordance with the described method of production under Art. 27, para. 1, item 7, or
p.002007: 7. (amend. - SG 102/2012, in force since 21.12.2012) no control tests have been carried out or they have not been carried out.
p.002007: carry out in accordance with the methods specified in Art. 27, para. 1, item 8, or
p.002007: 8. the particulars on the packaging and / or in the package leaflet are not in accordance with those approved at the time of issue
p.002007: the marketing authorization;
p.002007: 9. (new - SG 71/08, in force from 12.08.2008) the holder of the marketing authorization has not fulfilled
p.002007: obligations under Article 45 (1) of Regulation (EC) No 1901/2006.
p.002007: Art. 277. (1) The Executive Director of the BDA, regardless of the measures, shall be sent. 276, prohibits by order
p.002007: supplying the medicinal product and ordering its blocking and withdrawal when:
p.002007: 1. (amend. - SG 102/2012, in force since 21.12.2012) there is an unacceptable adverse reaction, or
p.002007: 2. lack of therapeutic efficacy, or
p.002007: 3. (amended, SG No. 102/2012, effective 21.12.2012) the benefit / risk balance is unfavorable, or
p.002007: 4. the quantitative and qualitative composition of the medicinal product does not correspond to the one declared at
p.002007: the marketing authorization, or
p.002007: 5. the control of the medicinal product and / or the ingredients and the intermediate stages of the manufacturing process
p.002007: has not been completed or does not meet the requirements under which the manufacturing authorization was granted.
p.002007: (2) The BDA Executive Director may impose a prohibition under para. 1 and only with respect to specific
p.002007: batches of the medicinal product.
p.002007: Art. 278. (1) The Executive Director of the BDA shall, by order, suspend or revoke the permit for
p.002007: use of a group or all medicinal products for which they are not manufactured
p.002007: the requirements under which the manufacturing authorization is granted are fulfilled.
p.002007: (2) The Executive Director of the BDA shall, in addition to the postal measures. 276 may temporarily suspend imports of
p.002007: group or all medicinal products from third countries or withdraw the import authorization granted to
p.002007: group or all medicinal products when they do not comply with the requirements of Chapter Five.
p.002007: (3) The Executive Director of the BDA shall, in addition to the postal measures. 276 may temporarily suspend or suspend by order
p.002007: withdraw the authorization to manufacture a group or all medicinal products not in the group
p.002007: compliance with the requirements of Chapter Five.
p.002007: Art. 279. (1) The orders under art. 276, 277 or 278 shall be served on the marketing authorization holder,
p.002007: respectively to the manufacturer or importer.
p.002007: (2) The orders under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
p.002007: the appeal does not suspend their enforcement.
...
p.002007: "in the field of medicines
p.002007: "products" are all activities aimed at concluding a contract for the purchase or sale of "
p.002007: medicinal products, other than wholesale, which do not include physical holding and which do
p.002007: express in negotiation independently and on behalf of another legal or natural person.
p.002007: 48. (Amended, SG No. 102/2012, effective 21.12.2012)
p.002007: "ostmarketing safety study" is anyone
p.002007: a study relating to an authorized medicinal product conducted in order to identify itself,
p.002007: characterize or determine the degree of safety risk, confirm the profile of
p.002007: the safety of the medicinal product or to evaluate the effectiveness of the risk management measures.
p.002007: 49. A "potential serious risk to public health" exists when there is a high degree of
p.002007: the likelihood that the use of a medicinal product will cause irreversible, irreversible and irreversible
p.002007: negative consequences. The evaluation process identifies the risk of causing harm to
p.002007: population health and actual exposure and wide exposure to the product. The serious one
p.002007: health risk in the context of the use of a particular medicinal product may be assessed at
p.002007: the following conditions:
p.002007: (a) efficacy - the data presented for therapeutic efficacy in relation to what is proposed
p.002007: indications / indications, of the proposed target group / patient groups and of the proposed dosage indicated in
p.002007: the patient leaflet draft does not fully protect the efficacy claims;
p.002007: (b) safety - the assessment of preclinical toxicity / pharmacological safety data; and
p.002007: clinical safety cannot convincingly defend the conclusion that all potential parties to
p.002007: the safety of the target group / patient groups is accurately and comprehensively reflected in
p.002007: the proposed leaflet for the patient or the absolute degree of risk is unacceptable;
p.002007: (c) quality - the proposed production method and control methods cannot guarantee the absence of
p.002007: a material defect in the quality of the product which may affect the safety and / or efficacy of
p.002007: product;
p.002007: d) benefit / risk ratio - the benefit / risk assessment is unfavorable given the nature of the
p.002007: the identified risk / risks and the potential benefit of the proposed indication (s) and target
p.002007: group / groups of patients.
p.002007: 50. "Representative of the person referred to in Article 26 (1) or of the holder of a marketing authorization" is a person,
p.002007: established on the territory of the Republic of Bulgaria, determined by the person under Art. 26, para. 1 or by the holder
p.002007: of the marketing authorization to represent it before the regulatory authorities in the territory of the Republic
p.002007: Bulgaria.
p.002007: 51. An "acceptable level of safety" is present when the data presented is accepted statistically
p.002007: reliable safety according to clinical trials conducted in accordance with Good Clinical Practice.
p.002007: 52. "Manufacture of a medicinal product" means all operations related to the procurement of materials,
p.002007: their processing in the production process, including packaging and labeling, quality
p.002007: control, batch release, storage, shipping and related operations.
p.002007: 53. (Amended, SG No. 84/2018) (*) "Clinical Trial Protocol" is a protocol within the meaning of Art. 2, paragraph
p.002007: 2, point 22 of Regulation (EU) No 536/2014.
p.002007: 54. "Placing on the market" means the distribution of a medicinal product on the market in the territory of
p.002007: Republic of Bulgaria beyond the direct control of the marketing authorization holder.
p.002007: 55. "Primary packaging" means packaging that comes into direct contact with the medicinal product.
p.002007: 56. "Radiopharmaceutical" is a medicinal product which, when ready for use, contains one or more
p.002007: radionuclides (radioactive isotopes) included for medical purposes.
p.002007: 57. "Radionuclide generator" means any system that includes a fixed mother radionuclide from which
p.002007: obtains a daughter radionuclide which is recovered by elution or other methods and used in
...
p.002007: 2. from July 1, 2007 - under the procedure of the Commercial Register Act.
p.002007: (4) State fees for recording the changes under para. 1 and 2 are not due. "
p.002007: § 25. In the Law on Patents and Registration of Utility Models (promulgated, SG No. 27/1993; amend. 83 of 1996)
p.002007: , issue. 11 of 1998, issue. 81 of 1999, issue. 45 and 66 of 2002; 17, 30 and 64 of 2006) in Art. 20 item 7 shall be repealed.
p.002007: § 26. In the Law on the Professional Organization of Master Pharmacists (promulgated, SG No. 75/2006; amended, No. 105
p.002007: from 2006) in Art. 5 item 9 is amended as follows:
p.002007: "9. give opinions on opening pharmacies in accordance with Article 228, Paragraph 1, Item 9 of the Law on Medicinal Products in
p.002007: human medicine. "
p.002007: § 27. In § 1, item 7 of the additional provision of the Law on Integration of Persons with Disabilities (promulgated, SG, issue.
p.002007: 81 of 2004; amend. 28, 88, 94, 103 and 105 of 2005; 18, 30, 33, 37, 63, 95, 97 and 108 of 2006) sentence
p.002007: the second is amended as follows: "Medical devices are not auxiliaries, devices and equipment".
p.002007: § 28. In the Law on Excise Duties and Tax Warehouses (promulgated, SG No. 91/2005; Amended, SG No. 105/2005, No. 30, 34)
p.002007: 63, 81, 105 and 108 of 2006) in Art. 22, para. 3, item 2 the words "The Law on Medicines and Pharmacies in Humane
p.002007: medicine "shall be replaced by the" Medicinal Products in Human Medicine Act ".
p.002007: § 29. In the Law on Genetically Modified Organisms (promulgated, SG No. 27/2005; amend. SG 88/99, SG No. 27/2005).
p.002007: 30 of 2006) in Art. 2, para. 2, item 3 the words "the Law on Medicines and Pharmacies in the Human Medicine" shall be replaced
p.002007: with the "Law on Medicinal Products in Human Medicine".
p.002007: § 30. In the Consumer Protection Act (promulgated in the State Gazette, issue 99 of 2005; amend., Issue 30, 51, 53, 59, 105 and 108 of 2006
p.002007: d.) in Art. 186, para. 2, item 4 the words "the Law on Medicines and Pharmacies in Human Medicine" shall be replaced by
p.002007: "The Law on Medicinal Products in Human Medicine".
p.002007: § 31. In the Health Act (promulgated in the State Gazette, issue 70 of 2004; amend., Issue 46, 76, 85, 88, 94 and 103 of 2005, issue 18, 30, 34,
p.002007: 59, 71, 75, 81, 95 and 102 of 2006), the following amendments are made:
p.002007: 1. In Art. 4 the words "the Law on Medicines and Pharmacies in Human Medicine" are replaced by "the Law on
p.002007: medicinal products in human medicine ".
p.002007: 2. In Art. 21, para. 3 the words "the Law on Medicines and Pharmacies in Human Medicine" are replaced by "the Law on
p.002007: medicinal products in human medicine ".
p.002007: § 32. In the Law on Control of Narcotic Substances and Precursors (promulgated, SG No. 30/1999; amended, No. 63)
p.002007: from 2000, issue. 74, 75 and 120 of 2002; 56 of 2003, issue. 76, 79 and 103 of 2005; 30, 75 and 82 of 2006)
p.002007: make the following changes:
p.002007: 1. In Art. 32, para. 3 the words "the Law on Medicines and Pharmacies in Human Medicine" are replaced by "the Law on
p.002007: medicinal products in human medicine ".
p.002007: 2. In Art. 33, para. 1, item 1 the words "the Law on Medicines and Pharmacies in Human Medicine" shall be replaced by "the Law
p.002007: for medicinal products in human medicine ".
p.002007: 3. In Art. 34 after the word "issue" the words "master pharmacist" shall be deleted.
p.002007: 4. In Art. 39, para. 2 the words "Article 55, item 2 of the Law on Medicines and Pharmacies in Human Medicine" shall be replaced by
p.002007: "Article 197, item 2 of the Law on Medicinal Products in Human Medicine".
p.002007: 5. In Art. 44a para. 3 is repealed.
p.002007: 6. In Art. 44b the words "master pharmacist," shall be deleted.
p.002007: 7. In § 1, item 14 of the additional provision the words "the Law on Medicines and Pharmacies in Human Medicine"
p.002007: are replaced by the "Medicinal Products for Human Use Act".
p.002007: § 33. In the Law on blood, blood donation and blood transfusion (promulgated, SG No. 102/2003; amended, No. 70/2004)
p.002007: , issue. 30 and 65 of 2006) in Art. 8, para. 4 the words "Law on Medicines and Pharmacies in Human Medicine" shall be
p.002007: replaced by "Medicinal Products in Human Medicine" Act.
p.002007: § 34. In the Environmental Protection Act (promulgated, SG No. 91/2002; amended, SG No. 98/2002; amend., SG No. 86/2006)
p.002007: 2003, issue. 70 of 2004, issue. 74, 77, 88, 95 and 105 of 2005; 30, 65, 82, 99, 102 and 105 of 2006) in Art. 140
p.002007: the words "pharmaceuticals and medical devices within the meaning of § 1, item 40 of the Supplementary
p.002007: provisions of the Medicines and Pharmacies in Human Medicine Act "are replaced by" medicinal products,
p.002007: within the meaning of the Human Medicinal Products and Medical Devices Act. "
p.002007: § 35. In the Food Act (promulgated, SG No. 90/1999; amended, SG No. 102/2003, No. 70/2004, Nos. 87, 99, and 105)
p.002007: 2005, issue. 30, 31, 34, 51, 55 and 96 of 2006) in Art. 2, para. 3 item 4 is amended as follows:
p.002007: "4. medicinal products within the meaning of the Human Medicinal Products Act."
p.002007: § 36. Until the enactment of the acts referred to in § 19, the enacted normative acts for the implementation of repeals
p.002007: The Law on Medicines and Pharmacies in Humane Medicine applies insofar as they do not contravene this Act.
p.002007: § 37. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of § 22, which
p.002007: shall enter into force one year after the entry into force of this Act.
p.002007: -------------------------
p.002007: The law was adopted by the 40th National Assembly on March 30, 2007 and was affixed with the official seal of
p.002007: National Assembly.
p.002007: Transitional and Final Provisions
p.002007: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002007: PRODUCTS IN HUMAN MEDICINE
p.002007: (Official Gazette, SG 71/08, IN EFFECT OF 12.08.2008)
p.002007: § 65. (1) Issued pursuant to the repealed Law on Medicines and Pharmacies in Human Medicine (promulgated, SG,
p.002007: pcs. 36 of 1995; amend. 61 of 1996, issue. 38 of 1998, issue. 30 of 1999, issue. 10, 37, 59 and 78 of 2000; 41 of
...
p.002011: of the Ministry of Health and through government delegated activities through the budget of the Ministry of Health
p.002011: the municipalities shall be paid with the funds under art. 1, para. 2, line 5.
p.002011: (2) The activities, medicinal products and medical devices under para. 1 shall be paid in accordance with the procedure and methodology,
p.002011: designated by the Minister of Health.
p.002011: (3) The funds under art. 1, para. 2, line 5 are transferred monthly by the end of the current month.
p.002011: § 7. The Supervisory Board of the National Health Insurance Fund has the right to carry out internal
p.002011: compensated changes in loans between the elements of expenses and transfers under Art. 1, para. 2 that are in
p.002011: within the approved budget.
p.002011: § 8. The Supervisory Board of the National Health Insurance Fund on the grounds of art. 26, para. 2 of the Law on
p.002011: health insurance is entitled to spend on the contingency reserve
p.002011: under Art. 1, para. 2, line 3.
p.002011: ...................................
p.002011: § 15. The law shall enter into force on January 1, 2011, with the exception of § 10, which shall enter into force on the day of
p.002011: its publication in the State Gazette.
p.002011: Transitional and Final Provisions
p.002011: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002011: (Promulgated - SG, issue 98 of 2010, in force since 01.01.2011)
p.002011: § 106. In the Law on Medicinal Products in Human Medicine (promulgated, SG No. 31/2007; amended, SG No. 19/2006)
p.002011: 2008; Constitutional Court Decision No. 5 of 2008 - issue no. 65 of 2008; amend. 71 of 2008, issue. 10, 23, 41,
p.002011: 88 and 102 of 2009 and issue no. 59 of 2010) throughout the words "the Regional Inspections for Conservation and Control of
p.002011: Public Health "," Regional Inspectorate for Public Health Protection and Control "and" RIPCPH "
p.002011: are replaced by "Regional Health Inspectorates", "Regional Health Inspectorate" and "RHI" respectively.
p.002011: ...................................
p.002011: § 121. The law shall enter into force on January 1, 2011, except for:
p.002011: 1. Paragraphs 1, 16, 20, 29, 30, 32, 33, 34, 35, 42, 44, § 56, Vol. 1 and 2, § 65, 68, 70, 76, 80, 81, 90, 92 , 96, § 102, Vol. 3, 4, 5,
p.002011: 7 and 8, § 105, Vol. 1, 3 and 5, § 107, Vol. 1, 2, 3, 4, 6, letter "a", Vol. 7, 10, 11, 13 and 15, letter "a ", § 109, 110, 112, 113, § 115, vol.
p.002011: 5, § 116, items 4 and 6, § 117, items 5 and 7 and § 118, item 1, which come into force from the day of promulgation of the law in
p.002011: "State Gazette";
p.002011: 2. paragraph 102, items 1, 2 and 6, which shall take effect from 1 March 2011;
p.002011: 3. paragraphs 22, item 1 (concerning Article 36, paragraph 1, second sentence), § 37, § 48, item 2, § 51 and 59, which come into force as of 1
p.002011: July 2011;
p.002011: 4. Paragraph 107, point 15, letter "b", which shall take effect on 30 September 2011.
p.002011: Transitional and Final Provisions
p.002011: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002011: PRODUCTS IN HUMAN MEDICINE
p.002011: (Official Gazette of the Republic of Bulgaria, issue 12 of 2011, effective 08.02.2011)
p.002011: § 24. Submitted valid applications and notifications of changes to the marketing authorizations prior to entry
p.002011: by virtue of this law are dealt with so far.
p.002011: § 25. The Minister of Health shall, in accordance with this law, adjust the ordinance under Art. 42 until
p.002011: three months after its entry into force.
p.002011: ...................................
p.002011: § 27. The law shall enter into force on the day of its promulgation in the State Gazette.
p.002011: Transitional and Final Provisions
p.002011: TO THE AMENDING ACT TO THE MEDICINAL ACT
...
p.002013: other medical professionals with experience in the field.
p.002013: (3) The National Council for Medicinal Products Prices and Reimbursement shall approve the guidelines and
p.002013: the algorithms of art. 259, para. 1, item 4 of the Law on Medicinal Products in Human Medicine within three
p.002013: months from the expiry of the term under para. 1.
p.002013: § 47. (1) Within three months from the entry into force of this law, the Minister of Health shall issue
p.002013: the ordinance under Art. 262, para. 4 of the Law on Medicinal Products in Human Medicine.
p.002013: (2) Within 6 months of the entry into force of this law, the Positive Medicinal List may be included
p.002013: medicinal products with new international non - patent names, without evaluation of
p.002013: health technologies.
p.002013: Transitional and Final Provisions
p.002013: TO THE LAW TO SUPPLEMENT THE LIMITATION OF LAW
p.002013: ADMINISTRATIVE REGULATION AND ADMINISTRATIVE CONTROL
p.002013: ECONOMIC ACTIVITY
p.002013: (Official Gazette, No. 103 OF 2017, IN EFFECT OF 01/01/2018)
p.002013: § 68. This Act shall enter into force on 1 January 2018.
p.002013: Transitional and Final Provisions
p.002013: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002013: PRODUCTS IN HUMAN MEDICINE
p.002013: (Official Gazette, SG 84/08, IN EFFECT OF 12/10/2018)
p.002013: § 70. Clinical trials of medicinal products authorized until this law enters into force,
p.002013: containing narcotic substances are carried out in the establishments for which licenses have been obtained
p.002013: conducting relevant clinical trials to date.
p.002013: § 71. (1) The Minister of Health shall determine the composition of the commission under Art. 103, para. 1 within three
p.002013: months from the entry into force of this Act.
p.002013: (2) The Commission under Art. 103, para. 1 is the successor to the Ethics Committee for Multicenter Testing.
p.002013: (3) The Commission under Art. 103, para. 1 shall also deliver opinions on pending proceedings before ethics committees,
p.002013: created to the medical establishments in the present order.
p.002013: (4) Until the composition of the commission under Art. 103, para. 1 Ethics Committee for Multicenter Testing
p.002013: continues to operate in the past.
p.002013: § 72. (1) The Central Ethics Committee shall cease its activity after all proceedings have been completed,
p.002013: formed before her.
p.002013: (2) The chairman of the Central Ethics Committee shall transmit the archive with a transceiver protocol
p.002013: of the Central Ethics Committee, determined by an order of the Minister of Health
p.002013: person from the Ministry of Health within one month after the termination of the activity of the
p.002013: Central Ethics Committee.
p.002013: § 73. (1) The heads of the medical establishments in which clinical trials are carried out in accordance with this
p.002013: law, designate a contact person in accordance with the requirements of Art. 107a within three months of entry
p.002013: by virtue of Art. 107a.
p.002013: (2) The Ethics Committees set up by the medical establishments in accordance with the previous procedure, continue to
p.002013: carry out their activities until the appointment of a contact person under Art. 107a, para. 1.
p.002013: (3) After designation of a contact person, mail. 107a, para. 1 the functions of the Ethics Committees set up by
p.002013: The medical establishments according to the previous procedure are carried out by the contact person under Art. 107a, para. 1, p
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| another country | Other Country |
| army | Soldier |
| authority | Relationship to Authority |
| children | Child |
| crime | Illegal Activity |
| criminal | criminal |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| gender | gender |
| illegal | Illegal Activity |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| infant | Infant |
| job | Occupation |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| orphan | orphan |
| parent | parents |
| parents | parents |
| party | political affiliation |
| property | Property Ownership |
| restricted | Incarcerated |
| sick | Physically Ill |
| single | Marital Status |
| substance | Drug Usage |
| union | Trade Union Membership |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| crime | ['illegal'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| drug | ['substance'] |
| education | ['educational'] |
| educational | ['education'] |
| illegal | ['crime'] |
| parent | ['parents'] |
| parents | ['parent'] |
| substance | ['drug'] |
Trigger Words
capacity
consent
ethics
harm
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input