79C3C34C52B45572883A05D425EB0F82

Medicinal Products in Human Medicine Act (2017)

https://www.bda.bg/images/stories/documents/regulations/zakoni/ZLPHM_28122017.pdf

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This file was generated: 2020-12-01 05:44:49

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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalIllegal Activitycrime1
PoliticalIllegal Activityillegal2
Politicalcriminalcriminal11
Politicalpolitical affiliationparty15
Politicalvulnerablevulnerable3
HealthDrug Usagedrug74
HealthDrug Usagesubstance81
HealthMentally Disableddisabled1
HealthMentally Disableddisability8
HealthMentally Incapacitatedincapable2
HealthMotherhood/Familyfamily1
HealthPhysically Disabledillness1
HealthPhysically Disabledphysically3
Healthpatients in emergency situationsemergencies2
SocialAccess to Social Goodsaccess6
SocialAgeage1
SocialChildchildren3
SocialIncarceratedliberty1
SocialIncarceratedrestricted2
SocialInfantinfant6
SocialLinguistic Proficiencylanguage4
SocialMarital Statussingle10
SocialMothersmothers1
SocialPolice Officerofficer1
SocialProperty Ownershipproperty16
SocialReligionfaith1
SocialSoldierarmy1
SocialSoldiermilitary1
SocialTrade Union Membershipunion64
SocialUnemploymentunemployed1
SocialVictim of Abuseabuse1
SocialWomenwomen1
SocialYouth/Minorsminor14
Socialeducationeducation5
Socialeducationeducational1
Socialemployeesemployees2
Socialgendergender1
Socialorphanorphan1
Socialparentsparent2
Socialparentsparents4
Socialphilosophical differences/differences of opinionopinion68
General/OtherIncapacitatedincapacitated1
General/OtherIncapacitatedincapacity1
General/OtherPublic Emergencyemergency11
General/OtherRelationship to Authorityauthority83
General/Otherdeclaration of helsinkihelsinki1
General/Otherparticipants in a control groupplacebo1

Political / Illegal Activity

Searching for indicator crime:

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p.002017: (2) The orders under para. 1 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 280. (1) In finding violations of the provisions of Chapter Eleven,
p.002017: respectively of the ordinance under art. 249, the Executive Director of the BDA orders an order
p.002017: stop advertising from spreading.
p.002017: (2) With the order under para. 1, the BDA Director may oblige the advertiser to
p.002017: publish or distribute, in agreement with the BDA, a rebuttal of the allegations in the advertisement
p.002017: by the same means and in the same format and volume.
p.002017: (3) The order under para. 2 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: Chapter fourteen.
p.002017: ADMINISTRATIVE PENALTY PROVISIONS
p.002017: Art. 281. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG, No. 102 of 2012)
p.002017: 01/02/2013) Who manufactures, imports, sells, stores or makes available for use in the Republic of Bulgaria
p.002017: medicinal products that are not authorized for use, except in cases under Art. 8, 9 and 10, as well as those with unknown
p.002017: origin if not more difficult
p.002017: shall be punished by a fine of BGN 25,000 to BGN 50,000.
p.002017: (2) The same punishment shall be imposed on the persons who produce, import, sell or
p.002017: allow non-compliant medicinal products to be used in the Republic of Bulgaria
p.002017: the requirements of the applicable pharmacopoeia and the conditions of their authorization.
p.002017: (3) When the violations under para. 1 and 2 are related to unauthorized medicinal products
p.002017: products containing narcotic substances, or when repeated, if the acts do not
p.002017: constitute a crime, the permit issued under this law shall be revoked.
p.002017: (4) Medical professionals who manufacture, sell or supply
p.002017: unauthorized medicinal products are deprived of the right to practice the profession
p.002017: your for a period of 6 months to two years.
p.002017: (5) The punishment under para. 4 shall be imposed by order of the Minister of Health under
p.002017: proposal of the BDA Executive Director.
p.002017: Art. 282. (1) Who sells medicinal products in packages or leaflets to the patient,
p.002017: who do not meet the requirements of this law shall be punished by a fine of BGN 750 up to BGN 1500;
p.002017: repeated infringement - with a fine from 1500 to 3000 BGN.
p.002017: (2) Whoever sells medicinal products without leaflets to the patient shall be liable to a fine of
p.002017: 750 to 1500 BGN, and in the case of repeated infringement - with a fine of 1500 to 3000 BGN.
p.002017: Art. 283. (1) Who imports, trades or makes available for use medicinal products with
p.002017: expired, is liable to a fine of BGN 10,000 to BGN 20,000.
p.002017: (2) Who breaks the primary / secondary packaging or sells / provides medicinal products
p.002017: products with broken primary / secondary packaging are punished with a fine of 750 to 1500 levs, and for
p.002017: repeated violation - with a fine from 1500 to 3000 BGN.
p.002017: Art. 284. (1) Who manufactures, imports or wholesale medicinal products or
p.002017: sells medicinal products without permission, is fined BGN 50,000.
p.002017: (2) (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 02.01.2013)
p.002017: Who manufactures, imports or wholesale medicinal products or sells medicinal products in violation of
p.002017: the authorization is granted or the sale, storage or supply of medicinal products which are of unknown origin,
p.002017: shall be punished by a fine of 25
p.002017: 000 to 50 000 BGN
...

Searching for indicator illegal:

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p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
p.002017: the medicinal product is classified as a prescription only product.
p.002017: Art. 177. Medicinal products that do not meet the requirements of Art. 173, 174 and
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p.002017: use or persons to whom he has assigned
p.002017: carrying out the activities of Chapter Eight;
p.002017: 6. (new - SG 102/2012, in force since 21.12.2012) to carry out a check on
p.002017: observance of the approved prices, the marginal prices or the registered prices at the sale of
p.002017: medical products;
p.002017: 7. (Renumbered from Item 6, SG No. 102/2012, effective 21.12.2012) to draw up acts for
p.002017: establishment of administrative violations.
p.002017: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002017: (3) (amend. - SG 98/10, in force from 01.01.2011) The Executive Director of
p.002017: The BDA or the relevant Director of the RIC, subject to the official's submission,
p.002017: having established the violation, has the right to:
p.002017: 1. order in writing the offender to suspend the violation under para. 1, Vol. 1;
p.002017: 2. requires the offender to declare that he will cease the violation under para. 1, item 1 and
p.002017: if necessary, oblige him to make the declaration public;
p.002017: 3. order the termination or prohibition of any violation under para. 1, item 1 and at
p.002017: the need to make an order for termination or prohibition of the infringement
p.002017: public domain.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) The chairman of the council under Art.
p.002017: 258, para. 1 has the right to order in writing the offender to cease the infringement,
p.002017: established during the inspection under para. 1, v. 6.
p.002017: Art. 271. (1) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: inspections shall have the right to:
p.002017: 1. stop construction and issue prescriptions when they find violations of hygiene standards and
p.002017: requirements in the construction execution process; illegal construction of facilities and facilities for
p.002017: manufacture, storage and sale of medicinal products shall notify the National Construction Control Directorate or
p.002017: the technical service of
p.002017: the municipality;
p.002017: 2. prohibit the commissioning and stop the operation of sites and
p.002017: facilities in violation of requirements and hygiene standards in production,
p.002017: storage and sale of medicinal products - until the elimination of the disorders;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008) block medicinal products in the presence of
p.002017: documented information on: non-compliance with quality requirements; medicinal products imported or
p.002017: produced in violation of this law; medicinal products that are available in packs of leaflets which do not
p.002017: meet the requirements of this one
p.002017: law; and send samples of them to the BDA;
p.002017: 4. give conclusions about the compliance of the objects of control with the normative
p.002017: the specified requirements;
p.002017: 5. issue orders, prescriptions and instructions within their competence,
p.002017: which are binding on all persons in the territory of the area concerned.
p.002017: (2) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: administrative measures under para. 1 or under Art. 270, para. 3 shall be imposed by an order of the director of the RII.
p.002017: (3) The orders under para. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 272. (1) The Executive Agency for Medicines shall:
p.002017: 1. (suppl. - SG 102/2012, in force from 02.01.2013) prohibits the commissioning and
p.002017: suspends the operation of sites and facilities in violation of the rules of Good Manufacturing Practice
p.002017: medicinal products and active substances as well as
...

Political / criminal

Searching for indicator criminal:

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p.002017: data with the regulatory authorities of other Member States, the European Commission and the European Commission
p.002017: drug agency.
p.002017: Art. 19a. (New, SG No. 60/2011, effective 05.08.2011) (1) The respective SICs shall also keep
p.002017: maintain public registers for the drugstore registration certificates they have issued.
p.002017: (2) Within 7 days from the issuance of a certificate for registration of a drugstore
p.002017: the respective RII sends to the Ministry of Health information on the issued act.
p.002017: (3) The Ministry of Health shall maintain and maintain on its website
p.002017: public national register of drugstore registration certificates issued.
p.002017: Section III.
p.002017: Financing
p.002017: Art. 20. (1) The activities of the BDA shall be financed by budgetary funds and revenues from
p.002017: own business.
p.002017: (2) (amend. - SG 15/2013, in force from 01.01.2014) The budgetary funds shall be
p.002017: provide a subsidy from the state budget through the budget of the Ministry of Finance
p.002017: healthcare.
p.002017: Art. 21. (1) The Executive Agency for Medicines shall be the revenue administrator of
p.002017: own activity, which are formed by:
p.002017: 1. chemical-pharmaceutical expertise;
p.002017: 2. laboratory analyzes and tests;
p.002017: 3. evaluation of documentation and issuance of permits, certificates, certificates and
p.002017: other documents specified in this law;
p.002017: 4. evaluation of the renewal, modification and deletion of the marketing authorization, and
p.002017: certificate of registration of a medicinal product;
p.002017: 5. maintenance of the marketing authorizations or the registration certificates of
p.002017: medicine;
p.002017: 6. fines and pecuniary sanctions imposed by criminal decrees issued for
p.002017: violations under this law;
p.002017: 7. consulting, publishing and research activities in the field of
p.002017: the medical sector;
p.002017: 8. coordination of investment projects for new construction and / or reconstruction
p.002017: existing facilities related to the manufacture of medicinal products;
p.002017: 9. carrying out inspections in relation to conformity assessment of the conditions of
p.002017: production with the requirements of Good Manufacturing Practice;
p.002017: 10. other sources.
p.002017: (2) In carrying out the activities under para. 1, items 1 - 5 and 7-9 the BDA collects fees in the amount,
p.002017: set in a tariff adopted by the Council of Ministers.
p.002017: (3) (New - SG 71/08, in force from 12.08.2008) In the tariff under para. 2 are defined as lower and different by
p.002017: amount of fees for carrying out the authorization procedures for the use, production and import of medicinal products
p.002017: products for small and medium - sized enterprises in
p.002017: pharmaceutical sector within the meaning of the Small and Medium Enterprises Act.
p.002017: Art. 22. (1) The financial resources under art. 21 is spent on:
p.002017: 1. the control activity of the BDA;
p.002017: 2. payment of activities under art. 21, para. 1, items 1 and 2, in cases where their implementation is
p.002017: assigned by the BDA under a contract to other persons;
p.002017: 3. (repealed, SG No. 38/2012, effective 01.07.2012)
p.002017: 4. creating, maintaining and maintaining the registers of art. 19, para. 1;
p.002017: 5. maintaining electronic data interchange systems with the regulatory authorities of
p.002017: the other Member States, the European Commission and the European Medicines Agency;
p.002017: 6. (suppl. - SG 102/2012, in force from 21.12.2012) information and publishing
p.002017: activity related to the quality, efficacy and safety of medicinal products and
...

p.002017: Art. 148. For obtaining a production permit the person under Art. 146 should
p.002017: has:
p.002017: 1. with appropriately qualified personnel, depending on the specifics of
p.002017: manufactured types of medicinal products and dosage forms;
p.002017: 2. at any one time with at least one qualified person who is eligible
p.002017: Art. 159;
p.002017: 3. premises for production, control and storage of medicinal products,
p.002017: provided with the necessary technical equipment and control laboratories.
p.002017: Art. 149. Managers of production and quality control of medicinal products
p.002017: products in manufacturing enterprises are persons:
p.002017: 1. who hold a Master's degree in a specialty
p.002017: "pharmacy", "chemistry" or "biology" and at least two years' practical experience in
p.002017: pharmaceutical production;
p.002017: 2. which meet the requirements of item 1 and have an additional recognized specialty in
p.002017: radiobiology or radiochemistry - for radiopharmaceuticals or for medicinal products,
p.002017: exposed to ionizing radiation;
p.002017: 3. with recognized specialty in clinical hematology, medical microbiology, virology or
p.002017: immunology - for the production of immunological medicinal products - vaccines, toxins, sera, for
p.002017: biotech products and for medicinal products derived from
p.002017: human plasma or human blood.
p.002017: Art. 150. (1) The person under art. 146 submits to the BDA an application in the form approved by
p.002017: the director of the agency.
p.002017: (2) Together with the application under para. 1 the applicant shall also submit:
p.002017: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002017: specialty, work record, criminal record or similar document, if not
p.002017: Bulgarian citizen, and employment contract for the persons under Art.
p.002017: 148, item 2 and art. 149;
p.002017: 2. copies of contracts for the assignment of production and / or control of the applications for
p.002017: production of products - in the cases of art. 151;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union,
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
p.002017: production of radiopharmaceuticals or medicinal products subject to ionization
p.002017: radiation during their production;
p.002017: 8. permission to use the premises for production, control and storage,
p.002017: issued by the order of the Spatial Planning Act, or other substitute document;
p.002017: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 10. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) In the manufacture of narcotic substances and dosage forms containing
p.002017: such substances are also complied with the requirements of the Drug Control Act and
p.002017: precursors.
p.002017: (4) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 2, Vol. 1,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
p.002017: perform by contract in another object on the territory of the Republic of Bulgaria or outside it, the persons under art. 146
p.002017: are required to indicate the location of this
p.002017: an object and a copy of the contract setting out the responsibilities of each party in respect of
p.002017: compliance with the requirements of Good Manufacturing Practice of Medicinal Products
p.002017: products and obligations of the qualified person under Art. 148, Vol. 2.
p.002017: Art. 152. (amend. - SG 102/2012, in force from 02.01.2013) (1) The principles and requirements for
p.002017: Good manufacturing practice for all types of medicinal products, clinical medicinal products
p.002017: test and of the active substances are determined by the ordinance of
p.002017: the Minister of Health and with acts and guidelines adopted by the European Commission.
p.002017: (2) The principles and requirements for a formal risk assessment to establish the
p.002017: Good manufacturing practice for excipients shall be determined by the ordinance under para. 1 and p
p.002017: guidelines adopted by the European Commission.
p.002017: Art. 153. (1) Upon receipt of an application under Art. 150 BDA evaluates the submitted documentation and
p.002017: perform on-site inspection of the production, control and storage sites, including in the cases under Art.
p.002017: 151, to establish the correspondence between the submitted documentation and the conditions of production, control
p.002017: and storage of source materials for manufacturing and finished medicinal products and their compliance
p.002017: with the requirements of
...

p.002017: from a document certifying that it is manufactured and controlled in accordance with standards,
p.002017: equivalent to Good manufacturing practice, including when this medicinal product
p.002017: has been issued
p.002017: marketing authorization.
p.002017: (6) (amend. - SG 71/08, in force from 12.08.2008) It is not required to carry out control tests of
p.002017: the territory of the Republic of Bulgaria, when in another Member State the requirements of para. 4 or 5 and
p.002017: the medicinal product intended for clinical trial is accompanied by a certificate of release for
p.002017: the batch issued by another
p.002017: qualified person.
p.002017: (7) The qualified person under para. 1 shall keep records of each lot imported
p.002017: medicinal product for at least 5 years and present it at the request of the control authorities.
p.002017: (8) The holder of the import authorization shall provide and maintain a locking system and
p.002017: withdrawal from the market of medicinal products which have shown non - compliance with the requirements for
p.002017: quality.
p.002017: (9) The holder of an import authorization shall be obliged to block and withdraw the medicinal products
p.002017: products which have shown non - compliance with the safety and efficacy requirements according to
p.002017: the ordinance under Art. 274, para. 1.
p.002017: (10) (Amended, SG No. 12/2011, effective 08.02.2011) The provisions of Art. 160, para. 1, vol.
p.002017: 4 and 7 shall also apply to import license holders.
p.002017: (11) The holder of an import permit shall provide the qualified person under Art. 161,
p.002017: para. 2, item 1 the necessary conditions for the fulfillment of his duties and shall notify immediately
p.002017: the control authorities when it is changed.
p.002017: (12) When instituting administrative criminal proceedings for infringements committed under
p.002017: the fulfillment of the obligations of the qualified person, the BDA shall order the holder of the authorization for
p.002017: import to remove the temporarily qualified person from
p.002017: the position.
p.002017: Art. 163a. (New, SG No. 12/2011, effective 08.02.2011) (1) When the BDA establishes
p.002017: deficiencies and deficiencies in the documentation submitted, it shall notify the applicant in writing and provide
p.002017: written instructions.
p.002017: (2) In the cases of para. 1 the term under Art. 164, para. 1 stops running until
p.002017: documentation as required.
p.002017: Art. 164. (1) The BDA Executive Director shall issue an import permit within 30 days
p.002017: from the date of submission of the application under Art. 162 or reasonably refused.
p.002017: (2) The refusal under para. 1 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: (3) The import permit shall be issued only for the medicinal products specified in the application
p.002017: products, their forms of active substances and for the intended medicinal products intended
p.002017: for the clinical trial and for the premises where the control and storage will be carried out.
p.002017: (4) The import authorization is open-ended.
p.002017: Art. 165. (1) The holder of an import permit from a third country shall submit to the BDA
p.002017: application when changing:
p.002017: 1. the person under art. 161, para. 2, Vol. 1;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and
p.002017: the forms for which the import authorization has been granted;
p.002017: 3. the address of the laboratory under Art. 161, para. 2, Vol. 2;
p.002017: 4. the court registration of the trader.
p.002017: (2) To the application under para. 1, the documents related to the change specified shall be attached
...

p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
p.002017: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Agency
p.002017: for nuclear regulation.
p.002017: (5) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the person under para. 1, Vol. 3,
p.002017: when he is a Bulgarian citizen.
p.002017: Art. 200. The Drug Enforcement Agency evaluates the documentation and performs it
p.002017: on - the - spot verification of the sites indicated in the application for their compliance with
p.002017: requirements for Good Distribution Practice.
p.002017: Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing,
p.002017: when it finds deficiencies in the documentation submitted.
p.002017: (2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
p.002017: Art. 202. (1) Within 90 days from the date of submission of the application under Art. 199, para. 1
p.002017: the Executive Director of the BDA issues the permit for wholesale trade or makes it motivated
p.002017: refusal.
p.002017: (2) The refusal under para. 1 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: Art. 203. Within 15 days from the date of submission of the documentation under Art. 199, para. 2
p.002017: the BDA Executive Director issues a Wholesale Trade Registration Certificate to
p.002017: the territory of the Republic of Bulgaria of the person under Art. 195, para. 1.
p.002017: Art. 204. (1) The permit for wholesale of medicinal products shall be indefinite.
p.002017: (2) The authorization under Art. 202 or the certificate under Art. 203 is terminated if
p.002017: the holder requested this in writing from the BDA Executive Director.
p.002017: (3) The person under art. 195 is obliged to notify the BDA in writing within 7 days after the termination of
p.002017: its activity in the wholesale of medicinal products. In these cases, the BDA Executive Director
p.002017: terminates the issued marketing authorizations / certificates
p.002017: of medicines.
...

p.002017: The requirements for the location and the premises of the pharmacy are laid down in the ordinance of
p.002017: Art. 219, para. 2.
p.002017: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in
p.002017: (requirements from 05.08.2011) Requirements to the device and premises of pharmacies under Art. 228, para.
p.002017: 5 shall be determined in the ordinance under para. 1.
p.002017: Art. 228. (amend. - SG 71/08, in force from 26.07.2008) (1) (amend. - SG 60/11, in force from 26.07.2008)
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002017: director of the BDA on the basis of a model application to
p.002017: applicable:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a country Party
p.002017: Agreement on the European Economic Area - Document for the up - to - date registration of the European Economic Area
p.002017: national legislation issued by the competent authority of the relevant
p.002017: the state of the persons under art. 222, para. 1;
p.002017: 2. employment contract or contract for management of the pharmacy, concluded with the master pharmacist
p.002017: or with a pharmacist assistant;
p.002017: 3. a copy of the act for the creation of the persons under Art. 222, para. 4;
p.002017: 4. documents certifying that the requirements of Art. 224 Hours;
p.002017: 5. (suppl. - SG 103/07, in force from 01.01.2018) criminal record of
p.002017: Master of Pharmacy, respectively of the Assistant Pharmacist appointed as Head of Pharmacy,
p.002017: if they are not Bulgarian citizens;
p.002017: 6. medical certificate of the Master of Pharmacy, respectively
p.002017: assistant pharmacist appointed as pharmacy manager;
p.002017: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002017: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued
p.002017: from the relevant RI;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002017: medicinal products are checked to see if the diploma of the master pharmacist / assistant pharmacist is presented
p.002017: issued by the relevant competent authority
p.002017: institution.
p.002017: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies under Art.
p.002017: 222, para. 4 and 6 shall be opened and closed at the request of the person representing the medical establishment.
p.002017: (4) (Renumbered from Paragraph (3), SG No. 60/2011, effective 05.08.2011)
p.002017: pharmacy in which medicinal products containing narcotic substances are marketed
p.002017: and the requirements of the Drugs and Precursors Control Act.
p.002017: (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.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy opened in a population
p.002017: a place with a population of less than 10,000 inhabitants is issued on the basis of
p.002017: application form to which shall be attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) the documents under para. 1, items 1 - 7a and
...

p.002017: 50 per cent of the fee determined in the tariff under Art. 21, para. 2 for the authorization of
p.002017: retail trade of medicinal products under Art. 222, para. 1.
p.002017: (6) (Renumbered from Paragraph (4), Suppl. - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 98)
p.002017: from 2010, in force from 01.01.2011, previous para. 5, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: d.) The application and documents under para. 1 and 5 shall be submitted to the BDA.
p.002017: (7) (Renumbered from Paragraph (5), amend. - SG 102/09, in force from 22.12.2009, amended - SG, issue 98
p.002017: from 2010, in force from 01.01.2011, previous para. 6, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: (d) Regional health inspections shall issue a hygienic conclusion within 14 days of the date
p.002017: of applying for it.
p.002017: (8) (New, SG No. 48/2015) On the day of receipt of the application under para. 1 and 5, the BDA shall send a request on its own motion
p.002017: to the Board of Directors of the Bulgarian Pharmaceutical Union for issuance of a certificate for registration in the national
p.002017: electronic register of the members of the Bulgarian Pharmaceutical Union - for the master pharmacist, head of
p.002017: pharmacy, as well as providing information on penalties imposed under the Commercial Law
p.002017: the organization of master pharmacists and the Health Act.
p.002017: (9) (New, SG No. 48/2015) The Managing Board shall submit the documents under para. 8th c
p.002017: 5 working days after receiving the request.
p.002017: (10) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 1, Vol. 5,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 229. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, repealed - SG No. 60/2011)
p.002017: (in force from 05.08.2011)
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 102/2009, effective 22.12.2009,
p.002017: ed. - SG, issue. 60 of 2011, in force since 05.08.2011, suppl. - SG, issue. 18 of 2014) Within one month from
p.002017: receipt of the documentation under Art. 228, para. 6 the Executive Director of the BDA after the opinion of
p.002017: The Expert Council for Retail Trade in Medicinal Products issues a marketing authorization
p.002017: retail with medicinal products at a pharmacy or make a motivated refusal to grant an authorization.
p.002017: The permit or refusal shall be
p.002017: served on the applicant.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation under Art.
p.002017: 228, para. 6 The BDA shall check the submitted documents and notify the applicant in writing of the established ones
p.002017: inconsistencies or incompleteness. In these cases
p.002017: the term under para. 2 shall cease to run from the day of notification until the deficiencies have been rectified.
p.002017: (4) (New - SG 71/08, in force from 12.08.2008) In case within 60 days from the date of notification
p.002017: under para. 3, the applicant has not remedied any inconsistencies or incompleteness found in the proceedings for the issuance of
p.002017: retail authorization for medicinal products
p.002017: products or for a change to an authorization is terminated.
p.002017: (5) (Renumbered from Paragraph (4), SG No. 71/2008, effective 12.08.2008, amended, SG No. 60/2008)
p.002017: 2011, effective 05.08.2011) The refusal of the BDA Executive Director to issue a
...

p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
p.002017: registration of a drugstore or for making a change under Art. 242 the respective RIC collects fees
p.002017: in the amount determined by the tariff under Art. 21, para. 2.
p.002017: (6) (New - SG 103 2017, in force from 01.01.2018)
p.002017: food safety ex officio establishes the circumstances of a person 's criminal record
p.002017: para. 2, item 2, when he is a Bulgarian citizen.
p.002017: Art. 240. (amend. - SG 60/11, in force from 05.08.2011) (1) Within 14 days from
p.002017: performing the inspection under Art. 239, para. 3 or by eliminating the incompleteness of art. 239, para. 4
p.002017: the director of RII issues a certificate for registration of a drugstore or makes a reasoned refusal
p.002017: for its publication.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012)
p.002017: refuses to issue a certificate of registration of the person under Art. 238, para. 2 when:
p.002017: 1. none of the documents under Art. 239, para. 2;
p.002017: 2. within the term of art. 239, para. 4 the applicant did not remove the incompleteness found.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) When, within the term of para. 1
p.002017: the director of RZI did not issue a certificate for registration of a drugstore or did not
p.002017: motivated refusal, it is considered that there is tacit consent.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 3 the applicant can start
p.002017: performing the requested activities in compliance with Art. 29 of the Administrative Restriction Act
p.002017: regulation and administrative control over the economic activity.
p.002017: (5) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012)
p.002017: of RZI under para. 1 shall be subject to appeal by the order of the Administrative Procedure Code.
p.002017: Art. 240a. (New, SG No. 102/2012, effective 21.12.2012) (1) The Director of
p.002017: the respective RZI shall terminate the registration of a drugstore by order:
p.002017: 1. at the request of the person who has received a certificate for registration of a drugstore;
p.002017: 2. by termination of the activity of the person under art. 238, para. 2, of which it notifies
...

p.002000: § 84. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: with the exception of § 65, which comes into force on 30 September 2011.
p.002000: Transitional and Final Provisions
p.002000: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002000: DRUGS AND PRECURSORS
p.002000: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002000: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002000: Transitional and Final Provisions
p.002000: TO THE LAW AMENDING AND SUPPLEMENTING THE STATE LAW
p.002000: EMPLOYEE
p.002000: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002000: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in
p.002000: "State Gazette":
p.002000: 1. The Council of Ministers shall bring the Classifier of posts in administration to
p.002000: compliance with this law;
p.002000: 2. the competent authorities shall bring the planning acts of the respective
p.002000: administration in accordance with this law.
p.002000: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002000: the independent financial audit, the Electronic Communications Act, the Financial Supervision Commission Act, the Access Act and
p.002000: disclosure of documents and declaring of belonging of Bulgarian citizens to the State Security and
p.002000: Intelligence Services of the Bulgarian People's Army, Law on Forfeiture in favor of the State of Property Acquired
p.002000: of criminal activity, the Conflict of Interest Prevention and Identification Act, the Code of Conduct
p.002000: social security, the Health Insurance Act, the Farmers Support Act, and
p.002000: The Roads Act is governed by the terms and procedures of § 36 of the transitional and final provisions of the Act
p.002000: amending and supplementing the
p.002000: the civil servant (State Gazette, issue 24 of 2006).
p.002000: (2) The act of appointment of the civil servant shall:
p.002000: 1. assigns the definitions in the Classifier of posts in the administration
p.002000: minimum rank for the position held, unless the employee holds a higher rank;
p.002000: 2. determines the individual basic monthly salary.
p.002000: (3) The additional necessary funds for social security contributions of the persons under para. 2 se
p.002000: provide, within the cost of wages, salaries and social security contributions,
p.002000: the budgets of the authorizing officers concerned.
p.002000: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account
p.002000: of the State Fund for Agriculture, resulting from this law.
p.002000: (5) The governing bodies of the National Social Security Institute and the National Social Security Institute
p.002000: Health Insurance Fund to make the necessary changes to the respective budgets,
p.002000: arising from this law.
p.002000: (6) Unused employment leave shall be maintained and shall not be maintained
p.002000: offset by cash benefits.
p.002000: § 86. (1) Within one month from the entry into force of this Act the individual basic monthly salary of the employee
p.002000: is determined so that the same, less the tax due and the mandatory social security contributions at the expense of
p.002000: the insured person, if they were owed, no lower than the gross monthly salary received so far,
...

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p.002017: and retail, clinical trials, safety and advertising of medicinal products;
p.002017: 10. perform laboratory analysis on suspected quality deviation,
p.002017: the efficacy and safety of medicinal products and undertakes the legal provisions
p.002017: measures;
p.002017: 10a. (new, SG No. 102/2012, effective 21.12.2012) shall exercise the functions of
p.002017: a competent body for pharmacovigilance monitoring;
p.002017: 11. (amend. - SG 102/2012, in force from 21.12.2012) organize and maintain a system
p.002017: for pharmacovigilance monitoring;
p.002017: 12. issue certificates under the WHO certification scheme;
p.002017: 12a. (new, SG No. 18/2014) issue certificates of Good Distribution Practice;
p.002017: 13. issue certificates of Good Manufacturing Practice;
p.002017: 14. (amend. - SG 18/04) consult the investment projects for construction of
p.002017: new and / or redevelopment of existing facilities related to the manufacture of medicinal products
p.002017: products in accordance with the rules of Good Manufacturing Practice;
p.002017: 15. performs the functions of coordinator and advisory body on problems,
p.002017: related to the quality, efficacy and safety of medicinal products;
p.002017: 16. performs consulting, scientific, information and publishing activities in the field
p.002017: the medicines sector;
p.002017: 17. coordinates and participates in activities related to the European Pharmacopoeia and to the
p.002017: the development of the Bulgarian Pharmacopoeia;
p.002017: 18. participate in activities in the field of medicinal products related to the work of the European Agency
p.002017: on Medicines, European Directorate for Quality of Medicines and Health, international
p.002017: bodies and organizations as well as with the implementation of
p.002017: international treaties to which the Republic of Bulgaria is a party;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) participates in the international
p.002017: harmonization and standardization of technical measures related to traceability
p.002017: drug safety, coordinated by the European Medicines Agency;
p.002017: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain
p.002017: national internet portal for medicinal products;
p.002017: 19. performs other activities specified by law.
p.002017: (6) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: medicines coordinates its activities with regional health inspections (RICs) in the area of
p.002017: control of medicinal products.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under
p.002017: this law related to preventing the entry and distribution of counterfeit
p.002017: medicinal products, is carried out in cooperation between the BDA and the customs authorities.
p.002017: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health
p.002017: inspections issue certificates for registration of drugstores.
p.002017: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002017: retail of medicinal products, which includes three representatives of the Bulgarian
p.002017: pharmaceutical union, one representative of the faculties of pharmacy of the medical colleges and
p.002017: four BDA representatives. The composition of the Board is determined by an order of the Executive Director of the BDA,
p.002017: agreed with the Minister of
p.002017: healthcare.
p.002017: (2) The council under para. 1 is an advisory unit which:
p.002017: 1. prepares opinions on the applications and documents submitted to the BDA under Art. 228, para. 1 and 5,
...

p.002017: pharmaceutical production;
p.002017: 2. which meet the requirements of item 1 and have an additional recognized specialty in
p.002017: radiobiology or radiochemistry - for radiopharmaceuticals or for medicinal products,
p.002017: exposed to ionizing radiation;
p.002017: 3. with recognized specialty in clinical hematology, medical microbiology, virology or
p.002017: immunology - for the production of immunological medicinal products - vaccines, toxins, sera, for
p.002017: biotech products and for medicinal products derived from
p.002017: human plasma or human blood.
p.002017: Art. 150. (1) The person under art. 146 submits to the BDA an application in the form approved by
p.002017: the director of the agency.
p.002017: (2) Together with the application under para. 1 the applicant shall also submit:
p.002017: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002017: specialty, work record, criminal record or similar document, if not
p.002017: Bulgarian citizen, and employment contract for the persons under Art.
p.002017: 148, item 2 and art. 149;
p.002017: 2. copies of contracts for the assignment of production and / or control of the applications for
p.002017: production of products - in the cases of art. 151;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union,
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
p.002017: production of radiopharmaceuticals or medicinal products subject to ionization
p.002017: radiation during their production;
p.002017: 8. permission to use the premises for production, control and storage,
p.002017: issued by the order of the Spatial Planning Act, or other substitute document;
p.002017: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 10. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) In the manufacture of narcotic substances and dosage forms containing
p.002017: such substances are also complied with the requirements of the Drug Control Act and
p.002017: precursors.
p.002017: (4) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 2, Vol. 1,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
p.002017: perform by contract in another object on the territory of the Republic of Bulgaria or outside it, the persons under art. 146
p.002017: are required to indicate the location of this
p.002017: an object and a copy of the contract setting out the responsibilities of each party in respect of
p.002017: compliance with the requirements of Good Manufacturing Practice of Medicinal Products
p.002017: products and obligations of the qualified person under Art. 148, Vol. 2.
p.002017: Art. 152. (amend. - SG 102/2012, in force from 02.01.2013) (1) The principles and requirements for
p.002017: Good manufacturing practice for all types of medicinal products, clinical medicinal products
p.002017: test and of the active substances are determined by the ordinance of
p.002017: the Minister of Health and with acts and guidelines adopted by the European Commission.
p.002017: (2) The principles and requirements for a formal risk assessment to establish the
p.002017: Good manufacturing practice for excipients shall be determined by the ordinance under para. 1 and p
p.002017: guidelines adopted by the European Commission.
p.002017: Art. 153. (1) Upon receipt of an application under Art. 150 BDA evaluates the submitted documentation and
p.002017: perform on-site inspection of the production, control and storage sites, including in the cases under Art.
p.002017: 151, to establish the correspondence between the submitted documentation and the conditions of production, control
p.002017: and storage of source materials for manufacturing and finished medicinal products and their compliance
p.002017: with the requirements of
p.002017: Good manufacturing practice.
p.002017: (2) The costs of carrying out on-site inspections under para. 1 shall be at the expense of the applicant.
p.002017: (3) For carrying out on-site inspections under para. 1 the applicant pays a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: Art. 154. (1) When the BDA establishes incompleteness in the submitted documentation and / or inconsistency between
...

p.002017: 5. (repealed, SG No. 12/2011, effective 08.02.2011)
p.002017: 6. notify immediately the control bodies in case of change of the qualified person
p.002017: under Art. 148, Vol. 2;
p.002017: 7. ensure at all times access of the control bodies to the premises and
p.002017: documentation;
p.002017: 8. provide to the qualified person under Art. 148, item 2 the necessary conditions for
p.002017: performance of his duties;
p.002017: 9. (new - SG 102/2012, in force from 02.01.2013) inform immediately the BDA and the holder of the permit for
p.002017: use if he / she receives information that the medicinal products fall within the scope of his authorization
p.002017: production, are falsified or there are doubts about falsification, regardless of whether these medicinal products
p.002017: products have been distributed within the legal supply chain or illegally,
p.002017: including through illicit sale through the information society services;
p.002017: 10. (new - SG 102/2012, in force from 02.01.2013) check whether
p.002017: the manufacturers, importers or traders from which it receives the active substances are
p.002017: registered by the competent authority of the Member State in which they are established;
p.002017: 11. (New, SG No. 102/2012, effective 02.01.2013) verify the authenticity and
p.002017: the quality of the active substances and of the excipients.
p.002017: (2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing permit shall exercise
p.002017: audits at the sites for the production and marketing of active substances for compliance with Good Manufacturing
p.002017: practice and Good distribution practice. The holder of the manufacturing authorization may
p.002017: contract with a third party yes
p.002017: performed the audit on his behalf and on his behalf.
p.002017: (3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the permit
p.002017: document the undertakings under para. 1, items 2 and 2a measures.
p.002017: (4) (Renumbered from Paragraph (2), SG No. 102/2012, effective 02.01.2013) The holder of a permit for
p.002017: manufacture keeps the samples and the documentation for the active medicinal products manufactured by him
p.002017: substances and medicinal products intended for clinical use
p.002017: tests, under the conditions and in the order specified in the ordinance under art. 152.
p.002017: (5) (Renumbered from Paragraph (3), SG No. 102/2012, in force from 02.01.2013) In the case of a medicinal product
p.002017: product for clinical trial, the holder of the manufacturing authorization shall ensure that
p.002017: all production operations shall be carried out in accordance with
p.002017: the information provided by the contracting authority to the BDA in accordance with the ordinance under Art. 82, para. 3.
p.002017: (6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013)
p.002017: each transaction is kept for 5 years and contains the date, name of the medicinal product
p.002017: product, quantity delivered, name and address of consignee, and batch number.
p.002017: (7) (Renumbered from Paragraph (5), SG No. 102/2012, effective 02.01.2013)
p.002017: a production authorization provides and maintains a system for blocking and withdrawing from the market
p.002017: medicinal products that have shown non-compliance with quality requirements.
p.002017: (8) (Renumbered from Paragraph (6), SG No. 102/2012, effective 02.01.2013)
p.002017: a manufacturing authorization is required to block and withdraw the medicinal products shown
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p.002017: Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
p.002017: Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria from
p.002017: third country of all types of medicinal products and medicinal products intended for clinical use
p.002017: testing may only be carried out by natural or legal persons registered as traders under the legislation
p.002017: of a Member State that are
p.002017: have received an import permit issued by the BDA Executive Director.
p.002017: (2) In order to obtain an import permit, the person under para. 1 must have:
p.002017: 1. (amend. - SG 102/2012, in force from 02.01.2013) at any time with at least one
p.002017: a qualified person who meets the requirements of Art. 159, para. 2 and 10;
p.002017: 2. (amend. - SG 102/2012, in force from 02.01.2013) with a laboratory for quality control in
p.002017: compliance with the requirements of the ordinance under Art. 152 and storage facilities for medicinal products, and
p.002017: clinical trial medicinal products provided with
p.002017: the necessary technical equipment, in accordance with the requirements of the ordinance under Art. 198.
p.002017: Art. 162. (1) In order to obtain an import permit, the person under Art. 161, para. 1 submits to the BDA
p.002017: an application in accordance with a model approved by the Executive Director of the Agency.
p.002017: (2) To the application under para. 1 shall apply:
p.002017: 1. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: Economic Space - Document for current registration under national law, issued by
p.002017: competent
p.002017: authority of the country concerned;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) list of the medicinal products
p.002017: products and forms to be imported;
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) a copy of the production permit,
p.002017: issued by the regulatory authority of the exporting country and a certificate attesting the conformity of
p.002017: conditions for production, control and storage with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 4. documents certifying the circumstances under Art. 159, para. 1 and 2 for
p.002017: the qualified person;
p.002017: 5. data on the address of a laboratory on the territory of the Republic of Bulgaria for performing full quantitative and
p.002017: qualitative analysis of at least the active substances and of all other tests and verifications for the demonstration of
p.002017: the quality of each imported batch of medicinal product in accordance with the requirements of the marketing authorization
p.002017: use in accordance with this law and the address of
p.002017: storage facilities;
p.002017: 6. a contract which defines the responsibilities of each party in respect of compliance with
p.002017: the principles of Good Manufacturing Practice by the contractor and the manner in which the qualified person under Art.
p.002017: 161, para. 2, item 1 shall perform its duties in the cases,
p.002017: when the person under Art. 161, para. 1 does not have its own laboratory;
p.002017: 7. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 71/2008, effective 12.08.2008) Upon receipt of an application under para. 1 BDA evaluates the submitted
p.002017: documentation and perform on - site verification of the laboratory for
p.002017: control and storage facilities for medicinal products and medicinal products intended for use
p.002017: a clinical trial to determine their compliance with the requirements of
p.002017: Good manufacturing practice and Good distribution practice.
p.002017: (4) (Renumbered from Paragraph (3), SG No. 71/2008, effective 12.08.2008) Where manufacturing premises are located
p.002017: in a third country with which the European Community has signed an agreement on the mutual recognition of certificates of Good
p.002017: production practice, the persons under art. 161, para. 1 shall attach to the application the address of each premises for
p.002017: manufacture of medicinal products, active substances or medicinal products intended for clinical trial,
p.002017: name, registered office and management address of the person who has received the manufacturing authorization, certificate,
p.002017: certifying compliance of the production, control and storage conditions with standards equivalent to
p.002017: standards approved by the requirements of the Good
p.002017: manufacturing practice, and the name of the qualified person.
p.002017: (5) (Renumbered from Paragraph (4), amend. - SG 71/08, in force from 12.08.2008) In cases other than
...

p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
p.002017: Art. 197. The persons under art. 195 must have:
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
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p.002017: for special medical purposes and infant formulas and follow-on formulas, and nutritional supplements, cosmetic and
p.002017: sanitary and hygienic
p.002017: funds.
p.002017: Art. 226. (1) On the territory of medical establishments for outpatient care may be
p.002017: open pharmacies to sell medicinal products to citizens.
p.002017: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, curative
p.002017: establishments for hospital care and medical establishments under art. 10 of the Law on medical establishments does not
p.002017: pharmacies can be opened to sell medicinal products to citizens.
p.002017: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009)
p.002017: The requirements for the location and the premises of the pharmacy are laid down in the ordinance of
p.002017: Art. 219, para. 2.
p.002017: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in
p.002017: (requirements from 05.08.2011) Requirements to the device and premises of pharmacies under Art. 228, para.
p.002017: 5 shall be determined in the ordinance under para. 1.
p.002017: Art. 228. (amend. - SG 71/08, in force from 26.07.2008) (1) (amend. - SG 60/11, in force from 26.07.2008)
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002017: director of the BDA on the basis of a model application to
p.002017: applicable:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a country Party
p.002017: Agreement on the European Economic Area - Document for the up - to - date registration of the European Economic Area
p.002017: national legislation issued by the competent authority of the relevant
p.002017: the state of the persons under art. 222, para. 1;
p.002017: 2. employment contract or contract for management of the pharmacy, concluded with the master pharmacist
p.002017: or with a pharmacist assistant;
p.002017: 3. a copy of the act for the creation of the persons under Art. 222, para. 4;
p.002017: 4. documents certifying that the requirements of Art. 224 Hours;
p.002017: 5. (suppl. - SG 103/07, in force from 01.01.2018) criminal record of
p.002017: Master of Pharmacy, respectively of the Assistant Pharmacist appointed as Head of Pharmacy,
p.002017: if they are not Bulgarian citizens;
p.002017: 6. medical certificate of the Master of Pharmacy, respectively
p.002017: assistant pharmacist appointed as pharmacy manager;
p.002017: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002017: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued
p.002017: from the relevant RI;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002017: medicinal products are checked to see if the diploma of the master pharmacist / assistant pharmacist is presented
p.002017: issued by the relevant competent authority
p.002017: institution.
p.002017: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies under Art.
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p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
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p.002017: (3) The orders under para. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 272a. (New, SG No. 102/2012, effective 02.01.2013) (1) By delegated acts under Art. 52b, paragraph
p.002017: 2 of Directive 2001/83 / EC lays down the necessary measures to prevent the placing on the market of
p.002017: medicinal products introduced into the European Union but not intended to be placed on the market in the European Union,
p.002017: for which there is enough
p.002017: grounds for suspecting that they have been falsified.
p.002017: (2) The Executive Agency for Medicinal Products shall take the necessary measures in accordance with the delegated ones
p.002017: acts under para. 1 to prevent the release of medicinal products introduced into the European Union
p.002017: union but not intended to be marketed
p.002017: of the European Union for which there are sufficient grounds for suspecting that they have been falsified.
p.002017: (3) The customs authorities shall notify the BDA of the introduction into the territory of the Republic
p.002017: Bulgaria of medicinal products under para. 1 with a view to taking measures under para. 2.
p.002017: Art. 273. (1) The conditions and the procedure for sampling, testing and
p.002017: their remuneration shall be determined in an ordinance of the Minister of Health.
p.002017: (2) When challenging the results of laboratory tests, they shall be made
p.002017: retesting. They shall be made upon written request from the interested party,
p.002017: made within 7 days from the date of receipt of the result of the original test.
p.002017: (3) The repeated tests under para. 2 shall be carried out by experts designated by
p.002017: the BDA's Executive Director, who did not participate in the initial test, c
p.002017: the presence of an authorized representative of the interested party.
p.002017: Art. 274. (1) The conditions and the order for blocking and withdrawal of medicinal products,
p.002017: have shown non - compliance with the requirements for quality, safety and efficacy, shall be defined in
p.002017: ordinance of the Minister of Health.
p.002017: (2) The conditions and procedure for the destruction, processing or use for others
p.002017: the goals of the medicinal products are set out in an ordinance of the Minister of Health.
p.002017: Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure proper validation of
p.002017: the processes of production and purification of medicinal products derived from human blood or human plasma,
p.002017: consistency in batch quality and ensuring, as far as technology allows, the absence of
p.002017: specific viral
p.002017: contamination.
p.002017: (2) Manufacturers shall notify the BDA of the method used to reduce or
p.002017: removal of pathogenic viruses that can be transmitted through medicinal products,
p.002017: obtained from human blood or human plasma.
p.002017: (3) The Drug Enforcement Agency shall test or send for testing to another
p.002017: official laboratory for control of medicinal products in the Republic of Bulgaria or in another
p.002017: Member State samples of the bulk / non - spilled product and / or test product or
p.002017: in the course of evaluating an application for marketing authorization under Art. 46, para. 1, item 2 or after issue
p.002017: of the marketing authorization.
p.002017: Art. 276. The Executive Director of the BDA shall, by order, suspend, revoke,
p.002017: suspend or change the marketing authorization / registration,
p.002017: when it is established that:
p.002017: 1. there is an unacceptable side effect when used properly, or
p.002017: 2. lack of therapeutic efficacy (therapeutic efficacy is lacking when
...

p.002017: active substance are considered to be the same active substance, unless they differ significantly in their nature
p.002017: safety and / or efficiency.
p.002017: 10. "Principal Investigator" is the doctor or dentist appointed by the contracting authority, who direct
p.002017: the overall conduct of the clinical trial in accordance with the approved protocol and the Good Guideline
p.002017: clinical practice and responsible for the work of
p.002017: the researchers.
p.002017: 11. "Defined daily dose" is an average daily maintenance dose of a drug
p.002017: product for use in adults according to the primary indication of the medicinal product.
p.002017: 12. "Good clinical practice" is the set of internationally recognized ethical and
p.002017: scientific quality requirements to be met when planning, conducting, reporting and
p.002017: reporting of clinical trials.
p.002017: 13. "Good laboratory practice" is a system of internationally recognized rules
p.002017: in terms of planning conditions, processes of organizing, executing, tracking and
p.002017: documentation of laboratory tests.
p.002017: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers all
p.002017: production sides - personnel, premises, facilities, materials, documentation, quality control, and aims
p.002017: to ensure safety, efficiency and
p.002017: according to the specification.
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
p.002017: establish a state of immunity or induce passive immunity. Allergens are medicinal products that are
p.002017: intended to identify or stimulate a specific targeted change in the immunological response
p.002017: to an allergic agent.
p.002017: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002017: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative, and
p.002017: when their bioavailability after application in the same
p.002017: the molar dose is similar to a degree which is a condition of equivalent efficacy and safety.
p.002017: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and extent of
p.002017: in which the active substance or the therapeutically significant portion of the test drug reaches
p.002017: from the dosage form to the systemic
p.002017: blood circulation.
p.002017: 20. "Tested medicinal product" means the dosage form of the active substance or placebo to be tested
p.002017: or used as a comparison in a clinical trial, including authorized products
p.002017: for use, but are used for unauthorized use or for the purpose of obtaining additional information on
p.002017: the authorized form, or they are
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p.002017: diseases "is a product that:
p.002017: (a) is intended for the diagnosis, prophylaxis or treatment of life-threatening diseases
p.002017: diseases or progressive chronic diseases affecting no more than 5 in 10
p.002017: 000 people on the territory of the country, or
p.002017: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002017: health-damaging chronic conditions (diseases with a high incidence of incapacity for work and
p.002017: disability) and evidence was provided that the sale of the product did not provide a satisfactory one
p.002017: returns to justify the investment needed for R&D without
p.002017: incentives for
p.002017: the creator of the product, and
p.002017: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of
p.002017: the condition, or if there is one, the proposed medicinal product
p.002017: far more benefits than that and benefits for those affected by this condition.
p.002017: 30. A "dosage form" is an acceptable accepting structure containing the active substance (s) which
p.002017: may or may not include excipients obtained by the application of certain technological
p.002017: operations providing the desired healing effect and
p.002017: storage stability over the shelf life.
p.002017: 31. (amend. - SG 71/08, in force from 12.08.2008) "Person established in the territory of a Member State"
p.002017: is a legal entity registered under the civil or commercial law of a Member State or
p.002017: created by a legal act having its registered office and registered office in a Member State or in a State -
p.002017: Party to the Agreement on
p.002017: The European Economic Area.
p.002017: 32. "Highway formulation" is a prescription for a medicinal product made in a pharmacy under
p.002017: prescription from a healthcare professional or an approved prescription for a particular patient.
p.002017: 33. "International non-patent name" is the recommended name of
p.002017: the active substance approved and published by the WHO.
p.002017: 34. "Medical specialists" are doctors, doctors of dental medicine,
p.002017: master pharmacists, nurses, midwives, medical assistants, paramedics, and
p.002017: assistant pharmacist.
p.002017: 35. "Medical sales representative" is a person who has undergone special training and
p.002017: having the scientific knowledge to provide accurate and complete information on
p.002017: the medicinal product it advertises.
p.002017: 35a. (new - SG 1/2014, in force from 03.01.2014) "Medical prescription" is a prescription of
p.002017: medicinal product or medical device issued by a person practicing regulated medical
p.002017: profession within the meaning of § 1, item 1 of the additional provisions of the Law on the recognition of
p.002017: professional qualifications and what is legal
p.002017: the right to do so in the Member State where the medical prescription is issued.
p.002017: 36. "Multicenter Clinical Trial" is a clinical trial conducted under
p.002017: one protocol but in more than one center and more than one researcher. The research
p.002017: centers may be located in the territory of one Member State in more than one
p.002017: Member State and / or Member States and third countries.
p.002017: 37. "Name of a medicinal product" is the name given to the product which may
p.002017: be:
p.002017: a) freely chosen name (trade name);
p.002017: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the commercial
...

p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
...

p.002017: re-registration, to which shall apply:
p.002017: 1. application for authorization of retail trade of medicinal products from
p.002017: the persons under art. 222, para. 1, according to the model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration of the person under art. 222, para. 1;
p.002017: 3. a copy of the issued in accordance with the repealed Law on Medicines and Pharmacies in
p.002017: human medicine permit to open a pharmacy;
p.002017: 4. a certified copy of the employment contract or contract for management assignment
p.002017: the pharmacy manager - in cases where such is required;
p.002017: 5. declaration by the persons under art. 222, para. 1 that the conditions under which it was issued are preserved
p.002017: the permit for retail sale of medicinal products of the persons under para. 2;
p.002017: 6. document for a one-time fee of BGN 100
p.002017: § 67. Persons who have submitted prior to the entry into force of this Law applications for re-registration under
p.002017: the order of repeal of § 16 of the transitional and final provisions which will carry on their business
p.002017: according to the requirements of this law, submit to the Ministry of
p.002017: within three months of its entry into force, the following documents:
p.002017: 1. an application in accordance with a model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration or certified copy of a similar document under national law
p.002017: of a Member State of the European Union, or under the law of another State Party
p.002017: of the Agreement on the European Economic Area, Art. 222, para. 1;
p.002017: 3. employment contract or contract for the management of the pharmacy concluded with the master pharmacist
p.002017: or pharmacist assistant.
p.002017: § 68. (1) Master-pharmacist or assistant-pharmacist who has been authorized for
p.002017: opening a pharmacy under the repealed § 16 of the transitional and final provisions,
p.002017: may transfer his issued permit to a person under Art. 222, para. 1.
p.002017: (2) For carrying out the transfer the persons under para. 1 filed with the Ministry of
p.002017: healthcare application to which attach:
p.002017: 1. application for authorization of retail trade of medicinal products from
p.002017: the persons under art. 222, para. 1, according to the model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration of the person under art. 222, para. 1;
p.002017: 3. a copy of the issued in accordance with the repealed Law on Medicines and Pharmacies in
p.002017: human medicine permit to open a pharmacy or permit to re - register under
p.002017: the procedure for repealing § 16 of the transitional and final provisions;
p.002017: 4. a certified copy of the employment contract or management contract of the head of
p.002017: pharmacy;
p.002017: 5. declaration by the persons under art. 222, para. 1 that the conditions under which it was issued are preserved
p.002017: the permit for retail sale of medicinal products of the persons under para. 1.
p.002017: (3) The transfer under para. 1 may be completed within one year of its entry into force
p.002017: of this law.
p.002017: § 69. The drugstores welded upon the entry into force of this Act shall continue to be
p.002017: carry out their activities on the basis of the issued certificates of registration.
...

Political / vulnerable

Searching for indicator vulnerable:

(return to top)
p.002017: (5) The consent of the minor, the parents or the guardian may be
p.002017: withdrawn at any time without negative consequences for the minor.
p.002017: (6) The express wish of the minor to withdraw at any time from
p.002017: the clinical trial must be considered by the investigator and, if necessary, by the
p.002017: the principal investigator.
p.002017: (7) The information of the test is provided to the minor or minor,
p.002017: about the potential risks and benefits of a physician who has experience with it in an understandable way
p.002017: minors.
p.002017: Art. 98. Informed consent to participate in a clinical trial is not required if
p.002017: imposes an immediate decision to save the person's life, and if at that moment that consent
p.002017: could not be received. The decision is made by at least two doctors who do not participate in
p.002017: the research team.
p.002017: Art. 99. (1) During the test the participant receives an additional upon request
p.002017: information from an independent entity.
p.002017: (2) The written information provided to the participants in the clinical trial of
p.002017: medicinal product, contains contact details of the independent person for additional
p.002017: information.
p.002017: Section II.
p.002017: A clinical trial with vulnerable patient groups
p.002017: Art. 100. A clinical trial of minors may be
p.002017: undertake, provided that:
p.002017: 1. the protocol is approved by the relevant ethics committee after discussion of the clinical,
p.002017: moral and psychosocial aspects of childhood, in which they participated no less than
p.002017: two pediatricians;
p.002017: 2. there is an expected direct benefit of the clinical trial for the group of patients who will
p.002017: be included;
p.002017: 3. the test is directly related to the clinical condition of the minor
p.002017: or the minor;
p.002017: 4. the investigational medicinal product is intended for diagnosis, treatment or
p.002017: prevention of diseases specific to minors;
p.002017: 5. the test is intended to be conducted on minors or minors;
p.002017: 6. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or data obtained through others
p.002017: research methods;
p.002017: 7. the results of clinical trials on adults and their results
p.002017: interpretations cannot be considered valid for both minors and minors;
p.002017: 8. the test is designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: defined in advance and are constantly monitored by
p.002017: test time;
p.002017: 9. the study is planned and is conducted in accordance with the guidelines of
p.002017: The European Medicines Agency;
p.002017: 10. no financial or other incentives are given except compensation.
...

p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
...

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.002017: measures;
p.002017: 10a. (new, SG No. 102/2012, effective 21.12.2012) shall exercise the functions of
p.002017: a competent body for pharmacovigilance monitoring;
p.002017: 11. (amend. - SG 102/2012, in force from 21.12.2012) organize and maintain a system
p.002017: for pharmacovigilance monitoring;
p.002017: 12. issue certificates under the WHO certification scheme;
p.002017: 12a. (new, SG No. 18/2014) issue certificates of Good Distribution Practice;
p.002017: 13. issue certificates of Good Manufacturing Practice;
p.002017: 14. (amend. - SG 18/04) consult the investment projects for construction of
p.002017: new and / or redevelopment of existing facilities related to the manufacture of medicinal products
p.002017: products in accordance with the rules of Good Manufacturing Practice;
p.002017: 15. performs the functions of coordinator and advisory body on problems,
p.002017: related to the quality, efficacy and safety of medicinal products;
p.002017: 16. performs consulting, scientific, information and publishing activities in the field
p.002017: the medicines sector;
p.002017: 17. coordinates and participates in activities related to the European Pharmacopoeia and to the
p.002017: the development of the Bulgarian Pharmacopoeia;
p.002017: 18. participate in activities in the field of medicinal products related to the work of the European Agency
p.002017: on Medicines, European Directorate for Quality of Medicines and Health, international
p.002017: bodies and organizations as well as with the implementation of
p.002017: international treaties to which the Republic of Bulgaria is a party;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) participates in the international
p.002017: harmonization and standardization of technical measures related to traceability
p.002017: drug safety, coordinated by the European Medicines Agency;
p.002017: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain
p.002017: national internet portal for medicinal products;
p.002017: 19. performs other activities specified by law.
p.002017: (6) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: medicines coordinates its activities with regional health inspections (RICs) in the area of
p.002017: control of medicinal products.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under
p.002017: this law related to preventing the entry and distribution of counterfeit
p.002017: medicinal products, is carried out in cooperation between the BDA and the customs authorities.
p.002017: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health
p.002017: inspections issue certificates for registration of drugstores.
p.002017: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002017: retail of medicinal products, which includes three representatives of the Bulgarian
p.002017: pharmaceutical union, one representative of the faculties of pharmacy of the medical colleges and
p.002017: four BDA representatives. The composition of the Board is determined by an order of the Executive Director of the BDA,
p.002017: agreed with the Minister of
p.002017: healthcare.
p.002017: (2) The council under para. 1 is an advisory unit which:
p.002017: 1. prepares opinions on the applications and documents submitted to the BDA under Art. 228, para. 1 and 5,
p.002017: which he presents to the Executive Director of the BDA;
p.002017: 2. make motivated proposals to the Minister of Health through
p.002017: the BDA's Executive Director for improving public access to medicines
...

p.002017: sole proprietors manufacturing, importing, wholesale or retail trade with
p.002017: medical products;
p.002017: 2. partners or shareholders holding more than 5 percent of the capital in commercial
p.002017: companies active in the manufacture, import, wholesale or retail of medicinal products
p.002017: products or work under contract with those companies.
p.002017: Section II.
p.002017: Registers
p.002017: Art. 18. (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 19. (1) The Executive Agency for Medicines shall keep and keep registers of:
p.002017: 1. (amended, SG No. 102/2012, effective 21.12.2012) Manufacturers and importers
p.002017: of medicinal products on the territory of the Republic of Bulgaria and the qualified persons under
p.002017: Art. 148, item 2 and under Art. 161, para. 2, Vol. 1;
p.002017: 2. (amend. - SG 102/02, in force from 21.12.2012) the manufacturers, importers and
p.002017: wholesalers of active substances;
p.002017: 3. the authorized and registered medicinal products on the territory of
p.002017: Republic of Bulgaria;
p.002017: 4. wholesalers of medicinal products on the territory of the Republic of Bulgaria;
p.002017: 4a. (new, SG No. 102/2012, effective 21.12.2012) intermediaries in the field of
p.002017: medicinal products;
p.002017: 5. (amend. - SG 60/11, in force from 05.08.2011) the issued permits for
p.002017: retailing of medicinal products;
p.002017: 6. approved clinical trials;
p.002017: 7. the licenses issued for parallel import;
p.002017: 8. (New, SG No. 18/2014) the notifications on export of medicinal products in the order
p.002017: to Chapter Nine "b".
p.002017: (2) The data from the registers under para. 1, items 1-5 and 7 shall be published within 14 days of issue
p.002017: of the relevant permission on the BDA website on the Internet.
p.002017: (3) The Drug Enforcement Agency maintains electronic exchange systems for
p.002017: data with the regulatory authorities of other Member States, the European Commission and the European Commission
p.002017: drug agency.
p.002017: Art. 19a. (New, SG No. 60/2011, effective 05.08.2011) (1) The respective SICs shall also keep
p.002017: maintain public registers for the drugstore registration certificates they have issued.
p.002017: (2) Within 7 days from the issuance of a certificate for registration of a drugstore
p.002017: the respective RII sends to the Ministry of Health information on the issued act.
p.002017: (3) The Ministry of Health shall maintain and maintain on its website
p.002017: public national register of drugstore registration certificates issued.
p.002017: Section III.
p.002017: Financing
p.002017: Art. 20. (1) The activities of the BDA shall be financed by budgetary funds and revenues from
p.002017: own business.
p.002017: (2) (amend. - SG 15/2013, in force from 01.01.2014) The budgetary funds shall be
p.002017: provide a subsidy from the state budget through the budget of the Ministry of Finance
p.002017: healthcare.
p.002017: Art. 21. (1) The Executive Agency for Medicines shall be the revenue administrator of
p.002017: own activity, which are formed by:
p.002017: 1. chemical-pharmaceutical expertise;
p.002017: 2. laboratory analyzes and tests;
p.002017: 3. evaluation of documentation and issuance of permits, certificates, certificates and
p.002017: other documents specified in this law;
p.002017: 4. evaluation of the renewal, modification and deletion of the marketing authorization, and
p.002017: certificate of registration of a medicinal product;
p.002017: 5. maintenance of the marketing authorizations or the registration certificates of
p.002017: medicine;
p.002017: 6. fines and pecuniary sanctions imposed by criminal decrees issued for
p.002017: violations under this law;
p.002017: 7. consulting, publishing and research activities in the field of
p.002017: the medical sector;
...

p.002017: conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
p.002017: compliance with the principles and guidelines for Good
p.002017: manufacturing practice; the declaration shall indicate the date on which the audit was carried out;
p.002017: 9. an assessment of the potential risk of the medicinal product to the environment for everyone
p.002017: the individual case and the measures envisaged to limit it;
p.002017: 10. results from:
p.002017: (a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.002017: (b) preclinical (toxicological and pharmacological) studies;
p.002017: (c) clinical trials;
p.002017: 11. a statement that in clinical trials conducted outside the territory of
p.002017: Member States have complied with the ethical principles of Good Clinical Practice;
p.002017: 12. (amended, SG No. 102/2012, effective 21.12.2012) summary of the system for
p.002017: pharmacovigilance monitoring, which includes the following elements:
p.002017: a) the name of the qualified person under Art. 191, curriculum vitae - education acquired
p.002017: professional experience in the field of pharmacovigilance monitoring and qualification for
p.002017: fulfillment of his duties in accordance with Chapter Eight;
p.002017: (b) any Member State in which the qualified person fulfills the obligations
p.002017: his;
p.002017: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002017: (d) the address at which the primary document of the traceability system is stored
p.002017: drug safety;
p.002017: 12a. (new - SG 102/2012, in force since 21.12.2012) statement by the applicant that
p.002017: has the necessary means to fulfill the obligations of Chapter Eight;
p.002017: 13. (Amended, SG No. 102/2012, effective 21.12.2012) risk management plan with
p.002017: a description of the risk management system that the applicant will put in place for that person
p.002017: medicinal product, together with a summary of the plan;
p.002017: 14. a brief description of the product according to Art. 34;
p.002017: 15. layout of the primary and secondary packaging of the product and a leaflet in
p.002017: compliance with the requirements of Chapter Six;
p.002017: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country where
p.002017: production shall be carried out accompanied by a certificate of good manufacturing practice or
p.002017: certificate certifying that the manufacture of the medicinal product and of the active substances included in
p.002017: its composition was done in accordance with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 17. a copy of the document identifying the medicinal product for treatment,
p.002017: prevention or diagnosis of rare diseases, accompanied by a copy of the opinion of
p.002017: The European Medicines Agency;
p.002017: 18. copies of any marketing authorization issued in another Member State or in
p.002017: a third country for the medicinal product for which a marketing authorization is sought;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) copy of the summary of the safety data, including
...

p.002017: a medicinal product containing active substances of well - established use that has not been used in
p.002017: the proposed combination for therapeutic purposes. In this
p.002017: no documentation is submitted in respect of each individual active substance.
p.002017: (3) When an active substance within the meaning of para. 1 has a proven new therapeutic indication on the base
p.002017: significant preclinical or clinical data related to the new indication, once for a period of
p.002017: one year the next applicant cannot rely on
p.002017: data on the new indication of the active substance.
p.002017: Art. 31. In the case where a medicinal product contains active substances used in the authorized composition
p.002017: for use medicinal products but not used in the proposed combination for therapeutic purposes, the person
p.002017: under Art. 26, para. 1 presents the results of preclinical and clinical trials related to
p.002017: this combination. In this case, the applicant does not provide documentation on the safety and efficacy of each
p.002017: separately
p.002017: active substance.
p.002017: Art. 32. The holder of an authorization to use a medicinal product may authorize the use of the pharmaceutical,
p.002017: the preclinical and clinical documentation contained in the dossier of the medicinal product when evaluating
p.002017: subsequent drug applications
p.002017: products of the same qualitative and quantitative composition as regards the active substances and with
p.002017: same dosage form.
p.002017: Art. 33. Conducting the necessary studies and tests to prepare authorization documentation
p.002017: for use and subsequent practical requirements for the authorization of medicinal products under
p.002017: Art. 28 and 29 is not a patent infringement
p.002017: or the supplementary protection certificate for a medicinal product.
p.002017: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002017: 1. name of the medicinal product, quantity of active substance for dosage
p.002017: unit, dosage form;
p.002017: 2. quantitative and qualitative composition in respect of the active substances and those of
p.002017: excipients for which information is essential for the proper application of
p.002017: product; the common name or chemical description is used;
p.002017: 3. dosage form;
p.002017: 4. clinical data:
p.002017: (a) therapeutic indications;
p.002017: (b) dosage and route of administration for adults and children;
p.002017: c) contraindications;
p.002017: (d) special warnings and precautions for use; for immunological
p.002017: medicinal products - precautions for persons handling and administering them
p.002017: patients, as well as the precautions to be taken by the patient;
p.002017: (e) interactions with other medicinal products or other forms of interaction;
p.002017: (f) use in pregnancy or lactation;
p.002017: (g) effects on the ability to drive and use machines;
p.002017: h) side effects;
...

p.002017: use;
p.002017: 10. date on which the content of the summary of the Summary of Product Characteristics was made
p.002017: product;
p.002017: 11. for radiopharmaceuticals - comprehensive information on internal radiation
p.002017: dosimetry;
p.002017: 12. for radiopharmaceuticals - detailed instructions for extemporaneous preparation and quality control and, where applicable
p.002017: applicable, the maximum storage time during which the relevant intermediate such as eluate or ready
p.002017: for pharmacist use corresponds to
p.002017: its specification.
p.002017: (2) In the summary of the medicinal products under Art. 28 - 33 parts of the short may not be included
p.002017: a characteristic of the reference medicinal product relating to the indications and dosage forms that have been
p.002017: under patent protection at a time when
p.002017: the generic product was on the market.
p.002017: (3) Requirements for the form and content of the summary of product characteristics
p.002017: shall be determined in the ordinance under Art. 42.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) The summary of the characteristics of medicinal products,
p.002017: included in the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains
p.002017: information with the following text: "This medicinal product is subject to additional monitoring". In front of the text
p.002017: signs in black color according to Art. 23 (5) of Regulation (EC) No 726/2004 of the European Parliament and
p.002017: The Council,
p.002017: accompanied by an explanatory note.
p.002017: (5) (New, SG No. 102/2012, effective 21.12.2012) The summary of product characteristics
p.002017: contains standard text that encourages medical professionals to report any suspected adverse drug reactions
p.002017: reaction according to the models of art. 185, para.
p.002017: 2, Vol. 4.
p.002017: Section III.
p.002017: Specific requirements for homeopathic medicinal products
p.002017: Art. 35. (1) A certificate for registration of a homeopathic medicinal product shall be issued
p.002017: by a simplified procedure if it fulfills the following conditions:
p.002017: 1. is administered orally or externally;
p.002017: 2. they are not indicated on its packaging or in other information related to it
p.002017: specific therapeutic indications;
p.002017: 3. it is diluted sufficiently to guarantee the safety of the product and contains no more than one
p.002017: ten thousandth of the mother's tincture or more than one hundredth of the smallest dose used in
p.002017: allopathy, of the active substances whose presence in
p.002017: allopathic medicinal product leads to mandatory medical prescription.
p.002017: (2) For the issuance of a certificate for registration of a homeopathic medicinal product the person under Art. 26, para.
p.002017: 1 shall submit to the BDA an application in a form in which a series of medicinal products may be indicated,
p.002017: obtained from the same homeopathic source or from the same
p.002017: same sources.
p.002017: (3) To demonstrate the pharmaceutical quality and homogeneity of batches of medicinal products
p.002017: product to the application under para. 2, the following documentation shall be attached:
p.002017: 1. (amend. - SG 71/08, in force from 12.08.2008) scientific name or
p.002017: pharmacopoeial name of the homeopathic source or sources together with the various
p.002017: routes of administration, dosage forms and degree of dilution;
p.002017: 2. a file describing the method of obtaining and controlling the homeopathic
p.002017: source or sources proving homeopathic use based on appropriate
p.002017: bibliography;
...

p.002017: manufacturer to carry out certain stages of production or control
p.002017: of the medicinal product.
p.002017: (2) When the BDA carries out an on-site inspection of a production site, the term under Art. 44
p.002017: stops running until a report of the results of the audit is drawn up.
p.002017: (3) In the cases of para. 1, items 2 and 3 the manufacturers shall pay a fee in the amount specified in
p.002017: the tariff under Art. 21, para. 2.
p.002017: Art. 47. (1) To the Executive Director of the BDA as consultative bodies shall be established
p.002017: the following specialized committees:
p.002017: 1. Committee for Medicinal Products;
p.002017: 2. Committee on Immunological Medicinal Products;
p.002017: 3. Committee for Homeopathic Medicinal Products;
p.002017: 4. Committee for Herbal Medicinal Products;
p.002017: 5. Radiopharmaceuticals Commission;
p.002017: 6. (new - SG 71/08, in force from 12.08.2008) Committee for Medicinal Products
p.002017: with application in pediatrics;
p.002017: 7. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force
p.002017: from 21.12.2012) Committee for Medicinal Products for Advanced Therapies;
p.002017: 8. (New, SG No. 102/2012, in force since 21.12.2012)
p.002017: pharmacovigilance monitoring.
p.002017: (2) If necessary, the BDA Executive Director may create others
p.002017: specialized committees outside the ones specified in para. 1.
p.002017: (3) Specialized commissions shall include specialists having scientific
p.002017: achievements and practical experience in the relevant fields of application of medicinal products.
p.002017: (4) External experts with a special status may be involved in the permanent composition of the commissions
p.002017: scientific knowledge and practical experience in the field of the specific drug group.
p.002017: (5) The Executive Director of the BDA shall determine by an order the composition of the commissions for a term
p.002017: three years, the amount of their remuneration and approve the terms and conditions of the
p.002017: their work.
p.002017: (6) By 30 January each year, the Executive Director of the BDA shall approve the lists of
p.002017: the experts outside the composition of the commissions under para. 1 after approval by the Minister of
p.002017: healthcare.
p.002017: (7) The BDA Executive Director may release a member of the BDA early
p.002017: specialized committee at his request for failure to fulfill his obligations for more than three
p.002017: months or in bad faith in the performance of its functions.
p.002017: (8) The composition of the commissions and the list of experts under para. 6 are announced on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 48. (1) The members of the specialized commissions under Art. 47, para. 1 and the experts under Art.
p.002017: 47, para. 4 sign a declaration, obliging them not to:
p.002017: 1. disclose data and circumstances that have become known to them on or on occasion
p.002017: carrying out their activity;
p.002017: 2. participate in activities related to the production or wholesale and retail trade with
p.002017: medical products.
p.002017: (2) In case the persons under para. 1 have participated in one of the preparation stages of
p.002017: the documentation necessary to authorize the use of the medicinal product cannot be provided
p.002017: participate in the meetings of the respective specialized commission under art. 47.
p.002017: (3) The persons under para. 1 shall not vote in decisions on matters on which they or
p.002017: their family members have commercial, financial or other interests.
...

p.002017: of the BDA issues the authorization for renewal of the marketing authorization / certificate for
p.002017: registration of the medicinal product or motivated refusal.
p.002017: Art. 59b. (New, SG No. 71/2008, effective 12.08.2008) (1) The Executive Director of the BDA
p.002017: refuses to renew the Marketing Authorization / Marketing Authorization
p.002017: product when, after evaluation of the dossier under Art. 59a, para. 1 se
p.002017: found that:
p.002017: 1. the medicinal product is harmful when used correctly, or
p.002017: 2. lack of therapeutic efficacy, or
p.002017: 3. the benefit / risk balance is unfavorable when used correctly, or
p.002017: 4. the quantitative and qualitative composition of the medicinal product does not correspond to
p.002017: descriptions in the file, or
p.002017: 5. the data in the file under art. 59a, para. 1 are incorrect, or
p.002017: 6. the control of the medicinal product and / or of the ingredients and the intermediate stages of
p.002017: the manufacturing process has not been performed or no other requirement is fulfilled, where it is
p.002017: the production authorization has been issued, or
p.002017: 7. some of the data in the file do not meet the requirements of Art. 59a, para. 1 and 2.
p.002017: (2) Refusal of the Executive Director of the BDA to renew the authorization for
p.002017: use / registration certificate of a medicinal product may be appealed in the order of
p.002017: Code of Administrative Procedure.
p.002017: (3) The refusal of the BDA Executive Director and the reasons shall be published on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 59c. (New, SG No. 60/2011, effective 05.08.2011, amended - SG No. 102/2012, effective 01.04.2013
p.002017: d.) The Drugs Executive Agency notifies the National Drug Price and Reimbursement Council
p.002017: products for the revoked and revoked marketing authorizations, as well as for the refusals to renew
p.002017: authorizations granted for
p.002017: medicinal products within 7 days of the issuance of the relevant act.
p.002017: Section VI.
p.002017: Changes to the marketing authorization issued
p.002017: Art. 60. (1) (amend. - SG 12/11, in force from 08.02.2011)
p.002017: a marketing authorization is obliged to notify the BDA of any change to
p.002017: the conditions under which the authorization was granted.
p.002017: (2) (Amended, SG No. 12/2011, effective 08.02.2011) Changes may be of the type
p.002017: IA, Type IB, Type II, Extension of Marketing Authorization and Emergency Restrictions
p.002017: safety measures.
p.002017: (3) (amend. - SG 12/11, in force from 08.02.2011) The conditions and criteria for
p.002017: classification of the changes shall be determined by the ordinance under Art. 42.
p.002017: (4) (amend. - SG 12/11, in force from 08.02.2011) Change that does not occur
p.002017: extension and whose classification remains uncertain after the conditions have been applied
p.002017: and the criteria of the ordinance under Art. 42, is considered to be a type IB change by default.
p.002017: (5) (New, SG No. 12/2011, effective 08.02.2011) As an exception to para. 4
p.002017: a change that is not an extension of scope and whose classification remains uncertain
p.002017: after applying the conditions and criteria of the ordinance under Art. 42, is considered to be a type II change
p.002017: the following cases:
p.002017: 1. at the request of the holder of the marketing authorization indicated in the application for
p.002017: change;
p.002017: 2. when the BDA after evaluating the validity of the notification under Art. 63 considered that
p.002017: change can have a significant impact on quality, safety or
...

p.002017: product and leaflet for the patient;
p.002017: 6. (New, SG No. 18/2014) inform the BDA of any action taken by it concerning temporary suspension
p.002017: placing on the market of a particular medicinal product, withdrawal from the market of a specific medicinal product, request for
p.002017: termination of the marketing authorization or the stated intention not to renew the marketing authorization,
p.002017: and indicate the reasons why this action was taken; in these cases the holder
p.002017: of the marketing authorization declares whether the actions taken by him are due to any of the
p.002017: the grounds under Art. 276 or under Art. 277;
p.002017: 7. (New, SG No. 18/2014) inform the BDA if the actions under item 6 have been undertaken in
p.002017: third country and are due to any of the grounds under art. 276 or under Art. 277;
p.002017: 8. (new, SG No. 18/2014) inform the European Medicines Agency when
p.002017: the actions under items 6 and 7 have been undertaken on the basis of Art. 276 and 277;
p.002017: 9. (new, SG No. 18/2014) provide sufficient quantities of the medicinal product
p.002017: product for satisfying the health needs of the population of the Republic of Bulgaria.
p.002017: (2) The holder of the marketing authorization / registration certificate is obliged
p.002017: upon request from the BDA to submit:
p.002017: 1. data in support of the positive benefit / risk ratio for the medicinal product;
p.002017: 2. (amend. - SG 18/04) data on the volume of sales of the medicinal product and
p.002017: any other information available to the marketing authorization holder,
p.002017: on the volume of prescriptions for the product;
p.002017: 3. a copy of the basic documentation of the drug monitoring system
p.002017: safety.
p.002017: (3) The Marketing Authorization Holder shall provide the BDA with the documentation on
p.002017: para. 2, item 3 within 7 days after receiving the request.
p.002017: Art. 69. (1) The holder of the authorization for use of the vaccine or immunological
p.002017: medicinal product intended for immunization prior to the release of each batch of product
p.002017: on the market is obliged to present in the BDA:
p.002017: 1. a sample of the final product and / or a sample of the bulk product / non-spilled product;
p.002017: 2. production and quality control protocols;
p.002017: 3. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (2) The holder of the authorization for the use of new immunological medicinal products or immunological medicinal products
p.002017: medicinal products manufactured with new or modified technologies or with technologies new to the individual manufacturer,
p.002017: fulfills the obligations under para. 1 for
p.002017: the specific period specified in the Marketing Authorization.
p.002017: (3) Within 60 days from the date of submission of the complete set of BDA documents
p.002017: evaluates production protocols and quality control of live vaccines,
p.002017: immunological and new immunological medicinal products and testing of the provided samples in an accredited one
p.002017: laboratory to determine whether the medicinal products under para. 1 and 2 are
p.002017: manufactured in accordance with approved specifications.
p.002017: (4) Upon a positive result of the test, the BDA shall issue a certificate of release
p.002017: of the lot.
p.002017: (5) The conditions, procedure, and requirements for the documentation for the issuance of
p.002017: batch release certificate for the products under para. 1 and 2 shall be determined in an ordinance of
p.002017: the Minister of Health.
...

p.002017: people unable to give informed consent, in the cases under Art. 100 and 101;
p.002017: 8. the anticipated compensation or compensation in the event of injury or death, which
p.002017: may be the result of a clinical trial;
p.002017: 9. the insurance covering the liability of the researcher and the assignor;
p.002017: 10. where necessary, the terms and conditions for the remuneration or compensation of
p.002017: the researchers and the participants in the clinical trial and the elements of the contract between
p.002017: the client and the medical establishment;
p.002017: 11. the conditions and procedure for recruiting participants.
p.002017: (2) The Ethics Committee shall:
p.002017: 1. gives a favorable opinion;
p.002017: 2. motivated refuses, or
p.002017: 3. requires a change in some of the documentation as a condition for receiving a positive one
p.002017: position.
p.002017: Art. 112. (1) Within 60 days from the submission of an application, the relevant ethics committee shall
p.002017: delivers an opinion to the applicant and the BDA.
p.002017: (2) Where the clinical trial includes a gene therapy medicinal product or
p.002017: somatic cell therapy or a medicinal product containing genetically modified
p.002017: organisms, the term under para. 1 is extended to 30 days.
p.002017: (3) The deadline for issuing an opinion is 180 days, when for clinical examination
p.002017: a trial involving a gene therapy or somatic cell therapy drug
p.002017: or a medicinal product containing genetically modified organisms is required to be consulted
p.002017: expert commission specially created by order of the BDA Director.
p.002017: Art. 113. (1) When evaluating the documentation, the Ethics Committee may require
p.002017: one additional written documentation from the applicant. The time limits under Art. 112 stop yes
p.002017: run until the required documentation is submitted.
p.002017: (2) The procedure for examining the study shall be terminated if, within 60 days from
p.002017: receiving the request for additional information, the contracting authority did not submit the request by
p.002017: commission documentation.
p.002017: Art. 114. (1) When the test will be conducted in more than one center in the territory
p.002017: of the Republic of Bulgaria, an application shall be submitted to the Ethics Committee for Multicenter Tests
p.002017: under Art. 103, para. 1.
p.002017: (2) When the test will be conducted in only one center in the territory of the Republic
p.002017: Bulgaria, an application may be submitted to the relevant Ethics Committee under Art. 103, para. 1 or 2 on
p.002017: choice of the contracting authority.
p.002017: (3) The opinion of the Ethics Committee under Art. 103, para. 1 is valid for all centers of
p.002017: the territory of the Republic of Bulgaria.
p.002017: (4) (New - SG 12/2011, in force from 08.02.2011) For submission of applications for
...

p.002017: the clinical trial, at the latest 15 days after receipt of information on their occurrence.
p.002017: Art. 139. (1) The assignor may fulfill its obligations under Art. 138, para. 1 and 3, such
p.002017: submit reports to the European Adverse Reaction Database.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) When the clinical trial is conducted outside
p.002017: Member States, the contracting entity shall submit reports of suspected unexpected serious adverse reactions
p.002017: reactions in the European Adverse Reactions Database.
p.002017: (3) (Amended, SG No. 102/2012, effective 21.12.2012) The format and content of
p.002017: reports of adverse reactions are specified in the ordinance under Art. 82, para. 3.
p.002017: (4) The contracting authority shall inform the researchers conducting the clinical trial with
p.002017: medicinal product, for any suspected unexpected serious adverse reaction,
p.002017: related to the investigational medicinal product, regardless of its origin.
p.002017: Art. 140. (1) The contracting authority shall provide the BDA and the respective commission once a year
p.002017: ethics list of all suspected serious side effects that are
p.002017: occurred during the previous period, and a safety report of the test participants.
p.002017: (2) (Amended, SG No. 102/2012, effective 21.12.2012) The form and content of
p.002017: the report shall be specified in the ordinance under Art. 82, para. 3.
p.002017: Art. 141. (1) The Executive Agency for Medicines shall document each provided under
p.002017: the order of art. 138, para. 1 and 3 information on suspected unexpected serious adverse reactions
p.002017: drug reactions of tested medicinal products.
p.002017: (2) The executive medicine agency shall immediately enter the information under para. 1 c
p.002017: European database of adverse reactions.
p.002017: Section VIII.
p.002017: Notification of completion of clinical trial
p.002017: Art. 142. (1) The assignor shall notify in writing the BDA and the relevant ethics committee about
p.002017: the completion of the test on the territory of the Republic of Bulgaria.
p.002017: (2) The notification must be submitted within 90 days of the completion of the survey in a format,
p.002017: defined in the ordinance under art. 82, para. 3.
p.002017: (3) Unless otherwise stated in the protocol approved by the relevant Ethics Committee,
p.002017: completion of the test is considered the last visit of a participant.
p.002017: (4) When the test is terminated prematurely, the contracting authority shall notify the BDA and
p.002017: the relevant ethics committee, within 15 days of the decision, stating the reasons
p.002017: for that.
p.002017: Art. 143. The contracting authority shall submit to the BDA and to the relevant ethics committee
p.002017: final clinical trial report.
p.002017: Art. 144. (1) The Executive Agency for Medicinal Products shall enter data in the European Clinical Trials Database
p.002017: for each clinical trial in the territory of the Republic of Bulgaria - application submitted, decision of
p.002017: ethics committee, permission to conduct,
...

p.002017: the reasons for this.
p.002017: (3) The Executive Director of the BDA within 30 days of receipt of the documentation
p.002017: under para. 2 approves the amended protocol or issues a reasoned refusal and notifies the holder of
p.002017: the marketing authorization.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 30 days of
p.002017: the date of receipt of the documentation under para. 2 sends to the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The BDA Executive Director shall refuse the changes under para. 1 with one or more of
p.002017: the reasons referred to in Art. 145f, para. 2, Vol. 2.
p.002017: (6) The holder of the marketing authorization may apply the changes under para. 1 next
p.002017: obtaining approval from the BDA and a positive opinion from the committee under Art. 103, para. 1,
p.002017: respectively the commissions under art. 103, para. 2.
p.002017: (7) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in
p.002017: the tariff under Art. 21, para. 2.
p.002017: Art. 145d. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: use shall submit a final report of the BDA study within 12 months of completion of the collection
p.002017: data. A summary of the results is attached to the report
p.002017: from the study.
p.002017: (2) The marketing authorization holder may submit a reasoned request to
p.002017: BDA for postponement of the term under para. 1 at least three months before the submission date of
p.002017: the final report referred to in the minutes.
p.002017: (3) The Drug Enforcement Agency shall approve or make a reasoned refusal
p.002017: the request under para. 2 and notify the holder of the marketing authorization.
p.002017: (4) When the holder of the marketing authorization based on the report under para. 1
p.002017: considered that a change to the marketing authorization was necessary, he submitted to the BDA an application for
p.002017: change in the order of Chapter Three, Section VI.
p.002017: (5) The BDA Executive Director shall by order suspend or terminate the marketing authorization,
p.002017: when the BDA based on the report under para. 1 and after consultation with the marketing authorization holder
p.002017: consider stopping or stopping
p.002017: of the Marketing Authorization.
p.002017: Art. 145f. (New, SG No. 102/2012, effective 21.12.2012) (1) When the study is conducted as on
p.002017: the territory of the Republic of Bulgaria and of the territory of other Member States for medicinal products,
p.002017: authorized under Regulation (EC) No 726/2004 of the European Parliament and of the Council or in accordance with Chapter
p.002017: third, section VII in fulfillment of the obligations under art. 55a or under Art. 56a, the authorization holder
p.002017: for use filed by
p.002017: the committee under Art. 56a, para. 1, item 1 of the draft protocol.
p.002017: (2) Within 60 days from the date of receipt of the documentation under para. 1 the committee under art.
p.002017: 56a, para. 1, item 1 prepares an opinion and sends to the holder of the marketing authorization:
p.002017: 1. notification of approval, or
p.002017: 2. a reasoned refusal when:
p.002017: (a) found that the study promoted the use of the medicinal product
p.002017: product, and / or
p.002017: (b) consider that the design of the study will not achieve the objectives of the report,
p.002017: and / or
...

p.002017: termination of the marketing authorization, including a timetable for the implementation of the opinion.
p.002017: The opinion shall be published on the European Internet Portal for Medicinal Products under Art. 68, para. 1, Vol. 4
p.002017: and sent to
p.002017: the holder of the marketing authorization.
p.002017: (10) Where in the opinion under para. 9 is a position for regulatory action
p.002017: action on marketing authorizations, the European Commission decides on
p.002017: modification, suspension or termination of marketing authorizations granted under the Regulation
p.002017: (EC) No 726/2004 of the European Parliament and of the Council.
p.002017: Art. 145k. (New, SG No. 102/2012, effective 21.12.2012) (1) Non-interventional
p.002017: surveys on the territory of the Republic of Bulgaria shall be conducted in accordance with Art. 145c - 145d.
p.002017: (2) When conducting non-interventional studies under para. 1 indicates the source
p.002017: of financing.
p.002017: Chapter Five.
p.002017: MANUFACTURE AND IMPORTATION OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES
p.002017: (TITLE AM. - SG, iss. 102 OF 2012, IN EFFECT OF 02/01/2013)
p.002017: Section I.
p.002017: Production
p.002017: Art. 146. (1) (amend. - SG 102/2012, in force from 02.01.2013) The production of all types
p.002017: medicinal products within the meaning of this Act and of medicinal products intended for clinical use
p.002017: testing, may be carried out on the territory of the Republic of Bulgaria only by natural or legal persons,
p.002017: registered as traders in the territory of a Member State who have been granted a manufacturing authorization,
p.002017: issued by the Director of
p.002017: Drug Enforcement Agency.
p.002017: (2) A production permit shall also be required in the cases where the products under para. 1 are
p.002017: intended for export only.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008)
p.002017: requires also for persons performing simultaneously or individually one of the following activities:
p.002017: full or partial production, various processes of packaging, packaging, repackaging, labeling, quality
p.002017: control and release of batches of medicinal products and
p.002017: medicinal products intended for clinical trial.
p.002017: (4) (Repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: (5) No production authorization is required where the cutting processes,
p.002017: mixing or packaging is carried out according to the main or pharmacopoeial formulation in a pharmacy.
p.002017: Art. 147. (amend. - SG 102/2012, in force from 02.01.2013) The Executive Agency for Medicines shall introduce
p.002017: information on marketing authorizations for medicinal products and certificates of good manufacturing
p.002017: practice in the European Union database.
p.002017: Art. 148. For obtaining a production permit the person under Art. 146 should
p.002017: has:
p.002017: 1. with appropriately qualified personnel, depending on the specifics of
p.002017: manufactured types of medicinal products and dosage forms;
p.002017: 2. at any one time with at least one qualified person who is eligible
p.002017: Art. 159;
p.002017: 3. premises for production, control and storage of medicinal products,
p.002017: provided with the necessary technical equipment and control laboratories.
p.002017: Art. 149. Managers of production and quality control of medicinal products
p.002017: products in manufacturing enterprises are persons:
p.002017: 1. who hold a Master's degree in a specialty
...

p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
p.002017: production of radiopharmaceuticals or medicinal products subject to ionization
p.002017: radiation during their production;
p.002017: 8. permission to use the premises for production, control and storage,
p.002017: issued by the order of the Spatial Planning Act, or other substitute document;
p.002017: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 10. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) In the manufacture of narcotic substances and dosage forms containing
p.002017: such substances are also complied with the requirements of the Drug Control Act and
p.002017: precursors.
p.002017: (4) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 2, Vol. 1,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
p.002017: perform by contract in another object on the territory of the Republic of Bulgaria or outside it, the persons under art. 146
p.002017: are required to indicate the location of this
p.002017: an object and a copy of the contract setting out the responsibilities of each party in respect of
p.002017: compliance with the requirements of Good Manufacturing Practice of Medicinal Products
p.002017: products and obligations of the qualified person under Art. 148, Vol. 2.
p.002017: Art. 152. (amend. - SG 102/2012, in force from 02.01.2013) (1) The principles and requirements for
p.002017: Good manufacturing practice for all types of medicinal products, clinical medicinal products
p.002017: test and of the active substances are determined by the ordinance of
p.002017: the Minister of Health and with acts and guidelines adopted by the European Commission.
p.002017: (2) The principles and requirements for a formal risk assessment to establish the
p.002017: Good manufacturing practice for excipients shall be determined by the ordinance under para. 1 and p
p.002017: guidelines adopted by the European Commission.
p.002017: Art. 153. (1) Upon receipt of an application under Art. 150 BDA evaluates the submitted documentation and
p.002017: perform on-site inspection of the production, control and storage sites, including in the cases under Art.
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p.002017: substances and medicinal products intended for clinical use
p.002017: tests, under the conditions and in the order specified in the ordinance under art. 152.
p.002017: (5) (Renumbered from Paragraph (3), SG No. 102/2012, in force from 02.01.2013) In the case of a medicinal product
p.002017: product for clinical trial, the holder of the manufacturing authorization shall ensure that
p.002017: all production operations shall be carried out in accordance with
p.002017: the information provided by the contracting authority to the BDA in accordance with the ordinance under Art. 82, para. 3.
p.002017: (6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013)
p.002017: each transaction is kept for 5 years and contains the date, name of the medicinal product
p.002017: product, quantity delivered, name and address of consignee, and batch number.
p.002017: (7) (Renumbered from Paragraph (5), SG No. 102/2012, effective 02.01.2013)
p.002017: a production authorization provides and maintains a system for blocking and withdrawing from the market
p.002017: medicinal products that have shown non-compliance with quality requirements.
p.002017: (8) (Renumbered from Paragraph (6), SG No. 102/2012, effective 02.01.2013)
p.002017: a manufacturing authorization is required to block and withdraw the medicinal products shown
p.002017: non-compliance with the requirements for quality, efficiency and safety, in accordance with the ordinance of
p.002017: Art. 274, para. 1.
p.002017: (9) (Renumbered from Paragraph (7), SG No. 102/2012, effective 02/01/2013)
p.002017: a manufacturing authorization is required to update production methods in accordance
p.002017: with the development of new technologies and the development of test drug products.
p.002017: (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.002017: 02.01.2013) Based on the manufacturing authorization issued under
p.002017: the order of this section, its holder may import the auxiliaries necessary for
p.002017: the manufacture of the medicinal products referred to in the marketing authorization
p.002017: production.
p.002017: Art. 160a. (New, SG No. 60/2011, effective 05.08.2011) (1) The Executive Director of the BDA
p.002017: by an order revokes the issued production permit when the conditions under art. 148 and they are not
p.002017: the requirements of Good Manufacturing Practice have been met,
p.002017: determined in accordance with Art. 152.
p.002017: (2) The BDA Executive Director shall by an order terminate the permit for
p.002017: production:
p.002017: 1. at the written request of its holder;
p.002017: 2. upon termination of the activities for which it was issued;
p.002017: 3. upon deletion of the registration of the trader;
p.002017: 4. at the death of the individual - sole trader.
p.002017: (3) The order under para. 1 may be appealed by the order of the Administrative Procedure
p.002017: Code, the appeal does not stop enforcement.
p.002017: Section II.
p.002017: Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
p.002017: Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria from
p.002017: third country of all types of medicinal products and medicinal products intended for clinical use
p.002017: testing may only be carried out by natural or legal persons registered as traders under the legislation
p.002017: of a Member State that are
p.002017: have received an import permit issued by the BDA Executive Director.
p.002017: (2) In order to obtain an import permit, the person under para. 1 must have:
...

p.002017: of § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002017: caused by a defect in the goods,
p.002017: provided for therein.
p.002017: Chapter Six.
p.002017: PACKAGING AND PACKAGE LEAFLET
p.002017: Art. 168. (1) The packaging of a medicinal product shall consist of primary and / or secondary
p.002017: packing and leaflet for the patient.
p.002017: (2) (amend. - SG 61/11, in force from 10.11.2011)
p.002017: medicinal products containing substances specified in the list under Art. 3, para. 2, item 2 of the Law on
p.002017: control of drugs and precursors is diagonally marked with two red bars and the secondary
p.002017: packaging of medicinal products containing substances from the list under Art. 3, para. 2, item 3 of the Control Act
p.002017: narcotic drugs and precursors - with two blue bars. The packaging must contain an indication that
p.002017: the medicinal product is only available at
p.002017: special medical prescription.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products included in
p.002017: the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains information
p.002017: with the following text: "This medicinal product is subject to additional monitoring". A text in front of the text is placed
p.002017: black in accordance with Article 23 (5) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, accompanied by
p.002017: from the explanatory note.
p.002017: (4) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products shall include
p.002017: a standard text asking patients to report to medical professionals or directly to
p.002017: BDA any suspected adverse drug reaction
p.002017: reaction according to the models of art. 185, para. 2, Vol. 4.
p.002017: (5) Where the medicinal product is authorized for use in the territory of the Republic
p.002017: Bulgaria, on its secondary packaging, shall be marked with a separate collection and
p.002017: recycling in accordance with the Waste Management Act and its implementing acts.
p.002017: (6) Where a medicinal product is authorized, its name shall be
p.002017: the outer carton, the dosage form and the content of the active substance in the dose
p.002017: the unit is also written in Braille.
p.002017: (7) The requirements of para. 6 shall not apply to vaccines and medicinal products in hospital
p.002017: packaging.
p.002017: (8) (New, SG No. 102/2012, effective 21.12.2012) On the outer packaging, and
p.002017: if not, on the immediate packaging of the medicinal products except
p.002017: radiopharmaceuticals, applied:
p.002017: 1. an individual identifier for the safety indicators it gives
p.002017: opportunity for wholesalers and retailers to:
p.002017: (a) verify the authenticity of the medicinal product;
p.002017: (b) identify the individual packaging;
p.002017: 2. a means by which to check the packaging of the medicinal product
p.002017: whether it was forged.
p.002017: Art. 168a. (New, SG No. 102/2012, effective 21.12.2012) (1) On the packaging of a medicinal product that
p.002017: shall be granted on medical prescription, safety indicators according to art. 168, para. 8, except
p.002017: of cases where the medicinal product is
p.002017: included in the list determined by the European Commission by a delegated act under art. 168b.
p.002017: (2) No indications for the packaging of a medicinal product dispensed without a medical prescription shall be given.
p.002017: safety under Art. 168, para. 8, except where the medicinal product is included in the list,
p.002017: designated by the European Commission by means of a delegated act
p.002017: under Art. 168b, having been assessed as being at risk of forgery.
p.002017: (3) The Medicines Executive Agency shall notify the European Commission of:
p.002017: 1. for medicinal products which are available without a prescription for which it is
p.002017: found that there was a risk of counterfeiting;
p.002017: 2. for medicinal products for which it has been established that there is no risk of
p.002017: falsification, taking into account the following criteria:
p.002017: (a) the price and sales volume of the medicinal product;
p.002017: (b) the number and incidence of cases of counterfeit medicinal products registered in
p.002017: within the European Union and in third countries, and the change in the number and frequency of such cases in
p.002017: historical plan;
p.002017: (c) specific characteristics of the medicinal products concerned;
p.002017: (d) the severity of the disease to be treated;
p.002017: (e) other potential risks to public health.
p.002017: Art. 168b. (New, SG No. 102/2012, effective 21.12.2012) (1) The Rules on
p.002017: the safety indicators under Art. 168, para. 8 are defined by the European Commission with
p.002017: the delegated acts referred to in Article 54a (2) of Directive 2001/83 / EC.
p.002017: (2) Safety indicators shall not be eliminated or partially or completely closed,
p.002017: unless the following conditions are met:
p.002017: 1. the holder of the manufacturing authorization before partially or fully
p.002017: removes or closes safety features, checks to see if the appropriate drug
p.002017: the product is authentic and has not been tampered with;
p.002017: 2. the holder of a production permit in compliance with the requirements of Art. 168, para.
p.002017: 8 may replace safety indicators with equivalents with respect to
p.002017: the ability to guarantee the authenticity, identification and assurance of
p.002017: evidence of tampering with the medicinal product.
p.002017: (3) Safety indicators shall be considered equivalent if:
p.002017: 1. meet the requirements laid down in the delegated acts referred to in Article 54a (2)
p.002017: of Directive 2001/83 / EC, and
p.002017: 2. are equally effective in allowing authentication; and
p.002017: the identification of medicinal products and the provision of evidence of forgery
p.002017: them.
p.002017: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of
p.002017: the medicinal product and in accordance with good manufacturing practice for medicinal products
p.002017: products.
p.002017: (5) The Medicines Executive Agency shall oversee the replacement of
p.002017: safety indicators.
p.002017: Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
p.002017: compliance with the particulars in the summary of product characteristics approved by the BDA when granting the marketing authorization
p.002017: use and meet the requirements set out in
p.002017: the ordinance under Art. 170.
p.002017: (2) The information on the packaging and the package leaflet may be in several languages, but
p.002017: one of them must be Bulgarian. The content of the information is different
p.002017: languages ​​must be identical.
p.002017: (3) The name of the medicinal product shall be written in Bulgarian
...

p.002017: the product is identified by the BDA in the Marketing Authorization / Registration Certificate or
p.002017: the authorization for parallel importation of the medicinal product into the territory of
p.002017: Republic of Bulgaria.
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
...

p.002017: the documentation for making a change in the classification shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish it on the page
p.002017: your online list of prescription medicines
p.002017: the territory of the Republic of Bulgaria.
p.002017: (2) The list under para. 1 is updated annually.
p.002017: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002017: or the certificate of registration, the BDA shall review and, where necessary, amend the classification according to
p.002017: the requirements of Art. 173 and the criteria specified
p.002017: in the ordinance under art. 178.
p.002017: Art. 181. Where a change in the classification of a medicinal product on the basis of
p.002017: significant pre-clinical or clinical trials, no subsequent applicant or marketing authorization holder
p.002017: may be invoked within one year from the date of the variation authorization issued by a regulatory authority of a country
p.002017: State upon filing
p.002017: an application to change the classification of the same substance.
p.002017: Art. 182. The European Medicines Agency shall be notified annually by the Executive Agency for Medicinal Products
p.002017: the Commission and the regulatory authorities of the other Member States for changes to the
p.002017: Art. 179.
p.002017: Chapter Eight.
p.002017: PHARMACEUTICAL SAFETY TRACKING
p.002017: Section I.
p.002017: General Provisions (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 183. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the drug agency organizes and maintains a drug tracking system
p.002017: safety to fulfill the obligations under this Chapter.
p.002017: (2) The system of para. 1 is used to gather information on the risks of medicinal products
p.002017: for patients' health and public health. The information covers adverse drug reports
p.002017: reactions when using the medicinal product in accordance with the approved summary of product characteristics, and
p.002017: misuse and use information that is inconsistent with the approved summary
p.002017: product characteristics, including information on side effects observed with
p.002017: execution of
p.002017: professional duties.
p.002017: (3) The Executive Agency for Medicines shall validate, process and classify the information under para.
p.002017: 2, conducts a scientific analysis of the data collected with a view to assessing the potential for reduction and
p.002017: risk prevention and take the necessary action
p.002017: with regard to the authorization of the medicinal product.
p.002017: (4) The Executive Agency for Medicines shall carry out audits of the system under para. 1 and on
p.002017: sends a report every two years to the European Commission on the results thereof.
p.002017: (5) The Medicines Executive Agency shall implement an adequate and effective quality system in order
p.002017: ensure compliance of the system under para. 1 with the requirements of this law. The minimum system requirements
p.002017: quality is determined by the Implementing Regulation (EU)
p.002017: № 520/2012.
p.002017: Art. 184. (Amended, SG No. 102/2012, effective 21.12.2012) (1) Medical
p.002017: Specialists are obliged to immediately inform the marketing authorization holder or the BDA of each
p.002017: suspected serious adverse reaction and provide at
p.002017: requesting additional information from case tracking.
p.002017: (2) Patients may report undesirable effects at any time
p.002017: medical specialists or the BDA.
p.002017: (3) In the cases of para. 1 and 2, where the communication concerns a biological medicinal product prescribed,
p.002017: distributed or sold on the territory of the Republic of Bulgaria, it must be clearly identified by
p.002017: the communicator with his trade name and account number or
p.002017: this information should be made available in follow-up.
p.002017: Art. 185. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the medicines agency maintains a national internet portal for related medicinal products
p.002017: with the European Internet portal for medicinal products under Art. 68, para. 1, Vol. 4.
p.002017: (2) The Executive Agency for Medicines shall make available through the portal under para. 1 at least
p.002017: following information:
p.002017: 1. the public evaluation reports under art. 53, para. 2 and their summaries;
p.002017: 2. the summary of product characteristics and leaflets;
p.002017: 3. summary of the risk management plans for the medicinal products authorized for
p.002017: use on the territory of the Republic of Bulgaria;
p.002017: 4. specimens of standardized reporting forms for suspected adverse reactions
p.002017: medical reactions by medical professionals and patients prepared in accordance with
p.002017: the requirements of Article 25 of Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 5. an updated list of medicinal products referred to in Article 23 of Regulation (EC) No
p.002017: 726/2004 of the European Parliament and of the Council;
p.002017: 6. communications providing information to the general public about concerns
p.002017: on the safety of the use of a medicinal product;
p.002017: 7. instructions for all ways and forms for reporting suspected unwanted
p.002017: drug reactions by medical professionals and patients.
p.002017: Art. 186. (amend. - SG 102/02, in force from 21.12.2012) The Executive Agency
p.002017: on medicinal products performs the following activities for medicinal products placed on the market in
p.002017: Republic of Bulgaria:
p.002017: 1. monitoring the outcome of the risk reduction measures for a medicinal product,
p.002017: contained in the risk management plan;
p.002017: 2. monitoring of the result of the fulfillment of conditions specified in Art. 55a, 56 or 56a;
p.002017: 3. evaluation of the update of the risk management system;
p.002017: 4. monitoring of the EudraVigilance database set up in accordance with Article 24
p.002017: of Regulation (EC) No 726/2004 of the European Parliament and of the Council on new risks or on
p.002017: change in already established and change in benefit / risk ratio.
p.002017: Art. 187. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: The European Medicines Agency and the Marketing Authorization Holder have been informed by the European Medicines Agency
p.002017: identifying signals for new risks or for changing identified risks, or when changing
p.002017: the benefit / risk ratio of the medicinal product.
p.002017: (2) The Committee under Art. 56a, para. 1, item 1 analyzes and prioritizes validated alerts for new risks or changes in
p.002017: already established for changing the benefit / risk ratio.
p.002017: (3) Where the Committee under Art. 56a, para. 1, item 1 recommends follow-up,
...

p.002017: The European Medicines Agency, the regulatory authorities of the other Member States, shall be informed by the European Medicines Agency
p.002017: The European Commission at least 24 hours prior to the public disclosure of information regarding concerns
p.002017: with the monitoring of the safety of a medicinal product, unless the protection of
p.002017: public health requires
p.002017: immediate disclosure of information.
p.002017: (2) The Medicines Executive Agency shall publish information relating to the active substances contained in
p.002017: medicinal products authorized in other countries
p.002017: Member States, using a harmonized draft communication and timetable for publication,
p.002017: proposed by the European Medicines Agency.
p.002017: (3) In the cases of para. 1 and 2 information containing personal data or representing
p.002017: trade secrets shall be deleted unless such disclosure is necessary for safeguarding
p.002017: of public health.
p.002017: Art. 189. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the medicines agency may delegate some of the rights and obligations under this chapter to
p.002017: regulatory authority of another Member State by concluding an agreement.
p.002017: (2) In the cases of para. 1 The BDA informs the European Commission, the European Medicines and Regulatory Agency
p.002017: authorities of the other Member States for the delegation of powers and publish a communication to the
p.002017: Internet portal under Art. 185, para. 1 or on the Internet
p.002017: your page.
p.002017: Art. 190. (amend. - SG 102/02, in force from 21.12.2012) (1) The holder of
p.002017: a marketing authorization is required to have a drug tracking system
p.002017: safety to fulfill its obligations under this Chapter.
p.002017: (2) The holder of a marketing authorization through the system of para. 1 makes a scientific assessment of the information collected
p.002017: on the safety of medicinal products, consider the possibility of minimizing or
p.002017: risk prevention and take the necessary
p.002017: measures.
p.002017: (3) The Marketing Authorization Holder shall implement an adequate and effective quality system to ensure
p.002017: compliance of the system under para. 1 with the requirements of this law. The minimum requirements for the
p.002017: quality is defined in the Implementing Regulation (EU)
p.002017: № 520/2012.
p.002017: (4) The marketing authorization holder shall regularly audit the system under para.
p.002017: 1. Information on the main findings of the audit shall be noted in the system's main documentation and shall serve
p.002017: to draw up a plan for the implementation of appropriate corrective actions. This one
p.002017: information may be deleted after complete corrective action.
p.002017: Art. 191. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the marketing authorization designates a qualified person with the appropriate qualification responsible for
p.002017: pharmacovigilance monitoring.
p.002017: (2) The person under para. 1 is established in the territory of a Member State and is permanent and
p.002017: continuously at the disposal of the holder of the marketing authorization.
p.002017: (3) To support the activity of the qualified person, the holder of the permit
p.002017: designates for use a person established in the territory of the Republic of Bulgaria. The appointment of
p.002017: such person does not release the qualified person under para. 1 of his responsibilities under this chapter.
...

p.002017: 3. monitors the outcome of the measures contained in the plan for
p.002017: risk management, or
p.002017: 4. monitor the result of the fulfillment of the conditions under Art. 55a, 56 or
p.002017: 56a;
p.002017: 5. update the risk management system;
p.002017: 6. monitors the data from the system under Art. 190, para. 1 to identify
p.002017: new risks or change in identified risks, and determine whether they have occurred
p.002017: changes in the benefit / risk balance of the observed medicinal product.
p.002017: (2) The content and procedure for maintaining the basic documentation of the
p.002017: pharmacovigilance monitoring is governed by Implementing Regulation (EU) No 520/2012.
p.002017: Art. 193. (Amended, SG No. 102/2012, effective 21.12.2012) The holder of a permit for
p.002017: use informs the BDA and the European Medicines Agency in the event that new signals are identified
p.002017: risks or to change the identified risks, or
p.002017: change in the benefit / risk ratio of a medicinal product.
p.002017: Art. 194. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of a permit for
p.002017: use concurrently or before providing the public with new information on related concerns
p.002017: by monitoring the safety of a medicinal product authorized in the territory of the Republic
p.002017: Bulgaria, informs BDA, European
p.002017: the Medicines Agency and the European Commission.
p.002017: (2) The information under para. 1 must be objective and not misleading.
p.002017: (3) Before disseminating information related to drug monitoring
p.002017: safety, the Marketing Authorization Holder agrees with the BDA in advance with
p.002017: except for the cases under para. 1.
p.002017: (4) For carrying out the evaluation of the information under para. 3 is paid a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: Art. 194a. (New, SG No. 102/2012, effective 21.12.2012) (1) The principles and
p.002017: the requirements of Good Practice for Monitoring Pharmacovigilance are set out in
p.002017: guidance issued by the European Medicines Agency.
p.002017: (2) In carrying out pharmacovigilance monitoring activities
p.002017: the holder of the marketing authorization complies with the good practice under para. 1.
p.002017: Section II.
p.002017: Collection and reporting of information on suspected adverse reactions
p.002017: (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 194b. (New, SG No. 102/2012, effective 21.12.2012) The holder of the authorization for
p.002017: use in fulfillment of their obligations under Art. 190 is required to document all reports of suspected spam
p.002017: drug reactions observed on the territory of the European Union or in third countries, reported spontaneously by
p.002017: medical professionals or from patients or emerging from post-marketing research.
p.002017: Art. 194c. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the permit
p.002017: submit for use electronically in the database "EudraVigilance" under Art. 24 of Regulation (EC) No
p.002017: 726/2004 of the European Parliament and of the Council of reports of serious suspected adverse reactions,
p.002017: occurred on the territory of the European Union and in
p.002017: third countries, within 15 days of the date of receipt of the communication.
p.002017: (2) The Marketing Authorization Holder submits to the EudraVigilance database electronically
p.002017: all suspected adverse reactions other than those mentioned in para. 1 occurred on the territory of
p.002017: European Union, within 90 days from the date of
p.002017: receiving the message.
p.002017: (3) The Marketing Authorization Holder monitors publications in specialized medical literature and
p.002017: report to the EudraVigilance database any suspected adverse drug drug listed in it
p.002017: reaction with the exception of suspected adverse reactions from medicinal products containing active
p.002017: substances listed in the article list
p.002017: 27 of Regulation (EC) No 726/2004 of the European Parliament and of the Council and described in
p.002017: literature sources monitored by the European Medicines Agency.
p.002017: (4) The marketing authorization holder establishes procedures for the collection of accurate and reliable data,
p.002017: allowing the scientific evaluation of reports of suspected adverse reactions. The owner
p.002017: of the Marketing Authorization collects a follow-up
p.002017: information regarding these messages and provides updated data in "EudraVigilance".
p.002017: (5) The form and content of the reports under para. 1 - 3 are determined by Regulation
p.002017: Implementation (EU) No 520/2012.
p.002017: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: register the medicines in the system of art. 183 all reports of suspected adverse drug reactions
p.002017: reactions occurring on the territory of the Republic of Bulgaria by
p.002017: medical professionals and patients, and requires, if necessary, additional
p.002017: case tracking information.
p.002017: (2) When reports of suspected adverse reactions occurring on
p.002017: the territory of the Republic of Bulgaria, have been submitted by the holder of the marketing authorization,
p.002017: it provides additional follow-up information to the BDA upon request.
p.002017: Art. 194d. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: medicines submit reports to the EudraVigilance database for all serious suspects
p.002017: adverse reactions occurring on the territory of
p.002017: Republic of Bulgaria, within 15 days from the date of their receipt.
p.002017: (2) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002017: reports of all suspected adverse reactions other than those specified in para. 1 occurred on
p.002017: the territory of the Republic of Bulgaria, within 90 days from the date
p.002017: of receiving the message.
p.002017: (3) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002017: reports of suspected adverse reactions occurring on the territory of the Republic of Bulgaria,
p.002017: due to improper use of the medicinal product. The Medicines Executive Agency shall inform thereof
p.002017: Ministry of Health
p.002017: and professional organizations of medical specialists.
p.002017: (4) Any body or institution to which information about a suspect has been received
p.002017: reported an adverse reaction occurring on the territory of the Republic of Bulgaria
p.002017: BDA for that.
p.002017: (5) The content and format of the communications and reports under para. 1 - 3 are determined by
p.002017: Implementing Regulation (EU) No 520/2012.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: the medication receives information from the marketing authorization holder about serious suspects
p.002017: adverse reactions occurring on the territory
p.002017: of the European Union or in a third country through the EudraVigilance database.
p.002017: (2) The requirements for monitoring information in the EudraVigilance database are
p.002017: set out in Implementing Regulation (EU) No 520/2012.
p.002017: Art. 194g. (New - SG 102/2012, in force since 21.12.2012) In the process of exchange of information of the BDA,
p.002017: the Marketing Authorization Holders and the European Medicines Agency are cooperating with the European Medicines Agency
p.002017: detect duplicate reports of suspected spam
p.002017: drug reactions.
p.002017: Section III.
p.002017: Periodic safety update reports (New, SG No. 102/2012, effective from
p.002017: 12/21/2012)
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the Marketing Authorization is obliged to make the European Agency for Europe available electronically
p.002017: medicines periodic safety update reports containing:
p.002017: 1. summaries of data on the benefit / risk balance of the medicinal product,
p.002017: including the results of all studies, with a view to their potential impact on
p.002017: the marketing authorization;
p.002017: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002017: available data, including clinical trial data for unauthorized indications and target groups,
p.002017: which are not included in the summary of
p.002017: product;
p.002017: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002017: the holder of the marketing authorization is in possession of the volume of prescriptions, including approximate ones
p.002017: number of persons who used the medicinal product
p.002017: or exposed to it for another reason.
p.002017: (2) The content and format of the electronic periodic updated reports on
p.002017: safety is determined by Implementing Regulation (EU) No 520/2012.
p.002017: (3) The information under para. 1 shall be collected and stored in a register established in the order of a member
p.002017: 25a of Regulation (EC) No 726/2004 of the European Parliament and of the Council, and is accessible to the BDA.
p.002017: Art. 194i. (New, SG No. 102/2012, effective 21.12.2012) The holders of
...

p.002017: medicinal products for human use within 30 days of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the retention, amendment, suspension or termination of validity
p.002017: of the relevant marketing authorizations, including a timetable for the implementation of
p.002017: the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. Decides to change, suspend or terminate the marketing authorizations,
p.002017: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 2. adopt a decision recommending change, suspension or termination of authorizations
p.002017: for use issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 2, Vol. 2.
p.002017: Section IV.
p.002017: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002017: 12/21/2012)
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure of
p.002017: the European Union level can be initiated by the European Commission, by the European Commission
p.002017: drug agency or from a Member State.
p.002017: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under
p.002017: the procedure for this section by notifying the regulatory authorities of the other Member States, the European Agency for Europe
p.002017: medicines and the European Commission, when for drug-related reasons
p.002017: safety, consider that a medicinal product placed on the Bulgarian market requires undertaking
p.002017: to any of the
p.002017: the following measures:
p.002017: 1. suspension or termination of the marketing authorization;
p.002017: 2. prohibition of distribution of a medicinal product;
p.002017: 3. issuing a refusal to renew the marketing authorization.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para.
p.002017: 2, when notified by the marketing authorization holder that for reasons related to
p.002017: drug safety monitoring, discontinued
p.002017: the distribution of the medicinal product has either taken or intends to take action on
p.002017: it will be removed from the market or it will not take any action to renew it
p.002017: the marketing authorization issued.
p.002017: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure
p.002017: under para. 2 and in cases where it considers that for reasons related to drug monitoring
p.002017: safety, a new contraindication or reduction should be added to a medicinal product
p.002017: the recommended dose or indication
p.002017: be limited.
p.002017: (5) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products shall provide the European Medicines Agency
p.002017: medicines and regulatory authorities of other Member States all the scientific information by which
p.002017: have, as well as the data assessment performed, and
p.002017: the reasons for initiating the procedure under this section.
p.002017: (6) (Amended, SG No. 18/2014) In the cases of para. 2 - 4 European Medicines Agency
p.002017: notifies the BDA of the initiation of the procedure when the safety concerns relate to others
p.002017: medicinal products belonging to or containing the same therapeutic group
p.002017: active substance with the product specified in the information under para. 5, or where this medicinal product is authorized
p.002017: for use in another or
p.002017: in other Member States.
p.002017: (7) (amend. - SG 18/04) In the cases of para. 4 when you do not have to
p.002017: take urgent measures, the BDA applies the procedure under Art. 77 or 79b.
p.002017: (8) (New, SG No. 18/2014) The Executive Agency for Medicines shall inform
p.002017: the holder of the marketing authorization in order to initiate the procedure under this section.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases under Art. 194y, para. 2 when
p.002017: considered it necessary to take urgent measures to protect public health, BDA
p.002017: may suspend the marketing authorization and prohibit the use of the medicinal product
p.002017: the territory of the Republic of Bulgaria until the adoption of the
...

p.002017: from the date of its receipt, issue an opinion on the retention, modification, suspension, termination
p.002017: of the relevant authorizations or refusals to renew them, including a timetable for
p.002017: implementation of the opinion.
p.002017: (2) Where the opinion recommends that the measures under Art. 194ts, para. 3, Vol. 5,
p.002017: the Executive Director of the BDA shall, by order, suspend or revoke the authorization for
p.002017: use, or refuses to renew it.
p.002017: (3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (4) Where in the opinion under para. 1 it is recommended to take measures under art. 194ts, para.
p.002017: 3, items 2 - 4, the holder of the marketing authorization takes the necessary actions and
p.002017: inform the BDA and the regulatory authorities of the other Member States.
p.002017: (5) Where, within the coordination group under Art. 77, para. 2 could not be reached,
p.002017: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002017: decision with recommendation for change, suspension or termination
p.002017: of the marketing authorization issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5
p.002017: interim and / or definitive measures.
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the Committee for Medicinal Products for Human Use, based on the recommendation under Art. 194ts, para.
p.002017: 3, within 30 days from the date of its receipt, issue an opinion on the retention, change,
p.002017: suspension, termination of the relevant marketing authorizations or refusal of
p.002017: their renewal, including a timetable for the implementation of the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. adopt a decision to change, suspend or terminate the validity of the permits
p.002017: for use, issued under Regulation (EC) No 726/2004 of the European Parliament and of the
p.002017: The Council;
p.002017: 2. adopt a decision recommending the change, suspension or termination of validity of
p.002017: marketing authorizations issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Drug Enforcement Agency shall implement the recommendations recommended in the decision of the European Medicines Agency
p.002017: The European Commission under para. 2, item 2 provisional and / or final measures.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) The recommendation under Art. 194c,
p.002017: para. 1, the opinion under art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and
p.002017: Art. 194h, para. 2 shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: Chapter Nine.
p.002017: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN
p.002017: THE MEDICINAL PRODUCTS AREA (HEADING, amended, SG No. 71/2008,
p.002017: POWER FROM 12.08.2008, ISM. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002017: (Title "Section I. Wholesale trade of medicinal products" - SG, issue 71 of 2008, in
p.002017: with effect from 12.08.2008)
p.002017: Art. 195. (1) Wholesale trade in medicinal products may be carried out physically and
p.002017: legal persons authorized to do so by a regulatory body of
p.002017: the Member State concerned.
p.002017: (2) When the person under para. 1 has warehouses on the territory of the Republic
p.002017: Bulgaria, it may carry out wholesale of medicinal products after receiving
p.002017: permission from the BDA Executive Director.
p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
...

p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
p.002017: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Agency
p.002017: for nuclear regulation.
p.002017: (5) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the person under para. 1, Vol. 3,
p.002017: when he is a Bulgarian citizen.
p.002017: Art. 200. The Drug Enforcement Agency evaluates the documentation and performs it
p.002017: on - the - spot verification of the sites indicated in the application for their compliance with
p.002017: requirements for Good Distribution Practice.
p.002017: Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing,
p.002017: when it finds deficiencies in the documentation submitted.
p.002017: (2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
p.002017: Art. 202. (1) Within 90 days from the date of submission of the application under Art. 199, para. 1
p.002017: the Executive Director of the BDA issues the permit for wholesale trade or makes it motivated
p.002017: refusal.
p.002017: (2) The refusal under para. 1 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: Art. 203. Within 15 days from the date of submission of the documentation under Art. 199, para. 2
p.002017: the BDA Executive Director issues a Wholesale Trade Registration Certificate to
p.002017: the territory of the Republic of Bulgaria of the person under Art. 195, para. 1.
p.002017: Art. 204. (1) The permit for wholesale of medicinal products shall be indefinite.
p.002017: (2) The authorization under Art. 202 or the certificate under Art. 203 is terminated if
p.002017: the holder requested this in writing from the BDA Executive Director.
p.002017: (3) The person under art. 195 is obliged to notify the BDA in writing within 7 days after the termination of
p.002017: its activity in the wholesale of medicinal products. In these cases, the BDA Executive Director
p.002017: terminates the issued marketing authorizations / certificates
p.002017: of medicines.
p.002017: Art. 205. (1) The Executive Agency for Medicines shall keep a register of the issued ones
p.002017: permits for wholesale trade in medicinal products under Art. 202, para. 1, which contains:
...

p.002017: 7. a proposal for a leaflet for the patient for the parallel medicinal product, accompanied by a declaration,
p.002017: that the contents of the package leaflet are identical to the contents of the product leaflet authorized for use in
p.002017: The Republic of Bulgaria, with the exception of the following
p.002017: data:
p.002017: (a) the name and management address of the parallel importer;
p.002017: (b) the name of the manufacturer, where different for the two products;
p.002017: (c) a period of stability when different for the two products;
p.002017: (d) excipients, where different in the two products;
p.002017: 8. in the case of repackaging:
p.002017: a) (amend. - SG 71/08, in force from 12.08.2008) a sample of the medicinal product
p.002017: as it will be marketed in Bulgaria;
p.002017: (b) a copy of the contract between the parallel importer and the importer
p.002017: partial production activity - packaging, labeling;
p.002017: (c) a certificate of Good Manufacturing Practice when repackaging processes take place
p.002017: carry out outside the territory of the Republic of Bulgaria;
p.002017: d) when performed by the person under Art. 213 - a copy of the manufacturing authorization,
p.002017: issued by the regulatory authority of the Member State where the repackaging takes place;
p.002017: 9. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) Where between the medicinal product for
p.002017: There are differences in parallel imports and the product authorized for use on the territory of the Republic of Bulgaria
p.002017: (in the composition of excipients and others), the person under para. 1 presents evidence that they did not
p.002017: reflect the therapeutic properties of the drug
p.002017: product for parallel imports.
p.002017: (4) In the cases of para. 3 the person under para. 1 indicates on the packaging and the package leaflet
p.002017: the patient of the parallel medicinal product differences.
p.002017: (5) Where the person under Art. 213 carries out repackaging and / or labeling of the medicinal product
p.002017: a product in Bulgarian on the territory of the Republic of Bulgaria, it must have
p.002017: manufacturing authorization issued by the BDA Executive Director.
p.002017: (6) The parallel imported product is used subject to the conditions of the authorization granted for
p.002017: use of the medicinal product on the territory of the Republic of Bulgaria.
p.002017: Art. 216. (1) The permit for parallel import into the territory of the Republic
p.002017: Bulgaria shall be issued within 45 days from the date of submission of the documentation to the BDA.
p.002017: (2) When the BDA requests additional documentation from the applicant, the term under para. 1 stops
p.002017: run until the requested information is received.
p.002017: (3) When requested by the BDA of the regulatory authority of the Member State from which it is carried out
p.002017: parallel import, information related to the granting of the import authorization
p.002017: medicinal product, the term under para. 1 is extended by 45 days.
p.002017: (4) If, within the term of para. 3 The BDA did not receive the requested documentation, the issuing procedure
p.002017: of a parallel import permit on the territory of the Republic of Bulgaria shall be terminated.
p.002017: (5) Licenses issued for parallel imports into the territory of
p.002017: The Republic of Bulgaria is published on the BDA website on the Internet.
p.002017: (6) The authorization for parallel importation shall be for a period of 5 years. New permission
...

p.002017: 5. the country where the export is planned to take place.
p.002017: Art. 217c. (New, SG No. 18/2014, declared unconstitutional by RKS No. 1 of 2015 - SG, No. 12/2015)
p.002017: (1) Upon receipt of a notification under Art. 217b BDA requires information on the medicinal product intended for export
p.002017: for a period of 6 months from the date of filing
p.002017: notification:
p.002017: 1. for the consumption of the respective medicinal product by the National Health Insurance Fund and / or by
p.002017: The Ministry of Health;
p.002017: 2. for the deliveries of the respective medicinal product in the Republic of Bulgaria by the holder of
p.002017: the marketing authorization.
p.002017: (2) The persons under para. 1 provide the information requested by the BDA within 15 days of receipt of
p.002017: the request.
p.002017: (3) The Executive Agency for Medicines shall perform an analysis of the received under para. 2 information about
p.002017: the respective medicinal product by comparing the data on the quantities used under para. 1, item 1 and
p.002017: the quantities delivered under para. 1, item 2 with the available data received in accordance with Art. 217b, item 4 for number of packages,
p.002017: intended for
p.002017: wear.
p.002017: (4) Where within 30 days from the date of receipt of the notification under Art. 217b, the executive
p.002017: the BDA director did not object to the export in writing, it is considered that there is a tacit consent for
p.002017: export.
p.002017: (5) The Executive Director of the BDA may, within the term of para. 4 to refuse by reasoned order the execution
p.002017: to export when, when carrying out the analysis under para. 3 found that:
p.002017: 1. the ones available at the time of notification under Art. 217b quantities of the respective drug
p.002017: product in the Republic of Bulgaria are not sufficient to meet the health needs of the population;
p.002017: 2. there may be a temporary shortage of the necessary for export as a result of the export
p.002017: meeting the health needs of the population with the quantities of the medicinal product concerned;
p.002017: 3. the lack of sufficient quantities of the respective medicinal product to satisfy the health requirements
p.002017: the needs of the population can seriously endanger the life and health of the population.
p.002017: (6) The refusal under para. 5 shall be subject to appeal by the order of the Administrative Procedure Code.
p.002017: (7) Data on export of medicinal products from the territory of the Republic of Bulgaria are provided
p.002017: posted on the BDA's website.
p.002017: Art. 217g. (New, SG No. 18/2014) Export of medicinal products shall be effected on time
p.002017: within three months from the expiry of the term under Art. 217c, para. 4.
p.002017: Chapter Ten.
p.002017: RETAIL TRADE OF MEDICINAL PRODUCTS
p.002017: Art. 218. Retail trade in medicinal products is carried out only in pharmacies and
p.002017: drugstores under the procedure of this law, except for the cases under art. 232, para. 2.
p.002017: Art. 219. (1) (amend. - SG 71/08, in force from 12.08.2008, add. - SG, iss. 23 in 2009, in force from
p.002017: March 30, 2009, Suppl. - SG, issue. 41 of 2009, in force since 02.06.2009, as amended. - SG, issue. 60 of 2011, in force since
p.002017: 08/05/2011) The pharmacy is a health establishment, where the following activities are performed: storage, preparation,
p.002017: packing, controlling, consulting, medical and non-prescribing
p.002017: for use in the Republic of Bulgaria medicinal products, medical devices, diet foods for
p.002017: special medical purposes and infant formulas and follow-on formulas and nutritional supplements, cosmetic and
p.002017: hygiene products.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The device, the order and
p.002017: the organization of the work of pharmacies, the nomenclature of medicinal products, are determined
p.002017: in an ordinance of the Minister of Health.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008, repealed - SG, iss. 23 in 2009, in force
p.002017: from 30.03.2009)
p.002017: Art. 220. (1) The activities under art. 219, para. 1 are performed by the Master of Pharmacy.
p.002017: (2) (suppl. - SG 71/08, in force from 12.08.2008) The master pharmacist shall be obliged
p.002017: to fulfill a prescription issued, including for dosage forms prepared under
p.002017: highway and pharmacopoeial formulation, according to the procedure specified in the ordinance under Art. 221, para. 1.
p.002017: (3) (amend. - SG 102/2012, in force from 02.01.2013) The assistant-pharmacist may perform all
p.002017: activities under art. 219, para. 1 under the control of a pharmacist, with the exception of: granting
p.002017: prescription drug, control and administration
p.002017: advice on medicinal products.
p.002017: Art. 221. (1) (Former text of Art. 221 - SG 71/08, in force from 12.08.2008)
p.002017: Health determines in an ordinance the medical professionals who can issue prescriptions, the order for prescribing
p.002017: medicinal products, the time limit for implementation, and the cases and the order in which the master pharmacist may
p.002017: to refuse to perform medically
p.002017: prescription.
p.002017: (2) (New, SG No. 71/2008, effective 12.08.2008, amended, SG No. 9/2011)
p.002017: Bulgarian citizens and foreigners who are allowed to reside in the country when traveling outside the Republic
p.002017: Bulgaria may carry or export medicinal products,
p.002017: intended for their treatment, under the conditions and in the order specified in the ordinance under para. 1.
p.002017: (3) (New, SG No. 71/2008, effective 12.08.2008, amended, SG No. 9/2011)
p.002017: Foreigners who have been issued a short-stay visa on the territory of the Republic of Bulgaria may
p.002017: possess medicinal products intended solely for their treatment, c
p.002017: quantities determined in the ordinance under para. 1.
p.002017: (4) (New, SG No. 1/2014, effective 03.01.2014) Requirements for medical
p.002017: prescriptions that are issued at the request of a patient who intends to use them in another
p.002017: Member State, as well as the recognition and enforcement of those issued in anotherXcountry
p.002017: State, shall be carried out under the conditions and in the order determined by the ordinance under para. 1.
p.002017: (5) (New, SG No. 1/2014, effective 03.01.2014) Reimbursement of expenses for medicinal products under
p.002017: medical prescriptions fulfilled in another Member State shall be carried out under the conditions and in accordance with the procedure laid down in
p.002017: the ordinance under Art. 80s, para. 4 of the Health Act
...

p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
p.002017: registration of a drugstore or for making a change under Art. 242 the respective RIC collects fees
p.002017: in the amount determined by the tariff under Art. 21, para. 2.
p.002017: (6) (New - SG 103 2017, in force from 01.01.2018)
p.002017: food safety ex officio establishes the circumstances of a person 's criminal record
p.002017: para. 2, item 2, when he is a Bulgarian citizen.
p.002017: Art. 240. (amend. - SG 60/11, in force from 05.08.2011) (1) Within 14 days from
p.002017: performing the inspection under Art. 239, para. 3 or by eliminating the incompleteness of art. 239, para. 4
...

p.002017: for its publication.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012)
p.002017: refuses to issue a certificate of registration of the person under Art. 238, para. 2 when:
p.002017: 1. none of the documents under Art. 239, para. 2;
p.002017: 2. within the term of art. 239, para. 4 the applicant did not remove the incompleteness found.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) When, within the term of para. 1
p.002017: the director of RZI did not issue a certificate for registration of a drugstore or did not
p.002017: motivated refusal, it is considered that there is tacit consent.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 3 the applicant can start
p.002017: performing the requested activities in compliance with Art. 29 of the Administrative Restriction Act
p.002017: regulation and administrative control over the economic activity.
p.002017: (5) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012)
p.002017: of RZI under para. 1 shall be subject to appeal by the order of the Administrative Procedure Code.
p.002017: Art. 240a. (New, SG No. 102/2012, effective 21.12.2012) (1) The Director of
p.002017: the respective RZI shall terminate the registration of a drugstore by order:
p.002017: 1. at the request of the person who has received a certificate for registration of a drugstore;
p.002017: 2. by termination of the activity of the person under art. 238, para. 2, of which it notifies
p.002017: the relevant REI.
p.002017: (2) Within 14 days of termination of the activity under para. 1, item 2 the person under art. 238, para. 2
p.002017: notifies the relevant RIC in writing.
p.002017: Art. 241. (1) (amend. - SG 60/11, in force from 05.08.2011)
p.002017: keep a register of issued drug registration certificates, which contains:
p.002017: 1. number and date of the certificate issued;
p.002017: 2. seat and address of the person who has received a drugstore registration certificate;
p.002017: 3. name, personal data and address of the head of the drugstore;
p.002017: 4. address of the drugstore;
p.002017: 5. date of termination of the registration and the reason for it;
p.002017: 6. notes on the entered circumstances.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) Data from the register shall be
p.002017: publish on the website of the respective RII on the Internet.
p.002017: Art. 241a. (New, SG No. 60/2011, effective 05.08.2011) The National Register of
p.002017: the issued certificates for registration of a drugstore under Art. 19a, para. 3 contains:
p.002017: 1. the name of the respective RHI which issued the registration certificate;
p.002017: 2. number and date of the issued certificate;
p.002017: 3. seat and address of the person who has received a drugstore registration certificate;
p.002017: 4. name of the head of the drugstore;
p.002017: 5. address of the drugstore;
p.002017: 6. date of termination of the registration and the reason for it.
p.002017: Art. 242. When the address of the drugstore or manager is changed, the person receiving it
p.002017: certificate of its opening, submits an application in accordance with Art. 239, para. 2 and related to
p.002017: change documents.
p.002017: Art. 243. The terms and conditions for the organization of work in the drugstore shall be laid down in an ordinance
p.002017: of the Minister of Health.
p.002017: Chapter eleven.
p.002017: ADVERTISING OF MEDICINAL PRODUCTS
p.002017: Art. 244. (1) Advertising of medicinal products is any form of information,
p.002017: presenting, promoting or offering to promote prescription, sale, or
p.002017: the use of the medicinal product and includes:
...

p.002017: side effects warnings as part of general safety measures
p.002017: of the medicinal product, commercial catalogs and price lists, provided that they do not include data
p.002017: promotional in relation to the medicinal product;
p.002017: 4. statements relating to human health or diseases when directly or
p.002017: do not indirectly refer to the treatment, prevention or diagnosis of medicinal products;
p.002017: 5. vaccination campaigns conducted by the Ministry of Health
p.002017: population when related materials do not contain data for a specific medicinal product.
p.002017: Art. 245. (1) The holder of the marketing authorization shall be obliged to create a scientific one
p.002017: a unit for the dissemination of information on the medicinal products for which he has received
p.002017: authorization for use under this law.
p.002017: (2) The marketing authorization holder shall be obliged to:
p.002017: 1. ensure that the advertising of the medicinal product is presented to the public or to
p.002017: medical professionals in a form that complies with the requirements of this Chapter; and
p.002017: compliance with the issued authorization for advertising by the BDA;
p.002017: 2. have data and materials from all advertising campaigns undertaken within the framework
p.002017: of his business, including information about the ad groups he is targeting,
p.002017: how it was implemented, and the date the campaign started.
p.002017: 3. ensure the training of medical sales representatives;
p.002017: 4. Execute precisely and in due time the instructions of the control officials
p.002017: of the ad.
p.002017: (3) The medical sales representatives shall report to the scientific units under para. 1 any information about
p.002017: the use of the medicinal products they advertise, especially with regard to adverse drug information
p.002017: drug reactions reported to them by medical
p.002017: specialists.
p.002017: Art. 245a. (New, SG No. 71/2008, effective 12.08.2008)
p.002017: medicinal products for which a marketing authorization has been granted under this Act.
p.002017: Art. 246. (1) The content of the advertisement must correspond to the data of the approved one
p.002017: when authorizing the use of the summary of product characteristics and present
p.002017: only the indications indicated in the marketing authorization.
p.002017: (2) The advertising of a medicinal product should only point to its correct one
p.002017: use by presenting objectively the therapeutic indications of the medicinal product without
p.002017: exaggerates the possibilities of treatment, prevention or diagnosis with the medicinal product.
p.002017: (3) Advertising must not contain misleading information.
p.002017: (4) (New, SG No. 71/2008, effective 12.08.2008) Advertising may not contain
p.002017: an offer and / or promise of a gift and / or other material or non-material benefit.
p.002017: (5) (New, SG No. 71/2008, effective 12.08.2008) Medical specialist or
p.002017: a person posing as a healthcare professional cannot perform directly or indirectly
p.002017: advertising of medicinal products in print and / or electronic media and on the Internet.
p.002017: Art. 247. Only medicinal products may be advertised to the public
p.002017: leave without a doctor's prescription.
p.002017: Art. 248. (Supplemented, SG No. 71/2008, effective 12.08.2008) Outside the cases under Art. 247 adverts are allowed
p.002017: vaccination campaigns conducted by marketing authorization holders, subject to the requirements of
p.002017: Art. 251 and under the conditions and in the order specified in the ordinance
p.002017: under Art. 249.
p.002017: Art. 248a. (New, SG No. 71/2008, effective 12.08.2008)
p.002017: internet of prescription medicines, except
...

p.002017: 2. medicinal products paid from the budget of the medical establishments under art. 5 of
p.002017: The Law on Health Care Facilities and the Budget of Health Care Facilities with State and / or Municipal
p.002017: participation under Art. 9 and 10 of the Medical Establishments Act;
p.002017: 3. medicinal products intended for the treatment of AIDS, infectious diseases, of
p.002017: diseases outside the scope of the Health Insurance Act, paid in accordance with Art. 82, para. 1, item 8 of
p.002017: The Health Act, as well as vaccines for compulsory immunizations and immunizations, vaccines for special indications and
p.002017: in exceptional circumstances, specific
p.002017: sera, immunoglobulins;
p.002017: 4. the marginal price of the medicinal products under Art. 261a, para. 4 by elements.
p.002017: (7) The Ministry of Health and the NHIF may submit proposals to the council
p.002017: under Art. 258, para. 1 for the review of included medicinal products in the Positive Medicinal Product
p.002017: a list under the conditions and in the order specified in the ordinance under Art. 261a, para. 5.
p.002017: (8) The National Health Insurance Fund shall pay for the medicinal products under para. 6, vol.
p.002017: 1 under the terms and procedure of the ordinance under Art. 45, para. 9 of the Health Insurance Act.
p.002017: (9) (New, SG No. 18/2014, Supplemented, SG No. 48/2015) Conditions, rules and criteria
p.002017: to include, modify and / or exclude medicinal products from the Positive Medicinal List and for
p.002017: maintaining the reimbursement status of medicinal products
p.002017: determine in the ordinance under art. 261a, para. 5.
p.002017: (10) (New, SG No. 48/2015) The medicinal products under Art. 45, para. 10, 13 and 19 of the Health Act
p.002017: insurance that has not been negotiated is not included in the Positive Drug List. The contracts for
p.002017: granting discounts go to council on
p.002017: the order specified in the ordinance under Art. 261a, para. 5.
p.002017: (11) (New, SG No. 48/2015) The medicinal products for which in the procedure under Art. 259, para. 1, item 7 is not
p.002017: prove positive when included, are excluded from
p.002017: Positive drug list.
p.002017: Art. 262a. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012,
p.002017: (in force since 21.12.2012)
p.002017: Art. 263. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 15 in 2013, is in force since 01.01.2014
p.002017: d.) With state budget funds outside the scope of compulsory health insurance may be
p.002017: pay for prescription medicines not included in the list under Art. 262,
p.002017: para. 1 required for the prevention or treatment of epidemic outbreaks, epidemics, pandemics, and
p.002017: in the presence of suspected or confirmed distribution of chemical or biological agents; or
p.002017: nuclear radiation.
p.002017: 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.002017: d.) (1) (Supplemented, SG No. 18/2014) Upon termination of the sales under Art. 54, para. 3 of a medicinal product that
p.002017: is included in the Positive Medicinal List, and when there is no international non-patent name within the relevant
p.002017: authorized for use by this law another medicinal product, the holder of the marketing authorization
p.002017: notifies the Ministry of Health and the National Board of Prices and Reimbursement in writing
p.002017: of medicinal products.
p.002017: (2) (Supplemented, SG No. 18/2014) The holder of the marketing authorization in writing
p.002017: notifies the Ministry of Health and the National Board of Prices and Reimbursement
p.002017: of medicinal products and in the event of discontinuation of sales of a medicinal product,
p.002017: the price of which is to establish a benchmark within the relevant international
p.002017: non-patent name and dosage form.
p.002017: (3) Where the product under para. 1 and 2 is intended to treat diseases that are
p.002017: shall be paid by the holder of the marketing authorization under the Health Insurance Act
p.002017: shall also notify the NHIF in writing within the time limits under para. 4.
p.002017: (4) The marketing authorization holder shall be obliged to make the notification under
p.002017: para. 1 not later than 18 months before the date of cessation of sales, but in the cases of
p.002017: para. 2 - not later than three months before the date of cessation of sales.
p.002017: (5) (Supplemented, SG No. 18/2014) Until the termination of the sales under para. 1 and 2 the holder of
p.002017: the marketing authorization is required to provide sufficient quantities of the medicinal product concerned for
p.002017: meeting health needs, unless
p.002017: when the suspension is due to any of the grounds under Art. 276 or under Art. 277.
p.002017: (6) After the expiry of the terms under para. 4 the Marketing Authorization Holder
p.002017: submit an application for the exclusion of the medicinal product from the
p.002017: Positive drug list.
p.002017: (7) Where, following the cessation of sales of the medicinal product, the holder of the
p.002017: the marketing authorization did not fulfill its obligation under para. 6, the council under art. 258, para. 1
p.002017: officially excludes him from the Positive Drug List.
p.002017: Art. 265. (1) The Council of Ministers shall establish a Transparency Committee.
p.002017: (2) (Supplemented, SG No. 60/2011, effective 05.08.2011) The composition of the Transparency Committee
p.002017: shall be determined by the Council of Ministers on the proposal of the Minister of Health. In her
p.002017: representatives of the Ministry of Health and the Ministry of Health are obligatory included
p.002017: labor and social policy, the BDA, the NHIF, the Bulgarian Medical Union, the Bulgarian Dental
p.002017: Union of the Bulgarian Pharmaceutical
p.002017: union and patient organizations and the pharmaceutical industry.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in
p.002017: (Effective 21.12.2012) A person who is a member of the Transparency Committee may not be a member of
p.002017: National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (4) The Council of Ministers shall lay down the rules and procedures for the work of the Commission
p.002017: for transparency.
p.002017: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012
p.002017: The Transparency Committee is an appealable body
p.002017: the decisions of the National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority
p.002017: ѝ.
p.002017: (3) The decisions under par. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a respective disease is without
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p.002017: their remuneration shall be determined in an ordinance of the Minister of Health.
p.002017: (2) When challenging the results of laboratory tests, they shall be made
p.002017: retesting. They shall be made upon written request from the interested party,
p.002017: made within 7 days from the date of receipt of the result of the original test.
p.002017: (3) The repeated tests under para. 2 shall be carried out by experts designated by
p.002017: the BDA's Executive Director, who did not participate in the initial test, c
p.002017: the presence of an authorized representative of the interested party.
p.002017: Art. 274. (1) The conditions and the order for blocking and withdrawal of medicinal products,
p.002017: have shown non - compliance with the requirements for quality, safety and efficacy, shall be defined in
p.002017: ordinance of the Minister of Health.
p.002017: (2) The conditions and procedure for the destruction, processing or use for others
p.002017: the goals of the medicinal products are set out in an ordinance of the Minister of Health.
p.002017: Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure proper validation of
p.002017: the processes of production and purification of medicinal products derived from human blood or human plasma,
p.002017: consistency in batch quality and ensuring, as far as technology allows, the absence of
p.002017: specific viral
p.002017: contamination.
p.002017: (2) Manufacturers shall notify the BDA of the method used to reduce or
p.002017: removal of pathogenic viruses that can be transmitted through medicinal products,
p.002017: obtained from human blood or human plasma.
p.002017: (3) The Drug Enforcement Agency shall test or send for testing to another
p.002017: official laboratory for control of medicinal products in the Republic of Bulgaria or in another
p.002017: Member State samples of the bulk / non - spilled product and / or test product or
p.002017: in the course of evaluating an application for marketing authorization under Art. 46, para. 1, item 2 or after issue
p.002017: of the marketing authorization.
p.002017: Art. 276. The Executive Director of the BDA shall, by order, suspend, revoke,
p.002017: suspend or change the marketing authorization / registration,
p.002017: when it is established that:
p.002017: 1. there is an unacceptable side effect when used properly, or
p.002017: 2. lack of therapeutic efficacy (therapeutic efficacy is lacking when
p.002017: found that the declared therapeutic results could not be obtained at the time of authorization
p.002017: for use), or
p.002017: 3. the benefit / risk balance is unfavorable when used correctly, or
p.002017: 4. the quantitative and qualitative composition of the medicinal product does not correspond to
p.002017: declarations at the time of marketing authorization, or
p.002017: 5. the data from the file under art. 27 - 32 are incorrect, or
p.002017: 6. (amend. - SG 71/08, in force from 12.08.2008) the data from the file under art. 27 - 32
p.002017: have not been supplemented or modified in accordance with the requirements of Chapter Three, Section VI, or
p.002017: 6a. (new - SG 102/2012, in force since 21.12.2012) the conditions under
p.002017: Art. 55a, 56 or 56a, or
p.002017: 6b. (new - SG 102/2012, in force since 21.12.2012) the production of the medicinal
p.002017: the product has not been produced in accordance with the described method of production under Art. 27, para. 1, Vol. 7,
p.002017: or
p.002017: 7. (amend. - SG 102/02, in force from 21.12.2012) no controls have been carried out
p.002017: tests or they are not carried out in accordance with the methods specified in Art. 27, para. 1, item 8, or
p.002017: 8. the particulars on the packaging and / or in the package leaflet are not in accordance with those approved by
p.002017: the granting of the marketing authorization;
p.002017: 9. (new - SG 71/08, in force from 12.08.2008) the holder of a permit for
p.002017: use has failed to fulfill the obligations of Article 45 (1) of Regulation (EC) No 1901/2006.
p.002017: Art. 277. (1) The Executive Director of the BDA, notwithstanding the measures under Art. 276,
p.002017: prohibits the supply of the medicinal product by order and orders its blocking
p.002017: its withdrawal from the market when:
p.002017: 1. (amend. - SG 102/02, in force from 21.12.2012) there is inadmissible undesirable
p.002017: drug reaction, or
p.002017: 2. lack of therapeutic efficacy, or
p.002017: 3. (amended, SG No. 102/2012, effective 21.12.2012) the benefit / risk ratio shall be
p.002017: unfavorable, or
p.002017: 4. the quantitative and qualitative composition of the medicinal product does not correspond to
p.002017: declarations at the time of marketing authorization, or
p.002017: 5. the control of the medicinal product and / or the constituents and the intermediate stages of
p.002017: the manufacturing process has not been completed or the requirements for which it was issued are not fulfilled
p.002017: the manufacturing authorization.
p.002017: (2) The BDA Executive Director may impose a prohibition under para. 1 and only under
p.002017: treatment of specific batches of the medicinal product.
p.002017: Art. 278. (1) The Executive Director of the BDA shall, by order, suspend or revoke it
p.002017: the authorization to use a group or all medicinal products for which it is relevant
p.002017: their place of production does not meet the requirements under which the authorization was granted
p.002017: for production.
p.002017: (2) In addition to the measures under Art. 276 may by order
p.002017: suspend the importation of a group or all medicinal products from third countries, or
p.002017: withdraw the authorization to import a group or all medicinal products when not
p.002017: comply with the requirements of Chapter Five.
p.002017: (3) In addition to the measures under Art. 276 may by order
p.002017: suspend or revoke the authorization to produce a group or all
p.002017: medicinal products which do not comply with the requirements of Chapter Five.
p.002017: Art. 279. (1) The orders under art. 276, 277 or 278 shall be served on the holder of
p.002017: the marketing authorization of the manufacturer or importer.
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p.002017: penalties.
p.002017: Art. 297. In the cases of Art. 281, 282, 283, 284, 285 and 287, the penal authority shall also order
p.002017: withdrawal of medicinal products subject to the offense in favor of the State,
p.002017: under the conditions and in the order specified in an ordinance of the Minister of Health.
p.002017: Additional provisions
p.002017: § 1. For the purposes of this Act:
p.002017: 1. (amend. - SG 102/02, in force from 02.01.2013) "Active substance" shall be any substance or
p.002017: a mixture of substances intended for use in the manufacture of a medicinal product which when used
p.002017: in its manufacture they become the active ingredient of this product, intended for the exercise of
p.002017: pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
p.002017: physiological functions
p.002017: or to make a medical diagnosis.
p.002017: 2. "Bioequivalence" is present when the medicinal products are pharmaceutical
p.002017: equivalent or pharmaceutical alternatives, and if their bioavailability after administration in
p.002017: the same molar dose is similar to such an extent that its effects in terms of efficacy and
p.002017: safety is substantially similar.
p.002017: 3. "Bioavailability" is the rate and extent at which the active substance or the therapeutically active part of it is absorbed
p.002017: of the dosage form and becomes available at the site of action. When the drug substance is intended to
p.002017: exercise a systemic therapeutic effect, bioavailability means the speed and degree at which a drug substance or
p.002017: therapeutically
p.002017: its active part is released from the dosage form and goes into general circulation.
p.002017: 4. "Researcher's Brochure" means the aggregate of clinical and non-clinical data for
p.002017: the investigational medicinal product (s) that are relevant for the test of the product or product
p.002017: products on people.
p.002017: 5. "Valid documentation" shall mean documentation which in content and completeness corresponds to
p.002017: the requirements laid down in a particular procedure under this Act.
p.002017: 6. "Substance with well established use in medical practice" is a substance for
p.002017: the following criteria may apply:
p.002017: (a) the period of proof of well-established use in medical practice is not less than 10 years from
p.002017: the date of the first systematic and documented use of the substance as a medicinal product in
p.002017: The European Union or the European Economic Community
p.002017: space;
p.002017: (b) quantitative aspects of the use of the substance, taking into account the degree of medical use
p.002017: practice, the degree of geographical use and the degree of tracking through the safety system,
p.002017: including pre-market research and scientific research published thereafter
p.002017: epidemiological literature
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p.002017: publications) and unity in the scientific community in scientific evaluations.
p.002017: 7. "Secondary packaging" is a packaging which does not come in direct contact with
p.002017: the medicinal product.
p.002017: 8. "Contracting Authority" means a natural or legal person, institution or organization which
p.002017: is responsible for initiating, managing and / or financing the clinical trial.
p.002017: 9. "Generic medicinal product" is a medicinal product which has the same qualitative and
p.002017: quantitative composition with respect to the active substances and the same dosage form as the reference
p.002017: medicinal product, and its bioequivalence with the reference medicinal product has been demonstrated to be appropriate
p.002017: bioavailability tests. The various immediate-release oral dosage forms are considered to be one
p.002017: and the same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of
p.002017: active substance are considered to be the same active substance, unless they differ significantly in their nature
p.002017: safety and / or efficiency.
p.002017: 10. "Principal Investigator" is the doctor or dentist appointed by the contracting authority, who direct
p.002017: the overall conduct of the clinical trial in accordance with the approved protocol and the Good Guideline
p.002017: clinical practice and responsible for the work of
p.002017: the researchers.
p.002017: 11. "Defined daily dose" is an average daily maintenance dose of a drug
p.002017: product for use in adults according to the primary indication of the medicinal product.
p.002017: 12. "Good clinical practice" is the set of internationally recognized ethical and
p.002017: scientific quality requirements to be met when planning, conducting, reporting and
p.002017: reporting of clinical trials.
p.002017: 13. "Good laboratory practice" is a system of internationally recognized rules
p.002017: in terms of planning conditions, processes of organizing, executing, tracking and
p.002017: documentation of laboratory tests.
p.002017: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers all
p.002017: production sides - personnel, premises, facilities, materials, documentation, quality control, and aims
p.002017: to ensure safety, efficiency and
p.002017: according to the specification.
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
p.002017: establish a state of immunity or induce passive immunity. Allergens are medicinal products that are
p.002017: intended to identify or stimulate a specific targeted change in the immunological response
p.002017: to an allergic agent.
p.002017: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002017: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative, and
p.002017: when their bioavailability after application in the same
p.002017: the molar dose is similar to a degree which is a condition of equivalent efficacy and safety.
p.002017: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and extent of
p.002017: in which the active substance or the therapeutically significant portion of the test drug reaches
p.002017: from the dosage form to the systemic
p.002017: blood circulation.
p.002017: 20. "Tested medicinal product" means the dosage form of the active substance or placebo to be tested
p.002017: or used as a comparison in a clinical trial, including authorized products
p.002017: for use, but are used for unauthorized use or for the purpose of obtaining additional information on
p.002017: the authorized form, or they are
p.002017: completed (in medicinal or packaged form) in a way other than the approved form.
p.002017: 21. "Researcher" means the doctor or dentist designated by the sponsor and the principal investigator,
p.002017: who practically conducts the clinical trial under the direction of the principal investigator according to
p.002017: the approved protocol and the Good Clinical Practice Guide at the Research Center for
p.002017: the clinical trial. If the clinical trial is conducted by a team, the investigator is the supervisor responsible for
p.002017: team and is called the Principal Investigator.
p.002017: 22. "Informed consent" is a statement of will that must be written, dated and signed in order to participate in
p.002017: a clinical trial taken completely free after being duly informed of its nature,
p.002017: significance, consequences and risks and properly documented by any person who is able to consent
p.002017: or when the person is not
p.002017: able to give his consent - from his legal representative.
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p.002017: for use as a medicinal product in the European Union;
p.002017: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that is
p.002017: has been authorized for use as a medicinal product in the European Union but differs in
p.002017: the safety and efficacy of a previously authorized substance;
p.002017: (c) a biological substance which has been authorized for use as a medicinal product in
p.002017: European Union, but with a different molecular structure, with different origins in terms of
p.002017: the source material or is obtained through a different manufacturing process;
p.002017: (d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which have not been
p.002017: authorized as a medicinal product in the European Union, or the mechanism for pairing molecules
p.002017: and radionuclides was not allowed in
p.002017: The European Union.
p.002017: 40. "Adverse event" means any adverse change in health status,
p.002017: observed when administering a medicinal product to a patient or clinical participant
p.002017: a test that is not necessarily causally related to this treatment.
p.002017: 41. (amend. - SG 102/2012, in force since 21.12.2012) "Adverse drug reaction" is any undesirable and
p.002017: unexpected response to a medicinal product. In the case of a clinical trial - any undesirable or unforeseen
p.002017: response to the investigational medicinal product independently
p.002017: of the administered dose. The types of side effects are:
p.002017: (a) "unexpected" - an adverse reaction not listed in the summary of product characteristics;
p.002017: the product or whose character, weight or output does not meet the product characteristics mentioned in the summary; in
p.002017: case of clinical trial is an adverse reaction whose nature, severity or outcome do not match
p.002017: of test information
p.002017: medicinal product specified in the investigator's brochure;
p.002017: (b) "suspected" - an adverse reaction for which the notifier or the holder
p.002017: of the Marketing Authorization implies that there is a possible causal link with
p.002017: the received medicinal product;
p.002017: (c) "serious" - any adverse effect on a health condition which has caused the death,
p.002017: imminent danger to life, hospitalization or prolongation of hospitalization, significant or
p.002017: permanent disability, disability and congenital
p.002017: anomalies;
p.002017: (d) combinations of reactions under letters "a", "b" and "c".
p.002017: 42. "Common name" means the international non-patent name of a medicinal or excipient
p.002017: (INN) recommended by WHO; if not, the name in the European Pharmacopoeia is used, if there
p.002017: missing - another pharmacopoeial name; when not
p.002017: pharmacopoeial name, the usual accepted name is used.
p.002017: 42a. (new - SG 102/2012, in force since 21.12.2012) "Main documentation of the system for
p.002017: Drug Safety Tracking "is a detailed description of the drug tracking system
p.002017: the safety used by the holder of the
p.002017: use in relation to one or more authorized medicinal products.
p.002017: 42b. (new - SG 48/2015) "Assessment of health technologies" is:
p.002017: (a) a form of research policy exploring the short-term
p.002017: and the long-term results associated with the implementation of health technologies and aims to
p.002017: provided information on alternative health strategies;
p.002017: (b) a multidisciplinary activity that systematically assesses technical characteristics,
p.002017: safety, clinical efficacy and effectiveness, cost, value effectiveness, organizational, social,
p.002017: the legal and ethical implications of the administration of medicinal products in health care and focus
p.002017: on clinical and economic value, the analysis being comparable to existing or
p.002017: best to
p.002017: currently an alternative.
p.002017: 43. "Batch" means the specified quantity of the medicine manufactured in accordance with
p.002017: a reproducible technological scheme has been established to provide the required batch
p.002017: homogeneity with respect to the required control parameters.
p.002017: 43a. (new, SG No. 102/2012, effective 21.12.2012) "Risk Management Plan"
p.002017: is a detailed description of the risk management system.
p.002017: 44. "Maintenance of the authorization for a medicinal product" includes all
p.002017: necessary activities to maintain the current registration status of the medicinal product
p.002017: product, including drug safety monitoring.
p.002017: 44a. (new - SG 48/2015) "Maintenance of reimbursement status" is an assessment of
p.002017: medicinal product on the basis of evidence of efficacy, therapeutic efficacy,
p.002017: safety and analysis of pharmacoeconomic indicators.
p.002017: 45. "Benefit" is the positive result / therapeutic efficacy of the medicinal product
p.002017: for an individual patient, a group of patients, or for the community. Quantification of expected
p.002017: the benefit involves an approximate calculation of the probability of this positive result.
p.002017: 46. ​​(amend. - SG 102/02, in force from 02.01.2013) "Excipient" shall be any
p.002017: an ingredient of a medicinal product other than the active substance and the packaging material.
p.002017: 47. "Post-marketing study" means any study conducted using the
p.002017: the medicinal product within the approved summary of product characteristics during the period
p.002017: after authorization for use.
p.002017: 47a. (new - SG 102/2012, in force from 02.01.2013) "Mediation in the field of medicinal products" are
p.002017: all activities except for the conclusion of a contract for the purchase or sale of medicinal products
p.002017: of wholesale, which do not involve physical holding and which are independently negotiated
p.002017: and on behalf of another
p.002017: legal or natural person.
p.002017: 48. (amend. - SG 102/2012, in force since 21.12.2012) "Post-marketing safety study" is any
p.002017: a study relating to an authorized medicinal product to identify itself,
p.002017: characterize or determine the degree of safety risk, confirm the profile of
p.002017: the safety of the medicinal product
...

p.002017: 59. "Herbal medicinal product" is a medicinal product containing as medicinal substances
p.002017: one or more herbal substances or one or more herbal preparations or one or more
p.002017: plant matter in combination with one or more
p.002017: herbal preparations.
p.002017: 60. "Vegetable substances" are mainly plants or parts of plants, algae, fungi, lichens, which are whole,
p.002017: broken or chopped, and used in the raw state, usually in the dried state, but sometimes also fresh.
p.002017: Some exudates that have not undergone specific treatment also apply to plant substances.
p.002017: The plant matter must have a specific botanical scientific name for the plant, from
p.002017: who
p.002017: originate according to the binomial system (genus, species, variety and author).
p.002017: 61. "Vegetable preparation" means the product obtained after extraction, distillation, squeezing, fractionation,
p.002017: purification, concentration or fermentation of the plant substance. The herbal preparation may be
p.002017: also ground or powdered vegetable
p.002017: substances, tinctures, extracts, essential oils, processed vegetable fluids / juices.
p.002017: 62. "Rare diseases" are diseases that are characterized by a frequency of
p.002017: prevalence no higher than 5 in 10,000 people.
p.002017: 63. "Reference medicinal product" is a medicinal product authorized in accordance with Art. 23 c
p.002017: compliance with the requirements of Art. 27.
p.002017: 64. "Defined daily dose reference value" for an international non-patent name with the relevant
p.002017: Anatomy Therapeutic Drug Classification Formula is the Lowest Value for a Defined Daily
p.002017: dose determined on the basis of defined daily dose values ​​for the different medicinal products for
p.002017: the relevant international non - patent name with the relevant dosage form
p.002017: anatomic therapy
p.002017: classification of medicines.
p.002017: 65. "Therapeutic course reference value" is the lowest therapeutic value
p.002017: a course determined on the basis of the values ​​of a therapeutic course of medicines internationally
p.002017: non-patent name with appropriate dosage form.
p.002017: 66. "Risk in use of a medicinal product" is:
p.002017: (a) the risk to the health of the patient or the risk to the health of the population associated with
p.002017: the quality, safety or efficacy of the medicinal product;
p.002017: (b) the risk of adverse effects on the environment.
p.002017: 67. "Serious adverse event" is any adverse change in health status that is
p.002017: causing fatal outcome, imminent danger to life, hospitalization or prolongation of
p.002017: hospitalization period, significant or lasting
p.002017: disability, disability and congenital anomalies.
p.002017: 68. "Batch Release Certificate" is a document issued by
p.002017: the qualified person of the manufacturer or importer for each individual lot and includes
p.002017: requirements in accordance with the specification as well as all test results for
p.002017: batch release.
p.002017: 69. "Certificate of additional protection" is a document that provides additional
p.002017: patent protection of the medicinal product for a maximum of 5 years after the expiry date of
p.002017: the basic patent.
p.002017: 69a. (new, SG No. 102/2012, effective 21.12.2012) "Risk Management System" is
p.002017: a system of pharmacovigilance measures and activities designed to
p.002017: identifying, characterizing, preventing or minimizing drug-related risks
p.002017: product, including an evaluation of the effectiveness of these
p.002017: activities and measures.
p.002017: 69b. (new - SG 102/2012, in force since 21.12.2012) "Tracking system of
p.002017: 'safety' is a system used by the marketing authorization holder and
p.002017: BDA for the accomplishment of the tasks and responsibilities of Chapter Eight intended for implementation
p.002017: monitoring the safety of authorized medicinal products and detection
p.002017: of any change in the benefit / risk ratio.
p.002017: 70. "Emergency restrictive safety measures" are temporary changes to product information with respect to
p.002017: one or more parts of the summary of product characteristics, indications, method of administration, contraindications
p.002017: and warnings that result from a new one
p.002017: information related to the safe use of the medicinal product.
p.002017: 71. "Spontaneous message" is a voluntarily sent message about suspected unwanted
p.002017: reaction when using the medicinal product to the marketing authorization holder, up to
p.002017: authorities for the supervision of medicinal products or other organizations not originating in
p.002017: a survey or other organized information gathering system.
p.002017: 72. "Shelf life of a medicinal product" is the time interval at which, if stored at
p.002017: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002017: based on stability studies of several batches of
p.002017: the finished form.
p.002017: 73. (amend. - SG 71/08, in force from 12.08.2008) "Relevant medicinal product of
p.002017: herbal medicinal product "is a product that contains the same active substances, regardless of composition
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
...

p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
p.002017: are sufficient to satisfy the nutritional needs of these infants up to
p.002017: the moment of introduction of suitable supplementary food.
p.002017: 88. (new - SG 41/09, in force from 02.06.2009) "Transitional foods" are foods,
p.002017: intended for the specific nutritional use of infants when administered appropriate
p.002017: supplemental food and which constitute the main liquid food of progressively increasing
p.002017: are the variety of foods in these infants.
p.002017: 89. (new - SG 12/11, in force from 08.02.2011) "Type IA change" is a change with
p.002017: minimal or no impact on quality, safety or efficacy
p.002017: of the respective medicinal product.
p.002017: 90. (new - SG 12/11, in force from 08.02.2011) "Type IB change" is a change,
p.002017: which is neither a Type IA nor a Type II change nor an extension of the authorization of
p.002017: use.
p.002017: 91. (new - SG 12/11, in force from 08.02.2011) "Type II change" is a change that does not
p.002017: is an extension of the marketing authorization and which can have a significant impact
p.002017: on the quality, safety or efficacy of the person concerned
p.002017: medicine.
p.002017: 92. (new - SG 102/2012, in force from 21.12.2012) "Delegated act" is an act under
p.002017: the meaning of Art. 290 of the Treaty on the Functioning of the European Union.
p.002017: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
p.002017: § 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and storage
p.002017: updating of medicinal products stored by the State Agency of the State Reserve and
p.002017: wartime stocks ".
p.002017: § 4. (Supplemented, SG No. 18/2014) This Act introduces the provisions of Directive 2001/83 / EC
p.002017: The European Parliament and the Council establishing a Community code for medicinal products for human use
p.002017: use as last amended by Directive 2004/27 / EC of the European Parliament and of the Council and Directive
p.002017: 2012/26 / EU of the European Parliament and of the Council of 25 October 2012 amending Directive
p.002017: 2001/83 / EC as regards
p.002017: pharmacovigilance (OJ L 299/1 of 27 October 2012).
p.002017: § 5. Data protection deadlines for the reference medicinal products shall be applied in accordance with the provisions
p.002017: of Art. 89 of Regulation (EC) No 726/2004 of the European Parliament and the
p.002017: Council and Art. 2 of Directive 2004/27 / EC of the European Parliament and of the Council.
p.002017: § 5a. (New, SG No. 60/2011, effective 30.09.2011) (1) (Amended, SG No. 102/2012, effective from
p.002017: 21.12.2012, amend. - SG, issue. 85 of 2017) Ministry of Health, National Council on
p.002017: prices and reimbursement of medicines, the Executive Agency for Medicines and Regional
p.002017: health inspections provide the opportunity to provide information and to accept applications and documents
p.002017: this law electronically under the terms and procedure of the Electronic Document and Electronic Certification Act
p.002017: services and the eGovernment Act.
p.002017: (2) Provision of information and acceptance of applications and documents under
...

p.002017: medicinal products submitted prior to the entry into force of this Act shall be considered and terminated
p.002017: under the conditions and in the manner provided therein.
p.002017: § 12. (1) Manufacturers of medicinal products authorized to manufacture under the procedure of
p.002017: repeal of the Medicines and Pharmacies Act in the human medicine, bring the manufacturing
p.002017: its activities in accordance with the requirements of this Act with respect to a qualified person
p.002017: under Art. 148, item 2 within three months from the entry into force of this Act.
p.002017: (2) Manufacturers welded to the entry into force of this Act shall carry out
p.002017: their activity on the basis of the Medicines and Pharmacies Act issued by them under the repealed Act
p.002017: in human medicine permissions.
p.002017: § 13. (1) The persons who have received a permit for wholesale of medicines under the procedure of
p.002017: the repealed Law on Medicines and Pharmacies in Human Medicine bring its business to
p.002017: compliance with the requirements of this law within 12 months of its entry into force.
p.002017: (2) Until the granting of a wholesale marketing authorization for medicinal products under the procedure of
p.002017: this law, but no later than the expiration of the term under para. 1, the persons under para. 1 carry out the activity
p.002017: based on what was issued under the repealed Humane Medicines and Pharmacies Act
p.002017: medicine medicine wholesale authorization.
p.002017: (3) By issuing a wholesale marketing authorization for medicinal products under the procedure of
p.002017: this law, respectively, with the expiration of the term under para. 1, issued pursuant to the repealed Law on
p.002017: medicines and drugstores in the human medicine wholesale marketing authorization drug
p.002017: terminated.
p.002017: § 14. (1) The persons who have received a permit for wholesale of medicines under the repealed Law on
p.002017: medicines and pharmacies in the human medicine can import medicinal products into the territory of
p.002017: Republic of Bulgaria from third countries on the basis of this authorization pending the receipt of an import permit in accordance with the
p.002017: this law, but not later than 12
p.002017: months after its entry into force.
p.002017: (2) Within one month from the entry into force of this Act the persons under para. 1 filed with the BDA
p.002017: notification of the person who will perform the functions of a qualified person within the meaning of Art.
p.002017: 161, para. 2, Vol. 1.
p.002017: § 15. The term of validity of the wholesale marketing authorizations for medical devices,
p.002017: issued under the repealed Law on Medicines and Pharmacies in Human Medicine,
p.002017: extended ex officio until 31 December 2007.
p.002017: § 16. (Repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: § 17. (1) The drugstores welded until the entry into force of this Act shall carry out the activity
p.002017: on the basis of their certificates issued under the repealed Medicines Act and
p.002017: pharmacies in human medicine.
p.002017: (2) Applications for Issuance of Certificates for Registration of Drugstores Submitted to
p.002017: the entry into force of this Act shall be considered and concluded under the conditions and in the manner provided
p.002017: in him.
p.002017: § 18. (1) (Am. - SG, iss. 71 in 2008, effective from 14.04.2008, amended - SG, iss. 10 in 2009, in
p.002017: effective from 29.01.2009) The positive medical list under this law shall be made in the order,
p.002017: provided for therein and shall enter into force on 31 March 2009.
p.002017: (2) (amend. - SG 71/08, in force from 14.04.2008) Until the entry into force of the list under para. 1 active
p.002017: Positive Medication List is the Positive Medicinal List adopted with the Ordinance for determining positive
p.002017: medical list in the Republic of Bulgaria (promulgated, SG, issue.
p.002017: 113 of 2003; amend. 18 of 2004, issue. 4 of 2005 and issue. 8, 107 and 112 of 2007).
p.002017: (3) (New, SG No. 71/2008, effective 14.04.2008; amend. - SG 23/09, in force from 30.03.2009)
p.002017: two months after the entry into force of the list under para. 1, medical care providers prescribe and the NHIF pays
p.002017: medicinal products according to the NHIF medicinal list, adopted by Decision No. РД-УС-04-127 of December 27
p.002017: 2007 to determine the conditions to be fulfilled by medical care providers, the procedure for conclusion
p.002017: of the contracts with them and other conditions under art. 55, para. 2, items 2, 4, 6 and 7 of the Health Act
p.002017: insurance.
p.002017: § 19. (1) Within three months from the entry into force of this Act:
p.002017: 1. The Council of Ministers shall amend and supplement the Rules of Procedure of the Executive
p.002017: a drug agency in accordance with this law;
p.002017: 2. the Minister of Health issues the ordinance under Art. 82, para. 3.
p.002017: (2) Within 6 months from the entry into force of this Act, the Council of Ministers shall adopt and
p.002017: the Minister of Health issues other normative acts for the implementation of the law.
p.002017: § 20. After the expiry of the first two years of the term of office of the members of the commissions under Art. 103, 107, 259 and 261 by lot
p.002017: determine the half of the members whose term of office is terminated.
p.002017: § 21. (amend. - SG 71/08, in force from 14.04.2008) Within two years from entering into
p.002017: by virtue of this law, the BDA shall take the necessary steps to accredit its laboratory for the control of
p.002017: medicinal products and active substances of the European
p.002017: Directorate for Quality of Medicines and Health.
p.002017: § 22. (In force since 14.04.2008) In the Health Insurance Act (promulgated, SG, issue 70 of
p.002017: 1998; amend. 93 and 153 of 1998; 62, 65, 67, 69, 110 and 113 of 1999, issue. 1, 31 and 64 of 2000
p.002017: , issue. 41 of 2001, issue. 1, 54, 74, 107, 112, 119 and 120 of 2002; 8, 50, 107 and 114 of 2003
p.002017: 28, 38, 49, 70, 85 and 111 of 2004; 39, 45, 76, 99, 102, 103 and 105 of 2005; 17, 18, 30, 33, 34,
p.002017: 59, 95 and 105 of 2006; 11 of 2007, issue. 26 of 2007 - Judgment No. 3 of the Constitutional Court
p.002017: from 2007) the following amendments are made:
p.002017: 1. In Art. 45:
p.002017: (a) paragraphs 4, 5, 6 and 7 are repealed;
p.002017: (b) paragraph 8 is amended as follows:
p.002017: "(8) The conditions and procedure for payment of medicinal products included in the Positive Medicinal List under Article 262
p.002017: of the Medicinal Products in Human Medicine, Medical Devices and Dietetic Products Act
p.002017: special medical purposes are governed by an ordinance of
...

p.002000: healthcare is provided to the Executive Agency for Medicinal Products by a foster care provider
p.002000: protocol of the archive of the completed proceedings.
p.002000: (3) Within two months of the entry into force of this Act, the Ministry of Transport
p.002000: healthcare is provided to the Executive Agency for Medicinal Products by a foster care provider
p.002000: Minutes kept by the Ministry of Health of the register of licenses issued
p.002000: retail of medicines in a pharmacy.
p.002000: (4) After issuing a permit in accordance with the procedure of para. 1 Ministry of Health
p.002000: shall, within three days, ex officio send a copy of it to the BDA
p.002000: entry in the register of issued marketing authorizations for medicinal products.
p.002000: (5) Upon completion of the proceedings under para. 1 Ministry of Health
p.002000: provides the Executive Agency for Medicinal Products with a transceiver protocol
p.002000: archive.
p.002000: § 68. (1) Applications for the issue or change of certificates of registration of
p.002000: drugstores submitted prior to the entry into force of this Act shall be considered under the terms and procedure,
p.002000: provided for therein.
p.002000: (2) Within one month of the entry into force of this Act, the Executive Agency for Medicines shall provide the
p.002000: the relevant Regional Health Inspectorate with the acceptance protocol of the applications and documents submitted for
p.002000: the procedures for the issue of certificates
p.002000: for registration of drugstores, as well as the archive of completed proceedings.
p.002000: (3) Within one month of the entry into force of this Act, the Executive Agency under the
p.002000: medicines provided to the Ministry of Health with a foster care
p.002000: the record kept by the BDA of the issued drug registration certificates.
p.002000: (4) Within one month of the submission of the register under para. 3 Ministry of Agriculture
p.002000: the health register shall be drawn up and published on its web site by the national register of the issues issued up to
p.002000: the entry into force of this law certificates for registration of drugstores.
p.002000: § 69. (1) Within three months from the entry into force of this Act the procedures for
p.002000: the validation or registration of prices of medicinal products shall be effected at
p.002000: so far, by the Committee on Medicinal Products Prices.
p.002000: (2) After the expiration of the term under para. 1 The Committee on Medicinal Products Prices shall submit to the Commission the
p.002000: prices and reimbursement by transceiving protocol applications and documents submitted for the procedures under
p.002000: para. 1, as well as the archive of the completed
p.002000: procedures for approving or registering drug prices.
p.002000: (3) After the expiration of the term under para. 1 The Committee on Medicinal Products Prices shall provide the Committee on Prices and
p.002000: reimbursement with the handover protocol, kept by the commission registers of the issued decisions for
p.002000: validation or registration of prices of
p.002000: medicinal products.
p.002000: § 70. (1) Within three months from the entry into force of this Act the procedures under
p.002000: inclusion, exclusion and / or modification of Positive Medicinal Products
p.002000: the list is made so far by the Positive Drug List Committee.
p.002000: (2) After the expiration of the term under para. 1 The Committee on the Positive Medicinal List shall submit it to the Commission
p.002000: on prices and reimbursement with the transceiver protocol, the applications and documents submitted for
p.002000: the procedures under para. 1, as well as an archive of completed procedures for turning on, off and / or changes to
p.002000: medicinal products from the Positive
p.002000: medication list.
p.002000: § 71. State fees paid under the procedures under § 69, para. 1 and § 70, para. 1, are spent
p.002000: to secure the relevant administrative proceedings as well as to the activity of
p.002000: Transparency Committee.
p.002000: § 72. (1) The prices determined in accordance with Art. 258, para. 1, of medicinal products which
p.002000: as of the entry into force of this Act, they are included in the Positive Medicinal List and are also considered
p.002000: their marginal prices for their retail sale in accordance with Art. 258, para. 3.
p.002000: (2) Within three months of the entry into force of this Act, the Commission for the prices of
p.002000: medicinal products are officially deleted from the register of marginal prices
p.002000: marginal prices of the medicinal products under para. 1.
p.002000: (3) Until 31 December 2012, marketing authorization holders may not change the price of
p.002000: medicinal product with the exception of its reduction for products which were in force at the time of entry into force of this Act
p.002000: a certain price but not included in the Positive
p.002000: medication list.
p.002000: § 73. (1) With the entry into force of this Act, the established marginal prices of the medicinal products granted under
p.002000: prescription, and the registered prices of non-prescription medicinal products,
p.002000: shall be considered their registered prices under Art. 258,
p.002000: para. 2.
...

p.002000: intends to introduce for the respective medicinal product.
p.002000: (3) In the cases of para. 2 The BDA shall notify the authorization holder in writing of
p.002000: use, stating the reasons for the obligation and the time limit for the submission of the
p.002000: the detailed description of the risk management system.
p.002000: (4) Within 30 days from receipt of the notification under para. 3 the holder of
p.002000: the marketing authorization may require the BDA to provide an opportunity to submit a
p.002000: information on the imposed obligation under para. 2.
p.002000: (5) Upon receipt of the request under para. 4 The BDA sets a deadline for submission of the
p.002000: information from the Marketing Authorization Holder.
p.002000: (6) On the basis of the information provided, the BDA may confirm the imposed
p.002000: obligation under para. 2 or cancel it.
p.002000: (7) The Executive Agency for Medicinal Products shall notify the holder of the decision taken
p.002000: under para. 6.
p.002000: (8) When the BDA confirms the obligation, the Executive Director issues it ex officio
p.002000: modification of the marketing authorization by including in it the obligation imposed
p.002000: under para. 2.
p.002000: § 123. Holders of marketing authorizations for medicinal products issued
p.002000: before July 21, 2012, fulfill the obligation under Art. 192, para. 1, item 1 with effect from 21 July 2015.
p.002000: or from the date of renewal of the marketing authorization for the medicinal product concerned in
p.002000: whichever comes first.
p.002000: § 124
p.002000: finish up to date.
p.002000: § 125. (1) Until the conditions and the term under Art. 2, point 3 of Directive 2010/84 / EU
p.002000: holders of marketing authorizations send messages for serious undesirable
p.002000: drug reactions occurring on the territory of the Republic of Bulgaria, to the BDA and to
p.002000: The European Medicines Agency within 15 days of receipt.
p.002000: (2) The Drug Enforcement Agency shall verify the fulfillment of the obligation under
p.002000: para. 1.
p.002000: (3) Where the communication relates to a serious adverse reaction that has occurred
p.002000: in the territory of a third country, holders of marketing authorizations within the period of para. 1
p.002000: notify the European Medicines Agency.
p.002000: § 126. (1) Holders of marketing authorizations shall submit periodically to the BDA
p.002000: updated safety reports in accordance with the time intervals under Art. 194k, para. 3 for
p.002000: medicinal products authorized before 21 July 2012 and for
p.002000: which the frequency and filing dates of periodic safety update reports do not
p.002000: are listed as conditions in the Marketing Authorization.
p.002000: (2) The provision of para. 1 shall apply until a different frequency or other dates are specified
p.002000: submission of reports in the Marketing Authorization or until date and frequency
p.002000: according to Art. 194l - 194n.
p.002000: § 127. (1) Holders of marketing authorizations shall submit periodically updated reports on
p.002000: safety under Art. 194h, para. 1 in the register under Art. 194h, para. 3 after the expiration of 12 months from the date,
p.002000: notified by the European Medicines Agency
p.002000: its functioning.
p.002000: (2) Until the term of para. 1 the marketing authorization holders submit
p.002000: the periodic safety update reports of the BDA and the regulatory authorities of
p.002000: other Member States in which the medicinal product concerned is authorized.
p.002000: § 128. Holders of authorization / certificate for retail sale of medicinal products in a pharmacy or drug store
p.002000: Art. 234, para. 5 place on the website the logo under Art. 234, para. 6 within one year from the date of
p.002000: publication of the act under art. 85c, paragraph 3 of
p.002000: Directive 2001/83 / EC.
p.002000: § 129. The Executive Agency for Medicines shall perform the first audit of the system under Art.
p.002000: 183, para. 1 and shall send the European Commission a report on its results by 21 at the latest
p.002000: September 2013
p.002000: § 130. (1) By March 20, 2013, the proceedings initiated and closed by the Commission under
p.002000: prices and reimbursement are completed by it in the previous order.
p.002000: (2) After 1 April 2013, the proceedings pending before the Commission on prices and
p.002000: reimbursement is completed by the National Board of Prices and Reimbursement of Medicinal Products
p.002000: products under the terms and procedures of this Act.
p.002000: (3) By 31 March 2013, the Price and Reimbursement Commission shall submit to the National Price Council
p.002000: and reimbursement of medicines with a protocol of acceptance of applications and documents submitted for
p.002000: the procedures under para. 1, as well as the archive of
p.002000: completed procedures.
p.002000: (4) By 31 March 2013, the Pricing and Reimbursement Committee has provided the
p.002000: National Council on Prices and Reimbursement of Medicinal Products with Reception and Transfer
p.002000: minutes kept by the commission registers.
p.002000: § 131. (1) By March 20, 2013, fees for submitting price confirmation / price caps,
p.002000: registering prices for medicinal products to include, exclude or change medicinal products in
p.002000: The positive drug list is collected by
p.002000: The Ministry of Health in the amounts specified in the tariff under Art. 21, para. 2.
p.002000: (2) The funds collected by March 20, 2013 under para. 1 shall be expended for the activity
p.002000: the Pricing and Reimbursement Committee and the Transparency Committee.
p.002000: § 132. Within three months of the entry into force of this Act, the Council of Ministers under
p.002000: proposal of the Minister of Health:
p.002000: 1. appoints the chairman and the members of the National Council for prices and reimbursement of
p.002000: medicinal products;
p.002000: 2. adopts the Rules of Procedure of the National Council for Prices and Reimbursement of
p.002000: medicinal products.
p.002000: § 133. (1) Within two months of the entry into force of this Act the Council of Ministers
p.002000: change the tariff under Art. 21, para. 2.
p.002000: (2) By 1 April 2013 the Council of Ministers shall adopt the ordinance under Art. 261a, para. 5.
p.002000: § 134. The obligations under art. 159, para. 4, Art. 168, para. 8, Art. 168a and 168b begin
p.002000: fulfill three years after the date of publication of the delegated acts under art. 54a
p.002000: of Directive 2001/83 / EC in the Official Journal of the European Union.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 138. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: except for:
p.002000: 1. paragraph 9, item 1, letter "a", § 29 - 36, § 38 - 43, § 44 regarding Art. 167a, 167b, 167b, 167g,
p.002000: 167e, Art. 167f, para. 1 and para. 2, item 1 and art. 167h, § 65-76, § 98, paragraphs 1 and 2, § 101, paragraph 1, letters "a" and "b", § 102, 103,106
p.002000: - 108, 111, 116, § 117, item 1, letters "a", "f", "g" and "l", effective January 2, 2013
p.002000: d .;
p.002013: 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
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
p.002013: of January 1, 2013, and § 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 after the entry into force of this Act, the Minister of
p.002013: the health care shall align with it the ordinance of art. 221, para. 1 of the Law on
p.002013: 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: (Official Gazette, SG 48/15)
p.002013: § 46. (1) Within three months from the entry into force of this Act, medical scientific companies shall submit to
p.002013: National Council on Drug Price and Reimbursement
p.002013: products manuals and algorithms of art. 259, para. 1, item 4 of the Law on Medicinal Products
p.002013: in human medicine.
p.002013: (2) When, within the term of para. 1, the medical scientific companies do not submit the manuals and algorithms under Art. 259, para. 1,
p.002013: Item 4 of the Law on Medicinal Products in Human Medicine, National Council on Prices and Reimbursement
p.002013: medicinal products are organized by national consultants or other healthcare professionals,
p.002013: who have experience
p.002013: in the relevant area.
p.002013: (3) The National Council for the prices and reimbursement of medicinal products shall approve
p.002013: the manuals and algorithms of art. 259, para. 1, item 4 of the Law on Medicinal Products in
p.002013: human medicine within three months from the expiry of the term under para. 1.
p.002013: § 47. (1) Within three months from the entry into force of this Act, the Minister of
p.002013: the health care shall issue the ordinance under art. 262, para. 4 of the Medicinal Products Act in
p.002013: human medicine.
p.002013: (2) Within 6 months from the entry into force of this Act in the Positive Medicinal List
p.002013: may include medicinal products with new international non-patent names without
p.002013: to have an assessment of 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: Relevant European legislation
p.002013: DIRECTIVE 2012/26 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: October 2012 amending Directive 2001/83 / EC as regards
p.002013: pharmacovigilance
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p.002017: GENERAL
p.002017: Section I.
p.002017: general provisions
p.002017: Art. 1. This Act regulates the terms and conditions for:
p.002017: 1. authorizing the use or registration of industrially produced or
p.002017: manufactured by a method involving an industrial process, medicinal products intended for
p.002017: human medicine;
p.002017: 2. (amend. - SG 102/2012, in force from 21.12.2012) authorization of the production and
p.002017: imports of medicinal products;
p.002017: 2a. (new - SG 102/2012, in force since 21.12.2012) production, import and
p.002017: wholesale of active substances;
p.002017: 3. authorization and conduct of clinical trials;
p.002017: 4. wholesale and retail trade in medicinal products;
p.002017: 5. parallel import of medicinal products;
p.002017: 5a. (new - SG 102/2012, in force since 21.12.2012) mediation in the field of
p.002017: medicinal products;
p.002017: 5b. (new, SG No. 18/2014) export of medicinal products under the procedure of Chapter Nine
p.002017: "b";
p.002017: 6. advertising of medicinal products;
p.002017: 7. monitoring the safety of medicinal products placed on the market;
p.002017: 8. the classification of the manner of prescribing and dispensing of medicinal products;
p.002017: 9. control of production and import, wholesale and retail trade, conducting of
p.002017: clinical trials, advertising, and the safety monitoring system for the released
p.002017: medicinal products on the market;
p.002017: 10. the pricing of medicinal products;
p.002017: 11. drawing up a positive medical list.
p.002017: Art. 2. This law is intended to create the conditions that ensure the marketing of
p.002017: medicinal products that meet the requirements for quality, safety and efficacy.
p.002017: Art. 3. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal product in
p.002017: human medicine is:
p.002017: 1. any substance or combination of substances presented as possessing properties
p.002017: for the treatment or prevention of human diseases, or
p.002017: 2. any substance or combination of substances that may be used or
p.002017: applied to humans for the purpose of:
p.002017: (a) restoration, correction or alteration of physiological functions through
p.002017: pharmacological, immunological or metabolic action, or
p.002017: b) making a medical diagnosis.
p.002017: (2) A substance is any substance the origin of which may be:
p.002017: 1. human (human blood, human blood products and others);
p.002017: 2. animal (microorganisms, animal organs, extracts, secretions, toxins,
p.002017: blood products and others);
p.002017: 3. plant (microorganisms, plants, plant parts, plant extracts,
p.002017: secrets and others);
p.002017: 4. chemical (elements, natural chemical materials, synthetic or semi-synthetic)
p.002017: substances and others).
p.002017: Art. 4. When a product simultaneously meets the characteristics of a medicinal product
p.002017: a product and a product governed by another law, the requirements of that law shall apply.
p.002017: Art. 5. Medicinal products shall be classified according to
p.002017: anatomical-therapeutic-chemical classification in accordance with the requirements of the World
p.002017: Health Organization (WHO).
p.002017: Art. 6. This law shall not apply to:
p.002017: 1. hermetically sealed radionuclides;
p.002017: 2. blood, plasma or blood cells of human origin, except for plasma which is
p.002017: obtained by a method involving an industrial process.
p.002017: Art. 7. (1) Manufacturing, import, wholesale and retail trade, advertising shall be allowed
p.002017: and treatment, prevention and diagnosis with only the medicines they have received
p.002017: authorization for use in the order of:
p.002017: 1. this law, or
p.002017: 2. Regulation (EC) No 726/2004 of the European Parliament and of the Council.
p.002017: (2) It is prohibited to import, trade, treat, prevent and diagnose with
p.002017: expired medicinal products.
p.002017: (3) Holding a permit or certificate of use, production and
p.002017: clinical trials of medicinal products issued under this Act shall not be justified
p.002017: discharge under applicable law.
p.002017: Art. 8. No marketing authorization is required under this Act for:
...

p.002017: is obliged to ensure compliance with the label, patient leaflet, classification,
p.002017: advertising and monitoring the safety of the marketed medicinal product under para. 1 with the requirements of this one
p.002017: law. Information on the packaging and the package leaflet
p.002017: the medicinal product under para. 1 does not have to be in Bulgarian.
p.002017: (4) The Executive Director of the BDA shall inform the European Commission of the issues
p.002017: permissions under para. 1, the name and address of the authorization holder, as well as the date of
p.002017: termination of their validity.
p.002017: Art. 12. (1) The official pharmacopoeia in the Republic of Bulgaria is the European Pharmacopoeia.
p.002017: (2) The official pharmacopoeia may be supplemented by the requirements of the Bulgarian Pharmacopoeia
p.002017: pharmacopoeia.
p.002017: (3) The Minister of Health shall determine with an order the dates of entry into force of
p.002017: the current edition of the Official Pharmacopoeia and its Supplements.
p.002017: (4) The order under para. 3 shall be promulgated in the State Gazette and published on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 13. (1) Monographs of the European Pharmacopoeia are obligatory for all substances, preparations and
p.002017: dosage forms contained therein. In cases where there are no monographs in the European Pharmacopoeia, the
p.002017: apply the requirements of the current editions of the pharmacopoeia of the Member States, the USA and Japan, if they are in
p.002017: in accordance with the general rules of
p.002017: The European Pharmacopoeia.
p.002017: (2) Where the specification contained in a monograph of the European Pharmacopoeia or in another national
p.002017: pharmacopoeia is insufficient to ensure the quality of the substance or dosage form, the BDA may
p.002017: request that the specification be supplemented by
p.002017: the applicant / holder of the marketing authorization.
p.002017: Chapter Two.
p.002017: MANAGEMENT AND FINANCING BODIES
p.002017: Section I.
p.002017: Authorities
p.002017: Art. 14. (1) Medicinal policy is part of the state health policy in the Republic
p.002017: Bulgaria and is implemented by the Minister of Health. (2) The Minister of Health shall:
p.002017: 1. is a national coordinator for the problems of medicinal products;
p.002017: 2. participates in international bodies and organizations performing activities in the field of
p.002017: medicinal products;
p.002017: 3. (repealed, SG No. 60/2011, effective 05.08.2011, new - SG No. 102/2012, in force
p.002017: of 21.12.2012) organizes the provision of public information to patients' organizations and to
p.002017: consumer organizations on actions taken against
p.002017: counterfeiting of medicinal products;
p.002017: 4. performs other activities specified by law.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 15. (1) A Pharmacopoeial Committee shall be established to the Minister of Health as
p.002017: an advisory body on the current pharmacopoeia.
p.002017: (2) The Minister of Health at the proposal of the Executive Director of
p.002017: The BDA determines by order the composition of the Pharmacopoeial Committee and the expert groups attached to it
p.002017: and approve the rules of procedure.
p.002017: (3) The activities of the Pharmacopoeia Committee shall be financed from the budget of the Ministry
p.002017: of health.
p.002017: Art. 16. (1) A Higher Board of Pharmacy shall be established with the Minister of Health, which shall include five
p.002017: representatives appointed by the Minister of Health, five representatives of the Bulgarian
...

p.002017: legislation.
p.002017: Section II.
p.002017: Requirements to the marketing authorization documentation
p.002017: Art. 27. (1) (amend. - SG 71/08, in force from 12.08.2008) To issue a permit for
p.002017: use of a medicinal product by the person under Art. 26, para. 1 submits an application to the BDA following a model, accompanied by a file
p.002017: in the format "Electronic Common Technical Document", which
p.002017: contains:
p.002017: 1. name and address of management / permanent address of the applicant and the representative under art. 26,
p.002017: para. 2; where the applicant is a person other than the manufacturer or manufacturers, the address of
p.002017: production sites;
p.002017: 2. name of the medicinal product;
p.002017: 3. data on the qualitative and quantitative composition of the medicinal product, such as
p.002017: points to the international non-patent name recommended by the WHO, if any,
p.002017: or the corresponding chemical name;
p.002017: 4. therapeutic indications, contraindications and side effects;
p.002017: 5. (amend. - SG 71/08, in force from 12.08.2008) dosage, dosage form,
p.002017: route of administration and route of administration and proposed shelf life;
p.002017: 6. precautionary measures and safety precautions during storage of the product, at
p.002017: its administration to patients and the disposal of product waste accompanied by
p.002017: guidance on the potential risks of the medicinal product to the environment;
p.002017: 7. description of the production method;
p.002017: 8. description of the control methods used by the manufacturer;
p.002017: 8a. (new - SG 102/2012, in force from 02.01.2013) declaration that the results of the audit under art. 160, para. 2,
p.002017: conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
p.002017: compliance with the principles and guidelines for Good
p.002017: manufacturing practice; the declaration shall indicate the date on which the audit was carried out;
p.002017: 9. an assessment of the potential risk of the medicinal product to the environment for everyone
p.002017: the individual case and the measures envisaged to limit it;
p.002017: 10. results from:
p.002017: (a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.002017: (b) preclinical (toxicological and pharmacological) studies;
p.002017: (c) clinical trials;
p.002017: 11. a statement that in clinical trials conducted outside the territory of
p.002017: Member States have complied with the ethical principles of Good Clinical Practice;
p.002017: 12. (amended, SG No. 102/2012, effective 21.12.2012) summary of the system for
p.002017: pharmacovigilance monitoring, which includes the following elements:
p.002017: a) the name of the qualified person under Art. 191, curriculum vitae - education acquired
p.002017: professional experience in the field of pharmacovigilance monitoring and qualification for
p.002017: fulfillment of his duties in accordance with Chapter Eight;
p.002017: (b) any Member State in which the qualified person fulfills the obligations
p.002017: his;
p.002017: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002017: (d) the address at which the primary document of the traceability system is stored
p.002017: drug safety;
p.002017: 12a. (new - SG 102/2012, in force since 21.12.2012) statement by the applicant that
p.002017: has the necessary means to fulfill the obligations of Chapter Eight;
...

p.002017: use within the territory of the Republic
p.002017: Bulgaria.
p.002017: (4) In the cases of para. 3 the person under art. 26, para. 1 shall indicate in the application under Art. 27, para. 1
p.002017: the Member State in which the reference product is authorized or has been authorized.
p.002017: (5) In the cases of para. 3 The BDA requires the regulatory authority of the Member State,
p.002017: referred to in the application under Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and
p.002017: the qualitative composition of the reference product and, if necessary, additional documentation.
p.002017: (6) The Executive Agency for Medicinal Products makes available on request to a regulatory authority of a Member State, c
p.002017: which has been submitted for a generic reference product that has been authorized or has been authorized
p.002017: for use on the territory of the Republic
p.002017: Bulgaria, the necessary information under para. 5 within one month from the date of request.
p.002017: (7) The ten-year period under par. 2 may be extended by up to one year at the request of the holder of
p.002017: the marketing authorization for the reference medicinal product if, within the first 8 years of dispensing
p.002017: the marketing authorization was granted to the holder of the reference medicinal product for the same product
p.002017: a new therapeutic indication whose significant clinical advantages over existing treatment options are scientific
p.002017: justified.
p.002017: (8) (New - SG 12/11, in force from 08.02.2011) When originally issued for a medicinal product
p.002017: marketing authorization in accordance with Art. 23, for any change in the amount of active substance, c
p.002017: the dosage form, in the amount in the package, in the route of administration of the medicinal product, and for all
p.002017: other changes or extensions of the marketing authorization shall also be granted in accordance with
p.002017: the requirements of this Act or the original marketing authorization shall be supplemented. All these permissions are considered as
p.002017: belonging to a global marketing authorization for the medicinal product for
p.002017: the purposes of applying this Article.
p.002017: Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary
p.002017: preclinical and / or clinical trials where the medicinal product referred to in
p.002017: application:
p.002017: 1. cannot be defined as generic, or
p.002017: 2. bioavailability tests do not prove bioequivalence, or
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) there is a change in the active substance or substances in
p.002017: the amount of active substance or substances per dosage unit, the therapeutic indication, of
p.002017: the dosage form, the route of administration against
p.002017: the reference medicinal product.
p.002017: 4. (repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: (2) Where the biological medicinal product referred to in the application is similar to a reference biological
p.002017: is not eligible to be classified as a generic medicinal product because of
p.002017: different production method or different starting materials compared to reference or other
p.002017: reasons, the applicant submits to the BDA the results of the required preclinical and / or clinical trials,
p.002017: related to these conditions.
p.002017: (3) In the cases of para. 1 and 2 the documentation specified in the ordinance under Art.
p.002017: 42.
p.002017: Art. 30. (1) The person under art. 26, para. 1 insofar as it does not violate industrial and commercial rights
p.002017: property, 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.002017: defined in the ordinance under art. 42 that the active substance included in the proposed authorization for
p.002017: use of a medicinal product is well established in medical practice, has recognized efficacy and
p.002017: acceptable level of safety. In these cases, the test results and tests may be replaced
p.002017: with the relevant ones
p.002017: scientific publications.
p.002017: (2) The person under para. 1 presents the results of the necessary preclinical and clinical trials in the case of
p.002017: a medicinal product containing active substances of well - established use that has not been used in
p.002017: the proposed combination for therapeutic purposes. In this
p.002017: no documentation is submitted in respect of each individual active substance.
p.002017: (3) When an active substance within the meaning of para. 1 has a proven new therapeutic indication on the base
p.002017: significant preclinical or clinical data related to the new indication, once for a period of
p.002017: one year the next applicant cannot rely on
p.002017: data on the new indication of the active substance.
p.002017: Art. 31. In the case where a medicinal product contains active substances used in the authorized composition
p.002017: for use medicinal products but not used in the proposed combination for therapeutic purposes, the person
p.002017: under Art. 26, para. 1 presents the results of preclinical and clinical trials related to
p.002017: this combination. In this case, the applicant does not provide documentation on the safety and efficacy of each
p.002017: separately
p.002017: active substance.
p.002017: Art. 32. The holder of an authorization to use a medicinal product may authorize the use of the pharmaceutical,
p.002017: the preclinical and clinical documentation contained in the dossier of the medicinal product when evaluating
p.002017: subsequent drug applications
p.002017: products of the same qualitative and quantitative composition as regards the active substances and with
p.002017: same dosage form.
p.002017: Art. 33. Conducting the necessary studies and tests to prepare authorization documentation
p.002017: for use and subsequent practical requirements for the authorization of medicinal products under
p.002017: Art. 28 and 29 is not a patent infringement
p.002017: or the supplementary protection certificate for a medicinal product.
p.002017: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002017: 1. name of the medicinal product, quantity of active substance for dosage
p.002017: unit, dosage form;
p.002017: 2. quantitative and qualitative composition in respect of the active substances and those of
p.002017: excipients for which information is essential for the proper application of
p.002017: product; the common name or chemical description is used;
p.002017: 3. dosage form;
p.002017: 4. clinical data:
p.002017: (a) therapeutic indications;
p.002017: (b) dosage and route of administration for adults and children;
p.002017: c) contraindications;
p.002017: (d) special warnings and precautions for use; for immunological
p.002017: medicinal products - precautions for persons handling and administering them
p.002017: patients, as well as the precautions to be taken by the patient;
p.002017: (e) interactions with other medicinal products or other forms of interaction;
p.002017: (f) use in pregnancy or lactation;
p.002017: (g) effects on the ability to drive and use machines;
p.002017: h) side effects;
p.002017: i) overdose (symptoms, antidotes, emergency measures);
p.002017: 5. pharmacological data:
p.002017: a) pharmacodynamic properties;
p.002017: b) pharmacokinetic properties;
p.002017: (c) preclinical safety data;
p.002017: 6. pharmaceutical data:
p.002017: (a) a list of excipients;
p.002017: (b) major incompatibilities;
p.002017: c) shelf life; shelf life after reconstitution of the medicinal product (at
p.002017: need) or after opening the immediate packaging for the first time;
p.002017: (d) special storage instructions;
p.002017: (e) the nature and composition of the packages;
p.002017: (f) specific instructions for disposal of the remainder of the medicinal product or of
p.002017: waste materials therefrom;
p.002017: 7. the holder of the marketing authorization;
p.002017: 8. registration number;
...

p.002017: the requirements for Good Manufacturing Practice;
p.002017: 5. copies of the authorizations or marketing authorizations received for the same products in
p.002017: other Member States;
p.002017: 6. layout of the primary and / or secondary packaging of the product;
p.002017: 7. product stability data.
p.002017: (4) The data requirements under para. 3 shall be determined in the ordinance under Art. 42.
p.002017: Art. 36. (1) For homeopathic medicinal products other than those specified in Art. 35, para.
p.002017: 1, the provisions of Art. 27 - 32.
p.002017: (2) For homeopathic medicinal products under para. 1 the person under art. 26, para. 1 does not present results from preclinical and
p.002017: clinical trials where it can prove with bibliographic evidence from the scientific literature that
p.002017: homeopathic use of the medicinal product or
p.002017: the homeopathic sources that make up it are safe.
p.002017: (3) In the cases of para. 2 of the bibliographic data must be established:
p.002017: 1. the homeopathic nature of the raw materials used and their traditional uses
p.002017: at the stated statement;
p.002017: 2. the safety of the homeopathic medicinal product with respect to the degree of
p.002017: dilution of each of the ingredients.
p.002017: Section IV.
p.002017: Specific requirements for traditional herbal medicinal products
p.002017: Art. 37. (1) Certificate of registration of a traditional herbal medicinal product
p.002017: is issued under a simplified procedure if it meets the following conditions:
p.002017: 1. there are therapeutic indications inherent in the use of traditional herbs
p.002017: medicinal products, and by composition and purpose, is intended for use without
p.002017: prescribing and monitoring;
p.002017: 2. is administered only in a fixed amount of the medicinal substance in a dose
p.002017: unit and at a specific dosage;
p.002017: 3. administered orally, by inhalation (inhalation) or intended for external use
p.002017: use;
p.002017: 4. the period of traditional use according to art. 38, para. 1, item 5 has expired;
p.002017: 5. the data on the traditional use of the medicinal product prove that it is not harmful
p.002017: under certain conditions of use and the pharmacological effect or efficacy of
p.002017: the medicinal product has been established through years of use and experience.
p.002017: (2) The Executive Agency for Medicines may apply the procedure under para. 1 versus vegetable
p.002017: medicinal product containing vitamins or minerals, the safety of which has been documented
p.002017: and whose action against herbal remedies
p.002017: substances in the product with respect to its specific indications is ancillary.
p.002017: Art. 38. (1) To issue a certificate of registration of a traditional plant
p.002017: medicinal product the person under Art. 26, para. 1 shall submit an application to the BDA, accompanied by the following
p.002017: documentation:
p.002017: 1. the data referred to in Art. 27, para. 1, items 1 - 9 and item 10, letter "a";
p.002017: 2. (amend. - SG 71/08, in force from 12.08.2008) a brief description of
p.002017: the product, except for the data under art. 34, para. 1, Vol. 5;
p.002017: 3. in the case of a herbal medicinal product within the meaning of Art. 37, para. 2 or the combined vegetable
p.002017: medicinal product - the information under art. 37, para. 1, item 5 for the combination; when the individual active substances of
p.002017: the combined product is not known enough
p.002017: provide data on the traditional use of each;
p.002017: 4. a copy of the marketing authorization or the plant registration certificate
p.002017: a medicinal product issued by a Member State or a third country and / or a copy of the refusal,
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p.002017: the medicinal product.
p.002017: (4) The submitted data under para. 1, item 5 shall also be valid in cases where during the 30-year period
p.002017: use in medical practice:
p.002017: 1. the relevant medicinal product of the product applied for
p.002017: registration, has been on the market without authorization or registration for use, or
p.002017: 2. when the number of ingredients in the medicinal product for which an application has been submitted
p.002017: registration, their amount in dosage unit is reduced or decreased.
p.002017: Art. 39. (1) Where the herbal medicinal product has been on the Community market for less than 15 years, but
p.002017: meets the conditions of Art. 37, para. 1, the BDA shall submit for the opinion the documentation under Art. 38, para. 1 on
p.002017: The Committee for Herbal Medicinal Products at
p.002017: European Medicines Agency.
p.002017: (2) The Executive Agency for Medicines shall take a final decision after
p.002017: the publication of a monograph by the committee under para. 1 for product compliance with the criteria
p.002017: for registration for traditional use.
p.002017: (3) In the cases of para. 1 the term under Art. 44 stops running.
p.002017: Art. 40. The Medicines Executive Agency may require the applicant to
p.002017: herbal medicinal product to submit documentation under Art. 27 - 32 or under Art. 35.
p.002017: Art. 41. (1) (amend. - SG 71/08, in force from 12.08.2008) The Executive Agency for Medicines shall publish
p.002017: on your site's list of herbal substances,
p.002017: preparations or combinations thereof used in traditional herbal medicinal products prepared
p.002017: by the Committee for Herbal Medicinal Products at the European Medicines Agency. The list contains for everyone
p.002017: herbal substance therapeutic indications, active ingredient content per unit dose and dosage,
p.002017: route of administration and other information necessary for the safe use of the herbal substance as traditional
p.002017: medicine.
p.002017: (2) When they propose a registration product for traditional use in the application
p.002017: contains a herbal substance, preparation or a combination thereof, listed in para. 1,
p.002017: the applicant does not submit the data referred to in Art. 38, para. 1, Vols 4 - 6.
p.002017: (3) When the herbal substance, the preparation or the combination thereof are excluded from the list under para. 1, the holder
p.002017: of the registration certificate of the herbal medicinal product must submit to the BDA the full
p.002017: documentation under art. 38 within three months of
p.002017: the change.
p.002017: (4) In case the holder of the plant registration certificate
p.002017: medicinal product does not fulfill the obligation under para. 3, the BDA terminates the certificate for
p.002017: product registration.
p.002017: Section V.
p.002017: Procedure for marketing authorization and registration
p.002017: of homeopathic and traditional herbal products
p.002017: Art. 42. The requirements for the data and documents from the file under Art. 27 - 32, Art. 35, para. 3,
p.002017: Art. 36, para. 2 and Art. 38 shall be determined in an ordinance of the Minister of Health.
p.002017: Art. 43. (1) Within 30 days from the date of submission of the documentation under Art. 27 - 32, Art. 35, para. 3 or under Art. 38
p.002017: The BDA shall verify the completeness of the parts of the dossier accompanying the application and their compliance with the requirements for
p.002017: the granting of the marketing authorization or
p.002017: the certificate of registration under this Act.
p.002017: (2) When it does not identify incompleteness or inconsistencies in the submitted documentation, the BDA
p.002017: notifies the applicant in writing, within the term of para. 1 that the documentation is valid. The notification is
p.002017: indicate the date from which the term under Art. 44.
p.002017: (3) When establishing incompleteness and / or inconsistencies in the documentation under para. 1, the BDA shall notify in writing
p.002017: provide the applicant with additional information and / or provide an oral or written explanation of the findings
p.002017: incompleteness and inconsistency within 14 days of
p.002017: the date of the notification.
...

p.002017: (5) When the requirements of para. 3 have been fulfilled within the set deadline, the BDA informs
p.002017: in writing to the applicant that the documentation is valid, indicating in the notification the date from which
p.002017: the term under Art. 44.
p.002017: Art. 44. The procedure for granting the marketing authorization or the registration of
p.002017: medicinal product starts from the date specified in the notification under Art. 43, para. 2, respectively under Art.
p.002017: 43, para. 5, and ends within 210 days.
p.002017: Art. 45. (1) When an application for authorization for use or registration of a medicinal product is submitted to the BDA
p.002017: 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.002017: granted marketing authorization for the same medicinal product
p.002017: BDA shall notify the applicant in writing of the application of the procedure under Art. 74.
p.002017: (2) When an application for a marketing authorization or registration of a medicinal product for which
p.002017: compliance with the data under Art. 27, para. 1, item 19 there is information that in a Member State the dossier of the same medicinal product
p.002017: product is under evaluation, BDA does not review the documentation under Art. 27 - 32 or Art. 35, para. 3, or
p.002017: under Art. 38 and notify in writing
p.002017: the applicant for the application of the procedure under Art. 75.
p.002017: (3) For the implementation of the provisions of para. 1 and 2 the medicinal product is defined as one and
p.002017: the same authorized in another Member State or as a product under evaluation
p.002017: the dossier in another Member State where the two medicinal products:
p.002017: 1. have the same qualitative and quantitative composition as regards the active substance
p.002017: substance / substances and are available in the same dosage form, with differences in
p.002017: excipients if this does not affect safety and efficacy, and when
p.002017: 2. belong to one company, or apply for medicinal products by persons belonging to
p.002017: the same company or associations of companies, or when applying for medicinal products
p.002017: persons who have concluded a license or another
p.002017: contract or joint action related to the marketing of the respective
p.002017: medicinal product in different Member States.
p.002017: Art. 46. ​​(1) When evaluating the BDA documentation:
p.002017: 1. may test the finished product, the intermediate, or the starting materials for
p.002017: the medicinal product, and send them to the laboratory for testing in the official control system
p.002017: medicinal laboratories in a Member State to determine whether the control methods of analysis used by
p.002017: the manufacturer and described in the dossier,
p.002017: meet the requirements;
p.002017: 2. confirm, after on-the-spot verification or on the basis of documents, that the manufacturers of medicinal products from
p.002017: third countries shall carry out the production in accordance with the data described in Art. 27, para. 1, item 7, and / or perform
p.002017: control in accordance with the methods described in Art.
p.002017: 27, para. 1, Vol. 8;
p.002017: 3. checks the production establishment specified in the application when
p.002017: the manufacturer / manufacturers of the medicinal products from third countries have, by way of exception, assigned to another
p.002017: manufacturer to carry out certain stages of production or control
p.002017: of the medicinal product.
p.002017: (2) When the BDA carries out an on-site inspection of a production site, the term under Art. 44
p.002017: stops running until a report of the results of the audit is drawn up.
...

p.002017: Art. 50. (1) When the BDA finds inconsistencies in the dossier with the requirements for granting a marketing authorization or
p.002017: certificate of registration under this law, notifies the applicant in writing to provide additional information,
p.002017: related to the documentation under Art. 27 - 32 or
p.002017: under Art. 35, para. 3, or under Art. 38 and / or provide an oral or written explanation of
p.002017: incompleteness and non-compliance found within 180 days from the date of notification.
p.002017: (2) In the cases of para. 1 the term under Art. 44 ceases to run from the date of notification to
p.002017: providing the requested information.
p.002017: (3) The Executive Director of the BDA shall terminate the procedure for issuing the BDA
p.002017: of a marketing authorization or a marketing authorization for a medicinal product where:
p.002017: 1. the applicant has not provided the information under para. 1 within the specified period;
p.002017: 2. the persons under art. 26, para. 1 request termination in writing.
p.002017: Art. 51. Within 10 days from the preparation of the evaluation report under Art. 49, para. 1
p.002017: the BDA Executive Director issues a Marketing Authorization / Registration Certificate
p.002017: of the medicinal product or a reasoned refusal.
p.002017: Art. 52. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 5 days from the date of
p.002017: issuance of the marketing authorization / registration certificate in the register of art. 19, para.
p.002017: 1, item 3, the following data on the permit / certificate shall be entered:
p.002017: 1. registration number;
p.002017: 2. number and date of the marketing authorization / registration certificate of
p.002017: the medicinal product;
p.002017: 3. name of the medicinal product;
p.002017: 4. the international non-patent name of each active substance;
p.002017: 5. the name and address of the holder of the marketing authorization / certificate of use
p.002017: registration;
p.002017: 5a. (new - SG 102/2012, in force since 21.12.2012) the conditions under art. 55a, 56 and 56a,
p.002017: entered in the Marketing Authorization / Registration Certificate;
p.002017: 6. date of change of the Marketing Authorization / Certificate
p.002017: registration;
p.002017: 7. date of termination of the marketing authorization / registration certificate;
p.002017: 8. other data.
p.002017: (2) The marketing authorization / marketing authorization for the medicinal product
p.002017: shall be served on the person under Art. 26, para. 1 and shall enter into force on the date of its entry in the register under Art.
p.002017: 19, para. 1, Vol. 3.
p.002017: Art. 53. (amend. - SG 102/02, in force from 21.12.2012) (1) The Executive Agency for Medicines shall publish
p.002017: on your website within 14 days of the granting of the marketing authorization / marketing authorization
p.002017: registration of the data under art. 52, para. 1, approved
p.002017: summary of product characteristics and package leaflet.
p.002017: (2) The Executive Agency for Medicinal Products shall publish on its website
p.002017: the assessment report under art. 49, para. 1 with the reasons for the decision, deleting the data,
p.002017: representing a trade secret.
p.002017: (3) The report under para. 2 shall be accompanied by a summary of a language comprehensible to the public.
p.002017: The summary contains a section relating to the conditions of use of the medicinal product.
p.002017: Art. 54. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of the permit for
p.002017: use / the registration certificate of the medicinal product shall notify the BDA in writing of the date of
p.002017: the actual marketing of the medicinal product in
...

p.002017: change can have a significant impact on quality, safety or
p.002017: the efficacy of the medicinal product.
p.002017: Art. 61. (amend. - SG 12/11, in force from 08.02.2011) (1) For each change of type
p.002017: IA, Type IB, Type II or Extension of Holder of Marketing Authorization
p.002017: the medicinal product submits to the BDA a separate notification, respectively an application.
p.002017: (2) When a change leads to a change in the summary data of
p.002017: the product, on the packaging and / or in the package leaflet, these changes are accepted as part of the application
p.002017: change and no separate application is made for them.
p.002017: (3) The Marketing Authorization Holder may group the changes when:
p.002017: 1. notify simultaneously the same type IA changes in the conditions of one or
p.002017: more marketing authorizations;
p.002017: 2. declares several changes to the terms of the marketing authorizations at the same time,
p.002017: belonging to the global marketing authorization under Art. 28, para. 8 of the medicinal product,
p.002017: provided that the relevant changes occur in one of the following cases:
p.002017: (a) one of the changes in the group is the extension of the marketing authorization;
p.002017: (b) one of the changes in the group is a type II change and all other changes in the group are
p.002017: changes resulting from the Type II change;
p.002017: c) one of the changes in the group is a type IB change and all other changes in the group are
p.002017: changes resulting from the type IB change;
p.002017: (d) all changes in the group are only administrative changes in
p.002017: the summary of product characteristics, patient package leaflet or packaging;
p.002017: (e) All changes in the group are changes in the active documentation of the asset
p.002017: substance, vaccine antigen background, or background documentation for
p.002017: plasma;
p.002017: (f) any changes to the group are in relation to a project designed to refine
p.002017: the manufacturing process and the quality of the medicinal product concerned or its
p.002017: active substance (s);
p.002017: (g) all changes in the group are changes that affect the quality of the pandemic
p.002017: influenza vaccine;
p.002017: h) all changes in the group are changes in the pharmacovigilance system by chapter
p.002017: the eighth;
p.002017: (i) any changes to the group are the result of a specific emergency safety measure; and
p.002017: were filed in accordance with Art. 66;
p.002017: k) all changes in the group are related to the inclusion of information about a given
p.002017: pharmacotherapeutic class;
p.002017: (l) any changes in the group are the result of the evaluation of the periodic report for the
p.002017: safety;
p.002017: (m) any changes to the group result from a post-authorization study
p.002017: for use under the supervision of the marketing authorization holder;
p.002017: (n) any changes to the group are the result of the fulfillment of a condition of authorization for
p.002017: use of art. 56;
p.002017: 3. the requested changes in the conditions of the same marketing authorization do not fall under
p.002017: the cases under item 2, provided that the BDA agreed to apply the same to these changes
p.002017: procedure.
p.002017: (4) When grouping changes under para. 3, items 2 and 3, the holder of the authorization for
p.002017: use submitted to the BDA:
p.002017: 1. single notification when at least one of the changes is type IB and all others are type
p.002017: IA or type IB;
p.002017: 2. a single application where the major change is type II and none of the other changes
p.002017: is not an extension of the marketing authorization;
p.002017: 3. a single application where the major change is the extension of
p.002017: the marketing authorization.
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p.002017: BDA:
p.002017: 1. approve the change or give a reasoned refusal and notify the holder of the change
p.002017: the marketing authorization;
p.002017: 2. notify the holder of the marketing authorization whether the approved change leads to
p.002017: change of data in the issued marketing authorization; when a change is required
p.002017: marketing authorization, Art. 64a.
p.002017: (7) The Marketing Authorization Holder may apply the approved change
p.002017: type II only after the issuance of a permit for change under Art. 64a.
p.002017: Art. 64a. (New, SG No. 12/2011, effective 08.02.2011) The Executive Director of
p.002017: The BDA shall issue an authorization for change of the marketing authorization within the following period:
p.002017: 1. thirty days from the issuance of the notification under Art. 62, para. 4, Vol. 2, Art. 63, para. 2, Vol. 2,
p.002017: respectively Art. 63, para. 6, item 2 or art. 64, para. 6, item 2, when the corresponding change leads to an extension
p.002017: 6 months within the period referred to in Article 13 (1) and (2) of Council Regulation (EEC) No 1768/92
p.002017: of 18 June 1992 establishing a supplementary certificate for the protection of medicinal products
p.002017: products in accordance with Art. 36 of Regulation (EC) No 1901/2006;
p.002017: 2. sixty days from the issuance of the notification under Art. 62, para. 4, item 2 - in case of type IA changes,
p.002017: which do not require immediate notification;
p.002017: 3. sixty days from the issuance of the notification under Art. 64, para. 6, item 2 - for type II changes;
p.002017: 4. one hundred and eighty days - in all other cases.
p.002017: Art. 64b. (New - SG 12/2011, in force from 08.02.2011) (1) In case of changes related to changes in the active
p.002017: substance for the purpose of the annual update of influenza vaccines, the holder of the marketing authorization
p.002017: submit to the BDA an application, accompanied by documentation determined by the ordinance under Art. 42. Within 7 days the BDA
p.002017: checks the completeness of
p.002017: the documentation submitted.
p.002017: (2) When the application meets the requirements of para. 1, the BDA shall notify the holder
p.002017: of the marketing authorization that the application is valid, stating the date from which the period of validity
p.002017: para. 3 starts to flow.
p.002017: (3) Within 45 days of receipt of a valid application, the BDA shall evaluate the documentation
p.002017: and prepares an evaluation report.
p.002017: (4) The Executive Agency for Medicinal Products may require the authorization holder to
p.002017: use to provide clinical and stability data for the medicinal product.
p.002017: The Marketing Authorization Holder submits to the BDA the required
p.002017: data within 12 days from the expiry of the term under para. 3.
p.002017: (5) The Executive Agency for Medicines shall evaluate the documentation and take the final decision
p.002017: decision within 10 days from receipt of the data under para. 4 by issuing a change permit
p.002017: or refusal.
p.002017: Art. 65. (1) When the holder of the marketing authorization establishes a health risk
p.002017: when using the medicinal product, it shall take urgent restrictive measures and
p.002017: immediately notify the BDA in writing.
p.002017: (2) The Executive Agency for Medicines shall decide on the measures within 24 hours from
p.002017: the notification.
p.002017: (3) When the BDA does not make its decision within the term under para. 2, the measures are considered to be approved.
p.002017: (4) When the BDA determines that there is a risk to human health from the use of
p.002017: the medicinal product orders the marketing authorization holder to take
p.002017: restrictive measures immediately.
p.002017: (5) In the cases of para. 1 and 4 of the Marketing Authorization Holder
p.002017: the product agrees with the BDA on the manner and deadlines for implementation of the measures taken.
p.002017: (6) The marketing authorization holder shall submit to
p.002017: the Executive Director of the BDA application for change in accordance with Art. 64 not later than 15 days
p.002017: after the date of action.
p.002017: Art. 66. (1) (amend. - SG 12/11, in force from 08.02.2011)
p.002017: marketing authorization for the medicinal product applies for the extension of
p.002017: the marketing authorization issued for:
p.002017: 1. change of active substance (s):
p.002017: (a) replacement of a chemically active substance with a different complex / derivative including
p.002017: salt / ester, with the same therapeutic moiety as the characteristics of
p.002017: efficacy / safety do not differ significantly;
p.002017: b) replacement with different isomer, different mixture of isomers, replacement of mixture with isolated
p.002017: isomer (for example of a single enantiomer racemate), wherein the characteristics of
p.002017: efficiency / safety do not differ significantly;
p.002017: (c) replacement of a biologically active substance with one having a slightly different molecular structure,
p.002017: in which the performance / safety characteristics do not differ significantly, except for
p.002017: changes in the active substance of seasonal,
p.002017: a pre-pandemic or pandemic influenza vaccine for human use;
p.002017: (d) modification of the vector used to produce the antigen or starting material,
p.002017: including a new core cell bank from another source, where the features of
p.002017: efficiency / safety do not differ significantly;
p.002017: (e) a new ligand or binding mechanism for a radiopharmaceutical in which
p.002017: the performance / safety characteristics do not differ significantly;
p.002017: (f) a change in the extraction solvent or in the ratio of vegetable
p.002017: substance / herbal preparation in which the efficacy / safety characteristics are not
p.002017: differ significantly;
p.002017: 2. change in the amount of active substance, dosage form and route of
p.002017: introduction:
p.002017: (a) change in bioavailability;
p.002017: (b) a change in pharmacokinetics, such as a change in the rate of release;
p.002017: (c) modification or addition of a new amount of the active substance / activity;
p.002017: (d) modifying or adding a new dosage form;
p.002017: e) change or addition of a new route of administration - in parenteral administration
p.002017: a distinction needs to be made between intraarterial, intravenous, intramuscular,
p.002017: subcutaneous and other routes of administration.
p.002017: (2) The application under para. 1 shall be submitted together with the documentation under Art. 27, para. 1, Vol. 10,
p.002017: related to the changes under par. 1.
p.002017: (3) The requirements to the documentation under para. 2 shall be determined in the ordinance under art. 42.
p.002017: (4) The name of the medicinal product in the marketing authorization granted
p.002017: the scope of the original marketing authorization is not changed.
p.002017: (5) Authorization to extend the scope of an authorization already granted for
p.002017: use of a medicinal product shall be carried out under the conditions and in accordance with Art. 49 - 51.
p.002017: Art. 67. (1) The holder of the marketing authorization for the medicinal product shall file
p.002017: application for a new marketing authorization for:
p.002017: 1. the addition or removal of one or more active substances, including
p.002017: antigenic components for vaccines;
p.002017: 2. a change in the quality of the active substance indicated in the dossier which is being modified
p.002017: substantially the safety and efficacy characteristics of the medicinal product, and
p.002017: the changed substance is defined as new;
p.002017: 3. adding a new or changing existing indication for treatment,
p.002017: prevention or diagnosis in another therapeutic area.
p.002017: (2) (New, SG No. 71/2008, effective 12.08.2008) The holder of the marketing authorization for
p.002017: the medicinal product applies for a new marketing authorization when the application is made
p.002017: the renewal of the marketing authorization was not filed within the time limit
p.002017: under Art. 59a, para. 1.
p.002017: (3) (Renumbered from Paragraph (2), SG No. 71/2008, effective 12.08.2008)
p.002017: is accompanied by documentation specified in the ordinance under Art. 42.
p.002017: (4) (Renumbered from Paragraph (3), Supplemented, SG No. 71/2008, effective 12.08.2008).
p.002017: 1 and 2 the procedure of art. 49 - 51.
p.002017: Art. 68. (amend. - SG 102/02, in force from 21.12.2012) (1) The holder of
p.002017: the Marketing Authorization / Marketing Authorization is required to:
p.002017: 1. take into account the achievements of scientific and technical progress and introduce all necessary
p.002017: changes in the documentation under Art. 27, para. 1, items 7 and 8 for the purpose of manufacturing the medicinal product
p.002017: and controls according to conventional scientific methods; changes are made in the order of chapters
p.002017: third and fifth;
p.002017: 2. immediately submit to the BDA any new information that may necessitate a change to
p.002017: the data and documents under art. 27 - 32 and in the summary of product characteristics;
p.002017: 3. immediately inform the BDA of any prohibition or restriction imposed by regulatory authorities of other countries in the
p.002017: which medicinal product has been placed on the market, the reasons for which such measures have been imposed, and
p.002017: any other new information you may have
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p.002017: the chairman of the Central Ethics Committee may invite the contracting authority or
p.002017: the principal investigator.
p.002017: (7) The Council of Ministers, upon a proposal by the Minister of Health, shall designate with
p.002017: Rules of Procedure of the Central Ethics Committee.
p.002017: Art. 108. (1) A member of the Central Ethics Committee may not be appointed to the same
p.002017: committee for more than two consecutive terms. The term of office is 4 years.
p.002017: (2) Every two years, one-half of the composition of the Central Ethics Committee shall be
p.002017: is updating.
p.002017: Section IV.
p.002017: Permission to conduct a clinical trial
p.002017: Art. 109. A clinical trial may begin when the following conditions are fulfilled:
p.002017: 1. the relevant ethics committee has given a favorable opinion, and
p.002017: 2. the Executive Director of the BDA has issued a written permit for its conduct,
p.002017: when any of the tested medicinal products is:
p.002017: (a) a gene therapy medicinal product;
p.002017: (b) somatic cell therapy medicinal product;
p.002017: (c) a medicinal product containing genetically modified organisms;
p.002017: (d) a high-tech medicinal product as defined in the Annex to the Regulation
p.002017: (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: (e) a medicinal product containing a biologically active substance (s)
p.002017: human or of animal origin or containing biological or human components
p.002017: animal origin, or in the manufacture of which such components are used, or
p.002017: 3. within the period specified by the law, the assignor has not been notified in writing by the BDA that
p.002017: the test cannot be conducted - for medicinal products other than those under item 2.
p.002017: Art. 110. (1) In order to obtain an opinion, the principal or coordinating researcher and
p.002017: the assignor shall submit to the respective ethics committee under art. 103
p.002017: 1. administrative documentation;
p.002017: 2. information about a participant;
p.002017: 3. documentation of the test report;
p.002017: 4. documentation of the tested medicinal product / products;
p.002017: 5. documentation of technical requirements and personnel;
p.002017: 6. data on the financing and the administrative organization of the test.
p.002017: (2) The content, form and requirements for the documentation under para. 1 are defined in
p.002017: the ordinance under Art. 82, para. 3.
p.002017: Art. 111. (1) The Ethics Committee shall prepare an opinion, having regard to the following:
p.002017: 1. the importance of the clinical trial;
p.002017: 2. the positive assessment of the ratio of expected benefits and risks according to Art.
p.002017: 90, item 1 and the motivation of the conclusions;
p.002017: 3. the clinical trial protocol;
p.002017: 4. the suitability of the principal investigator and the research team for the conduct
p.002017: the clinical trial;
p.002017: 5. the researcher's brochure;
p.002017: 6. availability of the necessary equipment and its corresponding quality;
...

p.002017: the register under Art. 167d the applicant submits to the BDA an application in the form approved by the executive
p.002017: Director of the BDA, which contains:
p.002017: 1. name, seat and address of management of the person under art. 167a;
p.002017: 2. a list of the active substances to be imported, manufactured or marketed;
p.002017: 3. the activities that the person under art. 167a will perform;
p.002017: 4. the address of the premises and the data on the technical equipment for the implementation of
p.002017: the activities of the persons under Art. 167a.
p.002017: (2) To the application under para. 1 shall apply:
p.002017: 1. data on the unique identification code of the trader and for the companies registered
p.002017: in a Member State - a document for current registration under national law issued
p.002017: by a competent authority of the country concerned;
p.002017: 2. document for paid fee under Art. 21, para. 2.
p.002017: (3) Within 60 days of receipt of the application and documentation under para. 1 and 2 of the BDA
p.002017: basis of risk assessment:
p.002017: 1. enter the person under Art. 167a in the register under Art. 167d, of which he informs him or
p.002017: 2. notify of the date of inspection for conformity assessment of
p.002017: the conditions for carrying out the activities under Art. 167a with the requirements of Good Manufacturing
p.002017: practice of art. 152, para. 1 and the Good Distribution Practices of Active Substances under Art. 198.
p.002017: (4) Where, as a result of the inspection under para. 3, item 2 BDA has established compliance with
p.002017: the requirements of Good Manufacturing Practice under Art. 152, para. 1 and Good Distributor
p.002017: active substance practices under Art. 198, it shall enter the applicant in the register under Art. 167g for which it
p.002017: informs.
p.002017: (5) The expenses for carrying out the inspection under para. 3, item 2 shall be at the expense of the applicant.
p.002017: (6) For carrying out the inspection under para. 3, item 2 the applicant shall pay a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: (7) In the cases of para. 3, item 1 and para. 4 the applicant may commence the activity
p.002017: after entry in the register under Art. 167g.
p.002017: Art. 167c. (New, SG No. 102/2012, effective 02/01/2013) When, within the term of art. 167b,
p.002017: para. 3 The BDA did not inform that an inspection would be carried out, the applicant could start
p.002017: carrying out the activity.
p.002017: Art. 167g. (New, SG No. 102/2012, effective 02.01.2013) (1) The Executive
p.002017: the medicines agency keeps a public register of importers, manufacturers and traders
p.002017: wholesale of active substances, containing:
p.002017: 1. name, seat and address of management of the person under art. 167a;
p.002017: 2. a list of the active substances that are imported, manufactured or marketed;
p.002017: 3. the activities that the person under art. 167a will perform;
p.002017: 4. address of the premises where the activities are carried out;
p.002017: 5. notes on the entered circumstances.
p.002017: (2) The Executive Agency for Medicines shall enter into the database under Art. 147
p.002017: information on registered importers, manufacturers and wholesalers of active
p.002017: substances.
p.002017: Art. 167d. (New - SG 102/02, in force from 02.01.2013) (1) The person under art. 167a
p.002017: submit to the BDA annually by 31 January a notification of changes in the information,
p.002017: entered in the register under Art. 167g.
p.002017: (2) When changes occur that may affect the quality of or
...

p.002017: Good manufacturing practice and Good distribution practices for active substances.
p.002017: (2) Importers may import active substances only if the following conditions are met:
p.002017: 1. the active substances were manufactured in accordance with Good standards
p.002017: manufacturing practices that are at least equivalent to those established by the European
p.002017: union, and
p.002017: 2. (In force from 02.07.2013) The active substances shall be accompanied in writing
p.002017: confirmation by the competent authority of the exporting country that:
p.002017: (a) Good manufacturing practice standards applicable to the site for
p.002017: production of the exported active substances are at least equivalent to those established by
p.002017: The European Union;
p.002017: (b) the production site concerned is subject to regular control and is effectively implemented by the Good
p.002017: manufacturing practice, including repeated and unannounced inspections, to ensure the protection of
p.002017: public health at least equivalent to that of
p.002017: The European Union, and
p.002017: (c) in the event of non-compliance, the exporting country will
p.002017: inform the BDA immediately.
p.002017: (3) (In force from 02.07.2013) The requirement of para. 2, item 2 shall not apply if the state
p.002017: exporter is included in the list under Art. 111b of Directive 2001/83 / EC.
p.002017: Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
p.002017: ensure the availability of medicinal products, the importer may import the active substance without the written request
p.002017: confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
p.002017: manufacturing practice where the manufacturing site of the active substance in the exporting country was
p.002017: inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines
p.002017: for good
p.002017: manufacturing practice.
p.002017: (2) In the cases of para. 1 The BDA shall notify the European Commission.
p.002017: Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of authorizations for
p.002017: proceedings, including those performing the activities of art. 168b, para. 2, are considered producers in the sense
p.002017: of § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002017: caused by a defect in the goods,
p.002017: provided for therein.
p.002017: Chapter Six.
p.002017: PACKAGING AND PACKAGE LEAFLET
p.002017: Art. 168. (1) The packaging of a medicinal product shall consist of primary and / or secondary
p.002017: packing and leaflet for the patient.
p.002017: (2) (amend. - SG 61/11, in force from 10.11.2011)
p.002017: medicinal products containing substances specified in the list under Art. 3, para. 2, item 2 of the Law on
p.002017: control of drugs and precursors is diagonally marked with two red bars and the secondary
p.002017: packaging of medicinal products containing substances from the list under Art. 3, para. 2, item 3 of the Control Act
p.002017: narcotic drugs and precursors - with two blue bars. The packaging must contain an indication that
p.002017: the medicinal product is only available at
p.002017: special medical prescription.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products included in
p.002017: the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains information
p.002017: with the following text: "This medicinal product is subject to additional monitoring". A text in front of the text is placed
p.002017: black in accordance with Article 23 (5) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, accompanied by
p.002017: from the explanatory note.
p.002017: (4) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products shall include
p.002017: a standard text asking patients to report to medical professionals or directly to
p.002017: BDA any suspected adverse drug reaction
p.002017: reaction according to the models of art. 185, para. 2, Vol. 4.
p.002017: (5) Where the medicinal product is authorized for use in the territory of the Republic
p.002017: Bulgaria, on its secondary packaging, shall be marked with a separate collection and
p.002017: recycling in accordance with the Waste Management Act and its implementing acts.
p.002017: (6) Where a medicinal product is authorized, its name shall be
p.002017: the outer carton, the dosage form and the content of the active substance in the dose
p.002017: the unit is also written in Braille.
p.002017: (7) The requirements of para. 6 shall not apply to vaccines and medicinal products in hospital
p.002017: packaging.
p.002017: (8) (New, SG No. 102/2012, effective 21.12.2012) On the outer packaging, and
p.002017: if not, on the immediate packaging of the medicinal products except
p.002017: radiopharmaceuticals, applied:
p.002017: 1. an individual identifier for the safety indicators it gives
p.002017: opportunity for wholesalers and retailers to:
p.002017: (a) verify the authenticity of the medicinal product;
p.002017: (b) identify the individual packaging;
p.002017: 2. a means by which to check the packaging of the medicinal product
p.002017: whether it was forged.
p.002017: Art. 168a. (New, SG No. 102/2012, effective 21.12.2012) (1) On the packaging of a medicinal product that
p.002017: shall be granted on medical prescription, safety indicators according to art. 168, para. 8, except
p.002017: of cases where the medicinal product is
p.002017: included in the list determined by the European Commission by a delegated act under art. 168b.
p.002017: (2) No indications for the packaging of a medicinal product dispensed without a medical prescription shall be given.
p.002017: safety under Art. 168, para. 8, except where the medicinal product is included in the list,
p.002017: designated by the European Commission by means of a delegated act
p.002017: under Art. 168b, having been assessed as being at risk of forgery.
p.002017: (3) The Medicines Executive Agency shall notify the European Commission of:
p.002017: 1. for medicinal products which are available without a prescription for which it is
p.002017: found that there was a risk of counterfeiting;
...

p.002017: 2. the holder of a production permit in compliance with the requirements of Art. 168, para.
p.002017: 8 may replace safety indicators with equivalents with respect to
p.002017: the ability to guarantee the authenticity, identification and assurance of
p.002017: evidence of tampering with the medicinal product.
p.002017: (3) Safety indicators shall be considered equivalent if:
p.002017: 1. meet the requirements laid down in the delegated acts referred to in Article 54a (2)
p.002017: of Directive 2001/83 / EC, and
p.002017: 2. are equally effective in allowing authentication; and
p.002017: the identification of medicinal products and the provision of evidence of forgery
p.002017: them.
p.002017: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of
p.002017: the medicinal product and in accordance with good manufacturing practice for medicinal products
p.002017: products.
p.002017: (5) The Medicines Executive Agency shall oversee the replacement of
p.002017: safety indicators.
p.002017: Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
p.002017: compliance with the particulars in the summary of product characteristics approved by the BDA when granting the marketing authorization
p.002017: use and meet the requirements set out in
p.002017: the ordinance under Art. 170.
p.002017: (2) The information on the packaging and the package leaflet may be in several languages, but
p.002017: one of them must be Bulgarian. The content of the information is different
p.002017: languages ​​must be identical.
p.002017: (3) The name of the medicinal product shall be written in Bulgarian
p.002017: language, and the international non-patent name of the medicinal substance is given according to
p.002017: WHO anatomical-therapeutic-chemical classification. The name and address of
p.002017: the holder of the marketing authorization may be written in Latin.
p.002017: (4) The information on the packaging and the package leaflet must be understandable to the patient
p.002017: language, be legible and indelible.
p.002017: (5) (New, SG No. 18/2014) The leaflet must be designed in such a way that it is
p.002017: clear and comprehensible, allowing the patient to take appropriate action at
p.002017: need, with the help of medical professionals.
p.002017: Art. 170. (1) (Former text of Article 170 - SG, issue 102 of 2012, in force since 01.03.2013)
p.002017: The requirements for the packaging and package leaflet of the medicinal products shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: (2) (New - SG, iss. 102 in 2012, in force since 21.12.2012, suppl. - SG, iss. 18 in 2014)
p.002017: a product authorized for use under this Act is not intended for direct delivery to the patient or
p.002017: not available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data specified in
p.002017: the ordinance under para. 1, not applied
p.002017: on the packaging or the package leaflet.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2
p.002017: The information on the packaging and the package leaflet may not be provided in English
p.002017: language.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) Delivery terms and procedure
p.002017: of the medicinal products under para. 2 shall be determined by the ordinance under art. 198.
p.002017: Chapter seven.
p.002017: CLASSIFICATION OF MEDICINAL PRODUCTS
...

p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
p.002017: the medicinal product is classified as a prescription only product.
p.002017: Art. 177. Medicinal products that do not meet the requirements of Art. 173, 174 and
p.002017: 175 and the criteria set out in the ordinance under Art. 178, are granted without medical prescription.
p.002017: Art. 178. The criteria for classification of medicinal products and the requirements for
p.002017: the documentation for making a change in the classification shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish it on the page
p.002017: your online list of prescription medicines
p.002017: the territory of the Republic of Bulgaria.
p.002017: (2) The list under para. 1 is updated annually.
p.002017: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002017: or the certificate of registration, the BDA shall review and, where necessary, amend the classification according to
p.002017: the requirements of Art. 173 and the criteria specified
p.002017: in the ordinance under art. 178.
p.002017: Art. 181. Where a change in the classification of a medicinal product on the basis of
p.002017: significant pre-clinical or clinical trials, no subsequent applicant or marketing authorization holder
p.002017: may be invoked within one year from the date of the variation authorization issued by a regulatory authority of a country
p.002017: State upon filing
p.002017: an application to change the classification of the same substance.
p.002017: Art. 182. The European Medicines Agency shall be notified annually by the Executive Agency for Medicinal Products
p.002017: the Commission and the regulatory authorities of the other Member States for changes to the
p.002017: Art. 179.
p.002017: Chapter Eight.
p.002017: PHARMACEUTICAL SAFETY TRACKING
p.002017: Section I.
p.002017: General Provisions (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 183. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the drug agency organizes and maintains a drug tracking system
p.002017: safety to fulfill the obligations under this Chapter.
p.002017: (2) The system of para. 1 is used to gather information on the risks of medicinal products
p.002017: for patients' health and public health. The information covers adverse drug reports
p.002017: reactions when using the medicinal product in accordance with the approved summary of product characteristics, and
p.002017: misuse and use information that is inconsistent with the approved summary
p.002017: product characteristics, including information on side effects observed with
p.002017: execution of
p.002017: professional duties.
p.002017: (3) The Executive Agency for Medicines shall validate, process and classify the information under para.
p.002017: 2, conducts a scientific analysis of the data collected with a view to assessing the potential for reduction and
p.002017: risk prevention and take the necessary action
p.002017: with regard to the authorization of the medicinal product.
...

p.002017: the marketing authorization;
p.002017: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002017: available data, including clinical trial data for unauthorized indications and target groups,
p.002017: which are not included in the summary of
p.002017: product;
p.002017: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002017: the holder of the marketing authorization is in possession of the volume of prescriptions, including approximate ones
p.002017: number of persons who used the medicinal product
p.002017: or exposed to it for another reason.
p.002017: (2) The content and format of the electronic periodic updated reports on
p.002017: safety is determined by Implementing Regulation (EU) No 520/2012.
p.002017: (3) The information under para. 1 shall be collected and stored in a register established in the order of a member
p.002017: 25a of Regulation (EC) No 726/2004 of the European Parliament and of the Council, and is accessible to the BDA.
p.002017: Art. 194i. (New, SG No. 102/2012, effective 21.12.2012) The holders of
p.002017: marketing authorizations / certificates for registration of medicinal products under Art. 28, 30, 35
p.002017: and 37 submit periodic safety update reports only when:
p.002017: 1. submission of a report is a condition under Art. 55a or 56, entered in the authorization for
p.002017: use / registration certificate, or
p.002017: 2. The Executive Agency for Medicinal Products or a regulatory authority of another Member State shall so request
p.002017: on the basis of safety considerations for the medicinal product or
p.002017: due to the absence of periodic safety update reports for the active substance contained in
p.002017: the medicinal product authorized
p.002017: use / registration certificate.
p.002017: Art. 194k. (New, SG No. 102/2012, effective 21.12.2012) (1) In the authorization for
p.002017: use / registration certificate is determined by the frequency of submission of periodic
p.002017: updated safety reports.
p.002017: (2) The filing dates of the reports depending on the frequency under para. 1 are calculated by
p.002017: the date of issue of the marketing authorization / registration certificate.
p.002017: (3) Periodic safety update reports shall be submitted through the following
p.002017: time intervals, except where reporting frequency is a condition of
p.002017: issuing the marketing authorization / registration certificate or is
p.002017: determined in accordance with Art. 194l, 194m and 194h:
p.002017: 1. every 6 months from the date of issue of the marketing authorization / certificate
p.002017: for the registration of a medicinal product by the date of its placing on the market;
p.002017: 2. every 6 months during the first two years from the date of placing on the market of
p.002017: the medicinal product;
p.002017: 3. once a year for the next two years;
p.002017: 4. once every three years after the fourth year from the date of placing on the market of
p.002017: the medicinal product.
p.002017: (4) Outside the cases under para. 3, periodic safety update reports are issued
p.002017: shall submit immediately upon request to the BDA or to a regulatory authority of a Member State.
p.002017: (5) Paragraphs 3 and 4 shall also apply to medicinal products authorized for use only
p.002017: the territory of the Republic of Bulgaria, which are not covered by Art. 194l.
p.002017: Art. 194l. (New, SG No. 102/2012, effective 21.12.2012) Where medicinal products which
p.002017: contain the same active substance or a combination of the same active substances, have been obtained separately
p.002017: marketing authorizations / registration certificate, frequency and filing dates for periodic updates
p.002017: safety reports may be modified and harmonized in order to carry out a uniform assessment of those reports.
p.002017: Art. 194m. (New, SG No. 102/2012, effective 21.12.2012) (1) The filing dates of
p.002017: the periodic safety update reports for the medicinal products under Art. 194l
p.002017: calculated according to the European Union reference date.
p.002017: (2) The European Union reference date under para. 1 is:
p.002017: 1. the date of the first authorization for use in the European Union of the medicinal product
p.002017: a product containing the relevant active substance or the corresponding combination of active substances
p.002017: substances, or
p.002017: 2. the earliest known date of authorization of the medicinal product,
p.002017: containing the relevant active substance or the corresponding combination of active substances, if
p.002017: the date referred to in item 1 cannot be determined.
p.002017: Art. 194n. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the permit
p.002017: for the use of medicinal products under Art. 194l may submit a reasoned request to the Committee
p.002017: medicinal products for human use, respectively to the coordination group under Art. 77, para. 2 for
p.002017: fixing a European Union reference date or changing the filing frequency of periodic updates
p.002017: safety reports
p.002017: on one of the following grounds:
p.002017: 1. reasons for public health;
p.002017: 2. to avoid duplicate assessment;
p.002017: 3. to achieve international harmonization.
p.002017: (2) the Committee for Medicinal Products for Human Use, respectively
p.002017: the coordination group of art. 77, para. 2 after consultation with the committee under Art. 56a, para. 1, v. 1
p.002017: approves the request or makes a reasoned refusal.
p.002017: (3) The filing frequency and the European Union reference date shall be fixed after
p.002017: consultation with the committee under Art. 56a, para. 1, item 1 of:
p.002017: 1. The Committee for Medicinal Products for Human Use - where at least one of the Marketing Authorizations
p.002017: for medicinal products containing the active substance concerned is provided in accordance with the centralized one
p.002017: procedure provided for in Chapter II of Title II of the
p.002017: Regulation (EC) No 726/2004 of the European Parliament and of the Council, or
p.002017: 2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
p.002017: (4) The European Union reference dates for medicinal products under
p.002017: Art. 194l and the harmonized frequency for submitting their periodic up-to-date reports
p.002017: safety shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: (5) The holder of the marketing authorization after the publication of the data under para. 4 presents to the BDA an application for
p.002017: modification of the marketing authorization for the medicinal product concerned. Any change in filing dates and on
p.002017: the frequency of submission of periodic safety update reports specified in the
p.002017: use, effective 6
p.002017: months after their date of publication.
p.002017: Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: Medicines evaluates periodic safety update reports for medicinal products for
p.002017: to determine if there are new risks, or a change in
p.002017: identified risks, or change in benefit / risk ratio.
p.002017: (2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic up-to-date reports on
p.002017: safety for medicinal products for which the Republic of Bulgaria has fulfilled the functions of a reference country
p.002017: within the meaning of Art. 76, and is determined by
p.002017: the coordination group of art. 77, para. 2.
...

p.002017: 2. prohibition of distribution of a medicinal product;
p.002017: 3. issuing a refusal to renew the marketing authorization.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para.
p.002017: 2, when notified by the marketing authorization holder that for reasons related to
p.002017: drug safety monitoring, discontinued
p.002017: the distribution of the medicinal product has either taken or intends to take action on
p.002017: it will be removed from the market or it will not take any action to renew it
p.002017: the marketing authorization issued.
p.002017: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure
p.002017: under para. 2 and in cases where it considers that for reasons related to drug monitoring
p.002017: safety, a new contraindication or reduction should be added to a medicinal product
p.002017: the recommended dose or indication
p.002017: be limited.
p.002017: (5) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products shall provide the European Medicines Agency
p.002017: medicines and regulatory authorities of other Member States all the scientific information by which
p.002017: have, as well as the data assessment performed, and
p.002017: the reasons for initiating the procedure under this section.
p.002017: (6) (Amended, SG No. 18/2014) In the cases of para. 2 - 4 European Medicines Agency
p.002017: notifies the BDA of the initiation of the procedure when the safety concerns relate to others
p.002017: medicinal products belonging to or containing the same therapeutic group
p.002017: active substance with the product specified in the information under para. 5, or where this medicinal product is authorized
p.002017: for use in another or
p.002017: in other Member States.
p.002017: (7) (amend. - SG 18/04) In the cases of para. 4 when you do not have to
p.002017: take urgent measures, the BDA applies the procedure under Art. 77 or 79b.
p.002017: (8) (New, SG No. 18/2014) The Executive Agency for Medicines shall inform
p.002017: the holder of the marketing authorization in order to initiate the procedure under this section.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases under Art. 194y, para. 2 when
p.002017: considered it necessary to take urgent measures to protect public health, BDA
p.002017: may suspend the marketing authorization and prohibit the use of the medicinal product
p.002017: the territory of the Republic of Bulgaria until the adoption of the
p.002017: final decision under art. 194h or 194h.
p.002017: (2) The Medicines Executive Agency shall notify the European Medicines Agency, the European Medicines Agency
p.002017: the Commission and the regulatory authorities of the other Member States for the measures taken under para. 1 within one working day
p.002017: day from their implementation and state the reasons for
p.002017: this.
p.002017: (3) Where the Medicines Executive Agency participates in the procedure under this section, at the request of the European Medicines Agency
p.002017: the BDA Commission takes the recommended provisional measures with regard to the Marketing Authorization for
p.002017: medicinal product or where the medicinal product is authorized under Regulation (EC) No
p.002017: 726/2004 of the European Union
p.002017: Parliament and Council - with regard to the product itself, pending the completion of the procedure.
...

p.002017: 6. immediately inform the BDA and the Marketing Authorization Holder, where applicable
p.002017: has established or suspects that the medicinal product subject to mediation is
p.002017: counterfeit;
p.002017: 7. check that the trader holds a wholesale trade permit with
p.002017: medical products;
p.002017: 8. verify that the manufacturer or importer holds an authorization for
p.002017: production / import;
p.002017: 9. to keep the data under item 3 for a period of at least 5 years and to provide them at
p.002017: request from the inspection bodies.
p.002017: (2) Requirements for mediation activities in the field of medicines
p.002017: products are determined by the ordinance under art. 198 and in European Commission guidance.
p.002017: Chapter Nine "a".
p.002017: PARALLEL IMPORTS OF MEDICINAL PRODUCTS (PREVIOUS SECTION II - SG, ISP.
p.002017: 71 FROM 2008, IN EFFECT OF 12/08/2008)
p.002017: Art. 213. (amend. - SG 71/08, in force from 12.08.2008) Parallel import of medicinal products
p.002017: products on the territory of the Republic of Bulgaria may be performed by a natural or legal person registered under
p.002017: Commercial law, under the law of a Member State, after obtaining a parallel import permit issued by
p.002017: the BDA Executive Director.
p.002017: Art. 214. (1) A medicinal product authorized for use in another Member State may
p.002017: shall be imported in parallel in the territory of the Republic of Bulgaria when it is identical or similar to
p.002017: medicinal product authorized for use in the Republic of Bulgaria under this Law.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 12/2011, in force from 08.02.2011)
p.002017: the meaning of para. 1 identical or similar medicinal product is the one available
p.002017: uniform qualitative and quantitative composition with respect to the active substance (s),
p.002017: comes in the same dosage form, comes in the same primary
p.002017: packaging with a similar graphic design to the package.
p.002017: Art. 215. (1) (amend. - SG 71/08, in force from 12.08.2008) For obtaining a permit for parallel
p.002017: import of a medicinal product into the territory of the Republic of Bulgaria by the person under Art. 213 applied to
p.002017: the Executive Director of the BDA, in which he indicates
p.002017: the Member State from which the medicinal product will be imported in parallel.
p.002017: (2) The following data and documents shall be attached to the application:
p.002017: 1. name, dosage form, amount of active substance in dosage form
p.002017: unit of marketing authorization for a medicinal product in the Republic of Bulgaria;
p.002017: 2. name, dosage form, amount of active substance in dosage form
p.002017: unit of medicinal product intended for parallel import;
p.002017: 3. (suppl. - SG 12/11, in force from 08.02.2011) name of the holder of
p.002017: the marketing authorization of the manufacturer, if any, other than the holder of
p.002017: the marketing authorization for the medicinal product intended for parallel import;
p.002017: 4. the number of the marketing authorization for the medicinal product in the Republic of Bulgaria and
p.002017: the authorization number of the medicinal product in the Member State of origin
p.002017: performs parallel imports;
p.002017: 5. statement on establishing the circumstances under art. 217, v. 1;
p.002017: 6. a copy of the leaflet for the patient and a sample of the medicinal product as it is
p.002017: sell in the Member State from which the parallel importation takes place, a translation of the contents of
p.002017: the leaflet in Bulgarian, accompanied by a declaration that the translation is in conformity with the original
p.002017: the leaflet;
p.002017: 7. a proposal for a leaflet for the patient for the parallel medicinal product, accompanied by a declaration,
p.002017: that the contents of the package leaflet are identical to the contents of the product leaflet authorized for use in
p.002017: The Republic of Bulgaria, with the exception of the following
p.002017: data:
p.002017: (a) the name and management address of the parallel importer;
p.002017: (b) the name of the manufacturer, where different for the two products;
p.002017: (c) a period of stability when different for the two products;
p.002017: (d) excipients, where different in the two products;
p.002017: 8. in the case of repackaging:
p.002017: a) (amend. - SG 71/08, in force from 12.08.2008) a sample of the medicinal product
p.002017: as it will be marketed in Bulgaria;
p.002017: (b) a copy of the contract between the parallel importer and the importer
...

p.002017: medicine;
p.002017: b) (amend. - SG 71/08, in force from 12.08.2008) a statement that the content of
p.002017: the leaflet under letter "a" is identical to the contents of the product leaflet authorized for
p.002017: use in the Republic of Bulgaria, except for the data under Art. 215, para. 2, item 7, letters "a" - "d";
p.002017: 4. document and report to the Marketing Authorization Holder and the BDA
p.002017: all reports of suspected adverse reactions to the medicinal product introduced
p.002017: product.
p.002017: Chapter Nine "b".
p.002017: EXPORT OF MEDICINAL PRODUCTS (NEW, SG No. 18/2014)
p.002017: Art. 217a. (New, SG No. 18/2014) (1) Export of medicinal products from the territory of the Republic of Bulgaria may
p.002017: to carry out a natural or legal person who holds a marketing authorization for a medicinal product
p.002017: products or marketing authorization holder
p.002017: production.
p.002017: (2) The holder of a manufacturing authorization may export only to
p.002017: its medicinal products.
p.002017: (3) For the purposes of this Chapter, exports are also intra - Community supplies within the framework of
p.002017: The European Union.
p.002017: (4) Export of medicinal products included in the Positive Medicinal List under Art.
p.002017: 262, para. 1, from the territory of the Republic of Bulgaria shall be made after notification to
p.002017: BDA on a case - by - case basis where the export is carried out by the holder of a
p.002017: wholesale of medicines.
p.002017: Art. 217b. (New, SG No. 18/2014) The notification under Art. 217a, para. 4 is filed by
p.002017: the Executive Director of the BDA and contains the following data:
p.002017: 1. name and address of management of the person under art. 217a, para. 1;
p.002017: 2. name, dosage form and quantity of active substance in dosage form
p.002017: unit of medicinal product intended for export;
p.002017: 3. number of the authorization for wholesale of medicinal products;
p.002017: 4. number of packages of the medicinal product intended for export;
p.002017: 5. the country where the export is planned to take place.
p.002017: Art. 217c. (New, SG No. 18/2014, declared unconstitutional by RKS No. 1 of 2015 - SG, No. 12/2015)
p.002017: (1) Upon receipt of a notification under Art. 217b BDA requires information on the medicinal product intended for export
p.002017: for a period of 6 months from the date of filing
p.002017: notification:
p.002017: 1. for the consumption of the respective medicinal product by the National Health Insurance Fund and / or by
p.002017: The Ministry of Health;
p.002017: 2. for the deliveries of the respective medicinal product in the Republic of Bulgaria by the holder of
p.002017: the marketing authorization.
p.002017: (2) The persons under para. 1 provide the information requested by the BDA within 15 days of receipt of
p.002017: the request.
p.002017: (3) The Executive Agency for Medicines shall perform an analysis of the received under para. 2 information about
p.002017: the respective medicinal product by comparing the data on the quantities used under para. 1, item 1 and
p.002017: the quantities delivered under para. 1, item 2 with the available data received in accordance with Art. 217b, item 4 for number of packages,
p.002017: intended for
p.002017: wear.
p.002017: (4) Where within 30 days from the date of receipt of the notification under Art. 217b, the executive
p.002017: the BDA director did not object to the export in writing, it is considered that there is a tacit consent for
p.002017: export.
p.002017: (5) The Executive Director of the BDA may, within the term of para. 4 to refuse by reasoned order the execution
...

p.002017: the budget of the medical establishments under art. 5 of the Medical Institutions Act and the budget of the medical establishments with
p.002017: state and / or
p.002017: municipal participation under Art. 9 and 10 of the Medical Institutions Act.
p.002017: (2) The positive medicinal list includes medicinal products classified under
p.002017: pharmacological groups according to the code of anatomical-therapeutic-chemical classification, with the relevant international ones
p.002017: non-patent names, their respective names, with the corresponding defined daily dose / therapeutic
p.002017: rate, price under art. 261a, para. 1, the marginal price of medicinal products when sold to
p.002017: retail, reference daily dose / therapeutic reference value, packaging value,
p.002017: calculated on the basis of a reference value / therapeutic course for a defined daily dose and payment level,
p.002017: needed for their treatment, as well as diseases under the International Disease Code (ICD).
p.002017: (3) For medicinal products for which there is no defined daily dose,
p.002017: the reference value is determined on the basis of therapeutic rate, concentration or volume.
p.002017: (4) (Supplemented, SG No. 48/2015) The medicinal products in the Positive Medicinal List shall be selected
p.002017: according to evidence of efficacy, therapeutic efficacy, safety and analysis of
p.002017: pharmacoeconomic indicators such as for medicines with a new international non-patent name are
p.002017: also performs health technology assessments. The assessment of health technologies is carried out under conditions and in order
p.002017: defined by an ordinance of
p.002017: the Minister of Health.
p.002017: (5) When one or more medicinal products of the same international non-patent name, the dosage form
p.002017: and concentration of the active substance, except for the medicinal products under Art. 29, already are
p.002017: included in the relevant part of the Positive
p.002017: medical list, no assessment under para. 4.
p.002017: (6) The positive medical list includes:
p.002017: 1. medicinal products intended for the treatment of diseases payable at
p.002017: the procedure of the Health Insurance Act;
p.002017: 2. medicinal products paid from the budget of the medical establishments under art. 5 of
p.002017: The Law on Health Care Facilities and the Budget of Health Care Facilities with State and / or Municipal
p.002017: participation under Art. 9 and 10 of the Medical Establishments Act;
p.002017: 3. medicinal products intended for the treatment of AIDS, infectious diseases, of
p.002017: diseases outside the scope of the Health Insurance Act, paid in accordance with Art. 82, para. 1, item 8 of
p.002017: The Health Act, as well as vaccines for compulsory immunizations and immunizations, vaccines for special indications and
p.002017: in exceptional circumstances, specific
p.002017: sera, immunoglobulins;
p.002017: 4. the marginal price of the medicinal products under Art. 261a, para. 4 by elements.
p.002017: (7) The Ministry of Health and the NHIF may submit proposals to the council
p.002017: under Art. 258, para. 1 for the review of included medicinal products in the Positive Medicinal Product
p.002017: a list under the conditions and in the order specified in the ordinance under Art. 261a, para. 5.
p.002017: (8) The National Health Insurance Fund shall pay for the medicinal products under para. 6, vol.
p.002017: 1 under the terms and procedure of the ordinance under Art. 45, para. 9 of the Health Insurance Act.
p.002017: (9) (New, SG No. 18/2014, Supplemented, SG No. 48/2015) Conditions, rules and criteria
p.002017: to include, modify and / or exclude medicinal products from the Positive Medicinal List and for
...

p.002017: (4) The Council of Ministers shall lay down the rules and procedures for the work of the Commission
p.002017: for transparency.
p.002017: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012
p.002017: The Transparency Committee is an appealable body
p.002017: the decisions of the National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority
p.002017: ѝ.
p.002017: (3) The decisions under par. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a respective disease is without
p.002017: alternative in the country, for a particular patient may be administered a medicinal product that is authorized for
p.002017: use in a Member State of the European Union,
p.002017: it is authorized for use according to the procedure of this law, but it is not distributed on the Bulgarian market.
p.002017: (2) Annually upon proposal by the medical establishments for hospital care and after the opinion of the respective
p.002017: the national consultant on the disease profile, the Minister of Health approves the list of
p.002017: the medicinal products under para. 1 which contains
p.002017: following information:
p.002017: 1. anatomical-therapeutic-chemical classification code;
p.002017: 2. an international non-patent name to which the product belongs;
p.002017: 3. disease according to the international disease code;
p.002017: 4. the dosage form and the amount of active substance;
p.002017: 5. additional information.
p.002017: (3) The list under para. 2 is published on the Ministry of Justice's website
p.002017: healthcare on the internet.
p.002017: (4) The conditions and procedure for inclusion, modification or exclusion of medicinal products in
p.002017: the list under para. 2 shall be determined by the ordinance under art. 9, para. 1.
p.002017: (5) The medicinal product under para. 1 is delivered by special order curative
p.002017: hospital care facility under the terms and procedures established by the ordinance under Art. 9, para. 1.
p.002017: (6) The head of the medical establishment under para. 5 is responsible for the implementation of
p.002017: the treatment under para. 1.
p.002017: Chapter thirteen.
p.002017: STATE CONTROLS ON MEDICINAL PRODUCTS
p.002017: Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
p.002017: 12/21/2012) The Ministry of Health supervises the state control over medicinal products.
p.002017: The direct management is carried out by the Chief State Health Inspector, by the President of
p.002017: the Council under Art. 258, para. 1, by the Executive Director of the BDA and by the Directors of the State Health Insurance Fund, which are state-owned
p.002017: control inspectors
p.002017: medicinal products.
p.002017: (2) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 in 2012, in
p.002017: (21 December 2012) The authorities responsible for the state control of medicinal products are the Council of the
p.002017: Art. 258, para. 1, BDA and RZI.
p.002017: (3) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 in 2012, in
p.002017: effective 21.12.2012) The direct control is exercised by officials - inspectors
...

p.002017: (5) The orders under para. 1 - 4 are subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 294. Who violates the provisions of this law or its implementing regulations,
p.002017: outside the cases under Art. 281 - 293, shall be punished by a fine from 1000 to 3000 levs, and in case of a repeated fine
p.002017: committing the same offense - with a fine of 3000 to 5000 BGN.
p.002017: Art. 295. (1) (amend. - SG 98/10, in force from 01.01.2011) The violations on this
p.002017: Act shall be established by acts drawn up by state inspectors of the BDA, respectively by the Health Insurance Fund.
p.002017: (2) The violations under Art. 289 shall be established by officials designated by
p.002017: the Minister of Health.
p.002017: (3) (amend. - SG 98/10, in force from 01.01.2011) The penal decrees shall be issued by the Minister
p.002017: of Health, by the Chief State Health Inspector, by the Executive Director of the BDA and by
p.002017: the directors of the SIC, depending on the subordination of
p.002017: the official who found the infringement.
p.002017: Art. 296. Drafting of acts, issuing, appealing and executing
p.002017: the penal decrees shall be executed in accordance with the procedure of the Administrative Offenses Act and
p.002017: penalties.
p.002017: Art. 297. In the cases of Art. 281, 282, 283, 284, 285 and 287, the penal authority shall also order
p.002017: withdrawal of medicinal products subject to the offense in favor of the State,
p.002017: under the conditions and in the order specified in an ordinance of the Minister of Health.
p.002017: Additional provisions
p.002017: § 1. For the purposes of this Act:
p.002017: 1. (amend. - SG 102/02, in force from 02.01.2013) "Active substance" shall be any substance or
p.002017: a mixture of substances intended for use in the manufacture of a medicinal product which when used
p.002017: in its manufacture they become the active ingredient of this product, intended for the exercise of
p.002017: pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
p.002017: physiological functions
p.002017: or to make a medical diagnosis.
p.002017: 2. "Bioequivalence" is present when the medicinal products are pharmaceutical
p.002017: equivalent or pharmaceutical alternatives, and if their bioavailability after administration in
p.002017: the same molar dose is similar to such an extent that its effects in terms of efficacy and
p.002017: safety is substantially similar.
p.002017: 3. "Bioavailability" is the rate and extent at which the active substance or the therapeutically active part of it is absorbed
p.002017: of the dosage form and becomes available at the site of action. When the drug substance is intended to
p.002017: exercise a systemic therapeutic effect, bioavailability means the speed and degree at which a drug substance or
p.002017: therapeutically
p.002017: its active part is released from the dosage form and goes into general circulation.
p.002017: 4. "Researcher's Brochure" means the aggregate of clinical and non-clinical data for
p.002017: the investigational medicinal product (s) that are relevant for the test of the product or product
p.002017: products on people.
p.002017: 5. "Valid documentation" shall mean documentation which in content and completeness corresponds to
p.002017: the requirements laid down in a particular procedure under this Act.
p.002017: 6. "Substance with well established use in medical practice" is a substance for
p.002017: the following criteria may apply:
p.002017: (a) the period of proof of well-established use in medical practice is not less than 10 years from
p.002017: the date of the first systematic and documented use of the substance as a medicinal product in
p.002017: The European Union or the European Economic Community
p.002017: space;
p.002017: (b) quantitative aspects of the use of the substance, taking into account the degree of medical use
p.002017: practice, the degree of geographical use and the degree of tracking through the safety system,
p.002017: including pre-market research and scientific research published thereafter
p.002017: epidemiological literature
p.002017: studies and, in particular, comparative epidemiological studies;
p.002017: (c) a high level of scientific interest in the use of the substance (number of scientific
p.002017: publications) and unity in the scientific community in scientific evaluations.
p.002017: 7. "Secondary packaging" is a packaging which does not come in direct contact with
p.002017: the medicinal product.
p.002017: 8. "Contracting Authority" means a natural or legal person, institution or organization which
p.002017: is responsible for initiating, managing and / or financing the clinical trial.
p.002017: 9. "Generic medicinal product" is a medicinal product which has the same qualitative and
p.002017: quantitative composition with respect to the active substances and the same dosage form as the reference
p.002017: medicinal product, and its bioequivalence with the reference medicinal product has been demonstrated to be appropriate
p.002017: bioavailability tests. The various immediate-release oral dosage forms are considered to be one
p.002017: and the same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of
p.002017: active substance are considered to be the same active substance, unless they differ significantly in their nature
p.002017: safety and / or efficiency.
p.002017: 10. "Principal Investigator" is the doctor or dentist appointed by the contracting authority, who direct
p.002017: the overall conduct of the clinical trial in accordance with the approved protocol and the Good Guideline
p.002017: clinical practice and responsible for the work of
p.002017: the researchers.
p.002017: 11. "Defined daily dose" is an average daily maintenance dose of a drug
p.002017: product for use in adults according to the primary indication of the medicinal product.
p.002017: 12. "Good clinical practice" is the set of internationally recognized ethical and
p.002017: scientific quality requirements to be met when planning, conducting, reporting and
p.002017: reporting of clinical trials.
p.002017: 13. "Good laboratory practice" is a system of internationally recognized rules
p.002017: in terms of planning conditions, processes of organizing, executing, tracking and
p.002017: documentation of laboratory tests.
p.002017: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers all
p.002017: production sides - personnel, premises, facilities, materials, documentation, quality control, and aims
p.002017: to ensure safety, efficiency and
p.002017: according to the specification.
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
p.002017: establish a state of immunity or induce passive immunity. Allergens are medicinal products that are
p.002017: intended to identify or stimulate a specific targeted change in the immunological response
p.002017: to an allergic agent.
p.002017: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002017: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative, and
p.002017: when their bioavailability after application in the same
p.002017: the molar dose is similar to a degree which is a condition of equivalent efficacy and safety.
p.002017: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and extent of
p.002017: in which the active substance or the therapeutically significant portion of the test drug reaches
p.002017: from the dosage form to the systemic
p.002017: blood circulation.
p.002017: 20. "Tested medicinal product" means the dosage form of the active substance or placebo to be tested
p.002017: or used as a comparison in a clinical trial, including authorized products
p.002017: for use, but are used for unauthorized use or for the purpose of obtaining additional information on
p.002017: the authorized form, or they are
p.002017: completed (in medicinal or packaged form) in a way other than the approved form.
p.002017: 21. "Researcher" means the doctor or dentist designated by the sponsor and the principal investigator,
p.002017: who practically conducts the clinical trial under the direction of the principal investigator according to
p.002017: the approved protocol and the Good Clinical Practice Guide at the Research Center for
p.002017: the clinical trial. If the clinical trial is conducted by a team, the investigator is the supervisor responsible for
p.002017: team and is called the Principal Investigator.
p.002017: 22. "Informed consent" is a statement of will that must be written, dated and signed in order to participate in
p.002017: a clinical trial taken completely free after being duly informed of its nature,
p.002017: significance, consequences and risks and properly documented by any person who is able to consent
p.002017: or when the person is not
p.002017: able to give his consent - from his legal representative.
p.002017: 23. "Whale" means any substance which is usually dissolved, suspended, before use,
p.002017: dilute or combine with radionuclides, resulting in the finished radioactive
p.002017: medicine.
p.002017: 24. "Clinical trial of a medicinal product" means any human study intended to
p.002017: the clinical, pharmacological and / or other pharmacodynamic effects of one or
p.002017: more tested medicinal products, and / or identify adverse reactions to one or more tested
p.002017: medicinal products, and / or to study the absorption, distribution, metabolism and excretion of one
p.002017: or more
p.002017: tested medicinal products to determine their safety and / or efficacy.
p.002017: 25. "Clinical advantage" is a significant therapeutic or diagnostic benefit of
p.002017: one medicinal product compared to a medicinal product which has already been authorized
p.002017: use.
p.002017: 26. "Coordinating researcher" means a researcher appointed to coordinate
p.002017: researchers from different centers participating in the multi-center test.
p.002017: 27. "Patient leaflet" is a leaflet containing information about the user that
p.002017: accompanies the medicinal product.
p.002017: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002017: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No 1394/2007.
p.002017: Of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and for
p.002017: amendment of the Directive
p.002017: 2001/83 / EC and Regulation (EC) No 726/2004.
p.002017: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product made from human
p.002017: blood components and by a method involving an industrial process. These include albumin, immunoglobulins,
p.002017: coagulation factors and antiproteases, solutions of
p.002017: plasma proteins, other plasma fractions or combinations thereof.
p.002017: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare
p.002017: diseases "is a product that:
p.002017: (a) is intended for the diagnosis, prophylaxis or treatment of life-threatening diseases
p.002017: diseases or progressive chronic diseases affecting no more than 5 in 10
p.002017: 000 people on the territory of the country, or
p.002017: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002017: health-damaging chronic conditions (diseases with a high incidence of incapacity for work and
p.002017: disability) and evidence was provided that the sale of the product did not provide a satisfactory one
p.002017: returns to justify the investment needed for R&D without
p.002017: incentives for
p.002017: the creator of the product, and
p.002017: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of
p.002017: the condition, or if there is one, the proposed medicinal product
p.002017: far more benefits than that and benefits for those affected by this condition.
p.002017: 30. A "dosage form" is an acceptable accepting structure containing the active substance (s) which
p.002017: may or may not include excipients obtained by the application of certain technological
p.002017: operations providing the desired healing effect and
p.002017: storage stability over the shelf life.
p.002017: 31. (amend. - SG 71/08, in force from 12.08.2008) "Person established in the territory of a Member State"
p.002017: is a legal entity registered under the civil or commercial law of a Member State or
p.002017: created by a legal act having its registered office and registered office in a Member State or in a State -
p.002017: Party to the Agreement on
p.002017: The European Economic Area.
p.002017: 32. "Highway formulation" is a prescription for a medicinal product made in a pharmacy under
p.002017: prescription from a healthcare professional or an approved prescription for a particular patient.
p.002017: 33. "International non-patent name" is the recommended name of
p.002017: the active substance approved and published by the WHO.
p.002017: 34. "Medical specialists" are doctors, doctors of dental medicine,
p.002017: master pharmacists, nurses, midwives, medical assistants, paramedics, and
p.002017: assistant pharmacist.
p.002017: 35. "Medical sales representative" is a person who has undergone special training and
p.002017: having the scientific knowledge to provide accurate and complete information on
p.002017: the medicinal product it advertises.
p.002017: 35a. (new - SG 1/2014, in force from 03.01.2014) "Medical prescription" is a prescription of
p.002017: medicinal product or medical device issued by a person practicing regulated medical
p.002017: profession within the meaning of § 1, item 1 of the additional provisions of the Law on the recognition of
p.002017: professional qualifications and what is legal
p.002017: the right to do so in the Member State where the medical prescription is issued.
p.002017: 36. "Multicenter Clinical Trial" is a clinical trial conducted under
p.002017: one protocol but in more than one center and more than one researcher. The research
p.002017: centers may be located in the territory of one Member State in more than one
p.002017: Member State and / or Member States and third countries.
p.002017: 37. "Name of a medicinal product" is the name given to the product which may
p.002017: be:
p.002017: a) freely chosen name (trade name);
p.002017: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the commercial
p.002017: the make or the name of the marketing authorization holder;
p.002017: c) (amend. - SG 12/11, in force from 08.02.2011) scientific name together with the trade name
p.002017: the make or the name of the marketing authorization holder.
p.002017: 38. "Scientific literature" is a publication / publications of the results of scientific research in
p.002017: specialized international scientific publications.
p.002017: 39. "New active substance" is:
p.002017: (a) a chemical, biological or radiopharmaceutical that has not been authorized
p.002017: for use as a medicinal product in the European Union;
p.002017: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that is
p.002017: has been authorized for use as a medicinal product in the European Union but differs in
p.002017: the safety and efficacy of a previously authorized substance;
p.002017: (c) a biological substance which has been authorized for use as a medicinal product in
p.002017: European Union, but with a different molecular structure, with different origins in terms of
p.002017: the source material or is obtained through a different manufacturing process;
p.002017: (d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which have not been
p.002017: authorized as a medicinal product in the European Union, or the mechanism for pairing molecules
p.002017: and radionuclides was not allowed in
p.002017: The European Union.
p.002017: 40. "Adverse event" means any adverse change in health status,
p.002017: observed when administering a medicinal product to a patient or clinical participant
p.002017: a test that is not necessarily causally related to this treatment.
p.002017: 41. (amend. - SG 102/2012, in force since 21.12.2012) "Adverse drug reaction" is any undesirable and
p.002017: unexpected response to a medicinal product. In the case of a clinical trial - any undesirable or unforeseen
p.002017: response to the investigational medicinal product independently
p.002017: of the administered dose. The types of side effects are:
p.002017: (a) "unexpected" - an adverse reaction not listed in the summary of product characteristics;
p.002017: the product or whose character, weight or output does not meet the product characteristics mentioned in the summary; in
p.002017: case of clinical trial is an adverse reaction whose nature, severity or outcome do not match
p.002017: of test information
p.002017: medicinal product specified in the investigator's brochure;
p.002017: (b) "suspected" - an adverse reaction for which the notifier or the holder
p.002017: of the Marketing Authorization implies that there is a possible causal link with
p.002017: the received medicinal product;
p.002017: (c) "serious" - any adverse effect on a health condition which has caused the death,
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p.002017: the legal and ethical implications of the administration of medicinal products in health care and focus
p.002017: on clinical and economic value, the analysis being comparable to existing or
p.002017: best to
p.002017: currently an alternative.
p.002017: 43. "Batch" means the specified quantity of the medicine manufactured in accordance with
p.002017: a reproducible technological scheme has been established to provide the required batch
p.002017: homogeneity with respect to the required control parameters.
p.002017: 43a. (new, SG No. 102/2012, effective 21.12.2012) "Risk Management Plan"
p.002017: is a detailed description of the risk management system.
p.002017: 44. "Maintenance of the authorization for a medicinal product" includes all
p.002017: necessary activities to maintain the current registration status of the medicinal product
p.002017: product, including drug safety monitoring.
p.002017: 44a. (new - SG 48/2015) "Maintenance of reimbursement status" is an assessment of
p.002017: medicinal product on the basis of evidence of efficacy, therapeutic efficacy,
p.002017: safety and analysis of pharmacoeconomic indicators.
p.002017: 45. "Benefit" is the positive result / therapeutic efficacy of the medicinal product
p.002017: for an individual patient, a group of patients, or for the community. Quantification of expected
p.002017: the benefit involves an approximate calculation of the probability of this positive result.
p.002017: 46. ​​(amend. - SG 102/02, in force from 02.01.2013) "Excipient" shall be any
p.002017: an ingredient of a medicinal product other than the active substance and the packaging material.
p.002017: 47. "Post-marketing study" means any study conducted using the
p.002017: the medicinal product within the approved summary of product characteristics during the period
p.002017: after authorization for use.
p.002017: 47a. (new - SG 102/2012, in force from 02.01.2013) "Mediation in the field of medicinal products" are
p.002017: all activities except for the conclusion of a contract for the purchase or sale of medicinal products
p.002017: of wholesale, which do not involve physical holding and which are independently negotiated
p.002017: and on behalf of another
p.002017: legal or natural person.
p.002017: 48. (amend. - SG 102/2012, in force since 21.12.2012) "Post-marketing safety study" is any
p.002017: a study relating to an authorized medicinal product to identify itself,
p.002017: characterize or determine the degree of safety risk, confirm the profile of
p.002017: the safety of the medicinal product
p.002017: or to evaluate the effectiveness of risk management measures.
p.002017: 49. "Potential serious risk to public health" exists when there is a high degree of probability
p.002017: use of the medicinal product to cause irreversible, irreversible and irreversible negative effects
p.002017: consequences. The evaluation process identifies the risk of harm to the health of the population and
p.002017: its actual exposure to the wide use of the product. The serious health risk in the context of
p.002017: use of
p.002017: a particular medicinal product may be evaluated under the following conditions:
...

p.002017: the marketing authorization to represent it before
p.002017: regulatory authorities on the territory of the Republic of Bulgaria.
p.002017: 51. An "acceptable level of safety" is present when the submitted data is accepted
p.002017: at statistically significant safety according to clinical trials conducted at
p.002017: compliance with Good Clinical Practice.
p.002017: 52. "Manufacture of a medicinal product" are all operations related to the procurement of materials, theirs
p.002017: processing in the production process, including packaging and labeling, quality control,
p.002017: batch release, storage, shipping and
p.002017: the control associated with these operations.
p.002017: 53. "Clinical Trial Protocol" is a document that describes the purpose (s), project (s),
p.002017: methodology, statistical processing and organization of the test. The protocol includes
p.002017: and any subsequent amendments thereto.
p.002017: 54. "Placing on the market" is the distribution of a medicinal product in a commercial one
p.002017: network on the territory of the Republic of Bulgaria beyond the direct control of the owner of the
p.002017: the marketing authorization.
p.002017: 55. "Primary packaging" means packaging that comes into direct contact with
p.002017: the medicinal product.
p.002017: 56. "Radiopharmaceutical" is a medicinal product which, when ready for use,
p.002017: contains one or more radionuclides (radioactive isotopes) for medical purposes.
p.002017: 57. "Radionuclide generator" means any system that includes a fixed mater
p.002017: a radionuclide from which a daughter radionuclide is produced which is recovered by elution or
p.002017: by other methods and is used in radiopharmaceuticals.
p.002017: 58. "radionuclide precursor" means any other radionuclide produced for radioactive purposes
p.002017: marking of another substance just before its introduction into the patient's body.
p.002017: 59. "Herbal medicinal product" is a medicinal product containing as medicinal substances
p.002017: one or more herbal substances or one or more herbal preparations or one or more
p.002017: plant matter in combination with one or more
p.002017: herbal preparations.
p.002017: 60. "Vegetable substances" are mainly plants or parts of plants, algae, fungi, lichens, which are whole,
p.002017: broken or chopped, and used in the raw state, usually in the dried state, but sometimes also fresh.
p.002017: Some exudates that have not undergone specific treatment also apply to plant substances.
p.002017: The plant matter must have a specific botanical scientific name for the plant, from
p.002017: who
p.002017: originate according to the binomial system (genus, species, variety and author).
p.002017: 61. "Vegetable preparation" means the product obtained after extraction, distillation, squeezing, fractionation,
p.002017: purification, concentration or fermentation of the plant substance. The herbal preparation may be
p.002017: also ground or powdered vegetable
p.002017: substances, tinctures, extracts, essential oils, processed vegetable fluids / juices.
p.002017: 62. "Rare diseases" are diseases that are characterized by a frequency of
p.002017: prevalence no higher than 5 in 10,000 people.
p.002017: 63. "Reference medicinal product" is a medicinal product authorized in accordance with Art. 23 c
p.002017: compliance with the requirements of Art. 27.
p.002017: 64. "Defined daily dose reference value" for an international non-patent name with the relevant
p.002017: Anatomy Therapeutic Drug Classification Formula is the Lowest Value for a Defined Daily
p.002017: dose determined on the basis of defined daily dose values ​​for the different medicinal products for
p.002017: the relevant international non - patent name with the relevant dosage form
p.002017: anatomic therapy
p.002017: classification of medicines.
p.002017: 65. "Therapeutic course reference value" is the lowest therapeutic value
p.002017: a course determined on the basis of the values ​​of a therapeutic course of medicines internationally
p.002017: non-patent name with appropriate dosage form.
p.002017: 66. "Risk in use of a medicinal product" is:
p.002017: (a) the risk to the health of the patient or the risk to the health of the population associated with
p.002017: the quality, safety or efficacy of the medicinal product;
p.002017: (b) the risk of adverse effects on the environment.
p.002017: 67. "Serious adverse event" is any adverse change in health status that is
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p.002017: activities and measures.
p.002017: 69b. (new - SG 102/2012, in force since 21.12.2012) "Tracking system of
p.002017: 'safety' is a system used by the marketing authorization holder and
p.002017: BDA for the accomplishment of the tasks and responsibilities of Chapter Eight intended for implementation
p.002017: monitoring the safety of authorized medicinal products and detection
p.002017: of any change in the benefit / risk ratio.
p.002017: 70. "Emergency restrictive safety measures" are temporary changes to product information with respect to
p.002017: one or more parts of the summary of product characteristics, indications, method of administration, contraindications
p.002017: and warnings that result from a new one
p.002017: information related to the safe use of the medicinal product.
p.002017: 71. "Spontaneous message" is a voluntarily sent message about suspected unwanted
p.002017: reaction when using the medicinal product to the marketing authorization holder, up to
p.002017: authorities for the supervision of medicinal products or other organizations not originating in
p.002017: a survey or other organized information gathering system.
p.002017: 72. "Shelf life of a medicinal product" is the time interval at which, if stored at
p.002017: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002017: based on stability studies of several batches of
p.002017: the finished form.
p.002017: 73. (amend. - SG 71/08, in force from 12.08.2008) "Relevant medicinal product of
p.002017: herbal medicinal product "is a product that contains the same active substances, regardless of composition
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
...

p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
p.002017: intellectual property rights.
p.002017: 82. "Homeopathic medicinal product" is a medicinal product made from substances,
p.002017: called a homeopathic source, according to European production procedures
p.002017: pharmacopoeia, and in the absence thereof, according to the national pharmacopoeia of a Member State.
p.002017: 83. "Price calculated on the basis of a benchmark" is the price formed for each
p.002017: medicinal product included in the Positive Medicinal List, calculated on the basis of that established
p.002017: reference value for a defined daily dose or therapeutic course.
p.002017: 84. "Center" is a structure of the medical establishment in which it is conducted clinically
p.002017: testing.
p.002017: 85. "Misuse of medicinal products" is permanent or occasional intentional misuse
p.002017: excessive use of medicinal products accompanied by harmful physical or
p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
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p.002017: products under development and research.
p.002017: (2) Data requirements for clinical packaging of medicinal products
p.002017: testing shall be determined in the ordinance under art. 170.
p.002017: which is:
p.002017: Art. 96. (1) Clinical testing of medicinal products shall be allowed only on a person,
p.002017: 1. informed in advance conversation with a doctor - member of the research team, about
p.002017: the objectives, risks and inconveniences of the test and the conditions under which it will be conducted;
p.002017: 2. informed of his right at any time to withdraw from the test without
p.002017: its negative consequences;
p.002017: 3. has given his / her written informed consent to participate after being acquainted with
p.002017: the nature, significance, consequences and potential risks of the clinical trial.
p.002017: (2) When the person is unable to write, informed consent to participate in the clinical trial shall be given
p.002017: orally in the presence of at least one independent witness who certifies in writing that the person
p.002017: has personally informed consent to participate in
p.002017: the clinical trial.
p.002017: (3) Informed consent under para. 1, item 3 and para. 2 can only give a capable person who understands
p.002017: the nature, significance, scope and potential risks of the clinical trial. Informed consent to participate in
p.002017: a clinical trial may be withdrawn at any time
p.002017: time.
p.002017: (4) Informed consent under para. 1, item 3 for a disabled adult is given by his / her legal person
p.002017: representative. The consent of the legal representative must represent the intended will of
p.002017: participant and can be withdrawn at any time without negatives
p.002017: consequences for the participant.
p.002017: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent gives
p.002017: the person appointed by the court.
p.002017: (6) The incapable adult is provided with information about the test,
p.002017: the potential risks and rewards of understanding it.
p.002017: (7) The explicit desire of an incapable adult to refuse to participate or to participate
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
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p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: defined in advance and are constantly monitored by
p.002017: test time;
p.002017: 9. the study is planned and is conducted in accordance with the guidelines of
p.002017: The European Medicines Agency;
p.002017: 10. no financial or other incentives are given except compensation.
p.002017: Art. 101. (1) Clinical trials on the persons under art. 96, para. 4 and 5, which are not in
p.002017: able to give informed consent shall be conducted in accordance with the requirements of art. 90.
p.002017: (2) In addition to the requirements of para. 1 inclusion in clinical trials of adults
p.002017: persons who are unable to give informed consent are permitted, provided that:
p.002017: 1. the relevant ethics committee with the participation of specialists with competence in the respective disease, or
p.002017: in the patient group approved the protocol after discussing clinical, moral and psychosocial aspects,
p.002017: relating to the disease in question and to
p.002017: the patient group;
p.002017: 2. it can be expected that the intake of the medicinal product being tested will
p.002017: lead to benefits that outweigh the risks or the risks are completely eliminated;
p.002017: 3. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or to data obtained through others
p.002017: research methods;
p.002017: 4. the test is directly related to life-threatening or leading to disability
p.002017: a disease in which the relevant adult is unable to give
p.002017: an informed consent;
p.002017: 5. clinical trials are designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: predefined and constantly monitored
p.002017: during the test;
p.002017: 6. no financial or other incentives are given except compensation.
p.002017: Art. 102. No clinical trial of a medicinal product on
p.002017: pregnant women and nursing mothers unless the medicinal product is required for treatment
p.002017: they may or may not be tested on another group of patients.
p.002017: Section III.
p.002017: Ethics Committees
p.002017: Art. 103. (1) (amend. - SG 60/11, in force from 05.08.2011) To the Minister of
p.002017: a multi - center ethics committee is set up by the Health Committee, whose composition is determined by
p.002017: Minister's order and includes regular and reserve members. Reserve members
p.002017: participate in committee meetings and have the right to vote in the absence of full members.
p.002017: (2) To the medical establishments where clinical trials are carried out shall be established
p.002017: ethics committees composed of the head of the hospital.
p.002017: (3) The Executive Agency for Medicines shall maintain and keep a register of the Committees on
p.002017: ethics.
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p.002017: 4. general information on the risks associated with the medicinal products delivered to
p.002017: Internet users in violation of the ordinance under Art. 234, para. 5.
p.002017: (2) The website of the BDA under para. 1 is linked to
p.002017: European Medicines Agency.
p.002017: Art. 234b. (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines shall participate in the
p.002017: information campaigns conducted by the European Commission and the European Medicines Agency
p.002017: the risk of counterfeit medicines
p.002017: products.
p.002017: Art. 235. (1) The permit for carrying out retail trade in medicinal products
p.002017: under Art. 229, para. 2 shall be terminated by termination of the activity of the persons under art. 222 and 225.
p.002017: (2) (Amended, SG No. 60/2011, effective 05.08.2011) The Executive Director of
p.002017: The BDA suspends the authorization to trade in medicinal products:
p.002017: 1. at the request of the person who has received a permit for retail trade;
p.002017: 2. when it is established that the pharmacy manager does not meet the requirements,
p.002017: referred to in Art. 224 and 225.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 14 days from termination
p.002017: of the activity under para. 1 persons under art. 222 and 225 shall notify the BDA in writing.
p.002017: Art. 236. (1) The pharmacy may not be closed for more than 30 days within one
p.002017: calendar year due to the absence of its manager.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 12/2011, effective 08.02.2011,
p.002017: ed. - SG, issue. 60 of 2011, effective 05.08.2011) When the pharmacy manager is unable to
p.002017: performs his / her duties due to the use of temporary disability leave due to illness, pregnancy and
p.002017: birth or adoption and parental leave in accordance with the Labor Code, pharmacy
p.002017: may work for no more than two years under the direction of another
p.002017: Master Pharmacist, respectively Assistant Pharmacist, in the cases under Art. 225, which meets the requirements of Art. 224
p.002017: In these
p.002017: cases, a permit is issued by the BDA Executive Director.
p.002017: (3) The permit under para. 2 shall be issued within 30 days.
p.002017: Art. 237. Upon termination of the activity of the person, authorized to open
p.002017: pharmacy, medicinal products may be sold to persons who have been authorized
p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
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p.002017: use.
p.002017: 26. "Coordinating researcher" means a researcher appointed to coordinate
p.002017: researchers from different centers participating in the multi-center test.
p.002017: 27. "Patient leaflet" is a leaflet containing information about the user that
p.002017: accompanies the medicinal product.
p.002017: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002017: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No 1394/2007.
p.002017: Of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and for
p.002017: amendment of the Directive
p.002017: 2001/83 / EC and Regulation (EC) No 726/2004.
p.002017: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product made from human
p.002017: blood components and by a method involving an industrial process. These include albumin, immunoglobulins,
p.002017: coagulation factors and antiproteases, solutions of
p.002017: plasma proteins, other plasma fractions or combinations thereof.
p.002017: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare
p.002017: diseases "is a product that:
p.002017: (a) is intended for the diagnosis, prophylaxis or treatment of life-threatening diseases
p.002017: diseases or progressive chronic diseases affecting no more than 5 in 10
p.002017: 000 people on the territory of the country, or
p.002017: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002017: health-damaging chronic conditions (diseases with a high incidence of incapacity for work and
p.002017: disability) and evidence was provided that the sale of the product did not provide a satisfactory one
p.002017: returns to justify the investment needed for R&D without
p.002017: incentives for
p.002017: the creator of the product, and
p.002017: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of
p.002017: the condition, or if there is one, the proposed medicinal product
p.002017: far more benefits than that and benefits for those affected by this condition.
p.002017: 30. A "dosage form" is an acceptable accepting structure containing the active substance (s) which
p.002017: may or may not include excipients obtained by the application of certain technological
p.002017: operations providing the desired healing effect and
p.002017: storage stability over the shelf life.
p.002017: 31. (amend. - SG 71/08, in force from 12.08.2008) "Person established in the territory of a Member State"
p.002017: is a legal entity registered under the civil or commercial law of a Member State or
p.002017: created by a legal act having its registered office and registered office in a Member State or in a State -
p.002017: Party to the Agreement on
p.002017: The European Economic Area.
p.002017: 32. "Highway formulation" is a prescription for a medicinal product made in a pharmacy under
p.002017: prescription from a healthcare professional or an approved prescription for a particular patient.
p.002017: 33. "International non-patent name" is the recommended name of
p.002017: the active substance approved and published by the WHO.
p.002017: 34. "Medical specialists" are doctors, doctors of dental medicine,
p.002017: master pharmacists, nurses, midwives, medical assistants, paramedics, and
p.002017: assistant pharmacist.
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p.002017: authorized as a medicinal product in the European Union, or the mechanism for pairing molecules
p.002017: and radionuclides was not allowed in
p.002017: The European Union.
p.002017: 40. "Adverse event" means any adverse change in health status,
p.002017: observed when administering a medicinal product to a patient or clinical participant
p.002017: a test that is not necessarily causally related to this treatment.
p.002017: 41. (amend. - SG 102/2012, in force since 21.12.2012) "Adverse drug reaction" is any undesirable and
p.002017: unexpected response to a medicinal product. In the case of a clinical trial - any undesirable or unforeseen
p.002017: response to the investigational medicinal product independently
p.002017: of the administered dose. The types of side effects are:
p.002017: (a) "unexpected" - an adverse reaction not listed in the summary of product characteristics;
p.002017: the product or whose character, weight or output does not meet the product characteristics mentioned in the summary; in
p.002017: case of clinical trial is an adverse reaction whose nature, severity or outcome do not match
p.002017: of test information
p.002017: medicinal product specified in the investigator's brochure;
p.002017: (b) "suspected" - an adverse reaction for which the notifier or the holder
p.002017: of the Marketing Authorization implies that there is a possible causal link with
p.002017: the received medicinal product;
p.002017: (c) "serious" - any adverse effect on a health condition which has caused the death,
p.002017: imminent danger to life, hospitalization or prolongation of hospitalization, significant or
p.002017: permanent disability, disability and congenital
p.002017: anomalies;
p.002017: (d) combinations of reactions under letters "a", "b" and "c".
p.002017: 42. "Common name" means the international non-patent name of a medicinal or excipient
p.002017: (INN) recommended by WHO; if not, the name in the European Pharmacopoeia is used, if there
p.002017: missing - another pharmacopoeial name; when not
p.002017: pharmacopoeial name, the usual accepted name is used.
p.002017: 42a. (new - SG 102/2012, in force since 21.12.2012) "Main documentation of the system for
p.002017: Drug Safety Tracking "is a detailed description of the drug tracking system
p.002017: the safety used by the holder of the
p.002017: use in relation to one or more authorized medicinal products.
p.002017: 42b. (new - SG 48/2015) "Assessment of health technologies" is:
p.002017: (a) a form of research policy exploring the short-term
p.002017: and the long-term results associated with the implementation of health technologies and aims to
p.002017: provided information on alternative health strategies;
p.002017: (b) a multidisciplinary activity that systematically assesses technical characteristics,
p.002017: safety, clinical efficacy and effectiveness, cost, value effectiveness, organizational, social,
p.002017: the legal and ethical implications of the administration of medicinal products in health care and focus
p.002017: on clinical and economic value, the analysis being comparable to existing or
p.002017: best to
p.002017: currently an alternative.
p.002017: 43. "Batch" means the specified quantity of the medicine manufactured in accordance with
p.002017: a reproducible technological scheme has been established to provide the required batch
p.002017: homogeneity with respect to the required control parameters.
...

p.002017: 62. "Rare diseases" are diseases that are characterized by a frequency of
p.002017: prevalence no higher than 5 in 10,000 people.
p.002017: 63. "Reference medicinal product" is a medicinal product authorized in accordance with Art. 23 c
p.002017: compliance with the requirements of Art. 27.
p.002017: 64. "Defined daily dose reference value" for an international non-patent name with the relevant
p.002017: Anatomy Therapeutic Drug Classification Formula is the Lowest Value for a Defined Daily
p.002017: dose determined on the basis of defined daily dose values ​​for the different medicinal products for
p.002017: the relevant international non - patent name with the relevant dosage form
p.002017: anatomic therapy
p.002017: classification of medicines.
p.002017: 65. "Therapeutic course reference value" is the lowest therapeutic value
p.002017: a course determined on the basis of the values ​​of a therapeutic course of medicines internationally
p.002017: non-patent name with appropriate dosage form.
p.002017: 66. "Risk in use of a medicinal product" is:
p.002017: (a) the risk to the health of the patient or the risk to the health of the population associated with
p.002017: the quality, safety or efficacy of the medicinal product;
p.002017: (b) the risk of adverse effects on the environment.
p.002017: 67. "Serious adverse event" is any adverse change in health status that is
p.002017: causing fatal outcome, imminent danger to life, hospitalization or prolongation of
p.002017: hospitalization period, significant or lasting
p.002017: disability, disability and congenital anomalies.
p.002017: 68. "Batch Release Certificate" is a document issued by
p.002017: the qualified person of the manufacturer or importer for each individual lot and includes
p.002017: requirements in accordance with the specification as well as all test results for
p.002017: batch release.
p.002017: 69. "Certificate of additional protection" is a document that provides additional
p.002017: patent protection of the medicinal product for a maximum of 5 years after the expiry date of
p.002017: the basic patent.
p.002017: 69a. (new, SG No. 102/2012, effective 21.12.2012) "Risk Management System" is
p.002017: a system of pharmacovigilance measures and activities designed to
p.002017: identifying, characterizing, preventing or minimizing drug-related risks
p.002017: product, including an evaluation of the effectiveness of these
p.002017: activities and measures.
p.002017: 69b. (new - SG 102/2012, in force since 21.12.2012) "Tracking system of
p.002017: 'safety' is a system used by the marketing authorization holder and
p.002017: BDA for the accomplishment of the tasks and responsibilities of Chapter Eight intended for implementation
p.002017: monitoring the safety of authorized medicinal products and detection
p.002017: of any change in the benefit / risk ratio.
p.002017: 70. "Emergency restrictive safety measures" are temporary changes to product information with respect to
p.002017: one or more parts of the summary of product characteristics, indications, method of administration, contraindications
p.002017: and warnings that result from a new one
...

p.002017: or as cooperatives under the Cooperatives Act, bring their names in line with
p.002017: § 2 of this Act and record the change in the commercial register, the BULSTAT register and in the respective
p.002017: Regional Health Center by 31 December 2007 "
p.002017: 2. Para. 2, 3 and 4:
p.002017: "(2) Individual dental care practices not registered as
p.002017: traders under the Commerce Act, align their names in accordance with § 2 of that law and
p.002017: register the change in the BULSTAT register and in the respective regional health center in
p.002017: term under para. 1.
p.002017: (3) The entry of the change of the name for the practices and centers under para. 1 c
p.002017: the commercial register and the BULSTAT register shall be carried out as follows:
p.002017: 1. by July 1, 2007 - in accordance with the provisions of the Commercial Act, the Cooperatives Act and the Law on Public Utilities
p.002017: register BULSTAT;
p.002017: 2. from July 1, 2007 - under the procedure of the Commercial Register Act.
p.002017: (4) State fees for recording the changes under para. 1 and 2 are not due. "
p.002017: § 25. In the Law on Patents and Registration of Utility Models (promulgated, SG No. 27/2005)
p.002017: 1993; 83, 1996, issue. 11 of 1998, issue. 81 of 1999, issue. 45 and 66 of 2002; 17, 30 and 64
p.002017: from 2006) in Art. 20 item 7 shall be repealed.
p.002017: § 26. In the Law on the Professional Organization of Master Pharmacists (promulgated SG 75/75)
p.002017: 2006; amend. 105 of 2006) in Art. 5 item 9 is amended as follows:
p.002017: "9. give opinions on opening pharmacies in accordance with Article 228, Paragraph 1, Item 9 of the Law on Pharmacy
p.002017: medicinal products in human medicine. "
p.002017: § 27. In § 1, item 7 of the additional provision of the Disability Integration Act (promulgated,
p.002017: SG, issue 81 of 2004; amend. 28, 88, 94, 103 and 105 of 2005; 18, 30, 33, 37, 63, 95, 97 and 108 of 2006
p.002017: (d) the second sentence is amended as follows: "Medical devices are not
p.002017: auxiliaries, accessories and equipment ".
p.002017: § 28. In the Law on Excise Duties and Tax Warehouses (promulgated, SG No. 91/2005; amend.
p.002017: from 2005, issue. 30, 34, 63, 81, 105 and 108 of 2006) in Art. 22, para. 3, item 2 the words "the Law on Medicines
p.002017: and drugstores in human medicine "are replaced by" the Human Medicines Act
p.002017: medicine ".
p.002017: § 29. In the Law on Genetically Modified Organisms (promulgated, SG No. 27/2005; amend. SG 88/99, No. 30)
p.002017: from 2006) in Art. 2, para. 2, item 3 the words "the Law on Medicines and Pharmacies in the Human Medicine" shall be replaced
p.002017: with the Humane Medicinal Products Act
p.002017: medicine ".
p.002017: § 30. In the Consumer Protection Act (promulgated, SG No. 99/2005; amend., Nos. 30, 51, 53, 59, 105 and 108)
p.002017: 2006) in Art. 186, para. 2, item 4 the words "The Law on Medicines and Pharmacies in Human Medicine" shall be
p.002017: replaced by "Medicinal Products in Human Medicine" Act.
p.002017: § 31. In the Health Act (promulgated, SG No. 70/2004; amend., Nos. 46, 76, 85, 88, 94 and 103 of
p.002017: 2005, issue. 18, 30, 34, 59, 71, 75, 81, 95 and 102 of 2006), the following amendments are made:
p.002017: 1. In Art. 4 the words "the Law on Medicines and Pharmacies in Human Medicine" are replaced
p.002017: with the "Law on Medicinal Products in Human Medicine".
p.002017: 2. In Art. 21, para. 3 the words "The Law on Medicines and Pharmacies in Human Medicine" are
p.002017: replaced by "Medicinal Products in Human Medicine" Act.
...

Health / Mentally Incapacitated

Searching for indicator incapable:

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p.002017: its negative consequences;
p.002017: 3. has given his / her written informed consent to participate after being acquainted with
p.002017: the nature, significance, consequences and potential risks of the clinical trial.
p.002017: (2) When the person is unable to write, informed consent to participate in the clinical trial shall be given
p.002017: orally in the presence of at least one independent witness who certifies in writing that the person
p.002017: has personally informed consent to participate in
p.002017: the clinical trial.
p.002017: (3) Informed consent under para. 1, item 3 and para. 2 can only give a capable person who understands
p.002017: the nature, significance, scope and potential risks of the clinical trial. Informed consent to participate in
p.002017: a clinical trial may be withdrawn at any time
p.002017: time.
p.002017: (4) Informed consent under para. 1, item 3 for a disabled adult is given by his / her legal person
p.002017: representative. The consent of the legal representative must represent the intended will of
p.002017: participant and can be withdrawn at any time without negatives
p.002017: consequences for the participant.
p.002017: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent gives
p.002017: the person appointed by the court.
p.002017: (6) The incapable adult is provided with information about the test,
p.002017: the potential risks and rewards of understanding it.
p.002017: (7) The explicit desire of an incapable adult to refuse to participate or to participate
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
p.002017: (3) The express wish of the minor to refuse to participate or to withdraw under
p.002017: any time in the clinical trial should be taken into account by the investigator, and at
p.002017: need - from the principal investigator.
p.002017: (4) A clinical trial on a minor shall be conducted upon receipt of written informed consent from
p.002017: the person from both parents or the guardian in compliance with Art. 96, para. 1 and 3. When one parent is unknown,
p.002017: died or was deprived of parental rights or not granted such rights in cases of divorce,
p.002017: written informed
...

Health / Motherhood/Family

Searching for indicator family:

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p.002017: (5) The Executive Director of the BDA shall determine by an order the composition of the commissions for a term
p.002017: three years, the amount of their remuneration and approve the terms and conditions of the
p.002017: their work.
p.002017: (6) By 30 January each year, the Executive Director of the BDA shall approve the lists of
p.002017: the experts outside the composition of the commissions under para. 1 after approval by the Minister of
p.002017: healthcare.
p.002017: (7) The BDA Executive Director may release a member of the BDA early
p.002017: specialized committee at his request for failure to fulfill his obligations for more than three
p.002017: months or in bad faith in the performance of its functions.
p.002017: (8) The composition of the commissions and the list of experts under para. 6 are announced on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 48. (1) The members of the specialized commissions under Art. 47, para. 1 and the experts under Art.
p.002017: 47, para. 4 sign a declaration, obliging them not to:
p.002017: 1. disclose data and circumstances that have become known to them on or on occasion
p.002017: carrying out their activity;
p.002017: 2. participate in activities related to the production or wholesale and retail trade with
p.002017: medical products.
p.002017: (2) In case the persons under para. 1 have participated in one of the preparation stages of
p.002017: the documentation necessary to authorize the use of the medicinal product cannot be provided
p.002017: participate in the meetings of the respective specialized commission under art. 47.
p.002017: (3) The persons under para. 1 shall not vote in decisions on matters on which they or
p.002017: their family members have commercial, financial or other interests.
p.002017: Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
p.002017: valid documentation of the BDA together with the relevant commission under Art. 47, para. 1 evaluates quality, safety and
p.002017: the efficacy of the medicinal product and produces an evaluation report commenting on the results of the pharmaceutical and
p.002017: the preclinical tests, the clinical trials, the risk management system and the
p.002017: monitoring the safety of the medicinal product concerned. The evaluation report prepared shall be submitted to
p.002017: the BDA Executive Director.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012) The report under para. 1 se
p.002017: updated in the presence of new information relevant to the assessment of quality, safety and health
p.002017: the efficacy of the medicinal product.
p.002017: (3) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012) Where the medicinal product contains genetically
p.002017: modified organisms, the BDA provides the Ministry of Environment and Water with the necessary
p.002017: dossier documentation for the medicinal product and
p.002017: requests an opinion within 60 days on the potential environmental risk.
p.002017: The sixty-day period is within the term of para. 1.
p.002017: (4) (Renumbered from Paragraph 3, SG No. 102/2012, effective 21.12.2012) In the cases of
p.002017: radiopharmaceuticals BDA provides the required documentation from the dossier of the medicinal product and requires it
p.002017: opinion within 60 days by the Nuclear Regulatory Agency with respect to
...

Health / Physically Disabled

Searching for indicator illness:

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p.002017: Internet users in violation of the ordinance under Art. 234, para. 5.
p.002017: (2) The website of the BDA under para. 1 is linked to
p.002017: European Medicines Agency.
p.002017: Art. 234b. (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines shall participate in the
p.002017: information campaigns conducted by the European Commission and the European Medicines Agency
p.002017: the risk of counterfeit medicines
p.002017: products.
p.002017: Art. 235. (1) The permit for carrying out retail trade in medicinal products
p.002017: under Art. 229, para. 2 shall be terminated by termination of the activity of the persons under art. 222 and 225.
p.002017: (2) (Amended, SG No. 60/2011, effective 05.08.2011) The Executive Director of
p.002017: The BDA suspends the authorization to trade in medicinal products:
p.002017: 1. at the request of the person who has received a permit for retail trade;
p.002017: 2. when it is established that the pharmacy manager does not meet the requirements,
p.002017: referred to in Art. 224 and 225.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 14 days from termination
p.002017: of the activity under para. 1 persons under art. 222 and 225 shall notify the BDA in writing.
p.002017: Art. 236. (1) The pharmacy may not be closed for more than 30 days within one
p.002017: calendar year due to the absence of its manager.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 12/2011, effective 08.02.2011,
p.002017: ed. - SG, issue. 60 of 2011, effective 05.08.2011) When the pharmacy manager is unable to
p.002017: performs his / her duties due to the use of temporary disability leave due to illness, pregnancy and
p.002017: birth or adoption and parental leave in accordance with the Labor Code, pharmacy
p.002017: may work for no more than two years under the direction of another
p.002017: Master Pharmacist, respectively Assistant Pharmacist, in the cases under Art. 225, which meets the requirements of Art. 224
p.002017: In these
p.002017: cases, a permit is issued by the BDA Executive Director.
p.002017: (3) The permit under para. 2 shall be issued within 30 days.
p.002017: Art. 237. Upon termination of the activity of the person, authorized to open
p.002017: pharmacy, medicinal products may be sold to persons who have been authorized
p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
...

Searching for indicator physically:

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p.002017: (4) (New - SG 71/08, in force from 12.08.2008) On the territory of the Republic of Bulgaria may be
p.002017: only medicinal products marketed by the Marketing Authorization Holder / Marketing Authorization Holder
p.002017: registration is established in the territory of a country
p.002017: state.
p.002017: Art. 24. (1) (amend. - SG 71/08, in force from 12.08.2008) Permission for use is not required for
p.002017: radiopharmaceuticals prepared immediately before use by authorized radionuclides
p.002017: generators, radionuclide precursors or kits in
p.002017: in accordance with the manufacturer's instructions.
p.002017: (2) The products of para. 1 shall be prepared by qualified persons in laboratories or
p.002017: institutes that have been authorized to carry out such activity under the terms of the
p.002017: safe use of nuclear energy.
p.002017: (3) The preparation, use and application of the products under para. 1 is performed
p.002017: according to the medical standard in nuclear medicine.
p.002017: Art. 25. (1) The criteria for determining a medicinal product intended for treatment,
p.002017: the prevention or diagnosis of rare diseases are covered by Regulation (EC) No 141/2000
p.002017: The European Parliament and the Council.
p.002017: (2) The conditions and procedure for granting a marketing authorization for medicinal products
p.002017: under para. 1 are laid down in Regulation (EC) No 726/2004 of the European Parliament and of the Council.
p.002017: Art. 26. (1) (amend. - SG 71/08, in force from 12.08.2008) Permission for use
p.002017: of a medicinal product, a certificate for registration of a homeopathic medicinal product under Art.
p.002017: 35 or certificate for registration of a traditional herbal medicinal product under Art. 37 on
p.002017: the territory of the Republic of Bulgaria is issued by the Executive Director of the BDA physically
p.002017: or a legal person established in the territory of a Member State.
p.002017: (2) When the person under para. 1 is not established in the territory of the Republic of Bulgaria, it
p.002017: appoints its representative.
p.002017: (3) The holder of the marketing authorization shall be responsible for the medicinal products placed on the market.
p.002017: The determination of a person under para. 2 shall not exempt the holder of the marketing authorization from
p.002017: responsibility in accordance with the effective ones in the Republic of Bulgaria
p.002017: legislation.
p.002017: Section II.
p.002017: Requirements to the marketing authorization documentation
p.002017: Art. 27. (1) (amend. - SG 71/08, in force from 12.08.2008) To issue a permit for
p.002017: use of a medicinal product by the person under Art. 26, para. 1 submits an application to the BDA following a model, accompanied by a file
p.002017: in the format "Electronic Common Technical Document", which
p.002017: contains:
p.002017: 1. name and address of management / permanent address of the applicant and the representative under art. 26,
p.002017: para. 2; where the applicant is a person other than the manufacturer or manufacturers, the address of
p.002017: production sites;
p.002017: 2. name of the medicinal product;
p.002017: 3. data on the qualitative and quantitative composition of the medicinal product, such as
p.002017: points to the international non-patent name recommended by the WHO, if any,
p.002017: or the corresponding chemical name;
p.002017: 4. therapeutic indications, contraindications and side effects;
p.002017: 5. (amend. - SG 71/08, in force from 12.08.2008) dosage, dosage form,
p.002017: route of administration and route of administration and proposed shelf life;
p.002017: 6. precautionary measures and safety precautions during storage of the product, at
...

p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. adopt a decision to change, suspend or terminate the validity of the permits
p.002017: for use, issued under Regulation (EC) No 726/2004 of the European Parliament and of the
p.002017: The Council;
p.002017: 2. adopt a decision recommending the change, suspension or termination of validity of
p.002017: marketing authorizations issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Drug Enforcement Agency shall implement the recommendations recommended in the decision of the European Medicines Agency
p.002017: The European Commission under para. 2, item 2 provisional and / or final measures.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) The recommendation under Art. 194c,
p.002017: para. 1, the opinion under art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and
p.002017: Art. 194h, para. 2 shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: Chapter Nine.
p.002017: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN
p.002017: THE MEDICINAL PRODUCTS AREA (HEADING, amended, SG No. 71/2008,
p.002017: POWER FROM 12.08.2008, ISM. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002017: (Title "Section I. Wholesale trade of medicinal products" - SG, issue 71 of 2008, in
p.002017: with effect from 12.08.2008)
p.002017: Art. 195. (1) Wholesale trade in medicinal products may be carried out physically and
p.002017: legal persons authorized to do so by a regulatory body of
p.002017: the Member State concerned.
p.002017: (2) When the person under para. 1 has warehouses on the territory of the Republic
p.002017: Bulgaria, it may carry out wholesale of medicinal products after receiving
p.002017: permission from the BDA Executive Director.
p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
p.002017: Art. 197. The persons under art. 195 must have:
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
...

p.002017: for all persons who have supplied the samples, the type, quantity and time of delivery and
p.002017: make this information available to inspection bodies on request.
p.002017: Art. 211. (1) Wholesalers must have a blocking and withdrawal system
p.002017: of medicinal products which have shown non-compliance with the requirements for quality, safety and health
p.002017: efficiency.
p.002017: (2) The holder of a wholesale trade permit shall be obliged to block and withdraw
p.002017: medicinal products which have shown non - compliance with the requirements for quality, safety and health
p.002017: efficiency according to the procedure specified in the ordinance under Art. 274, para. 1.
p.002017: Art. 212. (1) The Executive Director of the BDA shall notify the European Commission, the regulatory authorities of
p.002017: other Member States and the European Medicines Agency for wholesale marketing authorizations for
p.002017: suspended or revoked permissions for
p.002017: the reasons for this.
p.002017: (2) (amend. - SG 102/2012, in force from 02.01.2013) Where the executive director of the BDA
p.002017: establish that the person under Art. 195, para. 1 does not fulfill the obligations under Art. 207, para. 1, Vol. 2 - 14, he informs
p.002017: the regulatory authority of the Member State which granted the authorization
p.002017: wholesale, and the European Commission.
p.002017: (3) Where the regulatory body under para. 2 temporarily suspend or revoke permission for
p.002017: wholesale trade of the person under art. 195, para. 1, it shall notify the BDA Executive Director and
p.002017: The European Commission.
p.002017: Art. 212a. (New, SG No. 102/2012, effective 02/01/2013) (1) (Amended, SG No. 18/2012)
p.002017: 2014) Mediation in the field of medicinal products can physically and
p.002017: legal entities registered as commercial intermediaries within the meaning of the Commercial Law of
p.002017: The Republic of Bulgaria, which are registered for carrying out this activity by the BDA.
p.002017: (2) The persons under para. 1, who wish to register as intermediaries, shall file with the BDA
p.002017: notification according to a model approved by the BDA Executive Director, containing:
p.002017: 1. name, seat and address of management;
p.002017: 2. contact details.
p.002017: (3) To the notification under para. 2 shall apply:
p.002017: 1. data on the unique identification code;
p.002017: 2. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (4) The Executive Agency for Medicines shall enter in the public register the persons,
p.002017: mediators in the field of medicinal products.
p.002017: (5) The persons under para. 1 may mediate in the field of medicines
p.002017: products after submission of the notification under para. 2 in the BDA.
p.002017: (6) The persons under para. 1 shall notify the BDA within 7 days from the occurrence of a change in any of the
p.002017: the circumstances under para. 2.
p.002017: Art. 212b. (New - SG 102/02, in force from 02.01.2013) (1) The persons under art. 212a, para.
p.002017: 1 shall:
p.002017: 1. carry out their activity only with authorized medicinal products;
p.002017: 2. Have an emergency plan that contains effective measures for withdrawal of a medicinal product
p.002017: from the market at the disposal of the BDA or at the initiative of the manufacturer or the holder of the marketing authorization
p.002017: use of the respective medicinal product;
p.002017: 3. to store data including the following information for each transaction made
p.002017: through mediation medicinal products:
p.002017: (a) the date of the transaction;
...

Health / patients in emergency situations

Searching for indicator emergencies:

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p.002017: (3) When, within the term of para. 2 The BDA found inconsistencies in the submitted documentation with
p.002017: the requirements of the law and the ordinance under Art. 42, it notifies the authorization holder of
p.002017: use.
p.002017: (4) Within 30 days from receipt of the notification under para. 3 the holder of
p.002017: the marketing authorization may amend or supplement the documentation.
p.002017: (5) When, within the term of para. 4 the Marketing Authorization Holder did not submit
p.002017: changed or supplemented documentation, BDA terminates the procedure and notifies it
p.002017: the holder of the marketing authorization.
p.002017: (6) Within 30 days from receipt of the changed documentation under para. 4 BDA
p.002017: notify the holder of the marketing authorization:
p.002017: 1. whether he approves the change or not; where the change is not approved, they shall be indicated
p.002017: the reasons for this, and
p.002017: 2. whether the change leads to a change in the data in the issued marketing authorization;
p.002017: when a change in the issued marketing authorization is required, Art. 64a.
p.002017: (7) The Marketing Authorization Holder applies the type IB variation approved after
p.002017: receiving notification under para. 2, item 1, respectively under para. 6, item 1 for approval of the change.
p.002017: Art. 64. (amend. - SG 12/11, in force from 08.02.2011) (1) Where the application for
p.002017: Type II change meets the requirements of Art. 61, the BDA shall notify the authorization holder
p.002017: for use, that the application is valid, indicating the date from which the period under par. 2 starts to
p.002017: flowing.
p.002017: (2) Within 60 days of receipt of a valid application, the BDA shall prepare an evaluation report
p.002017: about change.
p.002017: (3) The term under para. 2 can be:
p.002017: 1. reduced in emergencies related to the safe use of
p.002017: the medicinal product, or
p.002017: 2. extended up to 90 days in the event of a change which is modified or added therapeutically
p.002017: testimony.
p.002017: (4) When the BDA finds inconsistencies in the submitted documentation with the requirements of
p.002017: the law and the ordinance under art. 42, it notifies the marketing authorization holder and determines
p.002017: deadline for submission of additional information and documentation.
p.002017: (5) In the cases of para. 4 the term under para. 2 stops running until the additional is presented
p.002017: information and documentation.
p.002017: (6) Within 15 days of the preparation of the evaluation report, the Executive Director of
p.002017: BDA:
p.002017: 1. approve the change or give a reasoned refusal and notify the holder of the change
p.002017: the marketing authorization;
p.002017: 2. notify the holder of the marketing authorization whether the approved change leads to
p.002017: change of data in the issued marketing authorization; when a change is required
p.002017: marketing authorization, Art. 64a.
p.002017: (7) The Marketing Authorization Holder may apply the approved change
p.002017: type II only after the issuance of a permit for change under Art. 64a.
p.002017: Art. 64a. (New, SG No. 12/2011, effective 08.02.2011) The Executive Director of
p.002017: The BDA shall issue an authorization for change of the marketing authorization within the following period:
p.002017: 1. thirty days from the issuance of the notification under Art. 62, para. 4, Vol. 2, Art. 63, para. 2, Vol. 2,
p.002017: respectively Art. 63, para. 6, item 2 or art. 64, para. 6, item 2, when the corresponding change leads to an extension
p.002017: 6 months within the period referred to in Article 13 (1) and (2) of Council Regulation (EEC) No 1768/92
...

p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
p.002017: intellectual property rights.
p.002017: 82. "Homeopathic medicinal product" is a medicinal product made from substances,
...

Social / Access to Social Goods

Searching for indicator access:

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p.002017: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain
p.002017: national internet portal for medicinal products;
p.002017: 19. performs other activities specified by law.
p.002017: (6) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: medicines coordinates its activities with regional health inspections (RICs) in the area of
p.002017: control of medicinal products.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under
p.002017: this law related to preventing the entry and distribution of counterfeit
p.002017: medicinal products, is carried out in cooperation between the BDA and the customs authorities.
p.002017: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health
p.002017: inspections issue certificates for registration of drugstores.
p.002017: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002017: retail of medicinal products, which includes three representatives of the Bulgarian
p.002017: pharmaceutical union, one representative of the faculties of pharmacy of the medical colleges and
p.002017: four BDA representatives. The composition of the Board is determined by an order of the Executive Director of the BDA,
p.002017: agreed with the Minister of
p.002017: healthcare.
p.002017: (2) The council under para. 1 is an advisory unit which:
p.002017: 1. prepares opinions on the applications and documents submitted to the BDA under Art. 228, para. 1 and 5,
p.002017: which he presents to the Executive Director of the BDA;
p.002017: 2. make motivated proposals to the Minister of Health through
p.002017: the BDA's Executive Director for improving public access to medicines
p.002017: products.
p.002017: (3) The organization and activity of the expert council under para. 1 shall be governed by regulations,
p.002017: issued by the BDA Executive Director on a proposal from the Board.
p.002017: (4) The members of the expert council under para. 1 shall not receive remuneration for participation in
p.002017: council meetings.
p.002017: (5) The expert council under para. 1 shall be reported annually to the Minister of
p.002017: healthcare.
p.002017: Art. 17c. (New, SG No. 18/2014) They may not be members of the Expert Council of
p.002017: Art. 17b, para. 1 people who are:
p.002017: 1. owners, members of management and control bodies of commercial companies or
p.002017: sole proprietors manufacturing, importing, wholesale or retail trade with
p.002017: medical products;
p.002017: 2. partners or shareholders holding more than 5 percent of the capital in commercial
p.002017: companies active in the manufacture, import, wholesale or retail of medicinal products
p.002017: products or work under contract with those companies.
p.002017: Section II.
p.002017: Registers
p.002017: Art. 18. (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 19. (1) The Executive Agency for Medicines shall keep and keep registers of:
p.002017: 1. (amended, SG No. 102/2012, effective 21.12.2012) Manufacturers and importers
p.002017: of medicinal products on the territory of the Republic of Bulgaria and the qualified persons under
p.002017: Art. 148, item 2 and under Art. 161, para. 2, Vol. 1;
p.002017: 2. (amend. - SG 102/02, in force from 21.12.2012) the manufacturers, importers and
p.002017: wholesalers of active substances;
p.002017: 3. the authorized and registered medicinal products on the territory of
p.002017: Republic of Bulgaria;
p.002017: 4. wholesalers of medicinal products on the territory of the Republic of Bulgaria;
...

p.002017: notification of reasons for disapproval of the clinical trial.
p.002017: (6) If the assignor does not submit an application under para. 2 within the time limit specified, the procedure shall be
p.002017: terminated and no clinical trial was conducted.
p.002017: Art. 119. (1) Within 60 days from the date of submission of the application for clinical trial with
p.002017: the medicinal products under Art. 109, item 2, the Executive Director of the BDA shall: 1. issue a permit for carrying out the BDA
p.002017: the clinical trial, or
p.002017: 2. Reasonably refuses to issue a permit.
p.002017: (2) The refusal under para. 1, item 2 shall be subject to appeal in the order of
p.002017: Code of Administrative Procedure.
p.002017: Art. 120. (1) In the cases of medicinal products under Art. 109, item 2, letters "a" - "c" the term under
p.002017: Art. 119, para. 1 for the authorization of the BDA to conduct a clinical trial may
p.002017: extended by 30 days.
p.002017: (2) In case the BDA consults the expert commission under Art. 112, para. 3 which
p.002017: assess the safety of the medicinal products under para. 1, the extension under para. 1 term can be
p.002017: extended by another 90 days.
p.002017: Art. 121. The Executive Director of the BDA refused to issue an authorization for the holding of a BDA
p.002017: clinical trial of gene therapy medicinal products where there is a risk of modification
p.002017: of the genome of the reproductive cells of the participant in
p.002017: the test.
p.002017: Art. 122. (1) In multicenter testing in the Republic of Bulgaria and in a third country, the BDA
p.002017: requires the contracting authority to provide a declaration that it will grant access to the representatives of
p.002017: BDA for inspection in order to establish compliance with the requirements and principles of the Good
p.002017: clinical practice and Good Manufacturing Practice.
p.002017: (2) When the contracting authority fails to submit the declaration under para. 1, the BDA does not consider
p.002017: the application submitted.
p.002017: Art. 123. The sponsor declares that it has been submitted to the BDA and to the Ethics Committee
p.002017: the documentation contains the same information.
p.002017: Art. 124. (1) The procedures in the Ethics Committee and in the BDA may be conducted
p.002017: simultaneously or sequentially at the option of the contracting authority.
p.002017: (2) The term under Art. 118, para. 1 for the examination of the documentation does not stop running at
p.002017: the lack of a decision by the Ethics Committee.
p.002017: Art. 125. The clinical trial shall be conducted in accordance with the protocol it has received
p.002017: positive opinion from the relevant ethics committee under art. 103, and under the conditions set out in
p.002017: the documentation submitted.
p.002017: Section V.
p.002017: Changes
p.002017: Art. 126. (1) The contracting authority may at any time make changes other than
p.002017: the substantial changes under Art. 127, para. 2, in the clinical trial protocol.
...

p.002017: the ordinance under Art. 152.
p.002017: Art. 160. (1) The holder of a manufacturing authorization shall:
p.002017: 1. ensure that production operations are carried out in accordance with the requirements
p.002017: of Good Manufacturing Practice and in accordance with the information approved by the BDA under Art.
p.002017: 27, para. 1, items 7 and 8, and in the case of medicinal products for clinical trial, in accordance with
p.002017: the information under Art. 110, para. 1, item 4, provided to the Agency by the contracting authority;
p.002017: 2. (amend. - SG 102/2012, in force from 02.01.2013) use only active substances,
p.002017: which are manufactured in accordance with the requirements of Good Manufacturing Practice for
p.002017: active substances;
p.002017: 2a. (new - SG 102/2012, in force from 02.01.2013) make sure that the excipients,
p.002017: used in medicinal products are manufactured in accordance with good manufacturing practice
p.002017: for excipients determined on the basis of a formal
p.002017: risk assessment in accordance with applicable guidelines adopted by the European Commission;
p.002017: 3. provide permanently qualified production and control personnel in accordance with
p.002017: the requirements of the ordinance under Art. 152;
p.002017: 4. (amend. - SG 12/11, in force from 08.02.2011) has only medicinal products
p.002017: products authorized to be used, subject to the requirements of this Act;
p.002017: 5. (repealed, SG No. 12/2011, effective 08.02.2011)
p.002017: 6. notify immediately the control bodies in case of change of the qualified person
p.002017: under Art. 148, Vol. 2;
p.002017: 7. ensure at all times access of the control bodies to the premises and
p.002017: documentation;
p.002017: 8. provide to the qualified person under Art. 148, item 2 the necessary conditions for
p.002017: performance of his duties;
p.002017: 9. (new - SG 102/2012, in force from 02.01.2013) inform immediately the BDA and the holder of the permit for
p.002017: use if he / she receives information that the medicinal products fall within the scope of his authorization
p.002017: production, are falsified or there are doubts about falsification, regardless of whether these medicinal products
p.002017: products have been distributed within the legal supply chain or illegally,
p.002017: including through illicit sale through the information society services;
p.002017: 10. (new - SG 102/2012, in force from 02.01.2013) check whether
p.002017: the manufacturers, importers or traders from which it receives the active substances are
p.002017: registered by the competent authority of the Member State in which they are established;
p.002017: 11. (New, SG No. 102/2012, effective 02.01.2013) verify the authenticity and
p.002017: the quality of the active substances and of the excipients.
p.002017: (2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing permit shall exercise
p.002017: audits at the sites for the production and marketing of active substances for compliance with Good Manufacturing
p.002017: practice and Good distribution practice. The holder of the manufacturing authorization may
p.002017: contract with a third party yes
p.002017: performed the audit on his behalf and on his behalf.
p.002017: (3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the permit
p.002017: document the undertakings under para. 1, items 2 and 2a measures.
...

p.002017: (2) The Executive Agency for Medicines shall keep a register of the certificates issued
p.002017: under Art. 203 for wholesale of medicinal products, which contains:
p.002017: 1. number and date of the certificate;
p.002017: 2. the number of the marketing authorization for the medicinal products and the body which has it
p.002017: has issued;
p.002017: 3. name, seat and address of management of the person receiving the certificate;
p.002017: 4. details of the person under art. 199, para. 2, Vol. 2;
p.002017: 5. date of deletion of the certificate from the register and the reason for it;
p.002017: 6. notes on the entered circumstances.
p.002017: (3) Data from the registers shall be published on the BDA website on the Internet.
p.002017: (4) (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines
p.002017: enter into the database under Art. 147 information on marketing authorizations issued
p.002017: of medicines.
p.002017: (5) (New, SG No. 102/2012, effective 02.01.2013) Upon request by the European Commission or by a State
p.002017: Member of the BDA shall provide information on the issued authorization for
p.002017: wholesale of medicines.
p.002017: Art. 206. (1) In case of change of the circumstances, related to the issued permit for wholesale trade,
p.002017: the holder submits an application to the BDA pursuant to Art. 199, to which
p.002017: apply the change-related documentation.
p.002017: (2) The permit for change shall be issued under the conditions and by the order of art. 200 - 202. When changing
p.002017: the storage premises shall be subject to the term of art. 202, and in other cases
p.002017: the deadline is 14 days.
p.002017: Art. 207. (1) The holder of a wholesale trade permit who carries out the activity
p.002017: on the territory of the Republic of Bulgaria, is obliged to:
p.002017: 1. shall provide access at all times to the control bodies of the premises for
p.002017: storage of medicinal products;
p.002017: 2. trade only in medicinal products authorized under this Law;
p.002017: 3. trade in medicinal products whose packaging and leaflets are in accordance with the authorization granted
p.002017: use, under the terms and procedure of this Act and their term of validity
p.002017: fitness has not expired;
p.002017: 4. supplies medicinal products only to manufacturers, importers or wholesalers of medicinal products,
p.002017: have been authorized to carry out this activity under the terms of
p.002017: this law;
p.002017: 4a. (new - SG 102/2012, in force from 02.01.2013) check whether the received medicinal products
p.002017: the products of the persons under item 4 are not falsified by checking the indicators for
p.002017: safety on the outer packaging;
p.002017: 5. supply medicinal products to other marketing authorization holders of
p.002017: wholesale, pharmacies and drugstores opened under this law;
p.002017: 5a. (new - SG 71/08, in force from 12.08.2008) supplies medicinal products
p.002017: medical establishments for own needs;
p.002017: 6. supply doctors and dentists with medicinal products when there is no place in the settlement
p.002017: pharmacy, under the conditions and in the order laid down in an ordinance of the Minister of Health
p.002017: healthcare;
p.002017: 6a. (new - SG 102/2012, in force from 02.01.2013) shall enter in the documents for
p.002017: delivery of batch number of delivered medicinal products;
p.002017: 6b. (new - SG 102/2012, in force from 02.01.2013) there is an emergency action plan
p.002017: situations containing effective measures to withdraw a medicinal product from the market by order of
p.002017: BDA or at the initiative of the manufacturer or the holder of
...

p.002017: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good Distributor
p.002017: practices, where applicable, issued by the BDA to the manufacturer, importer or wholesaler
p.002017: Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice in
p.002017: up to 90 days from
p.002017: carrying out the inspection.
p.002017: (2) When, as a result of an inspection under Art. 269, para. 3 found that the manufacturer,
p.002017: the importer or wholesaler of the medicinal products or the active substances does not comply
p.002017: the requirements of the law and / or the principles and guidelines of Good Manufacturing Practice and / or of
p.002017: Good distribution practices, the BDA issues an opinion on
p.002017: discrepancy.
p.002017: (3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued
p.002017: certificates under para. 1 and information under para. 2.
p.002017: Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of
p.002017: Chapter Eight, the BDA prescribes the removal of
p.002017: inconsistencies.
p.002017: (2) In the cases of para. 1 The BDA shall notify the Member States, the European Agency for the Protection of Energy
p.002017: medicines and the European Commission.
p.002017: right:
p.002017: Art. 270. (1) Within the limits of their competence, the officials under Art. 267, para. 3 have
p.002017: 1. (amend. - SG 102/2012, in force from 02.01.2013) access to all documents,
p.002017: related to the subject matter of the inspection, as well as to documents related directly or indirectly to a violation of
p.002017: this law or the legislation of the Member States implementing it
p.002017: the requirements of Directive 2001/83 / EC, regardless of the format of the document;
p.002017: 2. order each person to provide information about the violations under item 1, which are his
p.002017: famous;
p.002017: 2a. (new - SG 102/2012, in force from 02.01.2013) to inspect
p.002017: the manufacturing and trading sites of the manufacturers of medicinal products, active or auxiliary
p.002017: substances, as well as the laboratories used by the authorization holders
p.002017: production or import;
p.002017: 3. to inspect at any time the sites to be inspected and to require that
p.002017: verify and make copies of all documents relating to the overall business of
p.002017: the controlled site;
p.002017: 4. take samples of medicinal products, active substances and excipients for
p.002017: laboratory testing;
p.002017: 5. (amend. - SG 102/02, in force from 21.12.2012) to inspect the premises, archives, documents and
p.002017: the main documentation of the Marketing Authorization Holder of the Marketing Authorization Holder
p.002017: use or persons to whom he has assigned
p.002017: carrying out the activities of Chapter Eight;
p.002017: 6. (new - SG 102/2012, in force since 21.12.2012) to carry out a check on
p.002017: observance of the approved prices, the marginal prices or the registered prices at the sale of
p.002017: medical products;
p.002017: 7. (Renumbered from Item 6, SG No. 102/2012, effective 21.12.2012) to draw up acts for
p.002017: establishment of administrative violations.
p.002017: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002017: (3) (amend. - SG 98/10, in force from 01.01.2011) The Executive Director of
...

p.002000: 1. The Minister of Health shall amend and supplement the ordinances under Art. 82, para. 3, Art. 219,
p.002000: para. 2 and Art. 243 in accordance with this law.
p.002000: 2. The Council of Ministers shall adopt the ordinance under Art. 258, para. 5 and amend the tariff under Art. 21,
p.002000: para. 2 and the Regulations of the Ministry of Health in accordance with this
p.002000: law.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 84. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: with the exception of § 65, which comes into force on 30 September 2011.
p.002000: Transitional and Final Provisions
p.002000: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002000: DRUGS AND PRECURSORS
p.002000: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002000: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002000: Transitional and Final Provisions
p.002000: TO THE LAW AMENDING AND SUPPLEMENTING THE STATE LAW
p.002000: EMPLOYEE
p.002000: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002000: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in
p.002000: "State Gazette":
p.002000: 1. The Council of Ministers shall bring the Classifier of posts in administration to
p.002000: compliance with this law;
p.002000: 2. the competent authorities shall bring the planning acts of the respective
p.002000: administration in accordance with this law.
p.002000: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002000: the independent financial audit, the Electronic Communications Act, the Financial Supervision Commission Act, the Access Act and
p.002000: disclosure of documents and declaring of belonging of Bulgarian citizens to the State Security and
p.002000: Intelligence Services of the Bulgarian People's Army, Law on Forfeiture in favor of the State of Property Acquired
p.002000: of criminal activity, the Conflict of Interest Prevention and Identification Act, the Code of Conduct
p.002000: social security, the Health Insurance Act, the Farmers Support Act, and
p.002000: The Roads Act is governed by the terms and procedures of § 36 of the transitional and final provisions of the Act
p.002000: amending and supplementing the
p.002000: the civil servant (State Gazette, issue 24 of 2006).
p.002000: (2) The act of appointment of the civil servant shall:
p.002000: 1. assigns the definitions in the Classifier of posts in the administration
p.002000: minimum rank for the position held, unless the employee holds a higher rank;
p.002000: 2. determines the individual basic monthly salary.
p.002000: (3) The additional necessary funds for social security contributions of the persons under para. 2 se
p.002000: provide, within the cost of wages, salaries and social security contributions,
p.002000: the budgets of the authorizing officers concerned.
p.002000: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account
p.002000: of the State Fund for Agriculture, resulting from this law.
p.002000: (5) The governing bodies of the National Social Security Institute and the National Social Security Institute
p.002000: Health Insurance Fund to make the necessary changes to the respective budgets,
p.002000: arising from this law.
p.002000: (6) Unused employment leave shall be maintained and shall not be maintained
p.002000: offset by cash benefits.
...

Social / Age

Searching for indicator age:

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p.002017: one or more parts of the summary of product characteristics, indications, method of administration, contraindications
p.002017: and warnings that result from a new one
p.002017: information related to the safe use of the medicinal product.
p.002017: 71. "Spontaneous message" is a voluntarily sent message about suspected unwanted
p.002017: reaction when using the medicinal product to the marketing authorization holder, up to
p.002017: authorities for the supervision of medicinal products or other organizations not originating in
p.002017: a survey or other organized information gathering system.
p.002017: 72. "Shelf life of a medicinal product" is the time interval at which, if stored at
p.002017: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002017: based on stability studies of several batches of
p.002017: the finished form.
p.002017: 73. (amend. - SG 71/08, in force from 12.08.2008) "Relevant medicinal product of
p.002017: herbal medicinal product "is a product that contains the same active substances, regardless of composition
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
...

Social / Child

Searching for indicator children:

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p.002017: this combination. In this case, the applicant does not provide documentation on the safety and efficacy of each
p.002017: separately
p.002017: active substance.
p.002017: Art. 32. The holder of an authorization to use a medicinal product may authorize the use of the pharmaceutical,
p.002017: the preclinical and clinical documentation contained in the dossier of the medicinal product when evaluating
p.002017: subsequent drug applications
p.002017: products of the same qualitative and quantitative composition as regards the active substances and with
p.002017: same dosage form.
p.002017: Art. 33. Conducting the necessary studies and tests to prepare authorization documentation
p.002017: for use and subsequent practical requirements for the authorization of medicinal products under
p.002017: Art. 28 and 29 is not a patent infringement
p.002017: or the supplementary protection certificate for a medicinal product.
p.002017: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002017: 1. name of the medicinal product, quantity of active substance for dosage
p.002017: unit, dosage form;
p.002017: 2. quantitative and qualitative composition in respect of the active substances and those of
p.002017: excipients for which information is essential for the proper application of
p.002017: product; the common name or chemical description is used;
p.002017: 3. dosage form;
p.002017: 4. clinical data:
p.002017: (a) therapeutic indications;
p.002017: (b) dosage and route of administration for adults and children;
p.002017: c) contraindications;
p.002017: (d) special warnings and precautions for use; for immunological
p.002017: medicinal products - precautions for persons handling and administering them
p.002017: patients, as well as the precautions to be taken by the patient;
p.002017: (e) interactions with other medicinal products or other forms of interaction;
p.002017: (f) use in pregnancy or lactation;
p.002017: (g) effects on the ability to drive and use machines;
p.002017: h) side effects;
p.002017: i) overdose (symptoms, antidotes, emergency measures);
p.002017: 5. pharmacological data:
p.002017: a) pharmacodynamic properties;
p.002017: b) pharmacokinetic properties;
p.002017: (c) preclinical safety data;
p.002017: 6. pharmaceutical data:
p.002017: (a) a list of excipients;
p.002017: (b) major incompatibilities;
p.002017: c) shelf life; shelf life after reconstitution of the medicinal product (at
p.002017: need) or after opening the immediate packaging for the first time;
p.002017: (d) special storage instructions;
p.002017: (e) the nature and composition of the packages;
p.002017: (f) specific instructions for disposal of the remainder of the medicinal product or of
p.002017: waste materials therefrom;
p.002017: 7. the holder of the marketing authorization;
p.002017: 8. registration number;
p.002017: 9. date of first authorization or renewal of the authorization
p.002017: use;
p.002017: 10. date on which the content of the summary of the Summary of Product Characteristics was made
p.002017: product;
p.002017: 11. for radiopharmaceuticals - comprehensive information on internal radiation
p.002017: dosimetry;
p.002017: 12. for radiopharmaceuticals - detailed instructions for extemporaneous preparation and quality control and, where applicable
...

p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
p.002017: intellectual property rights.
p.002017: 82. "Homeopathic medicinal product" is a medicinal product made from substances,
p.002017: called a homeopathic source, according to European production procedures
p.002017: pharmacopoeia, and in the absence thereof, according to the national pharmacopoeia of a Member State.
p.002017: 83. "Price calculated on the basis of a benchmark" is the price formed for each
p.002017: medicinal product included in the Positive Medicinal List, calculated on the basis of that established
p.002017: reference value for a defined daily dose or therapeutic course.
p.002017: 84. "Center" is a structure of the medical establishment in which it is conducted clinically
p.002017: testing.
p.002017: 85. "Misuse of medicinal products" is permanent or occasional intentional misuse
p.002017: excessive use of medicinal products accompanied by harmful physical or
p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
p.002017: are sufficient to satisfy the nutritional needs of these infants up to
p.002017: the moment of introduction of suitable supplementary food.
p.002017: 88. (new - SG 41/09, in force from 02.06.2009) "Transitional foods" are foods,
p.002017: intended for the specific nutritional use of infants when administered appropriate
p.002017: supplemental food and which constitute the main liquid food of progressively increasing
p.002017: are the variety of foods in these infants.
p.002017: 89. (new - SG 12/11, in force from 08.02.2011) "Type IA change" is a change with
p.002017: minimal or no impact on quality, safety or efficacy
p.002017: of the respective medicinal product.
p.002017: 90. (new - SG 12/11, in force from 08.02.2011) "Type IB change" is a change,
p.002017: which is neither a Type IA nor a Type II change nor an extension of the authorization of
p.002017: use.
p.002017: 91. (new - SG 12/11, in force from 08.02.2011) "Type II change" is a change that does not
p.002017: is an extension of the marketing authorization and which can have a significant impact
p.002017: on the quality, safety or efficacy of the person concerned
p.002017: medicine.
p.002017: 92. (new - SG 102/2012, in force from 21.12.2012) "Delegated act" is an act under
p.002017: the meaning of Art. 290 of the Treaty on the Functioning of the European Union.
p.002017: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
p.002017: § 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and storage
...

Social / Incarcerated

Searching for indicator liberty:

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p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
...

Searching for indicator restricted:

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p.002017: a product authorized for use under this Act is not intended for direct delivery to the patient or
p.002017: not available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data specified in
p.002017: the ordinance under para. 1, not applied
p.002017: on the packaging or the package leaflet.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2
p.002017: The information on the packaging and the package leaflet may not be provided in English
p.002017: language.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) Delivery terms and procedure
p.002017: of the medicinal products under para. 2 shall be determined by the ordinance under art. 198.
p.002017: Chapter seven.
p.002017: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002017: Art. 171. (1) Depending on the manner of dispensing the medicinal products shall be
p.002017: classified as:
p.002017: 1. prescription medicinal products;
p.002017: 2. medicinal products dispensed without a prescription.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002017: the product is identified by the BDA in the Marketing Authorization / Registration Certificate or
p.002017: the authorization for parallel importation of the medicinal product into the territory of
p.002017: Republic of Bulgaria.
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
p.002017: the medicinal product is classified as a prescription only product.
p.002017: Art. 177. Medicinal products that do not meet the requirements of Art. 173, 174 and
p.002017: 175 and the criteria set out in the ordinance under Art. 178, are granted without medical prescription.
p.002017: Art. 178. The criteria for classification of medicinal products and the requirements for
p.002017: the documentation for making a change in the classification shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish it on the page
...

Social / Infant

Searching for indicator infant:

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p.002017: product in the Republic of Bulgaria are not sufficient to meet the health needs of the population;
p.002017: 2. there may be a temporary shortage of the necessary for export as a result of the export
p.002017: meeting the health needs of the population with the quantities of the medicinal product concerned;
p.002017: 3. the lack of sufficient quantities of the respective medicinal product to satisfy the health requirements
p.002017: the needs of the population can seriously endanger the life and health of the population.
p.002017: (6) The refusal under para. 5 shall be subject to appeal by the order of the Administrative Procedure Code.
p.002017: (7) Data on export of medicinal products from the territory of the Republic of Bulgaria are provided
p.002017: posted on the BDA's website.
p.002017: Art. 217g. (New, SG No. 18/2014) Export of medicinal products shall be effected on time
p.002017: within three months from the expiry of the term under Art. 217c, para. 4.
p.002017: Chapter Ten.
p.002017: RETAIL TRADE OF MEDICINAL PRODUCTS
p.002017: Art. 218. Retail trade in medicinal products is carried out only in pharmacies and
p.002017: drugstores under the procedure of this law, except for the cases under art. 232, para. 2.
p.002017: Art. 219. (1) (amend. - SG 71/08, in force from 12.08.2008, add. - SG, iss. 23 in 2009, in force from
p.002017: March 30, 2009, Suppl. - SG, issue. 41 of 2009, in force since 02.06.2009, as amended. - SG, issue. 60 of 2011, in force since
p.002017: 08/05/2011) The pharmacy is a health establishment, where the following activities are performed: storage, preparation,
p.002017: packing, controlling, consulting, medical and non-prescribing
p.002017: for use in the Republic of Bulgaria medicinal products, medical devices, diet foods for
p.002017: special medical purposes and infant formulas and follow-on formulas and nutritional supplements, cosmetic and
p.002017: hygiene products.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The device, the order and
p.002017: the organization of the work of pharmacies, the nomenclature of medicinal products, are determined
p.002017: in an ordinance of the Minister of Health.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008, repealed - SG, iss. 23 in 2009, in force
p.002017: from 30.03.2009)
p.002017: Art. 220. (1) The activities under art. 219, para. 1 are performed by the Master of Pharmacy.
p.002017: (2) (suppl. - SG 71/08, in force from 12.08.2008) The master pharmacist shall be obliged
p.002017: to fulfill a prescription issued, including for dosage forms prepared under
p.002017: highway and pharmacopoeial formulation, according to the procedure specified in the ordinance under Art. 221, para. 1.
p.002017: (3) (amend. - SG 102/2012, in force from 02.01.2013) The assistant-pharmacist may perform all
p.002017: activities under art. 219, para. 1 under the control of a pharmacist, with the exception of: granting
p.002017: prescription drug, control and administration
p.002017: advice on medicinal products.
p.002017: Art. 221. (1) (Former text of Art. 221 - SG 71/08, in force from 12.08.2008)
p.002017: Health determines in an ordinance the medical professionals who can issue prescriptions, the order for prescribing
p.002017: medicinal products, the time limit for implementation, and the cases and the order in which the master pharmacist may
p.002017: to refuse to perform medically
p.002017: prescription.
p.002017: (2) (New, SG No. 71/2008, effective 12.08.2008, amended, SG No. 9/2011)
p.002017: Bulgarian citizens and foreigners who are allowed to reside in the country when traveling outside the Republic
p.002017: Bulgaria may carry or export medicinal products,
...

p.002017: (3) The person under para. 1, authorized to trade in medicinal products, no
p.002017: can be the owner or participate in trading companies with the subject of production, import
p.002017: or wholesale of medicinal products,
p.002017: including in companies of related parties within the meaning of the Commercial Law.
p.002017: cases;
p.002017: Art. 224. The pharmacy manager must:
p.002017: 1. is a master pharmacist, respectively an assistant pharmacist, in accordance with the law
p.002017: 2. is not deprived of the right to practice the profession;
p.002017: 3. has not been convicted of any offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 4. has at least one year of experience as a master pharmacist.
p.002017: Art. 225. (amend. - SG 71/08, in force from 26.07.2008) (1) In a settlement on whose territory there is no
p.002017: opened a pharmacy, the right to carry out retail trade in medicinal products has a person under Art. 222, para. 1 which
p.002017: has concluded an employment contract or contract for managing a pharmacy with an assistant pharmacist or a master pharmacist with
p.002017: less than one year's work
p.002017: internship.
p.002017: (2) The assistant pharmacist or the master pharmacist under para. 1 is the head of
p.002017: pharmacy and necessarily work in it.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Assistant Pharmacist - Head of
p.002017: the pharmacy under para. 1, may perform the following activities: preservation and release without prescription of
p.002017: medicinal products, medical devices, dietary foods authorized for use in the Republic of Bulgaria
p.002017: for special medical purposes and infant formulas and follow-on formulas, and nutritional supplements, cosmetic and
p.002017: sanitary and hygienic
p.002017: funds.
p.002017: Art. 226. (1) On the territory of medical establishments for outpatient care may be
p.002017: open pharmacies to sell medicinal products to citizens.
p.002017: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, curative
p.002017: establishments for hospital care and medical establishments under art. 10 of the Law on medical establishments does not
p.002017: pharmacies can be opened to sell medicinal products to citizens.
p.002017: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009)
p.002017: The requirements for the location and the premises of the pharmacy are laid down in the ordinance of
p.002017: Art. 219, para. 2.
p.002017: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in
p.002017: (requirements from 05.08.2011) Requirements to the device and premises of pharmacies under Art. 228, para.
p.002017: 5 shall be determined in the ordinance under para. 1.
p.002017: Art. 228. (amend. - SG 71/08, in force from 26.07.2008) (1) (amend. - SG 60/11, in force from 26.07.2008)
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002017: director of the BDA on the basis of a model application to
p.002017: applicable:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a country Party
...

p.002017: retail with medicinal products at a pharmacy or make a motivated refusal to grant an authorization.
p.002017: The permit or refusal shall be
p.002017: served on the applicant.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation under Art.
p.002017: 228, para. 6 The BDA shall check the submitted documents and notify the applicant in writing of the established ones
p.002017: inconsistencies or incompleteness. In these cases
p.002017: the term under para. 2 shall cease to run from the day of notification until the deficiencies have been rectified.
p.002017: (4) (New - SG 71/08, in force from 12.08.2008) In case within 60 days from the date of notification
p.002017: under para. 3, the applicant has not remedied any inconsistencies or incompleteness found in the proceedings for the issuance of
p.002017: retail authorization for medicinal products
p.002017: products or for a change to an authorization is terminated.
p.002017: (5) (Renumbered from Paragraph (4), SG No. 71/2008, effective 12.08.2008, amended, SG No. 60/2008)
p.002017: 2011, effective 05.08.2011) The refusal of the BDA Executive Director to issue a
p.002017: permission shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002017: Art. 229a. (New, SG No. 23/2009, effective 30.03.2009) (1) (amend. - SG 41/09, in force from 30.03.2009)
p.002017: 02.06.2009, amend. - SG, issue. 98 of 2010, effective January 1, 2011, as amended. - SG, issue. 60 of 2011, in force since
p.002017: 08/05/2011) The Executive Agency for Medicinal Products officially sends to the Regional Health Insurance Institute at the location of the respective
p.002017: pharmacy with issued permit under art. 229, para. 2, which includes the retail trade of food
p.002017: supplements, dietary foods for special medical purposes, infant formulas and follow-on foods, copy of
p.002017: the permission for
p.002017: entry in the register of art. 14, para. 1 of the Food Act.
p.002017: (2) (amend. - SG 41/09, in force from 02.06.2009)
p.002017: retail trade of food supplements, dietetic foods for special medical purposes
p.002017: whole, infant formulas and follow-on foods are subject to control under the Food Act.
p.002017: Art. 230. (1) (amend. - SG 60/11, in force from 05.08.2011) The Executive Agency
p.002017: on medicines keep a register of issued licenses for retail trade of medicines
p.002017: products of art. 229, para. 2, which contains:
p.002017: 1. number and date of authorization;
p.002017: 2. (suppl. - SG 71/08, in force from 12.08.2008) name, type of the trader,
p.002017: the seat and management address of the authorized person;
p.002017: 3. (amend. - SG 12/11, in force from 08.02.2011) name, unique civil number of
p.002017: the pharmacy manager;
p.002017: 4. pharmacy address;
p.002017: 5. the activities to be performed in the pharmacy;
p.002017: 6. the date of termination of the permit and deletion from the register and the reason for
p.002017: this;
p.002017: 7. remarks on entered circumstances.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) Data from the register shall be
p.002017: published on the website of the Executive Agency for Medicines on the Internet.
p.002017: the face,
p.002017: Art. 231. (1) Upon change of the entries in the register under Art. 230, para. 1, items 2 - 5 circumstances received permission for
p.002017: retail trade of medicinal products,
p.002017: submit an application in accordance with Art. 228, para. 1, to which it also applies the change
p.002017: documents.
p.002017: (2) (New - SG 60/11, in force from 05.08.2011) In case of change
p.002017: both the name and type of merchant, pharmacy address and pharmacy manager
p.002017: a new application shall be submitted in accordance with Art. 228, para. 1 and the license fee shall be paid
p.002017: for retail sale of medicinal products in a pharmacy specified in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) A person who has received a permit for
...

p.002017: with the exception of the provision of § 64, item 2, which enters into force on April 14, 2008, and
p.002017: the provisions of § 9, item 4, § 41, 42 and 43, which shall enter into force on 26 July 2008.
p.002017: Final provisions
p.002017: TO THE LAW FOR AMENDMENT OF THE MEDICINAL PRODUCTS ACT
p.002017: HUMAN MEDICINE
p.002017: (Official Gazette of the Republic of Bulgaria, Issue 10 of 2009, Effective 29.01.2009)
p.002017: § 2. The law shall enter into force on January 29, 2009.
p.002017: Transitional and Final Provisions
p.002017: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002017: PRODUCTS IN HUMAN MEDICINE
p.002017: (Official Gazette of the Republic of Bulgaria, Issue 23 of 2009, Effective 30.03.2009)
p.002017: § 4. The persons who have received a permit under Art. 229, para. 2,
p.002017: including trading in nutritional supplements may also trade on
p.002017: retail sale of dietetic foods for special medical purposes.
p.002017: § 5. Within two months of the entry into force of this Act, the Ministry of
p.002017: Health officially sends to the respective RIPCPH at the location of pharmacies for
p.002017: entry in the register of art. 14, para. 1 of the Food Act a copy of the authorizations under Art. 229, para. 2,
p.002017: issued pending the entry into force of this Act.
p.002017: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002017: § 7. The law shall enter into force on March 30, 2009.
p.002017: Transitional and Final Provisions
p.002017: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002017: (Promulgated - SG, issue 41 of 2009, effective 02.06.2009)
p.002017: § 92. (1) The persons who have received a permit under Art. 229, para. 2
p.002017: of the Law on Medicinal Products in Human Medicine, which includes trading
p.002017: with nutritional supplements, they can also retail infant and transitional foods
p.002017: food.
p.002017: (2) Within two months of the entry into force of this Act, the Ministry of Health
p.002017: officially sends to the respective RIPCPH at the location of pharmacies operating and retail
p.002017: with infant formulas and follow-on foods under para. 1, for entry in the register under Art. 14, para. 1 of the Law on
p.002017: keep a copy of the permits under Art. 229, para. 2 of the Law on Medicinal Products in Human Medicine,
p.002017: issued pending entry into force of
p.002017: this law. "
p.002017: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002017: § 96. The law shall enter into force on the day of its promulgation in the State Gazette, p
p.002017: except for:
p.002017: 1. paragraphs 3, 5, 6 and 9, which shall take effect from 1 January 2009;
p.002017: 2. Paragraphs 26, 36, 38, 39, 40, 41, 42, 43, 44, 65, 66, 69, 70, 73, 77, 78, 79, 80, 81, 82, 83,
p.002017: 88, 89 and 90, which shall take effect from 1 July 2009;
p.002017: 3. paragraph 21, which shall take effect from 1 June 2010.
p.002017: Final provisions
p.002017: TO THE LAW FOR SUPPLEMENTATION OF THE MEDICINAL PRODUCTS ACT
p.002017: HUMAN MEDICINE
p.002017: (Official Gazette of the Republic of Bulgaria, issue 88 of 2009, effective 06.11.2009)
p.002017: § 2. The law shall enter into force on the day of its promulgation in the State Gazette.
p.002017: Transitional and Final Provisions
p.002017: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002017: PRODUCTS IN HUMAN MEDICINE
p.002017: (Official Gazette, issue 102 of 2009, effective 22.12.2009)
p.002017: § 4. (1) Master-pharmacists and
p.002017: Assistant pharmacists who have obtained permission to open a pharmacy in the settlements under Art. 228, para. 4 on
p.002017: the order of the repealed Law on Medicines and Pharmacies in Human Medicine (promulgated, SG No. 36/1995; Decision No.
p.002017: 10 of the Constitutional Court of 1996 - issue no. 61 of 1996; amend. 38 of 1998, issue. 30 of 1999, issue. 10 of 2000
p.002017: d .; 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:

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p.002017: 1, item 3, the following data on the permit / certificate shall be entered:
p.002017: 1. registration number;
p.002017: 2. number and date of the marketing authorization / registration certificate of
p.002017: the medicinal product;
p.002017: 3. name of the medicinal product;
p.002017: 4. the international non-patent name of each active substance;
p.002017: 5. the name and address of the holder of the marketing authorization / certificate of use
p.002017: registration;
p.002017: 5a. (new - SG 102/2012, in force since 21.12.2012) the conditions under art. 55a, 56 and 56a,
p.002017: entered in the Marketing Authorization / Registration Certificate;
p.002017: 6. date of change of the Marketing Authorization / Certificate
p.002017: registration;
p.002017: 7. date of termination of the marketing authorization / registration certificate;
p.002017: 8. other data.
p.002017: (2) The marketing authorization / marketing authorization for the medicinal product
p.002017: shall be served on the person under Art. 26, para. 1 and shall enter into force on the date of its entry in the register under Art.
p.002017: 19, para. 1, Vol. 3.
p.002017: Art. 53. (amend. - SG 102/02, in force from 21.12.2012) (1) The Executive Agency for Medicines shall publish
p.002017: on your website within 14 days of the granting of the marketing authorization / marketing authorization
p.002017: registration of the data under art. 52, para. 1, approved
p.002017: summary of product characteristics and package leaflet.
p.002017: (2) The Executive Agency for Medicinal Products shall publish on its website
p.002017: the assessment report under art. 49, para. 1 with the reasons for the decision, deleting the data,
p.002017: representing a trade secret.
p.002017: (3) The report under para. 2 shall be accompanied by a summary of a language comprehensible to the public.
p.002017: The summary contains a section relating to the conditions of use of the medicinal product.
p.002017: Art. 54. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of the permit for
p.002017: use / the registration certificate of the medicinal product shall notify the BDA in writing of the date of
p.002017: the actual marketing of the medicinal product in
p.002017: Republic of Bulgaria.
p.002017: (2) (Amended, SG No. 18/2014) The holder of the authorization for
p.002017: use / the registration certificate of a medicinal product shall notify the BDA at least two in writing
p.002017: months before the sale of a medicinal product ceases, regardless
p.002017: whether temporary or permanent.
p.002017: (3) (Amended, SG No. 18/2014) The holder of the authorization for
p.002017: the use / registration certificate of the medicinal product indicates the reasons for the suspension
p.002017: sales in accordance with Art. 68, para. 1, item 6 and declare whether undertaken
p.002017: from it actions under para. 2 shall be due to any of the grounds under Art. 276 or under Art. 277.
p.002017: (4) (Amended, SG No. 18/2014) Upon termination of the sales of the medicinal product
p.002017: product as a result of unforeseen circumstances the holder of the marketing authorization
p.002017: use / the registration certificate for a medicinal product shall notify the BDA in writing
p.002017: within 7 days of the establishment of the circumstances.
p.002017: d) At
p.002017: Art. 54a. (New, SG No. 60/2011, effective 05.08.2011) (1) (amend. - SG 18/04) receiving a signal
p.002017: in the Executive Agency for Cessation Drugs
p.002017: sales of a medicinal product, except in cases under Art. 54, para. 2 and 4, the agency
p.002017: carries out verification within 30 days of receiving the alert.
...

p.002017: the product is authentic and has not been tampered with;
p.002017: 2. the holder of a production permit in compliance with the requirements of Art. 168, para.
p.002017: 8 may replace safety indicators with equivalents with respect to
p.002017: the ability to guarantee the authenticity, identification and assurance of
p.002017: evidence of tampering with the medicinal product.
p.002017: (3) Safety indicators shall be considered equivalent if:
p.002017: 1. meet the requirements laid down in the delegated acts referred to in Article 54a (2)
p.002017: of Directive 2001/83 / EC, and
p.002017: 2. are equally effective in allowing authentication; and
p.002017: the identification of medicinal products and the provision of evidence of forgery
p.002017: them.
p.002017: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of
p.002017: the medicinal product and in accordance with good manufacturing practice for medicinal products
p.002017: products.
p.002017: (5) The Medicines Executive Agency shall oversee the replacement of
p.002017: safety indicators.
p.002017: Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
p.002017: compliance with the particulars in the summary of product characteristics approved by the BDA when granting the marketing authorization
p.002017: use and meet the requirements set out in
p.002017: the ordinance under Art. 170.
p.002017: (2) The information on the packaging and the package leaflet may be in several languages, but
p.002017: one of them must be Bulgarian. The content of the information is different
p.002017: languages ​​must be identical.
p.002017: (3) The name of the medicinal product shall be written in Bulgarian
p.002017: language, and the international non-patent name of the medicinal substance is given according to
p.002017: WHO anatomical-therapeutic-chemical classification. The name and address of
p.002017: the holder of the marketing authorization may be written in Latin.
p.002017: (4) The information on the packaging and the package leaflet must be understandable to the patient
p.002017: language, be legible and indelible.
p.002017: (5) (New, SG No. 18/2014) The leaflet must be designed in such a way that it is
p.002017: clear and comprehensible, allowing the patient to take appropriate action at
p.002017: need, with the help of medical professionals.
p.002017: Art. 170. (1) (Former text of Article 170 - SG, issue 102 of 2012, in force since 01.03.2013)
p.002017: The requirements for the packaging and package leaflet of the medicinal products shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: (2) (New - SG, iss. 102 in 2012, in force since 21.12.2012, suppl. - SG, iss. 18 in 2014)
p.002017: a product authorized for use under this Act is not intended for direct delivery to the patient or
p.002017: not available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data specified in
p.002017: the ordinance under para. 1, not applied
p.002017: on the packaging or the package leaflet.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2
p.002017: The information on the packaging and the package leaflet may not be provided in English
p.002017: language.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) Delivery terms and procedure
p.002017: of the medicinal products under para. 2 shall be determined by the ordinance under art. 198.
p.002017: Chapter seven.
p.002017: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002017: Art. 171. (1) Depending on the manner of dispensing the medicinal products shall be
p.002017: classified as:
p.002017: 1. prescription medicinal products;
p.002017: 2. medicinal products dispensed without a prescription.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002017: the product is identified by the BDA in the Marketing Authorization / Registration Certificate or
p.002017: the authorization for parallel importation of the medicinal product into the territory of
p.002017: Republic of Bulgaria.
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
...

Social / Marital Status

Searching for indicator single:

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p.002017: (e) All changes in the group are changes in the active documentation of the asset
p.002017: substance, vaccine antigen background, or background documentation for
p.002017: plasma;
p.002017: (f) any changes to the group are in relation to a project designed to refine
p.002017: the manufacturing process and the quality of the medicinal product concerned or its
p.002017: active substance (s);
p.002017: (g) all changes in the group are changes that affect the quality of the pandemic
p.002017: influenza vaccine;
p.002017: h) all changes in the group are changes in the pharmacovigilance system by chapter
p.002017: the eighth;
p.002017: (i) any changes to the group are the result of a specific emergency safety measure; and
p.002017: were filed in accordance with Art. 66;
p.002017: k) all changes in the group are related to the inclusion of information about a given
p.002017: pharmacotherapeutic class;
p.002017: (l) any changes in the group are the result of the evaluation of the periodic report for the
p.002017: safety;
p.002017: (m) any changes to the group result from a post-authorization study
p.002017: for use under the supervision of the marketing authorization holder;
p.002017: (n) any changes to the group are the result of the fulfillment of a condition of authorization for
p.002017: use of art. 56;
p.002017: 3. the requested changes in the conditions of the same marketing authorization do not fall under
p.002017: the cases under item 2, provided that the BDA agreed to apply the same to these changes
p.002017: procedure.
p.002017: (4) When grouping changes under para. 3, items 2 and 3, the holder of the authorization for
p.002017: use submitted to the BDA:
p.002017: 1. single notification when at least one of the changes is type IB and all others are type
p.002017: IA or type IB;
p.002017: 2. a single application where the major change is type II and none of the other changes
p.002017: is not an extension of the marketing authorization;
p.002017: 3. a single application where the major change is the extension of
p.002017: the marketing authorization.
p.002017: (5) Along with the application, respectively, the notification under para. 1 or 4, the holder of
p.002017: the marketing authorization shall submit:
p.002017: 1. documentation related to the changes, determined by the ordinance under Art. 42;
p.002017: 2. a document for a paid fee in the amount determined by the tariff under Art. 21, para. 2.
p.002017: (6) The Executive Director of the BDA shall approve the models of the application, respectively
p.002017: notification under para. 1 and 4, which are published on the BDA website.
p.002017: Art. 62. (amend. - SG 12/11, in force from 08.02.2011) (1) The holder of
p.002017: the Marketing Authorization can notify Type IA changes within 12 months of
p.002017: their implementation except changes that require immediate notification.
p.002017: (2) Type IA changes requiring immediate notification shall be determined by the ordinance
p.002017: under Art. 42.
p.002017: (3) In the cases of para. 2, the Marketing Authorization Holder notifies
p.002017: change of type IA immediately after its application.
p.002017: (4) Within 30 days from receipt of the notification under para. 1, respectively under para. 3, BDA
p.002017: notify the holder of the marketing authorization:
p.002017: 1. whether the change (s) are accepted / accepted or not; when the change / changes do not
p.002017: accepted / accepted, state the reasons for this, and
p.002017: 2. whether the change / changes lead to a change of the data in the issued
p.002017: marketing authorization; when a change to the marketing authorization is required,
p.002017: shall apply Art. 64a.
p.002017: (5) The Marketing Authorization Holder shall immediately suspend the application of
p.002017: the relevant change (s) type IA upon receipt of the notification under para. 4, Vol. 1
p.002017: for rejection.
...

p.002017: when using the medicinal product, it shall take urgent restrictive measures and
p.002017: immediately notify the BDA in writing.
p.002017: (2) The Executive Agency for Medicines shall decide on the measures within 24 hours from
p.002017: the notification.
p.002017: (3) When the BDA does not make its decision within the term under para. 2, the measures are considered to be approved.
p.002017: (4) When the BDA determines that there is a risk to human health from the use of
p.002017: the medicinal product orders the marketing authorization holder to take
p.002017: restrictive measures immediately.
p.002017: (5) In the cases of para. 1 and 4 of the Marketing Authorization Holder
p.002017: the product agrees with the BDA on the manner and deadlines for implementation of the measures taken.
p.002017: (6) The marketing authorization holder shall submit to
p.002017: the Executive Director of the BDA application for change in accordance with Art. 64 not later than 15 days
p.002017: after the date of action.
p.002017: Art. 66. (1) (amend. - SG 12/11, in force from 08.02.2011)
p.002017: marketing authorization for the medicinal product applies for the extension of
p.002017: the marketing authorization issued for:
p.002017: 1. change of active substance (s):
p.002017: (a) replacement of a chemically active substance with a different complex / derivative including
p.002017: salt / ester, with the same therapeutic moiety as the characteristics of
p.002017: efficacy / safety do not differ significantly;
p.002017: b) replacement with different isomer, different mixture of isomers, replacement of mixture with isolated
p.002017: isomer (for example of a single enantiomer racemate), wherein the characteristics of
p.002017: efficiency / safety do not differ significantly;
p.002017: (c) replacement of a biologically active substance with one having a slightly different molecular structure,
p.002017: in which the performance / safety characteristics do not differ significantly, except for
p.002017: changes in the active substance of seasonal,
p.002017: a pre-pandemic or pandemic influenza vaccine for human use;
p.002017: (d) modification of the vector used to produce the antigen or starting material,
p.002017: including a new core cell bank from another source, where the features of
p.002017: efficiency / safety do not differ significantly;
p.002017: (e) a new ligand or binding mechanism for a radiopharmaceutical in which
p.002017: the performance / safety characteristics do not differ significantly;
p.002017: (f) a change in the extraction solvent or in the ratio of vegetable
p.002017: substance / herbal preparation in which the efficacy / safety characteristics are not
p.002017: differ significantly;
p.002017: 2. change in the amount of active substance, dosage form and route of
p.002017: introduction:
p.002017: (a) change in bioavailability;
p.002017: (b) a change in pharmacokinetics, such as a change in the rate of release;
p.002017: (c) modification or addition of a new amount of the active substance / activity;
p.002017: (d) modifying or adding a new dosage form;
p.002017: e) change or addition of a new route of administration - in parenteral administration
p.002017: a distinction needs to be made between intraarterial, intravenous, intramuscular,
...

p.002017: the ordinance under para. 1, not applied
p.002017: on the packaging or the package leaflet.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2
p.002017: The information on the packaging and the package leaflet may not be provided in English
p.002017: language.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) Delivery terms and procedure
p.002017: of the medicinal products under para. 2 shall be determined by the ordinance under art. 198.
p.002017: Chapter seven.
p.002017: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002017: Art. 171. (1) Depending on the manner of dispensing the medicinal products shall be
p.002017: classified as:
p.002017: 1. prescription medicinal products;
p.002017: 2. medicinal products dispensed without a prescription.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002017: the product is identified by the BDA in the Marketing Authorization / Registration Certificate or
p.002017: the authorization for parallel importation of the medicinal product into the territory of
p.002017: Republic of Bulgaria.
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
p.002017: the medicinal product is classified as a prescription only product.
p.002017: Art. 177. Medicinal products that do not meet the requirements of Art. 173, 174 and
p.002017: 175 and the criteria set out in the ordinance under Art. 178, are granted without medical prescription.
p.002017: Art. 178. The criteria for classification of medicinal products and the requirements for
p.002017: the documentation for making a change in the classification shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish it on the page
p.002017: your online list of prescription medicines
p.002017: the territory of the Republic of Bulgaria.
p.002017: (2) The list under para. 1 is updated annually.
p.002017: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002017: or the certificate of registration, the BDA shall review and, where necessary, amend the classification according to
p.002017: the requirements of Art. 173 and the criteria specified
p.002017: in the ordinance under art. 178.
p.002017: Art. 181. Where a change in the classification of a medicinal product on the basis of
p.002017: significant pre-clinical or clinical trials, no subsequent applicant or marketing authorization holder
...

p.002017: procedure provided for in Chapter II of Title II of the
p.002017: Regulation (EC) No 726/2004 of the European Parliament and of the Council, or
p.002017: 2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
p.002017: (4) The European Union reference dates for medicinal products under
p.002017: Art. 194l and the harmonized frequency for submitting their periodic up-to-date reports
p.002017: safety shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: (5) The holder of the marketing authorization after the publication of the data under para. 4 presents to the BDA an application for
p.002017: modification of the marketing authorization for the medicinal product concerned. Any change in filing dates and on
p.002017: the frequency of submission of periodic safety update reports specified in the
p.002017: use, effective 6
p.002017: months after their date of publication.
p.002017: Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: Medicines evaluates periodic safety update reports for medicinal products for
p.002017: to determine if there are new risks, or a change in
p.002017: identified risks, or change in benefit / risk ratio.
p.002017: (2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic up-to-date reports on
p.002017: safety for medicinal products for which the Republic of Bulgaria has fulfilled the functions of a reference country
p.002017: within the meaning of Art. 76, and is determined by
p.002017: the coordination group of art. 77, para. 2.
p.002017: (3) A rapporteur from the Republic of Bulgaria shall participate in the single evaluation of the periodic reports
p.002017: updated safety reports for medicinal products where at least one of the products
p.002017: has been authorized under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
p.002017: The Council, and is designated as such by the committee under Art. 56a, para. 1, v. 1.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases under Art. 194o, para. 2 and 3 BDA,
p.002017: respectively, the rapporteur from the Republic of Bulgaria within 60 days from the date of receipt of the periodic
p.002017: an updated safety report shall prepare an evaluation report and send it electronically to the European
p.002017: the Medicines Agency and the regulatory authorities of the Member States. The Marketing Authorization Holder receives
p.002017: the evaluation report from
p.002017: European Medicines Agency.
p.002017: (2) Within 30 days of receipt of the report under para. 1 holder of the authorization for
p.002017: Member States' regulatory authorities or authorities may submit their comments
p.002017: to the European Medicines Agency and to the BDA.
p.002017: (3) Within 15 days from the date of receipt of the comments under para. 2 BDA updates
p.002017: the evaluation report, taking into account all the objections presented, and forwarding it to the committee
p.002017: under Art. 56a, para. 1, item 1 for approval and recommendation.
p.002017: (4) The European Medicines Agency has included the evaluation report adopted and
p.002017: the recommendation of the Committee under Art. 56a, para. 1, item 1 in the register under Art. 194h, para. 3 and sends it to
p.002017: the holder of the marketing authorization.
p.002017: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) Where the Republic of Bulgaria is not
p.002017: rapporteur in the procedure under Art. 194o, para. 2, the BDA may submit comments within the term under Art. 194p, para. 2 to
p.002017: The European Medicines Agency and the regulatory authority of the European Medicines Agency
p.002017: the Member State that produced the assessment report.
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and when none of the authorizations for
p.002017: the use of these products has not been issued under Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: the coordination group of art. 77, para. 2 within 30 days from the date of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the preservation, modification, suspension or termination of
p.002017: relevant marketing authorizations, including a timetable for the implementation of the opinion.
p.002017: (2) Where the represented Member States in the coordination group under Art. 77, para. 2
p.002017: they agree on the actions to be taken, the BDA implements
p.002017: the decision taken.
p.002017: (3) Where the opinion under para. 1 is to suspend or terminate the authorization for
p.002017: The BDA Executive Director issues an order.
p.002017: (4) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (5) When agreement cannot be reached within the coordination group under Art. 77, para. 2, the position of
p.002017: the majority of the Member States are referred to the European Commission, which decides on the change,
p.002017: suspension or termination of permissions for
p.002017: use issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 5.
p.002017: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and where at least one of the authorizations for
p.002017: the use has been issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: medicinal products for human use within 30 days of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the retention, amendment, suspension or termination of validity
p.002017: of the relevant marketing authorizations, including a timetable for the implementation of
p.002017: the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. Decides to change, suspend or terminate the marketing authorizations,
p.002017: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 2. adopt a decision recommending change, suspension or termination of authorizations
p.002017: for use issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 2, Vol. 2.
p.002017: Section IV.
p.002017: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002017: 12/21/2012)
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure of
...

p.002017: wholesalers, pharmacies and drugstores,
p.002017: located in the territory of the respective area.
p.002017: (3) The investment projects for the construction of new and / or shall be coordinated with the BDA
p.002017: redevelopment of existing facilities related to the manufacture of medicinal products
p.002017: in accordance with the rules of Good Manufacturing Practice for Medicinal Products.
p.002017: Art. 268a. (New - SG 60/11, in force from 05.08.2011) (1) Donations of medicinal products by holders of
p.002017: Authorization for use, manufacturers, wholesalers and retailers and the Bulgarian Red Cross can be made
p.002017: only after approval by the donor with the BDA by submitting an application in the form approved by the Minister of
p.002017: healthcare on
p.002017: proposal of the BDA Executive Director.
p.002017: (2) Donations shall be made in accordance with the rules of Good Donation Practice of
p.002017: World Health Organization.
p.002017: (3) Where within 10 days from the receipt of the application under para. 1 BDA does not
p.002017: replied in writing to the donor, it is considered that there is tacit agreement to perform
p.002017: the donation.
p.002017: (4) The medical establishments and the Bulgarian Red Cross shall notify the BDA of the received
p.002017: donations of medicinal products within 7 days of receipt.
p.002017: (5) At the end of each quarter, the BDA shall send information to the Ministry of Finance
p.002017: healthcare for the donations made under para. 4.
p.002017: (6) To make a donation of a medicinal product at the request of a medical establishment,
p.002017: intended for the treatment of a particular patient in a life-threatening condition, the donor
p.002017: notify the BDA within 7 days of its completion.
p.002017: (7) The donations under para. 6 may not exceed the amount required for a single use
p.002017: course of treatment.
p.002017: Art. 269. (1) The control under art. 267 is performed through inspections and laboratory tests.
p.002017: (2) The inspections and laboratory tests under para. 1 shall be carried out:
p.002017: 1. in connection with the granting of authorizations for use, production, import and certificates
p.002017: by the order of this law;
p.002017: 2. in connection with the supervision of the market of medicinal products;
p.002017: 3. at the request of the European Commission, of the European Agency of the European Communities
p.002017: medicines or by the competent authority of another Member State;
p.002017: 4. upon application by a manufacturer, importer or holder of an authorization for
p.002017: use out of the cases under item 1.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012)
p.002017: medicines carries out inspections:
p.002017: 1. to manufacturers of medicinal products located in the territory of the Republic
p.002017: Bulgaria, per Member State or in third countries;
p.002017: 2. to importers and wholesalers of medicinal products;
p.002017: 3. at the premises of the manufacturers, importers and wholesalers of the active
p.002017: substances located on the territory of the Republic of Bulgaria;
p.002017: 4. at the premises of manufacturers or wholesalers of active substances,
p.002017: located in third countries as well as manufacturers or importers of excipients;
p.002017: 5. at the premises of the holders of marketing authorization
p.002017: products and intermediaries in the field of medicinal products, registered in accordance with Art.
p.002017: 212a;
p.002017: 6. as part of the certification procedure relating to the monographs of
p.002017: The European Pharmacopoeia;
p.002017: 7. to manufacturers of starting materials at the written request of the manufacturer.
...

Social / Mothers

Searching for indicator mothers:

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p.002017: persons who are unable to give informed consent are permitted, provided that:
p.002017: 1. the relevant ethics committee with the participation of specialists with competence in the respective disease, or
p.002017: in the patient group approved the protocol after discussing clinical, moral and psychosocial aspects,
p.002017: relating to the disease in question and to
p.002017: the patient group;
p.002017: 2. it can be expected that the intake of the medicinal product being tested will
p.002017: lead to benefits that outweigh the risks or the risks are completely eliminated;
p.002017: 3. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or to data obtained through others
p.002017: research methods;
p.002017: 4. the test is directly related to life-threatening or leading to disability
p.002017: a disease in which the relevant adult is unable to give
p.002017: an informed consent;
p.002017: 5. clinical trials are designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: predefined and constantly monitored
p.002017: during the test;
p.002017: 6. no financial or other incentives are given except compensation.
p.002017: Art. 102. No clinical trial of a medicinal product on
p.002017: pregnant women and nursing mothers unless the medicinal product is required for treatment
p.002017: they may or may not be tested on another group of patients.
p.002017: Section III.
p.002017: Ethics Committees
p.002017: Art. 103. (1) (amend. - SG 60/11, in force from 05.08.2011) To the Minister of
p.002017: a multi - center ethics committee is set up by the Health Committee, whose composition is determined by
p.002017: Minister's order and includes regular and reserve members. Reserve members
p.002017: participate in committee meetings and have the right to vote in the absence of full members.
p.002017: (2) To the medical establishments where clinical trials are carried out shall be established
p.002017: ethics committees composed of the head of the hospital.
p.002017: (3) The Executive Agency for Medicines shall maintain and keep a register of the Committees on
p.002017: ethics.
p.002017: (4) The register of medical establishments to which ethics committees are established shall be
p.002017: published on the BDA website on the Internet.
p.002017: Art. 104. (1) The commissions under art. 103, para. 1 and 2 consist of 7 to 12 members who have
p.002017: qualification and experience to consider and evaluate the scientific, medical and ethical aspects of
p.002017: the proposed clinical trial.
p.002017: (2) The commissions under para. 1 shall include at least two non-medical members
p.002017: education - representatives of both sexes who are financially and administratively independent
p.002017: from the hospital where the clinical trial is being conducted.
...

Social / Police Officer

Searching for indicator officer:

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p.002017: the medical sales representatives of art. 244, para. 1, item 3 of the population.
p.002017: Art. 256. Samples of medicinal products shall be made available to medical specialists
p.002017: under the conditions and by the order specified in the ordinance under art. 249.
p.002017: Art. 257. (1) The medical commercial representatives of art. 244, para. 1, item 3 must have received training,
p.002017: organized by the marketing authorization holder who assigned them to have scientific knowledge and
p.002017: be able to deliver as accurate and complete as possible
p.002017: information on the medicinal product they are presenting.
p.002017: (2) During each visit, the medical sales representatives must
p.002017: have the summary of product characteristics and the pricing data for the medicinal product and
p.002017: the terms of payment and make them available upon request.
p.002017: (3) When presenting medicinal products to medical specialists
p.002017: medical sales representatives cannot offer gifts and other property
p.002017: non-material benefit.
p.002017: Chapter twelve.
p.002017: ADJUSTMENT OF THE PRICES OF THE MEDICINAL PRODUCTS (HEADING - SG, No.
p.002017: 102 FROM 2012)
p.002017: Section I.
p.002017: National Council for Prices and Reimbursement of Medicinal Products (New, SG No. 102/2006)
p.002017: from 2012, in force since 21.12.2012)
p.002017: Art. 258. (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.002017: d.) (1) (Amended, SG No. 43/2016) A National Council on Prices and
p.002017: reimbursement of medicinal products, hereinafter referred to as "tips". The Council is a legal entity of
p.002017: budget support - minor
p.002017: budget authorizing officer. It has the status of a state commission based in Sofia.
p.002017: (2) The activity of the council shall be financed from the state budget through the budget of
p.002017: Ministry of Health.
p.002017: (3) The Council is a collegial body and consists of a chairman and six members, three of whom are doctors or
p.002017: Master's in Pharmacy, two lawyers and two economists, all with at least 5 years of experience.
p.002017: The Chairman and the members of the Council are elected and dismissed by a decision of the Council of Ministers
p.002017: at the proposal of the Minister of
p.002017: healthcare. The chairman directs and represents the board.
p.002017: (4) The members of the council may not occupy a position or carry out activity under Art. 19,
p.002017: para. 6 of the Administration Act.
p.002017: (5) The activities of the Council shall be assisted by an administration whose structure and organization
p.002017: work is determined by the rules of procedure adopted by the Council of Ministers.
p.002017: Art. 259. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012,
p.002017: in force since 21.12.2012) (1) The Council shall:
p.002017: 1. approve, refuse to approve, amend or delete the price of medicinal products under
p.002017: Art. 261a, para. 1;
p.002017: 2. approve, refuse to approve, amend or delete the marginal price of medicinal products
p.002017: products of art. 261a, para. 2;
p.002017: 3. register, refuse to register, amend or delete the prices of the medicinal products
p.002017: products granted without a doctor's prescription under Art. 261a, para. 3;
p.002017: 4. (amend. - SG 48/2015) approve, repeal or amend pharmacotherapeutic guidelines, including
p.002017: criteria for evaluating the outcome of therapy, as well as recommendations for algorithms for treatment with
p.002017: medicinal products offered by relevant national consultants, medical research companies and
...

Social / Property Ownership

Searching for indicator property:

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p.002017: Regulation (EC) No 1901/2006.
p.002017: (2) (Supplemented, SG No. 18/2014) The documents under para. 1, items 18 and 18a with respect to
p.002017: Member States, respectively under point 19, shall be submitted only in the procedures under Section VII.
p.002017: (3) For radionuclide generators to the data of para. 1 are presented additionally
p.002017: the following documents:
p.002017: 1. a description of the system together with a detailed description of its components that it can
p.002017: affect the composition or quality of daughter radionuclides;
p.002017: 2. the qualitative and quantitative characteristics of the eluate or sublimate.
p.002017: (4) Documents and data from pharmaceutical, preclinical and clinical
p.002017: the tests shall be accompanied by summary reports prepared by experts with the necessary technical and
p.002017: qualification. An autobiographical report is attached to the reports
p.002017: to the experts who produced the report.
p.002017: (5) The dossier of the medicinal product shall be submitted in Bulgarian and / or English.
p.002017: (6) (New, SG No. 102/2012, effective 21.12.2012) The risk management system of para. 1, v. 13
p.002017: should be proportionate to the identified and potential risks of the medicinal product and of
p.002017: the need to collect safety data from
p.002017: post-marketing studies.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The holder of the permit
p.002017: for use updates the data from the file under para. 1. It shall apply to any change in the dossier
p.002017: the order of Chapter Three, Section VI, where applicable.
p.002017: Art. 28. (1) (amend. - SG 71/08, in force from 12.08.2008) The person under art. 26, para. 1 insofar as it does not violate
p.002017: industrial and commercial property rights, does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b" and "c",
p.002017: if it can prove that the medicinal product referred to in the application is generic to the reference medicinal product,
p.002017: which is allowed or is
p.002017: was authorized for use in a Member State not less than 8 years ago.
p.002017: (2) The holder of the authorization for use of the generic product under para. 1 cannot
p.002017: to place it on the market before the expiry of 10 years from the date of first authorization
p.002017: of the reference medicinal product.
p.002017: (3) The person under art. 26, para. 1, subject to the conditions of para. 1 and 2 may apply to the BDA for permission to
p.002017: use of a generic reference product and where the reference product was not authorized
p.002017: use within the territory of the Republic
p.002017: Bulgaria.
p.002017: (4) In the cases of para. 3 the person under art. 26, para. 1 shall indicate in the application under Art. 27, para. 1
p.002017: the Member State in which the reference product is authorized or has been authorized.
p.002017: (5) In the cases of para. 3 The BDA requires the regulatory authority of the Member State,
p.002017: referred to in the application under Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and
p.002017: the qualitative composition of the reference product and, if necessary, additional documentation.
p.002017: (6) The Executive Agency for Medicinal Products makes available on request to a regulatory authority of a Member State, c
p.002017: which has been submitted for a generic reference product that has been authorized or has been authorized
p.002017: for use on the territory of the Republic
...

p.002017: the requirements of this Act or the original marketing authorization shall be supplemented. All these permissions are considered as
p.002017: belonging to a global marketing authorization for the medicinal product for
p.002017: the purposes of applying this Article.
p.002017: Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary
p.002017: preclinical and / or clinical trials where the medicinal product referred to in
p.002017: application:
p.002017: 1. cannot be defined as generic, or
p.002017: 2. bioavailability tests do not prove bioequivalence, or
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) there is a change in the active substance or substances in
p.002017: the amount of active substance or substances per dosage unit, the therapeutic indication, of
p.002017: the dosage form, the route of administration against
p.002017: the reference medicinal product.
p.002017: 4. (repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: (2) Where the biological medicinal product referred to in the application is similar to a reference biological
p.002017: is not eligible to be classified as a generic medicinal product because of
p.002017: different production method or different starting materials compared to reference or other
p.002017: reasons, the applicant submits to the BDA the results of the required preclinical and / or clinical trials,
p.002017: related to these conditions.
p.002017: (3) In the cases of para. 1 and 2 the documentation specified in the ordinance under Art.
p.002017: 42.
p.002017: Art. 30. (1) The person under art. 26, para. 1 insofar as it does not violate industrial and commercial rights
p.002017: property, 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.002017: defined in the ordinance under art. 42 that the active substance included in the proposed authorization for
p.002017: use of a medicinal product is well established in medical practice, has recognized efficacy and
p.002017: acceptable level of safety. In these cases, the test results and tests may be replaced
p.002017: with the relevant ones
p.002017: scientific publications.
p.002017: (2) The person under para. 1 presents the results of the necessary preclinical and clinical trials in the case of
p.002017: a medicinal product containing active substances of well - established use that has not been used in
p.002017: the proposed combination for therapeutic purposes. In this
p.002017: no documentation is submitted in respect of each individual active substance.
p.002017: (3) When an active substance within the meaning of para. 1 has a proven new therapeutic indication on the base
p.002017: significant preclinical or clinical data related to the new indication, once for a period of
p.002017: one year the next applicant cannot rely on
p.002017: data on the new indication of the active substance.
p.002017: Art. 31. In the case where a medicinal product contains active substances used in the authorized composition
p.002017: for use medicinal products but not used in the proposed combination for therapeutic purposes, the person
p.002017: under Art. 26, para. 1 presents the results of preclinical and clinical trials related to
p.002017: this combination. In this case, the applicant does not provide documentation on the safety and efficacy of each
...

p.002017: establishments under para. 4, which do not have an open pharmacy, can be obtained from a pharmacy at a medical establishment,
p.002017: has received a retail authorization for medicinal products
p.002017: products under the conditions and in the order determined by the ordinance under art. 219, para. 2.
p.002017: (6) (Repealed, previous para. 4 - SG, iss. 71 in 2008, effective from 26.07.2008, previous para.
p.002017: 2011, in force since 05/08/2011) Pharmacies of outpatient medical establishments at
p.002017: The Ministry of Defense and the Ministry of the Interior may be led by a pharmacist assistant
p.002017: proposal from the relevant agency
p.002017: and after permission was issued by the Executive Director of the BDA.
p.002017: Art. 223. (1) A master pharmacist or an assistant pharmacist may be a manager
p.002017: only one pharmacy and must work in it.
p.002017: (2) (amend. - SG 12/11, in force from 08.02.2011) The Master of Pharmacy or
p.002017: pharmacist assistant pharmacist cannot be hired on contract with
p.002017: a sole proprietor or a trading company having a manufacturing activity,
p.002017: import, wholesale or retail of medicinal products.
p.002017: (3) The person under para. 1, authorized to trade in medicinal products, no
p.002017: can be the owner or participate in trading companies with the subject of production, import
p.002017: or wholesale of medicinal products,
p.002017: including in companies of related parties within the meaning of the Commercial Law.
p.002017: cases;
p.002017: Art. 224. The pharmacy manager must:
p.002017: 1. is a master pharmacist, respectively an assistant pharmacist, in accordance with the law
p.002017: 2. is not deprived of the right to practice the profession;
p.002017: 3. has not been convicted of any offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 4. has at least one year of experience as a master pharmacist.
p.002017: Art. 225. (amend. - SG 71/08, in force from 26.07.2008) (1) In a settlement on whose territory there is no
p.002017: opened a pharmacy, the right to carry out retail trade in medicinal products has a person under Art. 222, para. 1 which
p.002017: has concluded an employment contract or contract for managing a pharmacy with an assistant pharmacist or a master pharmacist with
p.002017: less than one year's work
p.002017: internship.
p.002017: (2) The assistant pharmacist or the master pharmacist under para. 1 is the head of
p.002017: pharmacy and necessarily work in it.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Assistant Pharmacist - Head of
p.002017: the pharmacy under para. 1, may perform the following activities: preservation and release without prescription of
p.002017: medicinal products, medical devices, dietary foods authorized for use in the Republic of Bulgaria
p.002017: for special medical purposes and infant formulas and follow-on formulas, and nutritional supplements, cosmetic and
p.002017: sanitary and hygienic
p.002017: funds.
p.002017: Art. 226. (1) On the territory of medical establishments for outpatient care may be
p.002017: open pharmacies to sell medicinal products to citizens.
p.002017: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, curative
p.002017: establishments for hospital care and medical establishments under art. 10 of the Law on medical establishments does not
p.002017: pharmacies can be opened to sell medicinal products to citizens.
p.002017: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009)
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p.002017: performs his / her duties due to the use of temporary disability leave due to illness, pregnancy and
p.002017: birth or adoption and parental leave in accordance with the Labor Code, pharmacy
p.002017: may work for no more than two years under the direction of another
p.002017: Master Pharmacist, respectively Assistant Pharmacist, in the cases under Art. 225, which meets the requirements of Art. 224
p.002017: In these
p.002017: cases, a permit is issued by the BDA Executive Director.
p.002017: (3) The permit under para. 2 shall be issued within 30 days.
p.002017: Art. 237. Upon termination of the activity of the person, authorized to open
p.002017: pharmacy, medicinal products may be sold to persons who have been authorized
p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
...

p.002017: the order of art. 251.
p.002017: Art. 254a. (New, SG No. 60/2011, effective 05.08.2011) (1) Advertising,
p.002017: intended for medical specialists shall not be authorized in accordance with Art. 250 - 252.
p.002017: (2) The advertisement under para. 1 shall be distributed upon notification to the BDA at
p.002017: which applies to the design of the advertisement and subject to the requirements of this chapter and the regulation
p.002017: under Art. 249.
p.002017: Art. 255. (1) It is prohibited to distribute samples of medicinal products,
p.002017: containing narcotic substances within the meaning of the Narcotics Control Act
p.002017: and precursors.
p.002017: (2) It is prohibited to directly provide samples of medicinal products from
p.002017: the medical sales representatives of art. 244, para. 1, item 3 of the population.
p.002017: Art. 256. Samples of medicinal products shall be made available to medical specialists
p.002017: under the conditions and by the order specified in the ordinance under art. 249.
p.002017: Art. 257. (1) The medical commercial representatives of art. 244, para. 1, item 3 must have received training,
p.002017: organized by the marketing authorization holder who assigned them to have scientific knowledge and
p.002017: be able to deliver as accurate and complete as possible
p.002017: information on the medicinal product they are presenting.
p.002017: (2) During each visit, the medical sales representatives must
p.002017: have the summary of product characteristics and the pricing data for the medicinal product and
p.002017: the terms of payment and make them available upon request.
p.002017: (3) When presenting medicinal products to medical specialists
p.002017: medical sales representatives cannot offer gifts and other property
p.002017: non-material benefit.
p.002017: Chapter twelve.
p.002017: ADJUSTMENT OF THE PRICES OF THE MEDICINAL PRODUCTS (HEADING - SG, No.
p.002017: 102 FROM 2012)
p.002017: Section I.
p.002017: National Council for Prices and Reimbursement of Medicinal Products (New, SG No. 102/2006)
p.002017: from 2012, in force since 21.12.2012)
p.002017: Art. 258. (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.002017: d.) (1) (Amended, SG No. 43/2016) A National Council on Prices and
p.002017: reimbursement of medicinal products, hereinafter referred to as "tips". The Council is a legal entity of
p.002017: budget support - minor
p.002017: budget authorizing officer. It has the status of a state commission based in Sofia.
p.002017: (2) The activity of the council shall be financed from the state budget through the budget of
p.002017: Ministry of Health.
p.002017: (3) The Council is a collegial body and consists of a chairman and six members, three of whom are doctors or
p.002017: Master's in Pharmacy, two lawyers and two economists, all with at least 5 years of experience.
p.002017: The Chairman and the members of the Council are elected and dismissed by a decision of the Council of Ministers
p.002017: at the proposal of the Minister of
p.002017: healthcare. The chairman directs and represents the board.
p.002017: (4) The members of the council may not occupy a position or carry out activity under Art. 19,
p.002017: para. 6 of the Administration Act.
p.002017: (5) The activities of the Council shall be assisted by an administration whose structure and organization
p.002017: work is determined by the rules of procedure adopted by the Council of Ministers.
...

p.002017: expired, is liable to a fine of BGN 10,000 to BGN 20,000.
p.002017: (2) Who breaks the primary / secondary packaging or sells / provides medicinal products
p.002017: products with broken primary / secondary packaging are punished with a fine of 750 to 1500 levs, and for
p.002017: repeated violation - with a fine from 1500 to 3000 BGN.
p.002017: Art. 284. (1) Who manufactures, imports or wholesale medicinal products or
p.002017: sells medicinal products without permission, is fined BGN 50,000.
p.002017: (2) (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 02.01.2013)
p.002017: Who manufactures, imports or wholesale medicinal products or sells medicinal products in violation of
p.002017: the authorization is granted or the sale, storage or supply of medicinal products which are of unknown origin,
p.002017: shall be punished by a fine of 25
p.002017: 000 to 50 000 BGN
p.002017: (3) (suppl. - SG 71/08, in force from 12.08.2008) In the cases of para. 1 and 2 organs
p.002017: of state control stop the operation of the site by order.
p.002017: (4) The order under para. 3 shall be subject to appeal by the order of the Administrative Procedure
p.002017: Code, and the appeal does not suspend its enforcement.
p.002017: Art. 284a. (New, SG No. 102/2012, effective 02.01.2013) Who produces, imports, exports, stores,
p.002017: sells or provides counterfeit medicinal products, and mediates the purchase and sale of
p.002017: falsified medicinal products, shall be punished by
p.002017: fine from BGN 25,000 to BGN 50,000
p.002017: Art. 284b. (New, SG No. 102/2012, effective 02/01/2013) Holder of a production permit, which
p.002017: does not fulfill its obligations under Art. 160, shall be punished by a pecuniary sanction from 5000 to 10 000 levs;
p.002017: re-committing the same violation - with property
p.002017: fine from BGN 10,000 to BGN 20,000
p.002017: Art. 284c. (New, SG No. 102/2012, effective 02.01.2013) Holder of a wholesale trade permit
p.002017: medicinal products, which does not fulfill its obligations under Art. 207, shall be punished by a pecuniary sanction from 2000 to
p.002017: 5000 BGN, and if you do the same again
p.002017: violation - with a property sanction from 5000 to 10 000 BGN.
p.002017: Art. 285. (1) Who trades in medicinal products without a certificate of release of
p.002017: batch, shall be punished by a fine of BGN 5,000 to BGN 10,000, and upon re-doing the same
p.002017: violation - with a fine of 10,000 to 20,000 BGN.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) A wholesaler who supplies medicinal drugstores
p.002017: prescription products are punished with a property sanction of 2500 to 5000 levs, and
p.002017: in the case of repeated infringement - with a fine from 5000 to 10,000
p.002017: BGN
p.002017: (3) Qualified person, authorized to sell lots of medicines
p.002017: products without a batch release certificate are fined 2500
p.002017: up to 5000 BGN
p.002017: Art. 285a. (New - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012
p.002017: (d) The Marketing Authorization Holder who has not notified the Minister of Health of
p.002017: suspension of sales under Art. 264, shall be punished by a pecuniary sanction of 25,000 to 50,000
p.002017: BGN
p.002017: Art. 285b. (New, SG No. 102/2012, effective 21.12.2012) Who produces, imports,
p.002017: exports, sells or stores active substances in violation of the requirements of this Act,
p.002017: fines from 10,000 to 20,000 BGN.
p.002017: Art. 285c. (New, SG No. 18/2014) Holder of a marketing authorization for a medicinal product which does not
p.002017: notified the BDA of export of medicinal products under Art. 217a, para. 4, shall be punished by a fine, respectively
p.002017: a pecuniary sanction in the amount of BGN 50,000 to BGN 100,000, and in the case of repeated infringement - in the amount of 100
p.002017: 000 to 200 000 BGN
p.002017: Art. 286. (1) For clinical trials performed in violation of this law, if the done does not constitute
p.002017: a fine of BGN 5,000 to 10,000 is imposed on the perpetrators who committed or committed the violation,
p.002017: and upon re-admission or making
p.002017: the same offense - a fine of 10,000 to 20,000 BGN.
p.002017: (2) To medical specialists who have admitted or committed violations under para. 1, can
p.002017: a sentence of "deprivation of the right to exercise their profession" was imposed from 6 months to two
p.002017: years.
p.002017: (3) The measure under para. 2 shall be imposed by the Minister of Health on the proposal of
...

p.002017: issued by the Executive Director of an Executive Agency
p.002017: "Medical Audit".
p.002017: Art. 290. (1) (amend. - SG 71/08, in force from 12.08.2008) Who advertises
p.002017: medicinal products which are not authorized for use under this Act shall be punished by
p.002017: fine from BGN 10,000 to BGN 20,000
p.002017: (2) (New, SG No. 71/2008, effective 12.08.2008) Who advertises a product, such as
p.002017: attributes and / or directs it to properties related to the prevention, diagnosis or treatment of
p.002017: human diseases, punishable by a fine of 10,000 to 20,000 BGN.
p.002017: (3) (prev. Para 2 - SG 71/08, in force from 12.08.2008) Who advertises
p.002017: medicinal products in violation of this law, shall be fined BGN 10,000 to BGN 20,000.
p.002017: (4) (Renumbered from Paragraph (3), amend. - SG 71/08, in force from 12.08.2008)
p.002017: para. 1 - 3 are also imposed on the persons who have allowed the broadcasting, publication and distribution of
p.002017: advertising.
p.002017: Art. 290a. (New - SG 71/08, in force from 12.08.2008) Medical specialist
p.002017: or a person posing as a healthcare professional performing direct or indirect advertising
p.002017: medicinal products in the print and / or electronic media, as well as on the Internet, are punished
p.002017: with a fine from 1000 to 5000 levs, and in the case of repeated violation - from 3000 to 10,000 levs.
p.002017: Art. 290b. (New, SG No. 60/2011, effective 05.08.2011) Who makes a donation to
p.002017: medicinal products in violation of Art. 268a, para. 1 shall be punished by a fine of from 1000 to 3000 levs
p.002017: repeated infringement - with a fine from 3000 to 5000 BGN.
p.002017: Art. 290c. (New - SG 102/2012, in force since 21.12.2012) The holder of a marketing authorization which
p.002017: conducts non-interventional studies in violation of this law, is punished by a property sanction of 5000
p.002017: up to BGN 10,000, and if you do the same again
p.002017: violation - with a property sanction from BGN 10,000 to BGN 20,000
p.002017: Art. 290g. (New, SG No. 102/2012, effective 21.12.2012) Holder of a marketing authorization which does not
p.002017: 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.002017: re-committing the same violation - with property
p.002017: fine from BGN 10,000 to BGN 20,000
p.002017: Art. 290d. (New, SG No. 102/2012, effective 21.12.2012) Permission holder
p.002017: for use which does not fulfill the obligations under Art. 190 - 192, 194b, 194c, 194h and 194i, shall be punished
p.002017: with a pecuniary sanction from BGN 5,000 to 10,000, and in the case of repeated infringement -
p.002017: with a property sanction of BGN 10,000 to BGN 20,000
p.002017: Art. 290s. (New, SG No. 102/2012, effective 21.12.2012) Holder of a marketing authorization which does not
p.002017: fulfills the obligations under Art. 193 and 194, shall be punished by a pecuniary sanction from 2000 to 5000 levs, and in case of a repeated sanction
p.002017: committing the same offense - with property
p.002017: fine from $ 5,000 to $ 10,000
p.002017: Art. 291. (1) (Supplemented, SG No. 60/2011, effective 05.08.2011, suppl. - SG 60/02, in force from 05.08.2011
p.002017: 07.08.2012, amended - SG, issue. 102 of 2012, effective 21.12.2012) Where the violations under Art. 281 -
p.002017: 284a, 285, 285b, art. 286, para. 1, Art. 287 and 287b, Art. 289, para. 1, Art. 289a, Art. 290, Art. 290b, Art. 292 and Art. 294 are
p.002017: committed by legal persons or sole proprietors, property penalties of not less than
p.002017: the triple amount of the minimum amounts of the respective fines and not more than triple the amount of the fines
p.002017: provided for
p.002017: the maximum amounts of the fines concerned.
p.002017: (2) (Supplemented, SG No. 60/2012, effective 07.08.2012) For violations of art. 289, para. 1
p.002017: the pecuniary sanction shall be nine times the amount of the excess amount if it exceeds the maximum
p.002017: the amount of the sanction under para. 1.
p.002017: (3) The imposition of a pecuniary sanction shall not preclude the imposition of a fine on the guilty persons
p.002017: officials.
p.002017: (4) The imposition of pecuniary sanctions shall not preclude the imposition of the measures provided for
p.002017: on the competence of medical professionals and qualified persons.
p.002017: Art. 292. (1) Who does not comply with the order, prescription or instruction of the bodies of
p.002017: state control under this law, except in cases under Art. 270, para. 1, item 2 and para. 3, shall be punished by a fine
p.002017: from 1500 to 3000 BGN
p.002017: (2) For failure to comply with an order under Art. 270, para. 1, item 2 and para. 3 guilty persons
p.002017: fined from 500 to 1000 levs
p.002017: Art. 293. (1) (amend. - SG 102/2012, in force from 02.01.2013) In case of non-compliance with the conditions,
p.002017: under which the manufacturing / import licenses, parallel importations, trade licenses have been issued
p.002017: wholesale and retail trade of medicinal products in a pharmacy, as well as in the cases under Art. 281, para. 1 - 3 and Art. 283, para. 1
p.002017: the Executive Director of the BDA issues an order for
p.002017: their seizure.
p.002017: (2) (amend. - SG 102/2012, in force from 02.01.2013) In case of non-compliance with the conditions,
p.002017: in which a certificate for registration of a drugstore was issued, as well as in the cases under Art. 287,
...

p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
p.002017: intellectual property rights.
p.002017: 82. "Homeopathic medicinal product" is a medicinal product made from substances,
p.002017: called a homeopathic source, according to European production procedures
p.002017: pharmacopoeia, and in the absence thereof, according to the national pharmacopoeia of a Member State.
p.002017: 83. "Price calculated on the basis of a benchmark" is the price formed for each
p.002017: medicinal product included in the Positive Medicinal List, calculated on the basis of that established
p.002017: reference value for a defined daily dose or therapeutic course.
p.002017: 84. "Center" is a structure of the medical establishment in which it is conducted clinically
p.002017: testing.
p.002017: 85. "Misuse of medicinal products" is permanent or occasional intentional misuse
p.002017: excessive use of medicinal products accompanied by harmful physical or
p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
p.002017: are sufficient to satisfy the nutritional needs of these infants up to
p.002017: the moment of introduction of suitable supplementary food.
p.002017: 88. (new - SG 41/09, in force from 02.06.2009) "Transitional foods" are foods,
p.002017: intended for the specific nutritional use of infants when administered appropriate
p.002017: supplemental food and which constitute the main liquid food of progressively increasing
p.002017: are the variety of foods in these infants.
p.002017: 89. (new - SG 12/11, in force from 08.02.2011) "Type IA change" is a change with
p.002017: minimal or no impact on quality, safety or efficacy
p.002017: of the respective medicinal product.
...

p.002000: law.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 84. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: with the exception of § 65, which comes into force on 30 September 2011.
p.002000: Transitional and Final Provisions
p.002000: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002000: DRUGS AND PRECURSORS
p.002000: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002000: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002000: Transitional and Final Provisions
p.002000: TO THE LAW AMENDING AND SUPPLEMENTING THE STATE LAW
p.002000: EMPLOYEE
p.002000: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002000: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in
p.002000: "State Gazette":
p.002000: 1. The Council of Ministers shall bring the Classifier of posts in administration to
p.002000: compliance with this law;
p.002000: 2. the competent authorities shall bring the planning acts of the respective
p.002000: administration in accordance with this law.
p.002000: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002000: the independent financial audit, the Electronic Communications Act, the Financial Supervision Commission Act, the Access Act and
p.002000: disclosure of documents and declaring of belonging of Bulgarian citizens to the State Security and
p.002000: Intelligence Services of the Bulgarian People's Army, Law on Forfeiture in favor of the State of Property Acquired
p.002000: of criminal activity, the Conflict of Interest Prevention and Identification Act, the Code of Conduct
p.002000: social security, the Health Insurance Act, the Farmers Support Act, and
p.002000: The Roads Act is governed by the terms and procedures of § 36 of the transitional and final provisions of the Act
p.002000: amending and supplementing the
p.002000: the civil servant (State Gazette, issue 24 of 2006).
p.002000: (2) The act of appointment of the civil servant shall:
p.002000: 1. assigns the definitions in the Classifier of posts in the administration
p.002000: minimum rank for the position held, unless the employee holds a higher rank;
p.002000: 2. determines the individual basic monthly salary.
p.002000: (3) The additional necessary funds for social security contributions of the persons under para. 2 se
p.002000: provide, within the cost of wages, salaries and social security contributions,
p.002000: the budgets of the authorizing officers concerned.
p.002000: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account
p.002000: of the State Fund for Agriculture, resulting from this law.
p.002000: (5) The governing bodies of the National Social Security Institute and the National Social Security Institute
p.002000: Health Insurance Fund to make the necessary changes to the respective budgets,
p.002000: arising from this law.
p.002000: (6) Unused employment leave shall be maintained and shall not be maintained
p.002000: offset by cash benefits.
p.002000: § 86. (1) Within one month from the entry into force of this Act the individual basic monthly salary of the employee
p.002000: is determined so that the same, less the tax due and the mandatory social security contributions at the expense of
p.002000: the insured person, if they were owed, no lower than the gross monthly salary received so far,
...

Social / Religion

Searching for indicator faith:

(return to top)
p.002017: 3. Committee for Homeopathic Medicinal Products;
p.002017: 4. Committee for Herbal Medicinal Products;
p.002017: 5. Radiopharmaceuticals Commission;
p.002017: 6. (new - SG 71/08, in force from 12.08.2008) Committee for Medicinal Products
p.002017: with application in pediatrics;
p.002017: 7. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force
p.002017: from 21.12.2012) Committee for Medicinal Products for Advanced Therapies;
p.002017: 8. (New, SG No. 102/2012, in force since 21.12.2012)
p.002017: pharmacovigilance monitoring.
p.002017: (2) If necessary, the BDA Executive Director may create others
p.002017: specialized committees outside the ones specified in para. 1.
p.002017: (3) Specialized commissions shall include specialists having scientific
p.002017: achievements and practical experience in the relevant fields of application of medicinal products.
p.002017: (4) External experts with a special status may be involved in the permanent composition of the commissions
p.002017: scientific knowledge and practical experience in the field of the specific drug group.
p.002017: (5) The Executive Director of the BDA shall determine by an order the composition of the commissions for a term
p.002017: three years, the amount of their remuneration and approve the terms and conditions of the
p.002017: their work.
p.002017: (6) By 30 January each year, the Executive Director of the BDA shall approve the lists of
p.002017: the experts outside the composition of the commissions under para. 1 after approval by the Minister of
p.002017: healthcare.
p.002017: (7) The BDA Executive Director may release a member of the BDA early
p.002017: specialized committee at his request for failure to fulfill his obligations for more than three
p.002017: months or in bad faith in the performance of its functions.
p.002017: (8) The composition of the commissions and the list of experts under para. 6 are announced on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 48. (1) The members of the specialized commissions under Art. 47, para. 1 and the experts under Art.
p.002017: 47, para. 4 sign a declaration, obliging them not to:
p.002017: 1. disclose data and circumstances that have become known to them on or on occasion
p.002017: carrying out their activity;
p.002017: 2. participate in activities related to the production or wholesale and retail trade with
p.002017: medical products.
p.002017: (2) In case the persons under para. 1 have participated in one of the preparation stages of
p.002017: the documentation necessary to authorize the use of the medicinal product cannot be provided
p.002017: participate in the meetings of the respective specialized commission under art. 47.
p.002017: (3) The persons under para. 1 shall not vote in decisions on matters on which they or
p.002017: their family members have commercial, financial or other interests.
p.002017: Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
p.002017: valid documentation of the BDA together with the relevant commission under Art. 47, para. 1 evaluates quality, safety and
p.002017: the efficacy of the medicinal product and produces an evaluation report commenting on the results of the pharmaceutical and
p.002017: the preclinical tests, the clinical trials, the risk management system and the
p.002017: monitoring the safety of the medicinal product concerned. The evaluation report prepared shall be submitted to
p.002017: the BDA Executive Director.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012) The report under para. 1 se
...

Social / Soldier

Searching for indicator army:

(return to top)
p.002000: para. 2 and the Regulations of the Ministry of Health in accordance with this
p.002000: law.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 84. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: with the exception of § 65, which comes into force on 30 September 2011.
p.002000: Transitional and Final Provisions
p.002000: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002000: DRUGS AND PRECURSORS
p.002000: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002000: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002000: Transitional and Final Provisions
p.002000: TO THE LAW AMENDING AND SUPPLEMENTING THE STATE LAW
p.002000: EMPLOYEE
p.002000: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002000: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in
p.002000: "State Gazette":
p.002000: 1. The Council of Ministers shall bring the Classifier of posts in administration to
p.002000: compliance with this law;
p.002000: 2. the competent authorities shall bring the planning acts of the respective
p.002000: administration in accordance with this law.
p.002000: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002000: the independent financial audit, the Electronic Communications Act, the Financial Supervision Commission Act, the Access Act and
p.002000: disclosure of documents and declaring of belonging of Bulgarian citizens to the State Security and
p.002000: Intelligence Services of the Bulgarian People's Army, Law on Forfeiture in favor of the State of Property Acquired
p.002000: of criminal activity, the Conflict of Interest Prevention and Identification Act, the Code of Conduct
p.002000: social security, the Health Insurance Act, the Farmers Support Act, and
p.002000: The Roads Act is governed by the terms and procedures of § 36 of the transitional and final provisions of the Act
p.002000: amending and supplementing the
p.002000: the civil servant (State Gazette, issue 24 of 2006).
p.002000: (2) The act of appointment of the civil servant shall:
p.002000: 1. assigns the definitions in the Classifier of posts in the administration
p.002000: minimum rank for the position held, unless the employee holds a higher rank;
p.002000: 2. determines the individual basic monthly salary.
p.002000: (3) The additional necessary funds for social security contributions of the persons under para. 2 se
p.002000: provide, within the cost of wages, salaries and social security contributions,
p.002000: the budgets of the authorizing officers concerned.
p.002000: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account
p.002000: of the State Fund for Agriculture, resulting from this law.
p.002000: (5) The governing bodies of the National Social Security Institute and the National Social Security Institute
p.002000: Health Insurance Fund to make the necessary changes to the respective budgets,
p.002000: arising from this law.
p.002000: (6) Unused employment leave shall be maintained and shall not be maintained
p.002000: offset by cash benefits.
p.002000: § 86. (1) Within one month from the entry into force of this Act the individual basic monthly salary of the employee
p.002000: is determined so that the same, less the tax due and the mandatory social security contributions at the expense of
...

Searching for indicator military:

(return to top)
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
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p.002017: request that the specification be supplemented by
p.002017: the applicant / holder of the marketing authorization.
p.002017: Chapter Two.
p.002017: MANAGEMENT AND FINANCING BODIES
p.002017: Section I.
p.002017: Authorities
p.002017: Art. 14. (1) Medicinal policy is part of the state health policy in the Republic
p.002017: Bulgaria and is implemented by the Minister of Health. (2) The Minister of Health shall:
p.002017: 1. is a national coordinator for the problems of medicinal products;
p.002017: 2. participates in international bodies and organizations performing activities in the field of
p.002017: medicinal products;
p.002017: 3. (repealed, SG No. 60/2011, effective 05.08.2011, new - SG No. 102/2012, in force
p.002017: of 21.12.2012) organizes the provision of public information to patients' organizations and to
p.002017: consumer organizations on actions taken against
p.002017: counterfeiting of medicinal products;
p.002017: 4. performs other activities specified by law.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 15. (1) A Pharmacopoeial Committee shall be established to the Minister of Health as
p.002017: an advisory body on the current pharmacopoeia.
p.002017: (2) The Minister of Health at the proposal of the Executive Director of
p.002017: The BDA determines by order the composition of the Pharmacopoeial Committee and the expert groups attached to it
p.002017: and approve the rules of procedure.
p.002017: (3) The activities of the Pharmacopoeia Committee shall be financed from the budget of the Ministry
p.002017: of health.
p.002017: Art. 16. (1) A Higher Board of Pharmacy shall be established with the Minister of Health, which shall include five
p.002017: representatives appointed by the Minister of Health, five representatives of the Bulgarian
p.002017: pharmaceutical union, two representatives of the National Health Insurance Fund (NHIF) and one each
p.002017: representative of the faculties of pharmacy at medical colleges. It is the Minister of Health
p.002017: chairman of the board without
p.002017: right to vote.
p.002017: (2) The High Pharmacy Council is an advisory body that deliberates and gives opinions
p.002017: by:
p.002017: 1. the main directions and priorities in the field of pharmacy;
p.002017: 2. ethical problems of pharmacy;
p.002017: 3. draft legislative acts related to pharmacy;
p.002017: 4. scientific priorities in the field of pharmacy;
p.002017: 5. programs for organizing public educational campaigns in the field of
p.002017: medicinal products.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: (4) The organization and activities of the Supreme Pharmacy Council shall be governed by regulations,
p.002017: issued by the Minister of Health at the proposal of the High Council on Pharmacy.
p.002017: Art. 17. (1) The Executive Agency for Medicines shall be a specialized body to the Minister
p.002017: of health to oversee the quality, safety and efficacy of medicines.
p.002017: (2) (amend. - SG 15/2013, in force from 01.01.2014)
p.002017: Medicines is a budget-funded legal entity with its seat in Sofia to the Minister
p.002017: of health.
p.002017: (3) The Executive Agency for Medicines shall be managed and represented by an Executive Agency
p.002017: director, who is appointed in accordance with the Law on Administration.
p.002017: (4) The structure, functions and organization of work of the BDA shall be defined in
p.002017: Rules of Procedure adopted by the Council of Ministers.
p.002017: (5) The Medicines Executive Agency shall:
p.002017: 1. issues authorizations for the manufacture of medicinal products;
...

p.002017: the development of the Bulgarian Pharmacopoeia;
p.002017: 18. participate in activities in the field of medicinal products related to the work of the European Agency
p.002017: on Medicines, European Directorate for Quality of Medicines and Health, international
p.002017: bodies and organizations as well as with the implementation of
p.002017: international treaties to which the Republic of Bulgaria is a party;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) participates in the international
p.002017: harmonization and standardization of technical measures related to traceability
p.002017: drug safety, coordinated by the European Medicines Agency;
p.002017: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain
p.002017: national internet portal for medicinal products;
p.002017: 19. performs other activities specified by law.
p.002017: (6) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: medicines coordinates its activities with regional health inspections (RICs) in the area of
p.002017: control of medicinal products.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under
p.002017: this law related to preventing the entry and distribution of counterfeit
p.002017: medicinal products, is carried out in cooperation between the BDA and the customs authorities.
p.002017: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health
p.002017: inspections issue certificates for registration of drugstores.
p.002017: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002017: retail of medicinal products, which includes three representatives of the Bulgarian
p.002017: pharmaceutical union, one representative of the faculties of pharmacy of the medical colleges and
p.002017: four BDA representatives. The composition of the Board is determined by an order of the Executive Director of the BDA,
p.002017: agreed with the Minister of
p.002017: healthcare.
p.002017: (2) The council under para. 1 is an advisory unit which:
p.002017: 1. prepares opinions on the applications and documents submitted to the BDA under Art. 228, para. 1 and 5,
p.002017: which he presents to the Executive Director of the BDA;
p.002017: 2. make motivated proposals to the Minister of Health through
p.002017: the BDA's Executive Director for improving public access to medicines
p.002017: products.
p.002017: (3) The organization and activity of the expert council under para. 1 shall be governed by regulations,
p.002017: issued by the BDA Executive Director on a proposal from the Board.
p.002017: (4) The members of the expert council under para. 1 shall not receive remuneration for participation in
p.002017: council meetings.
p.002017: (5) The expert council under para. 1 shall be reported annually to the Minister of
p.002017: healthcare.
p.002017: Art. 17c. (New, SG No. 18/2014) They may not be members of the Expert Council of
p.002017: Art. 17b, para. 1 people who are:
p.002017: 1. owners, members of management and control bodies of commercial companies or
p.002017: sole proprietors manufacturing, importing, wholesale or retail trade with
p.002017: medical products;
p.002017: 2. partners or shareholders holding more than 5 percent of the capital in commercial
p.002017: companies active in the manufacture, import, wholesale or retail of medicinal products
p.002017: products or work under contract with those companies.
p.002017: Section II.
p.002017: Registers
p.002017: Art. 18. (Repealed, SG No. 60/2011, effective 05.08.2011)
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p.002017: The European Commission.
p.002017: Art. 79. (1) Where the regulatory authorities of one or more Member States have adopted different decisions
p.002017: with regard to the authorization to use the same medicinal product or its temporary use
p.002017: suspension or withdrawal, the BDA referred the matter to the Committee for Medicinal Products for Human Use at
p.002017: European Medicines Agency for arbitration. The applicant or
p.002017: the Marketing Authorization Holder may refer the matter to the Committee for Medicinal Products for
p.002017: human use to the European Medicines Agency for arbitration
p.002017: a procedure at its discretion.
p.002017: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012) In the cases of para. 1 BDA or
p.002017: the applicant / marketing authorization holder shall submit to the
p.002017: The European Medicines Agency has all the information available on this subject.
p.002017: (4) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: (5) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 79a. (New, SG No. 60/2011, effective 05.08.2011) (1) Subject to
p.002017: the decision of the European Commission after the conclusion of the BDA arbitration procedure within 30 days
p.002017: days after receipt of notification:
p.002017: 1. issues, suspends or suspends a marketing authorization, or
p.002017: 2. Requests that changes be made to the permit issued to achieve
p.002017: in accordance with the European Commission decision.
p.002017: (2) The Medicines Executive Agency shall notify the European Commission and
p.002017: The European Medicines Agency for the act issued under para. 1.
p.002017: Art. 79b. (New, SG No. 102/2012, effective 21.12.2012) (1) In cases where the interests of
p.002017: The European Union and before deciding on the authorization of a medicinal product
p.002017: product, its suspension, termination or change, BDA, applicant or holder of
p.002017: marketing authorization may apply
p.002017: the question to the committee under art. 79, para. 1 for the application of the arbitration procedure.
p.002017: (2) In the cases of para. 1 where referral is the result of an evaluation of tracking data
p.002017: the safety of an authorized medicinal product, the matter is referred to the
p.002017: Art. 56a, para. 1, item 1 and the procedure of art. 194h or
p.002017: 194y.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall apply
p.002017: the procedure for Chapter Eight, Section IV, where one of the measures is necessary,
p.002017: referred to in Art. 194y, para. 2 and 3.
p.002017: (4) (New, SG No. 18/2014) Notwithstanding para. 1 - 3, when emergency action is needed to protect
p.002017: public health at some stage of the arbitration procedure, the BDA may suspend the authorization of
p.002017: use and prohibit the use of the respective medicinal product in the territory of the Republic of Bulgaria until
p.002017: acceptance of the final
p.002017: answer.
p.002017: (5) (New, SG No. 18/2014) In the cases of para. 4 The BDA informs the European
p.002017: the Commission, the European Medicines Agency and the other Member States for their reasons
p.002017: decision no later than the next business day.
p.002017: Art. 80. (amend. - SG 12/11, in force from 08.02.2011) The conditions and the procedure for carrying out
p.002017: changes to the authorizations granted under this section shall be governed by Regulation (EC) No 1234/2008 of the European Communities
...

p.002017: for use filed by
p.002017: the committee under Art. 56a, para. 1, item 1 of the draft protocol.
p.002017: (2) Within 60 days from the date of receipt of the documentation under para. 1 the committee under art.
p.002017: 56a, para. 1, item 1 prepares an opinion and sends to the holder of the marketing authorization:
p.002017: 1. notification of approval, or
p.002017: 2. a reasoned refusal when:
p.002017: (a) found that the study promoted the use of the medicinal product
p.002017: product, and / or
p.002017: (b) consider that the design of the study will not achieve the objectives of the report,
p.002017: and / or
p.002017: (c) the study is of a clinical trial nature.
p.002017: (3) In the cases of para. 2, item 1 the marketing authorization holder shall submit
p.002017: the notification of the BDA and the commissions under Art. 103, para. 1 or 2, where applicable.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 15 days of
p.002017: the date of receipt of the notification under para. 3 shall send the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The conduct of the study may commence upon receipt of a positive one
p.002017: opinion of the commission under art. 103, para. 1, respectively by a commission under Art. 103, para. 2.
p.002017: (6) The content and format of the protocol under para. 1 shall be determined by Regulation
p.002017: Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of the
p.002017: the pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Union
p.002017: Parliament and of the Council and in Directive 2001/83 / EC of the European Parliament and of the Council (OJ, L 159/5 of
p.002017: 20 June 2012), hereinafter referred to as "the
p.002017: Implementation (EU) No 520/2012 ".
p.002017: Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the authorization for use in the cases under Art. 145f, para. 1 implements planned significant changes to
p.002017: the minutes of the study after their prior approval by the committee under Art. 56a, para. 1, v. 1.
p.002017: (2) The holder of the marketing authorization shall submit to the committee referred to in Art. 56a, para. 1, vol.
p.002017: 1 the documentation related to the changes and the reasons for this.
p.002017: (3) Where the committee under Art. 56a, para. 1, item 1 approved the changes to the protocol, the holder
p.002017: of the marketing authorization shall notify the BDA and the Commission under Art. 103, para. 1, respectively commissions
p.002017: under Art. 103, para. 2.
p.002017: (4) The holder of the marketing authorization may apply the changes under para. 1 next
p.002017: receiving a positive opinion from the commission under art. 103, para. 1, respectively the commissions under
p.002017: Art. 103, para. 2.
p.002017: Art. 145h. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: submit electronically to the committee under Art. 56a, para. 1, item 1 final report, accompanied by
p.002017: summarizing the results of the study within 12 months
p.002017: upon completion of data collection.
p.002017: (2) The marketing authorization holder may submit a reasoned request to
p.002017: the committee under Art. 56a, para. 1, item 1 for postponement of the term under para. 1 at least three months before the date of
...

p.002017: Chapter Five.
p.002017: MANUFACTURE AND IMPORTATION OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES
p.002017: (TITLE AM. - SG, iss. 102 OF 2012, IN EFFECT OF 02/01/2013)
p.002017: Section I.
p.002017: Production
p.002017: Art. 146. (1) (amend. - SG 102/2012, in force from 02.01.2013) The production of all types
p.002017: medicinal products within the meaning of this Act and of medicinal products intended for clinical use
p.002017: testing, may be carried out on the territory of the Republic of Bulgaria only by natural or legal persons,
p.002017: registered as traders in the territory of a Member State who have been granted a manufacturing authorization,
p.002017: issued by the Director of
p.002017: Drug Enforcement Agency.
p.002017: (2) A production permit shall also be required in the cases where the products under para. 1 are
p.002017: intended for export only.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008)
p.002017: requires also for persons performing simultaneously or individually one of the following activities:
p.002017: full or partial production, various processes of packaging, packaging, repackaging, labeling, quality
p.002017: control and release of batches of medicinal products and
p.002017: medicinal products intended for clinical trial.
p.002017: (4) (Repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: (5) No production authorization is required where the cutting processes,
p.002017: mixing or packaging is carried out according to the main or pharmacopoeial formulation in a pharmacy.
p.002017: Art. 147. (amend. - SG 102/2012, in force from 02.01.2013) The Executive Agency for Medicines shall introduce
p.002017: information on marketing authorizations for medicinal products and certificates of good manufacturing
p.002017: practice in the European Union database.
p.002017: Art. 148. For obtaining a production permit the person under Art. 146 should
p.002017: has:
p.002017: 1. with appropriately qualified personnel, depending on the specifics of
p.002017: manufactured types of medicinal products and dosage forms;
p.002017: 2. at any one time with at least one qualified person who is eligible
p.002017: Art. 159;
p.002017: 3. premises for production, control and storage of medicinal products,
p.002017: provided with the necessary technical equipment and control laboratories.
p.002017: Art. 149. Managers of production and quality control of medicinal products
p.002017: products in manufacturing enterprises are persons:
p.002017: 1. who hold a Master's degree in a specialty
p.002017: "pharmacy", "chemistry" or "biology" and at least two years' practical experience in
p.002017: pharmaceutical production;
p.002017: 2. which meet the requirements of item 1 and have an additional recognized specialty in
p.002017: radiobiology or radiochemistry - for radiopharmaceuticals or for medicinal products,
p.002017: exposed to ionizing radiation;
p.002017: 3. with recognized specialty in clinical hematology, medical microbiology, virology or
p.002017: immunology - for the production of immunological medicinal products - vaccines, toxins, sera, for
p.002017: biotech products and for medicinal products derived from
p.002017: human plasma or human blood.
p.002017: Art. 150. (1) The person under art. 146 submits to the BDA an application in the form approved by
p.002017: the director of the agency.
p.002017: (2) Together with the application under para. 1 the applicant shall also submit:
p.002017: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002017: specialty, work record, criminal record or similar document, if not
p.002017: Bulgarian citizen, and employment contract for the persons under Art.
p.002017: 148, item 2 and art. 149;
p.002017: 2. copies of contracts for the assignment of production and / or control of the applications for
p.002017: production of products - in the cases of art. 151;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union,
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
p.002017: production of radiopharmaceuticals or medicinal products subject to ionization
p.002017: radiation during their production;
p.002017: 8. permission to use the premises for production, control and storage,
p.002017: issued by the order of the Spatial Planning Act, or other substitute document;
p.002017: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 10. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) In the manufacture of narcotic substances and dosage forms containing
p.002017: such substances are also complied with the requirements of the Drug Control Act and
p.002017: precursors.
...

p.002017: Code, the appeal does not stop enforcement.
p.002017: Section II.
p.002017: Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
p.002017: Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria from
p.002017: third country of all types of medicinal products and medicinal products intended for clinical use
p.002017: testing may only be carried out by natural or legal persons registered as traders under the legislation
p.002017: of a Member State that are
p.002017: have received an import permit issued by the BDA Executive Director.
p.002017: (2) In order to obtain an import permit, the person under para. 1 must have:
p.002017: 1. (amend. - SG 102/2012, in force from 02.01.2013) at any time with at least one
p.002017: a qualified person who meets the requirements of Art. 159, para. 2 and 10;
p.002017: 2. (amend. - SG 102/2012, in force from 02.01.2013) with a laboratory for quality control in
p.002017: compliance with the requirements of the ordinance under Art. 152 and storage facilities for medicinal products, and
p.002017: clinical trial medicinal products provided with
p.002017: the necessary technical equipment, in accordance with the requirements of the ordinance under Art. 198.
p.002017: Art. 162. (1) In order to obtain an import permit, the person under Art. 161, para. 1 submits to the BDA
p.002017: an application in accordance with a model approved by the Executive Director of the Agency.
p.002017: (2) To the application under para. 1 shall apply:
p.002017: 1. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: Economic Space - Document for current registration under national law, issued by
p.002017: competent
p.002017: authority of the country concerned;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) list of the medicinal products
p.002017: products and forms to be imported;
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) a copy of the production permit,
p.002017: issued by the regulatory authority of the exporting country and a certificate attesting the conformity of
p.002017: conditions for production, control and storage with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 4. documents certifying the circumstances under Art. 159, para. 1 and 2 for
p.002017: the qualified person;
p.002017: 5. data on the address of a laboratory on the territory of the Republic of Bulgaria for performing full quantitative and
p.002017: qualitative analysis of at least the active substances and of all other tests and verifications for the demonstration of
p.002017: the quality of each imported batch of medicinal product in accordance with the requirements of the marketing authorization
p.002017: use in accordance with this law and the address of
p.002017: storage facilities;
p.002017: 6. a contract which defines the responsibilities of each party in respect of compliance with
p.002017: the principles of Good Manufacturing Practice by the contractor and the manner in which the qualified person under Art.
p.002017: 161, para. 2, item 1 shall perform its duties in the cases,
p.002017: when the person under Art. 161, para. 1 does not have its own laboratory;
p.002017: 7. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
...

p.002017: the medicines agency keeps a public register of importers, manufacturers and traders
p.002017: wholesale of active substances, containing:
p.002017: 1. name, seat and address of management of the person under art. 167a;
p.002017: 2. a list of the active substances that are imported, manufactured or marketed;
p.002017: 3. the activities that the person under art. 167a will perform;
p.002017: 4. address of the premises where the activities are carried out;
p.002017: 5. notes on the entered circumstances.
p.002017: (2) The Executive Agency for Medicines shall enter into the database under Art. 147
p.002017: information on registered importers, manufacturers and wholesalers of active
p.002017: substances.
p.002017: Art. 167d. (New - SG 102/02, in force from 02.01.2013) (1) The person under art. 167a
p.002017: submit to the BDA annually by 31 January a notification of changes in the information,
p.002017: entered in the register under Art. 167g.
p.002017: (2) When changes occur that may affect the quality of or
p.002017: the safety of the active substances that are produced, imported or distributed by the individual
p.002017: under Art. 167a shall notify the BDA immediately.
p.002017: Art. 167f. (1) (New, SG No. 102/2012, effective 02.01.2013) The production, the import and
p.002017: wholesale of active substances on the territory of the Republic of Bulgaria, including active substances
p.002017: substances intended for export shall be carried out in accordance with
p.002017: Good manufacturing practice and Good distribution practices for active substances.
p.002017: (2) Importers may import active substances only if the following conditions are met:
p.002017: 1. the active substances were manufactured in accordance with Good standards
p.002017: manufacturing practices that are at least equivalent to those established by the European
p.002017: union, and
p.002017: 2. (In force from 02.07.2013) The active substances shall be accompanied in writing
p.002017: confirmation by the competent authority of the exporting country that:
p.002017: (a) Good manufacturing practice standards applicable to the site for
p.002017: production of the exported active substances are at least equivalent to those established by
p.002017: The European Union;
p.002017: (b) the production site concerned is subject to regular control and is effectively implemented by the Good
p.002017: manufacturing practice, including repeated and unannounced inspections, to ensure the protection of
p.002017: public health at least equivalent to that of
p.002017: The European Union, and
p.002017: (c) in the event of non-compliance, the exporting country will
p.002017: inform the BDA immediately.
p.002017: (3) (In force from 02.07.2013) The requirement of para. 2, item 2 shall not apply if the state
p.002017: exporter is included in the list under Art. 111b of Directive 2001/83 / EC.
p.002017: Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
p.002017: ensure the availability of medicinal products, the importer may import the active substance without the written request
p.002017: confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
p.002017: manufacturing practice where the manufacturing site of the active substance in the exporting country was
p.002017: inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines
p.002017: for good
p.002017: manufacturing practice.
p.002017: (2) In the cases of para. 1 The BDA shall notify the European Commission.
p.002017: Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of authorizations for
p.002017: proceedings, including those performing the activities of art. 168b, para. 2, are considered producers in the sense
p.002017: of § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002017: caused by a defect in the goods,
p.002017: provided for therein.
p.002017: Chapter Six.
p.002017: PACKAGING AND PACKAGE LEAFLET
p.002017: Art. 168. (1) The packaging of a medicinal product shall consist of primary and / or secondary
p.002017: packing and leaflet for the patient.
...

p.002017: 1. an individual identifier for the safety indicators it gives
p.002017: opportunity for wholesalers and retailers to:
p.002017: (a) verify the authenticity of the medicinal product;
p.002017: (b) identify the individual packaging;
p.002017: 2. a means by which to check the packaging of the medicinal product
p.002017: whether it was forged.
p.002017: Art. 168a. (New, SG No. 102/2012, effective 21.12.2012) (1) On the packaging of a medicinal product that
p.002017: shall be granted on medical prescription, safety indicators according to art. 168, para. 8, except
p.002017: of cases where the medicinal product is
p.002017: included in the list determined by the European Commission by a delegated act under art. 168b.
p.002017: (2) No indications for the packaging of a medicinal product dispensed without a medical prescription shall be given.
p.002017: safety under Art. 168, para. 8, except where the medicinal product is included in the list,
p.002017: designated by the European Commission by means of a delegated act
p.002017: under Art. 168b, having been assessed as being at risk of forgery.
p.002017: (3) The Medicines Executive Agency shall notify the European Commission of:
p.002017: 1. for medicinal products which are available without a prescription for which it is
p.002017: found that there was a risk of counterfeiting;
p.002017: 2. for medicinal products for which it has been established that there is no risk of
p.002017: falsification, taking into account the following criteria:
p.002017: (a) the price and sales volume of the medicinal product;
p.002017: (b) the number and incidence of cases of counterfeit medicinal products registered in
p.002017: within the European Union and in third countries, and the change in the number and frequency of such cases in
p.002017: historical plan;
p.002017: (c) specific characteristics of the medicinal products concerned;
p.002017: (d) the severity of the disease to be treated;
p.002017: (e) other potential risks to public health.
p.002017: Art. 168b. (New, SG No. 102/2012, effective 21.12.2012) (1) The Rules on
p.002017: the safety indicators under Art. 168, para. 8 are defined by the European Commission with
p.002017: the delegated acts referred to in Article 54a (2) of Directive 2001/83 / EC.
p.002017: (2) Safety indicators shall not be eliminated or partially or completely closed,
p.002017: unless the following conditions are met:
p.002017: 1. the holder of the manufacturing authorization before partially or fully
p.002017: removes or closes safety features, checks to see if the appropriate drug
p.002017: the product is authentic and has not been tampered with;
p.002017: 2. the holder of a production permit in compliance with the requirements of Art. 168, para.
p.002017: 8 may replace safety indicators with equivalents with respect to
p.002017: the ability to guarantee the authenticity, identification and assurance of
p.002017: evidence of tampering with the medicinal product.
p.002017: (3) Safety indicators shall be considered equivalent if:
p.002017: 1. meet the requirements laid down in the delegated acts referred to in Article 54a (2)
p.002017: of Directive 2001/83 / EC, and
p.002017: 2. are equally effective in allowing authentication; and
p.002017: the identification of medicinal products and the provision of evidence of forgery
p.002017: them.
p.002017: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of
p.002017: the medicinal product and in accordance with good manufacturing practice for medicinal products
...

p.002017: Art. 194. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of a permit for
p.002017: use concurrently or before providing the public with new information on related concerns
p.002017: by monitoring the safety of a medicinal product authorized in the territory of the Republic
p.002017: Bulgaria, informs BDA, European
p.002017: the Medicines Agency and the European Commission.
p.002017: (2) The information under para. 1 must be objective and not misleading.
p.002017: (3) Before disseminating information related to drug monitoring
p.002017: safety, the Marketing Authorization Holder agrees with the BDA in advance with
p.002017: except for the cases under para. 1.
p.002017: (4) For carrying out the evaluation of the information under para. 3 is paid a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: Art. 194a. (New, SG No. 102/2012, effective 21.12.2012) (1) The principles and
p.002017: the requirements of Good Practice for Monitoring Pharmacovigilance are set out in
p.002017: guidance issued by the European Medicines Agency.
p.002017: (2) In carrying out pharmacovigilance monitoring activities
p.002017: the holder of the marketing authorization complies with the good practice under para. 1.
p.002017: Section II.
p.002017: Collection and reporting of information on suspected adverse reactions
p.002017: (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 194b. (New, SG No. 102/2012, effective 21.12.2012) The holder of the authorization for
p.002017: use in fulfillment of their obligations under Art. 190 is required to document all reports of suspected spam
p.002017: drug reactions observed on the territory of the European Union or in third countries, reported spontaneously by
p.002017: medical professionals or from patients or emerging from post-marketing research.
p.002017: Art. 194c. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the permit
p.002017: submit for use electronically in the database "EudraVigilance" under Art. 24 of Regulation (EC) No
p.002017: 726/2004 of the European Parliament and of the Council of reports of serious suspected adverse reactions,
p.002017: occurred on the territory of the European Union and in
p.002017: third countries, within 15 days of the date of receipt of the communication.
p.002017: (2) The Marketing Authorization Holder submits to the EudraVigilance database electronically
p.002017: all suspected adverse reactions other than those mentioned in para. 1 occurred on the territory of
p.002017: European Union, within 90 days from the date of
p.002017: receiving the message.
p.002017: (3) The Marketing Authorization Holder monitors publications in specialized medical literature and
p.002017: report to the EudraVigilance database any suspected adverse drug drug listed in it
p.002017: reaction with the exception of suspected adverse reactions from medicinal products containing active
p.002017: substances listed in the article list
p.002017: 27 of Regulation (EC) No 726/2004 of the European Parliament and of the Council and described in
p.002017: literature sources monitored by the European Medicines Agency.
p.002017: (4) The marketing authorization holder establishes procedures for the collection of accurate and reliable data,
p.002017: allowing the scientific evaluation of reports of suspected adverse reactions. The owner
p.002017: of the Marketing Authorization collects a follow-up
p.002017: information regarding these messages and provides updated data in "EudraVigilance".
p.002017: (5) The form and content of the reports under para. 1 - 3 are determined by Regulation
p.002017: Implementation (EU) No 520/2012.
p.002017: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: register the medicines in the system of art. 183 all reports of suspected adverse drug reactions
p.002017: reactions occurring on the territory of the Republic of Bulgaria by
p.002017: medical professionals and patients, and requires, if necessary, additional
p.002017: case tracking information.
p.002017: (2) When reports of suspected adverse reactions occurring on
p.002017: the territory of the Republic of Bulgaria, have been submitted by the holder of the marketing authorization,
p.002017: it provides additional follow-up information to the BDA upon request.
p.002017: Art. 194d. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: medicines submit reports to the EudraVigilance database for all serious suspects
p.002017: adverse reactions occurring on the territory of
p.002017: Republic of Bulgaria, within 15 days from the date of their receipt.
p.002017: (2) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002017: reports of all suspected adverse reactions other than those specified in para. 1 occurred on
p.002017: the territory of the Republic of Bulgaria, within 90 days from the date
p.002017: of receiving the message.
p.002017: (3) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002017: reports of suspected adverse reactions occurring on the territory of the Republic of Bulgaria,
p.002017: due to improper use of the medicinal product. The Medicines Executive Agency shall inform thereof
p.002017: Ministry of Health
p.002017: and professional organizations of medical specialists.
p.002017: (4) Any body or institution to which information about a suspect has been received
p.002017: reported an adverse reaction occurring on the territory of the Republic of Bulgaria
p.002017: BDA for that.
p.002017: (5) The content and format of the communications and reports under para. 1 - 3 are determined by
p.002017: Implementing Regulation (EU) No 520/2012.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: the medication receives information from the marketing authorization holder about serious suspects
p.002017: adverse reactions occurring on the territory
p.002017: of the European Union or in a third country through the EudraVigilance database.
p.002017: (2) The requirements for monitoring information in the EudraVigilance database are
p.002017: set out in Implementing Regulation (EU) No 520/2012.
p.002017: Art. 194g. (New - SG 102/2012, in force since 21.12.2012) In the process of exchange of information of the BDA,
p.002017: the Marketing Authorization Holders and the European Medicines Agency are cooperating with the European Medicines Agency
p.002017: detect duplicate reports of suspected spam
p.002017: drug reactions.
p.002017: Section III.
p.002017: Periodic safety update reports (New, SG No. 102/2012, effective from
p.002017: 12/21/2012)
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the Marketing Authorization is obliged to make the European Agency for Europe available electronically
p.002017: medicines periodic safety update reports containing:
p.002017: 1. summaries of data on the benefit / risk balance of the medicinal product,
p.002017: including the results of all studies, with a view to their potential impact on
p.002017: the marketing authorization;
p.002017: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002017: available data, including clinical trial data for unauthorized indications and target groups,
p.002017: which are not included in the summary of
p.002017: product;
p.002017: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002017: the holder of the marketing authorization is in possession of the volume of prescriptions, including approximate ones
p.002017: number of persons who used the medicinal product
...

p.002017: issuing the marketing authorization / registration certificate or is
p.002017: determined in accordance with Art. 194l, 194m and 194h:
p.002017: 1. every 6 months from the date of issue of the marketing authorization / certificate
p.002017: for the registration of a medicinal product by the date of its placing on the market;
p.002017: 2. every 6 months during the first two years from the date of placing on the market of
p.002017: the medicinal product;
p.002017: 3. once a year for the next two years;
p.002017: 4. once every three years after the fourth year from the date of placing on the market of
p.002017: the medicinal product.
p.002017: (4) Outside the cases under para. 3, periodic safety update reports are issued
p.002017: shall submit immediately upon request to the BDA or to a regulatory authority of a Member State.
p.002017: (5) Paragraphs 3 and 4 shall also apply to medicinal products authorized for use only
p.002017: the territory of the Republic of Bulgaria, which are not covered by Art. 194l.
p.002017: Art. 194l. (New, SG No. 102/2012, effective 21.12.2012) Where medicinal products which
p.002017: contain the same active substance or a combination of the same active substances, have been obtained separately
p.002017: marketing authorizations / registration certificate, frequency and filing dates for periodic updates
p.002017: safety reports may be modified and harmonized in order to carry out a uniform assessment of those reports.
p.002017: Art. 194m. (New, SG No. 102/2012, effective 21.12.2012) (1) The filing dates of
p.002017: the periodic safety update reports for the medicinal products under Art. 194l
p.002017: calculated according to the European Union reference date.
p.002017: (2) The European Union reference date under para. 1 is:
p.002017: 1. the date of the first authorization for use in the European Union of the medicinal product
p.002017: a product containing the relevant active substance or the corresponding combination of active substances
p.002017: substances, or
p.002017: 2. the earliest known date of authorization of the medicinal product,
p.002017: containing the relevant active substance or the corresponding combination of active substances, if
p.002017: the date referred to in item 1 cannot be determined.
p.002017: Art. 194n. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the permit
p.002017: for the use of medicinal products under Art. 194l may submit a reasoned request to the Committee
p.002017: medicinal products for human use, respectively to the coordination group under Art. 77, para. 2 for
p.002017: fixing a European Union reference date or changing the filing frequency of periodic updates
p.002017: safety reports
p.002017: on one of the following grounds:
p.002017: 1. reasons for public health;
p.002017: 2. to avoid duplicate assessment;
p.002017: 3. to achieve international harmonization.
p.002017: (2) the Committee for Medicinal Products for Human Use, respectively
p.002017: the coordination group of art. 77, para. 2 after consultation with the committee under Art. 56a, para. 1, v. 1
p.002017: approves the request or makes a reasoned refusal.
p.002017: (3) The filing frequency and the European Union reference date shall be fixed after
p.002017: consultation with the committee under Art. 56a, para. 1, item 1 of:
p.002017: 1. The Committee for Medicinal Products for Human Use - where at least one of the Marketing Authorizations
p.002017: for medicinal products containing the active substance concerned is provided in accordance with the centralized one
p.002017: procedure provided for in Chapter II of Title II of the
p.002017: Regulation (EC) No 726/2004 of the European Parliament and of the Council, or
p.002017: 2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
p.002017: (4) The European Union reference dates for medicinal products under
p.002017: Art. 194l and the harmonized frequency for submitting their periodic up-to-date reports
p.002017: safety shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: (5) The holder of the marketing authorization after the publication of the data under para. 4 presents to the BDA an application for
p.002017: modification of the marketing authorization for the medicinal product concerned. Any change in filing dates and on
p.002017: the frequency of submission of periodic safety update reports specified in the
p.002017: use, effective 6
p.002017: months after their date of publication.
p.002017: Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: Medicines evaluates periodic safety update reports for medicinal products for
p.002017: to determine if there are new risks, or a change in
p.002017: identified risks, or change in benefit / risk ratio.
p.002017: (2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic up-to-date reports on
p.002017: safety for medicinal products for which the Republic of Bulgaria has fulfilled the functions of a reference country
p.002017: within the meaning of Art. 76, and is determined by
p.002017: the coordination group of art. 77, para. 2.
p.002017: (3) A rapporteur from the Republic of Bulgaria shall participate in the single evaluation of the periodic reports
p.002017: updated safety reports for medicinal products where at least one of the products
p.002017: has been authorized under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
p.002017: The Council, and is designated as such by the committee under Art. 56a, para. 1, v. 1.
...

p.002017: measures from the decision under para. 5.
p.002017: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and where at least one of the authorizations for
p.002017: the use has been issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: medicinal products for human use within 30 days of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the retention, amendment, suspension or termination of validity
p.002017: of the relevant marketing authorizations, including a timetable for the implementation of
p.002017: the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. Decides to change, suspend or terminate the marketing authorizations,
p.002017: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 2. adopt a decision recommending change, suspension or termination of authorizations
p.002017: for use issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 2, Vol. 2.
p.002017: Section IV.
p.002017: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002017: 12/21/2012)
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure of
p.002017: the European Union level can be initiated by the European Commission, by the European Commission
p.002017: drug agency or from a Member State.
p.002017: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under
p.002017: the procedure for this section by notifying the regulatory authorities of the other Member States, the European Agency for Europe
p.002017: medicines and the European Commission, when for drug-related reasons
p.002017: safety, consider that a medicinal product placed on the Bulgarian market requires undertaking
p.002017: to any of the
p.002017: the following measures:
p.002017: 1. suspension or termination of the marketing authorization;
p.002017: 2. prohibition of distribution of a medicinal product;
p.002017: 3. issuing a refusal to renew the marketing authorization.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para.
p.002017: 2, when notified by the marketing authorization holder that for reasons related to
p.002017: drug safety monitoring, discontinued
p.002017: the distribution of the medicinal product has either taken or intends to take action on
p.002017: it will be removed from the market or it will not take any action to renew it
p.002017: the marketing authorization issued.
p.002017: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure
p.002017: under para. 2 and in cases where it considers that for reasons related to drug monitoring
p.002017: safety, a new contraindication or reduction should be added to a medicinal product
p.002017: the recommended dose or indication
p.002017: be limited.
...

p.002017: active substance with the product specified in the information under para. 5, or where this medicinal product is authorized
p.002017: for use in another or
p.002017: in other Member States.
p.002017: (7) (amend. - SG 18/04) In the cases of para. 4 when you do not have to
p.002017: take urgent measures, the BDA applies the procedure under Art. 77 or 79b.
p.002017: (8) (New, SG No. 18/2014) The Executive Agency for Medicines shall inform
p.002017: the holder of the marketing authorization in order to initiate the procedure under this section.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases under Art. 194y, para. 2 when
p.002017: considered it necessary to take urgent measures to protect public health, BDA
p.002017: may suspend the marketing authorization and prohibit the use of the medicinal product
p.002017: the territory of the Republic of Bulgaria until the adoption of the
p.002017: final decision under art. 194h or 194h.
p.002017: (2) The Medicines Executive Agency shall notify the European Medicines Agency, the European Medicines Agency
p.002017: the Commission and the regulatory authorities of the other Member States for the measures taken under para. 1 within one working day
p.002017: day from their implementation and state the reasons for
p.002017: this.
p.002017: (3) Where the Medicines Executive Agency participates in the procedure under this section, at the request of the European Medicines Agency
p.002017: the BDA Commission takes the recommended provisional measures with regard to the Marketing Authorization for
p.002017: medicinal product or where the medicinal product is authorized under Regulation (EC) No
p.002017: 726/2004 of the European Union
p.002017: Parliament and Council - with regard to the product itself, pending the completion of the procedure.
p.002017: Art. 194x. (New - SG 102/2012, in force since 21.12.2012) The Executive Agency for Medicines shall publish
p.002017: announcement of the national internet portal under art. 185, para. 1 on how stakeholders can
p.002017: provide information to the European Internet portal under Art. 68, para. 1, item 4 for the medicinal product subject to
p.002017: the procedure under Art. 194y, and for
p.002017: the opportunity to participate in a public hearing, if announced.
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) The Committee under Art. 56a, para. 1, item 1 by the time of
p.002017: 60 days from the date of the announcement of the European Internet procedure
p.002017: portal makes a reasoned recommendation.
p.002017: (2) The holder of the marketing authorization may, within the term of para. 1 to provide
p.002017: written comments.
p.002017: (3) The recommendation under para. 1 shall be published on the European Internet portal under Art. 68, para. 1, vol.
p.002017: 4 and contains one or more of the following conclusions:
p.002017: 1. no further investigation or action is required on
p.002017: Community level;
p.002017: 2. the holder of the marketing authorization must carry out additional work
p.002017: study and analysis of data;
p.002017: 3. the marketing authorization holder must carry out post-marketing
p.002017: a safety study with a subsequent evaluation of its results;
p.002017: 4. the Member State or the holder of the marketing authorization to apply measures to
p.002017: risk reduction;
p.002017: 5. the marketing authorization must be suspended, suspended or issued
p.002017: refusal to renew it;
p.002017: 6. the marketing authorization must be modified.
p.002017: (4) The specific measures under para. 3, item 4, as well as the conditions and restrictions that should
p.002017: be included in the marketing authorization, the recommendation states.
p.002017: (5) In the cases of para. 3, item 6, when the changes are related to the amendment or addition of information in the brief
p.002017: a specification, on the packaging or package leaflet of the medicinal product, shall be included in the recommendation
p.002017: the wording of the amended or added
p.002017: information and the place where it should be displayed.
p.002017: Art. 194h. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: no medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the coordination group under Art. 77, para. 2 on the basis of the recommendation under Art. 194s within 30 days
p.002017: from the date of its receipt, issue an opinion on the retention, modification, suspension, termination
p.002017: of the relevant authorizations or refusals to renew them, including a timetable for
p.002017: implementation of the opinion.
p.002017: (2) Where the opinion recommends that the measures under Art. 194ts, para. 3, Vol. 5,
p.002017: the Executive Director of the BDA shall, by order, suspend or revoke the authorization for
p.002017: use, or refuses to renew it.
p.002017: (3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (4) Where in the opinion under para. 1 it is recommended to take measures under art. 194ts, para.
p.002017: 3, items 2 - 4, the holder of the marketing authorization takes the necessary actions and
p.002017: inform the BDA and the regulatory authorities of the other Member States.
p.002017: (5) Where, within the coordination group under Art. 77, para. 2 could not be reached,
p.002017: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002017: decision with recommendation for change, suspension or termination
p.002017: of the marketing authorization issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5
p.002017: interim and / or definitive measures.
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the Committee for Medicinal Products for Human Use, based on the recommendation under Art. 194ts, para.
p.002017: 3, within 30 days from the date of its receipt, issue an opinion on the retention, change,
p.002017: suspension, termination of the relevant marketing authorizations or refusal of
p.002017: their renewal, including a timetable for the implementation of the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. adopt a decision to change, suspend or terminate the validity of the permits
p.002017: for use, issued under Regulation (EC) No 726/2004 of the European Parliament and of the
p.002017: The Council;
p.002017: 2. adopt a decision recommending the change, suspension or termination of validity of
p.002017: marketing authorizations issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Drug Enforcement Agency shall implement the recommendations recommended in the decision of the European Medicines Agency
p.002017: The European Commission under para. 2, item 2 provisional and / or final measures.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) The recommendation under Art. 194c,
p.002017: para. 1, the opinion under art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and
p.002017: Art. 194h, para. 2 shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: Chapter Nine.
p.002017: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN
...

p.002017: permission from the BDA Executive Director.
p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
p.002017: Art. 197. The persons under art. 195 must have:
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
...

p.002017: the market on the territory of the Republic of Bulgaria for its intention to carry out parallel imports and
p.002017: upon request, provide him with a sample of the medicinal product in parallel;
p.002017: 2. keep for 5 years the following documentation: name and address of the person to whom he / she is
p.002017: delivered in parallel the imported medicinal product, date of delivery, delivered quantity
p.002017: and batch number;
p.002017: 3. submit to the BDA:
p.002017: (a) an updated patient leaflet for the parallel imported product in accordance with
p.002017: changes have occurred in the granted marketing authorization in the Republic of Bulgaria
p.002017: medicine;
p.002017: b) (amend. - SG 71/08, in force from 12.08.2008) a statement that the content of
p.002017: the leaflet under letter "a" is identical to the contents of the product leaflet authorized for
p.002017: use in the Republic of Bulgaria, except for the data under Art. 215, para. 2, item 7, letters "a" - "d";
p.002017: 4. document and report to the Marketing Authorization Holder and the BDA
p.002017: all reports of suspected adverse reactions to the medicinal product introduced
p.002017: product.
p.002017: Chapter Nine "b".
p.002017: EXPORT OF MEDICINAL PRODUCTS (NEW, SG No. 18/2014)
p.002017: Art. 217a. (New, SG No. 18/2014) (1) Export of medicinal products from the territory of the Republic of Bulgaria may
p.002017: to carry out a natural or legal person who holds a marketing authorization for a medicinal product
p.002017: products or marketing authorization holder
p.002017: production.
p.002017: (2) The holder of a manufacturing authorization may export only to
p.002017: its medicinal products.
p.002017: (3) For the purposes of this Chapter, exports are also intra - Community supplies within the framework of
p.002017: The European Union.
p.002017: (4) Export of medicinal products included in the Positive Medicinal List under Art.
p.002017: 262, para. 1, from the territory of the Republic of Bulgaria shall be made after notification to
p.002017: BDA on a case - by - case basis where the export is carried out by the holder of a
p.002017: wholesale of medicines.
p.002017: Art. 217b. (New, SG No. 18/2014) The notification under Art. 217a, para. 4 is filed by
p.002017: the Executive Director of the BDA and contains the following data:
p.002017: 1. name and address of management of the person under art. 217a, para. 1;
p.002017: 2. name, dosage form and quantity of active substance in dosage form
p.002017: unit of medicinal product intended for export;
p.002017: 3. number of the authorization for wholesale of medicinal products;
p.002017: 4. number of packages of the medicinal product intended for export;
p.002017: 5. the country where the export is planned to take place.
p.002017: Art. 217c. (New, SG No. 18/2014, declared unconstitutional by RKS No. 1 of 2015 - SG, No. 12/2015)
p.002017: (1) Upon receipt of a notification under Art. 217b BDA requires information on the medicinal product intended for export
p.002017: for a period of 6 months from the date of filing
p.002017: notification:
p.002017: 1. for the consumption of the respective medicinal product by the National Health Insurance Fund and / or by
p.002017: The Ministry of Health;
p.002017: 2. for the deliveries of the respective medicinal product in the Republic of Bulgaria by the holder of
p.002017: the marketing authorization.
p.002017: (2) The persons under para. 1 provide the information requested by the BDA within 15 days of receipt of
p.002017: the request.
p.002017: (3) The Executive Agency for Medicines shall perform an analysis of the received under para. 2 information about
...

p.002017: for special medical purposes and infant formulas and follow-on formulas, and nutritional supplements, cosmetic and
p.002017: sanitary and hygienic
p.002017: funds.
p.002017: Art. 226. (1) On the territory of medical establishments for outpatient care may be
p.002017: open pharmacies to sell medicinal products to citizens.
p.002017: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, curative
p.002017: establishments for hospital care and medical establishments under art. 10 of the Law on medical establishments does not
p.002017: pharmacies can be opened to sell medicinal products to citizens.
p.002017: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009)
p.002017: The requirements for the location and the premises of the pharmacy are laid down in the ordinance of
p.002017: Art. 219, para. 2.
p.002017: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in
p.002017: (requirements from 05.08.2011) Requirements to the device and premises of pharmacies under Art. 228, para.
p.002017: 5 shall be determined in the ordinance under para. 1.
p.002017: Art. 228. (amend. - SG 71/08, in force from 26.07.2008) (1) (amend. - SG 60/11, in force from 26.07.2008)
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002017: director of the BDA on the basis of a model application to
p.002017: applicable:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a country Party
p.002017: Agreement on the European Economic Area - Document for the up - to - date registration of the European Economic Area
p.002017: national legislation issued by the competent authority of the relevant
p.002017: the state of the persons under art. 222, para. 1;
p.002017: 2. employment contract or contract for management of the pharmacy, concluded with the master pharmacist
p.002017: or with a pharmacist assistant;
p.002017: 3. a copy of the act for the creation of the persons under Art. 222, para. 4;
p.002017: 4. documents certifying that the requirements of Art. 224 Hours;
p.002017: 5. (suppl. - SG 103/07, in force from 01.01.2018) criminal record of
p.002017: Master of Pharmacy, respectively of the Assistant Pharmacist appointed as Head of Pharmacy,
p.002017: if they are not Bulgarian citizens;
p.002017: 6. medical certificate of the Master of Pharmacy, respectively
p.002017: assistant pharmacist appointed as pharmacy manager;
p.002017: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002017: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued
p.002017: from the relevant RI;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002017: medicinal products are checked to see if the diploma of the master pharmacist / assistant pharmacist is presented
p.002017: issued by the relevant competent authority
p.002017: institution.
p.002017: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies under Art.
...

p.002017: and the requirements of the Drugs and Precursors Control Act.
p.002017: (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.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy opened in a population
p.002017: a place with a population of less than 10,000 inhabitants is issued on the basis of
p.002017: application form to which shall be attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) the documents under para. 1, items 1 - 7a and
p.002017: a document issued by the mayor of the respective municipality certifying the number of residents of
p.002017: the respective settlement;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) document for paid fee in
p.002017: 50 per cent of the fee determined in the tariff under Art. 21, para. 2 for the authorization of
p.002017: retail trade of medicinal products under Art. 222, para. 1.
p.002017: (6) (Renumbered from Paragraph (4), Suppl. - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 98)
p.002017: from 2010, in force from 01.01.2011, previous para. 5, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: d.) The application and documents under para. 1 and 5 shall be submitted to the BDA.
p.002017: (7) (Renumbered from Paragraph (5), amend. - SG 102/09, in force from 22.12.2009, amended - SG, issue 98
p.002017: from 2010, in force from 01.01.2011, previous para. 6, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: (d) Regional health inspections shall issue a hygienic conclusion within 14 days of the date
p.002017: of applying for it.
p.002017: (8) (New, SG No. 48/2015) On the day of receipt of the application under para. 1 and 5, the BDA shall send a request on its own motion
p.002017: to the Board of Directors of the Bulgarian Pharmaceutical Union for issuance of a certificate for registration in the national
p.002017: electronic register of the members of the Bulgarian Pharmaceutical Union - for the master pharmacist, head of
p.002017: pharmacy, as well as providing information on penalties imposed under the Commercial Law
p.002017: the organization of master pharmacists and the Health Act.
p.002017: (9) (New, SG No. 48/2015) The Managing Board shall submit the documents under para. 8th c
p.002017: 5 working days after receiving the request.
p.002017: (10) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 1, Vol. 5,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 229. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, repealed - SG No. 60/2011)
p.002017: (in force from 05.08.2011)
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 102/2009, effective 22.12.2009,
p.002017: ed. - SG, issue. 60 of 2011, in force since 05.08.2011, suppl. - SG, issue. 18 of 2014) Within one month from
p.002017: receipt of the documentation under Art. 228, para. 6 the Executive Director of the BDA after the opinion of
p.002017: The Expert Council for Retail Trade in Medicinal Products issues a marketing authorization
p.002017: retail with medicinal products at a pharmacy or make a motivated refusal to grant an authorization.
p.002017: The permit or refusal shall be
p.002017: served on the applicant.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation under Art.
p.002017: 228, para. 6 The BDA shall check the submitted documents and notify the applicant in writing of the established ones
p.002017: inconsistencies or incompleteness. In these cases
p.002017: the term under para. 2 shall cease to run from the day of notification until the deficiencies have been rectified.
...

p.002017: pharmacy specified in the tariff under Art. 21, para. 2.
p.002017: (5) (Renumbered from Paragraph (2), SG No. 60/2011, effective 05.08.2011)
p.002017: the permit permitting the change under para. 1, the provisions of Art. 229
p.002017: Art. 232. (1) Doctors and doctors in dental medicine may store medicines
p.002017: products on a list determined by the Minister of Health.
p.002017: (2) Where there is no pharmacy in the settlement, the persons under para. 1 can store and yes
p.002017: sell medicinal products only if they have been authorized to do so in the order specified in
p.002017: ordinance of the Minister of Health.
p.002017: Art. 233. The head of the pharmacy shall be responsible for the activities referred to in Art. 219,
p.002017: para. 1.
p.002017: Art. 234. (1) It is prohibited to sell medicinal products through automatic machines, except for
p.002017: the medicinal products specified in the list specified in the ordinance under Art. 219, para. 2.
p.002017: (2) The automatic machines under para. 1 may be owned only by the persons under Art. 222 and Art. 238,
p.002017: para. 2.
p.002017: (3) The sale of medicinal products shall be prohibited.
p.002017: (4) It is prohibited to sell on the Internet medicines medicinal products
p.002017: prescription.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) Medicinal products without
p.002017: prescription may only be sold online from a pharmacy or drugstore that they have obtained
p.002017: authorization under the terms and conditions of this Act and the ordinance under Art. 219, para. 2, respectively
p.002017: Art. 243.
p.002017: (6) (New, SG No. 102/2012, effective 02.01.2013) The pharmacies and drugstores of para. 5
p.002017: publish on the website through which they trade medicinal products without
p.002017: prescription, a general logo recognizable throughout the European Union.
p.002017: (7) (New, SG No. 102/2012, effective 02.01.2013) Requirements to the common logo
p.002017: under para. 6 shall be determined by a delegated act under Art. 85c (3) of Directive 2001/83 / EC.
p.002017: Art. 234a. (New, SG No. 102/2012, effective 02.01.2013) (1) The Executive
p.002017: Medicines Agency publishes and maintains on its website:
p.002017: 1. information on national legislation applicable to the marketing of medicinal products for
p.002017: Internet sales, including information that there may be differences between
p.002017: Member States with regard to the classification of
p.002017: the medicinal products and the conditions for their delivery;
p.002017: 2. information on the purpose of the common logo;
p.002017: 3. a list of persons offering medicinal products for sale on the Internet, and
p.002017: the addresses of their websites;
p.002017: 4. general information on the risks associated with the medicinal products delivered to
p.002017: Internet users in violation of the ordinance under Art. 234, para. 5.
p.002017: (2) The website of the BDA under para. 1 is linked to
p.002017: European Medicines Agency.
p.002017: Art. 234b. (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines shall participate in the
p.002017: information campaigns conducted by the European Commission and the European Medicines Agency
p.002017: the risk of counterfeit medicines
p.002017: products.
p.002017: Art. 235. (1) The permit for carrying out retail trade in medicinal products
p.002017: under Art. 229, para. 2 shall be terminated by termination of the activity of the persons under art. 222 and 225.
p.002017: (2) (Amended, SG No. 60/2011, effective 05.08.2011) The Executive Director of
p.002017: The BDA suspends the authorization to trade in medicinal products:
...

p.002017: pharmacy, medicinal products may be sold to persons who have been authorized
p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
p.002017: registration of a drugstore or for making a change under Art. 242 the respective RIC collects fees
...

p.002017: internet of prescription medicines, except
p.002017: vaccination advertising campaigns carried out in accordance with Art. 248 and approved by the competent
p.002017: organs.
p.002017: Art. 249. The requirements for the advertising of medicinal products shall be laid down in an ordinance
p.002017: of the Minister of Health.
p.002017: Art. 250. An application for a marketing authorization for a medicinal product shall be submitted by
p.002017: the holder of the marketing authorization or the authorized product
p.002017: face.
p.002017: Art. 251. (1) The person under art. 250 submits an application to the BDA on
p.002017: a model approved by the Executive Director of the Agency, accompanied by:
p.002017: 1. advertising project;
p.002017: 2. a notarized power of attorney from the holder of the marketing authorization,
p.002017: when the application is submitted by another person;
p.002017: 3. the literary sources of the quotations, tables or other materials used,
p.002017: when there are any;
p.002017: 4. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (2) The advertising projects under para. 1, item 1 must be clear, with intelligible text, in cases where
p.002017: and, where available, to evaluate all its elements - text and
p.002017: illustrations.
p.002017: (3) An Expert Council on Advertising shall be established at the BDA. It includes doctors and practitioners with practical experience in
p.002017: the field of advertising. The Executive Director of the BDA shall determine by an order the composition of the Board to which it is appointed
p.002017: include one representative of the Professional Ethics Committee of the Bulgarian Medical Association, the Bulgarian Medical Association
p.002017: dental
p.002017: Union and the Bulgarian Pharmaceutical Union, the amount of the remuneration of its members and approves regulations
p.002017: about the terms and conditions for his work. The board can be
p.002017: representatives of patient organizations are also included.
p.002017: (4) The council under para. 3 prepares expertise for the advertising project and prepares an opinion by
p.002017: the BDA Executive Director.
p.002017: (5) In case of finding inconsistencies of the advertising with the requirements of this law within 7 days from
p.002017: the date of submission of the application under para. 1 The BDA gives written instructions for their removal in one month
p.002017: term from the date of notification. The time limit for pronouncement is suspended
p.002017: run for the period from the day of notification to the elimination of inconsistencies.
p.002017: (6) In case the applicant does not comply with the instructions within one month from the date of
p.002017: the notification under para. 5, the authorization procedure is terminated.
p.002017: Art. 252. (1) Within one month from submission of the documentation under Art. 251, para. 1 on the basis of the opinion under Art.
p.002017: 251, para. 4, the BDA Executive Director authorizes the advertisement by order or makes a reasoned refusal for which
p.002017: notify the authorization holder of
p.002017: use.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When, within the term of para. 1
p.002017: the BDA's executive director did not authorize the advertisement or motivated it
p.002017: refusal, it is considered that there is tacit agreement with the project of advertising under Art. 251, para. 1, item 1 and she
p.002017: can be distributed.
p.002017: (3) (Renumbered from Paragraph (2), SG No. 60/2011, effective 05.08.2011)
...

p.002017: shall also notify the NHIF in writing within the time limits under para. 4.
p.002017: (4) The marketing authorization holder shall be obliged to make the notification under
p.002017: para. 1 not later than 18 months before the date of cessation of sales, but in the cases of
p.002017: para. 2 - not later than three months before the date of cessation of sales.
p.002017: (5) (Supplemented, SG No. 18/2014) Until the termination of the sales under para. 1 and 2 the holder of
p.002017: the marketing authorization is required to provide sufficient quantities of the medicinal product concerned for
p.002017: meeting health needs, unless
p.002017: when the suspension is due to any of the grounds under Art. 276 or under Art. 277.
p.002017: (6) After the expiry of the terms under para. 4 the Marketing Authorization Holder
p.002017: submit an application for the exclusion of the medicinal product from the
p.002017: Positive drug list.
p.002017: (7) Where, following the cessation of sales of the medicinal product, the holder of the
p.002017: the marketing authorization did not fulfill its obligation under para. 6, the council under art. 258, para. 1
p.002017: officially excludes him from the Positive Drug List.
p.002017: Art. 265. (1) The Council of Ministers shall establish a Transparency Committee.
p.002017: (2) (Supplemented, SG No. 60/2011, effective 05.08.2011) The composition of the Transparency Committee
p.002017: shall be determined by the Council of Ministers on the proposal of the Minister of Health. In her
p.002017: representatives of the Ministry of Health and the Ministry of Health are obligatory included
p.002017: labor and social policy, the BDA, the NHIF, the Bulgarian Medical Union, the Bulgarian Dental
p.002017: Union of the Bulgarian Pharmaceutical
p.002017: union and patient organizations and the pharmaceutical industry.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in
p.002017: (Effective 21.12.2012) A person who is a member of the Transparency Committee may not be a member of
p.002017: National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (4) The Council of Ministers shall lay down the rules and procedures for the work of the Commission
p.002017: for transparency.
p.002017: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012
p.002017: The Transparency Committee is an appealable body
p.002017: the decisions of the National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority
p.002017: ѝ.
p.002017: (3) The decisions under par. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a respective disease is without
p.002017: alternative in the country, for a particular patient may be administered a medicinal product that is authorized for
p.002017: use in a Member State of the European Union,
p.002017: it is authorized for use according to the procedure of this law, but it is not distributed on the Bulgarian market.
p.002017: (2) Annually upon proposal by the medical establishments for hospital care and after the opinion of the respective
p.002017: the national consultant on the disease profile, the Minister of Health approves the list of
p.002017: the medicinal products under para. 1 which contains
p.002017: following information:
p.002017: 1. anatomical-therapeutic-chemical classification code;
p.002017: 2. an international non-patent name to which the product belongs;
p.002017: 3. disease according to the international disease code;
p.002017: 4. the dosage form and the amount of active substance;
p.002017: 5. additional information.
p.002017: (3) The list under para. 2 is published on the Ministry of Justice's website
p.002017: healthcare on the internet.
p.002017: (4) The conditions and procedure for inclusion, modification or exclusion of medicinal products in
p.002017: the list under para. 2 shall be determined by the ordinance under art. 9, para. 1.
p.002017: (5) The medicinal product under para. 1 is delivered by special order curative
p.002017: hospital care facility under the terms and procedures established by the ordinance under Art. 9, para. 1.
p.002017: (6) The head of the medical establishment under para. 5 is responsible for the implementation of
p.002017: the treatment under para. 1.
p.002017: Chapter thirteen.
p.002017: STATE CONTROLS ON MEDICINAL PRODUCTS
p.002017: Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
p.002017: 12/21/2012) The Ministry of Health supervises the state control over medicinal products.
...

p.002017: use out of the cases under item 1.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012)
p.002017: medicines carries out inspections:
p.002017: 1. to manufacturers of medicinal products located in the territory of the Republic
p.002017: Bulgaria, per Member State or in third countries;
p.002017: 2. to importers and wholesalers of medicinal products;
p.002017: 3. at the premises of the manufacturers, importers and wholesalers of the active
p.002017: substances located on the territory of the Republic of Bulgaria;
p.002017: 4. at the premises of manufacturers or wholesalers of active substances,
p.002017: located in third countries as well as manufacturers or importers of excipients;
p.002017: 5. at the premises of the holders of marketing authorization
p.002017: products and intermediaries in the field of medicinal products, registered in accordance with Art.
p.002017: 212a;
p.002017: 6. as part of the certification procedure relating to the monographs of
p.002017: The European Pharmacopoeia;
p.002017: 7. to manufacturers of starting materials at the written request of the manufacturer.
p.002017: (4) The Medicines Executive Agency shall carry out inspections of manufacturers of
p.002017: medicinal products established in a third country in connection with an application for
p.002017: obtaining a marketing authorization or import.
p.002017: (5) (Amended, SG No. 102/2012, effective 21.12.2012) The inspections under para. 3 and 4 are
p.002017: carried out in accordance with guidelines adopted by the European Commission.
p.002017: (6) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines
p.002017: participate, at the request of the European Commission, the European Medicines Agency or a Member State, in
p.002017: carrying out inspections under para. 3 in the European Union or in the third
p.002017: countries.
p.002017: (7) (Amended, SG No. 102/2012, effective 21.12.2012)
p.002017: medicines cooperates and exchanges information with the European Medicines Agency at
p.002017: planning and carrying out the inspections under para. 3.
p.002017: (8) (New, SG No. 102/2012, in force since 21.12.2012)
p.002017: medicines cooperates with the European Medicines Agency in coordinating
p.002017: inspections in third countries.
p.002017: Art. 269a. (New, SG No. 102/2012, effective 21.12.2012) (1) The officials of
p.002017: Art. 267, para. 3 prepare a report for each inspection carried out under Art. 269, para. 3 and 4 for compliance with
p.002017: principles and guidelines for Good Manufacturing Practice or Good Distribution
p.002017: practices, or to comply with the requirements of Chapter Eight, and the requirements of this Act.
p.002017: (2) The report under para. 1 shall be provided to the verified person who may submit
p.002017: notes on it.
p.002017: (3) Upon receiving a reasoned request, the BDA shall electronically send the reports on
p.002017: para. 1 of the competent authority of another Member State or of the European Agency for the European Union
p.002017: medicines.
p.002017: Art. 269b. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good Distributor
p.002017: practices, where applicable, issued by the BDA to the manufacturer, importer or wholesaler
p.002017: Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice in
p.002017: up to 90 days from
p.002017: carrying out the inspection.
p.002017: (2) When, as a result of an inspection under Art. 269, para. 3 found that the manufacturer,
p.002017: the importer or wholesaler of the medicinal products or the active substances does not comply
p.002017: the requirements of the law and / or the principles and guidelines of Good Manufacturing Practice and / or of
p.002017: Good distribution practices, the BDA issues an opinion on
p.002017: discrepancy.
p.002017: (3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued
p.002017: certificates under para. 1 and information under para. 2.
p.002017: Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of
p.002017: Chapter Eight, the BDA prescribes the removal of
p.002017: inconsistencies.
p.002017: (2) In the cases of para. 1 The BDA shall notify the Member States, the European Agency for the Protection of Energy
p.002017: medicines and the European Commission.
p.002017: right:
p.002017: Art. 270. (1) Within the limits of their competence, the officials under Art. 267, para. 3 have
...

p.002017: violation of this law, as well as medicinal products that are available in packs of leaflets which
p.002017: do not meet the requirements of this law; order withdrawals from pharmacies and, if necessary
p.002017: drugstores, from wholesale warehouses, from manufacturers and medical establishments, and notify
p.002017: this Ministry of
p.002017: healthcare;
p.002017: 5. suspend clinical trials for established disorders until they are corrected or
p.002017: orders their termination;
p.002017: 5a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: effective 02.01.2013) orders the blocking, downloading and destruction of counterfeit goods
p.002017: medicinal and non-originating medicinal products;
p.002017: 5b. (new - SG 60/11, in force from 05.08.2011) carries out inspections of
p.002017: the donations made under Art. 268a, para. 1;
p.002017: 6. issue orders, instructions and instructions within its competence,
p.002017: which are binding on all persons;
p.002017: 7. (new - SG 60/11, in force from 05.08.2011) place medicinal products under suspension
p.002017: products and active substances in case of doubt as to their quality deviation by affixing
p.002017: certificates at production sites.
p.002017: (2) The compulsory administrative measures under para. 1 or under Art. 270, para. 3 are imposed by
p.002017: order of the BDA Director.
p.002017: (3) The orders under para. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 272a. (New, SG No. 102/2012, effective 02.01.2013) (1) By delegated acts under Art. 52b, paragraph
p.002017: 2 of Directive 2001/83 / EC lays down the necessary measures to prevent the placing on the market of
p.002017: medicinal products introduced into the European Union but not intended to be placed on the market in the European Union,
p.002017: for which there is enough
p.002017: grounds for suspecting that they have been falsified.
p.002017: (2) The Executive Agency for Medicinal Products shall take the necessary measures in accordance with the delegated ones
p.002017: acts under para. 1 to prevent the release of medicinal products introduced into the European Union
p.002017: union but not intended to be marketed
p.002017: of the European Union for which there are sufficient grounds for suspecting that they have been falsified.
p.002017: (3) The customs authorities shall notify the BDA of the introduction into the territory of the Republic
p.002017: Bulgaria of medicinal products under para. 1 with a view to taking measures under para. 2.
p.002017: Art. 273. (1) The conditions and the procedure for sampling, testing and
p.002017: their remuneration shall be determined in an ordinance of the Minister of Health.
p.002017: (2) When challenging the results of laboratory tests, they shall be made
p.002017: retesting. They shall be made upon written request from the interested party,
p.002017: made within 7 days from the date of receipt of the result of the original test.
p.002017: (3) The repeated tests under para. 2 shall be carried out by experts designated by
p.002017: the BDA's Executive Director, who did not participate in the initial test, c
p.002017: the presence of an authorized representative of the interested party.
p.002017: Art. 274. (1) The conditions and the order for blocking and withdrawal of medicinal products,
p.002017: have shown non - compliance with the requirements for quality, safety and efficacy, shall be defined in
p.002017: ordinance of the Minister of Health.
p.002017: (2) The conditions and procedure for the destruction, processing or use for others
p.002017: the goals of the medicinal products are set out in an ordinance of the Minister of Health.
p.002017: Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure proper validation of
p.002017: the processes of production and purification of medicinal products derived from human blood or human plasma,
p.002017: consistency in batch quality and ensuring, as far as technology allows, the absence of
p.002017: specific viral
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p.002017: the same molar dose is similar to such an extent that its effects in terms of efficacy and
p.002017: safety is substantially similar.
p.002017: 3. "Bioavailability" is the rate and extent at which the active substance or the therapeutically active part of it is absorbed
p.002017: of the dosage form and becomes available at the site of action. When the drug substance is intended to
p.002017: exercise a systemic therapeutic effect, bioavailability means the speed and degree at which a drug substance or
p.002017: therapeutically
p.002017: its active part is released from the dosage form and goes into general circulation.
p.002017: 4. "Researcher's Brochure" means the aggregate of clinical and non-clinical data for
p.002017: the investigational medicinal product (s) that are relevant for the test of the product or product
p.002017: products on people.
p.002017: 5. "Valid documentation" shall mean documentation which in content and completeness corresponds to
p.002017: the requirements laid down in a particular procedure under this Act.
p.002017: 6. "Substance with well established use in medical practice" is a substance for
p.002017: the following criteria may apply:
p.002017: (a) the period of proof of well-established use in medical practice is not less than 10 years from
p.002017: the date of the first systematic and documented use of the substance as a medicinal product in
p.002017: The European Union or the European Economic Community
p.002017: space;
p.002017: (b) quantitative aspects of the use of the substance, taking into account the degree of medical use
p.002017: practice, the degree of geographical use and the degree of tracking through the safety system,
p.002017: including pre-market research and scientific research published thereafter
p.002017: epidemiological literature
p.002017: studies and, in particular, comparative epidemiological studies;
p.002017: (c) a high level of scientific interest in the use of the substance (number of scientific
p.002017: publications) and unity in the scientific community in scientific evaluations.
p.002017: 7. "Secondary packaging" is a packaging which does not come in direct contact with
p.002017: the medicinal product.
p.002017: 8. "Contracting Authority" means a natural or legal person, institution or organization which
p.002017: is responsible for initiating, managing and / or financing the clinical trial.
p.002017: 9. "Generic medicinal product" is a medicinal product which has the same qualitative and
p.002017: quantitative composition with respect to the active substances and the same dosage form as the reference
p.002017: medicinal product, and its bioequivalence with the reference medicinal product has been demonstrated to be appropriate
p.002017: bioavailability tests. The various immediate-release oral dosage forms are considered to be one
p.002017: and the same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of
p.002017: active substance are considered to be the same active substance, unless they differ significantly in their nature
p.002017: safety and / or efficiency.
p.002017: 10. "Principal Investigator" is the doctor or dentist appointed by the contracting authority, who direct
p.002017: the overall conduct of the clinical trial in accordance with the approved protocol and the Good Guideline
p.002017: clinical practice and responsible for the work of
p.002017: the researchers.
p.002017: 11. "Defined daily dose" is an average daily maintenance dose of a drug
p.002017: product for use in adults according to the primary indication of the medicinal product.
p.002017: 12. "Good clinical practice" is the set of internationally recognized ethical and
p.002017: scientific quality requirements to be met when planning, conducting, reporting and
p.002017: reporting of clinical trials.
p.002017: 13. "Good laboratory practice" is a system of internationally recognized rules
p.002017: in terms of planning conditions, processes of organizing, executing, tracking and
p.002017: documentation of laboratory tests.
p.002017: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers all
p.002017: production sides - personnel, premises, facilities, materials, documentation, quality control, and aims
p.002017: to ensure safety, efficiency and
p.002017: according to the specification.
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
p.002017: establish a state of immunity or induce passive immunity. Allergens are medicinal products that are
p.002017: intended to identify or stimulate a specific targeted change in the immunological response
p.002017: to an allergic agent.
p.002017: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002017: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative, and
p.002017: when their bioavailability after application in the same
p.002017: the molar dose is similar to a degree which is a condition of equivalent efficacy and safety.
p.002017: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and extent of
p.002017: in which the active substance or the therapeutically significant portion of the test drug reaches
p.002017: from the dosage form to the systemic
p.002017: blood circulation.
p.002017: 20. "Tested medicinal product" means the dosage form of the active substance or placebo to be tested
p.002017: or used as a comparison in a clinical trial, including authorized products
p.002017: for use, but are used for unauthorized use or for the purpose of obtaining additional information on
p.002017: the authorized form, or they are
p.002017: completed (in medicinal or packaged form) in a way other than the approved form.
...

p.002017: having the scientific knowledge to provide accurate and complete information on
p.002017: the medicinal product it advertises.
p.002017: 35a. (new - SG 1/2014, in force from 03.01.2014) "Medical prescription" is a prescription of
p.002017: medicinal product or medical device issued by a person practicing regulated medical
p.002017: profession within the meaning of § 1, item 1 of the additional provisions of the Law on the recognition of
p.002017: professional qualifications and what is legal
p.002017: the right to do so in the Member State where the medical prescription is issued.
p.002017: 36. "Multicenter Clinical Trial" is a clinical trial conducted under
p.002017: one protocol but in more than one center and more than one researcher. The research
p.002017: centers may be located in the territory of one Member State in more than one
p.002017: Member State and / or Member States and third countries.
p.002017: 37. "Name of a medicinal product" is the name given to the product which may
p.002017: be:
p.002017: a) freely chosen name (trade name);
p.002017: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the commercial
p.002017: the make or the name of the marketing authorization holder;
p.002017: c) (amend. - SG 12/11, in force from 08.02.2011) scientific name together with the trade name
p.002017: the make or the name of the marketing authorization holder.
p.002017: 38. "Scientific literature" is a publication / publications of the results of scientific research in
p.002017: specialized international scientific publications.
p.002017: 39. "New active substance" is:
p.002017: (a) a chemical, biological or radiopharmaceutical that has not been authorized
p.002017: for use as a medicinal product in the European Union;
p.002017: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that is
p.002017: has been authorized for use as a medicinal product in the European Union but differs in
p.002017: the safety and efficacy of a previously authorized substance;
p.002017: (c) a biological substance which has been authorized for use as a medicinal product in
p.002017: European Union, but with a different molecular structure, with different origins in terms of
p.002017: the source material or is obtained through a different manufacturing process;
p.002017: (d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which have not been
p.002017: authorized as a medicinal product in the European Union, or the mechanism for pairing molecules
p.002017: and radionuclides was not allowed in
p.002017: The European Union.
p.002017: 40. "Adverse event" means any adverse change in health status,
p.002017: observed when administering a medicinal product to a patient or clinical participant
p.002017: a test that is not necessarily causally related to this treatment.
p.002017: 41. (amend. - SG 102/2012, in force since 21.12.2012) "Adverse drug reaction" is any undesirable and
p.002017: unexpected response to a medicinal product. In the case of a clinical trial - any undesirable or unforeseen
p.002017: response to the investigational medicinal product independently
p.002017: of the administered dose. The types of side effects are:
p.002017: (a) "unexpected" - an adverse reaction not listed in the summary of product characteristics;
p.002017: the product or whose character, weight or output does not meet the product characteristics mentioned in the summary; in
p.002017: case of clinical trial is an adverse reaction whose nature, severity or outcome do not match
p.002017: of test information
p.002017: medicinal product specified in the investigator's brochure;
p.002017: (b) "suspected" - an adverse reaction for which the notifier or the holder
p.002017: of the Marketing Authorization implies that there is a possible causal link with
p.002017: the received medicinal product;
p.002017: (c) "serious" - any adverse effect on a health condition which has caused the death,
p.002017: imminent danger to life, hospitalization or prolongation of hospitalization, significant or
p.002017: permanent disability, disability and congenital
p.002017: anomalies;
p.002017: (d) combinations of reactions under letters "a", "b" and "c".
p.002017: 42. "Common name" means the international non-patent name of a medicinal or excipient
...

p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
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p.002017: excessive use of medicinal products accompanied by harmful physical or
p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
p.002017: are sufficient to satisfy the nutritional needs of these infants up to
p.002017: the moment of introduction of suitable supplementary food.
p.002017: 88. (new - SG 41/09, in force from 02.06.2009) "Transitional foods" are foods,
p.002017: intended for the specific nutritional use of infants when administered appropriate
p.002017: supplemental food and which constitute the main liquid food of progressively increasing
p.002017: are the variety of foods in these infants.
p.002017: 89. (new - SG 12/11, in force from 08.02.2011) "Type IA change" is a change with
p.002017: minimal or no impact on quality, safety or efficacy
p.002017: of the respective medicinal product.
p.002017: 90. (new - SG 12/11, in force from 08.02.2011) "Type IB change" is a change,
p.002017: which is neither a Type IA nor a Type II change nor an extension of the authorization of
p.002017: use.
p.002017: 91. (new - SG 12/11, in force from 08.02.2011) "Type II change" is a change that does not
p.002017: is an extension of the marketing authorization and which can have a significant impact
p.002017: on the quality, safety or efficacy of the person concerned
p.002017: medicine.
p.002017: 92. (new - SG 102/2012, in force from 21.12.2012) "Delegated act" is an act under
p.002017: the meaning of Art. 290 of the Treaty on the Functioning of the European Union.
p.002017: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
p.002017: § 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and storage
p.002017: updating of medicinal products stored by the State Agency of the State Reserve and
p.002017: wartime stocks ".
p.002017: § 4. (Supplemented, SG No. 18/2014) This Act introduces the provisions of Directive 2001/83 / EC
p.002017: The European Parliament and the Council establishing a Community code for medicinal products for human use
p.002017: use as last amended by Directive 2004/27 / EC of the European Parliament and of the Council and Directive
p.002017: 2012/26 / EU of the European Parliament and of the Council of 25 October 2012 amending Directive
p.002017: 2001/83 / EC as regards
p.002017: pharmacovigilance (OJ L 299/1 of 27 October 2012).
p.002017: § 5. Data protection deadlines for the reference medicinal products shall be applied in accordance with the provisions
p.002017: of Art. 89 of Regulation (EC) No 726/2004 of the European Parliament and the
p.002017: Council and Art. 2 of Directive 2004/27 / EC of the European Parliament and of the Council.
p.002017: § 5a. (New, SG No. 60/2011, effective 30.09.2011) (1) (Amended, SG No. 102/2012, effective from
p.002017: 21.12.2012, amend. - SG, issue. 85 of 2017) Ministry of Health, National Council on
p.002017: prices and reimbursement of medicines, the Executive Agency for Medicines and Regional
p.002017: health inspections provide the opportunity to provide information and to accept applications and documents
p.002017: this law electronically under the terms and procedure of the Electronic Document and Electronic Certification Act
p.002017: services and the eGovernment Act.
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p.002017: conditions, as well as the relevant software products.
p.002017: Transitional and Final Provisions
p.002017: § 6. The Law on Medicines and Pharmacies in Human Medicine (promulgated, SG No. 36/1995;
p.002017: pcs. 61 of 1996 - Decision No. 10 of the Constitutional Court of 1996; amend. 38 of 1998, issue. 30
p.002017: from 1999, issue. 10 of 2000, issue. 37 of 2000 - Decision No. 3 of the Constitutional Court of 2000;
p.002017: amend. 59 of 2000, issue. 78 of 2000 - Decision No. 7 of the Constitutional Court of 2000; edit,
p.002017: pcs. 41 of 2001, issue. 107 and 120 of 2002; ref., issue 2 of 2003; amend. 56, 71 and 112 of 2003,
p.002017: pcs. 70 and 111 of 2004, nos. 37, 76, 85, 87, 99 and 105 of 2005; 30, 31, 34, 75 and 105 of 2006)
p.002017: cancel, except for the provision of Art. 10, para. 2, which shall apply for a period of up to one year from
p.002017: the day this law enters into force.
p.002017: § 7. (1) The marketing authorizations for medicinal products issued prior to their entry into force
p.002017: of this law under national procedure, which are also allowed in the Member States under
p.002017: the centralized procedure shall be terminated with effect from 1 January 2007.
p.002017: (2) Marketing authorizations for medicinal products issued before the entry into force of
p.002017: this law under the national procedure shall be brought into conformity with its requirements by the date
p.002017: of their renewal.
p.002017: (3) Marketing authorizations for medicinal products covered by Regulation (EC) No 726/2004
p.002017: of the European Parliament and of the Council and are authorized for use under the repealed Medicines Act and
p.002017: drugstores in human medicine as substantially similar products but are not authorized for use in
p.002017: European Union in a centralized way
p.002017: procedure is terminated.
p.002017: (4) Medicinal products authorized in the European Union for centralized use
p.002017: a procedure whose national marketing authorization is terminated in accordance with para. 1, can be sold on
p.002017: the territory of the Republic of Bulgaria in packs and leaflets in accordance with the terminated national authorization for
p.002017: use for a period not exceeding one
p.002017: year from the date of termination.
p.002017: § 8. (1) The approved marginal prices and the registered prices in the order of the repealed Law on Medicines and Pharmacies in
p.002017: human medicine for medicinal products authorized in the European Union for centralized use
p.002017: a procedure whose national authorization is
p.002017: use is terminated in accordance with § 7, para. 1 shall remain in force for one year from the date of
p.002017: its termination.
p.002017: (2) The approved marginal prices and the registered prices in the order of the repealed Law on
p.002017: medicines and pharmacies in human medicine for medicinal products, other than those under para. 1,
p.002017: shall remain in force until 31 December 2007.
p.002017: § 9. (1) The applications for authorization for use, renewal, change of issued
p.002017: permits submitted prior to the entry into force of this Act shall be considered and terminated at
p.002017: the terms and conditions provided therein.
p.002017: (2) Submitted applications and documentation for authorization of medicinal products
p.002017: products that fall within the scope of the procedure under Art. 74, respectively under Art. 75, are brought into
p.002017: compliance with the requirements of this law within three months of its entry into force.
p.002017: (3) When, within the term of para. 2 the application and documentation under para. 2 are not listed in
p.002017: in accordance with the requirements of this law, the procedure for reviewing them is terminated.
p.002017: § 10. (1) The clinical trials authorized until the entry into force of this Act shall be
p.002017: finish up to date.
p.002017: (2) Applications for conducting a clinical trial in the territory of the Republic
p.002017: Bulgaria shall be submitted, examined and terminated under the conditions and by the procedure of this Act, after
p.002017: the entry into force of the ordinance under Art. 82, para. 3.
p.002017: (3) Applications for changes to permitted clinical trials submitted prior to entry into the
p.002017: force of this law shall be considered and concluded under the conditions and in the order provided in it.
...

p.002017: its requirements within one year of its entry into force.
p.002017: (4) The persons under para. 3 submit to the Ministry of Health an application for
p.002017: re-registration, to which shall apply:
p.002017: 1. application for authorization of retail trade of medicinal products from
p.002017: the persons under art. 222, para. 1, according to the model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration of the person under art. 222, para. 1;
p.002017: 3. a copy of the issued in accordance with the repealed Law on Medicines and Pharmacies in
p.002017: human medicine permit to open a pharmacy;
p.002017: 4. a certified copy of the employment contract or contract for management assignment
p.002017: the pharmacy manager - in cases where such is required;
p.002017: 5. declaration by the persons under art. 222, para. 1 that the conditions under which it was issued are preserved
p.002017: the permit for retail sale of medicinal products of the persons under para. 2;
p.002017: 6. document for a one-time fee of BGN 100
p.002017: § 67. Persons who have submitted prior to the entry into force of this Law applications for re-registration under
p.002017: the order of repeal of § 16 of the transitional and final provisions which will carry on their business
p.002017: according to the requirements of this law, submit to the Ministry of
p.002017: within three months of its entry into force, the following documents:
p.002017: 1. an application in accordance with a model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration or certified copy of a similar document under national law
p.002017: of a Member State of the European Union, or under the law of another State Party
p.002017: of the Agreement on the European Economic Area, Art. 222, para. 1;
p.002017: 3. employment contract or contract for the management of the pharmacy concluded with the master pharmacist
p.002017: or pharmacist assistant.
p.002017: § 68. (1) Master-pharmacist or assistant-pharmacist who has been authorized for
p.002017: opening a pharmacy under the repealed § 16 of the transitional and final provisions,
p.002017: may transfer his issued permit to a person under Art. 222, para. 1.
p.002017: (2) For carrying out the transfer the persons under para. 1 filed with the Ministry of
p.002017: healthcare application to which attach:
p.002017: 1. application for authorization of retail trade of medicinal products from
p.002017: the persons under art. 222, para. 1, according to the model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration of the person under art. 222, para. 1;
p.002017: 3. a copy of the issued in accordance with the repealed Law on Medicines and Pharmacies in
p.002017: human medicine permit to open a pharmacy or permit to re - register under
p.002017: the procedure for repealing § 16 of the transitional and final provisions;
p.002017: 4. a certified copy of the employment contract or management contract of the head of
p.002017: pharmacy;
p.002017: 5. declaration by the persons under art. 222, para. 1 that the conditions under which it was issued are preserved
p.002017: the permit for retail sale of medicinal products of the persons under para. 1.
p.002017: (3) The transfer under para. 1 may be completed within one year of its entry into force
p.002017: of this law.
p.002017: § 69. The drugstores welded upon the entry into force of this Act shall continue to be
...

p.002000: the procedures under para. 1, as well as the archive of
p.002000: completed procedures.
p.002000: (4) By 31 March 2013, the Pricing and Reimbursement Committee has provided the
p.002000: National Council on Prices and Reimbursement of Medicinal Products with Reception and Transfer
p.002000: minutes kept by the commission registers.
p.002000: § 131. (1) By March 20, 2013, fees for submitting price confirmation / price caps,
p.002000: registering prices for medicinal products to include, exclude or change medicinal products in
p.002000: The positive drug list is collected by
p.002000: The Ministry of Health in the amounts specified in the tariff under Art. 21, para. 2.
p.002000: (2) The funds collected by March 20, 2013 under para. 1 shall be expended for the activity
p.002000: the Pricing and Reimbursement Committee and the Transparency Committee.
p.002000: § 132. Within three months of the entry into force of this Act, the Council of Ministers under
p.002000: proposal of the Minister of Health:
p.002000: 1. appoints the chairman and the members of the National Council for prices and reimbursement of
p.002000: medicinal products;
p.002000: 2. adopts the Rules of Procedure of the National Council for Prices and Reimbursement of
p.002000: medicinal products.
p.002000: § 133. (1) Within two months of the entry into force of this Act the Council of Ministers
p.002000: change the tariff under Art. 21, para. 2.
p.002000: (2) By 1 April 2013 the Council of Ministers shall adopt the ordinance under Art. 261a, para. 5.
p.002000: § 134. The obligations under art. 159, para. 4, Art. 168, para. 8, Art. 168a and 168b begin
p.002000: fulfill three years after the date of publication of the delegated acts under art. 54a
p.002000: of Directive 2001/83 / EC in the Official Journal of the European Union.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 138. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: except for:
p.002000: 1. paragraph 9, item 1, letter "a", § 29 - 36, § 38 - 43, § 44 regarding Art. 167a, 167b, 167b, 167g,
p.002000: 167e, Art. 167f, para. 1 and para. 2, item 1 and art. 167h, § 65-76, § 98, paragraphs 1 and 2, § 101, paragraph 1, letters "a" and "b", § 102, 103,106
p.002000: - 108, 111, 116, § 117, item 1, letters "a", "f", "g" and "l", effective January 2, 2013
p.002000: d .;
p.002013: 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
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
p.002013: of January 1, 2013, and § 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 after the entry into force of this Act, the Minister of
p.002013: the health care shall align with it the ordinance of art. 221, para. 1 of the Law on
p.002013: 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: (Official Gazette, SG 48/15)
...

Social / Unemployment

Searching for indicator unemployed:

(return to top)
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
...

Social / Victim of Abuse

Searching for indicator abuse:

(return to top)
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
...

Social / Women

Searching for indicator women:

(return to top)
p.002017: (2) In addition to the requirements of para. 1 inclusion in clinical trials of adults
p.002017: persons who are unable to give informed consent are permitted, provided that:
p.002017: 1. the relevant ethics committee with the participation of specialists with competence in the respective disease, or
p.002017: in the patient group approved the protocol after discussing clinical, moral and psychosocial aspects,
p.002017: relating to the disease in question and to
p.002017: the patient group;
p.002017: 2. it can be expected that the intake of the medicinal product being tested will
p.002017: lead to benefits that outweigh the risks or the risks are completely eliminated;
p.002017: 3. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or to data obtained through others
p.002017: research methods;
p.002017: 4. the test is directly related to life-threatening or leading to disability
p.002017: a disease in which the relevant adult is unable to give
p.002017: an informed consent;
p.002017: 5. clinical trials are designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: predefined and constantly monitored
p.002017: during the test;
p.002017: 6. no financial or other incentives are given except compensation.
p.002017: Art. 102. No clinical trial of a medicinal product on
p.002017: pregnant women and nursing mothers unless the medicinal product is required for treatment
p.002017: they may or may not be tested on another group of patients.
p.002017: Section III.
p.002017: Ethics Committees
p.002017: Art. 103. (1) (amend. - SG 60/11, in force from 05.08.2011) To the Minister of
p.002017: a multi - center ethics committee is set up by the Health Committee, whose composition is determined by
p.002017: Minister's order and includes regular and reserve members. Reserve members
p.002017: participate in committee meetings and have the right to vote in the absence of full members.
p.002017: (2) To the medical establishments where clinical trials are carried out shall be established
p.002017: ethics committees composed of the head of the hospital.
p.002017: (3) The Executive Agency for Medicines shall maintain and keep a register of the Committees on
p.002017: ethics.
p.002017: (4) The register of medical establishments to which ethics committees are established shall be
p.002017: published on the BDA website on the Internet.
p.002017: Art. 104. (1) The commissions under art. 103, para. 1 and 2 consist of 7 to 12 members who have
p.002017: qualification and experience to consider and evaluate the scientific, medical and ethical aspects of
p.002017: the proposed clinical trial.
p.002017: (2) The commissions under para. 1 shall include at least two non-medical members
p.002017: education - representatives of both sexes who are financially and administratively independent
...

Social / Youth/Minors

Searching for indicator minor:

(return to top)
p.002017: has personally informed consent to participate in
p.002017: the clinical trial.
p.002017: (3) Informed consent under para. 1, item 3 and para. 2 can only give a capable person who understands
p.002017: the nature, significance, scope and potential risks of the clinical trial. Informed consent to participate in
p.002017: a clinical trial may be withdrawn at any time
p.002017: time.
p.002017: (4) Informed consent under para. 1, item 3 for a disabled adult is given by his / her legal person
p.002017: representative. The consent of the legal representative must represent the intended will of
p.002017: participant and can be withdrawn at any time without negatives
p.002017: consequences for the participant.
p.002017: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent gives
p.002017: the person appointed by the court.
p.002017: (6) The incapable adult is provided with information about the test,
p.002017: the potential risks and rewards of understanding it.
p.002017: (7) The explicit desire of an incapable adult to refuse to participate or to participate
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
p.002017: (3) The express wish of the minor to refuse to participate or to withdraw under
p.002017: any time in the clinical trial should be taken into account by the investigator, and at
p.002017: need - from the principal investigator.
p.002017: (4) A clinical trial on a minor shall be conducted upon receipt of written informed consent from
p.002017: the person from both parents or the guardian in compliance with Art. 96, para. 1 and 3. When one parent is unknown,
p.002017: died or was deprived of parental rights or not granted such rights in cases of divorce,
p.002017: written informed
p.002017: consent is given by the minor and by the parent exercising parental rights.
p.002017: (5) The consent of the minor, the parents or the guardian may be
p.002017: withdrawn at any time without negative consequences for the minor.
p.002017: (6) The express wish of the minor to withdraw at any time from
p.002017: the clinical trial must be considered by the investigator and, if necessary, by the
p.002017: the principal investigator.
p.002017: (7) The information of the test is provided to the minor or minor,
p.002017: about the potential risks and benefits of a physician who has experience with it in an understandable way
p.002017: minors.
p.002017: Art. 98. Informed consent to participate in a clinical trial is not required if
p.002017: imposes an immediate decision to save the person's life, and if at that moment that consent
p.002017: could not be received. The decision is made by at least two doctors who do not participate in
p.002017: the research team.
p.002017: Art. 99. (1) During the test the participant receives an additional upon request
p.002017: information from an independent entity.
p.002017: (2) The written information provided to the participants in the clinical trial of
p.002017: medicinal product, contains contact details of the independent person for additional
p.002017: information.
p.002017: Section II.
p.002017: A clinical trial with vulnerable patient groups
p.002017: Art. 100. A clinical trial of minors may be
p.002017: undertake, provided that:
p.002017: 1. the protocol is approved by the relevant ethics committee after discussion of the clinical,
p.002017: moral and psychosocial aspects of childhood, in which they participated no less than
p.002017: two pediatricians;
p.002017: 2. there is an expected direct benefit of the clinical trial for the group of patients who will
p.002017: be included;
p.002017: 3. the test is directly related to the clinical condition of the minor
p.002017: or the minor;
p.002017: 4. the investigational medicinal product is intended for diagnosis, treatment or
p.002017: prevention of diseases specific to minors;
p.002017: 5. the test is intended to be conducted on minors or minors;
p.002017: 6. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or data obtained through others
p.002017: research methods;
p.002017: 7. the results of clinical trials on adults and their results
p.002017: interpretations cannot be considered valid for both minors and minors;
p.002017: 8. the test is designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: defined in advance and are constantly monitored by
p.002017: test time;
p.002017: 9. the study is planned and is conducted in accordance with the guidelines of
p.002017: The European Medicines Agency;
p.002017: 10. no financial or other incentives are given except compensation.
p.002017: Art. 101. (1) Clinical trials on the persons under art. 96, para. 4 and 5, which are not in
p.002017: able to give informed consent shall be conducted in accordance with the requirements of art. 90.
p.002017: (2) In addition to the requirements of para. 1 inclusion in clinical trials of adults
p.002017: persons who are unable to give informed consent are permitted, provided that:
p.002017: 1. the relevant ethics committee with the participation of specialists with competence in the respective disease, or
...

p.002017: (2) It is prohibited to directly provide samples of medicinal products from
p.002017: the medical sales representatives of art. 244, para. 1, item 3 of the population.
p.002017: Art. 256. Samples of medicinal products shall be made available to medical specialists
p.002017: under the conditions and by the order specified in the ordinance under art. 249.
p.002017: Art. 257. (1) The medical commercial representatives of art. 244, para. 1, item 3 must have received training,
p.002017: organized by the marketing authorization holder who assigned them to have scientific knowledge and
p.002017: be able to deliver as accurate and complete as possible
p.002017: information on the medicinal product they are presenting.
p.002017: (2) During each visit, the medical sales representatives must
p.002017: have the summary of product characteristics and the pricing data for the medicinal product and
p.002017: the terms of payment and make them available upon request.
p.002017: (3) When presenting medicinal products to medical specialists
p.002017: medical sales representatives cannot offer gifts and other property
p.002017: non-material benefit.
p.002017: Chapter twelve.
p.002017: ADJUSTMENT OF THE PRICES OF THE MEDICINAL PRODUCTS (HEADING - SG, No.
p.002017: 102 FROM 2012)
p.002017: Section I.
p.002017: National Council for Prices and Reimbursement of Medicinal Products (New, SG No. 102/2006)
p.002017: from 2012, in force since 21.12.2012)
p.002017: Art. 258. (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.002017: d.) (1) (Amended, SG No. 43/2016) A National Council on Prices and
p.002017: reimbursement of medicinal products, hereinafter referred to as "tips". The Council is a legal entity of
p.002017: budget support - minor
p.002017: budget authorizing officer. It has the status of a state commission based in Sofia.
p.002017: (2) The activity of the council shall be financed from the state budget through the budget of
p.002017: Ministry of Health.
p.002017: (3) The Council is a collegial body and consists of a chairman and six members, three of whom are doctors or
p.002017: Master's in Pharmacy, two lawyers and two economists, all with at least 5 years of experience.
p.002017: The Chairman and the members of the Council are elected and dismissed by a decision of the Council of Ministers
p.002017: at the proposal of the Minister of
p.002017: healthcare. The chairman directs and represents the board.
p.002017: (4) The members of the council may not occupy a position or carry out activity under Art. 19,
p.002017: para. 6 of the Administration Act.
p.002017: (5) The activities of the Council shall be assisted by an administration whose structure and organization
p.002017: work is determined by the rules of procedure adopted by the Council of Ministers.
p.002017: Art. 259. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012,
p.002017: in force since 21.12.2012) (1) The Council shall:
p.002017: 1. approve, refuse to approve, amend or delete the price of medicinal products under
p.002017: Art. 261a, para. 1;
p.002017: 2. approve, refuse to approve, amend or delete the marginal price of medicinal products
p.002017: products of art. 261a, para. 2;
p.002017: 3. register, refuse to register, amend or delete the prices of the medicinal products
p.002017: products granted without a doctor's prescription under Art. 261a, para. 3;
p.002017: 4. (amend. - SG 48/2015) approve, repeal or amend pharmacotherapeutic guidelines, including
p.002017: criteria for evaluating the outcome of therapy, as well as recommendations for algorithms for treatment with
...

Social / education

Searching for indicator education:

(return to top)
p.002017: route of administration and route of administration and proposed shelf life;
p.002017: 6. precautionary measures and safety precautions during storage of the product, at
p.002017: its administration to patients and the disposal of product waste accompanied by
p.002017: guidance on the potential risks of the medicinal product to the environment;
p.002017: 7. description of the production method;
p.002017: 8. description of the control methods used by the manufacturer;
p.002017: 8a. (new - SG 102/2012, in force from 02.01.2013) declaration that the results of the audit under art. 160, para. 2,
p.002017: conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
p.002017: compliance with the principles and guidelines for Good
p.002017: manufacturing practice; the declaration shall indicate the date on which the audit was carried out;
p.002017: 9. an assessment of the potential risk of the medicinal product to the environment for everyone
p.002017: the individual case and the measures envisaged to limit it;
p.002017: 10. results from:
p.002017: (a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.002017: (b) preclinical (toxicological and pharmacological) studies;
p.002017: (c) clinical trials;
p.002017: 11. a statement that in clinical trials conducted outside the territory of
p.002017: Member States have complied with the ethical principles of Good Clinical Practice;
p.002017: 12. (amended, SG No. 102/2012, effective 21.12.2012) summary of the system for
p.002017: pharmacovigilance monitoring, which includes the following elements:
p.002017: a) the name of the qualified person under Art. 191, curriculum vitae - education acquired
p.002017: professional experience in the field of pharmacovigilance monitoring and qualification for
p.002017: fulfillment of his duties in accordance with Chapter Eight;
p.002017: (b) any Member State in which the qualified person fulfills the obligations
p.002017: his;
p.002017: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002017: (d) the address at which the primary document of the traceability system is stored
p.002017: drug safety;
p.002017: 12a. (new - SG 102/2012, in force since 21.12.2012) statement by the applicant that
p.002017: has the necessary means to fulfill the obligations of Chapter Eight;
p.002017: 13. (Amended, SG No. 102/2012, effective 21.12.2012) risk management plan with
p.002017: a description of the risk management system that the applicant will put in place for that person
p.002017: medicinal product, together with a summary of the plan;
p.002017: 14. a brief description of the product according to Art. 34;
p.002017: 15. layout of the primary and secondary packaging of the product and a leaflet in
p.002017: compliance with the requirements of Chapter Six;
p.002017: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country where
p.002017: production shall be carried out accompanied by a certificate of good manufacturing practice or
p.002017: certificate certifying that the manufacture of the medicinal product and of the active substances included in
p.002017: its composition was done in accordance with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 17. a copy of the document identifying the medicinal product for treatment,
...

p.002017: Art. 102. No clinical trial of a medicinal product on
p.002017: pregnant women and nursing mothers unless the medicinal product is required for treatment
p.002017: they may or may not be tested on another group of patients.
p.002017: Section III.
p.002017: Ethics Committees
p.002017: Art. 103. (1) (amend. - SG 60/11, in force from 05.08.2011) To the Minister of
p.002017: a multi - center ethics committee is set up by the Health Committee, whose composition is determined by
p.002017: Minister's order and includes regular and reserve members. Reserve members
p.002017: participate in committee meetings and have the right to vote in the absence of full members.
p.002017: (2) To the medical establishments where clinical trials are carried out shall be established
p.002017: ethics committees composed of the head of the hospital.
p.002017: (3) The Executive Agency for Medicines shall maintain and keep a register of the Committees on
p.002017: ethics.
p.002017: (4) The register of medical establishments to which ethics committees are established shall be
p.002017: published on the BDA website on the Internet.
p.002017: Art. 104. (1) The commissions under art. 103, para. 1 and 2 consist of 7 to 12 members who have
p.002017: qualification and experience to consider and evaluate the scientific, medical and ethical aspects of
p.002017: the proposed clinical trial.
p.002017: (2) The commissions under para. 1 shall include at least two non-medical members
p.002017: education - representatives of both sexes who are financially and administratively independent
p.002017: from the hospital where the clinical trial is being conducted.
p.002017: (3) For the needs of their work, the commissions under para. 1 can attract outsiders
p.002017: specialists.
p.002017: (4) In the case of clinical trials on minors to assist the
p.002017: The respective Ethics Committee at the medical establishment must attract its activity
p.002017: external specialists.
p.002017: Art. 105. (1) The mandate of the members of the ethics committees under Art. 103, para. 1 and 2 is c
p.002017: duration 4 years.
p.002017: (2) Every two years, one-half of the composition of the Ethics Committees shall be updated.
p.002017: (3) A member of the Ethics Committee may not be appointed to the same committee for more
p.002017: from two consecutive terms.
p.002017: Art. 106. (1) The Ethics Commissions under Art. 103, para. 1 and 2 within one month of creation
p.002017: prepare written standard operating procedures in accordance with the Good Rules
p.002017: clinical practice to determine the terms and conditions for their work.
p.002017: (2) The standard operating procedures of ethics committees shall be approved by
p.002017: the BDA Executive Director.
p.002017: (3) The meetings of the Ethics Committees shall be closed. If necessary, the President of
...

p.002017: practice in the European Union database.
p.002017: Art. 148. For obtaining a production permit the person under Art. 146 should
p.002017: has:
p.002017: 1. with appropriately qualified personnel, depending on the specifics of
p.002017: manufactured types of medicinal products and dosage forms;
p.002017: 2. at any one time with at least one qualified person who is eligible
p.002017: Art. 159;
p.002017: 3. premises for production, control and storage of medicinal products,
p.002017: provided with the necessary technical equipment and control laboratories.
p.002017: Art. 149. Managers of production and quality control of medicinal products
p.002017: products in manufacturing enterprises are persons:
p.002017: 1. who hold a Master's degree in a specialty
p.002017: "pharmacy", "chemistry" or "biology" and at least two years' practical experience in
p.002017: pharmaceutical production;
p.002017: 2. which meet the requirements of item 1 and have an additional recognized specialty in
p.002017: radiobiology or radiochemistry - for radiopharmaceuticals or for medicinal products,
p.002017: exposed to ionizing radiation;
p.002017: 3. with recognized specialty in clinical hematology, medical microbiology, virology or
p.002017: immunology - for the production of immunological medicinal products - vaccines, toxins, sera, for
p.002017: biotech products and for medicinal products derived from
p.002017: human plasma or human blood.
p.002017: Art. 150. (1) The person under art. 146 submits to the BDA an application in the form approved by
p.002017: the director of the agency.
p.002017: (2) Together with the application under para. 1 the applicant shall also submit:
p.002017: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002017: specialty, work record, criminal record or similar document, if not
p.002017: Bulgarian citizen, and employment contract for the persons under Art.
p.002017: 148, item 2 and art. 149;
p.002017: 2. copies of contracts for the assignment of production and / or control of the applications for
p.002017: production of products - in the cases of art. 151;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union,
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
...

p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
p.002017: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Agency
p.002017: for nuclear regulation.
p.002017: (5) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the person under para. 1, Vol. 3,
p.002017: when he is a Bulgarian citizen.
...

p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
p.002017: registration of a drugstore or for making a change under Art. 242 the respective RIC collects fees
p.002017: in the amount determined by the tariff under Art. 21, para. 2.
p.002017: (6) (New - SG 103 2017, in force from 01.01.2018)
p.002017: food safety ex officio establishes the circumstances of a person 's criminal record
p.002017: para. 2, item 2, when he is a Bulgarian citizen.
...

Searching for indicator educational:

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p.002017: of 21.12.2012) organizes the provision of public information to patients' organizations and to
p.002017: consumer organizations on actions taken against
p.002017: counterfeiting of medicinal products;
p.002017: 4. performs other activities specified by law.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 15. (1) A Pharmacopoeial Committee shall be established to the Minister of Health as
p.002017: an advisory body on the current pharmacopoeia.
p.002017: (2) The Minister of Health at the proposal of the Executive Director of
p.002017: The BDA determines by order the composition of the Pharmacopoeial Committee and the expert groups attached to it
p.002017: and approve the rules of procedure.
p.002017: (3) The activities of the Pharmacopoeia Committee shall be financed from the budget of the Ministry
p.002017: of health.
p.002017: Art. 16. (1) A Higher Board of Pharmacy shall be established with the Minister of Health, which shall include five
p.002017: representatives appointed by the Minister of Health, five representatives of the Bulgarian
p.002017: pharmaceutical union, two representatives of the National Health Insurance Fund (NHIF) and one each
p.002017: representative of the faculties of pharmacy at medical colleges. It is the Minister of Health
p.002017: chairman of the board without
p.002017: right to vote.
p.002017: (2) The High Pharmacy Council is an advisory body that deliberates and gives opinions
p.002017: by:
p.002017: 1. the main directions and priorities in the field of pharmacy;
p.002017: 2. ethical problems of pharmacy;
p.002017: 3. draft legislative acts related to pharmacy;
p.002017: 4. scientific priorities in the field of pharmacy;
p.002017: 5. programs for organizing public educational campaigns in the field of
p.002017: medicinal products.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: (4) The organization and activities of the Supreme Pharmacy Council shall be governed by regulations,
p.002017: issued by the Minister of Health at the proposal of the High Council on Pharmacy.
p.002017: Art. 17. (1) The Executive Agency for Medicines shall be a specialized body to the Minister
p.002017: of health to oversee the quality, safety and efficacy of medicines.
p.002017: (2) (amend. - SG 15/2013, in force from 01.01.2014)
p.002017: Medicines is a budget-funded legal entity with its seat in Sofia to the Minister
p.002017: of health.
p.002017: (3) The Executive Agency for Medicines shall be managed and represented by an Executive Agency
p.002017: director, who is appointed in accordance with the Law on Administration.
p.002017: (4) The structure, functions and organization of work of the BDA shall be defined in
p.002017: Rules of Procedure adopted by the Council of Ministers.
p.002017: (5) The Medicines Executive Agency shall:
p.002017: 1. issues authorizations for the manufacture of medicinal products;
p.002017: 2. issues authorizations for use and certificates for registration of medicinal products
p.002017: products;
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) issue permits and
p.002017: wholesale trade certificates for medicinal products;
p.002017: 4. issue permits for parallel import of medicinal products;
p.002017: 5. (amend. - SG 60/11, in force from 05.08.2011) issue, refuse or terminate
p.002017: retail marketing authorizations for medicinal products;
p.002017: 5a. (new - SG 102/2012, in force from 21.12.2012) shall enter the manufacturers,
p.002017: importers and wholesalers of active substances;
p.002017: 5b. (new, SG No. 102/2012, effective 21.12.2012) keep a register of persons,
p.002017: mediators in the field of medicinal products;
...

Social / employees

Searching for indicator employees:

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p.002017: 4. thirty days when the application for registration, modification or deletion of
p.002017: price under art. 261a, para. 3;
p.002017: 5. thirty days for approval / registration of the price of medicinal products for which
p.002017: a parallel import permit has been obtained;
p.002017: 6. (new, SG No. 48/2015) ninety days when an application for inclusion is submitted
p.002017: in the Positive Medicinal Product List for a new international non-patent
p.002017: name;
p.002017: 7. (new, SG No. 48/2015) sixty days, when an application for
p.002017: maintaining the reimbursement status of the included medicinal product in the Positive Medicinal Product
p.002017: list.
p.002017: (2) For the medicinal products under Art. 262, para. 5 the council shall act within thirty
p.002017: days when an application for price approval under Art. 261a, para. 1 and turn on
p.002017: product in the Positive Medication List.
p.002017: (3) The time limits under para. 1 and 2 shall commence on the date of submission of the application in the order of
p.002017: the ordinance under Art. 261a, para. 5.
p.002017: Art. 259c. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012,
p.002017: (in force since 21.12.2012)
p.002017: Art. 259g. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012,
p.002017: (in force since 21.12.2012)
p.002017: Art. 260. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012,
p.002017: public authorities, officials and applicants under this Chapter are
p.002017: shall be obliged to assist the council and its staff in the execution of the delegated tasks
p.002017: their duties.
p.002017: Art. 261. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 05.08.2011)
p.002017: 12/21/2012) (1) The members of the council and its employees shall be obliged not to disclose circumstances and
p.002017: facts made known to them in the course of or in connection with the performance of their official duties under this Act, except under
p.002017: a written request from a public authority when
p.002017: this is provided by law.
p.002017: (2) In connection with their obligations under para. 1 persons sign a model declaration,
p.002017: approved by the Chairman of the Board.
p.002017: Section II.
p.002017: Regulation and registration of the prices of medicinal products. Algorithms for treatment with
p.002017: medicinal products (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 261a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102/2012)
p.002017: 21.12.2012) (1) The Council regulates the prices of medicinal products included in the Positive Medicinal Product
p.002017: list under Art. 262, para. 1 and paid with public funds, in accordance
p.002017: with the lowest reference prices from Member States.
p.002017: (2) The Council shall regulate the marginal prices of medicinal products to be granted under
p.002017: medical prescription, other than those under para. 1 according to the lowest reference prices of
p.002017: Member States.
p.002017: (3) The Council registers maximum retail selling prices for medicinal products
p.002017: non-prescription products.
p.002017: (4) The price determined in accordance with the procedure of para. 1, is also the marginal cost of medicinal products at
p.002017: retail.
p.002017: (5) The Council of Ministers, upon a proposal by the Minister of Health, shall determine by an ordinance the conditions and rules for
p.002017: regulation of the prices of the medicinal products under para. 1, to regulate the marginal prices of medical allowances
...

p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
...

Social / gender

Searching for indicator gender:

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p.002017: and warnings that result from a new one
p.002017: information related to the safe use of the medicinal product.
p.002017: 71. "Spontaneous message" is a voluntarily sent message about suspected unwanted
p.002017: reaction when using the medicinal product to the marketing authorization holder, up to
p.002017: authorities for the supervision of medicinal products or other organizations not originating in
p.002017: a survey or other organized information gathering system.
p.002017: 72. "Shelf life of a medicinal product" is the time interval at which, if stored at
p.002017: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002017: based on stability studies of several batches of
p.002017: the finished form.
p.002017: 73. (amend. - SG 71/08, in force from 12.08.2008) "Relevant medicinal product of
p.002017: herbal medicinal product "is a product that contains the same active substances, regardless of composition
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
...

Social / orphan

Searching for indicator orphan:

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p.002013: COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 of 19 June 2012
p.002013: the year of the pharmacovigilance activities provided for in the Regulation
p.002013: (EC) No 726/2004 of the European Parliament and of the Council and in a Directive
p.002013: 2001/83 / EC of the European Parliament and of the Council
p.002013: COMMISSION REGULATION (EC) No 1234/2008 of 24 November
p.002013: consideration of changes to the terms of marketing authorizations for medicinal products for
p.002013: human use and veterinary medicinal products
p.002013: REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: 13 November 2007 on advanced therapy medicinal products and amending
p.002013: Directive 2001/83 / EC and Regulation (EC) No 726/2004
p.002013: REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: 12 December 2006 on medicinal products for pediatric use and amending
p.002013: Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC and
p.002013: Regulation (EC) No 726/2004
p.002013: REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: 31 March 2004 establishing Community procedures for the authorization and control of medicinal products for
p.002013: human and veterinary use and on the creation of a European one
p.002013: Medicines Agency (Consolidated Version)
p.002013: COMMISSION REGULATION (EC) No 1084/2003 of 3 June 2003 examining changes to the conditions
p.002013: of the marketing authorizations for medicinal products for human use and veterinary medicinal products granted
p.002013: by a competent authority of
p.002013: Member State (repealed)
p.002013: REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (EC) No 141/2000
p.002013: December 16, 1999 for orphan drugs
p.002013: COUNCIL REGULATION (Council of the European Community) No 2309/93 of 22 July 1993 establishing
p.002013: the Community procedure for granting authorizations (licenses) and the supervision of medicinal products
p.002013: funds used in human and veterinary medicine
p.002013: medicine, and a European Medicines Assessment Agency is set up (repealed)
p.002013: COUNCIL REGULATION (EEC) No 1768/92 of 18 June 1992
...

Social / parents

Searching for indicator parent:

(return to top)
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
p.002017: (3) The express wish of the minor to refuse to participate or to withdraw under
p.002017: any time in the clinical trial should be taken into account by the investigator, and at
p.002017: need - from the principal investigator.
p.002017: (4) A clinical trial on a minor shall be conducted upon receipt of written informed consent from
p.002017: the person from both parents or the guardian in compliance with Art. 96, para. 1 and 3. When one parent is unknown,
p.002017: died or was deprived of parental rights or not granted such rights in cases of divorce,
p.002017: written informed
p.002017: consent is given by the minor and by the parent exercising parental rights.
p.002017: (5) The consent of the minor, the parents or the guardian may be
p.002017: withdrawn at any time without negative consequences for the minor.
p.002017: (6) The express wish of the minor to withdraw at any time from
p.002017: the clinical trial must be considered by the investigator and, if necessary, by the
p.002017: the principal investigator.
p.002017: (7) The information of the test is provided to the minor or minor,
p.002017: about the potential risks and benefits of a physician who has experience with it in an understandable way
p.002017: minors.
p.002017: Art. 98. Informed consent to participate in a clinical trial is not required if
p.002017: imposes an immediate decision to save the person's life, and if at that moment that consent
p.002017: could not be received. The decision is made by at least two doctors who do not participate in
p.002017: the research team.
p.002017: Art. 99. (1) During the test the participant receives an additional upon request
p.002017: information from an independent entity.
p.002017: (2) The written information provided to the participants in the clinical trial of
p.002017: medicinal product, contains contact details of the independent person for additional
p.002017: information.
p.002017: Section II.
...

Searching for indicator parents:

(return to top)
p.002017: the clinical trial.
p.002017: (3) Informed consent under para. 1, item 3 and para. 2 can only give a capable person who understands
p.002017: the nature, significance, scope and potential risks of the clinical trial. Informed consent to participate in
p.002017: a clinical trial may be withdrawn at any time
p.002017: time.
p.002017: (4) Informed consent under para. 1, item 3 for a disabled adult is given by his / her legal person
p.002017: representative. The consent of the legal representative must represent the intended will of
p.002017: participant and can be withdrawn at any time without negatives
p.002017: consequences for the participant.
p.002017: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent gives
p.002017: the person appointed by the court.
p.002017: (6) The incapable adult is provided with information about the test,
p.002017: the potential risks and rewards of understanding it.
p.002017: (7) The explicit desire of an incapable adult to refuse to participate or to participate
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
p.002017: (3) The express wish of the minor to refuse to participate or to withdraw under
p.002017: any time in the clinical trial should be taken into account by the investigator, and at
p.002017: need - from the principal investigator.
p.002017: (4) A clinical trial on a minor shall be conducted upon receipt of written informed consent from
p.002017: the person from both parents or the guardian in compliance with Art. 96, para. 1 and 3. When one parent is unknown,
p.002017: died or was deprived of parental rights or not granted such rights in cases of divorce,
p.002017: written informed
p.002017: consent is given by the minor and by the parent exercising parental rights.
p.002017: (5) The consent of the minor, the parents or the guardian may be
p.002017: withdrawn at any time without negative consequences for the minor.
p.002017: (6) The express wish of the minor to withdraw at any time from
p.002017: the clinical trial must be considered by the investigator and, if necessary, by the
p.002017: the principal investigator.
p.002017: (7) The information of the test is provided to the minor or minor,
p.002017: about the potential risks and benefits of a physician who has experience with it in an understandable way
p.002017: minors.
p.002017: Art. 98. Informed consent to participate in a clinical trial is not required if
p.002017: imposes an immediate decision to save the person's life, and if at that moment that consent
p.002017: could not be received. The decision is made by at least two doctors who do not participate in
p.002017: the research team.
p.002017: Art. 99. (1) During the test the participant receives an additional upon request
p.002017: information from an independent entity.
p.002017: (2) The written information provided to the participants in the clinical trial of
p.002017: medicinal product, contains contact details of the independent person for additional
p.002017: information.
p.002017: Section II.
p.002017: A clinical trial with vulnerable patient groups
p.002017: Art. 100. A clinical trial of minors may be
p.002017: undertake, provided that:
p.002017: 1. the protocol is approved by the relevant ethics committee after discussion of the clinical,
...

Social / philosophical differences/differences of opinion

Searching for indicator opinion:

(return to top)
p.002017: (b) any Member State in which the qualified person fulfills the obligations
p.002017: his;
p.002017: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002017: (d) the address at which the primary document of the traceability system is stored
p.002017: drug safety;
p.002017: 12a. (new - SG 102/2012, in force since 21.12.2012) statement by the applicant that
p.002017: has the necessary means to fulfill the obligations of Chapter Eight;
p.002017: 13. (Amended, SG No. 102/2012, effective 21.12.2012) risk management plan with
p.002017: a description of the risk management system that the applicant will put in place for that person
p.002017: medicinal product, together with a summary of the plan;
p.002017: 14. a brief description of the product according to Art. 34;
p.002017: 15. layout of the primary and secondary packaging of the product and a leaflet in
p.002017: compliance with the requirements of Chapter Six;
p.002017: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country where
p.002017: production shall be carried out accompanied by a certificate of good manufacturing practice or
p.002017: certificate certifying that the manufacture of the medicinal product and of the active substances included in
p.002017: its composition was done in accordance with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 17. a copy of the document identifying the medicinal product for treatment,
p.002017: prevention or diagnosis of rare diseases, accompanied by a copy of the opinion of
p.002017: The European Medicines Agency;
p.002017: 18. copies of any marketing authorization issued in another Member State or in
p.002017: a third country for the medicinal product for which a marketing authorization is sought;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) copy of the summary of the safety data, including
p.002017: data contained in periodic safety update reports and, where available, communications
p.002017: for suspected side effects
p.002017: reactions;
p.002017: 19. a list of the Member States in which an application for authorization is submitted
p.002017: for the use of a medicinal product;
p.002017: 20. (amend. - SG 71/08, in force from 12.08.2008) copy of the summary of product characteristics, proposed
p.002017: by the person under Art. 26, para. 1, or a copy of the summary of product characteristics approved by the regulatory authority
p.002017: authority of a Member State (s) already issued
p.002017: marketing authorization;
p.002017: 21. a copy of the refusal of the marketing authorization in a Member State or in a third
p.002017: country accompanied by motives; suspension or termination information
p.002017: the validity of the marketing authorization;
p.002017: 22. a copy of the proposed package leaflet for the patient, accompanied by a summary of the evaluation results
p.002017: at the level of readability of the contents of the package leaflet from the patient's target group or copy
p.002017: from a leaflet approved by the regulatory body of
p.002017: a Member State which has already granted a marketing authorization;
p.002017: 23. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2;
p.002017: 24. (new - SG 71/08, in force from 26.07.2008) the documents under art. 7 of
p.002017: Regulation (EC) No 1901/2006.
...

p.002017: the product, except for the data under art. 34, para. 1, Vol. 5;
p.002017: 3. in the case of a herbal medicinal product within the meaning of Art. 37, para. 2 or the combined vegetable
p.002017: medicinal product - the information under art. 37, para. 1, item 5 for the combination; when the individual active substances of
p.002017: the combined product is not known enough
p.002017: provide data on the traditional use of each;
p.002017: 4. a copy of the marketing authorization or the plant registration certificate
p.002017: a medicinal product issued by a Member State or a third country and / or a copy of the refusal,
p.002017: accompanied by the reasons for the decision;
p.002017: 5. (amend. - SG 71/08, in force from 12.08.2008) bibliographic data or
p.002017: expert opinions proving that the herbal medicinal product for which it was submitted
p.002017: the application for registration or the product corresponding thereto has at least 30 years of use
p.002017: in world medical practice, of which at least 15 years of use in the territory of a country
p.002017: Member by the date of submission of the application for registration;
p.002017: 6. bibliographic data on the safety of the product, accompanied by an expert
p.002017: a report;
p.002017: 7. a copy of the manufacturing authorization, accompanied by a certificate of Good
p.002017: manufacturing practice or with a certificate proving that the product is manufactured under conditions,
p.002017: equivalent to the requirements of Good Manufacturing Practice.
p.002017: (2) The Executive Agency for Medicinal Products may request from the applicant an additional one
p.002017: information for the safety assessment of the medicinal product under para. 1.
p.002017: (3) The Executive Agency for Medicinal Products may request an opinion from the Committee for Herbal Medicinal Products
p.002017: to the European Medicines Agency on the accuracy of the data under para. 1, item 5, as his
p.002017: provided the necessary parts of the dossier to
p.002017: the medicinal product.
p.002017: (4) The submitted data under para. 1, item 5 shall also be valid in cases where during the 30-year period
p.002017: use in medical practice:
p.002017: 1. the relevant medicinal product of the product applied for
p.002017: registration, has been on the market without authorization or registration for use, or
p.002017: 2. when the number of ingredients in the medicinal product for which an application has been submitted
p.002017: registration, their amount in dosage unit is reduced or decreased.
p.002017: Art. 39. (1) Where the herbal medicinal product has been on the Community market for less than 15 years, but
p.002017: meets the conditions of Art. 37, para. 1, the BDA shall submit for the opinion the documentation under Art. 38, para. 1 on
p.002017: The Committee for Herbal Medicinal Products at
p.002017: European Medicines Agency.
p.002017: (2) The Executive Agency for Medicines shall take a final decision after
p.002017: the publication of a monograph by the committee under para. 1 for product compliance with the criteria
p.002017: for registration for traditional use.
p.002017: (3) In the cases of para. 1 the term under Art. 44 stops running.
p.002017: Art. 40. The Medicines Executive Agency may require the applicant to
p.002017: herbal medicinal product to submit documentation under Art. 27 - 32 or under Art. 35.
p.002017: Art. 41. (1) (amend. - SG 71/08, in force from 12.08.2008) The Executive Agency for Medicines shall publish
p.002017: on your site's list of herbal substances,
p.002017: preparations or combinations thereof used in traditional herbal medicinal products prepared
p.002017: by the Committee for Herbal Medicinal Products at the European Medicines Agency. The list contains for everyone
p.002017: herbal substance therapeutic indications, active ingredient content per unit dose and dosage,
p.002017: route of administration and other information necessary for the safe use of the herbal substance as traditional
p.002017: medicine.
p.002017: (2) When they propose a registration product for traditional use in the application
p.002017: contains a herbal substance, preparation or a combination thereof, listed in para. 1,
p.002017: the applicant does not submit the data referred to in Art. 38, para. 1, Vols 4 - 6.
p.002017: (3) When the herbal substance, the preparation or the combination thereof are excluded from the list under para. 1, the holder
...

p.002017: medical products.
p.002017: (2) In case the persons under para. 1 have participated in one of the preparation stages of
p.002017: the documentation necessary to authorize the use of the medicinal product cannot be provided
p.002017: participate in the meetings of the respective specialized commission under art. 47.
p.002017: (3) The persons under para. 1 shall not vote in decisions on matters on which they or
p.002017: their family members have commercial, financial or other interests.
p.002017: Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
p.002017: valid documentation of the BDA together with the relevant commission under Art. 47, para. 1 evaluates quality, safety and
p.002017: the efficacy of the medicinal product and produces an evaluation report commenting on the results of the pharmaceutical and
p.002017: the preclinical tests, the clinical trials, the risk management system and the
p.002017: monitoring the safety of the medicinal product concerned. The evaluation report prepared shall be submitted to
p.002017: the BDA Executive Director.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012) The report under para. 1 se
p.002017: updated in the presence of new information relevant to the assessment of quality, safety and health
p.002017: the efficacy of the medicinal product.
p.002017: (3) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012) Where the medicinal product contains genetically
p.002017: modified organisms, the BDA provides the Ministry of Environment and Water with the necessary
p.002017: dossier documentation for the medicinal product and
p.002017: requests an opinion within 60 days on the potential environmental risk.
p.002017: The sixty-day period is within the term of para. 1.
p.002017: (4) (Renumbered from Paragraph 3, SG No. 102/2012, effective 21.12.2012) In the cases of
p.002017: radiopharmaceuticals BDA provides the required documentation from the dossier of the medicinal product and requires it
p.002017: opinion within 60 days by the Nuclear Regulatory Agency with respect to
p.002017: the quality and safety of the product. The sixty-day period is within the term of para. 1.
p.002017: (5) (Renumbered from Paragraph (4), amend. - SG 102/02, in force from 21.12.2012) Where
p.002017: The Ministry of the Environment and Waters and the Nuclear Regulatory Agency do not express their opinion in the
p.002017: the established under para. 3 and 4 terms, their opinion is considered positive.
p.002017: Art. 50. (1) When the BDA finds inconsistencies in the dossier with the requirements for granting a marketing authorization or
p.002017: certificate of registration under this law, notifies the applicant in writing to provide additional information,
p.002017: related to the documentation under Art. 27 - 32 or
p.002017: under Art. 35, para. 3, or under Art. 38 and / or provide an oral or written explanation of
p.002017: incompleteness and non-compliance found within 180 days from the date of notification.
p.002017: (2) In the cases of para. 1 the term under Art. 44 ceases to run from the date of notification to
p.002017: providing the requested information.
p.002017: (3) The Executive Director of the BDA shall terminate the procedure for issuing the BDA
p.002017: of a marketing authorization or a marketing authorization for a medicinal product where:
p.002017: 1. the applicant has not provided the information under para. 1 within the specified period;
p.002017: 2. the persons under art. 26, para. 1 request termination in writing.
p.002017: Art. 51. Within 10 days from the preparation of the evaluation report under Art. 49, para. 1
p.002017: the BDA Executive Director issues a Marketing Authorization / Registration Certificate
p.002017: of the medicinal product or a reasoned refusal.
p.002017: Art. 52. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 5 days from the date of
p.002017: issuance of the marketing authorization / registration certificate in the register of art. 19, para.
p.002017: 1, item 3, the following data on the permit / certificate shall be entered:
p.002017: 1. registration number;
p.002017: 2. number and date of the marketing authorization / registration certificate of
p.002017: the medicinal product;
p.002017: 3. name of the medicinal product;
...

p.002017: the field of clinical trials, when referred to by the ethics committees under art. 103, para. 1 and 2,
p.002017: by the BDA or by the contracting authority.
p.002017: (5) The Central Ethics Committee shall exercise methodological guidance towards
p.002017: ethics committees under art. 103, para. 1 and 2.
p.002017: (6) The meetings of the Central Ethics Committee shall be closed. If necessary
p.002017: the chairman of the Central Ethics Committee may invite the contracting authority or
p.002017: the principal investigator.
p.002017: (7) The Council of Ministers, upon a proposal by the Minister of Health, shall designate with
p.002017: Rules of Procedure of the Central Ethics Committee.
p.002017: Art. 108. (1) A member of the Central Ethics Committee may not be appointed to the same
p.002017: committee for more than two consecutive terms. The term of office is 4 years.
p.002017: (2) Every two years, one-half of the composition of the Central Ethics Committee shall be
p.002017: is updating.
p.002017: Section IV.
p.002017: Permission to conduct a clinical trial
p.002017: Art. 109. A clinical trial may begin when the following conditions are fulfilled:
p.002017: 1. the relevant ethics committee has given a favorable opinion, and
p.002017: 2. the Executive Director of the BDA has issued a written permit for its conduct,
p.002017: when any of the tested medicinal products is:
p.002017: (a) a gene therapy medicinal product;
p.002017: (b) somatic cell therapy medicinal product;
p.002017: (c) a medicinal product containing genetically modified organisms;
p.002017: (d) a high-tech medicinal product as defined in the Annex to the Regulation
p.002017: (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: (e) a medicinal product containing a biologically active substance (s)
p.002017: human or of animal origin or containing biological or human components
p.002017: animal origin, or in the manufacture of which such components are used, or
p.002017: 3. within the period specified by the law, the assignor has not been notified in writing by the BDA that
p.002017: the test cannot be conducted - for medicinal products other than those under item 2.
p.002017: Art. 110. (1) In order to obtain an opinion, the principal or coordinating researcher and
p.002017: the assignor shall submit to the respective ethics committee under art. 103
p.002017: 1. administrative documentation;
p.002017: 2. information about a participant;
p.002017: 3. documentation of the test report;
p.002017: 4. documentation of the tested medicinal product / products;
p.002017: 5. documentation of technical requirements and personnel;
p.002017: 6. data on the financing and the administrative organization of the test.
p.002017: (2) The content, form and requirements for the documentation under para. 1 are defined in
p.002017: the ordinance under Art. 82, para. 3.
p.002017: Art. 111. (1) The Ethics Committee shall prepare an opinion, having regard to the following:
p.002017: 1. the importance of the clinical trial;
p.002017: 2. the positive assessment of the ratio of expected benefits and risks according to Art.
p.002017: 90, item 1 and the motivation of the conclusions;
p.002017: 3. the clinical trial protocol;
p.002017: 4. the suitability of the principal investigator and the research team for the conduct
p.002017: the clinical trial;
p.002017: 5. the researcher's brochure;
p.002017: 6. availability of the necessary equipment and its corresponding quality;
p.002017: 7. the correspondence and completeness of the written information to be provided, and
p.002017: the procedure for obtaining informed consent and the validity of the test
p.002017: people unable to give informed consent, in the cases under Art. 100 and 101;
p.002017: 8. the anticipated compensation or compensation in the event of injury or death, which
p.002017: may be the result of a clinical trial;
p.002017: 9. the insurance covering the liability of the researcher and the assignor;
p.002017: 10. where necessary, the terms and conditions for the remuneration or compensation of
p.002017: the researchers and the participants in the clinical trial and the elements of the contract between
p.002017: the client and the medical establishment;
p.002017: 11. the conditions and procedure for recruiting participants.
p.002017: (2) The Ethics Committee shall:
p.002017: 1. gives a favorable opinion;
p.002017: 2. motivated refuses, or
p.002017: 3. requires a change in some of the documentation as a condition for receiving a positive one
p.002017: position.
p.002017: Art. 112. (1) Within 60 days from the submission of an application, the relevant ethics committee shall
p.002017: delivers an opinion to the applicant and the BDA.
p.002017: (2) Where the clinical trial includes a gene therapy medicinal product or
p.002017: somatic cell therapy or a medicinal product containing genetically modified
p.002017: organisms, the term under para. 1 is extended to 30 days.
p.002017: (3) The deadline for issuing an opinion is 180 days, when for clinical examination
p.002017: a trial involving a gene therapy or somatic cell therapy drug
p.002017: or a medicinal product containing genetically modified organisms is required to be consulted
p.002017: expert commission specially created by order of the BDA Director.
p.002017: Art. 113. (1) When evaluating the documentation, the Ethics Committee may require
p.002017: one additional written documentation from the applicant. The time limits under Art. 112 stop yes
p.002017: run until the required documentation is submitted.
p.002017: (2) The procedure for examining the study shall be terminated if, within 60 days from
p.002017: receiving the request for additional information, the contracting authority did not submit the request by
p.002017: commission documentation.
p.002017: Art. 114. (1) When the test will be conducted in more than one center in the territory
p.002017: of the Republic of Bulgaria, an application shall be submitted to the Ethics Committee for Multicenter Tests
p.002017: under Art. 103, para. 1.
p.002017: (2) When the test will be conducted in only one center in the territory of the Republic
p.002017: Bulgaria, an application may be submitted to the relevant Ethics Committee under Art. 103, para. 1 or 2 on
p.002017: choice of the contracting authority.
p.002017: (3) The opinion of the Ethics Committee under Art. 103, para. 1 is valid for all centers of
p.002017: the territory of the Republic of Bulgaria.
p.002017: (4) (New - SG 12/2011, in force from 08.02.2011) For submission of applications for
p.002017: the Ministry of Health collects an opinion from the Ethics Committee
p.002017: a fee in the amount determined by the tariff under Art. 21, para. 2.
p.002017: Art. 115. (1) Where the opinion of the respective Ethics Committee under Art. 103 e
p.002017: negative, the contracting authority may appeal within 90 days from the date of notification
p.002017: its decision before the Central Ethics Committee.
p.002017: (2) When the negative opinion of the respective Ethics Committee under Art. 103 was prepared without taking
p.002017: the opinion of the expert commission under art. 112, para. 3, the contracting authority may within 14 days from the date of notification
p.002017: to request in writing that the committee review it
p.002017: your opinion.
p.002017: (3) The expert commission under Art. 112, para. 3 within 60 days from the date of receipt of the written application by
p.002017: the contracting authority decides on the negative opinion of the relevant ethics committee and can challenge it
p.002017: or endorse, in writing, informing her.
p.002017: The Ethics Committee takes a final opinion, which it sends to the contracting authority.
p.002017: (4) Where the expert commission under Art. 112, para. 3 supported the negative opinion,
p.002017: the contracting authority may, within 14 days from the date of notification, appeal against the decision to
p.002017: Central Ethics Committee.
p.002017: (5) The opinion of the Central Ethics Committee is final and binding
p.002017: the relevant ethics committee.
p.002017: Art. 116. (1) The contracting authority shall submit to the BDA an application in accordance with a specimen for carrying out of
p.002017: clinical trial.
p.002017: (2) Where the applicant for the clinical trial is not the sponsor, the application shall be
p.002017: is accompanied by documentation certifying that the person is authorized by
p.002017: the contracting authority.
p.002017: (3) Where the assignor is not registered as a natural or legal person of
p.002017: the territory of the Republic of Bulgaria, the application shall be accompanied by a document containing the data
p.002017: of his authorized representative for the territory of the Republic of Bulgaria.
p.002017: (4) The following shall be attached to the application:
p.002017: 1. administrative documents;
p.002017: 2. information about a participant;
p.002017: 3. documentation of the test report;
p.002017: 4. documentation of the tested medicinal product / products;
p.002017: 5. documentation of technical requirements and personnel;
p.002017: 6. documentation of financing and administrative organization of the test.
p.002017: (5) The content, form and requirements for the documentation under para. 4 are defined in
p.002017: the ordinance under Art. 82, para. 3.
p.002017: Art. 117. (1) When evaluating the documentation under Art. 116 The BDA may, in writing, only once
p.002017: requested additional documentation from the applicant.
p.002017: (2) The time limits under Art. 118, 119 and 120 shall cease to run until the request has been submitted
p.002017: documentation.
...

p.002017: clinical trial of gene therapy medicinal products where there is a risk of modification
p.002017: of the genome of the reproductive cells of the participant in
p.002017: the test.
p.002017: Art. 122. (1) In multicenter testing in the Republic of Bulgaria and in a third country, the BDA
p.002017: requires the contracting authority to provide a declaration that it will grant access to the representatives of
p.002017: BDA for inspection in order to establish compliance with the requirements and principles of the Good
p.002017: clinical practice and Good Manufacturing Practice.
p.002017: (2) When the contracting authority fails to submit the declaration under para. 1, the BDA does not consider
p.002017: the application submitted.
p.002017: Art. 123. The sponsor declares that it has been submitted to the BDA and to the Ethics Committee
p.002017: the documentation contains the same information.
p.002017: Art. 124. (1) The procedures in the Ethics Committee and in the BDA may be conducted
p.002017: simultaneously or sequentially at the option of the contracting authority.
p.002017: (2) The term under Art. 118, para. 1 for the examination of the documentation does not stop running at
p.002017: the lack of a decision by the Ethics Committee.
p.002017: Art. 125. The clinical trial shall be conducted in accordance with the protocol it has received
p.002017: positive opinion from the relevant ethics committee under art. 103, and under the conditions set out in
p.002017: the documentation submitted.
p.002017: Section V.
p.002017: Changes
p.002017: Art. 126. (1) The contracting authority may at any time make changes other than
p.002017: the substantial changes under Art. 127, para. 2, in the clinical trial protocol.
p.002017: (2) In the cases of para. 1 the contracting authority shall keep the documentation related to the changes, and
p.002017: it shall be made available to the BDA and the Ethics Committee upon request.
p.002017: Art. 127. (1) A change in the conduct of a clinical trial may be requested by
p.002017: BDA, when necessary to ensure the safety of participants, scientific
p.002017: the value of testing and / or adherence to the Good Clinical Practice rules.
p.002017: (2) A significant change in the conduct of the study is any change in the protocol
p.002017: and / or in the information and documentation under Art. 110 and 116, which affects:
p.002017: 1. the safety or physical and mental integrity of the participants;
p.002017: 2. the scientific value of the study;
p.002017: 3. conducting or organizing the survey;
p.002017: 4. the quality or safety of any of the tested medicinal products.
p.002017: Art. 128. (1) The contracting authority may apply planned substantial changes to the protocol
p.002017: of the test and in the documentation under Art. 110 and 116 when:
p.002017: 1. the relevant Ethics Committee has given a positive opinion in writing;
p.002017: 2. the BDA Executive Director has issued a written authorization for this - for clinical purposes
p.002017: tests with medicinal products under art. 109, item 2, or
p.002017: 3. within the period specified by the law, the assignor has not been notified by the BDA of not accepting
p.002017: the proposed changes in the clinical trial of medicinal products under Art. 109, Vol. 3.
p.002017: (2) The provision of para. 1 shall not apply to changes to the approved protocol which are
p.002017: require to protect participants from imminent danger when new information emerges,
p.002017: related to the conduct of the test or to the design of the tests
p.002017: medicine.
p.002017: (3) In the cases of para. 2 the contracting authority shall immediately inform the commission under para. 1, item 1 and
p.002017: BDA for new information available, measures taken and changes to the protocol implemented.
p.002017: Art. 129. (1) When planning significant changes in the clinical trial and in
p.002017: the documentation under Art. 110 and 116 the applicant submits a written application in a model to the BDA and to
p.002017: the relevant ethics committee.
p.002017: (2) The application shall be accompanied by the documentation necessary to justify the
p.002017: changes and certifying that after applying the change, the ratio estimate
p.002017: between the benefit and the risk under Art. 90, item 1 shall be retained.
p.002017: (3) The requirements for the application and documentation for change shall be specified in the ordinance
p.002017: under Art. 82, para. 3.
p.002017: Art. 130. (1) Within 35 days of receipt of an application for change, the Ethics Committee
p.002017: shall notify the contracting authority of its decision by issuing:
p.002017: 1. a positive opinion on the changes requested, or
p.002017: 2. a motivated refusal for changes in the clinical trial.
p.002017: (2) Within 35 days from the date of receipt of an application with a positive opinion
p.002017: of the BDA Ethics Committee:
p.002017: 1. approve the changes in the clinical trial of medicinal products under Art. 109, item 2, or
p.002017: 2. does not approve the changes, explicitly motivating.
p.002017: (3) If, within 35 days of submission of clinical change documentation
p.002017: tests with medicinal products under art. 109, item 3 the applicant did not receive a notification of refusal,
p.002017: proposed changes can be made.
p.002017: Art. 131. (1) In the cases of art. 130, para. 2, item 2 the contracting authority may submit an amendment
p.002017: in the proposed motives, at the latest 14 days before the date of application
p.002017: changes.
p.002017: (2) Within 14 days from the date of receipt of the changed documentation under para. 1 BDA
p.002017: issues a change in the authorization for a clinical trial of medicinal products under Art. 109, Vol. 2
p.002017: or refuses.
p.002017: (3) The refusal under para. 2 shall not be subject to appeal.
p.002017: Section VI.
p.002017: Suspension of clinical trial
p.002017: Art. 132. (1) The contracting authority or the researcher may take urgent measures to
p.002017: protect participants in the clinical trial from sudden risks to theirs
p.002017: safety and health.
p.002017: (2) In the cases of para. 1, the contracting authority shall immediately inform the BDA and the relevant commission
p.002017: ethics of the actions taken and the reasons that caused them.
p.002017: Art. 133. (1) When the test is carried out under conditions other than those determined at the time of granting the permit, or
p.002017: information is available to disprove the scientific validity of
p.002017: testing, or whether there is a risk to the safety of participants, the BDA may suspend
p.002017: conducting the test or terminating it.
p.002017: (2) Termination may be required for a particular center or for all centers at
p.002017: multicenter clinical trial on the territory of the Republic of Bulgaria.
p.002017: (3) In the event of termination of the clinical trial at all Centers of
p.002017: the territory of the Republic of Bulgaria BDA, before taking action under para. 1, informs
p.002017: in writing by the contracting authority and the principal or coordinating researcher.
p.002017: (4) Within 7 days of receipt of the notification, the assignor and / or the principal
p.002017: researchers may express an opinion on the measures taken by the BDA.
p.002017: (5) The provision of para. 3 shall not apply where there is an imminent risk of
p.002017: the health and safety of the test participants.
p.002017: Art. 134. In the cases under Art. 133, para. 1 The BDA shall immediately notify the relevant Commission on
p.002017: ethics, the regulatory authorities of all Member States, the European Medicines Agency and
p.002017: The European Commission on the measures taken and the reasons for this.
p.002017: Section VII.
p.002017: Safety monitoring
p.002017: Art. 135. (1) The principal investigator shall immediately inform the contracting authority orally or
p.002017: in writing for any serious adverse event occurring during the clinical trial at
p.002017: participant in the center for which he is responsible.
p.002017: (2) Following the notification under para. 1 shall submit a detailed written report.
p.002017: (3) Upon notification under para. 1 and in the report under para. 2 the test participant shall
p.002017: identifies with a unique code number specified in the test report.
p.002017: (4) The provisions of para. 1 and 2 shall not apply if in the clinical trial protocol
p.002017: or the researcher's brochure explicitly states that it does not require an emergency message for
p.002017: a specific serious adverse event.
p.002017: (5) The investigator shall report to the sponsor all adverse events or
p.002017: laboratory abnormalities identified in the protocol as critical to
p.002017: safety, in time and format in accordance with protocol requirements.
p.002017: Art. 136. When the outcome of a clinical adverse event
...

p.002017: the benefit / risk ratio for the medicinal product.
p.002017: (2) The marketing authorization holder shall notify the BDA of any new one
p.002017: information that could affect the benefit / risk balance of the medicinal product.
p.002017: (3) The obligation under para. 2 shall not exempt the holder of the marketing authorization from
p.002017: the requirement of Art. 194h for providing the information under para. 2 and through the periodic ones
p.002017: updated safety reports.
p.002017: Art. 145c. (New, SG No. 102/2012, effective 21.12.2012) (1) When the study is conducted only on
p.002017: the territory of the Republic of Bulgaria in fulfillment of an obligation under Art. 56a, the holder of the authorization for
p.002017: use drafts of the study protocol in the BDA. The draft minutes, together with
p.002017: written consent under Art. 145a, para. 2, it does
p.002017: submit to the committees under art. 103, para. 1 or 2, where applicable.
p.002017: (2) The Executive Director of the BDA within 60 days from the date of receipt of the BDA
p.002017: the documentation under para. 1 shall send the marketing authorization holder a notification of
p.002017: approve the study or make a reasoned refusal.
p.002017: (3) The Executive Director of the BDA shall refuse to conduct the study with one or
p.002017: more than the reasons under Art. 145f, para. 2, Vol. 2.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 60 days of
p.002017: the date of receipt of the documentation under para. 1 shall send the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The study may be initiated after obtaining the approval of
p.002017: BDA and positive opinion from the commission under art. 103, para. 1, respectively by the commissions under art.
p.002017: 103, para. 2.
p.002017: (6) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in
p.002017: the tariff under Art. 21, para. 2.
p.002017: Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: use apply significant changes to the protocol in the cases under art. 145c, para. 1 after their preliminary
p.002017: approval by the BDA and the Commission under Art. 103, para. 1,
p.002017: respectively the commissions under art. 103, para. 2.
p.002017: (2) The holder of the marketing authorization shall submit to the BDA and to the commission under Art.
p.002017: 103, para. 1, respectively in the commissions under art. 103, para. 2, documentation related to the changes, and
p.002017: the reasons for this.
p.002017: (3) The Executive Director of the BDA within 30 days of receipt of the documentation
p.002017: under para. 2 approves the amended protocol or issues a reasoned refusal and notifies the holder of
p.002017: the marketing authorization.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 30 days of
p.002017: the date of receipt of the documentation under para. 2 sends to the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The BDA Executive Director shall refuse the changes under para. 1 with one or more of
p.002017: the reasons referred to in Art. 145f, para. 2, Vol. 2.
p.002017: (6) The holder of the marketing authorization may apply the changes under para. 1 next
p.002017: obtaining approval from the BDA and a positive opinion from the committee under Art. 103, para. 1,
p.002017: respectively the commissions under art. 103, para. 2.
p.002017: (7) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in
p.002017: the tariff under Art. 21, para. 2.
p.002017: Art. 145d. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: use shall submit a final report of the BDA study within 12 months of completion of the collection
p.002017: data. A summary of the results is attached to the report
p.002017: from the study.
p.002017: (2) The marketing authorization holder may submit a reasoned request to
p.002017: BDA for postponement of the term under para. 1 at least three months before the submission date of
p.002017: the final report referred to in the minutes.
p.002017: (3) The Drug Enforcement Agency shall approve or make a reasoned refusal
p.002017: the request under para. 2 and notify the holder of the marketing authorization.
p.002017: (4) When the holder of the marketing authorization based on the report under para. 1
p.002017: considered that a change to the marketing authorization was necessary, he submitted to the BDA an application for
p.002017: change in the order of Chapter Three, Section VI.
p.002017: (5) The BDA Executive Director shall by order suspend or terminate the marketing authorization,
p.002017: when the BDA based on the report under para. 1 and after consultation with the marketing authorization holder
p.002017: consider stopping or stopping
p.002017: of the Marketing Authorization.
p.002017: Art. 145f. (New, SG No. 102/2012, effective 21.12.2012) (1) When the study is conducted as on
p.002017: the territory of the Republic of Bulgaria and of the territory of other Member States for medicinal products,
p.002017: authorized under Regulation (EC) No 726/2004 of the European Parliament and of the Council or in accordance with Chapter
p.002017: third, section VII in fulfillment of the obligations under art. 55a or under Art. 56a, the authorization holder
p.002017: for use filed by
p.002017: the committee under Art. 56a, para. 1, item 1 of the draft protocol.
p.002017: (2) Within 60 days from the date of receipt of the documentation under para. 1 the committee under art.
p.002017: 56a, para. 1, item 1 prepares an opinion and sends to the holder of the marketing authorization:
p.002017: 1. notification of approval, or
p.002017: 2. a reasoned refusal when:
p.002017: (a) found that the study promoted the use of the medicinal product
p.002017: product, and / or
p.002017: (b) consider that the design of the study will not achieve the objectives of the report,
p.002017: and / or
p.002017: (c) the study is of a clinical trial nature.
p.002017: (3) In the cases of para. 2, item 1 the marketing authorization holder shall submit
p.002017: the notification of the BDA and the commissions under Art. 103, para. 1 or 2, where applicable.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 15 days of
p.002017: the date of receipt of the notification under para. 3 shall send the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The conduct of the study may commence upon receipt of a positive one
p.002017: opinion of the commission under art. 103, para. 1, respectively by a commission under Art. 103, para. 2.
p.002017: (6) The content and format of the protocol under para. 1 shall be determined by Regulation
p.002017: Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of the
p.002017: the pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Union
p.002017: Parliament and of the Council and in Directive 2001/83 / EC of the European Parliament and of the Council (OJ, L 159/5 of
p.002017: 20 June 2012), hereinafter referred to as "the
p.002017: Implementation (EU) No 520/2012 ".
p.002017: Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the authorization for use in the cases under Art. 145f, para. 1 implements planned significant changes to
p.002017: the minutes of the study after their prior approval by the committee under Art. 56a, para. 1, v. 1.
p.002017: (2) The holder of the marketing authorization shall submit to the committee referred to in Art. 56a, para. 1, vol.
p.002017: 1 the documentation related to the changes and the reasons for this.
p.002017: (3) Where the committee under Art. 56a, para. 1, item 1 approved the changes to the protocol, the holder
p.002017: of the marketing authorization shall notify the BDA and the Commission under Art. 103, para. 1, respectively commissions
p.002017: under Art. 103, para. 2.
p.002017: (4) The holder of the marketing authorization may apply the changes under para. 1 next
p.002017: receiving a positive opinion from the commission under art. 103, para. 1, respectively the commissions under
p.002017: Art. 103, para. 2.
p.002017: Art. 145h. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: submit electronically to the committee under Art. 56a, para. 1, item 1 final report, accompanied by
p.002017: summarizing the results of the study within 12 months
p.002017: upon completion of data collection.
p.002017: (2) The marketing authorization holder may submit a reasoned request to
p.002017: the committee under Art. 56a, para. 1, item 1 for postponement of the term under para. 1 at least three months before the date of
p.002017: submission of the final report referred to in the minutes.
p.002017: (3) The Committee under Art. 56a, para. 1, item 1 approves or makes a reasoned refusal of the request under
p.002017: para. 2 and notify the holder of the marketing authorization.
p.002017: (4) The content and format of the report under para. 1 shall be determined by the Implementing Regulation
p.002017: (EU) No 520/2012.
p.002017: Art. 145i. (New, SG No. 102/2012, effective 21.12.2012) (1) The Committee under Art. 56a, para. 1, item 1 on the basis
p.002017: of the report under Art. 145h, para. 1 and after consulting the marketing authorization holder issues
p.002017: a reasoned recommendation for a marketing authorization
p.002017: the medicinal product and sends it to:
p.002017: 1. The Committee for Medicinal Products for Human Use under Art. 5 of Regulation (EC)
p.002017: No 726/2004 of the European Parliament and of the Council, or
p.002017: 2. the coordination group of art. 77, para. 2.
p.002017: (2) In the cases of para. 1, item 2, when the committee under art. 56a, para. 1, item 1 recommended a change,
p.002017: suspension or termination of the marketing authorization, coordination group represented
p.002017: from the Member States in which the study was conducted, issue an opinion on the necessary actions which
p.002017: should be taken with regard to authorization
p.002017: for use, including a timetable for its implementation.
p.002017: (3) When the Member States represented in the coordination group agree on
p.002017: the opinion under para. 2, it shall be published on the European Internet portal for medicinal products under Art. 68,
p.002017: para. 1, item 4 and shall be sent to the holder of the authorization for
p.002017: use.
p.002017: (4) The BDA Executive Director in accordance with the opinion under para. 2 stops
p.002017: the operation or termination of the marketing authorization.
p.002017: (5) Where in the opinion under para. 2 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization within the specified implementation schedule submits to the BDA an application for a change to
p.002017: the order of Chapter Three, Section VI, including
p.002017: updated summary of product characteristics and package leaflet.
p.002017: (6) Where agreement cannot be reached within the coordination group,
p.002017: the position of the majority of the Member States is submitted to the European Commission, which
p.002017: adopts the decision to change, suspend or terminate the marketing authorization issued by
p.002017: the relevant regulatory authorities of the Member States.
p.002017: (7) The decision under para. 6 is published on the European Medicines Portal
p.002017: products of art. 68, para. 1, item 4 and shall be sent to the holder of the marketing authorization.
p.002017: (8) The Medicines Executive Agency shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 6 and inform the European Medicines Agency and the European Medicines Agency
p.002017: commission.
p.002017: (9) In the cases of para. 1, item 1 The Committee for Medicinal Products for Human Use, in accordance with the recommendation
p.002017: of the Committee under Art. 56a, para. 1, item 1 issues an opinion on the retention, amendment, suspension or
p.002017: termination of the marketing authorization, including a timetable for the implementation of the opinion.
p.002017: The opinion shall be published on the European Internet Portal for Medicinal Products under Art. 68, para. 1, Vol. 4
p.002017: and sent to
p.002017: the holder of the marketing authorization.
p.002017: (10) Where in the opinion under para. 9 is a position for regulatory action
p.002017: action on marketing authorizations, the European Commission decides on
p.002017: modification, suspension or termination of marketing authorizations granted under the Regulation
p.002017: (EC) No 726/2004 of the European Parliament and of the Council.
p.002017: Art. 145k. (New, SG No. 102/2012, effective 21.12.2012) (1) Non-interventional
p.002017: surveys on the territory of the Republic of Bulgaria shall be conducted in accordance with Art. 145c - 145d.
p.002017: (2) When conducting non-interventional studies under para. 1 indicates the source
p.002017: of financing.
p.002017: Chapter Five.
p.002017: MANUFACTURE AND IMPORTATION OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES
p.002017: (TITLE AM. - SG, iss. 102 OF 2012, IN EFFECT OF 02/01/2013)
p.002017: Section I.
p.002017: Production
p.002017: Art. 146. (1) (amend. - SG 102/2012, in force from 02.01.2013) The production of all types
p.002017: medicinal products within the meaning of this Act and of medicinal products intended for clinical use
p.002017: testing, may be carried out on the territory of the Republic of Bulgaria only by natural or legal persons,
p.002017: registered as traders in the territory of a Member State who have been granted a manufacturing authorization,
p.002017: issued by the Director of
p.002017: Drug Enforcement Agency.
p.002017: (2) A production permit shall also be required in the cases where the products under para. 1 are
p.002017: intended for export only.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008)
p.002017: requires also for persons performing simultaneously or individually one of the following activities:
p.002017: full or partial production, various processes of packaging, packaging, repackaging, labeling, quality
p.002017: control and release of batches of medicinal products and
...

p.002017: on medicinal products performs the following activities for medicinal products placed on the market in
p.002017: Republic of Bulgaria:
p.002017: 1. monitoring the outcome of the risk reduction measures for a medicinal product,
p.002017: contained in the risk management plan;
p.002017: 2. monitoring of the result of the fulfillment of conditions specified in Art. 55a, 56 or 56a;
p.002017: 3. evaluation of the update of the risk management system;
p.002017: 4. monitoring of the EudraVigilance database set up in accordance with Article 24
p.002017: of Regulation (EC) No 726/2004 of the European Parliament and of the Council on new risks or on
p.002017: change in already established and change in benefit / risk ratio.
p.002017: Art. 187. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: The European Medicines Agency and the Marketing Authorization Holder have been informed by the European Medicines Agency
p.002017: identifying signals for new risks or for changing identified risks, or when changing
p.002017: the benefit / risk ratio of the medicinal product.
p.002017: (2) The Committee under Art. 56a, para. 1, item 1 analyzes and prioritizes validated alerts for new risks or changes in
p.002017: already established for changing the benefit / risk ratio.
p.002017: (3) Where the Committee under Art. 56a, para. 1, item 1 recommends follow-up,
p.002017: the coordination group of art. 77, para. 2 or the Committee for Medicinal Products for
p.002017: drafts an opinion on regulatory actions regarding the authorization of
p.002017: use within a schedule drawn up in accordance with the severity and degree of danger.
p.002017: (4) The Medicines Executive Agency implements the recommendations in the opinion of
p.002017: the coordination group of art. 77, para. 2 or in the decision of the European Commission provisional
p.002017: and / or final measures.
p.002017: Art. 188. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: The European Medicines Agency, the regulatory authorities of the other Member States, shall be informed by the European Medicines Agency
p.002017: The European Commission at least 24 hours prior to the public disclosure of information regarding concerns
p.002017: with the monitoring of the safety of a medicinal product, unless the protection of
p.002017: public health requires
p.002017: immediate disclosure of information.
p.002017: (2) The Medicines Executive Agency shall publish information relating to the active substances contained in
p.002017: medicinal products authorized in other countries
p.002017: Member States, using a harmonized draft communication and timetable for publication,
p.002017: proposed by the European Medicines Agency.
p.002017: (3) In the cases of para. 1 and 2 information containing personal data or representing
p.002017: trade secrets shall be deleted unless such disclosure is necessary for safeguarding
p.002017: of public health.
p.002017: Art. 189. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the medicines agency may delegate some of the rights and obligations under this chapter to
p.002017: regulatory authority of another Member State by concluding an agreement.
p.002017: (2) In the cases of para. 1 The BDA informs the European Commission, the European Medicines and Regulatory Agency
p.002017: authorities of the other Member States for the delegation of powers and publish a communication to the
p.002017: Internet portal under Art. 185, para. 1 or on the Internet
p.002017: your page.
...

p.002017: (2) Within 30 days of receipt of the report under para. 1 holder of the authorization for
p.002017: Member States' regulatory authorities or authorities may submit their comments
p.002017: to the European Medicines Agency and to the BDA.
p.002017: (3) Within 15 days from the date of receipt of the comments under para. 2 BDA updates
p.002017: the evaluation report, taking into account all the objections presented, and forwarding it to the committee
p.002017: under Art. 56a, para. 1, item 1 for approval and recommendation.
p.002017: (4) The European Medicines Agency has included the evaluation report adopted and
p.002017: the recommendation of the Committee under Art. 56a, para. 1, item 1 in the register under Art. 194h, para. 3 and sends it to
p.002017: the holder of the marketing authorization.
p.002017: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) Where the Republic of Bulgaria is not
p.002017: rapporteur in the procedure under Art. 194o, para. 2, the BDA may submit comments within the term under Art. 194p, para. 2 to
p.002017: The European Medicines Agency and the regulatory authority of the European Medicines Agency
p.002017: the Member State that produced the assessment report.
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and when none of the authorizations for
p.002017: the use of these products has not been issued under Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: the coordination group of art. 77, para. 2 within 30 days from the date of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the preservation, modification, suspension or termination of
p.002017: relevant marketing authorizations, including a timetable for the implementation of the opinion.
p.002017: (2) Where the represented Member States in the coordination group under Art. 77, para. 2
p.002017: they agree on the actions to be taken, the BDA implements
p.002017: the decision taken.
p.002017: (3) Where the opinion under para. 1 is to suspend or terminate the authorization for
p.002017: The BDA Executive Director issues an order.
p.002017: (4) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (5) When agreement cannot be reached within the coordination group under Art. 77, para. 2, the position of
p.002017: the majority of the Member States are referred to the European Commission, which decides on the change,
p.002017: suspension or termination of permissions for
p.002017: use issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 5.
p.002017: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and where at least one of the authorizations for
p.002017: the use has been issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: medicinal products for human use within 30 days of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the retention, amendment, suspension or termination of validity
p.002017: of the relevant marketing authorizations, including a timetable for the implementation of
p.002017: the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. Decides to change, suspend or terminate the marketing authorizations,
p.002017: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 2. adopt a decision recommending change, suspension or termination of authorizations
p.002017: for use issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 2, Vol. 2.
p.002017: Section IV.
p.002017: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002017: 12/21/2012)
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure of
p.002017: the European Union level can be initiated by the European Commission, by the European Commission
p.002017: drug agency or from a Member State.
p.002017: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under
p.002017: the procedure for this section by notifying the regulatory authorities of the other Member States, the European Agency for Europe
p.002017: medicines and the European Commission, when for drug-related reasons
p.002017: safety, consider that a medicinal product placed on the Bulgarian market requires undertaking
p.002017: to any of the
p.002017: the following measures:
p.002017: 1. suspension or termination of the marketing authorization;
...

p.002017: 4 and contains one or more of the following conclusions:
p.002017: 1. no further investigation or action is required on
p.002017: Community level;
p.002017: 2. the holder of the marketing authorization must carry out additional work
p.002017: study and analysis of data;
p.002017: 3. the marketing authorization holder must carry out post-marketing
p.002017: a safety study with a subsequent evaluation of its results;
p.002017: 4. the Member State or the holder of the marketing authorization to apply measures to
p.002017: risk reduction;
p.002017: 5. the marketing authorization must be suspended, suspended or issued
p.002017: refusal to renew it;
p.002017: 6. the marketing authorization must be modified.
p.002017: (4) The specific measures under para. 3, item 4, as well as the conditions and restrictions that should
p.002017: be included in the marketing authorization, the recommendation states.
p.002017: (5) In the cases of para. 3, item 6, when the changes are related to the amendment or addition of information in the brief
p.002017: a specification, on the packaging or package leaflet of the medicinal product, shall be included in the recommendation
p.002017: the wording of the amended or added
p.002017: information and the place where it should be displayed.
p.002017: Art. 194h. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: no medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the coordination group under Art. 77, para. 2 on the basis of the recommendation under Art. 194s within 30 days
p.002017: from the date of its receipt, issue an opinion on the retention, modification, suspension, termination
p.002017: of the relevant authorizations or refusals to renew them, including a timetable for
p.002017: implementation of the opinion.
p.002017: (2) Where the opinion recommends that the measures under Art. 194ts, para. 3, Vol. 5,
p.002017: the Executive Director of the BDA shall, by order, suspend or revoke the authorization for
p.002017: use, or refuses to renew it.
p.002017: (3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (4) Where in the opinion under para. 1 it is recommended to take measures under art. 194ts, para.
p.002017: 3, items 2 - 4, the holder of the marketing authorization takes the necessary actions and
p.002017: inform the BDA and the regulatory authorities of the other Member States.
p.002017: (5) Where, within the coordination group under Art. 77, para. 2 could not be reached,
p.002017: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002017: decision with recommendation for change, suspension or termination
p.002017: of the marketing authorization issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5
p.002017: interim and / or definitive measures.
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the Committee for Medicinal Products for Human Use, based on the recommendation under Art. 194ts, para.
p.002017: 3, within 30 days from the date of its receipt, issue an opinion on the retention, change,
p.002017: suspension, termination of the relevant marketing authorizations or refusal of
p.002017: their renewal, including a timetable for the implementation of the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. adopt a decision to change, suspend or terminate the validity of the permits
p.002017: for use, issued under Regulation (EC) No 726/2004 of the European Parliament and of the
p.002017: The Council;
p.002017: 2. adopt a decision recommending the change, suspension or termination of validity of
p.002017: marketing authorizations issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Drug Enforcement Agency shall implement the recommendations recommended in the decision of the European Medicines Agency
p.002017: The European Commission under para. 2, item 2 provisional and / or final measures.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) The recommendation under Art. 194c,
p.002017: para. 1, the opinion under art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and
p.002017: Art. 194h, para. 2 shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: Chapter Nine.
p.002017: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN
p.002017: THE MEDICINAL PRODUCTS AREA (HEADING, amended, SG No. 71/2008,
p.002017: POWER FROM 12.08.2008, ISM. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002017: (Title "Section I. Wholesale trade of medicinal products" - SG, issue 71 of 2008, in
p.002017: with effect from 12.08.2008)
p.002017: Art. 195. (1) Wholesale trade in medicinal products may be carried out physically and
p.002017: legal persons authorized to do so by a regulatory body of
p.002017: the Member State concerned.
p.002017: (2) When the person under para. 1 has warehouses on the territory of the Republic
p.002017: Bulgaria, it may carry out wholesale of medicinal products after receiving
p.002017: permission from the BDA Executive Director.
p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
p.002017: Art. 197. The persons under art. 195 must have:
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
...

p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible ma