0A4F4F9BD490A749D5437F821CF06DF1

Medicinal Products in Human Medicine Act, Chapter 4, Articles 91 and 92 (2016)

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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 Activitycrime2
PoliticalIllegal Activityillegal4
Politicalcriminalcriminal1
Politicalpolitical affiliationparty12
Politicalvulnerablevulnerable3
HealthDrug Usagedrug77
HealthDrug Usageinfluence4
HealthDrug Usagesubstance77
HealthDrug Usageusage12
HealthMentally Disableddisability4
HealthMentally Incapacitatedincapable6
HealthPhysically Disabledillness2
HealthPregnantpregnant1
HealthUnconscious Peopleunconscious1
Healthbreastfeedingbreastfeeding1
Healthillill1
SocialAccess to Social Goodsaccess6
SocialAgeage3
SocialChildchild1
SocialChildchildren2
SocialIncarceratedrestricted1
SocialInfantinfant5
SocialLinguistic Proficiencylanguage9
SocialMarital Statussingle19
SocialMothersmothers1
SocialProperty Ownershipproperty33
SocialSoldierarmed forces1
SocialSoldierarmy1
SocialSoldiermilitary1
SocialThreat of Stigmathreat7
SocialThreat of Violenceviolence1
SocialTrade Union Membershipunion27
SocialUnemploymentunemployed1
SocialVictim of Abuseabuse1
SocialWomenwomen1
SocialYouth/Minorsminor16
Socialeducationeducation6
Socialeducationeducational2
Socialemployeesemployees3
Socialgendergender1
Socialorphanorphan1
Socialparentsparent1
Socialparentsparents5
Socialphilosophical differences/differences of opinionopinion71
General/OtherIncapacitatedincapacity2
General/OtherPublic Emergencyemergency2
General/OtherRelationship to Authorityauthority66
General/Otherparticipants in a control groupplacebo1

Political / Illegal Activity

Searching for indicator crime:

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p.(None):
p.(None):
p.(None): Art. 280. (1) In case that infringement of the provisions of chapter eleventh, respectively of the regulation according
p.(None): to Art. 249 are established, executive director of the BDA shall order termination of the proliferation of advertising.
p.(None): (2) By the order according to para 1 the executive director of the BDA can oblige the advertiser to publish or
p.(None): proliferate in a manner coordinated with the BDA a disclaimer of the statements in the advertising through the same
p.(None): media and in the same format and volume.
p.(None): (3) The order according to para 2 shall be subject to appeal under the terms of the Administrative Procedure Code.
p.(None):
p.(None): Chapter fourteen.
p.(None): ADMINISTRATIVE PENAL PROVISIONS
p.(None):
p.(None): Art. 281. (1) 9amend. – SG, 102/2012, in force from 02.01.2013) Whoever manufactures, imports, sells, stores, or
p.(None): provides for use in Republic of Bulgaria medicinal products, which have no marketing authorisation, except for the
p.(None): cases according to Art. 8, 9, and 10, if he/she is not a subject to heavier punishment, shall be penalised with a fine
p.(None): from BGN 25,000 to BGN 50,000, if not subject to more severe penalty.
p.(None): (2) The same penalty shall also be imposed on the persons who manufacture, import, sell, or permit the use in Republic
p.(None): of Bulgaria of medicinal products, which do not comply with the requirements of the acting pharmacopoeia and the
p.(None): conditions of their marketing authorisation.
p.(None): (3) Where the infringements according to para 1 and 2 are associated with unauthorised medicinal products containing
p.(None): narcotic substances or in case repeated perpetration the authorisation issued under the terms of this Act shall
p.(None): be bereaved provided that the deed shall not constitute a crime.
p.(None): (4) Medical specialists who manufacture, sell, or provide for use unauthorised medicinal products shall be deprived of
p.(None): the right to exercise the profession for a term of 6 months to two
p.(None):
p.(None): years.
p.(None): (5) The penalty according to para 4 shall be imposed by and order of the Minister of
p.(None): Health according to a proposal by the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 282. (1) Whoever sells medicinal products in packaging or with patient information leaflets, which do not comply
p.(None): with the requirements of this Act, shall be penalised with a fine from BGN 750 to BGN 1,500 and in case of a repeated
p.(None): perpetration of the same infringement - with a fine from BGN 1,500 o BGN 3,000.
p.(None): (2) Whoever sells medicinal products without patient information leaflets shall be penalised with a fine from
p.(None): BGN 750 to BGN 1,500 and in case of a repeated perpetration of the same infringement - with a fine from BGN 1,500 to
p.(None): BGN 3,000.
p.(None):
p.(None):
p.(None): Art. 283. (1) Whoever imports, trades with, or provides for same medicinal products with expired validity term shall be
p.(None): penalised with a fine from BGN 10 000 to BGN 20 000.
p.(None): (2) Whoever breaks the primary/secondary packaging or sells/provides medicinal products with broken
p.(None): primary/secondary packaging shall be penalised with a fine from BGN 750 to BGN 1500 and in case of a repeated
p.(None): infringement with a fine from BGN 1,500 to BGN 3,000.
p.(None):
p.(None):
p.(None): Art. 284. (1) Whoever manufactures, imports, or conducts wholesale with medicinal products, or sells without
p.(None): respective authorisation or in infringement of an issued authorisation shall be penalised with a fine from BGN 50,000.
...

p.(None): fine from BGN 10,000 to BGN 20,000.
p.(None): (2) (Amend. – SG, 60/2011, in force from 5. 8. 2011) A wholesaler who supplies drugstores with medicinal
p.(None): products upon doctor's prescription, outside the lists approved by the Minister of Health shall be penalised with a
p.(None): property sanction from BGN 2500 to 5000 and in case of repeated infringement with a fine from BGN 5,000 to BGN 10,000.
p.(None): (3) A qualified person who has permitted sale of batches of medicinal products without certificate of batch release of
p.(None): any separate batch shall be penalised with a fine from BGN 2,500 to BGN 5,000.
p.(None):
p.(None):
p.(None): Art. 285a. (New – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012) Holder of an authorisation for use, who
p.(None): fails to notify the Minister of health for termination of the sales under Art. 264 shall be punished by a property
p.(None): sanction of BGN 25 000 to 50 000.
p.(None):
p.(None):
p.(None): Art. 285b. (new – SG, 102/2012, in force from 21.12.2012) Anyone, who manufactures, imports, exports, sells or keeps
p.(None): active substances in violation of this act, shall be punished by a fine BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 285c. (new – SG 18/14) A holder of a permit for wholesale of medicinal products failing to notify BDA of carrying
p.(None): out export of medicinal products under Art. 217a, par. 4 shall be punished with a fine, respectively with a proprietary
p.(None): sanction from BGN50 000 to BGN100 000, and in case of repeated the same violation – from BGN100 000 to BGN200 000.
p.(None):
p.(None):
p.(None): Art. 286. (1) In case of clinical trials conducted in infringement of this Act, provided no crime has been committed,
p.(None): the guilty persons shall be penalised with a fine from BGN 5,000 to BGN 10000 and in case of repeated permission or
p.(None): commitment of the same infringement – with a fine from BGN 10000 to BGN 20000.
p.(None): (2) Medial specialists who have permitted or committed infringements according to para 1 can be imposed the penalty of
p.(None): "deprived of the right to exercise the profession" for a term from 6 months to two years.
p.(None): (3) The measure according to para 2 shall be imposed by the Minister of Health according to a proposal by
p.(None): the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 287. (1) (Supl.. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Whoever conducts retail trade in medicinal products without having respective authorisation/certificate, or
p.(None): works in violation of his/her issued authorisation/certificate, shall be penalised by a fine from BGN 5,000 to BGN
p.(None): 10,000.
p.(None): (2) The penalty according to para 1 shall also be imposed on persons who conduct retail trade in pharmacy or drugstore
p.(None): after the authorisation/certificate has ceased to be in effect.
p.(None): (3) (Supl. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from
p.(None):
p.(None): 5. 8. 2011) Whoever sells, or stores in a drug store medicinal products, prescribed by doctor’s prescription, or
p.(None): products or goods of human health significance, outside the ones, determined in the ordinance under Art. 243,
p.(None): shall be punished by the fine under para 1, and in repeated perpetration of the infringement the issued
p.(None): registration of the drug store will be deprived of.
...

Searching for indicator illegal:

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p.(None): 2a. (new – SG, 102/2012, in force from 02.01.2013) be certain that the assisting substances, put in the
p.(None): medicinal products are manufactured in compliance with the appropriate Good manufacturing practices for assisting
p.(None): substances, determined on the basis of an official risk assessment in compliance with the applicable directives,
p.(None): adopted by the European Commission;
p.(None): 3. ensure on a permanent basis qualified personnel for the production and control according to the
p.(None): requirements the regulation according to Art. 152;
p.(None): 4. (amend. – SG 12/11, in force from 08.02.2011) only dispose of medicinal products, which have marketing authorisation
p.(None): fulfilling the requirements of this Act;
p.(None): 5. (revoked – SG 12/11, in force from 08.02.2011);
p.(None): 6. immediately notify the control bodies in case of substitution of the qualified person according to Art. 148, point
p.(None): 2;
p.(None): 7. ensure access of the control bodies to the premises and the documentation at any
p.(None): time;
p.(None): 8. ensures to the qualified person according to Art. 148, point 2 the required condition
p.(None): to fulfill his obligations.
p.(None): 9. (new – SG, 102/2012, in force from 02.01.2013) inform immediately the BDA and the use authorisation holder, if
p.(None): information is received that the medicinal products, which fall in the scope of hi/her manufacture automation, are
p.(None): falsified or there are suspects for falsification, notwithstanding of the fact whether these medicinal products
p.(None): have been disseminated within the
p.(None):
p.(None): frames of the legal supply or an illegal way, including through illegal sale through the services of the information
p.(None): society;
p.(None): 10 (new – SG, 102/2012, in force from 02.01.2013) check if the manufacturers, importers or traders, from whom he/she
p.(None): receives active substances have been register by the competent body of the Member state in which they are established;
p.(None): 11. (new – SG, 102/2012, in force from 02.01.2013) check up the authenticity and quality of the active and assisting
p.(None): substances.
p.(None): (2) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall perform audits in
p.(None): the production sites and trade with active substances for observation of the Good manufacturing practice
p.(None): and the Good distribution practice. The manufacture authorisation holder may sign a contract with a third person
p.(None): to carry out the audit on his/her behalf and on his/her account.
p.(None): (3) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall document the undertaken
p.(None): under Para.. 1, p. 2 and 2a measures.
p.(None): (4) (former Para. 2 – SG, 102/2012, in force from 01.01.2013)The manufacturing authorisation holder shall
p.(None): keep the samples of and the documentation for the manufactured medicinal products, active substances, and
p.(None): medicinal products intended for clinical trials under the conditions and under the terms laid down in the regulation
p.(None): according to Art. 152.
p.(None): (5) (former Para. 3 – SG, 102/2012, in force from 01.01.2013)The In case of a medicinal product intended for clinical
p.(None): trials, the manufacturing authorisation holder shall guarantee that all manufacturing operations shall be carried out
...

p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
p.(None): 3. are intended for treatment of out-patients but their use can cause serious adverse drug reactions, which can require
p.(None): specialist prescribing and monitoring in the course of treatment.
p.(None):
p.(None):
p.(None): Art. 176. (1) The BDA can refuse to approve the dispensing regime of a medicinal product requested by the
p.(None): applicant according to Art. 26, para 1, on the grounds of assessment of:
p.(None): 1. the maximum single dose, maximum daily dose, quantity of the active substance in one dose unit, pharmaceutical
p.(None): form, specific appearance of the primary product packaging, and/or
p.(None): 2. other specific conditions of use.
p.(None): (2) The BDA can refuse to indicate the exact category of a medicinal product according to Art. 172 but pursuant to the
...

p.(None): confirmed prices, limit prices or registered prices during sale of medicinal products;
p.(None): 7. (former Art. 6 - SG, 102/2012, in force from 21.12.2012) draw up statements of administrative
p.(None): infringements.
p.(None): (2) (repealed - SG, 102/2012, in force from 21.12.2012).
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011) The Executive Director of BDA of the corresponding director of
p.(None): RHI, depending of the administrative person, who determined the violence, has right to:
p.(None): 1. order in written form to the violator to cease the violation according to Para. 1, point
p.(None): 1;
p.(None): 2. requires from the violator to declare that it will cease the violation according to Para.
p.(None): 1, point 1 and when it is necessary to makes the declaration matter publicly available.
p.(None): 3. to order cease or prohibition of each violation according to Para. 1, point 1 and when it is necessary to order for
p.(None): cease or prohibition of violation matter publicly available.
p.(None): (4) (new - SG, 102/2012, in force from 21.12.2012). The Council chairperson under Art. 258, Para. 1 shall have the
p.(None): right to order in writing to the violator to stop the violation, found during the inspection under Para. 1, p. 6.
p.(None):
p.(None):
p.(None): Art. 271. (1) (amend., - SG 98/10, in force from 01.01.2011) The regional health inspectorates shall be
p.(None): entitled to:
p.(None): 1. stop construction and issue directions where violations of hygienic norms and requirements have been
p.(None): established in the course of construction; notify the Directorate for
p.(None):
p.(None): National Construction Control or the municipal technical office in case of illegal construction of sites and
p.(None): equipment for manufacture, storage, and sale of medicinal products shall be established;
p.(None): 2. prohibit the commissioning and stop the operation of sites and equipment in case of violation of the hygienic norms
p.(None): for the manufacture, storage, and sale of medicinal products – until the elimination of the violations;
p.(None): 3. block medicinal products in case of available documented information of discrepancies with the
p.(None): quality requirements; medicinal products imported or manufactured in infringement of this Act; as well as medicinal
p.(None): products, which are offered in packaging non- complying with the requirements of this Act; order the recall of such
p.(None): medicinal products from pharmacies and drugstores, wholesale warehouse, manufacturers, and
p.(None): healthcare establishments in case of necessity and notify for that the Ministry of Health;
p.(None): 4. give conclusions of the compliance of the controlled sites with the legal determined requirements;
p.(None): 5. issue orders, directions, and instructions in the field of their competency, which shall be obligatory for all
p.(None): persons on the territory of the respective district.
p.(None): (2) ()amend., - SG 98/10, in force from 01.01.2011 The compulsory administrative measures according to para
p.(None): 1 or pursuant to art.270, para 3 shall be imposed by an order of the director of RHI,
p.(None): (3) The orders according to para 2 shall be subject to appeal under the terms of the Administrative Proceeding Code
p.(None): whereas the appeal shall not stop their execution.
p.(None):
p.(None):
p.(None): Art. 272. (1) The BDA shall:
p.(None): 1. (suppl. – SG, 102/2012, in force from 02.01.2013) prohibit the commissioning and stop the operation of sites and
...

Political / criminal

Searching for indicator criminal:

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p.(None): 2. The Council of Ministers shall adopt the Ordinance under Art. 258, Para. 5 and shall amend the tariff under Art. 21,
p.(None): Para. 2 and the Rules of procedure of the Ministry of Health in compliance with this Act.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 84. This Act shall come into force from the day of its publication in the State Gazette, with the exception of § 65,
p.(None): which shall come into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.(None):
p.(None): (PROM. - SG 38/12, IN FORCE FROM 01.07.2012)
p.(None):
p.(None): § 84. (In force from 18.05.2012) Within one month after the promulgation of this Act in the State Gazette:
p.(None): 1. The Council of Ministers shall adjust the Classified of positions in administration to the provision of this Act;
p.(None): 2. the competent bodies shall adjust the structural acts of the respective administration to the provisions of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 85. (1) The legal relationships with the persons from administrations under the Radio and Television Act, Independent
p.(None): Financial Audit Act, Electronic Communications Act, Financial Supervision Commission Act, Act on Access to and
p.(None): Disclosure of the Documents and Announcing Affiliation of Bulgarian Citizens with the State Security Service and
p.(None): the Intelligence Services of the Bulgarian Popular Army, Act on Seizure in Favour of the State of
p.(None): Property, Acquired through Criminal Activity Act on Prevention and Findings of Conflict of Interests, Code of Social
p.(None): Insurance, Health Insurance Act, Agricultural Producers Assistance Act, Roads Act shall be regulated subject to
p.(None): compliance with the provisions and following the procedure of § 36 of the Transitional and Conclusive Provisions of the
p.(None): Act amending and supplementing the Civil Servants Act (SG 24/06).
p.(None): (2) By the act of appointment of a civil servant:
p.(None): 1. the minimum rank for the occupied position shall be conferred, as determined in the Classified of positions in the
p.(None): administration, unless the servant hold a higher rank;
p.(None): 2. individual monthly salary shall be fixed.
p.(None): (3) Additionally required funds for insurance contributions of the persons under par. 2 shall be provided within the
p.(None): cost of salaries, remunerations and insurance contributions within the budgets of the respective administrators of
p.(None): budget credits.
p.(None): (4) Council of Ministers must make necessary adjustments in the out-of-budget account of State Fund "Agriculture",
p.(None): arising out of this Act.
p.(None): (5) Managing bodies of National Social Insurance Institute and of National Health Insurance Fund must make
p.(None): necessary adjustments in the respective budgets, arising out of this
p.(None):
p.(None): Act.
p.(None): (6) The non-used leaves regulated in the employment agreement shall be kept and shall
p.(None): not be compensated with a financial benefit.
p.(None):
p.(None):
p.(None): § 86. (1) Within one month after entering of this Act into force the individual basic monthly salary of the employee
p.(None): shall be determined in such a way that the salary after the due tax and the obligatory insurance contributions
p.(None): chargeable to the insured person, where they have been payable, shall not be less than the gross monthly salary
...

Political / political affiliation

Searching for indicator party:

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p.(None): advertising of medicinal products;
p.(None): 10. carry out laboratory analysis in case of doubt of deviation in the quality, efficacy, and safety of the medicinal
p.(None): products and shall undertake the measures provided by law;
p.(None): 10a (new – SG, 102/2012, in force from 21.12.2012) carries out the functions of a competent body for
p.(None): vigilance medicinal safety;
p.(None): 11. (amend. - SG, 102/2012, in force from 21.12.2012) organize and maintain a system for vigilance the medicinal
p.(None): safety;
p.(None): 12. issue certificates according to the certification system of the World Health Organisation;
p.(None): 12a. (new – SG 18/14) issue certificates of Good Distribution Practice;
p.(None): 13. Issue Good Manufacturing Practice certificates;
p.(None): 14. (amend. – SG 18/14) consult investment projects for the construction of new and/or refurbishing of existing sites
p.(None): relating to the manufacture of medicinal products in accordance with the rules of Good Manufacturing Practice;
p.(None): 15. execute the functions of national coordinator and consulting body on the issues relating to the
p.(None): quality, efficacy, and safety of medicinal products;
p.(None): 16. carry out consulting, scientific, information, and publishing activity in the domain of the medicinal sector;
p.(None): 17. coordinate and participate in activities relating to the European Pharmacopoeia and the development of the
p.(None): Bulgarian Pharmacopoeia;
p.(None): 18. take part in activities in the field of the medicinal products relating to the work of the European Medicines
p.(None): Agency, the European Directorate of the Quality of the Medicinal Products and Healthcare, of international bodies and
p.(None): organisations, as well as relating to the fulfillment of international treaties in which Bulgaria is a party to;
p.(None): 18a (new – SG, 102/2012, in force from 21.12.2012) participate in the international harmonisation and
p.(None): standardisation of the technical measures, referring to vigilance the medicinal safety under the coordination of the
p.(None): European Medicines Agency;
p.(None): 18b (new – SG, 102/2012, in force from 21.12.2012) establish and maintain a national internet portal for medicinal
p.(None): products;
p.(None): 19. carry out other activities provided by a law.
p.(None): (6) (amend., - SG 98/10, in force from 01.01.2011) The Bulgarian Drug Agency coordinates its activity with
p.(None): the Regional health inspectorates (RHI) in the field of the control on the medicinal products.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The implementation of this act measures, related to
p.(None): prevention of entering and dissemination of falsified medicinal products shall be carried out in cooperation
p.(None): between the Bulgarian Drug Agency and the customs authorities.
p.(None):
p.(None): Art. 17a (New – SG, 60/2011, in force from 05.08. 2011) The Regional health inspectorates shall issue
p.(None): authorisations for registration of drug stores.
p.(None):
p.(None):
p.(None): Art. 17b. (new – SG 18/14) (1) Expert drug retail trade council shall be set up subordinated to the
p.(None): Managing Director of the BDA including three representatives of Bulgarian Pharmaceutical Association, one
p.(None): representative of every Pharmaceutical department of Higher Medicinal Schools and four representatives of the BDA. The
...

p.(None): be:
p.(None): 1. persons with educational qualification master’s degree in pharmacy, chemistry, or biology and at least two-year
p.(None): practical experience in the pharmaceutical manufacture;
p.(None): 2. for the manufacture of radiopharmaceuticals or medicinal products subjected to ionizing radiation –
p.(None): persons who comply with the requirements according to point 1 and have an additionally recognised specialty in
p.(None): radiobiology or radiochemistry.
p.(None): 3. for the manufacture of immunological medicinal products including vaccines, toxins, sera, biotechnological products,
p.(None): and medicinal products obtained from human plasma or human blood – persons with recognised speciality in medical
p.(None): haematology, medical microbiology, virology, or immunology.
p.(None):
p.(None):
p.(None): Art. 150. (1) The person according to Art. 146 shall submit to the BDA a formal application as approved
p.(None): by the director of the Agency.
p.(None): (2) Together with the application according to para 1 the applicant shall also submit:
p.(None): 1. diploma, document for acquired speciality, document for length of service, certificate of clean court record, and
p.(None): employment contract for the persons according to Art. 148, point 2, and Art. 149;
p.(None): 2. copies of contracts of assignment of the manufacture and/or control of the products ordered for manufacture – in the
p.(None): cases according to Art. 151;
p.(None): 3.(amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code
p.(None):
p.(None): of the trader or cooperation from the Trade register, and for the companies, registered in a EU Member State or in a
p.(None): state – party on the Agreement for the EEA – a document for updated registration under the national legislation, issued
p.(None): by a competent body of the relevant state;
p.(None): 4. (amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 02.01.2013)) a list of
p.(None): the production activities and the medicinal forms, which will be manufactured;
p.(None): 5. schemes of the premises for the manufacture, control, and storage and a dossier of the manufacturing capacity;
p.(None): 6. assessment of the environmental impact during the manufacture of the medicinal products for the cases
p.(None): stipulated in the Environmental Protection Act;
p.(None): 7. authorisation by the Nuclear Regulatory Agency where the application concerns manufacture of
p.(None): radiopharmaceuticals or medicinal products subjected to ionised radiation during their manufacture;
p.(None): 8. authorisation for the use of the premises for manufacture, control, and storage issued according to order of the
p.(None): Spatial Development Act or another substituting document;
p.(None): 9. (amend., - SG 98/10, in force from 01.01.2011, repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 10. document for paid fee, in amount determined in the tariff to Art. 21, para 2.
p.(None): (3) For the manufacturing of narcotic substances and pharmaceutical forms containing such substances, the
p.(None): requirements of the Control on Drugs and Precursors Act shall be observed.
p.(None):
p.(None):
p.(None): Art. 151. Where some aspects of the stages of manufacture or control tests within the manufacturing process shall be
p.(None): carried in another site of the territory of Bulgaria or abroad under contract, the persons according to Art. 146 shall
...

p.(None): medicinal products, which he has an issued manufacturing authorisation for.
p.(None): (2) Importer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued import authorisation for.
p.(None):
p.(None):
p.(None): Art. 197. The persons according to Art. 195 shall dispose of:
p.(None): 1. suitable premises, equipment and outfits, and transport vehicles ensuring correct storage, distribution,
p.(None): and transportation of the medicinal products in compliance with the requirements of the Good Distribution
p.(None): Practice;
p.(None): 2. personnel and responsible master-pharmacist with at least two years length of service in his speciality and whose
p.(None): obligations shall be laid down in the regulation according to Art. 198.
p.(None):
p.(None):
p.(None): Art. 198. (amend. – SG, 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.(None): Distribution Practice of medicinal products and of active substances shall be adopted by an ordinance of the Minister
p.(None): of Health and by directives, adopted by the European Commission.
p.(None):
p.(None):
p.(None): Art. 199. (1) The persons according to Art. 195, para 2, shall submit to the BDA:
p.(None): 1. application containing name, place of business and address of management of the trader; address and description of
p.(None): the premises and equipment for the storage of the medicinal products;
p.(None): 2. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification
p.(None):
p.(None): code of the trader of cooperation from the Trade Register and for the companies, registered in a EU Member State or
p.(None): a state – party on the EEA Agreement – a document for updated registration according to the national
p.(None): legislation, issued by a competent body of the relevant state;
p.(None): 3. name, certificate of clean court record, diploma for higher education and length of service for the responsible
p.(None): master - pharmacist according to Art. 197, point 2, and a copy of his/her employment contract;
p.(None): 4. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 5. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 6. document certifying the legal grounds for the use of the premises;
p.(None): 7. (amend., - SG 98/10, in force from 01.01.2011) conclusion of the Regional Health Inspectorates after inspection on
p.(None): the spot evidencing that the health requirements in the whole sale premises according to the regulation according to
p.(None): Art. 198.
p.(None): 8. document for paid fee as laid down in the tariff Art. 21, para 2.
p.(None): (2) The persons according to Art. 195, para 1, shall submit to the BDA an application accompanied by the following
p.(None): documents:
p.(None): 1. copy of the wholesale authorisation issued by a regulatory body of a Member State;
p.(None): 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.(None): 3. address of the premises for the storage of the medicinal products on the territory of the Member State.
p.(None): (3) In case of wholesale of narcotic substances, as well as pharmaceutical forms containing such
p.(None): substances, the requirements of the Control on Drugs and Precursors Act shall also be applied.
p.(None): (4) In case of wholesale of radiopharmaceuticals, an opinion of the Nuclear Regulatory Agency shall also be submitted.
p.(None):
p.(None):
...

p.(None): 3. keep data, including the following information about each deal with medicinal product, realised via intermediation:
p.(None): a) date of the deal;
p.(None): b) name of the medicinal product;
p.(None): c) the realised quantity vial intermediation;
p.(None): d) name and address of the persons, received, and delivered the medicinal product;
p.(None): e) lot number;
p.(None): 4. observe the requirements of the Good distribution practice, adopted by the ordinance under Art. 198;
p.(None): 5. maintain a quality system, determining the responsibilities, processes and management risk
p.(None): measures, related to his/her activity;
p.(None): 6. immediately inform BDA and the marketing authorisation holder, where he/she has
p.(None):
p.(None): found or suspects that the medicinal products – subject of the intermediation, has been falsified;
p.(None): 7. check whether the trader holds wholesale authorisation for trade with medicinal products;
p.(None): 8. check up whether the manufacturer or importer holds an authorisation for manufacture/import;
p.(None): 9. keep the data under p. 3 for the term of at least 5 years and provide them upon request of the control bodies.
p.(None): (2) The requirements to the intermediary activities in the area of the medicinal products shall be determined by the
p.(None): ordinance under Art. 198 and in the European Commission directives.
p.(None):
p.(None): Section .
p.(None): Parallel Import of Medicinal Products
p.(None):
p.(None): Art. 213. Parallel import of medicinal products on the territory of the Republic or Bulgaria can be performed by a
p.(None): natural or legal person registered according to the Commerce Act, the legislation of a Member State, or the
p.(None): legislation of a state party to the Agreement on the European Economic Area after receipt of a parallel import
p.(None): authorisation issued by the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 214. (1) A medicinal product authorised for use in another Member State, can be imported on the territory of the
p.(None): Republic of Bulgaria, provided that it is identical or similar to a medicinal product authorised for use in the
p.(None): Republic of Bulgaria under the terms of this Act.
p.(None): (2) (Amen. - SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011) Within the meaning of
p.(None): Para 1, a medicinal product is identical or similar shall be the one, that has identical qualitative and
p.(None): quantitative composition with respect to the active substance(s), is supplied in the same pharmaceutical form,
p.(None): the same primary packaging, with the same graphic design of the packaging
p.(None):
p.(None):
p.(None): Art. 215. (1) (Amen. And suppl. - SG 71/2008, in force from 12.08.2008) To obtain authorisation to
p.(None): perform parallel import on the territory of the Republic of Bulgaria, the person according to Art. 213, para 1 shall
p.(None): submit to the executive director of BDA an application stating the Member State from which the parallel import of the
p.(None): medicinal product is to be effected from.
p.(None): (2) The following data and documents shall be appended to the application:
p.(None): 1. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product authorised for
p.(None): use in the Republic of Bulgaria;
...

p.(None): transitional food, as well as food supplements, cosmetic and sanitary-hygienic articles.
p.(None):
p.(None):
p.(None): Art. 226. (1) Pharmacies for selling medicinal products to citizens can be opened on the territory of healthcare
p.(None): establishments for outpatient care.
p.(None): (2) Pharmacies for selling medicinal products to citizens cannot be opened on the territory of healthcare
p.(None): establishments to Art. 21, para 2 of the Health Act, therapeutic establishments for hospital care, and
p.(None): healthcare establishments according to Art. 10 of the Medical Establishments Act.
p.(None):
p.(None):
p.(None): Art. 227. (1) (Prev. text of Art. 227 – SG 102/09, in force from 22.12.2009) The requirements relating
p.(None): to the location and to the premises of the pharmacy shall be laid down in the regulation according to Art. 219, para 2.
p.(None): (2) (New – SG 102/09, in force from 22.12.2009, amend. – SG, 60/2011, in force from
p.(None): 5. 8. 2011) The requirements to the structure and the premises of pharmacies as per Art. 228, para. 5 shall be set
p.(None): forth in an ordinance mentioned in para. 1.
p.(None):
p.(None):
p.(None): Art. 228. (Amen. - SG 71/2008, in force from 26.07.2008) (1) (amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Authorisation for retail trade with medicinal product shall be issued by the executive director of BDA, on the grounds
p.(None): of a formal application accompanied with the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 222, Para. 1;
p.(None): 2. labour contract or a contract for managing a pharmacy, signed with a Master of Pharmacy or assistant
p.(None): Pharmacist;
p.(None): 3. copy of the act for establishing the persons under Art. 222, para 4;
p.(None): 4. documents, evidencing that the requirements of Art. 224 have been observed;
p.(None): 5. certificate of court record of the Master of Pharmacy, respectively of the assistant pharmacist indicated as manager
p.(None): of the pharmacy;
p.(None): 6. medical certificate of the Master of Pharmacy or the assistant pharmacist, manager of the pharmacy;
p.(None): 7. (suppl. – SG, 60/2011, in force from 5. 8. 2011; revoked - SG 48/15)
p.(None): 7a. (new - SG, 60/2011, in force from 5. 8. 2011) hygiene conclusion, issued by the relevant RHI;
p.(None): 8. document for paid state fee in the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (2) (New - SG, 60/2011, in force from 5. 8. 2011) While issuing an authorisation for retail trade with medicinal
p.(None): products a check up shall be performed if the produced diploma of the Master Pharmacist /Assistant Pharmacist has been
p.(None): issued by the relevant competent institution.
p.(None): (3) (Former Para. 2, amend. - SG, 60/2011, in force from 5. 8. 2011) The pharmacies of
p.(None):
p.(None): the therapeutic establishments according to Art. 222, para 4 and 6 shall be opened and closed according to the request
p.(None): of the person representing the healthcare establishment;
p.(None): (4) (Former Para. 3, amend. - SG, 60/2011, in force from 5. 8. 2011) For opening a pharmacy, in which medicinal
...

p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
p.(None): Art. 239. (1) (amend. – SG, 60/2011, in force from 5. 8. 2011) Drugstores shall be opened after
p.(None): registration at the relevant RHI.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 238,
p.(None):
p.(None): para 2, shall submit to the RHI a registration application accompanied by the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
p.(None): In the cases, where it is found that the requirements of the Ordinance under Art. 243 have not been observed,
p.(None): within 7 day term after the inspection the RHI shall give instructions and shall determine term for removing them.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011). Within 14 day term from receiving the application and the
p.(None): documents under Para. 2, the director of RHI shall notify in writing the persons for finding irregularities
p.(None): in them and shall determine a term for their removal.
p.(None): (5) (New – SG, 60/2011, in force from 5. 8. 2011). For submitting a registration application for a drug
p.(None): store or for performing a change under Art. 242, the relevant RHI shall collect charges in the amount, determined by
p.(None): the tariff under Art. 21, Para. 2.
p.(None):
...

p.(None): substances in case of doubt in their quality by placing establishment signs in the production sites.
p.(None): (2) The compulsory measures according to Para. 1 shall or pursuant to Art. 270, Para. 3 shall be imposed by an order of
p.(None): the director of the BDA.
p.(None): (3) The orders according to Para. 2 shall be subject to appeal under the terms the Administrative
p.(None): Procedure Code, whereas the appeal shall not stop their execution.
p.(None):
p.(None):
p.(None): Art. 272a (new – SG, 102/2012, in force from 02.01.2013) (1) With delegated acts under Para. 52b, Para. 2 of
p.(None): Directive 2001/83/EC the needed measures shall be established for prevention setting in turnover medicinal
p.(None): products, introduced to the EU but intended for placing on the market of the EU for which there are sufficient grounds
p.(None): for suspect that they are falsified.
p.(None): (2) The BDA shall undertake the needed measures in compliance with the delegated acts under Para. 1 for prevention
p.(None): placing in turnover medicinal products, introduced to EU, but not intended for placing on the EU market, for which
p.(None): there a sufficient suspects that they are falsified.
p.(None): (3) The customs bodies shall notify BDA about introduction on the territory of the Republic of Bulgaria
p.(None): medicinal products under Para. 1 in view to undertaking measures under Para. 2.
p.(None):
p.(None):
p.(None): Art. 273. (1) The conditions and order for taking samples, conduct of teats, and payment thereof shall be laid down in
p.(None): a regulation of the Minister of Health.
p.(None): (2) Repeated tests shall be conducted in case of litigation of the results of conducted laboratory tests. These shall
p.(None): be conducted upon a written request by the interested party made within 7 days of the date of receipt of the results of
p.(None): the initial test.
p.(None): (3) The repeated tests according to para 2 shall be conducted by experts appointed by the executive director of the BDA
p.(None): who have not participated in the initial test and in the presence of a representative on the interested party.
p.(None):
p.(None):
p.(None): Art. 274. (1) The conditions and order for blocking and recall of medicinal products, which have shown
p.(None): discrepancies with the requirements to quality, efficacy, and safety shall be paid down in a regulation of the Minister
p.(None): of Health.
p.(None): (2) The conditions and order for destruction, reprocessing, and otherwise use of medicinal products shall be
p.(None): paid down in a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 275. (1) During exercising control, the BDA shall undertake all necessary measures to ensure correct validation of
p.(None): the processes of manufacture and purification of the medicinal products obtained from human blood or human
p.(None): plasma, consistency of batch quality, and guaranteeing the absence of specific viral contamination in so far as
p.(None): technology allows.
p.(None): (2) Manufacturers shall notify the BDA of the method used for decreasing or elimination of pathogenic viruses, which
p.(None): can be transmitted through medicinal products obtained from
p.(None):
p.(None): human blood or human plasma.
p.(None): (3) The BDA shall test or forward to another official laboratory for control of medicinal products in Republic of
p.(None): Bulgaria or another Member State samples of bulk product and/or medicinal product for a test or in the
p.(None): course of assessment of an application for marketing authorisation according to Art. 46, para 1, point 2, or
p.(None): after issuing a marketing authorisation.
p.(None):
p.(None):
p.(None): Art. 276. The executive director of the BDA shall temporarily stop, bereave, or amend by an order the marketing
p.(None): authorisation of a medicinal product or its registration where it shall be established that:
...

p.(None): active substance shall be regarded as the same active substance except if these are significantly
p.(None): different in respect of safety and/or efficacy.
p.(None): 10. "Principal researcher" shall mean an appointed by the contracting authority medical doctor or doctor in dental
p.(None): medicine who is managing the overall conduct of a clinical test in compliance with an approved protocol and the rules
p.(None): for Good Clinical Practice and is responsible for the work of the researchers.
p.(None): 11. "Defined daily dose" shall be the mean daily maintenance dose of a given medicinal product, which administered to
p.(None): adults according to the main indication of a medicinal product.
p.(None): 12. "Good clinical practice" shall mean the aggregate of internationally recognised ethical and scientific
p.(None): quality requirement, which shall be observed during the planning, conduct, accounting, and reporting of clinical
p.(None): trials.
p.(None): 13. "Good laboratory practice" shall mean a system of rules in respect if the conditions for planning, processes of
p.(None): organizing, conduct, follow up, and documenting of laboratory tests.
p.(None): 14. "Good manufacturing practice" shall mean a system of rules encompassing all aspects of manufacture:
p.(None): personnel, premises, equipment, materials, documentation, and quality control and has the purpose of ensuring safety,
p.(None): efficacy, and compliance with a specification.
p.(None): 15.. (Suppl. - SG 71/2008 in force from 12.08.2008) "Member State" shall mean a State Member of the European Union, or
p.(None): a State, party of the Agreement of the EEA.
p.(None): 16. "Labeling" shall mean information on the immediate or outer packaging of a medicinal product.
p.(None): 17. "Immunological medicinal product" shall mean a medicinal product, which contains vaccines, toxins, sera, or
p.(None): allergens. Agents used to create active immunity or establish a condition of immunity or invoke passive
p.(None): immunity shall be involved in the scope of vaccines, toxins, and sera. Allergens shall mean medicinal products,
p.(None): which are intended to identify or stimulate specific purposeful change in the immunological response to an allergens
p.(None): agent.
p.(None): 18. "Bioequivalence study" shall mean a clinical test aimed at proving that two medicinal
p.(None):
p.(None): products are bioequivalent provided that they are pharmaceutically equivalent or pharmaceutical alternatives and
p.(None): provided that their bioavailability after administration of the same molar dose are similar to a degree, which is a
p.(None): condition for equivalence in respect of efficacy and safety.
p.(None): 19. "Bioavailability study" shall mean a clinical test aimed at showing what is the rate and degree which an active
p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
p.(None): used in an unauthorised indication or with a view of obtaining additional information for an authorised form, or are
...

p.(None): a) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases or chronic diseases taking
p.(None): progressive course, which affect not more than 5 of 10,000 people on the territory of a state or
p.(None): b) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases and severely health damaging
p.(None): chronic disease (diseases with high percentage of disease-related incapacity of work or disability) and are there is
p.(None): evidence appended that the sale of the product does ensure satisfactory return, which can justify the required
p.(None): investment for scientific research and development without having stimuli for the creator of the product, and
p.(None): c) where the is no satisfactory method of diagnostics, prophylaxis, or treatment of a given condition or where there is
p.(None): such method the proposed medicinal product has significantly more advantages and benefits for the people affected by
p.(None): this condition.
p.(None): 30. "Pharmaceutical form" shall mean an adequate for intake structure containing active substance(s), which can
p.(None): include or cannot include excipients and which is obtained through application of certain technological operations
p.(None): ensuring the desired healing effect and stability at storage within the expiry term.
p.(None): 31.. (Amen. - SG 71/2008 in force from 12.08.2008) "Any person, established on the territory of a Member State shall
p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
p.(None): 34. "Medical specialists" shall mean medical doctors, doctors in dental medicine, masters of pharmacy,
p.(None): nurses, midwives, medical laboratory assistants, medical auxiliaries and pharmacy assistants.
p.(None): 35. "Medical trade representative" shall mean a person who has passed special training and possessing scientific
p.(None): knowledge for the presentation of accurate and comprehensive information about the medicinal product he is
p.(None): advertising.
p.(None): 35a. (new – SG 1/14, in force from 03.01.2014)”Medical prescription” shall mean a prescription of a
p.(None): medicinal product, issued by a person who exercises a regulated medical profession within the meaning of § 1,
p.(None): item 1 of the Additional Provisions of the Recognition of Professional Qualifications Act and who is legally entitled
p.(None): to do so in the Member State in which the medical prescription is issued.
p.(None): 36. "Multicentre clinical test" shall mean a clinical test, which is conducted according to a single protocol but in
p.(None): more than one site and by more than one researcher. Researcher sites can be situated in the territory of one Member
p.(None): State, more than one Member State, and/or in Member States and third states.
...

p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
...

p.(None): contain:
p.(None): 1. application for issuing authorisation for retail trade with medicinal products by the persons under Art. 222, para
p.(None): 1, according to a form, approved by the Minister of Health;
p.(None): 2. updated certificate for listing into the trade register, correspondingly a document for updated registration of the
p.(None): person under Art. 222, para 1;
p.(None): 3. copy of the issued authorisation for opening a pharmacy, as provided by the Act on the Medicines and Pharmacies in
p.(None): the Human Medicine
p.(None): 4. certified copy of the employment contract or a contract for assignment of management of the head of the pharmacy –
p.(None): in the cases, where such is required;
p.(None): 5. declaration of the persons under Art. 222, para 1, that the conditions have been met for issuing the authorisation
p.(None): for retail trade with medicinal products of the persons under para 2;
p.(None): 6. document for a single paid fee in the amount of BGN 100.
p.(None):
p.(None):
p.(None): § 67. The persons, who have filed by this Act comes into force application for re- registration as
p.(None): provided by the repealed § 16 of the Transitional and Final Provisions, who will perform their activity as provided by
p.(None): the requirements of this Act, shall file in the Ministry of Health within 3 months after its coming into force, the
p.(None): following documents:
p.(None): 1. application, according to a form, approved by the Minister of Health;
p.(None): 2.updated certificate for listing in the trade register, or a document for updated registration or a
p.(None): certified copy of a similar document according to the national legislation of an EU Member State or the legislation of
p.(None): another Member- State – party of the EEA, under Art. 222, para 1;
p.(None): 3. employment contract or a contract for management of the pharmacy, signed with a Master of Pharmacy of Assistant
p.(None): Pharmacist.
p.(None):
p.(None):
p.(None): § 68. (1) Master of Pharmacy of Assistant Pharmacist, who has received authorisation for opening a pharmacy, as
p.(None): provided by the repealed § 16 of the Transitional and Final Provisions may transfer the issued authorisation
p.(None): to a person under Art. 222, para 1.
p.(None): (2) For performing the transfer, the persons under para 1 shall file in the Ministry of Health an application, which
p.(None): shall contain:
p.(None): 1. an application for issuing authorisation for retail trade with medicinal products by the persons under Art. 222,
p.(None): para 1, according to a form, approved by the Minister of Health;
p.(None): 2. an updated certificate for listing in the trade register, or a document for updated registration of
p.(None): the persons under Art. 22, para 1;
p.(None): 3. copy of the issued, as provided by the Act on the Medicines and Pharmacies in the Human Medicine, authorisation for
p.(None): opening a pharmacy or authorisation for re-registration, as provided by the repealed § 16 of the Transitional and Final
p.(None): Provisions;
p.(None): 4. a certified copy of the employment contract or a contract for management of the head of the pharmacy;
p.(None): 5. a declaration of the persons under Art. 222, para 1 that the conditions, in which the authorisation for retail trade
p.(None): with medicinal products of the persons under para 1 have been met;
p.(None): (3) The transfer under para 1 may be done within the term of 1 year after this Act comes
p.(None):
p.(None): into force.
p.(None):
p.(None):
p.(None): § 69. The drugstores, status quo at the time of this Act’s coming into force shall continue to perform its activity on
...

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Searching for indicator vulnerable:

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p.(None): for the minor person.
p.(None): (6) The express will of the minor person to at any time withdraw from the clinical test must be taken into
p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
p.(None): contain contact details of an independent person for additional information.
p.(None):
p.(None): Section .
p.(None): Clinical Trials in Vulnerable Patient Groups
p.(None):
p.(None): Art. 100. A clinical test in minor or underage persons can be undertaken provided that:
p.(None): 1. the study protocol has been approved by the respective ethics committee after discussion of the
p.(None): clinical, moral, and psycho-social aspects of childhood age in which at least two paediatricians have participated;
p.(None): 2. there is an anticipated direct benefit of the clinical test for the patient group, which is to be included;
p.(None): 3. the study is directly associated with the clinical condition from which the minor or underage person is suffering;
p.(None): 4. the study medicinal product is designated for the diagnosis, treatment, or prophylaxis of diseases, which are
p.(None): specific for minor or underage persons;
p.(None): 5. the study is designated to be conducted in minor or underage persons;
p.(None):
p.(None): 6. the study purpose is to check data obtained in clinical trials in persons who are capable of giving
p.(None): informed consent or of data obtained by other research methods;
p.(None): 7. the results obtained from clinical trials in adults and the interpretation thereof cannot be considered also valid
p.(None): for minor or underage persons;
p.(None): 8. the study is planned in a manner that pain, inconvenience, fear, and other disease- associated foreseeable risks are
...

p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
...

Health / Drug Usage

Searching for indicator drug:

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p.(None): manufacture under the terms of this Act;
p.(None): 4. active and auxiliary substances;
p.(None): 5. medicinal products in the course of development and/or test;
p.(None): 6. medicinal products designated for export.
p.(None): 7. (new - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) medicinal product
p.(None): for modern therapy, prepared for a certain patient upon an individual medical prescription, in reference to
p.(None): specific standards for quality and is applied in a medical institution to the explicit professional responsibility of
p.(None): the physician.
p.(None):
p.(None):
p.(None): Art. 8a (new – SG, 102/2012, in force from 21.12.2012) In manufacture of medicinal products, intended only for export,
p.(None): of intermediate products, active substances and of assisting substances , the relevant provisions of Chapter Five shall
p.(None): apply.
p.(None):
p.(None):
p.(None): Art. 9. (1) The treatment of a specific patient a medicinal product, which has not been authorised under the terms of
p.(None): chapter three, can be applied according to a special procedure for therapeutic establishment for hospital care under
p.(None): the terms and procedures as set out in an ordinance issued by the Minister of Health.
p.(None): (2) The manager of the healthcare establishment shall be responsible for the treatment according to para 1.
p.(None):
p.(None):
p.(None): Art. 10. (1) The Minister of Health can authorise for certain period of time treatment with a medicinal product which
p.(None): has not been authorised according to chapter three, by an order on the basis of reasoned proposal from chief state
p.(None): health inspector coordinated with the director Bulgarian Drug Agency (BDA) wherever there is a declared epidemic in the
p.(None): country caused by pathogenic microorganisms or toxins or there is suspected or confirmed dissemination of
p.(None): chemical agents or nuclear radiation and there is no suitable medicinal product authorised for use.
p.(None): (2) In the cases under para 1, the marketing authorisation holders, manufacturers, and medical specialists shall not
p.(None): bear civil or administrative and penal
p.(None): responsibility for the consequences of the use in an unauthorised indication of a medicinal product or of a
p.(None): medicinal product, which has not been authorised according to chapter three.
p.(None): (3) para 2 does not exclude the responsibility for defective products according to the Consumer Protection Act.
p.(None):
p.(None):
p.(None): Art. 11. (1) The Minister of Health may, due to reasons relating to the protection of the health of the population,
p.(None): instruct by way of order the Executive Director of the BDA to authorise the use of a medicinal product, which has not
p.(None): been authorised for use on the territory of the Republic of Bulgaria and for which no application for issuing
p.(None): of an authorisation has been submitted but which has been authorised in another Member State.
p.(None): (2) In the cases under para 1, the director of BDA, or his authorised representative shall:
p.(None): 1. inform the holder of the marketing authorisation for the medicinal product on the
p.(None):
p.(None): initiation of a procedure for the authorisation of the medicinal product for use;
p.(None): 2. register the person referred to in point 1 as a holder of the issued authorisation;
p.(None): 3. demand from the regulatory body of the Member State that has issued the marketing authorisation a copy of the
p.(None): assessment report and a copy of the marketing authorisation.
p.(None): (3) (suppl. – SG, 102/2012, in force from 21.12.2012) The Bulgarian Drug Agency shall be obliged to ensure
p.(None): compliance of the label, patient information leaflet, classification, advertising, and follow-up of the
p.(None): safety of the medicinal product released on the market according to Para. 1 with the requirements of this Act.
p.(None): The information on the packing and in the leaflet of the medicinal product under Para. 1 shall not be obligatorily in
p.(None): the Bulgarian language.
p.(None): (4) The Executive Director of BDA shall inform the European Commission about the authorisation issued according to para
p.(None): 1, the name and address of the authorisation holder, as well as about the date of termination of the validity thereof.
p.(None):
p.(None):
p.(None): Art. 12. (1) The official pharmacopoeia of the Republic of Bulgaria shall be the European Pharmacopoeia
p.(None): (2) The official pharmacopoeia may be supplemented with the requirements of the Bulgarian pharmacopoeia.
p.(None): (3) The Minister of Health shall determine by way of order the dates of entry into effect of the current edition of the
p.(None): official pharmacopoeia and the annexes thereof.
p.(None): (4) The order according to para 3 shall be promulgated in the State Gazette and published on the internet
p.(None): site of BDA.
p.(None):
p.(None):
p.(None): Art. 13. (1) The monographs of the European Pharmacopoeia shall be obligatory for all substances, preparations, and
p.(None): pharmaceutical forms contained therein. In the cases where there is no monographs in the European Pharmacopoeia, the
p.(None): requirements of the current editions of the pharmacopoeias of the Member States, the U.S.A, and Japan provided that
p.(None): these are in compliance with the general rules of the European Pharmacopoeia.
p.(None): (2) Where the specification contained in a monograph of the European Pharmacopoeia or other national pharmacopoeia
p.(None): is insufficient to ensure the quality of the substance or pharmaceutical form, the Bulgarian Drug
p.(None): Agency can require supplementation of the specification by the applicant/marketing authorisation holder.
p.(None):
p.(None): Chapter two.
p.(None): MANAGING AND FINANCING BODIES
p.(None):
p.(None): Section I. Managing Bodies
p.(None):
p.(None): Art. 14. (1) The medicinal product policy in the Republic of Bulgaria is part of the State health policy and is
p.(None): implemented by the Minister of Health.
p.(None): (2) The Minister of Health shall:
p.(None): 1. be the national coordinator for the problems of medicinal product;
p.(None): 2. take part in international bodies and organisations carrying out activities in the domain of the medicinal products;
p.(None): 3. (repealed – SG, 60/2011, in force from 05.08.2011 new – SG, 102/2012, in force from 21.12.2012) organize provision
p.(None): of public information to the patient organisations and to the
p.(None):
p.(None): consumers organisations about the actions, undertaken against falsification of medicinal products.
p.(None): 4. Carry out other activities set out by a law.
p.(None): When activities according para 2, point 3 carried out, the Ministry of Health collect taxes in amount, determined in
p.(None): tariff according to Art. 21, para 2.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None):
p.(None):
p.(None): Art. 15. (1) Pharmacopoeia Committee shall be established with the Minister of Health as a consulting body on issues
p.(None): relating to the current pharmacopoeia.
p.(None): (2) The Minister of Health shall, on the grounds of a proposal of the Executive Director of the BDA determine by an
p.(None): order the composition of the Pharmacopoeia Committee and the expert groups thereto and shall approve the regulation
p.(None): relating to their activity.
p.(None): (3) The activity of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 16. (1) Higher Council of Pharmacy shall be established to the Minister of Health as a consulting body on issues
p.(None): relating to pharmacy. It shall be composed by five representatives appointed by the Minister of Health, five
p.(None): representatives from Bulgarian Pharmaceutical Union, two representatives from National Health Insurance Fund (NHIF) and
p.(None): one representative from Faculty of pharmacy of the high medicinal schools. The Minister of Health is a chairman of the
p.(None): council without right of vote.
p.(None): (2) The Higher Council of Pharmacy is consultative body, which discuss and provide statements for:
p.(None): 1. Basic approaches and priorities in the pharmaceutical area;
p.(None): 2. Ethical problems of the pharmacy;
p.(None): 3. Projects for normative acts, related with the pharmacy;
p.(None): 4. The scientific priorities in the area of pharmacy;
p.(None): 5. Programs for organisation of social educational campaign in the area of medicinal products.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None): (4) The organisation and the activity of the Higher Council of Pharmacy are settled with ordinance issued by the
p.(None): Minister of Health, after proposal of Higher Council of Pharmacy.
p.(None):
p.(None):
p.(None): Art. 17. (1) The Bulgarian Drug Agency shall be a specialised body at the Minister of Health for the surveillance on
p.(None): the quality, safety, and efficacy of the medicinal products.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) The Bulgarian Drug Agency shall be a legal entity budget financed with
p.(None): registered office in the city of Sofia with the Minister of Health.
p.(None): (3) The Bulgarian Drug Agency shall be managed and represented by an Executive Director who shall be appointed under
p.(None): the terms of the Administration Act.
p.(None): (4) The structure, functions, and work organisation of the Bulgarian Drug Agency shall be regulated by statutes adopted
p.(None): by the Council of Ministers.
p.(None): (5) The Bulgarian Drug Agency shall:
p.(None): 1. issue manufacture authorisation for medicinal products;
p.(None): 2. issue marketing authorisations and registration certificated for medicinal products;
p.(None): 3. issue authorisations for wholesale of medicinal products;
p.(None): 4. issue authorisations for parallel import of medicinal products;
p.(None):
p.(None): 5. (amend. – SG, 60/2011, in force from 05.08.2011), issue, refuse or terminate authorisations for retail
p.(None): trade with medicinal products;
p.(None): 5a (new – SG, 102/2012, in force from 21.12.2012) enters the producers, importers and wholesale traders with active
p.(None): substances;
p.(None): 5b (new – SG, 102/2012, in force from 21.12.2012) keeps register of the persons, carrying out
p.(None): intermediation activity in the area of the medicinal products;
p.(None): 6. issue authorisations to conduct clinical trials of medicinal products;
p.(None): 7. carry out assessment of the quality, efficacy, safety of medicinal products in relation with their marketing
p.(None): authorisations;
p.(None): 8. issue authorisations for the advertising of medicinal products;
p.(None): 9. exert control on the manufacture, import, storage, wholesale and retail trade, clinical trials, safety, and
p.(None): advertising of medicinal products;
p.(None): 10. carry out laboratory analysis in case of doubt of deviation in the quality, efficacy, and safety of the medicinal
p.(None): products and shall undertake the measures provided by law;
p.(None): 10a (new – SG, 102/2012, in force from 21.12.2012) carries out the functions of a competent body for
p.(None): vigilance medicinal safety;
p.(None): 11. (amend. - SG, 102/2012, in force from 21.12.2012) organize and maintain a system for vigilance the medicinal
p.(None): safety;
p.(None): 12. issue certificates according to the certification system of the World Health Organisation;
p.(None): 12a. (new – SG 18/14) issue certificates of Good Distribution Practice;
p.(None): 13. Issue Good Manufacturing Practice certificates;
p.(None): 14. (amend. – SG 18/14) consult investment projects for the construction of new and/or refurbishing of existing sites
p.(None): relating to the manufacture of medicinal products in accordance with the rules of Good Manufacturing Practice;
p.(None): 15. execute the functions of national coordinator and consulting body on the issues relating to the
p.(None): quality, efficacy, and safety of medicinal products;
p.(None): 16. carry out consulting, scientific, information, and publishing activity in the domain of the medicinal sector;
p.(None): 17. coordinate and participate in activities relating to the European Pharmacopoeia and the development of the
p.(None): Bulgarian Pharmacopoeia;
p.(None): 18. take part in activities in the field of the medicinal products relating to the work of the European Medicines
p.(None): Agency, the European Directorate of the Quality of the Medicinal Products and Healthcare, of international bodies and
p.(None): organisations, as well as relating to the fulfillment of international treaties in which Bulgaria is a party to;
p.(None): 18a (new – SG, 102/2012, in force from 21.12.2012) participate in the international harmonisation and
p.(None): standardisation of the technical measures, referring to vigilance the medicinal safety under the coordination of the
p.(None): European Medicines Agency;
p.(None): 18b (new – SG, 102/2012, in force from 21.12.2012) establish and maintain a national internet portal for medicinal
p.(None): products;
p.(None): 19. carry out other activities provided by a law.
p.(None): (6) (amend., - SG 98/10, in force from 01.01.2011) The Bulgarian Drug Agency coordinates its activity with
p.(None): the Regional health inspectorates (RHI) in the field of the control on the medicinal products.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The implementation of this act measures, related to
p.(None): prevention of entering and dissemination of falsified medicinal products shall be carried out in cooperation
p.(None): between the Bulgarian Drug Agency and the customs authorities.
p.(None):
p.(None): Art. 17a (New – SG, 60/2011, in force from 05.08. 2011) The Regional health inspectorates shall issue
p.(None): authorisations for registration of drug stores.
p.(None):
p.(None):
p.(None): Art. 17b. (new – SG 18/14) (1) Expert drug retail trade council shall be set up subordinated to the
p.(None): Managing Director of the BDA including three representatives of Bulgarian Pharmaceutical Association, one
p.(None): representative of every Pharmaceutical department of Higher Medicinal Schools and four representatives of the BDA. The
p.(None): members of the council shall be appointed by an order of the Managing Director of BDA agreed by the Minister of Health.
p.(None): (2) The council referred to in par. 1 is a consultancy unit, which shall:
p.(None): 1. issue opinions on the submitted to the BDA applications and documents under Art. 228, par. 1 and 5 which they are
p.(None): submitting to the Managing Director of BDA;
p.(None): 2. make justified proposals to the Minister of Health through the Managing Director of BDA for improvement of the
p.(None): access of individuals to drugs.
p.(None): (3) The organization and the activity of the expert council under par. 1 shall be regulated by regulations issued by
p.(None): the Managing Director of BDA upon council’s proposal.
p.(None): (4) The members of the expert council referred to in par. 1 shall not get paid for the participation in council
p.(None): meetings.
p.(None): (5) The expert council referred to in par. 1 shall report on their activity on an annual basis to the Minister of
p.(None): Health.
p.(None):
p.(None):
p.(None): Art. 17c. (new – SG 18/14) Cannot be members of the expert council referred to in Art.
p.(None): 17b, par.1 persons who are:
p.(None): 1. owners, members of managing and supervisory bodies of business companies or sole traders with a scope of business
p.(None): production, import, wholesale or retail trade with drugs;
p.(None): 2. partners or shareholders holding more than 5 per cent of the equity of business companies with a scope
p.(None): of business production, import, wholesale or retail trade with drugs or working under a full time employment agreement
p.(None): in such companies.
p.(None):
p.(None): Section II. Registers
p.(None):
p.(None): Art. 18. (Repealed - SG, 60/2011, in force from 05.08. 2011)
p.(None):
p.(None):
p.(None): Art. 19. (1) The Bulgarian Drug Agency shall keep registers of:
p.(None): 1. (amend. – SG, 102/2012, in force from 21.12.2012) manufacturers and importers of medicinal products on the territory
p.(None): of the Republic of Bulgaria and qualified persons according to Art. 148, point 2,and Art. 161, Para. 2, p. 1;
p.(None): 2. (amend. – SG, 102/2012, in force from 21.12.2012) the manufacturers, importers and the wholesale traders of active
p.(None): substances;
p.(None): 3. authorised/registered medicinal products on the territory of the Republic of Bulgaria;
p.(None): 4. wholesalers of medicinal products on the territory of the Republic of Bulgaria;
p.(None): 4a (new - SG, 102/2012, in force from 21.12.2012) the intermediation in the area of medicinal products;
p.(None): 5. (amend. - SG, 60/2011, in force from 05.08. 2011).the issued authorisations for retail
p.(None):
p.(None): trade with medicinal products;
p.(None): 6. authorised clinical trials;
p.(None): 7. issued authorisations for parallel import;
p.(None): 8. (new – SG 18/14) issued permits for the export of drugs subject to compliance with the provisions of Chapter Nine
p.(None): “b”.
p.(None): (2) The data of the registers according to Para. 1, points 1 to 5 and point 7 shall be published on the internet site
p.(None): of the Bulgarian Drug Agency.
p.(None): (3) The Bulgarian Drug Agency shall maintain systems for electronic data exchange with the regulatory bodies of
p.(None): other Member States, European Commission, and the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 19a. (New - SG, 60/2011, in force from 05.08. 2011) (1) The relevant Regional health inspectorates (RHI) shall
p.(None): keep and maintain public registers for the issued by them authorisations for registration of drug
p.(None): stores.
p.(None): (2) Within 7-day term from the issuance of an authorisation for registration of a drug store, the relevant RHI shall
p.(None): submit information to the Ministry of Health about the issued act.
p.(None): (3) The Ministry of Health shall keep and maintain on its internet site a public national register of the issued
p.(None): authorisations for registration of a drug store.
p.(None):
p.(None): Section III. Financing
p.(None):
p.(None): Art. 20. (1) The activity of the Bulgarian Drug Agency is financed from the budget funds and its own activity.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) Budget funds shall be ensured by a subsidy from the state budget
p.(None): through the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 21. (1) The Bulgarian Drug Agency shall be the administrator of the revenues of its own activity, namely:
p.(None): 1. chemico-pharmaceutical examinations;
p.(None): 2. laboratory analyses and tests;
p.(None): 3. assessment of documentation and issue of authorisations, certificates, and other documents set forth in
p.(None): this Act;
p.(None): 4. evaluation by the renewal, variation and cease of marketing authorisation approval and certificate for registration
p.(None): of medicinal product;
p.(None): 5. maintenance of marketing authorisations of medicinal products;
p.(None): 6. fines and property sanctions imposed by penal ordinances issued for infringements of this Act;
p.(None): 7. consulting, publishing, and research activities in the field of the drug sector;
p.(None): 8. coordination of investment projects for the construction of new and/or refurbishing of existing sites relating to
p.(None): the manufacture of medicinal products;
p.(None): 9. conduct of inspections in connection with assessment of compliance of the manufacturing conditions with
p.(None): the requirements of Good Manufacturing Practice;
p.(None): 10 other sources.
p.(None): (2) During the execution of the activities according to para 1, points 1 – 5, points 7 – 9 the Bulgarian Drug Agency
p.(None): shall collect fees to the amounts as defined in a tariff adopted by the
p.(None):
p.(None): Council of Ministers.
p.(None): (3) (New - SG 71/2008, in force from 12.08.2008) The tariff under para 2 shall have determined lower and various in
p.(None): amount fees for realisation of the procedures on permission for usage, production and import of medicinal products for
p.(None): small and medium enterprises in the pharmaceutical sector in the meaning of the Small- and Medium-Size Enterprises Act.
p.(None):
p.(None):
p.(None): Art. 22. (1) The funds according to Art. 21 shall be spent for:
p.(None): 1. control activity of the BDA;
p.(None): 2. Payment of the activities according to Art. 21, Para. 1, p. 1 and 2, when The BDA is assigned their execution of
p.(None): another persons by contract;
p.(None): 3. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 4. establishment and maintenance and update of the registers according to Art. 19, Para.
p.(None): 1;
p.(None): 5. maintenance of systems for electronic data exchange with the regulatory bodies of
p.(None): the other Member States, with the European Commission, with and the European Medicines Agency;
p.(None): 6. (suppl. – SG, 102/2012, in force from 21.12.2012) information and publishing activities relating to the quality,
p.(None): efficacy, and safety of the medicinal products and vigilance medicinal safety;
p.(None): 7. provision of the activity of the specialised commissions according to Art. 47, Par. 1 and 2 and the council
p.(None): according to Art. 251, Para. 3;
p.(None): 8. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 9. participations in international and national inter-laboratory tests;
p.(None): 10. (amend. – SG. 60/2011, in force from 5. 8. 2011; revoked – SG 38/12, in force from 01.07.2012)
...

p.(None): by the executive director BDA to a natural or legal person established on the territory of a Member State or a state
p.(None): member of the European Economic Area.
p.(None): (2) Where the person according to para 1 is not established on the territory of the Republic of
p.(None): Bulgaria, it shall designate a representative.
p.(None): (3) The marketing authorisation holder takes responsibility for the medicinal products placed on the territory of the
p.(None): Republic of Bulgaria. The designation of a person according to para 2 shall not release the marketing authorisation
p.(None): holder from responsibility according to the acting legislation in Republic of Bulgaria.
p.(None):
p.(None): Section II.
p.(None): Requirements Relating to the Documentation for Granting a Marketing Authorisation
p.(None):
p.(None): Art. 27. (1) For granting a marketing authorisation of a medicinal product, the person
p.(None):
p.(None): according to Art. 26, para 1, shall submit to the BDA a formal application accompanied by a dossier in the format of
p.(None): the Common Technical Document, which shall contain:
p.(None): 1. name and address of management and/or permanent address of the applicant according to Art. 26, para 2;
p.(None): where the applicant is a person other than the manufacturer(s) – address of the manufacture sties;
p.(None): 2. name of the medicinal product;
p.(None): 3. qualitative and quantitative particulars of the medicinal product, including its international
p.(None): non-proprietary name (INN) recommended by the WHO, where an INN for the medicinal product exists, or the
p.(None): relevant chemical name;
p.(None): 4. therapeutic indications, contraindications and adverse drug reactions;
p.(None): 5. posology, pharmaceutical form, method and route of administration and expected shelf-life;
p.(None): 6. precautions and safety measures during storage of the medicinal product, its administration to patients
p.(None): and for the disposal of waste products together with an indication of potential risks for the environment;
p.(None): 7. description of the method of manufacture;
p.(None): 8. description of the control methods employed by the manufacturer;
p.(None): 8a (new – SG, 102/2012, in force from 02.01.2013) declaration, that the audit results under Art. 160, Para. 2,
p.(None): conducted by the manufacturer of the medicinal product confirm that the active substance has been produced in
p.(None): compliance with the principles and directives for good production practice; the declaration shall indicate the date on
p.(None): which the audit is conducted;
p.(None): 9. assessment of the potential risks presented by the medicinal product for the environment for every
p.(None): individual case and measures for the limitation thereof;
p.(None): 10. results of:
p.(None): a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.(None): b) preclinical (toxicological and pharmacological) tests;
p.(None): c) clinical trials;
p.(None): 11. declaration that the ethic principles of the Good Manufacturing Practice have been complied with in the clinical
p.(None): trials conducted outside the territory of the Member States;
p.(None): 12. (amend. – SG, 102/2012, in force from 21.12.2012) a summary of the system
p.(None): a) for vigilance the medicinal safety, which shall include the following elements:
...

p.(None): 1. change of the active substance(s):
p.(None): a. replacement of a chemical active substance by a different by a different salt/ester, complex/derivative, including
p.(None): the same therapeutic moiety, where the efficacy/safety characteristics are not significantly different.
p.(None): b. replacement by a different isomer, mixture of isomers, of a mixture by an isolated isomer (e.g. racemate with single
p.(None): enantiomer), where the efficacy/safety characteristics are not significantly different;
p.(None): c. replacement of a biological active substance with one of a slightly different molecular structure where the
p.(None): efficacy/safety characteristics are not significantly different, with the exception of changes to the active
p.(None): substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
p.(None):
p.(None): d. modification of the vector used to produce the antigen of the source material, including a new master cell bank from
p.(None): a different source, where the efficacy/safety characteristics are not significantly different;
p.(None): e. a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy/safety
p.(None): characteristics are not significantly different
p.(None): f. change to the extraction solvent of the ration of herbal drug to herbal drug preparation where the efficacy/safety
p.(None): characteristics are not significantly different.
p.(None): 2. Changes to strength, pharmaceutical form and route of administration:
p.(None): a. change of bioavailability;
p.(None): b. change of pharmacokinetics e.g. change in rate of release;
p.(None): c. change or addition of a new strength/potency;
p.(None): d. change or addition of a new pharmaceutical form; e.g. change or addition of a new route of administration– for
p.(None): parenteral application to differentiate between intraarterial, intravenous, intramuscular, subcutaneous and
p.(None): other routs of administration.
p.(None): (2) The application according to para 1 shall be accompanied by the documentation according to Art. 27, para 1, point
p.(None): 10, associated with variations according to para 1.
p.(None): (3) The requirements to the documentation according to para 2 shall be laid down in the regulation according to Art.
p.(None): 42.
p.(None): (4) The name of the medicinal product in the granted authorisation for enlargement of the scope of the initial
p.(None): marketing authorisation shall not be changed.
p.(None): (5) The granting of an authorisation for enlargement of the scope of a granted marketing authorisation of a medicinal
p.(None): product shall be performed under the conditions and under the terms of Art. 49 - 51.
p.(None):
p.(None):
p.(None): Art. 67. (1) The marketing authorisation holder of a medicinal product shall submit an application for granting a new
p.(None): marketing authorisation in case of:
p.(None): 1. addition or deletion of one or more active substances including antigenic components in case of vaccines;
p.(None): 2. change in the quality of the active substance indicated in the dossier, which essentially changes the safety and
...

p.(None): medicinal product; the information shall include the positive, as well as the negative results from the
p.(None): clinical tests or other researches of all indicators and populations, notwithstanding of the fact whether
p.(None): they are included in the use authorisation, as well as data for use of the medicinal product, where this use is
p.(None): outside the conditions of the use authorisation;
p.(None): 4. keep and update the information about the medicinal product with the current scientific knowledge, including the
p.(None): conclusions from the assessment and recommendations, published in the European internet portal for medicinal products,
p.(None): established under Art. 26 of Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 5. disseminate the medicinal product with the last approved short characteristic of the product and a leaflet for the
p.(None): patient.
p.(None): 6. (new – SG 18/14) inform BDA of every action undertaken by them, related to temporary suspension of
p.(None): offering on the market of a specific medicinal product, withdrawal from the market of a particular medicinal product,
p.(None): request for termination of a marketing authorisation or stated intention of non-renewal of the marketing authorisation,
p.(None): and also to indicate the reasons for which this action has been taken; in these cases the marketing authorisation
p.(None): holder declare whether the undertaken by them actions are due to any of the reasons under Art. 276 or Art. 277;
p.(None): 7. (new – SG 18/14) inform BDA, if the actions referred to in item 6 are undertaken in a third country and are due to
p.(None): any of the reasons referred to in Art. 276 or Art. 277;
p.(None): 8. (new – SG 18/14) inform European drug agency where the actions under items 6 and 7 are undertaken on the grounds of
p.(None): Art. 276 and 277;
p.(None): 9. (new – SG 18/14) provide sufficient quantities of medicinal products for satisfying the health care needs of the
p.(None): individuals in the Republic of Bulgaria.
p.(None): (2) The marketing authorisation/registration certificate holder shall be obliged to submit to the BDA upon request the
p.(None): following:
p.(None): 1. data in support of the positive benefit/risk ratio of the medicinal product;
p.(None): 2. (amend. – SG 18/14) information about the sales volume of the medicinal products and any other information available
p.(None): to the holder of the marketing authorisation regarding the medicinal prescriptions for the product;
p.(None): 3. a copy of the basic documentation of the vigilance system of the medicinal safety.
p.(None): (3) The marketing authorisation holder shall submit to BDA the documentation under Para. 2, p. 3 within 7 day term
p.(None): after receiving the request.
p.(None):
p.(None):
p.(None): Art. 69. (1) The marketing authorisation holder of a vaccine or immunological medicinal product designated for
p.(None): immunisation shall be obliged to submit to the BDA the following prior to the placing of any batch of the product on
p.(None): the market:
p.(None): 1. a sample of the finished product and/or a sample of the bulk/not finalised product;
p.(None): 2. protocols of the manufacturing and quality control;
p.(None): 3. document for paid fee as paid down in the tariff according to Art. 21, para 2.
p.(None): (2) The marketing authorisation holder of new immunological medicinal products or immunological medicinal
p.(None): products manufactured by new or altered technologies or by
p.(None):
...

p.(None): (2) The applicant shall submit to the European Medicines Agency the dossier of the medicinal product and the summary of
p.(None): product characteristics.
p.(None): (3) In the cases according to para 1, provided that the BDA has approved the assessment report, draft
p.(None): summary of product characteristics and packaging mock-up and package leaflet submitted by the Reference Member
p.(None): State, the executive director of the BDA may, upon a request of the applicant, grant a marketing authorisation of the
p.(None): medicinal product prior to the completion of the arbitrage procedure according to para 1.
p.(None): (4) After the accomplishment of the arbitrage procedure, the executive director of the BDA shall put the granted
p.(None): marketing authorisation according to para 3 into effect in compliance with the decision of the European Commission.
p.(None):
p.(None):
p.(None): Art. 79. (1) Where the regulatory authorities of one or several Member States have made different decisions with
p.(None): respect to the marketing authorisation of the same medicinal product or with respect to its temporary suspension
p.(None): or revocation, the BDA or the applicant/marketing authorisation holder may refer the issue to the
p.(None): Committee on Medicinal products in Human Medicine to the European Medicines Agency for application of the
p.(None): arbitrage procedure. The Applicant or the marketing authorisation holder may apply the question to the Committee for
p.(None): Human Medicinal Products at the European Evaluation Agency for applying arbitration procedure upon its
p.(None): evaluation.
p.(None): (2) (repealed – SG, 102/2012, in force from 21.12.2012)
p.(None): (3) (amend. – SG 18/14) Bulgarian drug agency shall apply the procedure of Chapter Eight, Section IV, where one of the
p.(None): measures referred to in Art. 194s, par. 2 and 3.
p.(None): (4) (new – SG 18/14) Notwithstanding the provision of par. 1 – 3, where urgent action for the protection of the public
p.(None): health is required at a certain stage of the arbitration procedure, BDA may suspend the effect of the marketing
p.(None): authorisation and to prohibit the use of the respective medicinal product in the Republic of Bulgaria until the
p.(None): adoption of the final decision.
p.(None): (5) (new- SG 18/14) In cases referred to in par. 4 BDA shall inform the European
p.(None):
p.(None): commission, the European Drug Agency and the other Member States of the reasons for their decision on the next work day
p.(None): at the latest.
p.(None):
p.(None):
p.(None): Art. 79a (New – SG, 60/2011, in force from 5. 8. 2011) Depending on the decision of the European Commission after
p.(None): finalisation of the arbitration procedure, the BDA within the term of 30 days from receiving the notification, shall:
p.(None): 1. issue, temporarily stop or terminate an authorisation for use, or
p.(None): 2. request amendments to be made in the issued authorisation for reaching compliance with the decision of the European
p.(None): Commission.
p.(None): (2) The BDA shall notify the European Commission and the European Agency on Medicines about the issued act
p.(None): under Para. 1.
p.(None):
p.(None):
p.(None): Art. 79b (new – SG, 102/2012, in force from 21.12.2012) (1) In the cases where interests of the EU have been
p.(None): affected and before decision taking for issuance of a marketing authorisation of a medicinal products, for
p.(None): its temporary termination, or its change, BDA, the applicant or the marketing authorisation holder may refer the
p.(None): issue to the Committee under Art. 79, Para. 1 for applying arbitration procedure.
p.(None): (2) In the cases under Para. 1, where the reference is as a result of a data assessment, related to vigilance of the
p.(None): medicinal safety of a medicinal product, permitted for use, the issue shall be referred to the committee under Art.
p.(None): 56a, Para. 1, p. 1 and the procedure under Art. 194x or 194y shall be applied.
p.(None): (3)Where undertaking of urgent actions are needed, the procedure of Chapter Eight, Section V shall be applied.
p.(None):
p.(None):
p.(None): Art. 80. (amend. – SG 12/11, in force from 08.02.2011) Terms and procedure for effecting variations to
...

p.(None): (4) The provisions of para 1 and 2 shall not apply provided that the protocol of the clinical test or the researcher’s
p.(None): brochure explicitly states that there is no requirement for an urgent report of a specific serious adverse event.
p.(None): (5) The researcher shall report to the contracting authority any adverse events or laboratory aberrations,
p.(None): which are defined in the study protocol as critical with respect to safety, within the timelines and format as required
p.(None): by the protocol.
p.(None):
p.(None):
p.(None): Art. 136. Where the outcome of an adverse event during the conduct of a clinical test is death, the researcher shall
p.(None): be obliged to submit to the contracting authority and the ethics committees any information requested
p.(None): additionally.
p.(None):
p.(None): Art. 137. The contracting authority shall keep detailed records of any serious adverse events provided to him by the
p.(None): researchers and shall present these upon request to the BDA or the regulatory bodies of the Member States where
p.(None): the clinical test is conducted in case of multicentre clinical test.
p.(None):
p.(None):
p.(None): Art. 138. (1) The contracting authority shall notify the BDA, the regulatory bodies of all Member States where the
p.(None): clinical test is conducted in case of a multicentre test, and the respective ethics committee of any
p.(None): suspected serious adverse drug reaction occurring in the course of the clinical test, which has resulted in death or
p.(None): has been life-threatening not later than 7 days of receipt of information thereof.
p.(None): (2) The contracting authority shall provide the bodies according to para 1 with additional information on the case
p.(None): within 8 days of the date of the notification sent.
p.(None): (3) The contracting authority shall notify the bodies according to para 1 of any other suspected unexpected serious
p.(None): drug reactions occurring in the course of the clinical test, which are different from those set out in para 1, not
p.(None): later than 15 days from the date of receipt of the information for their occurrence.
p.(None):
p.(None):
p.(None): Art. 139. (1) The contracting authority can fulfil his obligations according to Art. 138, para 1 and 3, by entering his
p.(None): reports in the European adverse drug reactions database.
p.(None): (2) Where the clinical test is also conducted in countries outside the Member States and the European Economic Area,
p.(None): the contracting authority shall enter his reports of suspected unexpected serious adverse drug reactions in
p.(None): the European adverse drug reactions database.
p.(None): (3) (amend. – SG, 102/2012, in force from 21.12.2012) The format and content of the reports for adverse drug reactions
p.(None): shall be determined by the regulation according to Art. 82, Para. 3.
p.(None): (4) The contracting authority shall inform the researchers conducting a clinical test with medicinal product about any
p.(None): suspected unexpected serious adverse drug reaction associated with the study medicinal product irrespective of its
p.(None): origin.
p.(None):
p.(None):
p.(None): Art. 140. (1) The contracting authority shall submit to the BDA and the respective ethics committee a list of all
p.(None): suspected serious adverse drug reactions occurring during the past period and a report about the safety of the study
p.(None): subjects once yearly.
p.(None): (2) (amend. – SG, 102/2012, in force from 21.12.2012) The format and content of the reports for adverse drug reactions
p.(None): shall be determined by the regulation according to Art. 82, Para. 3.
p.(None):
p.(None):
p.(None): Art. 141. (1) The BDA shall document any information about suspected unexpected serious adverse drug
p.(None): reactions of the study medicinal products provided under the terms of Art. 138, para 1 and 3.
p.(None): (2) The BDA shall immediately enter the information according to para 1 in the European adverse drug reactions
p.(None): database.
p.(None):
p.(None): Section V.
p.(None): Notification of Clinical Test Closure
p.(None):
p.(None): Art. 142. (1) The contracting authority shall notify in writing the BDA and the respective ethics committee of the
p.(None): closure of the clinical test on the territory of the Republic of Bulgaria.
p.(None): (2) The notification shall be submitted within 90 days of the closure of the clinical test in a format as defined by
p.(None): the regulation according to Art. 82, para 3.
p.(None): (3) Provided that nothing is otherwise stipulated in the protocol as approved by the respective ethics
p.(None): committee, the last subject visit shall be considered as end of study.
p.(None): (4) Where the study is prematurely terminated, the contracting authority shall notify the BDA and the respective ethics
p.(None): committee within 15 days of taking such decision providing the reasons thereof.
p.(None):
p.(None):
p.(None): Art. 143. The contracting authority shall submit a final report of the clinical test to the BDA and the respective
p.(None): ethics committee.
p.(None):
p.(None):
p.(None): Art. 144. (1) The BDA shall enter data of any clinical test conducted on the territory of the Republic of Bulgaria in
p.(None): the European clinical trials database: application submitted, ethics committee decision, authorisation, essential
p.(None): amendments, end of study, and data of any audit conducted.
...

p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
p.(None): 3. are intended for treatment of out-patients but their use can cause serious adverse drug reactions, which can require
p.(None): specialist prescribing and monitoring in the course of treatment.
p.(None):
p.(None):
p.(None): Art. 176. (1) The BDA can refuse to approve the dispensing regime of a medicinal product requested by the
p.(None): applicant according to Art. 26, para 1, on the grounds of assessment of:
p.(None): 1. the maximum single dose, maximum daily dose, quantity of the active substance in one dose unit, pharmaceutical
p.(None): form, specific appearance of the primary product packaging, and/or
p.(None): 2. other specific conditions of use.
p.(None): (2) The BDA can refuse to indicate the exact category of a medicinal product according to Art. 172 but pursuant to the
p.(None): criteria according to Art. 174 and Art. 175 shall determine whether a medicinal product shall be classified as a
p.(None): product dispensed only on medical prescription.
p.(None):
p.(None):
p.(None): Art. 177. Medicinal products, which do not meet the requirements according to Art. 173, 174, and 175 and the criteria
p.(None): laid down in the regulation according to Art. 178, shall be dispensed without medical prescription.
p.(None):
p.(None):
p.(None): Art. 178. The criteria for classification of medicinal products and the requirements to the documentation for changing
p.(None): the classification shall be determines by a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 179. (1) The BDA shall draw and publish on its internet site a list of the medicinal products, which shall be
p.(None): dispensed on the territory of the Republic of Bulgaria on medical prescription.
p.(None): (2) The list according to para 1 shall be updated annually.
p.(None):
...

p.(None): pharmaco-vigilance for implementation of the obligations under this Chapter.
p.(None): (2) The system under Para. 1 shall be used for collecting information about the risks of medicinal products for the
p.(None): patients’ health and for public health. The information shall cover reports for unwilling medicinal reactions in use of
p.(None): a medicinal product in compliance with the confirmed short characteristics, as well as information for misuse
p.(None): and use, which is not in compliance with the confirmed short characteristics of the product, including
p.(None): information for unwilling medicinal reactions, observed while fulfilling professional duties.
p.(None): (3) The BDA shall valid the process and classify the information under Para. 2, make scientific analysis of the
p.(None): collected data in view to an assessment of the possibilities for decreasing and preventing the risk and shall
p.(None): undertake the needed actions in relation to permit for use of the medicinal product.
p.(None): (4) The BDA shall carry out audits of the system under Para. 1 and every 2 years shall submit to the European
p.(None): Commission a report with the results from them.
p.(None): (5) The BDA shall apply an adequate and effective quality system in order to provide compliance of the system under
p.(None): Para. 1 with the requirements of this act. The minimal requirements for the quality system shall be
p.(None): determined by Implementation Regulation (EU) N 520/2012.
p.(None):
p.(None):
p.(None): Art. 184. (amend. – SG, 102/2012, in force from 21.12.2012) (1) Medical specialists shall be obliged to immediately
p.(None): report to the marketing authorisation holder or to the BDA any suspected serious or unexpected adverse drug
p.(None): reaction and to provide upon request additional information from the vigilance of the case.
p.(None): (2) The patients may report adverse medicinal reactions at any time to the medical
p.(None):
p.(None): specialists or to BDA.
p.(None): (3) In the cases under Para. 1 and 2 where the report refers to biological medicinal product, prescribed, disseminated
p.(None): or sold on the territory of the Republic of Bulgaria, it must be clearly identified by the reporter with its trade name
p.(None): and lot number or this information is provided during the additional vigilance.
p.(None):
p.(None):
p.(None): Art. 185. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall maintain national internet portal for
p.(None): medicinal products, connected to the European internet portal for medicinal products under Art. 68, Para. 1, p. 4.
p.(None): (2) The BDA shall provide through the portal under Para. 1 at least the following information:
p.(None): 1. the public assessment reports under Art. 53, Para. 2 and their summaries;
p.(None): 2. the short characteristics of the products and the leaflets;
p.(None): 3. summary of the risk management plans of the medicinal products, permitted for use on the territory of the Republic
p.(None): of Bulgaria;
p.(None): 4. standard forms for reporting of suspected adverse reactions by medical specialists and patients, drawn up with
p.(None): compliance with the requirements of Art. 25 of Regulation (EC) N 726/2004 of the European Parliament and of the
p.(None): Council;
p.(None): 5. updated list of the medicinal products under Art. 23 of Regulation (EC) N 726/2004 of the European Parliament and of
p.(None): the Council;
...

p.(None): 1. adopt as decision for change, termination or interruption of the marketing authorisations,
p.(None): issue under Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt decision with a recommendation for change, termination or interruption of the marketing authorisations, issued
p.(None): by the relevant Member States regulatory bodies.
p.(None): (3) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 2, p. 2.
p.(None):
p.(None): Section IV.
p.(None): Urgent Procedure at European Union Level. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194t. (new – SG, 102/2012, in force from 21.12.2012) (1) Urgent procedure at the level of the European Union may
p.(None): be initiated by the European Commission, by the European Medicines Agency or by a Member State.
p.(None): (2) (amend. – SG 18/14) The BDA shall initiate an urgent procedure under this section by notification of the regulatory
p.(None): bodies of the other Member States, the European Medicines Agency and the European Commission where upon
p.(None): considerations, related with pharmaco- vigilance considers, that for a certain medicinal product, placed on the
p.(None): Bulgarian market, one of the following measures are needed to be undertaken:
p.(None): 1. termination or interruption of the marketing authorisation;
p.(None): 2. prohibition of distribution of the medicinal product;
p.(None): 3. issuing a refusal for renewing the marketing authorisation.
p.(None): (3) (amend. – SG 18/14) The BDA shall initiate the procedure under Para. 2 where they are advised by the marketing
p.(None): authorisation holder that, for reasons related to tracing of drug safety, they terminate the distribution of the
p.(None): medicinal product or they have undertaken or they intend to undertake actions for its withdrawal from the market, or
p.(None): will not undertake actions for the renewal of the issued marketing authorisation.
p.(None): (4) (amend. – SG 18/14) The BDA may initiate the procedure under par. 2 in the cases where they consider that for
p.(None): reasons, related to tracing of drug safety, regarding a particular medicinal product new counter-indications may be
p.(None): added or the recommended dose should be reduced, or the indications shall be limited.
p.(None): (5) (amend. – SG 18/14) The BDA shall submit to the European Medicines Agency and to the regulatory authorities of the
p.(None): other Member States the entire scientific information, available to them, as well as the performed data assessment and
p.(None): the justifications for the initiation of the procedure pursuant to the provisions of this section.
p.(None): (6) (amend. – SG 18/14) In the cases referred to par. 2 - 4 the European Medicines Agency shall notify the BDA of the
p.(None): initiation of the procedure, where the concerns regarding safety are related also to other medicinal products,
p.(None): belonging to one and the same therapeutic group or contain the same active substance with the product, indicated in the
p.(None): information under
p.(None):
p.(None): par. 5 or where this medicinal product is permitted for use also in other Member States.
p.(None): (7) (amend. – SG 18/14) In the cases under Para. 4, where no urgent measures are required, BDA shall apply the
p.(None): procedure under Art. 77 or Art. 79b.
p.(None): (8) (new – SG 18/14) BDA shall inform the marketing authorisation holder of the initiation of the procedure under the
p.(None): provisions of this section.
p.(None):
p.(None):
p.(None): Art. 194u. (new – SG, 102/2-12, in force from 21.12.2012) (1) In the cases under Art. 194s, Para. 2, where BDA
p.(None): considers, that urgent measures are needed to be undertaken for protection of public health, BDA may temporary to
...

p.(None):
p.(None): shall be published on the internet site of the BDA.
p.(None): (6) The parallel import authorisation shall be valid for 5 years. New authorisation shall be issued under the terms of
p.(None): Art. 215.
p.(None): (7) The parallel import authorisation shall not be automatically cancelled where the marketing authorisation
p.(None): holder of the medicinal product launched on the market on the territory of the Republic of Bulgaria would withdraw it
p.(None): for reasons, which are not associated with a threat for the health of the population.
p.(None):
p.(None):
p.(None): Art. 217. The parallel import authorisation holder shall be obliged to:
p.(None): 1. notify the marketing authorisation holder of the medicinal product launched on the territory of the Republic of
p.(None): Bulgaria of his intention to effect parallel import and provide a sample of the parallel imported medicinal product
p.(None): upon request;
p.(None): 2. keep the following information for 5 years: name and address of the person whom the parallel imported medicinal
p.(None): product is to be delivered to, date of delivery, delivered quantity, and batch number;
p.(None): 3. submit in BDA:
p.(None): a) actualised patient’s leaflet of parallel imported product according with the variations in issued marketing
p.(None): authorisation of the approved medicinal product in Republic of Bulgaria;
p.(None): b)(Amen. - SG 71/2008, in force from 12.08.2008) declaration that the content of the leaflet according to letter "a"
p.(None): shall be identical with the content of the product leaflet, approved in Republic of Bulgaria except of the data
p.(None): according to Art. 215, para 2, point 7, letters "a" – "d";
p.(None): 4. document and report to the marketing authorisation holder and the BDA all reports of adverse drug reactions of the
p.(None): imported medicinal product.
p.(None):
p.(None): Chapter nine.
p.(None): "B" EXPORT OF MEDICINAL PRODUCTS (NEW – SG 18/14)
p.(None):
p.(None): Art. 217a. (new – SG 18/14) (1) Export of medicinal products from the territory of the Republic of Bulgaria may be done
p.(None): by a natural person or a legal entity holding a permit for wholesale with medicinal products or by a holder of a
p.(None): production license.
p.(None): (2) Holders of a production license may carry out export only of the medicinal products manufactured by them.
p.(None): (3) Within the meaning of this Chapter, export shall also be an intra-Community supply within the European Union.
p.(None): (4) Export of medicinal products included in the Positive Medicines List referred to in Art. 262, par. 1 from the
p.(None): territory of the Republic of Bulgaria shall take place upon notification of BDA in every individual case, where the
p.(None): export is being carried out by the holder of a permit for wholesale of drugs.
p.(None):
p.(None):
p.(None): Art. 217b. (new – SG 18/14) The notification referred to in Art. 217a, par. 4 shall be send to the Managing Director of
p.(None): BDA and shall contain the following information:
p.(None): 1. name and registered address of the person under Art. 217a, par. 1;
p.(None): 2. name, pharmaceutical form and active substance quantity in a dose unit of the medicinal product
p.(None): intended for export;
p.(None): 3. reference number of the permit for wholesale of medicinal products;
p.(None): 4. number of packages of the medicinal product intended for export;
p.(None):
p.(None): 5. the state of destination of the export.
p.(None):
p.(None):
...

p.(None): medicinal products under Art. 228, Para. 5, may make a change under Art. 230, Para. 1, p. 4 only in a populated place
p.(None): with population up to 10 000 citizens.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011) Where the person under Para. 3 wishes to make a change under Art.
p.(None): 230, Para. 1, p. 4 in a populated place with population up to 10 000 citizens, he/she shall pay the charge for issuance
p.(None): an authorisation for retail trade with medicinal products in a pharmacy, determined by the tariff under Art. 21, Para.
p.(None): 2.
p.(None): (5) (Former Para. 2, - SG, 60/2011, in force from 5. 8. 2011) at issuing the authorisation allowing the change
p.(None): according to para 1, the provisions in Art. 229 shall be applied.
p.(None):
p.(None):
p.(None): Art. 232. (1) Physicians and physicians in dental medicine can keep medicinal products
p.(None):
p.(None): according to a list determined by the Minister of Health.
p.(None): (2) Where there is no pharmacy in a settlement, the persons according to para 1 can only keep and sell medicinal
p.(None): products provided that they have received authorisation therefore according to an order laid down in a regulation of
p.(None): the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 233. The manager of the pharmacy takes the responsibility for the activities according to Art. 219,
p.(None): para 1.
p.(None):
p.(None):
p.(None): Art. 234. (1) Prohibited shall be the sale of medicinal products through automatic machines except for
p.(None): the medicinal products indicated in a list determined to the regulation according to Art. 219, para 2.
p.(None): (2) The automatic machines according to para 1 can be possession only on the persons according to Art. 222 and Art.
p.(None): 238, para 2.
p.(None): (3) The bargain trade with drug products shall be prohibited
p.(None): (4) The sale of medicinal products dispensed on medical prescription via internet shall be prohibited.
p.(None): (5) (New – SG, 60/2011, in force from 5. 8. 2011) Medicinal products without doctor’s prescription may be sold on
p.(None): internet only by a pharmacy or drug store, which have received authorisation under the terms and conditions of this Act
p.(None): and the ordinance under Art. 219, Para. 2, or Art. 243.
p.(None): (6) (new – SG, 102/2012, in force from 02.01.2013) The pharmacies and drug stores under Para. 5 shall publish on the
p.(None): internet site, which is for their trade with medicinal products without doctor’s prescription a general logo,
p.(None): recognizable for the whole EU.
p.(None): (7) (new – SG, 102/2012, in force from 02.01.2013) The requirements to the general logo under Para. 6 shall be
p.(None): determined by a delegated act under Art. 85c, Para. 3 of Directive 2001/83/EC.
p.(None):
p.(None):
p.(None): Art. 234a (new – SG, 102/2012, in force from 02.01.2013) (1) The BDA shall publish and maintain on its internet site:
p.(None): 1. information about the national legislation, applicable for offering medicinal products for sale on internet,
p.(None): including information about the fact, that there may exist differences between the Member States in relation to the
p.(None): classification of the medicinal products and of the conditions for their delivery;
p.(None): 2. information about the purpose of the general logo;
p.(None): 3. list of the persons, offering medicinal products for sale on internet, as well as the addresses of their internet
p.(None): sites;
p.(None): 4. general information about the risks, related to the medicinal products, delivered to the consumers via internet in
p.(None): violation of the ordinance under Art. 234, Para. 5.
p.(None): (2) The BDA internet site under Para. 1 shall be connected with the internet site of the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 234b (new – SG, 102/2012, in force from 02.01.2013) The BDA shall participate in information campaigns, organised
p.(None): by the European Commission and the European Medicines Agency about the danger of falsified medicinal products.
p.(None):
p.(None): Art. 235. (1) The authorisation to carry out retail trade with medicinal products shall be cancelled with the
p.(None): termination of the activity of the persons according to Art. 222.
...

p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
p.(None): In the cases, where it is found that the requirements of the Ordinance under Art. 243 have not been observed,
p.(None): within 7 day term after the inspection the RHI shall give instructions and shall determine term for removing them.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011). Within 14 day term from receiving the application and the
p.(None): documents under Para. 2, the director of RHI shall notify in writing the persons for finding irregularities
p.(None): in them and shall determine a term for their removal.
p.(None): (5) (New – SG, 60/2011, in force from 5. 8. 2011). For submitting a registration application for a drug
p.(None): store or for performing a change under Art. 242, the relevant RHI shall collect charges in the amount, determined by
p.(None): the tariff under Art. 21, Para. 2.
p.(None):
p.(None):
p.(None): Art. 240 (Amend. - SG, 60/2011, in force from 5. 8. 2011). Within 14 day term after the inspection under Art. 239,
p.(None): Para. 3 or after removing the irregularities under Art. 239, Para. 4, the director of the RDA shall issue a
p.(None): registration certificate for a drug store or shall give a grounded refusal for its issuance.
p.(None): (2) (new – SG, 102. 2012, in force from 2.1.2013) The director of the RDA shall provide grounded refusal to issue a
p.(None): registration certificate to the persons under Art. 238, Para. 2, where:
p.(None): 1. some of the documents under Art. 239, Para. 2 has not been produced;
p.(None): 2. within the term under Art. 239, Para. 4 the applicant has not removed the found incompleteness.
p.(None): (3) (new – SG, 102. 2012, in force from 21.12.2012) Where within the term under Para. 1 the RDA director has not issued
p.(None): a registration certificate of drug store or has not refused with a ground, it shall be accepted that there is a silent
p.(None): agreement.
p.(None): (4) (new – SG, 102. 2012, in force from 21.12.2012) IN the cases under Para. 3, the applicant may begin carrying out
p.(None): the actions, applied for while observing Art. 29 of the Act on Restriction of the Administrative Regulation and
p.(None): Administration Control on Economic Activity.
p.(None): (5) (former Para. 2 – SG, 102. 2012, in force from 21.12.2012) The refusal of the executive director of
p.(None): the RDA under Para. 1, to issue certificate of registration shall be subject to appeal under the terms of the
p.(None): Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 240a (new - SG, 102. 2012, in force from 21.12.2012) (1) The RDA director shall
p.(None):
p.(None): terminate by an order the registration of a drug store:
p.(None): 1. upon request of the persons, received a registration certificate for a drug store;
p.(None): 2. with termination of the person’s activity under Art. 238, Para. 2, for which he/she shall notify the relevant RDA.
p.(None): (2) Within 14-day term from termination of the activity under Para. 1, p. 2, the person under Art. 238, Para. 2 shall
p.(None): notify in writing the RDA.
p.(None):
p.(None):
p.(None): Art. 241. (1) (Amend. - SG, 60/2011, in force from 5. 8. 2011) The relevant RHI shall keep a record of the issued
p.(None): certificates for a drugstore authorisation, which shall contain:
p.(None): 1. number and date of the issued certificate;
p.(None): 2. place of business and address of management of the persons who have received certificates for registration of
p.(None): drugstore;
p.(None): 3. name, personal data, and address of the manager of the drugstore;
p.(None): 4. address of the drugstore;
p.(None): 5. date of cancelling the registration and reason therefore;
p.(None): 6. remarks relating to the inscribed circumstances.
p.(None): (2) (Amend. - SG, 60/2011, in force from 5. 8. 2011) Data of the register shall be published on the
p.(None): internet site of the relevant RHI.
p.(None):
p.(None):
p.(None): Art. 241a. (New - SG, 60/2011, in force from 5. 8. 2011) The National register of the issued registration certificates
p.(None): of a drug store under Art. 19a, Para. 3 shall contain:
p.(None): 1. name of the relevant RHI, issued the registration certificate;
p.(None): 2. number and date of the issued certificate;
p.(None): 3. seat and address of the persons, received the registration certificate for a drug store;
p.(None): 4. name of the drug store manager;
p.(None): 5. address of the drug store;
p.(None): 6. date of termination of the registration and ground for that.
p.(None):
p.(None):
p.(None): Art. 242. In case of change of the address of the drugstore of the manager, the person who has received the
p.(None): authorisation to open the pharmacy shall submit an application under the terms of Art. 239, para 2, and documents
p.(None): associated with the change.
p.(None):
p.(None):
p.(None): Art. 243. The conditions and order for the organisation of work in a drugstore shall be paid down in a regulation of
p.(None): the Minister of Health.
p.(None):
p.(None): Chapter eleven.
p.(None): ADVERTISING MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 244. (1) Advertising of medicinal products shall be any form of information, provision, promotion, or offers aimed
p.(None): at stimulating the prescribing, sale, or use of a medicinal product and shall include:
p.(None): 1. advertising intended for the population;
p.(None): 2. advertising, intended for medical specialists;
p.(None): 3. visit of a medical trade representative with medical specialists;
p.(None):
p.(None): 4. provision of samples to medicinal products;
p.(None): 5. sponsorship of promotional meetings and scientific congresses visited by medical specialists including taking
p.(None): their travel and stay expenses in the respective country where the event is taking place.
p.(None): (2) The following shall not be considered advertising of medicinal products:
p.(None): 1. text on the secondary packaging and in the patient information leaflet, which has been approved in the procedure for
p.(None): marketing authorisation;
p.(None): 2. correspondence on the occasion of a specific issue or problems associated with a given medicinal product;
p.(None): 3. informative announcements and instructions as to changes in the packaging, warnings for adverse drug
p.(None): reactions as a part of the overall safety measures for the medicinal product, trade catalogues and pricelists provided
p.(None): that these do not contain data of advertising character with respect to the medicinal product;
p.(None): 4. statements relating to human health or diseases provided that when these do not directly or indirectly bear on
p.(None): treatment, prophylaxis, or diagnostics with medicinal products;
p.(None): 5. campaigns carried out by the Ministry of Health for vaccination of the population where the associated materials do
p.(None): not contain data for a specific medicinal product.
p.(None):
p.(None):
p.(None): Art. 245. (1) The marketing authorisation holder shall be obliged to establish a scientific unit for the
p.(None): proliferation of information fir the medicinal products for which he has received marketing authorisation
p.(None): under the terms of this Act.
p.(None): (2) The marketing authorisation holder shall be obliged to:
p.(None): 1. guarantee that the advertising of a medicinal product is presented to the population and medical specialists in an
p.(None): appearance corresponding to the requirements of this chapter and in compliance with the advertising authorisation
p.(None): issued by the BDA;
p.(None): 2. have at his disposal data and materials of all advertising campaigns undertaken within the framework of his activity
p.(None): including information about the groups, which the advertising is intended for, about the method of its realisation, as
p.(None): well as the starting date of the advertising campaign;
p.(None): 3. guarantee the training of the medical trade representatives;
p.(None): 4. accurately and timely fulfil the instructions of the persons responsible for the control of advertising.
p.(None): (3) The medical trade representatives must report to the scientific units according to para 1 any information about the
p.(None): use of the advertised medicinal products, particularly with respect of the information of adverse drug reactions
p.(None): communicated to them by the medical specialists.
p.(None):
p.(None):
p.(None): Art. 245a. (New – SG. 71/2008, in force from 12. 08. 2008) Advertisement shall be admitted only of
p.(None): medicinal products, for which an authorisation has been issued under this Act.
p.(None):
p.(None):
p.(None): Art. 246. (1) The content of the advertising must comply with the data of the approved during the marketing
p.(None): authorisation procedure summary of product characteristics and only present the indications approved therein.
p.(None): (2) Advertising of a medicinal product must only bear on its correct use by objectively presenting the therapeutic
p.(None): indications of the medicinal product without exaggerating its therapeutic, prophylactic, and diagnostic
p.(None): capacities.
p.(None): (3) The advertising must not contain misleading information.
p.(None):
p.(None): (4) (New – SG. 71/2008, in force from 12.08.2008) The advertisement shall not contain proposal and/or promise for a
p.(None): gift and/or another property or non-property benefit.
p.(None): (5) (New – SG. 71/2008, in force from 12.08.2008) A medical specialist or a person, representing himself/herself as
p.(None): a medical specialist shall not perform direct or indirect advertisement of medicinal products in the printed
p.(None): and/or electronic media, as well as in internet.
p.(None):
p.(None):
p.(None): Art. 247. Advertising to the population shall only be allowed for medicinal products dispensed without
p.(None): medical prescription.
p.(None):
p.(None):
p.(None): Art. 248. Besides the cases according to Art. 247, advertising campaigns carried out by marketing authorisation
...

p.(None): control shall be exercised by officials – inspectors and experts appointed by orders of the Council
p.(None): chairpersons under Art. 258, Para. 1 and of the director of the BDA or the director of corresponding RHI depending on
p.(None): their subjection.
p.(None): (4) For the execution of their control functions, the bodies according to Para. 1 can request the
p.(None): assistance of the bodies of the Ministry of Interior.
p.(None):
p.(None):
p.(None): Art. 267a (New – SG, 60/2011, in force from 5. 8. 2011, amend. - SG 102/2012, in force from 21.12.2012) The Executive
p.(None): Agency Medical Audit shall perform control for observation of the confirmed phrmaco-therapeutic guides and performing
p.(None): evaluation of the effectiveness of the therapy in compliance with the criteria under art. 259, Para. 1, p. 4.
p.(None):
p.(None):
p.(None): Art. 268. (1) The BDA shall exercise control on:
p.(None): 1. (suppl. - SG 102/2012, in force from 21.12.2012)the compliance of the premises, equipment, and conditions
p.(None): for manufacture, control, storage, and trade in medicinal products and active substances and for the observation of the
p.(None): Good Manufacturing Practice for medicinal products and the Good Distribution Practice;
p.(None): 2. (amend. - SG 102/2012, in force from 21.12.2012) the activity of the manufacturers, importers, marketing
p.(None): authorisation holders, manufacturers, importers, wholesalers of medicinal products, and active substances of
p.(None): intermediaries in the area of medicinal products, pharmacies, and drugstores;
p.(None): 3. the quality, safety, and efficacy of the medicinal products;
p.(None): 4. the clinical trials with medicinal products and the control of the observation of the requirements of the Good
p.(None): Clinical Practice;
p.(None): 5. drug information associated with marketing and advertising authorisation;
p.(None): 6. (amend. - SG 102/2012, in force from 21.12.2012) the pharmaco-vigilance system of the marketing authorisation
p.(None): holders and for observation of the requirements of the Good practice for pharmaco-vigilance.
p.(None):
p.(None): (2) (amend., - SG 98/10, in force from 01.01.2011) The regional health inspectorates shall exercise control over the
p.(None): premises, equipment, and conditions for storage of and trade in medicinal products, as well as over the activity of the
p.(None): wholesalers, pharmacies, and drugstores situated on the territory of the respective region.
p.(None): (3) Investment projects for construction of new and/or refurbishment of existing sites associated with the manufacture
p.(None): of medicinal products in compliance with the rules for Good Manufacturing Practice of medicinal products shall be
p.(None): coordinated with the BDA.
p.(None):
p.(None):
p.(None): Art. 268a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Donations of medicinal products from holders authorisation
p.(None): for use, producers, wholesale and retail traders and from the Bulgarian red cross may be done only after coordination
p.(None): of the donator with the BDA through producing an application according to a form, confirmed by the Minister of Health
p.(None): upon proposal of the executive director of BDA.
p.(None): (2) The donations shall be done while observing the rules for Good donation practice of the World Health Organisation.
p.(None): (3) Where within 10 day term from receiving the application under Para. 1, BDA fails to respond in writing to the
p.(None): donator, it shall be accepted, that there is a silent agreement for the donation.
p.(None): (4) The medical establishments and the Bulgarian red cross shall inform BDA for the received donations of medicinal
...

p.(None): Art. 274. (1) The conditions and order for blocking and recall of medicinal products, which have shown
p.(None): discrepancies with the requirements to quality, efficacy, and safety shall be paid down in a regulation of the Minister
p.(None): of Health.
p.(None): (2) The conditions and order for destruction, reprocessing, and otherwise use of medicinal products shall be
p.(None): paid down in a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 275. (1) During exercising control, the BDA shall undertake all necessary measures to ensure correct validation of
p.(None): the processes of manufacture and purification of the medicinal products obtained from human blood or human
p.(None): plasma, consistency of batch quality, and guaranteeing the absence of specific viral contamination in so far as
p.(None): technology allows.
p.(None): (2) Manufacturers shall notify the BDA of the method used for decreasing or elimination of pathogenic viruses, which
p.(None): can be transmitted through medicinal products obtained from
p.(None):
p.(None): human blood or human plasma.
p.(None): (3) The BDA shall test or forward to another official laboratory for control of medicinal products in Republic of
p.(None): Bulgaria or another Member State samples of bulk product and/or medicinal product for a test or in the
p.(None): course of assessment of an application for marketing authorisation according to Art. 46, para 1, point 2, or
p.(None): after issuing a marketing authorisation.
p.(None):
p.(None):
p.(None): Art. 276. The executive director of the BDA shall temporarily stop, bereave, or amend by an order the marketing
p.(None): authorisation of a medicinal product or its registration where it shall be established that:
p.(None): 1. there is an inadmissible adverse drug reaction during correct use or
p.(None): 2. there is lack of therapeutic efficacy (lack of therapeutic shall be where it has been established that the
p.(None): declared therapeutic results cannot be achieved at its marketing authorisation), or
p.(None): 3. the benefit/risk ratio is unfavourable during correct use, or
p.(None): 4. the quantitative and qualitative composition of a medicinal product does not comply with that declared at the
p.(None): marketing authorisation, or
p.(None): 5. the data in the dossier according to Art. 27 - 32 are untrue, or
p.(None): 6. (Amen. - SG 71/2008, in force from 12.08.2008) the data in the dossier according to Art. 27 - 32 have not been
p.(None): supplemented of amended in compliance with the requirements of Chapter Three, Section six, or
p.(None): 6a (new – SG, 102/2012, in force from 21.12.2012) the conditions under Art. 55a or 56a are not fulfilled, or
p.(None): 6b (new – SG, 102/2012, in force from 21.12.2012) the manufacture of the medicinal product has not been carried out in
p.(None): compliance with the described way of manufacture under Art. 27, Para. 1, p. 7, or
p.(None): 7. (amend. – SG, 102/2012, in force from 21.12.2012) the control tests are not conducted or they have not been
p.(None): conducted in compliance with the methods laid down in Art. 27, Para. 1,
p.(None): p. 8, or
p.(None): 8. the data on the packaging and/or leaflet is not in compliance with those approved at the issuing of the marketing
p.(None): authorisation.
p.(None): 9. (New - SG 71/2008, in force from 12.08.2008) the owner of the authorisation for use has not fulfilled the
p.(None): obligations under Art. 45, para 1 of Regulation (EC) N 1901/2006.
p.(None):
p.(None):
p.(None): Art. 277. (1) The executive director of the BDA irrespective of the measures according to Art. 276, shall prohibit by
p.(None): an order the supply with the medicinal product and shall order its blocking and recall from the market where:
p.(None): 1. (amend. – SG, 102/2012, in force from 21.12.2012) there is an inadmissible adverse drug reaction or
p.(None): 2. there is lack of therapeutic efficacy, or
p.(None): 3. (amend. – SG, 102/2012, in force from 21.12.2012) the benefit/risk ratio is unfavourable, or
p.(None): 4. the quantitative and qualitative composition of a medicinal product does not comply with that declared at the
p.(None): marketing authorisation, or
p.(None): 5. the control of the medicinal product and/or its ingredients and on the intermediate stages of the manufacturing
p.(None): process has not been done or the requirements under which the manufacture authorisation ahs been granted are not met.
p.(None): (2) The executive director of the BDA can also impose a ban according to para 1 on
p.(None):
p.(None): concrete batches of a medicinal product.
p.(None):
p.(None):
p.(None): Art. 278. (1) The executive director of the BDA shall, by an order, temporarily stop or bereave the marketing
p.(None): authorisation of a group of or all medicinal products, for which the requirements as regards the place
p.(None): manufacture for which the manufacturing authorisation has been granted are not met.
p.(None): (2) The executive director of the BDA besides the measures according to Art. 276, can, by an order, temporarily
p.(None): stop the import of a group of or all medicinal products from third countries or bereave the issued import
p.(None): authorisation for a group of or all medicinal products where these do not comply with the requirements of chapter five.
p.(None): (3) The executive director of the BDA besides the measures according to Art. 276, can, by an order, temporarily stop or
p.(None): bereave the manufacturing authorisation for a group of or all medicinal products, which are not in compliance with the
p.(None): requirements of chapter five.
p.(None):
p.(None):
...

p.(None): out export of medicinal products under Art. 217a, par. 4 shall be punished with a fine, respectively with a proprietary
p.(None): sanction from BGN50 000 to BGN100 000, and in case of repeated the same violation – from BGN100 000 to BGN200 000.
p.(None):
p.(None):
p.(None): Art. 286. (1) In case of clinical trials conducted in infringement of this Act, provided no crime has been committed,
p.(None): the guilty persons shall be penalised with a fine from BGN 5,000 to BGN 10000 and in case of repeated permission or
p.(None): commitment of the same infringement – with a fine from BGN 10000 to BGN 20000.
p.(None): (2) Medial specialists who have permitted or committed infringements according to para 1 can be imposed the penalty of
p.(None): "deprived of the right to exercise the profession" for a term from 6 months to two years.
p.(None): (3) The measure according to para 2 shall be imposed by the Minister of Health according to a proposal by
p.(None): the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 287. (1) (Supl.. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Whoever conducts retail trade in medicinal products without having respective authorisation/certificate, or
p.(None): works in violation of his/her issued authorisation/certificate, shall be penalised by a fine from BGN 5,000 to BGN
p.(None): 10,000.
p.(None): (2) The penalty according to para 1 shall also be imposed on persons who conduct retail trade in pharmacy or drugstore
p.(None): after the authorisation/certificate has ceased to be in effect.
p.(None): (3) (Supl. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from
p.(None):
p.(None): 5. 8. 2011) Whoever sells, or stores in a drug store medicinal products, prescribed by doctor’s prescription, or
p.(None): products or goods of human health significance, outside the ones, determined in the ordinance under Art. 243,
p.(None): shall be punished by the fine under para 1, and in repeated perpetration of the infringement the issued
p.(None): registration of the drug store will be deprived of.
p.(None): (4) In the cases according to para 1 and 2, the bodies of the state control on the medicinal products
p.(None): shall stop the operation of the site by an order.
p.(None): (5) The order according to para 4 shall be subject to appeal under the terms of the Administrative Procedure Code;
p.(None): however, the appeal shall not stop its execution.
p.(None): (6) (Repealed - SG 71/2008 in force from 12.08.2008).
p.(None):
p.(None):
p.(None): Art. 287a. (New - SG 71/2008 in force from 12.08.2008). (1) Medical specialist, who works with persons,
p.(None): performing retail trade with medicinal products, without having authorisation/certificate for this, shall
p.(None): be punished by a fine of BGN 2500 to 5000
p.(None): (2) The punishment under para 1 shall be imposed on a person under para 1, who works in a pharmacy or a drugstore after
p.(None): termination of the action of the authorisation/certificate.
p.(None): (3)In case of established more than 2 violations under para 1 and 2, the Minister of Health may deprive the medical
p.(None): specialist of the right to exercise his/her profession for the term of up to 2 years.
p.(None):
p.(None):
p.(None): Art. 287b. (new – SG, 102/2012, in force from 02.01.2013) Anyone, who carries out trade with medicinal products on
p.(None): internet in violation of this act and the ordinance under Art. 234, Para. 5 shall be punished by a fine of BGN 5000 to
p.(None): 10 000.
p.(None):
p.(None):
p.(None): Art. 288. (1) A retailer in medicinal products who has permitted an incapable person to exercise activities, pointed
p.(None): out in Art. 219, shall be penalised with a property sanction from BGN 5,000 to BGN 10,000 and in case of repeated
...

p.(None): the triple amount of the stipulated maximum amounts of the respective fines.
p.(None): (2) (suppl. – SG 60.12, in force from 07.08.2012) For infringements according to Art. 289, para 1 the property
p.(None): sanction shall be the nine-fold amount of the overdrawn amount provided that it exceeds the maximum amount of
p.(None): the sanction according to para 1.
p.(None): (3) The imposing of a property sanction shall not exclude fining of the guilty officials.
p.(None): (4) The imposing of property sanctions shall not exclude the imposing of the stipulated measures regarding the right of
p.(None): the medical specialists and qualified persons.
p.(None):
p.(None):
p.(None): Art. 292. (1) Whoever shall not execute an order, directions, or instruction of the bodies of the state control, except
p.(None): in the cases pursuant to Art. 270, para 1, issue 2 and para 3 shall be penalised with a fine from BGN 1,500 to BGN
p.(None): 3,000.
p.(None): (2) For failure to execute an order, pursuant Art. 270, para 1, issue 2 and 3, the blamed persons shall be penalised
p.(None): with a fine of from BGN 500 to BGN1000.
p.(None):
p.(None):
p.(None): Art. 293. (1) (amend. – SG, 102/2012, in force from 02.01.2013)In cases according Art. 281, Para. 1-3, Art. 283, Para.
p.(None): 1, as and of non-observance of the condition under which the authorisations to retail trade with medicinal products in
p.(None): a pharmacy, the BDA executive director shall issue an order for the bereavement thereof.
p.(None): (2) In case of non-observance of the conditions under which the
p.(None): authorisations/certificates for registration of a drug store as well as in the cases under 287, Para. 3, the director
p.(None): of the BDA shall issue an order for the bereavement thereof.
p.(None): (3) In case of non-observance of the obligation to notify according to Art. 204, Para. 3, for the termination of the
p.(None): activity on the part of a wholesaler of medicinal products, the executive director of the BDA shall issue an order for
p.(None): the bereavement the issued authorisation.
p.(None): (4) (amend. – SG, 102/2012, in force from 02.01. 2013) In case of non-observance of the obligation to notify according
p.(None): to Art. 235, Para. 3, for the termination of the activity on the part of a holder of an authorisation to retail trade
p.(None): with medicinal products, the BDA executive director shall issue an order for bereavement of the issued authorisation.
p.(None): (5) The orders according to Para. 1 - 4 shall be subject to appeal under the terms of the Administrative Procedure
p.(None): Code, however, the appeal shall not stop their execution.
p.(None):
p.(None): Art. 294. Whoever infringes the provisions of this Act or the regulations for its implementation, except
p.(None): for the cases according to Art. 281-293, shall be penalised with a fine from BGN 1,000 to BGN 3,000 and in case of
p.(None): repeated perpetration of the same infringement – with a fine from BGN 3,000 to BGN 5,000.
p.(None):
p.(None):
p.(None): Art. 295. (1) (amend., - SG 98/10, in force from 01.01.2011) The infringements according to this Act shall be
p.(None): established by virtue of deeds drawn up by state inspectors of the BDA or of the RHI.
p.(None): (2) The infringements according to Art. 289 shall only be established by officials appointed by the
p.(None): Minister of Health.
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011) The penal ordinances shall be issued by the Minister of Health, the
...

p.(None): market in the European Union as a medicinal product but is different with respect to safety and efficacy from
p.(None): a formerly authorised substance;
p.(None): c) biological substance, which has been authorised to market in the European Union as a medicinal product but has
p.(None): different molecular structure, different origin with respect to the starting material, or has been obtained
p.(None): through a different manufacturing process;
p.(None): d) radiopharmaceutical substance the radionuclides or molecular bonds (ligands) of which have not been
p.(None): authorised in the European Union as a medicinal product or the mechanism of bonding in a couple of the molecules
p.(None): and radionuclides has not been authorised in the European Union.
p.(None): 40. "Adverse event" shall mean any untoward unfavorable change the health condition observed during the administration
p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
p.(None): disability, and innate anomalies;
p.(None): d) combination of reactions according to subsections "a", "b", and "c".
p.(None): 42. "Common name" shall mean the international non-proprietary name (INN) of a medicinal substance or
p.(None): excipient recommended by the World Health Organisation; if not any, the name in the European Pharmacopoeia shall be
p.(None): used; if there is no such name there, another pharmacopoeia name shall be used; if there is no pharmacopoeia name, the
p.(None): common name shall be used.
p.(None): 42a (new – SG, 102/2012, in force from 21.12.2012) "Basic documentation of a system of pharmaco-vigilance" is a detail
p.(None): description of the pharmaco-vigilance system, used by the marketing authorisation holder in relation or one or more
p.(None): authorised for use medicinal products.
p.(None): 42b. (new - SG48/15) "Health technology assessment" shall mesn:
p.(None): a) a form of policy on research that examines the short- and long-term outcomes related to the implementation of
p.(None): health technologies and aims to provide information concerning alternative health strategies;
p.(None): b) multidisciplinary activity that systematically evaluates technical specifications, safety, clinical efficacy and
...

p.(None): ratio.
p.(None): 70. "Urgent limitation safety measures" shall mean temporary changes in the product information with respect of one
p.(None): or more parts of the summary of product characteristics, indications, method of administration,
p.(None): contraindications, and warnings, which result from new information associated with the safe use of a medicinal product.
p.(None): 71. "Spontaneous report" shall mean a voluntarily report for a suspected adverse reaction during the use of
p.(None): a medicinal product forwarded to the marketing authorisation holder, to the bodies for supervision on the medicinal
p.(None): products, or to other organisations, which is not originating from a study or another organised system for data
p.(None): capturing.
p.(None): 72. "Expiry period of a medicinal product" shall mean the interval of time during which, if a medicinal product is
p.(None): stored under the prescribed conditions, it shall comply with the specification developed on the grounds of
p.(None): stability tests of several batches of the finished form.
p.(None): 73. (Amen. - SG 71/2008, in force from 12.08.2008) "Medicinal product equivalent to a herbal medicinal product"
p.(None): shall mean a product containing the same active substances irrespective of the composition of the excipients
p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
...

p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
p.(None): § 3. The Council of Ministers shall determine the conditions and order for the supply, storage and renewal of the
p.(None): medicinal products kept in the State Agency "State Reserve and War-time Reserves".
p.(None):
p.(None):
p.(None): § 4. (suppl. – SG 18/14) This Act shall implement the provisions of Directive 2001/83/EC of the European Parliament
p.(None): and the Council on the Community code relating to medicinal products for human use subsequently amended
p.(None): by Directive 2004/27/EC of the European Parliament and the Council and of Directive 2012/26/EU of the European
p.(None): Parliament and of the Council of 25 October 2012.
p.(None):
p.(None):
p.(None): § 5. The data protection periods for reference medicinal products shall be applied according to the
p.(None): provisions of Art. 89 of Regulation (EC) № 726/2004 of the European Parliament and the Council and Art. 2 of Directive
p.(None): 2004/27/EC of the European Parliament and the Council
p.(None):
p.(None):
p.(None): § 5a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG, 102/2012, in force from 21.12.2012) The Ministry
p.(None): of Health, the National Council on prices and reimbursement of medicinal products, the BDA and the Regional health
p.(None): inspectorates shall provide opportunity for giving information and accepting applications and documents under this Act
p.(None): electronically under the terms and conditions of the Electronic Document and Electronic Signature Act and
p.(None): the Electronic Government Act.
p.(None): (2) Providing information and accepting applications and documents in electronic way
p.(None):
p.(None): shall be done after providing the relevant technical and organisation conditions, as well as the relevant programme
p.(None): products.
...

p.(None): 15 days from their receiving.
p.(None): (2) The BDA shall check the fulfillment of the obligation under Para. 1.
p.(None): (3) Where the notification refers a serious reverse medicinal reaction, occurred on the territory of a third state, the
p.(None): marketing authorisation holders within the term under Para. 1 shall notify the European Medicines Agency.
p.(None):
p.(None):
p.(None): § 126. (1) The marketing authorisation holders shall submit to BDA periodic updated safety reports in compliance with
p.(None): the time intervals under Art. 194k, Para. 3 for the medicinal products, which have issued marketing authorisations
p.(None): before 21 June 2012 and for which the frequency and the dates a of submitting the periodic updated safety
p.(None): reports have not been entered as conditions in the marketing authorisations.
p.(None): (2) The provision of Para. 1 shall apply by determination of another frequency or other dates for submitting the
p.(None): reports in the marketing authorisation or by determining dates and frequency under Art. 194l-194n.
p.(None):
p.(None):
p.(None): § 127. (1) The marketing authorisation holders shall provide periodic updated safety reports under Art. 194h, Para. 1
p.(None): in the register under Art. 194h, Para. 3 after expiry of 12 months from the date on which the European Medicines Agency
p.(None): announces its functioning.
p.(None): (2) By the time the term under Para. 1 comes, the marketing authorisation holders shall produce periodic updated safety
p.(None): reports to BDA and to the regulatory bodies if the other Member States, in which the relevant medicinal products is
p.(None): permitted for use.
p.(None):
p.(None):
p.(None): § 128. The wholesale trade authorisation/certificate holders of medicinal products in a pharmacy or drug store under
p.(None): Art. 234, Para. 5 shall place on the internet site the logo under Art. 234, Para. 6 within the term of up to 1 year
p.(None): from the date of publication of the act under Art. 85a, Para. 3 of Directive 2001/83/EC.
p.(None):
p.(None):
p.(None): § 129. The BDA shall carry out the first audit of the system under Art. 183, Para. 1 and shall submit to the European
p.(None): Commission a report with the results from it by 21, September 2013 latest.
p.(None):
p.(None):
p.(None): § 130. (1) By 20 March 2013 the initiated and not finalised procedures before the Commission on Prices
p.(None): and Reimbursement shall be finalised by it under the current procedure.
p.(None): (2) After 1 April 2013 not finalised procedure before the Commission on Prices and Reimbursement shall be
p.(None): finalised by the National council on prices and reimbursement of medicinal products under the terms and
p.(None): procedure of this act.
p.(None): (3) Within the term of up to 31 March 2013 the Commission on Prices and
p.(None):
p.(None): Reimbursement shall produce to the National council on prices and reimbursement of medicinal products by a record
p.(None): protocol the applications and documents, submitted for the procedures under Para. 1 as well as the archive of the
p.(None): finalised procedures.
p.(None): (4) Within the term of up to 31 March 2013 Commission on Prices and Reimbursement shall produce to the National council
p.(None): on prices and reimbursement of medicinal products by a record protocol the kept registers by the Commission.
p.(None):
p.(None):
p.(None): § 131. (1) By 20 March 2013 the fees for submitting an application for confirmation of process / limit prices,
p.(None): registration of process of medicinal products, for inclusion, exclusion or changes of medicinal products in the
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p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011, repealed – SG, 102/2012, in force from 21.12.2012)
p.(None): (3) (repealed – SG, 102/2012, in force from 21.12.2012) (4) (repealed – SG, 102/2012, in force from 21.12.2012) (5)
p.(None): (repealed – SG, 102/2012, in force from 21.12.2012) (6) (repealed – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None):
p.(None): Art. 145a. (new - SG, 102/2012, in force from 21.12.2012) (1) Non-interventional pos- marketing safety studies shall be
p.(None): conducted upon initiative of the marketing authorisation holder or in fulfillment of the conditions of Art. 55a and 56a
p.(None): and are related to data collection of medicinal safety by patiednt and medical specialists.
p.(None):
p.(None): (2) Where with the study, collection of data is planned by patients, their consent must be received. The personal
p.(None): data of the patients shall be processed while observing the requirements of the Act on Personal Data
p.(None): Protection.
p.(None): (3) The medical specialists shall not receive financial or other benefits for participation in the non-interventional
p.(None): safety studies, unless compensations for the spent time and means.
p.(None):
p.(None):
p.(None): Art. 145b. (new – SG, 102/2012, in force from 21.12.2012) (1) During the study under Art. 145c, Para. 1 and Art. 145f,
p.(None): Para. 1 the holder of the marketing authorisation shall carry out monitoring of the obtained data and shall account for
p.(None): their impact over the correlation benefit- risk for the medicinal product.
p.(None): (2) The marketing authorisation holder shall announce to BDA about each new information, which could
p.(None): influence the correlation benefit-risk for the medicinal product.
p.(None): (3) The obligation under Para. 2 shall not liberate the marketing authorisation holder from the requirements of Art.
p.(None): 194h for providing the information under Para. 2 and through the periodic updated safety reports.
p.(None):
p.(None):
p.(None): Art. 145c. (new – SG, 102/2012, in force from 21.12.2012) (1) Where the study is conducted only on the
p.(None): territory of the Republic of Bulgaria in implementation of the obligation under Art. 56a, the holder of the marketing
p.(None): authorisation shall produce a draft protocol of the study to BDA. The draft protocol, with a written consent
p.(None): under Art. 145a, Para. 2 shall be produced also to the commissions under Art. 103, Para. 1 or 2, where
p.(None): applicable.
p.(None): (2) The BDA executive director, within the term of up to 60 days from the date of receiving the
p.(None): documentation under Para. 1, the marketing authorisation holder shall submit a notification of the study or shall give
p.(None): a grounded refusal.
p.(None): (3) The BDA executive director shall refuse conducting of the study with one or more of the grounds under Art. 145f,
p.(None): Para. 2, p. 2.
p.(None): (4) The commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2 within the term of up to 60 days
p.(None): from the date of receiving the documentation under Para. 1 shall submit to the marketing authorisation holder a
p.(None): positive or negative opinion.
p.(None): (5) Conducting of the study may start after receiving approval by BDA and a positive opinion by the commission under
...

p.(None): (5) The expenses for performing the inspection under Para. 3, p. 2 shall be on the account of the
p.(None): applicant.
p.(None): (6) For the inspection under Para. 3, p. 2 the applicant shall pay a fee in the amount, determined by the tariff under
p.(None): Art. 21, Para. 2.
p.(None): (7) In the cases under Para. 3, p. 1 and Para. 4 the applicant may start to carry out his/her activity after
p.(None): registering in the register under Art. 167d.
p.(None):
p.(None):
p.(None): Art. 167c. (new – SG, 102/2012, in force from 02.01.2013) Where within the term under Art. 167b, Para. 3 BDA fails to
p.(None): notify, that an inspection will be carried out, the applicant may start carrying out the activity.
p.(None):
p.(None):
p.(None): Art. 167d. (new – SG, 102/2012, in force from 02.01.2013) (1) The BDA shall keep a public register of the importers,
p.(None): manufacturers and wholesale traders with active substances, which shall contain:
p.(None): 1. name management address of the person under Art. 167a;
p.(None): 2. list of the active substances to be imported, manufactured or traded;
p.(None): 3. the activities, which the person under Art. 167a will carry out;
p.(None): 4. 4. Premise address in which the activities will be carried out;
p.(None): 5. 5. Notes on the entered circumstances.
p.(None): (2) The BDA shall enter in the data base under Art. 147 the information about the registered importers,
p.(None): manufacturers and wholesale traders of active substances.
p.(None):
p.(None):
p.(None): Art. 167e. (new – SG, 102/2012, in force from 02.01.2013) (1) The person under Art. 167a shall submit to BDA yearly by
p.(None): 31 January a notification about changes in the information, entered in the register under Art. 167d.
p.(None): (2) In case of changes, which may influence the quality or safety of the active substances, which are manufactured,
p.(None): imported or disseminated, the person under Art. 167a shall notify the
p.(None):
p.(None): BDA immediately
p.(None):
p.(None):
p.(None): Art. 167f. (1) (new – SG, 102/2012, in force from 02.01.2013) The manufacture, import and wholesale trade of active
p.(None): substances on the territory of the Republic of Bulgaria, including active substances, intended for export, shall
p.(None): be carried out in compliance with the Good manufacturing practice and the Good dissemination practices for
p.(None): active substances.
p.(None): (2) The importers may import active substances only if the following conditions have been observed:
p.(None): 1. the active substances are manufactured in compliance with standards for Good manufacturing practice,
p.(None): which are at least equivalent to the ones, established in the European Union and
p.(None): 2. (in force from 02.07.2013) the active substances are accompanied by a written confirmation by the
p.(None): competent body of the state-importer, that:
p.(None): a) the standards for good manufacturing practice, applicable to the object for manufacture of the
p.(None): exported active substances are at least equivalent to the ones, established by the European Union;
p.(None): b) The relevant object for manufacture shall be subject to a regular control and in it effectively is applied the
p.(None): Good manufacturing practice, where this includes multiple and immediate inspections in view to guaranteeing
p.(None): protection of the public health, at least equal to the one in the European Union, and
...

p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
...

p.(None): to BDA within the term of up to 2. March 2013 an application and entry documents under Art. 167b.
p.(None): (2)The manufacturers and importers, who have manufactured or imported active substances on the basis of their
p.(None): issued authorisations for manufacture/import by 2 January 2013, shall not pay fee for their entry into the register
p.(None): under Art. 167.
p.(None): (3) By 2 March 2013 the persons under Para. 2 shall carry out activities of manufacture and import of active
p.(None): substances, based on their issued authorisations for manufacture/import.
p.(None):
p.(None):
p.(None): § 120. Persons, who carry out intermediation in the area of medicinal products and have started their activity
p.(None): before 2 January 2013, shall be registered under the conditions and procedure of Art. 212a within the term of
p.(None): up to 2 March 2013.
p.(None):
p.(None):
p.(None): § 121. The started marketing authorisation procedures by the enforcement of this act shall be finalised under the terms
p.(None): and procedure, provided by it.
p.(None):
p.(None):
p.(None): § 122. (1) The marketing authorisations holders shall not apply a system for risk management under Art.
p.(None): 192, Para. 1, p. 2 for medicinal products, who have been issued marketing authorisations before 21, July
p.(None): 2012, apart from the cases under Para. 2.
p.(None): (2) The BDA may impose obligations of the marketing authorisation holder to establish and apply a risk management
p.(None): system, where he/she considers, that for a certain medicinal products there are suspects, which may influence
p.(None): the benefit/risk ratio. In this case BDA shall require from the marketing authorisation holder to produce a
p.(None): detailed description of the risk management system, which he/she intends to introduce for the relevant medicinal
p.(None): product.
p.(None): (3) In the cases under Para. 2, BDA shall notify in writing the marketing authorisation holder by pointing out the
p.(None): motives for imposing the obligation and the term for producing a detailed description of the risk management
p.(None): system.
p.(None): (4) Within 30-day term after receiving the notification under Para. 3, the marketing authorisation holder
p.(None): may request from BDA providing an opportunity for producing information about the imposed obligation under Para. 2.
p.(None): (5) After receiving the request under Para. 4, BDA shall determine and term for producing the information
p.(None): by the marketing authorisation holder.
p.(None): (6) Based on the produced information, BDA may confirm the imposed obligation under Para. 2 or withdraw it.
p.(None): (7) The BDA shall notify the holder about the decision, taken under Para. 6.
p.(None): (8) Where BDA confirms the obligation, the executive director shall issue officially a change of the marketing
p.(None): authorisation by including in it a condition for the imposed obligation under Para. 2.
p.(None):
p.(None):
p.(None): § 123. The marketing authorisation holders of medicinal products, issued before 21 June 2012, shall fulfill the
p.(None): obligation under Art. 192, Para. 1, p. 1 starting from 21 July 2015 or from the date of renewal of the marketing
p.(None): authorisation of the relevant medicinal product, depending on which of the two dates will come first.
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p.(None): 1. authorisation for use or registration of medicinal products designated for the human medicine, which are
p.(None): industrially manufactured or the manufacturing method, which includes industrial process;
p.(None): 2. (amend. – SG, 102, in force from 21.12.2012) authorisation of manufacturing and import of medicinal products;
p.(None): 2a (new – SG, 102/2012, in force from 21.12.2012) manufacturing, import and wholesale trade with active substances;
p.(None): 3. approval and conducting clinical trials;
p.(None): 4. wholesale of and retail trade in medicinal products;
p.(None): 5. parallel import of medicinal products;
p.(None): 5a (new – SG, 102/2012, in force from 21.12.2012) intermediation in the area of medicinal products
p.(None): 5b (new – SG 18/14) export of medicinal products according to the provisions of Chapter
p.(None):
p.(None): Nine
p.(None):
p.(None): “b”;
p.(None): 6. advertising medicinal products;
p.(None): 7. follow-up of the safety of the medicinal products released on the market;
p.(None): 8. classification of the method of prescribing and dispensing medicinal products;
p.(None): 9. control of the manufacture and import, wholesale and retail trade, conducting clinical
p.(None): trials, advertising, and the system for the follow-up of the safety the medicinal products released on the market;
p.(None): 10. pricing of medicinal products;
p.(None): 11. development of Positive Medicines List.
p.(None):
p.(None):
p.(None): Art. 2. The purpose of this Act is to create conditions for providing the release on the market of medicinal products,
p.(None): which comply with the requirements relating to quality, safety, and
p.(None):
p.(None): efficacy.
p.(None):
p.(None):
p.(None): Art. 3. (1) Medicinal product in human medicine shall be:
p.(None): 1.any substance or combination of substances, which are intended for treatment or prophylactic of diseases
p.(None): in humans, or
p.(None): 2. any substance or combination of substances, which may be used or applied to humans with the aim of:
p.(None): a) recovery, correction, or modification of physiological functions in humans by means of pharmacological,,
p.(None): immunological or metabolic action, or
p.(None): b) diagnostic purposes.
p.(None): (2) Substance is any matter, the origin or which could be:
p.(None): 1. human (human blood, human blood products, and others);
p.(None): 2. animal (microorganisms, animal organs, extracts, secretions, toxins, blood products, and others.);
p.(None): 3. vegetal (microorganisms, plants and parts thereof, plant extracts, secretions, and others.);
p.(None): 1 State Gazette
p.(None): 4. chemical (elements, natural chemical materials, synthetic and semi synthetic substances, and others).
p.(None):
p.(None):
p.(None): Art. 4. Where a product meets simultaneously the characteristics of both medicinal product and another
p.(None): product regulated by other law, the provisions of this Act shall apply.
p.(None):
p.(None):
p.(None): Art. 5. Medicinal products shall be classified according to the anatomic-therapeutic- chemical classification
p.(None): in accordance with the requirements of the World Health Organisation (WHO).
p.(None):
p.(None):
p.(None): Art. 6. This Act shall not be applicable to:
p.(None): 1. hermetically closed radionuclides;
p.(None): 2. blood, plasma, or blood cells derived by a method including an industrial process.
p.(None):
p.(None):
p.(None): Art. 7. (1) Only the manufacture of, import, wholesale and retail trade in, advertising of and treatment,
p.(None): prophylaxis, and diagnosis with medicinal products, which have received marketing authorisation, shall be
p.(None): permitted under terms of:
p.(None): 1. this Act or
p.(None): 2. Regulation (EC) N 726/2004 of the European Parliament and of the Council.
p.(None): (2) The import of, trade in, treatment, prophylaxis and diagnosis with medicinal products beyond their expiry date
p.(None): shall be prohibited.
p.(None): (3) Possession of a marketing authorisation or certificate of use, manufacture, and clinical trials of
...

p.(None): safety of the medicinal product released on the market according to Para. 1 with the requirements of this Act.
p.(None): The information on the packing and in the leaflet of the medicinal product under Para. 1 shall not be obligatorily in
p.(None): the Bulgarian language.
p.(None): (4) The Executive Director of BDA shall inform the European Commission about the authorisation issued according to para
p.(None): 1, the name and address of the authorisation holder, as well as about the date of termination of the validity thereof.
p.(None):
p.(None):
p.(None): Art. 12. (1) The official pharmacopoeia of the Republic of Bulgaria shall be the European Pharmacopoeia
p.(None): (2) The official pharmacopoeia may be supplemented with the requirements of the Bulgarian pharmacopoeia.
p.(None): (3) The Minister of Health shall determine by way of order the dates of entry into effect of the current edition of the
p.(None): official pharmacopoeia and the annexes thereof.
p.(None): (4) The order according to para 3 shall be promulgated in the State Gazette and published on the internet
p.(None): site of BDA.
p.(None):
p.(None):
p.(None): Art. 13. (1) The monographs of the European Pharmacopoeia shall be obligatory for all substances, preparations, and
p.(None): pharmaceutical forms contained therein. In the cases where there is no monographs in the European Pharmacopoeia, the
p.(None): requirements of the current editions of the pharmacopoeias of the Member States, the U.S.A, and Japan provided that
p.(None): these are in compliance with the general rules of the European Pharmacopoeia.
p.(None): (2) Where the specification contained in a monograph of the European Pharmacopoeia or other national pharmacopoeia
p.(None): is insufficient to ensure the quality of the substance or pharmaceutical form, the Bulgarian Drug
p.(None): Agency can require supplementation of the specification by the applicant/marketing authorisation holder.
p.(None):
p.(None): Chapter two.
p.(None): MANAGING AND FINANCING BODIES
p.(None):
p.(None): Section I. Managing Bodies
p.(None):
p.(None): Art. 14. (1) The medicinal product policy in the Republic of Bulgaria is part of the State health policy and is
p.(None): implemented by the Minister of Health.
p.(None): (2) The Minister of Health shall:
p.(None): 1. be the national coordinator for the problems of medicinal product;
p.(None): 2. take part in international bodies and organisations carrying out activities in the domain of the medicinal products;
p.(None): 3. (repealed – SG, 60/2011, in force from 05.08.2011 new – SG, 102/2012, in force from 21.12.2012) organize provision
p.(None): of public information to the patient organisations and to the
p.(None):
p.(None): consumers organisations about the actions, undertaken against falsification of medicinal products.
p.(None): 4. Carry out other activities set out by a law.
p.(None): When activities according para 2, point 3 carried out, the Ministry of Health collect taxes in amount, determined in
p.(None): tariff according to Art. 21, para 2.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None):
p.(None):
p.(None): Art. 15. (1) Pharmacopoeia Committee shall be established with the Minister of Health as a consulting body on issues
p.(None): relating to the current pharmacopoeia.
p.(None): (2) The Minister of Health shall, on the grounds of a proposal of the Executive Director of the BDA determine by an
p.(None): order the composition of the Pharmacopoeia Committee and the expert groups thereto and shall approve the regulation
...

p.(None):
p.(None): Section II.
p.(None): Requirements Relating to the Documentation for Granting a Marketing Authorisation
p.(None):
p.(None): Art. 27. (1) For granting a marketing authorisation of a medicinal product, the person
p.(None):
p.(None): according to Art. 26, para 1, shall submit to the BDA a formal application accompanied by a dossier in the format of
p.(None): the Common Technical Document, which shall contain:
p.(None): 1. name and address of management and/or permanent address of the applicant according to Art. 26, para 2;
p.(None): where the applicant is a person other than the manufacturer(s) – address of the manufacture sties;
p.(None): 2. name of the medicinal product;
p.(None): 3. qualitative and quantitative particulars of the medicinal product, including its international
p.(None): non-proprietary name (INN) recommended by the WHO, where an INN for the medicinal product exists, or the
p.(None): relevant chemical name;
p.(None): 4. therapeutic indications, contraindications and adverse drug reactions;
p.(None): 5. posology, pharmaceutical form, method and route of administration and expected shelf-life;
p.(None): 6. precautions and safety measures during storage of the medicinal product, its administration to patients
p.(None): and for the disposal of waste products together with an indication of potential risks for the environment;
p.(None): 7. description of the method of manufacture;
p.(None): 8. description of the control methods employed by the manufacturer;
p.(None): 8a (new – SG, 102/2012, in force from 02.01.2013) declaration, that the audit results under Art. 160, Para. 2,
p.(None): conducted by the manufacturer of the medicinal product confirm that the active substance has been produced in
p.(None): compliance with the principles and directives for good production practice; the declaration shall indicate the date on
p.(None): which the audit is conducted;
p.(None): 9. assessment of the potential risks presented by the medicinal product for the environment for every
p.(None): individual case and measures for the limitation thereof;
p.(None): 10. results of:
p.(None): a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.(None): b) preclinical (toxicological and pharmacological) tests;
p.(None): c) clinical trials;
p.(None): 11. declaration that the ethic principles of the Good Manufacturing Practice have been complied with in the clinical
p.(None): trials conducted outside the territory of the Member States;
p.(None): 12. (amend. – SG, 102/2012, in force from 21.12.2012) a summary of the system
p.(None): a) for vigilance the medicinal safety, which shall include the following elements:
p.(None): b) which is to be implemented and, where appropriate, description of the risk management system;
p.(None): c) name of the qualified person under Art. 191, a CV – education, acquired professional experience in the area of
p.(None): vigilance the medicinal safety and qualification for performing his/her duties under Chapter Eight;
p.(None): d) each Member state in which the qualified person fulfils his/her duties;
p.(None): e) address, tel. fax, e-amil address of the person under letter "a";
p.(None): f) address, at which the basic document is kept of the system for vigilance medicinal
p.(None): safety;
p.(None): 12a. (new - SG, 102/2012, in force from 21.12.2012) declaration by the applicant that
p.(None): he/she has the needed means for fulfilling the obligations under Chapter Eight;
...

p.(None): application according to Art. 27, para 1, the Member State where the reference product is or has been authorised to
p.(None): market.
p.(None): (5) In the cases according to para 3, the BDA shall request from the regulatory authority of the Member State indicated
p.(None): in the application according to Art. 27, para 1, a confirmation of the information according to para 4, the qualitative
p.(None): and quantitative composition of the reference product and, if necessary, additional documentation.
p.(None): (6) At the request of a regulatory authority of a Member State where the application for a medicinal product generic to
p.(None): a referent medicinal product, which is or has been authorised to market on the territory of the Republic of
p.(None): Bulgaria, is submitted, the BDA shall submit the requested information according to para 5 within one month from
p.(None): the request date.
p.(None): (7) The ten-year period according to para 2 may be extended by maximum one year at the request of the marketing
p.(None): authorisation holder of the reference medicinal product provided that during the first 8 years from the issue
p.(None): of the marketing authorisation of the reference medicinal product its marketing authorisation holder has
p.(None): received authorisation for a new therapeutic indication the significant clinical advantages of which versus the
p.(None): existing therapeutic opportunities are scientifically well-grounded.
p.(None): (8) (new – SG 12/11, in force from 08.02.2011) Where for a medicinal product an initial marketing authorisation has
p.(None): been issued according to Art. 23, regarding each change of the strength of the active substance, in the pharmaceutical
p.(None): form, of the quantity per package, of the administrative route of the medicinal product, as well as regarding
p.(None): all other changes or extensions of the range of the marketing authorisation, an authorisation according
p.(None): to the requirements of this Act shall be also issued or the initial marketing authorisation shall be
p.(None): supplemented. All these authorisations shall be considered belonging to a general marketing authorisation of the
p.(None): medicinal product for the purposes of application of this Article.
p.(None):
p.(None):
p.(None): Art. 29. (1) The person according to Art. 26, para 1, shall submit to the BDA the results of the required preclinical
p.(None): and/or clinical trials in the cases where the medicinal product indicated in the application:
p.(None): 1. cannot be defined as generic or
p.(None): 2. the bioavailability tests do not prove bioequivalence, or
p.(None): 3. there is a change in the active substance(s), therapeutic indications, pharmaceutical form, and/or posology compared
p.(None): with the reference medicinal product, or
p.(None): 4. is offered in dosage units, which are different compared with the reference medicinal product.
p.(None): (2) Where a biological medicinal product indicated in the application as similar to a reference biological
p.(None): medicinal product does not comply with the conditions to be determined as
p.(None):
p.(None): a generic medicinal product due to different method of manufacture or different starting materials compared with the
p.(None): reference product, or for other reasons, the applicant shall submit to the BDA the results of the required preclinical
p.(None): and/or clinical trials associated with these conditions.
p.(None): (3) In the cases according to para 1 and 2 the documentation as laid down in the regulation according
p.(None): to Art. 42 shall also be submitted.
p.(None):
p.(None):
p.(None): Art. 30. (1) The person according to Art. 26, para 1, insofar as he does not infringe the industrial and commercial
p.(None): property, shall not submit to the BDA the data according to Art. 27, para 1, point 10, letters "b" and "c" provided
p.(None): that he can prove that the conditions laid down in the regulation according to Art. 42 to the effect that the
p.(None): active substance included in the composition of the medicinal product applied for marketing authorisation has a
p.(None): well-established use in the medical practice and possesses acknowledged efficacy and acceptable safety level. In these
p.(None): cases, the results from the tests and tests may be replaced by the relevant scientific publications.
p.(None): (2) The person according to para 1 shall submit the results from the required preclinical and clinical trials in
p.(None): case that the medicinal product containing active substances with well- established use, which have not been
p.(None): used for therapeutic use in the proposed combination. In this case, the documentation relating to each active substance
p.(None): shall not be submitted.
p.(None): (3) Where an active substance within the meaning of para 1 has a proven new therapeutic indication on the
p.(None): basis of significant preclinical or clinical data associated with the new indication, the next applicant may not refer
p.(None): to the data for the new indication of the active substance more than once in a year.
p.(None):
p.(None):
p.(None): Art. 31. In case, when medicinal product containing active substances used in the composition of
p.(None): authorised medicinal products but which are not used in the proposed combination for therapeutic purposes,
p.(None): the person according to Art. 26, para 1, shall submit the results of the preclinical trials and clinical trials
p.(None): associated with this combination. In
p.(None): this case the applicant shall not submit documentation relating to the safety and efficacy of each separate active
p.(None): substance.
p.(None):
p.(None):
p.(None): Art. 32. The marketing authorisation holder of a medicinal product may authorise the use of the pharmaceutical,
p.(None): preclinical and clinical documentation contained in the dossier of the medicinal product for the assessment of
p.(None): subsequent applications for medicinal products with the same qualitative and quantitative composition with respect to
p.(None): the active substances and with the same pharmaceutical form.
p.(None):
p.(None):
p.(None): Art. 33. Conducting the necessary studies and tests for the purpose of preparing the documentation for marketing
p.(None): authorisation and the subsequent practical requirements in connection with the authorisation to market of
p.(None): medicinal products according to Art. 28 and Art. 29 shall not be regarded as breach of patent rights or to
p.(None): supplementary protection certificates of medicinal products.
p.(None):
p.(None):
p.(None): Art. 34. (1) The summary of product characteristics shall contain the following information:
p.(None):
p.(None): 1. name of the medicinal product, quantity of the active substance in a dose unit, and pharmaceutical form;
p.(None): 2. qualitative and quantitative composition in terms of the active substances and constituents of the
p.(None): excipient, the information of which is essential for proper administration of the medicinal product. The usual common
p.(None): name or chemical description shall be used;
p.(None): 3. pharmaceutical form;
p.(None): 4. clinical particulars:
p.(None): a) therapeutic indications,
p.(None): b) posology and method of administration for adults and, where necessary, for children,
p.(None): c) contra-indications,
p.(None): d) special warnings and precautions for use and, in the case of immunological medicinal products, any special
p.(None): precautions to be taken by persons handling such products and administering them to patients, together with
p.(None): any precautions to be taken by the patient,
p.(None): e) interaction with other medicinal products and other forms of interactions,
p.(None): f) use during pregnancy and lactation,
p.(None): g) effects on ability to drive and to use machines,
p.(None): h) undesirable effects,
p.(None): i) overdose (symptoms, antidotes, emergency measures).
p.(None): 5. pharmacological properties:
p.(None): a) pharmacodynamic properties,
p.(None): b) pharmacokinetic properties,
p.(None): c) preclinical safety data.
p.(None): 6. pharmaceutical particulars:
p.(None): a) list of excipients,
p.(None): b) major incompatibilities,
p.(None): c) shelf life, where necessary after reconstitution of the medicinal product or where the immediate packaging is opened
p.(None): for the first time,
p.(None): d) special precautions for storage,
p.(None): e) nature and contents of container,
...

p.(None): years of use in the medical practice:
p.(None): 1. the medicinal product, which is similar to the product which is applied for registration, has been marketed without
p.(None): authorisation or registration or
p.(None): 2. where the number of the components or the strength of the medicinal product, which is applied for registration, is
p.(None): decreased.
p.(None):
p.(None):
p.(None): Art. 39. (1) Where the product has been used in the Community for less than 15 years, but is otherwise eligible for
p.(None): simplified registration Art. 37, para 1, the BDA shall submit the documentation according to Art. 38, para
p.(None): 1, to the Committee on Herbal Medicinal Products for opinion.
p.(None): (2) The BDA shall make the final decision following the establishment of the monograph of the Committee according to
p.(None): para 1 on the compliance or the product with the criteria for registration for traditional use.
p.(None): (3) In the cases according to para 1 the term according to Art. 44 shall cease to run.
p.(None):
p.(None):
p.(None): Art. 40. The BDA may request from the applicant for herbal medicinal product to submit the documentation according to
p.(None): Art. 27 - 32 or according to Art. 35.
p.(None):
p.(None):
p.(None): Art. 41. (1) The BDA shall publish on its internet site a list of the herbal substances, preparations, or
p.(None): combinations thereof used in the traditional herbal medicinal products established by the Committee on Herbal
p.(None): Medicinal Products of the European Evaluation Agency. The list shall contain therapeutic indications, strength,
p.(None): posology and method of administration as well as other information, which is necessary for the safe use of the herbal
p.(None): substance as a traditional medicinal product.
p.(None): (2) Where the product proposed in the application for registration for traditional use contains herbal
p.(None): substance, preparation, or combination of products included in the list according to para 1, the applicant shall not
p.(None): submit the data according to Art. 38, para 1, points 4 - 6.
p.(None): (3) Where the herbal substance, preparation, or combination thereof are excluded from
p.(None):
p.(None): the list according to para 1, the holder of the registration certificate of a herbal medicinal product must submit to
p.(None): the BDA the full documentation according to Art. 38 within three months from the amendment.
p.(None): (4) In case the holder of the registration certificate of the herbal medicinal product does not fulfil the obligation
p.(None): according to para 3, the BDA shall cancel the registration certificate of the product.
p.(None):
p.(None): Section V.
p.(None): Procedure for Granting Marketing Authorisation of Medicinal Products and Registration of Homeopathic and Traditional
p.(None): Herbal Products
p.(None):
p.(None): Art. 42. The requirements relating to the dossier data and documentation according to Art. 27 - 32, Art. 35, para 3,
p.(None): Art. 36, para 2, and Art. 38 shall be laid dawn in a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 43. (1) Within 30 of the submission date of the documentation according to Art. 27- 32, Art. 35, para 3, or
p.(None): according to Art. 38, the BDA shall review the completeness of the parts of the dossier accompanying the
p.(None): application and their compliance with the requirements for granting a the marketing authorisation or the
p.(None): registration certificate according to this Act.
p.(None): (2) Where no incompleteness or discrepancies in the documentation according to para 1 are established, the BDA shall,
p.(None): within the term according to para 1 above, notify the applicant in writing that the documentation is valid. This
p.(None): notification shall state the date from which the time limit according to Art. 44 shall start to run.
p.(None): (3) Where incompleteness and/or discrepancies in the documentation according to para 1 are established, the BDA shall
...

p.(None): applicant in writing that the documentation is valid stating in the notification the date from which the term
p.(None): according to Art. 44 shall start to run.
p.(None):
p.(None):
p.(None): Art. 44. The procedure for granting marketing authorisation or registration certificate of a medicinal product shall
p.(None): start from the date indicated in the notification according to Art. 43, para 2, respectively Art. 43, para 5, and shall
p.(None): end within 210 days.
p.(None):
p.(None):
p.(None): Art. 45. (1) Where in the BDA has been submitted an application for marketing authorisation or
p.(None): registration of a medicinal product for which, according to Art. 27, para 1, point 18, there is information of a
p.(None): marketing authorisation granted in a Member State, the BDA shall notify the applicant in writing to implement the
p.(None): procedure according to Art. 74.
p.(None): (2) Where in the BDA has been submitted an application for marketing authorisation or registration of a medicinal
p.(None): product for which, according to Art. 27, para 1, point 19, there is
p.(None):
p.(None): information that the dossier of the same medicinal product is in a procedure of assessment in a Member State, the BDA
p.(None): shall not review the documentation according to Art. 27-32 or Art. 35, para 3, or according to Art. 38 and shall notify
p.(None): the applicant in writing to implement the procedure according to Art. 75.
p.(None): (3) For the implementation of the provisions of para 1 and 2, a medicinal product shall be deemed as the same as
p.(None): authorised in another Member State, or as a product in a procedure of assessment of the dossier in another Member State
p.(None): where both medicinal products:
p.(None): 1. have the same qualitative and quantitative composition with respect t the active substance(s) and are
p.(None): offered in the same pharmaceutical form, whereas admissible shall be differences in the excipients provided that this
p.(None): shall not affect the safety and efficacy, and where
p.(None): 2. belong to the same company or the application for the medicinal products is submitted by the same company or group
p.(None): of companies, or where the application for the medicinal products is submitted by persons who have concluded a
p.(None): license or other agreement or conduct joint activities relating to the placing on the market of the respective
p.(None): medicinal product in different Member States.
p.(None):
p.(None):
p.(None): Art. 46. (1) For the assessment of the documentation the BDA shall:
p.(None): 1. may conduct tests of the final product, intermediate product, or the starting materials of the medicinal product or
p.(None): forward these for tests in a laboratory in a Member State belonging to the system of official medicines control
p.(None): laboratories in order to establish whether the control methods of analysis used by the manufacturer and described in
p.(None): the dossier comply with the requirements;
p.(None): 2. confirm, following inspection on the spot or by documents, whether the manufacturers of medicinal products from
p.(None): third states conduct the manufacture in compliance with the data set out in Art. 27, para 1, point 7, and/or conduct
p.(None): the control in compliance with the methods set out in Art. 27, para 1, point 8;
p.(None): 3. inspect the manufacturing site indicated in the application where the manufacturer(s) has, by way of exception,
p.(None): assigned to another manufacturer to conduct certain stages of the manufacture or control of the medicinal product.
p.(None): (2) Where the BDA conducts an inspection on the spot of a manufacturing site, the term according to Art. 44 shall cease
...

p.(None): in writing to submit additional information associated with the documentation according to Art. 27-32 or
p.(None): according to Art. 35, para 3, or according to Art. 38, and or to present an oral or written explanation of
p.(None): the established incompleteness and discrepancies within 180 days of the notification date.
p.(None): (2) In the cases according to para 1, the term according to Art. 44 shall cease to run as from the notification date
p.(None): until the presentation of the requested information.
p.(None): (3) The executive director of the BDA shall terminate the procedure for granting a marketing authorisation
p.(None): or authorisation for registration of a medicinal product where:
p.(None): 1. the applicant has not submitted the information according to para 1 within the required time limit;
p.(None): 2. the persons according to Art. 26, para 1, request its termination in writing.
p.(None):
p.(None):
p.(None): Art. 51. Within 10 days of the establishment of the assessment report according to Art. 49, para 1, the executive
p.(None): director of the BDA shall issue a marketing authorisation/registration certificate of the medicinal product or make a
p.(None): motivated refusal.
p.(None):
p.(None):
p.(None): Art. 52. (1) (amend. – SG, 102/2012, in force from 21.12.2012) Within 5 days of granting, the marketing
p.(None): authorisation/registration certificate in the register according to Art. 19, Para. 1, point 3, which shall contain the
p.(None): following data for the certificate:
p.(None): 1. registration number;
p.(None): 2. number and date of the marketing authorisation/registration certificate of the medicinal product;
p.(None): 3. name of the medicinal product;
p.(None): 4. international non-proprietary name of any active substance;
p.(None): 5. name and address of the holder of the marketing authorisation/registration certificate; 5a (new - SG, 102/2012, in
p.(None): force from 21.12.2012) the conditions of Art. 55a, 56 and
p.(None): 56a, entered in the authorisation for use/registration certificate;
p.(None): 6. date of variation of the marketing authorisation/registration certificate;
p.(None): 7. date of termination of the marketing authorisation/registration certificate;
p.(None): 8. other data.
p.(None): (2) The marketing authorisation/registration certificate of the medicinal product shall be delivered to the person
p.(None): according to Art. 26, Para. 1, and shall enter into effect as from the date
p.(None):
p.(None): of its inscription in the register according to Art. 19, Para. 1, point 3.
p.(None):
p.(None):
p.(None): Art. 53. (1) (amend. – SG, 102/2012, in force from 21.12.2012) The BDA shall publish on its internet site data
p.(None): according to Art. 52, Para.1 for the marketing authorisation of the medicinal product granted and the
p.(None): approved summary of product characteristics and the datas of the leaflet.
p.(None): (2) The BDA shall publish o its internet site the assessment report under art. 49, Para. 1 with the motives of the
p.(None): decision taken while deleting the data, representing commercial secret.
p.(None): (3) The report under Para. 2 shall be accompanied by a summary in understandable by the public language. The summary
p.(None): shall contain a section, related to the conditions for use of the medicinal product.
p.(None):
p.(None):
p.(None): Art. 54. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of a marketing authorisation/registration
p.(None): certificate of a medicinal product shall notify the BDA in writing about the date of actual placing on the market of
...

p.(None): the medicinal product shall submit separate notifications, respectively applications to the BDA for each
p.(None): variation of type IA, type IB or type II or for extension of the range.
p.(None): (2) If a concrete variation leads to a change in the data of the summary characteristic of the product, of the
p.(None): labelling or of the leaflet, these changes shall be assumed as a part of the declared variation and about them separate
p.(None): application shall not be submitted.
p.(None): (3) Holder of the marketing authorisation may arrange the variations in groups, where:
p.(None): 1. notifies simultaneously of one and the same variations of type IA in the conditions of
p.(None):
p.(None): one or several marketing authorisations;
p.(None): 2. declares simultaneously several variations in the conditions of the marketing authorisations, belonging to
p.(None): a global marketing authorisation for the medicinal products as per Art. 28, Para 8, provided that the envisaged
p.(None): variations fall under one of the following cases:
p.(None): a) one of the variations in the group constitutes extension of the marketing authorisation;
p.(None): b) one of the variations in the group constitutes a variation of type II, and all the other variations appear as a
p.(None): consequence of the variation of type II;
p.(None): c) one of the variations in the group constitutes variation of type IB, and all the other variations appear as a
p.(None): consequence of the variation of IB
p.(None): d) all variations in the group relate solely to changes of administrative nature to the summary product
p.(None): characteristics, labelling and package leaflet;
p.(None): e) all variations in the group are changes to the Active Substance Master File, Vaccine Antigen Master File or Plasma
p.(None): Master File;
p.(None): f) all variations in the group relate to a project intended to improve the manufacturing process and the quality of the
p.(None): medicinal product concerned or its active substance(s);
p.(None): g) all variations in the group are changes affecting the quality of a human pandemic influenza vaccine;
p.(None): h) all variations in the group are changes to the pharmaco-vigilance system referred to in Chapter Eight;
p.(None): i) all variations in the group are consequential to a given urgent safety restriction and are submitted in accordance
p.(None): with Art. 66;
p.(None): k) all variations in the group relate to the implementation of a given class labelling;
p.(None): l) all variations of the group are consequential to the assessment of a given periodic update report on the safety;
p.(None): m) all variations in the group are consequential to a given post-authorisation study conducted under the
p.(None): supervision of the holder of the marketing authorisation;
p.(None): n) all variations in the group are consequential to a specific obligation carried out pursuant to Art. 56;
p.(None): 3. the declared variations to the terms of the same marketing authorisation do not fall within one of the cases
p.(None): specified in item 2, provided that the BDS agrees to subject those variations to the same procedure.
p.(None): (4) Where variations as per Para 3, items 2 and 3 are grouped, holder of the marketing authorisation shall submit to
p.(None): the BDA:
p.(None): 1. a single notification, where at least one of the variations is a variation of type IB and all variations are of type
p.(None): IA or of type IB;
p.(None): 2. a single application, if the main variation is of type II and none of the rest of variations is an extension of the
p.(None): marketing authorisation;
p.(None): 3. a single application, where the main variation is extension of the marketing authorisation.
...

p.(None): authorisation;
p.(None): 2. shall notify the holder of the marketing authorisation if the approved variation leads to amendment of the data in
p.(None): the issued marketing authorisation; where amendment of the issued marketing authorisation is needed, Art. 64a shall be
p.(None): applied.
p.(None): (7) The holder of the marketing authorisation shall apply the approved variation of type II only after the
p.(None): authorisation for amendment as per Art. 64a is issued.
p.(None):
p.(None):
p.(None): Art. 64a. (new – SG 12/11, in force from 08.02.2011) Executive Director of the BDA shall issue amendment of the
p.(None): decision granting the marketing authorisation within following time limits:
p.(None): 1.30 days following the issuance of the notification under Art. 62, Para 4, item 4, Art. 63, Para 2, item 2,
p.(None): respectively under Art. 63, Para 6, item 2 and under Art. 64, Para 6, item 2, where the respective variation leads
p.(None): to sex-months extension of the period, envisaged in Art. 13, Paragraphs 1 and 2 of Council Regulation No
p.(None): 1768/92 of 18 June 1992 concerning the provision of supplementary protection certificate as set out in Art. 36 of
p.(None): Regulation (EC) No 1901/2006;
p.(None): 2. 60 days following the issuance of the notification under Art. 62, Para 4, item 2 – in case of variations of type IA,
p.(None): which do not require immediate notification;
p.(None): 3. 60 days following the issuance of the notification under Art. 64, Para 6, item 2 – for variations of type II;
p.(None): 4. 180 days – in all other cases.
p.(None):
p.(None):
p.(None): Art. 64b. (new – SG 12/11, in force from 08.02.2011) (1) In case of variations concerning
p.(None):
p.(None): changes to the active substance for the purposes of the annual update of a human influenza vaccine, the holder of
p.(None): marketing authorisation shall submit application, with attached thereto documentation, as specified in the regulation
p.(None): envisaged in Art. 42. Within 7- days period, the BDA shall examine the completeness of the submitted documentation.
p.(None): (2) If the application concerned fulfils the requirements of Para 1, the BDA shall notify the holder of the marketing
p.(None): authorisation, shall acknowledge the receipt of valid application and state the date, from which the specified time
p.(None): limit in Para 3 starts.
p.(None): (3) Within 45- days period from the receipt of a valid application, the BDA shall assess the documentation and prepare
p.(None): an assessment report.
p.(None): (4) The BDA may request the holder of marketing authorisation to provide the clinical data and the stability data of
p.(None): the medicinal product. The holder of marketing authorisation shall submit to the BDA data required within 12 days
p.(None): following the elapse of the time limit stipulated in Para 3.
p.(None): (5) The BDA shall assess the documentation and take final decision within 10 days term from the receipt of the data
p.(None): referred to in Para1, by issuing authorisation for variation or rejection.
p.(None):
p.(None):
p.(None): Art. 65. (1) Where the marketing authorisation holder has established a risk for the health from the use of the
p.(None): medicinal product, he shall undertake urgent limiting measures and shall immediately notify the BDA in writing.
p.(None): (2) The BDA shall pass a judgment regarding the measures within 24 hours of the notification.
p.(None): (3) Where the BDA has not passed a judgment within the term according to para 2, it shall be presumed that the measures
p.(None): have been approved.
p.(None): (4) Where the BDA has established that there is a risk for the health of the population from the use of medicinal
p.(None): product, it shall order the marketing authorisation holder to immediately undertake limiting measures.
p.(None): (5) In the cases according to para 1 and 4, the marketing authorisation holder of the medicinal product shall
p.(None): coordinate the method and term of implementation of the undertaken measures with the BDA.
p.(None): (6) Marketing authorisation holder of the medicinal product shall submit to the executive director of The BDA a
p.(None): variation application under the terms Art. 64 not later than 15 from the date undertaking the measures.
p.(None):
p.(None):
p.(None): Art. 66. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of the marketing authorisation of a medicinal
p.(None): product shall submit an application for enlargement of the scope of the granted marketing authorisation in case of:
p.(None): 1. change of the active substance(s):
p.(None): a. replacement of a chemical active substance by a different by a different salt/ester, complex/derivative, including
p.(None): the same therapeutic moiety, where the efficacy/safety characteristics are not significantly different.
p.(None): b. replacement by a different isomer, mixture of isomers, of a mixture by an isolated isomer (e.g. racemate with single
p.(None): enantiomer), where the efficacy/safety characteristics are not significantly different;
p.(None): c. replacement of a biological active substance with one of a slightly different molecular structure where the
p.(None): efficacy/safety characteristics are not significantly different, with the exception of changes to the active
p.(None): substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
p.(None):
p.(None): d. modification of the vector used to produce the antigen of the source material, including a new master cell bank from
p.(None): a different source, where the efficacy/safety characteristics are not significantly different;
p.(None): e. a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy/safety
p.(None): characteristics are not significantly different
p.(None): f. change to the extraction solvent of the ration of herbal drug to herbal drug preparation where the efficacy/safety
p.(None): characteristics are not significantly different.
p.(None): 2. Changes to strength, pharmaceutical form and route of administration:
p.(None): a. change of bioavailability;
p.(None): b. change of pharmacokinetics e.g. change in rate of release;
p.(None): c. change or addition of a new strength/potency;
p.(None): d. change or addition of a new pharmaceutical form; e.g. change or addition of a new route of administration– for
p.(None): parenteral application to differentiate between intraarterial, intravenous, intramuscular, subcutaneous and
p.(None): other routs of administration.
p.(None): (2) The application according to para 1 shall be accompanied by the documentation according to Art. 27, para 1, point
p.(None): 10, associated with variations according to para 1.
p.(None): (3) The requirements to the documentation according to para 2 shall be laid down in the regulation according to Art.
p.(None): 42.
p.(None): (4) The name of the medicinal product in the granted authorisation for enlargement of the scope of the initial
p.(None): marketing authorisation shall not be changed.
p.(None): (5) The granting of an authorisation for enlargement of the scope of a granted marketing authorisation of a medicinal
p.(None): product shall be performed under the conditions and under the terms of Art. 49 - 51.
p.(None):
p.(None):
p.(None): Art. 67. (1) The marketing authorisation holder of a medicinal product shall submit an application for granting a new
p.(None): marketing authorisation in case of:
p.(None): 1. addition or deletion of one or more active substances including antigenic components in case of vaccines;
p.(None): 2. change in the quality of the active substance indicated in the dossier, which essentially changes the safety and
p.(None): efficacy characteristics of the medicinal product, and the changed substance is defined as a new one;
p.(None): 3. addition of a new or change in an existing therapeutic, prophylactic, or diagnostic indication in another
p.(None): therapeutic field.
p.(None): (2) (New - SG 71/2008, in force from 12.08.2008) The owner of the authorisation for use of the medicinal product shall
p.(None): file an application for issuing new authorisation for use, where the application for renewal of the authorisation for
p.(None): use was not filed within the term under Art. 59a, para 1.
p.(None): (3) (Former para 2 - SG 71/2008, in force from 12.08.2008) The application shall be accompanied by the documentation
p.(None): laid down in the regulation according to Art. 42.
p.(None): (4) (Former para 3 - SG 71/2008, in force from 12.08.2008) The procedure according to Art. 49 – 51 shall be applied in
p.(None): the cases according to para 1 and 2.
p.(None):
p.(None):
p.(None): Art. 68. (1) (amend. – SG, 102/2012, in force from 21.12.2012)The holder of the marketing
p.(None): authorisation/registration certificate of a medicinal product shall be obliged to:
p.(None): 1. report the achievements of the scientific-technical progress and introduce all the needed changes in the
p.(None): documentation under Art. 27, Para. 1, p. 7 and 8 in view the medicinal product to be produced and controlled under the
p.(None): commonly adopted new methods; the changes
p.(None):
p.(None): shall be made under Chapters Three and Five;
p.(None): 2. submit immediately to BDA any new information, which may affect the variation in the data and documents according to
p.(None): Art. 27 - 32 and in the summary of product characteristics;
p.(None): 3. inform immediately the BDA about any ban or limitation imposed by regulatory authorities of other
p.(None): states where the medicinal product is placed on the market, about the reasons standing behind those
...

p.(None): (7) The Council of Ministers, according to a proposal of the Minister of Health, shall determine the conditions and
p.(None): order for the work of the Central Ethics Committee by a regulation.
p.(None):
p.(None):
p.(None): Art. 108. (1) A member of the Central Ethics Committee cannot be appointed in the same committee for more than two
p.(None): consecutive mandates. The duration of a mandate shall be 4 years.
p.(None): (2) Half of the composition of the Central Ethics Committee shall be renewed every 2
p.(None): years.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): met:
p.(None): Section V.
p.(None): Authorisation to Conduct a Clinical Test
p.(None):
p.(None): Art. 109. A clinical test can be started provided that the following conditions have been
p.(None):
p.(None): 1. the respective ethics committee has given a positive opinion and
p.(None): 2. the executive director of BDA has issued a written authorisation for the conduct
p.(None): thereof where one of the study medicinal products is either:
p.(None): a) a medicinal product for gene therapy;
p.(None): b) a medicinal product for somato-cellular therapy;
p.(None): c) a medicinal product, which contains genetically modified organisms;
p.(None): d) a high technology medicinal product described in the Annex to Regulation (EC) 726/2004 of the European
p.(None): Parliament and the Council;
p.(None): e) a medicinal product, which contains biological substance(s) of human or animal origin or contains biological
p.(None): components of human or animal origin or the manufacturing process of which involves such components, or
p.(None): 3. the contracting authority has not been notified by the BDA in writing that the clinical test cannot be conducted
p.(None): within the time limit as set out by the law; for medicinal products outside those according to 2.
p.(None):
p.(None):
p.(None): Art. 110. (1) For obtaining opinion, the principal researcher or the coordinating researcher shall submit to
p.(None): the respective ethics committee according to Art. 103 the following documentation:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (2) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 111. (1) The ethics committee shall establish an opinion taking into consideration the following:
p.(None): 1. importance of the clinical test;
p.(None): 2. positive assessment of the ratio between the anticipated benefits and risks according to Art. 90, para 1, and the
p.(None): motivation of the conclusions;
p.(None): 3. protocol of the clinical test;
...

p.(None): (2) Where the change according to Art. 165, para 1, point 3, cannot be assessed by documents, the BDA shall conduct
p.(None): inspections on the spot. In these cases the term according to para 1, point 2, shall cease to run until the
p.(None): accomplishment of the inspection.
p.(None): (3) The expenses for the conduct of the inspection on the spot according to para 2 shall be for the account of the
p.(None): account of the applicant.
p.(None): (4) For the conduct of the inspection on the spot according to para 2 the applicant shall pay a fee to the amount as
p.(None): laid down on the tariff according to Art. 21, para 2.
p.(None):
p.(None):
p.(None): Art. 167. (1) The BDA shall keep a register according to Art. 19, para 1, point 2, of the issued import authorisations,
p.(None): which shall contain:
p.(None): 1. number and date of the import authorisation;
p.(None): 2. name, place of business and address of management of the person, who has been granted import authorisation;
p.(None): 3. address of the premises for the control and storage of the medicinal products;
p.(None): 4. (amend. – SG, 102/2012, in force from 02.01.2013) the medicinal products, and forms for which the authorisation has
p.(None): been obtained;
p.(None): 5. name of the person according to Art. 161, para 2, point 1;
p.(None): 6. date of deletion of the import authorisation from the register and reason thereof.
p.(None): (2) Data from the register shall be published on the internet site of the BDA.
p.(None):
p.(None): Section III.
p.(None): PRODUCTION, IMPORT AND WHOLESALE TRADE WITH ACTIVE SUBSTANCES (NEW – SG, 102/2012, IN FORCE FROM 02.01.2013)
p.(None):
p.(None): Art. 167a. (new – SG, 102/2012, in force from 02.01.2013) Manufacture, import or wholesale trade with
p.(None): active substance may be carried out by natural or legal persons, registered as traders under the legislation of an EU
p.(None): Member State and entered in to the register under Art. 167.
p.(None):
p.(None):
p.(None): Art. 167b. (new – SG, 102/2012, in force from 02.01.2013) (1) For entering into the register under Art. 167d, the
p.(None): applicant shall submit to BDA an application according to a form, confirmed by the BDA executive director, which shall
p.(None): contain:
p.(None): 1. name, management central office of the person under Art. 167a;
p.(None): 2. a list of the active substances, which will be imported, manufactured or traded;
p.(None): 3. the activities, which the person under Art. 167a will carry out;
p.(None):
p.(None): 4. Premise addresses for the technical equipment for realizing the activity of the persons under Art. 167a;
p.(None): (2) The application under Para. 1 shall have attached:
p.(None): 1. data about the single identification code (SIC) of the trader and for the companies, registered in an EU Member
p.(None): State p a document for current registration under the national legislation, issued by a competent body of the
p.(None): relevant state;
p.(None): 2. document for a paid fee under Art. 21, Para. 2.
p.(None): (3) Within the term of 60 days after the application and the documents under Para. 1 and 2 are received, BDA, on the
p.(None): basis of the risk assessment shall:
p.(None): 1. enter the person under Art. 167a in the register under Art. 167d, for which shall notify,
p.(None): or
p.(None): 2. notify about the date of the inspection, carried out for establishing the compliance of
p.(None): the conditions for the activities under Art. 167a with the requirements of the Good manufacturing practice under Art.
...

p.(None): active substances.
p.(None): (2) The importers may import active substances only if the following conditions have been observed:
p.(None): 1. the active substances are manufactured in compliance with standards for Good manufacturing practice,
p.(None): which are at least equivalent to the ones, established in the European Union and
p.(None): 2. (in force from 02.07.2013) the active substances are accompanied by a written confirmation by the
p.(None): competent body of the state-importer, that:
p.(None): a) the standards for good manufacturing practice, applicable to the object for manufacture of the
p.(None): exported active substances are at least equivalent to the ones, established by the European Union;
p.(None): b) The relevant object for manufacture shall be subject to a regular control and in it effectively is applied the
p.(None): Good manufacturing practice, where this includes multiple and immediate inspections in view to guaranteeing
p.(None): protection of the public health, at least equal to the one in the European Union, and
p.(None): c) in case of a found failure to observe the requirements, the state exporter shall inform immediately the BDA.
p.(None): (3) (in force from 02.07.2013) The requirement of Para. 2, p. 2 shall not apply if the state exporter is included in
p.(None): the list under Art. 111b of Directive 2001/83/EC
p.(None):
p.(None):
p.(None): Art. 167g. (new – SG, 102/2012, in force from 02.07.2013) (1) As an exception, where it is needed to be provided
p.(None): availability of medicinal products, the importer may import the active substance without a written confirmation under
p.(None): Art. 167f, Para. 2, p. 2 for the term, not longer than the validity term of the certificate for Good manufacturing
p.(None): practice, where the object for manufacture of an active substance in the state exporter has been inspected by a regular
p.(None): body of a Member State and it has been found, that it observes the principle and directives for Good manufacturing
p.(None): practice.
p.(None): (2) In the cases of Para. 1, BDA shall notify the European Commission.
p.(None):
p.(None):
p.(None): Art. 167h. (new – SG, 102/2012, in force from 02.01.2013) manufacturing authorisation holders, including those, who
p.(None): fulfill the activities under Art. 168b, Para. 2 shall be considered as manufacturers in the meaning of § 13, p. 3 of
p.(None): the Additional Provisions of the Act on Consumer Protection and shall bare responsibility for harms, caused by goods
p.(None): defects, provided in it.
p.(None):
p.(None): Chapter six.
p.(None): PACKAGING AND LEAFLETS OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 168 (1) Medicinal product packaging consists of primary and/or secondary packaging and patient
p.(None): information leaflet.
p.(None): (2) (amend. - SG 61/11, in force from 10.11.2011) The secondary packaging of medicinal
p.(None):
p.(None): products containing substances specified in the list under Art. 3, para 2, item 2 of the Control on Drugs and
p.(None): Precursors Act shall be marked diagonally with two red strips and the secondary packaging of medicinal products
p.(None): containing substances specified in the list under Art. 3, para 2, item 2 of the Control on Drugs and Precursors Act –
p.(None): with two blue strips. The packaging shall obligatorily contain a notice that the medicinal product shall only be
p.(None): dispensed by special medical prescription.
p.(None): (3) (amend. – SG, 102/2012, in force from 21.12.2012) The leaflet of the medical products, included in
p.(None): the list under Art. 23 of Regulation (EC) N 7262004 of the European Parliament and of the Council
p.(None): contains information with the following text: "This medicinal product is subject to additional observation".
p.(None): Before the text a sign is placed in black cooler under Art. 23, Para. 5 of Regulation (EC) N 7262004 of the European
p.(None): Parliament and of the Council, accompanied by an explanatory note.
p.(None): (4) (amend. – SG, 102/2012, in force from 21,12,2012) The leaflet of the medicinal products shall included
p.(None): a standard text, by which the patients are invited to report to the medical specialists or directly to BDA about every
p.(None): suspected unwilling medicinal reaction according to the samples in Art. 185, Para. 2, p. 4.
p.(None): (5) Where a medicinal product is to be authorised for use on the territory of the Republic of Bulgaria, a marking for
p.(None): separate collection and recycling according to the Waste Management Act and the acts for the application thereof shall
p.(None): be placed in its secondary packaging.
p.(None): (6) Where a medicinal product is to be authorised for use, its name on the secondary packaging, pharmaceutical form,
p.(None): and content of active substance in a single dose shall also be printed in the Braille’s alphabet.
p.(None): (7) The requirements of para 6 are not applied for vaccines and medicinal products in hospital’s packages.
p.(None): (8) (new – SG, 102/2012, in force from 21.12.2012) On the secondary package (if there is no such) on the initial
p.(None): package of the medicinal products, with the exception of radio- pharmaceutics, the following shall be placed:
p.(None): 1. individual identification sign for indicators of safety, which gives opportunity for the wholesale and retail
p.(None): traders to:
p.(None): a) check up the authenticity of the medicinal product;
p.(None): b) to identify separate packages.
p.(None): 2. a means, which may check up the package of the medicinal product if it has been
p.(None): faked.
p.(None):
p.(None):
p.(None): Art. 168a. (new – SG, 102/2012, in force from 21.12.2012) (1). On the package of the medicinal product, which is
p.(None): prescribed by a doctor’s prescription, safety indicators shall be placed under Art. 168, Para. 8 with the
p.(None): exception of the cases, in which the medicinal product has been included in the list, determined by the European
p.(None): Commission by a delegated act under Art. 168b.
p.(None): (2) On the package of a medicinal product, which does not need doctor’s prescription, no safety indicators shall be
p.(None): placed under Art. 168, Para. 8, with the exception of the cases, in which the medicinal product is included in the
p.(None): list, determined by the European Commission by a delegated act under Art. 168b, after it has been assessed, that it may
p.(None): be put to a risk to be faked.
p.(None): (3) The BDA shall notify the European Commission:
...

p.(None): indicators with ones, equal to them in relation to the possibility for guaranteeing the authenticity,
p.(None): identification and provision of evidences for faking the medicinal product.
p.(None): (3) The safety indicators shall be considered as equal, if:
p.(None): 1. they meet the requirements, determined by the delegated acts under Art. 54a, Para. 2 of Directive 2001/83/EC and
p.(None): 2. they are so effected that they allow the check of authenticity and identification of the medicinal products and
p.(None): provide evidences for their being faked.
p.(None): (4) The replacement under Para. 2, p. 2 shall be made without opening the initial packing of the medicinal product and
p.(None): in compliance with the Good manufacturing practice for medicinal products.
p.(None): (5) The BDA shall carry out supervision on the replacement of the safety indicators.
p.(None):
p.(None):
p.(None): Art. 169. (1) The information of the packaging and the medicinal product leaflet must be in full compliance with the
p.(None): data in the summary of product characteristics approved by the BDA upon the issue of the marketing authorisation and
p.(None): must comply with the requirements set out in the regulation according to Art. 170.
p.(None): (2) The information on the packaging and leaflet can be in several languages but one of these must obligatorily be
p.(None): Bulgarian language. The content of the information in various languages must be identical.
p.(None): (3) The name of the medicinal product shall obligatorily be written in the Bulgarian language and the
p.(None): international non-proprietary name of the medicinal substance shall be written according to the
p.(None): Anatomic-Chemical-Therapeutic Classification of the WHO. The name
p.(None): and address of the marketing authorisation holder can be written in Latin.
p.(None): (4) The information of the packaging and leaflet must be in a language comprehensible for the patient and must be
p.(None): readable and indelible.
p.(None): (5) (new – SG 18/14) The leaflet must be produced so that to be clear and understandable, and to allow
p.(None): the patient to undertake adequate actions, where required, with the assistance of the health care specialists.
p.(None):
p.(None): Art.170. (1) (former text of Art. 170 – SG, 102/2012, in force from 01.03.2012) The requirements relating
p.(None): to the packaging and leaflets of medicinal products shall be determined by an ordinance of the Minister of Health.
p.(None): (2) (new - SG, 102/2012, in force from 01.03.2012; suppl. – SG 18/14) Where a medicinal product,
p.(None): permitted for use under this act, is not intended for direct supply to the patient or is not available on the market in
p.(None): the Republic of Bulgaria, BDA may permit its use, where some of the data, determined by the ordinance under
p.(None): Para. 1 has not been placed on the package or in the leaflet.
p.(None): (3) (new - SG, 102/2012, in force from 01.03.2012) In the cases under Para. 2, the information on the packing and in
p.(None): the leaflets may not be provided in the Bulgarian language.
p.(None): (4) (new - SG, 102/2012, in force from 01.03.2012) The conditions and procedure for supply of medicinal products under
p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
...

p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
p.(None): 3. are intended for treatment of out-patients but their use can cause serious adverse drug reactions, which can require
p.(None): specialist prescribing and monitoring in the course of treatment.
p.(None):
p.(None):
p.(None): Art. 176. (1) The BDA can refuse to approve the dispensing regime of a medicinal product requested by the
p.(None): applicant according to Art. 26, para 1, on the grounds of assessment of:
p.(None): 1. the maximum single dose, maximum daily dose, quantity of the active substance in one dose unit, pharmaceutical
p.(None): form, specific appearance of the primary product packaging, and/or
p.(None): 2. other specific conditions of use.
p.(None): (2) The BDA can refuse to indicate the exact category of a medicinal product according to Art. 172 but pursuant to the
p.(None): criteria according to Art. 174 and Art. 175 shall determine whether a medicinal product shall be classified as a
p.(None): product dispensed only on medical prescription.
p.(None):
p.(None):
p.(None): Art. 177. Medicinal products, which do not meet the requirements according to Art. 173, 174, and 175 and the criteria
p.(None): laid down in the regulation according to Art. 178, shall be dispensed without medical prescription.
p.(None):
p.(None):
p.(None): Art. 178. The criteria for classification of medicinal products and the requirements to the documentation for changing
p.(None): the classification shall be determines by a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 179. (1) The BDA shall draw and publish on its internet site a list of the medicinal products, which shall be
p.(None): dispensed on the territory of the Republic of Bulgaria on medical prescription.
p.(None): (2) The list according to para 1 shall be updated annually.
p.(None):
p.(None): Art. 180. Should new data of a medicinal product, which has a marketing
p.(None): authorisation/registration certificate issued, become available, the BDA shall reconsider and if necessary change the
p.(None): classification in accordance with the requirements of Art. 173 and the criteria laid down in the regulation according
p.(None): to Art. 178.
p.(None):
p.(None):
p.(None): Art. 181. In the cases where a change in the classification of a given medicinal product is authorised on the
p.(None): grounds of significant preclinical and clinical trials, next applicants or marketing authorisation holders
p.(None): cannot refer within one year of the date of authorisation of the change issued by a regulatory body of a member country
p.(None): when submitting an application for a change in the classification of the same substance.
p.(None):
p.(None):
p.(None): Art. 182. Annually the BDA shall notify the European commission and the regulatory bodies of the other Member States of
p.(None): changes occurred in the list according to Art. 179.
p.(None):
p.(None): Chapter eight.
p.(None): PHARMACO-VIGILANCE
p.(None):
p.(None): Section I.
p.(None): General Provisions. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 183. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall organize and maintain a system for
p.(None): pharmaco-vigilance for implementation of the obligations under this Chapter.
p.(None): (2) The system under Para. 1 shall be used for collecting information about the risks of medicinal products for the
p.(None): patients’ health and for public health. The information shall cover reports for unwilling medicinal reactions in use of
p.(None): a medicinal product in compliance with the confirmed short characteristics, as well as information for misuse
p.(None): and use, which is not in compliance with the confirmed short characteristics of the product, including
p.(None): information for unwilling medicinal reactions, observed while fulfilling professional duties.
p.(None): (3) The BDA shall valid the process and classify the information under Para. 2, make scientific analysis of the
p.(None): collected data in view to an assessment of the possibilities for decreasing and preventing the risk and shall
p.(None): undertake the needed actions in relation to permit for use of the medicinal product.
p.(None): (4) The BDA shall carry out audits of the system under Para. 1 and every 2 years shall submit to the European
p.(None): Commission a report with the results from them.
p.(None): (5) The BDA shall apply an adequate and effective quality system in order to provide compliance of the system under
...

p.(None): 2. scientific assessment of the correlation benefit/risk of the medicinal product; the assessment shall be
p.(None): based on all available data, including data from clinical tests for non- permitted indications and for
p.(None): target groups, which have not been included in the product short characteristics;
p.(None): 3. all the data about the volume of the sales of the medicinal product and any other information, which the marketing
p.(None): authorisation holder has about the volume of the prescriptions, including the approximate number of the persons, having
p.(None): used the medicinal product or exposed to its impact because of some other reason.
p.(None): (2) The contents and form of the electronic periodic upated vigilance reports shall be provided by the Implementation
p.(None): Regulation (EU) N 520/2012.
p.(None):
p.(None): (3) The information under Para. 1 shall e collected and stored in a regitr, established under Art. 25a of Regulation
p.(None): (EC) N 726/2004 of the European Parliament an of the Council and shall be accessible for BDA.
p.(None):
p.(None):
p.(None): Art. 194i. (new – SG, 102/2012, in force from 21.12.2012). The marketing authorisations holders for registration of
p.(None): medicinal products under Art. 28, 30, 35 and 37 shall submit periodic updated vigilance reports in cases, where:
p.(None): 1. submitting a report shall be a conditions under art. 55 or 56, entered in the marketing authorisation or
p.(None): registration certificate, or
p.(None): 2. The BDA or a regulatory body if another Member State shall require this on the basis of safety considerations of the
p.(None): medicinal product or because of a lack o periodic updated safety reports for the active substance, contained in
p.(None): the medicinal product, to which marketing authorisation or registration certificate has been issued.
p.(None):
p.(None):
p.(None): Art. 194k. (new – SG, 102/2012, in force from 21.12.2012). (1) The marketing authorisation/registration
p.(None): certificate shall determine frequency o submission of the periodic updated safety reports.
p.(None): (2) The dates of submission of the reports, depending on the frequency under Para. 1 shall be calculated from the
p.(None): date of issuance of the marketing authorisation/registration certificate.
p.(None): (3)The periodic updated safety reports shall be submitted during time intervals with the exception of the cases,
p.(None): where the frequency of submission of the reports is a condition for issuance of the marketing
p.(None): authorisation/registration certificate or it has been determined in compliance with Art. 194l, 194m and 194n:
p.(None): 1. every 6 months from the date of issuance of the marketing authorisation/registration certificate of a medicinal
p.(None): product till the date of its placement on the market;
p.(None): 2. every 6 months during the first 2 years from the date of placement on the market of the medicinal product;
p.(None): 3. once a year during the following 2 years;
p.(None): 4. once every 3 years after the 4th year from the date of placement on the market of the medicinal product;
p.(None): (4) Apart from the cases under Para. 3, the periodic updated safety reports shall be submitted immediately upon request
p.(None): of BDA or a regulatory body of a Member State.
p.(None):
p.(None):
p.(None): Art. 194l. (new – SG, 102/2012, in force from 21.12.2012) Where the medicinal products, which contain one and the same
p.(None): active substance, or combination lf one and the same active substances, have received separate marketing
p.(None): authorisations/ registration certificates, the frequency and the date of submitting of the periodic updated safety
p.(None): reports may be changed and harmonised in view to performing one assessment of these reports.
p.(None):
p.(None):
p.(None): Art. 194m. (new – SG, 102/2012, in force from 21.12.2012) (1) The dates of submission of the periodic updated
p.(None): safety reports for the medicinal products under art. 194l shall be calculated according to the reference date
p.(None): of the European Union.
p.(None): (2) The reference date of the EU under Para. 1 is:
p.(None): 1. the ate of the first marketing authorisation in the European Union of the medicinal
p.(None):
p.(None): product, containing the relevant active substance or the relevant combination of the active substances, or
p.(None): 2.the earliest of the known dates of the marketing authorisations of the medicinal product, containing the relevant
p.(None): active substance or the relevant combination of active substances, if the date, indicated in p. 1 cannot be found.
p.(None):
p.(None):
p.(None): Art. 194n. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder of
p.(None): medicinal products under Art. 194l may submit a motivated request to the Committee of Medicinal Products for human use
p.(None): or to the coordination group under Art. 77, Para. 2 for defining the reference date of the EU or for change of the
p.(None): frequency of submitting periodic updated vigilance reports on one of the following grounds:
p.(None): 1. reasons, related to public health;
p.(None): 2. in order to be avoided duplicating of an assessment;
p.(None): 3. in order to be reached international harmonisation.
p.(None): (2) The Committee on Medicinal Products for human use, or the coordination group under Art. 77, Para. 2 after
p.(None): consultations with the committee under Art. 56a, Para. 1, p. 1 shall approve the request or shall make a motivated
p.(None): refusal.
p.(None): (3) The frequency of submitting and the reference ate of the EU shall be defined after consultation with the committee
p.(None): under Art. 56a, Para. 1. P. 1 by:
p.(None): 1.The Committee on Medicinal Products for human use – where at least on of the marketing authorisations
p.(None): for medicinal products, containing the relevant active substance has been provided in compliance with the centralised
p.(None): procedure, provided in Title II, Chapter 1 of Regulation (EC) N 726/2004 of the European Parliament and of the Council,
p.(None): or
p.(None): 2. the coordination group under Art. 77, Para. 2 – for cases, different from the ones, indicated in p. 1.
p.(None): (4) The list with the reference dates of the EU of the medicinal products under Art. 194l and the harmonised frequency
p.(None): for submitting their periodic updated vigilance reports shall be published on the European internet portal under Art.
p.(None): 68, Para. 1, p. 4.
p.(None): (5) The marketing authorisation holder after publication of the data under Para. 4 shall produce to BDA an
p.(None): application for change of the marketing authorisation of the relevant medicinal product. Each change of the
p.(None): dates of submitting the frequency of submission of the periodic updated safety reports, defined in the marketing
p.(None): authorisation, shall come into force 6 months after the date of their publication.
p.(None):
p.(None):
p.(None): Art. 194o. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall assess the periodic updated safety reports
p.(None): fpr the medicinal products, in order to define whether there are new risks or change of the established risks or change
p.(None): of the correlation benefit/risk.
p.(None): (2) The BDA shall carry out single assessment of the periodic updated safety reports of the medicinal products for
p.(None): which the Republic of Bulgaria has fulfilled the functions of a reference state in the meaning of Art. 76 and has been
p.(None): defined by the coordination group under art. 77, Para. 2.
...

p.(None): 2. prohibition of distribution of the medicinal product;
p.(None): 3. issuing a refusal for renewing the marketing authorisation.
p.(None): (3) (amend. – SG 18/14) The BDA shall initiate the procedure under Para. 2 where they are advised by the marketing
p.(None): authorisation holder that, for reasons related to tracing of drug safety, they terminate the distribution of the
p.(None): medicinal product or they have undertaken or they intend to undertake actions for its withdrawal from the market, or
p.(None): will not undertake actions for the renewal of the issued marketing authorisation.
p.(None): (4) (amend. – SG 18/14) The BDA may initiate the procedure under par. 2 in the cases where they consider that for
p.(None): reasons, related to tracing of drug safety, regarding a particular medicinal product new counter-indications may be
p.(None): added or the recommended dose should be reduced, or the indications shall be limited.
p.(None): (5) (amend. – SG 18/14) The BDA shall submit to the European Medicines Agency and to the regulatory authorities of the
p.(None): other Member States the entire scientific information, available to them, as well as the performed data assessment and
p.(None): the justifications for the initiation of the procedure pursuant to the provisions of this section.
p.(None): (6) (amend. – SG 18/14) In the cases referred to par. 2 - 4 the European Medicines Agency shall notify the BDA of the
p.(None): initiation of the procedure, where the concerns regarding safety are related also to other medicinal products,
p.(None): belonging to one and the same therapeutic group or contain the same active substance with the product, indicated in the
p.(None): information under
p.(None):
p.(None): par. 5 or where this medicinal product is permitted for use also in other Member States.
p.(None): (7) (amend. – SG 18/14) In the cases under Para. 4, where no urgent measures are required, BDA shall apply the
p.(None): procedure under Art. 77 or Art. 79b.
p.(None): (8) (new – SG 18/14) BDA shall inform the marketing authorisation holder of the initiation of the procedure under the
p.(None): provisions of this section.
p.(None):
p.(None):
p.(None): Art. 194u. (new – SG, 102/2-12, in force from 21.12.2012) (1) In the cases under Art. 194s, Para. 2, where BDA
p.(None): considers, that urgent measures are needed to be undertaken for protection of public health, BDA may temporary to
p.(None): terminate the marketing authorisation and to ban the use of the medicinal product on the territory of the Republic of
p.(None): Bulgaria until a final decision is taken under Art. 194x or 194y.
p.(None): (2) The BDA shall notify the European Medicines Agency, the European Commission and the regulatory bodies of the other
p.(None): Member States about the measures, undertaken under Para. 1 within the term of up to 1 working day after their
p.(None): application and shall indicate the grounds for that.
p.(None): (3) Where the BDA participates in the procedure under this Section, upon request of the European Commission, BDA shall
p.(None): undertake the recommended temporary measures in relation to the marketing authorisation of the medicinal
p.(None): product, or where the medicinal product is permitted for use under Regulation (EC) N 726/2004 0f the European
p.(None): Parliament and of the Council – in relation to the very product, by the finalisation of the procedure.
p.(None):
p.(None):
...

p.(None): 7. check whether the trader holds wholesale authorisation for trade with medicinal products;
p.(None): 8. check up whether the manufacturer or importer holds an authorisation for manufacture/import;
p.(None): 9. keep the data under p. 3 for the term of at least 5 years and provide them upon request of the control bodies.
p.(None): (2) The requirements to the intermediary activities in the area of the medicinal products shall be determined by the
p.(None): ordinance under Art. 198 and in the European Commission directives.
p.(None):
p.(None): Section .
p.(None): Parallel Import of Medicinal Products
p.(None):
p.(None): Art. 213. Parallel import of medicinal products on the territory of the Republic or Bulgaria can be performed by a
p.(None): natural or legal person registered according to the Commerce Act, the legislation of a Member State, or the
p.(None): legislation of a state party to the Agreement on the European Economic Area after receipt of a parallel import
p.(None): authorisation issued by the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 214. (1) A medicinal product authorised for use in another Member State, can be imported on the territory of the
p.(None): Republic of Bulgaria, provided that it is identical or similar to a medicinal product authorised for use in the
p.(None): Republic of Bulgaria under the terms of this Act.
p.(None): (2) (Amen. - SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011) Within the meaning of
p.(None): Para 1, a medicinal product is identical or similar shall be the one, that has identical qualitative and
p.(None): quantitative composition with respect to the active substance(s), is supplied in the same pharmaceutical form,
p.(None): the same primary packaging, with the same graphic design of the packaging
p.(None):
p.(None):
p.(None): Art. 215. (1) (Amen. And suppl. - SG 71/2008, in force from 12.08.2008) To obtain authorisation to
p.(None): perform parallel import on the territory of the Republic of Bulgaria, the person according to Art. 213, para 1 shall
p.(None): submit to the executive director of BDA an application stating the Member State from which the parallel import of the
p.(None): medicinal product is to be effected from.
p.(None): (2) The following data and documents shall be appended to the application:
p.(None): 1. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product authorised for
p.(None): use in the Republic of Bulgaria;
p.(None): 2. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product intended for
p.(None): parallel import;
p.(None): 3. (suppl. – SG 12/11, in force from 08.02.2011) name of the marketing authorisation holder and the manufacturer if a
p.(None): person different from the marketing authorisation holder, name of the medicinal product intended for parallel import;
p.(None): 4. number of the marketing authorisation of the medicinal product in the Republic of Bulgaria and number of the
p.(None): marketing authorisation of the medicinal product in the Member State where the parallel import is to be effected from;
p.(None): 5. declaration for establishment of circumstances pursuant 217, issue 1;
p.(None): 6. copy of the patient information leaflet and a sample of the medicinal product in the form in which it is sold in the
p.(None): Member State where the parallel import is to be effected from,
p.(None):
p.(None): translation of the patient information leaflet in the Bulgarian language accompanied by a declaration that
p.(None): the translation is in compliance with the original of the leaflet;
p.(None): 7. proposal for patient information leaflet of the parallel imported medicinal product accompanied by a
p.(None): declaration that the content of the leaflet is identical with the content of the medicinal product authorised in the
p.(None): Republic of Bulgaria except for the following data:
p.(None): a) name and address of management of the person effecting the parallel import;
p.(None): b) name of manufacturer where it is different for both products;
p.(None): c) stability period where it is different for both products;
p.(None): d) excipients where these are different in both products;
p.(None): 8. in case of repackaging:
p.(None): a) sample of the parallel import product;
...

p.(None): shall be identical with the content of the product leaflet, approved in Republic of Bulgaria except of the data
p.(None): according to Art. 215, para 2, point 7, letters "a" – "d";
p.(None): 4. document and report to the marketing authorisation holder and the BDA all reports of adverse drug reactions of the
p.(None): imported medicinal product.
p.(None):
p.(None): Chapter nine.
p.(None): "B" EXPORT OF MEDICINAL PRODUCTS (NEW – SG 18/14)
p.(None):
p.(None): Art. 217a. (new – SG 18/14) (1) Export of medicinal products from the territory of the Republic of Bulgaria may be done
p.(None): by a natural person or a legal entity holding a permit for wholesale with medicinal products or by a holder of a
p.(None): production license.
p.(None): (2) Holders of a production license may carry out export only of the medicinal products manufactured by them.
p.(None): (3) Within the meaning of this Chapter, export shall also be an intra-Community supply within the European Union.
p.(None): (4) Export of medicinal products included in the Positive Medicines List referred to in Art. 262, par. 1 from the
p.(None): territory of the Republic of Bulgaria shall take place upon notification of BDA in every individual case, where the
p.(None): export is being carried out by the holder of a permit for wholesale of drugs.
p.(None):
p.(None):
p.(None): Art. 217b. (new – SG 18/14) The notification referred to in Art. 217a, par. 4 shall be send to the Managing Director of
p.(None): BDA and shall contain the following information:
p.(None): 1. name and registered address of the person under Art. 217a, par. 1;
p.(None): 2. name, pharmaceutical form and active substance quantity in a dose unit of the medicinal product
p.(None): intended for export;
p.(None): 3. reference number of the permit for wholesale of medicinal products;
p.(None): 4. number of packages of the medicinal product intended for export;
p.(None):
p.(None): 5. the state of destination of the export.
p.(None):
p.(None):
p.(None): Art. 217c. (new – SG 18/14; declared anti-constitutional CCD No 1 of 2015 - SG 12/2015) (1) Upon receipt
p.(None): of a notification under Art. 217b, BDA shall request information about the medicinal product intended for export for a
p.(None): period of the last 6 months as from the day of the notification:
p.(None): 1. about the consumption of the respective medicinal product from the National Health Insurance Fund and/or from the
p.(None): Ministry of Health;
p.(None): 2. about the supplied quantities of the respective medicinal product to the Republic of Bulgaria by the holder of the
p.(None): marketing authorisation.
p.(None): (2) The persons referred to in par. 1 shall provide the information requested by BDA within 15 days after the request.
p.(None): (3) BDA shall analyze the information about the respective medicinal product, received subject to
p.(None): compliance with the provision of par. 2, and shall compare the information about the used quantities under par. 1, item
p.(None): 1 and the supplier quantities under par. 1, item 2 with the available information obtained pursuant to
p.(None): the provision of Art. 217b, item 4 about the number of packages intended for export.
p.(None): (4) Where within 30 days as from the date of receipt of the notification under Art. 217b, the Managing Director of BDA
p.(None): does not object in writing the export, it shall be deemed that there is a tacit consent to the export.
...

p.(None): and or/municipal participation, according to Art. 9 and 10 of the Medical Establishments Act with state participation.
p.(None): (2) Positive Medicines List shall include medicinal products classified by pharmacological
p.(None): groups according to the code of the anatomo-therapeutic- chemical classification with the respective
p.(None): international non-proprietary names, the names, attached to them, with the respective defined daily doses/therapeutic
p.(None): course , reference price (value) under Art. 261a, Para. 1, limit price of the medicinal products in their retail sale,
p.(None): referent value for the defined daily dose/therapeutic course, value of the package, calculated on the basis
p.(None): of the reference value/therapeutic course for a defined daily dose and level of payment, needed for their treatment,
p.(None): as well as sicknesses on the international code of sickness (ICS).
p.(None): (3) For the medicinal products for which there is not defined daily dose, the reference value shall be defined on the
p.(None): basis therapeutic course, concentration or volume.
p.(None): (4) (suppl. - SG 48/15) The medicinal products in the Positive Medicines List shall be selected according to proof for
p.(None): effectiveness, therapeutic efficiency, safety and analysis of the pharmaco-economic indicators, provided that for
p.(None): medicinal products with new international non- proprietary names shall also be carried out health technology
p.(None): assessment. Health technology assessment shall be carried out under conditions and procedures specified by the Minister
p.(None): of Health
p.(None): (5) Where on or more medicinal products with the same international non-patent name, medicinal form and
p.(None): concentration of active substance, with the exception of the medicinal products under Art. 29, have already
p.(None): been included in the relevant part of the Positive Medicines List, the assessment under Para. 4 shall not be made.
p.(None): (6) The Positive Medicines List shall include:
p.(None): 1. medicinal products for treatment of diseases paid under the terms of Health Insurance
p.(None): Act;
p.(None): 2. medicinal products paid by the budget of the healthcare establishments according to
p.(None): Art. 5 of the Medical Establishments Act and by the budget of the therapeutic establishments according to Art. 9 and
p.(None): 10 of the Medical Establishments Act with state and or municipality participation;
p.(None): 3. medicinal products intended for treatment of AIDS, of infection diseases, of treatment of diseases out of range of
p.(None): Health Insurance Act, paid under the terms of Art. 82, Para. 1, point 8 from the Health Act, as well as vaccines for
p.(None): obligatory immunisations and re-immunisations, vaccines on special indicators and in extraordinary circumstances,
p.(None): specific serums, immune globulins;
p.(None): 4. limit price of the medicinal products under Art. 261a, Para. 4 on elements.
p.(None):
p.(None): (7) The Ministry of Health and NHIF may make grounded proposals to the Council under Art. 258. Para. 1for
p.(None): re-examination of included medicinal products in the Positive Medicines List under the terms and conditions, determined
p.(None): by the Ordinance under Art. 261a, Para. 5.
p.(None): (8) The NHIF shall pay the medicinal products under Para. 6, p. 1,under the terms and conditions of the Ordinance under
p.(None): Art. 45, Para. 9 of the Health Insurance Act.
p.(None): (9) (new – SG 18/14; amend. - SG 48/15) The terms and conditions, the rules and the criteria for the inclusion,
...

p.(None): a member of the Transparency Commission shall not be a member of the Council.
p.(None): (4) The Council of Ministers determines with Rules the condition and the order for work of the Transparency Commission.
p.(None):
p.(None):
p.(None): Art. 266. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) The
p.(None): Transparency Commission shall be a body before which decisions of the Council may be appealed.
p.(None): (2) The decisions of the Transparency Commission shall be taken by a majority of two thirds of its members.
p.(None): (3) The decisions of Para. 2 could be appealed under the terms of the Administrative Procedure Code and the appeal has
p.(None): no suspense effect.
p.(None):
p.(None):
p.(None): Art. 266a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Where the treatment of a relevant sickness is without
p.(None): alternative in the country, for a concrete patient may be applied a medicinal products, which is authorised for use in
p.(None): an EU Member State, authorised for use under this Act, but is not sold on the Bulgarian market.
p.(None): (2) Annually, upon proposal of the medical establishments for hospital assistance after an opinion of the relevant
p.(None): national consultant on the profile of the sickness, the Minister of Health shall confirm a list of the medicinal
p.(None): products under Para. 1, which shall contain the following information:
p.(None): 1. code on the anatomy-therapeutic – chemical classification;
p.(None): 2. international non-patent name, to which the product belongs; 3.sickness according to international code of
p.(None): sicknesses; 4.medicinal form and quantity active substance;
p.(None): 5. additional information.
p.(None): (3) The list under Para. 2 shall be published on the internet site of the Ministry of Health.
p.(None): (4) The terms and conditions for inclusion, changes or exclusion of medicinal products in the list under Para. 2 shall
p.(None): be determined by the Ordinance under Art. 9, Para. 1.
p.(None):
p.(None): (5) The medicinal product under Para. 1 shall be supplied upon a special order of a medical establishment for hospital
p.(None): assistance under terms and conditions, determined by the Ordinance under Art. 9, Para. 1.
p.(None): (6) The head of the medical establishment under Para. 5 shall bear responsibility for applying the treatment under
p.(None): Para. 1.
p.(None):
p.(None): Chapter thirteen.
p.(None): STATE CONTROL ON THE MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 267. (1) (amend., - SG 98/10, in force from 01.01.2011, suppl. – SG 102/2012, in force from 21.12.2012) The
p.(None): Ministry of Health shall exercise the state control on the medicinal products. The immediate management shall be
p.(None): executed by the chief state health inspector, the Council chairperson under Art. 258, Para. 1, the executive director
p.(None): of the BDA, and the directors of the regional health inspectorates (RHI) who shall be state inspectors for the control
p.(None): of the medicinal products.
p.(None): (2) (amend., - SG 98/10, in force from 01.01.2011, suppl. – SG 102/2012, in force from 21.12.2012)) Bodies for state
p.(None): control of the medicinal products shall be the Council under Art. 258, Para. 1, BDA and RHI.
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011, suppl. – SG 102/2012, in force from 21.12.2012) The immediate
p.(None): control shall be exercised by officials – inspectors and experts appointed by orders of the Council
...

p.(None): Code, however, the appeal shall not stop their execution.
p.(None):
p.(None): Art. 294. Whoever infringes the provisions of this Act or the regulations for its implementation, except
p.(None): for the cases according to Art. 281-293, shall be penalised with a fine from BGN 1,000 to BGN 3,000 and in case of
p.(None): repeated perpetration of the same infringement – with a fine from BGN 3,000 to BGN 5,000.
p.(None):
p.(None):
p.(None): Art. 295. (1) (amend., - SG 98/10, in force from 01.01.2011) The infringements according to this Act shall be
p.(None): established by virtue of deeds drawn up by state inspectors of the BDA or of the RHI.
p.(None): (2) The infringements according to Art. 289 shall only be established by officials appointed by the
p.(None): Minister of Health.
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011) The penal ordinances shall be issued by the Minister of Health, the
p.(None): chief state health inspector, and the directors of the BDA and RHI depending on the subjection of the official, who has
p.(None): established the infringement.
p.(None):
p.(None):
p.(None): Art. 296. The drawing of the deeds and the issue, appeal and the execution of penal ordinances shall be made in
p.(None): compliance with the provisions of the Administrative Violations and Penalties Act.
p.(None):
p.(None):
p.(None): Art. 297. In the cases pursuant Art. 281, 282, 283, 284, 285 and 287 the penalty body enact a bereavement of the
p.(None): medicinal products for state benefit, the subject of the infringement by rules and order, determined in a regulation by
p.(None): the Minister of Health.
p.(None):
p.(None): Additional provisions
p.(None):
p.(None): § 1. Within the meaning of this Act:
p.(None): 1. "Active substance" shall mean any substance (ingredient) intended to be used for manufacturing of medicinal product,
p.(None): which during it production turns in active component of this product, intended for exercising pharmacologic,
p.(None): immunologic or metabolic action with the purpose of restoration, correction or change of physiologic functions or
p.(None): for putting a medical diagnosis.
p.(None): 2. "Bioequivalence" shall be in place where medicinal products are pharmaceutically equivalent or pharmaceutical
p.(None): alternatives and if their bio availabilities after administration of the same molar dose are similar to such extent
p.(None): that their effects with respect to efficacy and safety are essentially similar.
p.(None): 3. "Bioavailability" shall mean the rate and degree at which an active substance or its therapeutically active part is
p.(None): absorbed from the pharmaceutical form and it becomes available at its site of action. Where the medicinal substance is
p.(None): intended to exert a systemic therapeutic effect, bioavailability shall mean the rate and degree at which the medicinal
p.(None): substance or its therapeutically active part is released from the pharmaceutical form and passes into the total
p.(None): circulation.
p.(None): 4. "Researcher’s brochure" shall mean the aggregate of clinical and non clinical data of tests of medicinal product(s),
p.(None): which are relevant to the clinical test of the product(s) in man.
p.(None): 5. "Valid documentation" shall mean any documentation which is compliant with the requirements laid down in
p.(None): a give procedure pursuant to this Act both with respect to content and
p.(None):
p.(None): completeness.
p.(None): 6. "Substance with well established use in medical practice" shall mean a substance to which the following criteria can
p.(None): be applied:
p.(None): a) the period for proving the well established use in medical practice is not less than 10 years from the date of
p.(None): the first systematised and documented use of the substance as a medicinal product in the European Union or in
p.(None): the European Economic Area;
p.(None): b) quantitative aspects of the use of the substance, taking into consideration the degree of use in medical practice,
p.(None): the degree of use on geographical principle, and the degree of follow- up through the pharmaco-vigilance system
p.(None): including pre- and post marketing studies and published scientific literature for epidemiological studies
p.(None): and comparative epidemiological studies in particular;
p.(None): c) high degree of scientific interest in the use of the substance (number of scientific publications) and coherence
p.(None): in scientific assessments.
p.(None): 7. "Outer packaging" shall mean the packaging, which does not come in immediate contact with the medicinal
p.(None): product.
p.(None): 8. "Contracting authority" shall mean a natural or legal person, institution, or organisation responsible for the
p.(None): start-up, management, and/or financing of a clinical test.
p.(None): 9. "Generic medicinal product" shall mean a medicinal product, which has the same qualitative and quantitative
p.(None): composition as regards the active substances and the same pharmaceutical form as the reference medicinal
p.(None): product and its bioequivalence compared to the reference medicinal product has been proven in adequate
p.(None): bioavailability studies. Various immediate release oral pharmaceutical forms shall be regarded as the same
p.(None): pharmaceutical form. Various salts, esters, ethers, isomers, mixtures of isomers, complexes, or derivatives of an
p.(None): active substance shall be regarded as the same active substance except if these are significantly
p.(None): different in respect of safety and/or efficacy.
p.(None): 10. "Principal researcher" shall mean an appointed by the contracting authority medical doctor or doctor in dental
p.(None): medicine who is managing the overall conduct of a clinical test in compliance with an approved protocol and the rules
p.(None): for Good Clinical Practice and is responsible for the work of the researchers.
p.(None): 11. "Defined daily dose" shall be the mean daily maintenance dose of a given medicinal product, which administered to
p.(None): adults according to the main indication of a medicinal product.
p.(None): 12. "Good clinical practice" shall mean the aggregate of internationally recognised ethical and scientific
p.(None): quality requirement, which shall be observed during the planning, conduct, accounting, and reporting of clinical
p.(None): trials.
p.(None): 13. "Good laboratory practice" shall mean a system of rules in respect if the conditions for planning, processes of
p.(None): organizing, conduct, follow up, and documenting of laboratory tests.
p.(None): 14. "Good manufacturing practice" shall mean a system of rules encompassing all aspects of manufacture:
p.(None): personnel, premises, equipment, materials, documentation, and quality control and has the purpose of ensuring safety,
p.(None): efficacy, and compliance with a specification.
p.(None): 15.. (Suppl. - SG 71/2008 in force from 12.08.2008) "Member State" shall mean a State Member of the European Union, or
p.(None): a State, party of the Agreement of the EEA.
p.(None): 16. "Labeling" shall mean information on the immediate or outer packaging of a medicinal product.
p.(None): 17. "Immunological medicinal product" shall mean a medicinal product, which contains vaccines, toxins, sera, or
p.(None): allergens. Agents used to create active immunity or establish a condition of immunity or invoke passive
p.(None): immunity shall be involved in the scope of vaccines, toxins, and sera. Allergens shall mean medicinal products,
p.(None): which are intended to identify or stimulate specific purposeful change in the immunological response to an allergens
p.(None): agent.
p.(None): 18. "Bioequivalence study" shall mean a clinical test aimed at proving that two medicinal
p.(None):
p.(None): products are bioequivalent provided that they are pharmaceutically equivalent or pharmaceutical alternatives and
p.(None): provided that their bioavailability after administration of the same molar dose are similar to a degree, which is a
p.(None): condition for equivalence in respect of efficacy and safety.
p.(None): 19. "Bioavailability study" shall mean a clinical test aimed at showing what is the rate and degree which an active
p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
p.(None): used in an unauthorised indication or with a view of obtaining additional information for an authorised form, or are
p.(None): made up (in a pharmaceutical form or packaged) in a manner, which is different from the authorised form.
p.(None): 21. "Researcher" shall mean an appointed by the contracting authority and the principal researcher medical doctor or
p.(None): doctor in dental medicine who practically conducts a clinical test under the management of a principal researcher in
p.(None): compliance with an approved protocol and the guidelines for Good Clinical Practice in an investigational site for the
p.(None): conduct of a clinical test. If a clinical test is not conducted by a team, the researcher shall be the manager
p.(None): responsible for the team and shall be called principal researcher.
p.(None): 22. "Informed consent" shall mean a decision to participate in a clinical test, which must be in writing, dated and
p.(None): signed and taken freely by any person capable of giving his consent or
p.(None): – where a person is incapable of giving his consent by his legal representative after being duly informed about the
p.(None): essence, importance, consequences and risks of a clinical test and documented in an adequate manner.
p.(None): 23. "Kit" shall mean any substance, which – usually before use – shall be dissolved, suspended, diluted, or combined
p.(None): with radionuclides as a result of which procedure the finished radioactive medicinal product is obtained.
p.(None): 24. "Clinical test of a medicinal product" shall mean any study in man intended for discovering or
p.(None): confirming clinical, pharmacological, and/or other pharmacodynamic effects of one or more study medicinal products, and
p.(None): /or for determination of the adverse reactions to one or more study medicinal products, and/or for studying the
p.(None): absorption, distribution, metabolism, and excretion of one or more study medicinal products with the purpose of
p.(None): establishing their safety and/or efficacy.
p.(None): 25. "Clinical advantage" shall mean a significant therapeutic or diagnostic advantage of a medicinal product compared
p.(None): to a medicinal product, which has already received marketing authorisation.
p.(None): 26. "Coordinating researcher" shall mean a researcher appointed for the purpose of coordinating the researchers or
p.(None): various sites participating in a multicentre test.
p.(None): 27. "Patient information leaflet" shall mean a leaflet accompanying a medicinal product and containing information for
p.(None): the customer.
p.(None): 27a. (New - SG 71/2008 in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) "Medicinal product
p.(None): for modern therapy" is a medicinal product, determined in Art. 2 of Regulation (EC) N 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on the medicinal products for modern therapy and amending Directive
p.(None): 2001/83/EC and Regulation (EC) № 726/2004.
p.(None): 28. "Medicinal product obtained from human plasma or human blood" shall mean a medicinal product produced
p.(None): from human blood constituents and by a method involving industrial process. The following shall be ascribed to this
p.(None): group: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, and other plasma
p.(None): fractions and combinations thereof.
p.(None): 29. "Medicinal product intended for treatment, prophylaxis, and diagnostics of rare
p.(None):
p.(None): diseases" shall mean a product, which:
p.(None): a) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases or chronic diseases taking
p.(None): progressive course, which affect not more than 5 of 10,000 people on the territory of a state or
p.(None): b) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases and severely health damaging
p.(None): chronic disease (diseases with high percentage of disease-related incapacity of work or disability) and are there is
p.(None): evidence appended that the sale of the product does ensure satisfactory return, which can justify the required
p.(None): investment for scientific research and development without having stimuli for the creator of the product, and
p.(None): c) where the is no satisfactory method of diagnostics, prophylaxis, or treatment of a given condition or where there is
p.(None): such method the proposed medicinal product has significantly more advantages and benefits for the people affected by
p.(None): this condition.
p.(None): 30. "Pharmaceutical form" shall mean an adequate for intake structure containing active substance(s), which can
p.(None): include or cannot include excipients and which is obtained through application of certain technological operations
p.(None): ensuring the desired healing effect and stability at storage within the expiry term.
p.(None): 31.. (Amen. - SG 71/2008 in force from 12.08.2008) "Any person, established on the territory of a Member State shall
p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
p.(None): 34. "Medical specialists" shall mean medical doctors, doctors in dental medicine, masters of pharmacy,
p.(None): nurses, midwives, medical laboratory assistants, medical auxiliaries and pharmacy assistants.
p.(None): 35. "Medical trade representative" shall mean a person who has passed special training and possessing scientific
p.(None): knowledge for the presentation of accurate and comprehensive information about the medicinal product he is
p.(None): advertising.
p.(None): 35a. (new – SG 1/14, in force from 03.01.2014)”Medical prescription” shall mean a prescription of a
p.(None): medicinal product, issued by a person who exercises a regulated medical profession within the meaning of § 1,
p.(None): item 1 of the Additional Provisions of the Recognition of Professional Qualifications Act and who is legally entitled
p.(None): to do so in the Member State in which the medical prescription is issued.
p.(None): 36. "Multicentre clinical test" shall mean a clinical test, which is conducted according to a single protocol but in
p.(None): more than one site and by more than one researcher. Researcher sites can be situated in the territory of one Member
p.(None): State, more than one Member State, and/or in Member States and third states.
p.(None): 37. "Name of a medicinal product" shall mean the name given to a medicinal product, which can be:
p.(None): a) a freely selected name (trade name);
p.(None): b) (amend. – SG 12/11, in force from 08.02.2011) a common name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation;
p.(None): c) (amend. – SG 12/11, in force from 08.02.2011) scientific name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation.
p.(None): 38. "Scientific literature" shall mean publication(s) of results from scientific research in specialised international
p.(None): scientific editions.
p.(None):
p.(None): 39. "New active substance" shall mean:
p.(None): a) chemical, biological, or radiopharmaceutical substance, which has not been authorised to market in
p.(None): the European Union as a medicinal product;
p.(None): b) isomer, mixture of isomers, complex or derivative or salt of a chemical substance, which has been authorised to
p.(None): market in the European Union as a medicinal product but is different with respect to safety and efficacy from
p.(None): a formerly authorised substance;
p.(None): c) biological substance, which has been authorised to market in the European Union as a medicinal product but has
p.(None): different molecular structure, different origin with respect to the starting material, or has been obtained
p.(None): through a different manufacturing process;
p.(None): d) radiopharmaceutical substance the radionuclides or molecular bonds (ligands) of which have not been
p.(None): authorised in the European Union as a medicinal product or the mechanism of bonding in a couple of the molecules
p.(None): and radionuclides has not been authorised in the European Union.
p.(None): 40. "Adverse event" shall mean any untoward unfavorable change the health condition observed during the administration
p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
p.(None): disability, and innate anomalies;
p.(None): d) combination of reactions according to subsections "a", "b", and "c".
p.(None): 42. "Common name" shall mean the international non-proprietary name (INN) of a medicinal substance or
p.(None): excipient recommended by the World Health Organisation; if not any, the name in the European Pharmacopoeia shall be
p.(None): used; if there is no such name there, another pharmacopoeia name shall be used; if there is no pharmacopoeia name, the
p.(None): common name shall be used.
p.(None): 42a (new – SG, 102/2012, in force from 21.12.2012) "Basic documentation of a system of pharmaco-vigilance" is a detail
p.(None): description of the pharmaco-vigilance system, used by the marketing authorisation holder in relation or one or more
p.(None): authorised for use medicinal products.
p.(None): 42b. (new - SG48/15) "Health technology assessment" shall mesn:
p.(None): a) a form of policy on research that examines the short- and long-term outcomes related to the implementation of
p.(None): health technologies and aims to provide information concerning alternative health strategies;
p.(None): b) multidisciplinary activity that systematically evaluates technical specifications, safety, clinical efficacy and
p.(None): effectiveness, cost, cost effectiveness, organizational, social, legal and ethical consequences of
p.(None): administration of medicinal products in health care and focuses on value - clinical and economic, provided
p.(None): that the analysis is comparative to existing or best alternative at the time;
p.(None):
p.(None): 43. "Batch" shall mean a definite quantity of a medicinal product manufactured according to an established reproducible
p.(None): technological scheme ensuring the required batch homogeneity with respect to the required quality characteristics.
p.(None): 43a. (new – SG, 102/2012, in force from 21.12.2012) "plan for risk management" is a detailed description of the system
p.(None): for risk management.
p.(None): 44. "Maintenance of a marketing authorisation" shall include all required activities with regard to the maintenance of
p.(None): an updated registration status of a medicinal product including pharmaco-vigilance.
p.(None): 45. "Benefit" shall mean a positive result/therapeutic efficacy of a medicinal product for a definite patient,
p.(None): patient group, or the society. Quantitative assessment of the anticipated benefit shall include approximate
p.(None): calculation of the probability of this positive result.
p.(None): 46. (amend. – SG, 102/2012, in force from 02.01.2013) "Auxiliary substance" is any component of a medicinal product,
p.(None): different for the active substance and the packing material.
p.(None): 47. "Post marketing study" shall mean any study conducted during the use of a medicinal product within the approved
p.(None): summary of product characteristics during the period after the authorisation to market.
p.(None): 47a (new - SG, 102/2012, in force from 02.01.2013) "Mediation in the area of medicinal products" are all the
p.(None): activities, which aim at signing contract for buying or selling of medicinal products with the exception of wholesale
p.(None): trade, which do not include physical keeping and which are expressed in negotiating independent and on behalf of
p.(None): another legal or natural person.
p.(None): 48. "Post marketing safety study" shall mean any study, related to an authorised for use medicinal product, conducted
p.(None): with the purpose of identification, characterisation of defining the risk level in relation of safety, to confirm the
p.(None): safety profile of the medicinal product or to assess the effectiveness of the measures for risk management.
p.(None): 49. "Potential serious risk for the population" shall exist where there is a high probability a medicinal product to
p.(None): cause irremovable, irremediable, and irreversible consequences. The assessment process shall identify the threat of
p.(None): causing damages to the health of the population and its actual exposition during wide use of the product. The serious
p.(None): risk for the health in the context of the use of a given medicinal can be assessed under the following conditions:
...

p.(None): the Republic of Bulgaria.
p.(None): 51. "Acceptable safety level" shall be in place where the submitted data shall be accepted as
p.(None): statistically reliable safety according to clinical trials conducted in compliance with the Good Clinical Practice.
p.(None): 52. "Manufacture of a medicinal product" shall mean all operations relating to the supply
p.(None):
p.(None): of materials, their processing during the manufacturing process including packaging and labeling, quality control,
p.(None): batch release, storage, shipment, and operations control relating there to.
p.(None): 53. "Clinical test protocol" shall mean a document describing the purpose(s), design, methodology, statistical
p.(None): processing, and organisation of a clinical test. The protocol shall also include all subsequent amendments thereto.
p.(None): 54. "Placing on the market" shall mean the distribution of a medicinal product in the trade network on the territory of
p.(None): the Republic of Bulgaria outside the direct control of the marketing authorisation holder.
p.(None): 55. "Immediate packaging" shall mean the packaging, which enters in immediate contact with a product.
p.(None): 56. "Radiopharmaceutical" shall mean a medicinal product, which when in a ready for use form contains one or more
p.(None): radionuclides (radioactive isotopes) included with medical purpose.
p.(None): 57. "Radionuclide generator" shall mean any system, which includes a fixed maternal radionuclide from which a filial
p.(None): radionuclide is obtained, which is separated by elusion or other methods and is used in a radiopharmaceutical.
p.(None): 58. "Radionuclide precursor" shall mean any other radionuclide manufactured for radioactive marking of another
p.(None): substance immediately before its introduction in a patient’s body.
p.(None): 59. "Herbal medicinal product" shall mean a medicinal product containing as active ingredient one or more
p.(None): herbal substances or one or more herbal preparations, or one or more herbal substances in a combination with one or
p.(None): more herbal preparations.
p.(None): 60. "Herbal substances" shall basically mean plants or parts of plants, seaweed, mushrooms, and lichens,
p.(None): which are whole, broken, or cut, usually dried or sometimes fresh. Certain exudates, which have not been subjected to
p.(None): specific processing, shall also be assigned to the herbal substances. Herbal substances shall have be accurately
p.(None): defined botanical scientific name of the plant wherefrom they originate according to the binominal system (species,
p.(None): sort, variety, and author).
p.(None): 61. "Herbal preparation" shall mean the product obtained after extraction, distillation, pressing, fractionation,
p.(None): purification, concentration, or fermentation of herbal substance. The herbal preparation can also represent
p.(None): ground or powdered herbal substances, tinctures, extracts, essential oils, and processed herbal liquids/juices.
p.(None): 62. "Rare diseases" shall mean the diseases, which are characterised with incidence of not more than 5 in 10,000 of the
p.(None): population.
p.(None): 63. "Reference medicinal product" shall mean a medicinal product authorised under the terms of Art. 23 in compliance
p.(None): with the requirements of Art. 27.
p.(None): 64. "Reference value of a defined daily dose" on an international non-proprietary name with the corresponding
p.(None): pharmaceutical for according to the anatomo-therapeutic classification of medicinal products shall mean the lowest
p.(None): value of a defined daily dose determined on the basis of the values of a defined daily dose for various medicinal
p.(None): products for the international non-proprietary with the corresponding pharmaceutical form according to the
p.(None): anatomo- therapeutic classification of medicinal products.
p.(None): 65. "Reference value of a therapeutic course" shall be the lowest value of a therapeutic course determined on the basis
p.(None): of the values of a therapeutic course of the medicinal products according to international non-proprietary name with
p.(None): the corresponding pharmaceutical form.
p.(None): 66. "Risk during the use of a medicinal product" shall mean:
p.(None): a) risk for the health of the patient or risk for the health of the population, which is associated
p.(None): with the quality, safety, or efficacy of a medicinal product;
p.(None): b) risk of undesirable effects on the environment.
...

p.(None): 69b (new – SG, 102/2012, in force from 21.12.2012) "Pharmaco-vigilance system" is a system, used by the marketing
p.(None): authorisation holder and BDA for implementation of the tasks and responsibilities under Chapter Eight, intended for
p.(None): observation of vigilance of the permitted for use medicinal products and for finding every change in the benefit/risk
p.(None): ratio.
p.(None): 70. "Urgent limitation safety measures" shall mean temporary changes in the product information with respect of one
p.(None): or more parts of the summary of product characteristics, indications, method of administration,
p.(None): contraindications, and warnings, which result from new information associated with the safe use of a medicinal product.
p.(None): 71. "Spontaneous report" shall mean a voluntarily report for a suspected adverse reaction during the use of
p.(None): a medicinal product forwarded to the marketing authorisation holder, to the bodies for supervision on the medicinal
p.(None): products, or to other organisations, which is not originating from a study or another organised system for data
p.(None): capturing.
p.(None): 72. "Expiry period of a medicinal product" shall mean the interval of time during which, if a medicinal product is
p.(None): stored under the prescribed conditions, it shall comply with the specification developed on the grounds of
p.(None): stability tests of several batches of the finished form.
p.(None): 73. (Amen. - SG 71/2008, in force from 12.08.2008) "Medicinal product equivalent to a herbal medicinal product"
p.(None): shall mean a product containing the same active substances irrespective of the composition of the excipients
p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
...

p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
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p.(None): 1. chemico-pharmaceutical examinations;
p.(None): 2. laboratory analyses and tests;
p.(None): 3. assessment of documentation and issue of authorisations, certificates, and other documents set forth in
p.(None): this Act;
p.(None): 4. evaluation by the renewal, variation and cease of marketing authorisation approval and certificate for registration
p.(None): of medicinal product;
p.(None): 5. maintenance of marketing authorisations of medicinal products;
p.(None): 6. fines and property sanctions imposed by penal ordinances issued for infringements of this Act;
p.(None): 7. consulting, publishing, and research activities in the field of the drug sector;
p.(None): 8. coordination of investment projects for the construction of new and/or refurbishing of existing sites relating to
p.(None): the manufacture of medicinal products;
p.(None): 9. conduct of inspections in connection with assessment of compliance of the manufacturing conditions with
p.(None): the requirements of Good Manufacturing Practice;
p.(None): 10 other sources.
p.(None): (2) During the execution of the activities according to para 1, points 1 – 5, points 7 – 9 the Bulgarian Drug Agency
p.(None): shall collect fees to the amounts as defined in a tariff adopted by the
p.(None):
p.(None): Council of Ministers.
p.(None): (3) (New - SG 71/2008, in force from 12.08.2008) The tariff under para 2 shall have determined lower and various in
p.(None): amount fees for realisation of the procedures on permission for usage, production and import of medicinal products for
p.(None): small and medium enterprises in the pharmaceutical sector in the meaning of the Small- and Medium-Size Enterprises Act.
p.(None):
p.(None):
p.(None): Art. 22. (1) The funds according to Art. 21 shall be spent for:
p.(None): 1. control activity of the BDA;
p.(None): 2. Payment of the activities according to Art. 21, Para. 1, p. 1 and 2, when The BDA is assigned their execution of
p.(None): another persons by contract;
p.(None): 3. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 4. establishment and maintenance and update of the registers according to Art. 19, Para.
p.(None): 1;
p.(None): 5. maintenance of systems for electronic data exchange with the regulatory bodies of
p.(None): the other Member States, with the European Commission, with and the European Medicines Agency;
p.(None): 6. (suppl. – SG, 102/2012, in force from 21.12.2012) information and publishing activities relating to the quality,
p.(None): efficacy, and safety of the medicinal products and vigilance medicinal safety;
p.(None): 7. provision of the activity of the specialised commissions according to Art. 47, Par. 1 and 2 and the council
p.(None): according to Art. 251, Para. 3;
p.(None): 8. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 9. participations in international and national inter-laboratory tests;
p.(None): 10. (amend. – SG. 60/2011, in force from 5. 8. 2011; revoked – SG 38/12, in force from 01.07.2012)
p.(None): (2) ( suppl. SG 71/2008, in force from 12.08.2008; amend. and suppl. – SG 12/11, in force from 08.02. 2011, amend. –
p.(None): SG, 60/2011, in force from 5.8.2011, amend. – SG, 102.2012, in force from 21.12.2012) The funds according to Art. 114,
p.(None): Para. 4, and Art. 259, Para. 5 shall be spent for:
p.(None): 1. (amend. – SG, 60/2011, in force from 5.8.2011).
p.(None): 2. activities of the Pharmacopoeia Committee;
p.(None): 3. (amend. – SG, 60/2011, in force from 5.8.2011, amend. – SG, 102.2012, in force from 21.12.2012) ).activities of the
p.(None): Transparency Commission, the Central Commission on Ethics and the Commission on Ethics for Multi-centre Tests;
p.(None): 4. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 5. (suppl. – SG 71/08, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011, amend. –
p.(None): SG, 60/2011, in force from 5.8.2011; revoked – SG 38/12, in force from 01.07.2012)
p.(None):
p.(None): Chapter three.
p.(None): PLACING MEDICINAL PRODUCTS ON THE MARKET
p.(None):
p.(None): Section I. General Provisions
p.(None):
p.(None): Art. 23. (1) An industrially manufactured medicinal product or a medicinal product obtained by a method
p.(None): involving an industrial process may only be placed on the market after a
p.(None):
p.(None): marketing authorisation or a registration certificate has been issued under the terms of:
p.(None): 1. this Act or
p.(None): 2. Regulation (EC) 726/2004 of the European Parliament and the Council.
p.(None): (2) A marketing authorisation within the meaning of para 1 shall also be required for a radionuclide generator,
p.(None): radionuclide precursor, or a kit.
p.(None): (3) Types of procedures according to para 1 shall be:
p.(None): 1. centralised procedure;
p.(None): 2. mutual recognition /decentralised procedure;
p.(None): 3. national procedure.
p.(None): (4) (New - SG 71/2008, in force from 12.08.2008) On the territory of the Republic of Bulgaria may be placed on the
p.(None): market only medicinal products, whose owner of permission for usage/certificate for registration has been established
p.(None): on the territory of a Member State.
p.(None):
p.(None):
p.(None): Art. 24. (1) Marketing authorisation shall not be required for radiopharmaceuticals prepared immediately
p.(None): before use from authorised radionuclide generators, radionuclide precursors, or kits in accordance with the
p.(None): manufacturer’s instructions.
p.(None): (2) The products according to para 1 shall be prepared by qualified persons I laboratories or institutes authorised for
p.(None): such activity under the terms of the Safe Use of Nuclear Energy Act.
p.(None): (3) The preparation, use, and administration of the products according to para 1 shall be performed in compliance with
p.(None): the nuclear medicine standard.
p.(None):
p.(None):
p.(None): Art. 25. (1) The criteria for the determination of a medicinal product designated for the treatment, prophylaxis, or
p.(None): diagnostics of rare diseases are laid down in Regulation (EC) N 141/2000 of the European Parliament and of
p.(None): the Council.
p.(None): (2) The conditions and order for granting of a marketing authorisation of the medicinal products according to para 1
p.(None): are laid down in (EC) N 726/2004 of the European Parliament and of the Council.
p.(None):
p.(None):
p.(None): Art. 26. (1) A marketing authorisation of a medicinal product, a registration certificate for the authorisation of a
p.(None): homeopathic medicinal product according to Art. 35, or a registration certificate for the authorisation of a
p.(None): traditional herbal medicinal product according to Art. 37 on the territory of the Republic of Bulgaria shall be issued
p.(None): by the executive director BDA to a natural or legal person established on the territory of a Member State or a state
p.(None): member of the European Economic Area.
...

p.(None): authorisation/registration certificate of medicinal product where certain data in the dossier do not comply with the
p.(None): requirements of Art. 27 - 32.
p.(None): (3) The executive director of the BDA shall refuse registration of a traditional herbal medicinal product where,
p.(None): after assessment of the documentation, it shall be established that the product does not comply with the conditions
p.(None): according to Art. 37, para 1, the data in the dossier do not comply with Art. 38, or:
p.(None): 1. the qualitative and quantitative composition does not comply with those described in the dossier;
p.(None): 2. the medicinal product can be noxious at correct use;
p.(None): 3. the data for the traditional use are insufficient, especially where the pharmacological properties or the efficacy
p.(None): are not proven on the basis long-standing use and the experience acquired;
p.(None): 4. the pharmaceutical quality of the medicinal product is insufficiently grounded.
p.(None):
p.(None): Art. 58. The marketing authorisation holder takes the responsibility for the completeness and authenticity of the data
p.(None): in the dossier.
p.(None):
p.(None):
p.(None): Art. 59. (1) The refusal of the executive director of the BDA to grant a marketing
p.(None): authorisation/registration certificate of a medicinal product may be appealed under the terms of the Administrative
p.(None): Procedure Code.
p.(None): (2) The refusal of the executive director of the BDA and the motives thereof shall be published on the internet site of
p.(None): the Agency.
p.(None):
p.(None):
p.(None): Art. 59a. (New - SG 71/2008, in force from 12.08.2008) (1) (amend. – SG, 102/2012, in force from 21.12.2012) In the
p.(None): cases under Art. 55, Para. 2 and 5 not later than 6 months before expiry of the term of the authorisation for
p.(None): usage/certificate for registration, its owner shall file to BDA application for renewal, accompanied with a summarised
p.(None): dossier in relation to the quality, safety and efficacy of the medicinal product, including data assessment, contained
p.(None): in the reports for suspected unwilling medicinal reactions and the periodical updated safety reports, submitted under
p.(None): Chapter Eight, and all the approved changes after issuing the authorisation for usage/certificate for
p.(None): registration.
p.(None): (2) The requirements for the data and the documents of the dossier under para 1 shall be determined by the ordinance
p.(None): under Art. 42.
p.(None): (3) within 120 days after filing the application and the documentation under para 1, BDA shall assess the quality,
p.(None): safety and efficacy of the medicinal product and shall prepare an assessment report, which shall be submitted
p.(None): to the executive director of BDA
p.(None): (4) In cases, where incompleteness and/or incompatibilities have been established in the presented documentation
p.(None): under para 1, BDA shall notify in writing the owner of the authorisation for usage/certificate for
p.(None): registration and shall give instructions for their removal. The owner of the authorisation for
p.(None): usage/certificate for registration shall remove the incompleteness and/or incompatibilities in the
p.(None): documentation within the term of 30 days after the date of receiving the notification.
p.(None): (5) within the term of 10 days after receiving the assessment report under para 3, the executive director of BDA
p.(None): shall issue authorisation for renewal of the authorisation for usage/certificate for registration of the
p.(None): medicinal product or a motivated refusal.
p.(None):
p.(None):
p.(None): Art. 59b. (New - SG 71/2008, in force from 12.08.2008) (1) The executive director of BDA shall refuse renewal of
p.(None): the authorisation for usage/certificate for registration of the medicinal product, in cases where after the
p.(None): assessment of the dossier under Art. 59a, para 1 it is established, that:
p.(None): 1. the medicinal product is hazardous in correct usage, or
p.(None): 2. there is not therapeutic efficacy, or
p.(None): 3. the relation between usefulness/risk is unfavourable in correct usage, or
p.(None): 4. the quantity and quality composition of the medicinal product do not comply with the one, described in the dossier,
p.(None): or
p.(None): 5. the data in the dossier under. 59a, para 1 are not true, or
p.(None): 6. the control of the medicinal product and/or of the ingredients and of the interim stages of the production process
p.(None): has not been performed or another requirement has not been fulfilled, where the authorisation for production has been
p.(None): issued, or
p.(None): 7. some of the data in the dossier do not comply with the requirements of Art. 59a, para
p.(None):
p.(None): 1 and 2.
p.(None): (2) The refusal of the executive director of BDA to renew the authorisation for the usage/certificate for
p.(None): registration of the medicinal product may be appealed, as provided by the Administrative Procedure Code.
p.(None): (3) The refusal of the executive director of BDA and the motives shall be published on the BDA website.
p.(None):
p.(None):
p.(None): Art. 59c. (New – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 01.04.2013) The BDA
p.(None): shall notify the National council of prices and reimbursement of medicinal products about the terminated and
p.(None): withdrawn authorisations for use, as well as the made refusals for renewal of issued authorisations for use of
p.(None): medicinal products within 7 day term from issuance of the relevant act.
p.(None):
p.(None): Section VI.
p.(None): Variations in Granted Marketing Authorisation
p.(None):
p.(None): Art. 60. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of a marketing authorisation of the medicinal
p.(None): product shall be obliged to notify the BDA about any change in the conditions under which the permit has been granted.
p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011)Variations may be of type IA, of type IB, of type II, extension of the
p.(None): marketing authorisation and urgent restricting measures of safety.
p.(None): (3) (amend. – SG 12/11, in force from 08.02.2011) Terms and criteria of classification of the variation shall be laid
p.(None): down in the regulation envisaged in Art. 42.
p.(None): (4) (amend. – SG 12/11, in force from 08.02.2011) Any variation, which is not an extension and whose
p.(None): classification is undetermined after application of the terms and criteria stipulated in the envisaged in Art. 42
p.(None): regulation, shall be considered a variation of type IB by default.
p.(None): (5) (new – SG 12/11, in force from 08.02.2011) As an exception from Para 4, and whose classification is undetermined
...

p.(None): (2) The patients may report adverse medicinal reactions at any time to the medical
p.(None):
p.(None): specialists or to BDA.
p.(None): (3) In the cases under Para. 1 and 2 where the report refers to biological medicinal product, prescribed, disseminated
p.(None): or sold on the territory of the Republic of Bulgaria, it must be clearly identified by the reporter with its trade name
p.(None): and lot number or this information is provided during the additional vigilance.
p.(None):
p.(None):
p.(None): Art. 185. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall maintain national internet portal for
p.(None): medicinal products, connected to the European internet portal for medicinal products under Art. 68, Para. 1, p. 4.
p.(None): (2) The BDA shall provide through the portal under Para. 1 at least the following information:
p.(None): 1. the public assessment reports under Art. 53, Para. 2 and their summaries;
p.(None): 2. the short characteristics of the products and the leaflets;
p.(None): 3. summary of the risk management plans of the medicinal products, permitted for use on the territory of the Republic
p.(None): of Bulgaria;
p.(None): 4. standard forms for reporting of suspected adverse reactions by medical specialists and patients, drawn up with
p.(None): compliance with the requirements of Art. 25 of Regulation (EC) N 726/2004 of the European Parliament and of the
p.(None): Council;
p.(None): 5. updated list of the medicinal products under Art. 23 of Regulation (EC) N 726/2004 of the European Parliament and of
p.(None): the Council;
p.(None): 6. announcements, providing information of the wide public about suspicions about safety of usage of a
p.(None): certain medicinal product;
p.(None): 7. instructions for all ways and forms for announcements of suspected adverse medicinal reactions by medical
p.(None): specialists and patients.
p.(None):
p.(None):
p.(None): Art. 186. (1) (amend. – SG, 102/2012, in force from 21.12.2012) The BDA shall carry out the following actions for the
p.(None): medicinal products, placed on the market of the Republic of Bulgaria:
p.(None): 1. monitoring of the result of the measures for decreasing the risk for a medical products, contained in the risk
p.(None): management plan;
p.(None): 2. monitoring of the result of implementation of conditions, indicated in Art. 55a, 56, or
p.(None):
p.(None): 56a;
p.(None):
p.(None): 3. assessment of the updating of the risk management system;
p.(None): 4. monitoring of the data base of Eudra Vigilance", created in compliance with Art. 24 of
p.(None): Regulation (EC) N 726/2004 of the European Parliament and of the Council for new risks or for change of already
p.(None): established and for change of the correlation benefit/risk.
p.(None):
p.(None):
p.(None): Art. 187. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall inform the European Medicines Agency
p.(None): and the marketing authorisation holder at identification of signals for new risks or change of found risks or in
p.(None): case of change of the correlation benefit/risk of a medicinal products.
p.(None): (2) The committee under Art. 56a, Para. 1, p. 1 shall analyze and prioritize the valid signals for new risks or for
...

Health / Mentally Disabled

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p.(None): controlled throughout the clinical test;
p.(None): 9. the study has been planned and shall be conducted in compliance with the guidelines of the European Medicines
p.(None): Agency;
p.(None): 10. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 101. (1) Clinical trials in the persons according to Art. 96, para 4 and 5, who are not capable of giving informed
p.(None): consent, shall be conducted in compliance with the requirements of Art. 90.
p.(None): (2) Except for the requirements of para 1, inclusion of major persons who are not capable of giving informed consent in
p.(None): clinical trials is permitted provided that:
p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
...

p.(None): 26. "Coordinating researcher" shall mean a researcher appointed for the purpose of coordinating the researchers or
p.(None): various sites participating in a multicentre test.
p.(None): 27. "Patient information leaflet" shall mean a leaflet accompanying a medicinal product and containing information for
p.(None): the customer.
p.(None): 27a. (New - SG 71/2008 in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) "Medicinal product
p.(None): for modern therapy" is a medicinal product, determined in Art. 2 of Regulation (EC) N 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on the medicinal products for modern therapy and amending Directive
p.(None): 2001/83/EC and Regulation (EC) № 726/2004.
p.(None): 28. "Medicinal product obtained from human plasma or human blood" shall mean a medicinal product produced
p.(None): from human blood constituents and by a method involving industrial process. The following shall be ascribed to this
p.(None): group: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, and other plasma
p.(None): fractions and combinations thereof.
p.(None): 29. "Medicinal product intended for treatment, prophylaxis, and diagnostics of rare
p.(None):
p.(None): diseases" shall mean a product, which:
p.(None): a) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases or chronic diseases taking
p.(None): progressive course, which affect not more than 5 of 10,000 people on the territory of a state or
p.(None): b) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases and severely health damaging
p.(None): chronic disease (diseases with high percentage of disease-related incapacity of work or disability) and are there is
p.(None): evidence appended that the sale of the product does ensure satisfactory return, which can justify the required
p.(None): investment for scientific research and development without having stimuli for the creator of the product, and
p.(None): c) where the is no satisfactory method of diagnostics, prophylaxis, or treatment of a given condition or where there is
p.(None): such method the proposed medicinal product has significantly more advantages and benefits for the people affected by
p.(None): this condition.
p.(None): 30. "Pharmaceutical form" shall mean an adequate for intake structure containing active substance(s), which can
p.(None): include or cannot include excipients and which is obtained through application of certain technological operations
p.(None): ensuring the desired healing effect and stability at storage within the expiry term.
p.(None): 31.. (Amen. - SG 71/2008 in force from 12.08.2008) "Any person, established on the territory of a Member State shall
p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
...

p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
p.(None): disability, and innate anomalies;
p.(None): d) combination of reactions according to subsections "a", "b", and "c".
p.(None): 42. "Common name" shall mean the international non-proprietary name (INN) of a medicinal substance or
p.(None): excipient recommended by the World Health Organisation; if not any, the name in the European Pharmacopoeia shall be
p.(None): used; if there is no such name there, another pharmacopoeia name shall be used; if there is no pharmacopoeia name, the
p.(None): common name shall be used.
p.(None): 42a (new – SG, 102/2012, in force from 21.12.2012) "Basic documentation of a system of pharmaco-vigilance" is a detail
p.(None): description of the pharmaco-vigilance system, used by the marketing authorisation holder in relation or one or more
p.(None): authorised for use medicinal products.
p.(None): 42b. (new - SG48/15) "Health technology assessment" shall mesn:
p.(None): a) a form of policy on research that examines the short- and long-term outcomes related to the implementation of
p.(None): health technologies and aims to provide information concerning alternative health strategies;
p.(None): b) multidisciplinary activity that systematically evaluates technical specifications, safety, clinical efficacy and
p.(None): effectiveness, cost, cost effectiveness, organizational, social, legal and ethical consequences of
p.(None): administration of medicinal products in health care and focuses on value - clinical and economic, provided
p.(None): that the analysis is comparative to existing or best alternative at the time;
p.(None):
p.(None): 43. "Batch" shall mean a definite quantity of a medicinal product manufactured according to an established reproducible
p.(None): technological scheme ensuring the required batch homogeneity with respect to the required quality characteristics.
...

p.(None): with the requirements of Art. 27.
p.(None): 64. "Reference value of a defined daily dose" on an international non-proprietary name with the corresponding
p.(None): pharmaceutical for according to the anatomo-therapeutic classification of medicinal products shall mean the lowest
p.(None): value of a defined daily dose determined on the basis of the values of a defined daily dose for various medicinal
p.(None): products for the international non-proprietary with the corresponding pharmaceutical form according to the
p.(None): anatomo- therapeutic classification of medicinal products.
p.(None): 65. "Reference value of a therapeutic course" shall be the lowest value of a therapeutic course determined on the basis
p.(None): of the values of a therapeutic course of the medicinal products according to international non-proprietary name with
p.(None): the corresponding pharmaceutical form.
p.(None): 66. "Risk during the use of a medicinal product" shall mean:
p.(None): a) risk for the health of the patient or risk for the health of the population, which is associated
p.(None): with the quality, safety, or efficacy of a medicinal product;
p.(None): b) risk of undesirable effects on the environment.
p.(None): 67. "Serious adverse event" shall mean any unfavorable change in the health condition,
p.(None):
p.(None): which has become the cause of lethal outcome, immediate threat to life, hospitalisation or extension of
p.(None): hospitalisation, significant or durable injury, disability, and innate anomalies.
p.(None): 68. "Batch release certificate" shall mean a document issued for each batch by the qualified person of the
p.(None): manufacturer or importer and shall include the requirements according to the specification, as well as all results from
p.(None): the tests for the release of the batch.
p.(None): 69. "Additional protection certificate" shall mean a document, which shall provide additional patent
p.(None): protection for a medicinal product of maximum 5 years after the lapse date of the main patent.
p.(None): 69a (new – SG, 102/2012, in force from 21.12.2012) "Risk management system" is a system of measures and
p.(None): activities for pharmaco-vigilance, intended for identification, characteristics, prevention or setting to
p.(None): minimum risks, related to the medicinal product, including effectiveness assessment of these activities and measures.
p.(None): 69b (new – SG, 102/2012, in force from 21.12.2012) "Pharmaco-vigilance system" is a system, used by the marketing
p.(None): authorisation holder and BDA for implementation of the tasks and responsibilities under Chapter Eight, intended for
p.(None): observation of vigilance of the permitted for use medicinal products and for finding every change in the benefit/risk
p.(None): ratio.
p.(None): 70. "Urgent limitation safety measures" shall mean temporary changes in the product information with respect of one
p.(None): or more parts of the summary of product characteristics, indications, method of administration,
p.(None): contraindications, and warnings, which result from new information associated with the safe use of a medicinal product.
...

Health / Mentally Incapacitated

Searching for indicator incapable:

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p.(None): determined by the regulation according to Art. 170.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): has:
p.(None): Art. 96. (1) A clinical test with medicinal products shall only be allowed in a person who
p.(None):
p.(None): 1. been informed in a preliminary conversation with a physician member of the study
p.(None): team about the purposes, risks and inconveniences of the study and about the conditions in which it is to be conducted;
p.(None): 2. been informed about his/her right to withdraw from the study at any time without this having any negative
p.(None): consequences for him/her;
p.(None): 3. personally given written informed consent to participate having been familiarised of the essence, importance,
p.(None): consequences, and eventual risks of the clinical test.
p.(None): (2) Where the person cannot write, the informed consent to participate in the clinical test shall be given by word of
p.(None): mouth in the presence of at least one independent witness who shall certify in writing that this subject has expressed
p.(None): informed consent to participate in the clinical test in person.
p.(None): (3) The informed consent according to para 1, point 3, and para 2 can only be given by a capable person who
p.(None): understands the essence, importance, scope, consequences, and eventual risks of the clinical test. Informed
p.(None): consent to participate in a clinical test can be withdrawn at any time.
p.(None): (4) The informed consent according to para 1, point 3, of an incapable major person shall be given by his/her
p.(None): legal representative. The consent of the legal representative must represent the supposed will of the subject
p.(None): and can be withdrawn at any time without negative consequences for the subject.
p.(None): (5) In the cases according to Art. 162, para 3 of the Health Act, informed consent shall be given by the person
p.(None): appointed by the court.
p.(None): (6) An incapable person shall be given information about the clinical test, eventual risks, and benefits in accordance
p.(None): with his/her capability to understand.
p.(None): (7) The explicit will of an incapable major person to refuse to participate in or to withdraw from the clinical test at
p.(None): any time must be taken into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None):
p.(None): Art. 97. (1) A clinical test in a minor person shall be conducted after obtaining written informed consent by both
p.(None): subject’s parents or guardians with observation of Art. 96, para 1 and 3.
p.(None): (2) Parents’ or guardians’ consent must represent the supposed will of the minor person and can be withdrawn at any
p.(None): time without negative consequences for the minor person.
p.(None): (3) The express will of the minor person to participate or to at any time withdraw from the clinical test must be taken
p.(None): into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (4) A clinical test in a minor person shall be conducted after obtaining written informed consent by both parents and
p.(None): the guardian in compliance of Art. 96, para 1 and 3. Where one of the parents is unknown, deceased, or deprived of
...

p.(None): the respective ethics committee according to Art. 103 the following documentation:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (2) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 111. (1) The ethics committee shall establish an opinion taking into consideration the following:
p.(None): 1. importance of the clinical test;
p.(None): 2. positive assessment of the ratio between the anticipated benefits and risks according to Art. 90, para 1, and the
p.(None): motivation of the conclusions;
p.(None): 3. protocol of the clinical test;
p.(None): 4. to what extent the principal researcher and the study team are adequate for the conduct of the
p.(None): clinical test;
p.(None): 5. researcher’s brochure;
p.(None): 6. availability of the required equipment and its adequate quality;
p.(None): 7. compliance and completeness of the written information, which is to be given, as well as the procedure for obtaining
p.(None): informed consent and the validity of the clinical test in human subjects incapable of giving informed consent in the
p.(None): cases according to Art. 100 and 101;
p.(None): 8. provided indemnity or recovery in case of injury or death, which could result from the clinical test;
p.(None): 9. insurance covering researcher or contracting authority liability;
p.(None): 10. where necessary, the conditions and order for remuneration or indemnification of study researchers and subjects
p.(None): and the elements of the contract between the contracting authority and the healthcare establishment;
p.(None): 11. conditions and order for subject recruitment.
p.(None): (2) The ethics committee shall:
p.(None): 1. give positive opinion;
p.(None): 2.. refuse in a motivated manner, or
p.(None): 3. request amendment of a part of the documentation as a condition for obtaining a positive opinion.
p.(None):
p.(None):
p.(None): Art. 112. (1) Within 60 days from the submission of an application, the ethics committee shall pass resolution with an
p.(None): opinion, which shall be sent to the applicant and the BDA.
p.(None): (2) Where the clinical test involves a medicinal product for gene therapy or somato- cellular therapy or a medicinal
p.(None): product containing genetically modified organisms, the time limit according to para 1 shall be extended by 30 days.
p.(None): (3) Where for the review of a clinical test involving a medicinal product for gene therapy or somato-0-cellular therapy
...

p.(None): shall be punished by the fine under para 1, and in repeated perpetration of the infringement the issued
p.(None): registration of the drug store will be deprived of.
p.(None): (4) In the cases according to para 1 and 2, the bodies of the state control on the medicinal products
p.(None): shall stop the operation of the site by an order.
p.(None): (5) The order according to para 4 shall be subject to appeal under the terms of the Administrative Procedure Code;
p.(None): however, the appeal shall not stop its execution.
p.(None): (6) (Repealed - SG 71/2008 in force from 12.08.2008).
p.(None):
p.(None):
p.(None): Art. 287a. (New - SG 71/2008 in force from 12.08.2008). (1) Medical specialist, who works with persons,
p.(None): performing retail trade with medicinal products, without having authorisation/certificate for this, shall
p.(None): be punished by a fine of BGN 2500 to 5000
p.(None): (2) The punishment under para 1 shall be imposed on a person under para 1, who works in a pharmacy or a drugstore after
p.(None): termination of the action of the authorisation/certificate.
p.(None): (3)In case of established more than 2 violations under para 1 and 2, the Minister of Health may deprive the medical
p.(None): specialist of the right to exercise his/her profession for the term of up to 2 years.
p.(None):
p.(None):
p.(None): Art. 287b. (new – SG, 102/2012, in force from 02.01.2013) Anyone, who carries out trade with medicinal products on
p.(None): internet in violation of this act and the ordinance under Art. 234, Para. 5 shall be punished by a fine of BGN 5000 to
p.(None): 10 000.
p.(None):
p.(None):
p.(None): Art. 288. (1) A retailer in medicinal products who has permitted an incapable person to exercise activities, pointed
p.(None): out in Art. 219, shall be penalised with a property sanction from BGN 5,000 to BGN 10,000 and in case of repeated
p.(None): perpetration of the infringement the issued retail trade authorisation shall be bereaved.
p.(None): (2) In the cases according to para 1 the bodies of the state control shall stop the operation of the
p.(None): site by an order.
p.(None):
p.(None):
p.(None): Art. 289. (1) (prev. text of Art. 289 – SG 60.12, in force from 07.08.2012) Whoever sells medicinal products on prices
p.(None): different from those formed under the terms of this law shall be penalised with a fine from BGN 5,000 to BGN 10,000 and
p.(None): in case of repeated perpetration of the same infringement – with a fine from BGN 6,000 to BGN 12,000.
p.(None): (2) (new – SG 60.12, in force from 07.08.2012, amend. – SG, 102/2012, in force from 21.12.2012) A marketing
p.(None): authorisation holder who fails to fulfill an obligation set out by the Ordinance under Art. 261a, Para. 5,
p.(None): shall be punishable by property sanction amounting from BGN 5000 to BGN 10 000, and in case of repeated offence – by a
p.(None): property sanction amounting from BGN 10 000 to BGN 20 000.
p.(None): (3) (new - SG, 102/2012, in force from 21.12.2012). The violations under Para. 1 and 2 shall be found out by acts,
p.(None): drawn up by officials, determined by the Council chairperson under Art. 258, Para. 1, and the penal decrees shall be
p.(None): issued by the Council chairperson under Art. 258, Para. 1 or a council member, authorised by him/her.
p.(None):
p.(None): Art. 289a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG, 102/2012, in force from 21.12.2012) whoever
...

p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
p.(None): used in an unauthorised indication or with a view of obtaining additional information for an authorised form, or are
p.(None): made up (in a pharmaceutical form or packaged) in a manner, which is different from the authorised form.
p.(None): 21. "Researcher" shall mean an appointed by the contracting authority and the principal researcher medical doctor or
p.(None): doctor in dental medicine who practically conducts a clinical test under the management of a principal researcher in
p.(None): compliance with an approved protocol and the guidelines for Good Clinical Practice in an investigational site for the
p.(None): conduct of a clinical test. If a clinical test is not conducted by a team, the researcher shall be the manager
p.(None): responsible for the team and shall be called principal researcher.
p.(None): 22. "Informed consent" shall mean a decision to participate in a clinical test, which must be in writing, dated and
p.(None): signed and taken freely by any person capable of giving his consent or
p.(None): – where a person is incapable of giving his consent by his legal representative after being duly informed about the
p.(None): essence, importance, consequences and risks of a clinical test and documented in an adequate manner.
p.(None): 23. "Kit" shall mean any substance, which – usually before use – shall be dissolved, suspended, diluted, or combined
p.(None): with radionuclides as a result of which procedure the finished radioactive medicinal product is obtained.
p.(None): 24. "Clinical test of a medicinal product" shall mean any study in man intended for discovering or
p.(None): confirming clinical, pharmacological, and/or other pharmacodynamic effects of one or more study medicinal products, and
p.(None): /or for determination of the adverse reactions to one or more study medicinal products, and/or for studying the
p.(None): absorption, distribution, metabolism, and excretion of one or more study medicinal products with the purpose of
p.(None): establishing their safety and/or efficacy.
p.(None): 25. "Clinical advantage" shall mean a significant therapeutic or diagnostic advantage of a medicinal product compared
p.(None): to a medicinal product, which has already received marketing authorisation.
p.(None): 26. "Coordinating researcher" shall mean a researcher appointed for the purpose of coordinating the researchers or
p.(None): various sites participating in a multicentre test.
p.(None): 27. "Patient information leaflet" shall mean a leaflet accompanying a medicinal product and containing information for
p.(None): the customer.
p.(None): 27a. (New - SG 71/2008 in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) "Medicinal product
p.(None): for modern therapy" is a medicinal product, determined in Art. 2 of Regulation (EC) N 1394/2007 of the European
...

Health / Physically Disabled

Searching for indicator illness:

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p.(None): only under strict doctor’s control in a medical establishment for medicinal help and in case of
p.(None): radiopharmaceutical specialist – only under the control of an authorised person;
p.(None): 3. the leaflet, as well as in any medical information, attached to the medicinal product should contain a text, which
p.(None): pays attention to the medicinal specialists, that some of the available data for the medicinal product are subject to
p.(None): further researches.
p.(None): (3) The marketing authorisation/registration certificate under Para. 1 shall be issued for the term of 1 year and for
p.(None): each following year may be extended on the basis of an assessment of the fulfillment of the conditions under Para. 2.
p.(None):
p.(None):
p.(None): Art. 56a (new – SG, 102/2012, in force from 21.12.2012) (1) After issuing the marketing authorisation/registration
p.(None): certificate, BDA may olige the holder of the marketing authorisation/registration certificate
p.(None): to conduct:
p.(None): 1. post-marketing safety research, if there are concerns for identified or potential risks or lack of information,
p.(None): related to vigilance the medicinal safety for the relevant medicinal product, where the same risks refer to other
p.(None): medicinal products, after consultations with the Committee for risk assessment in the area of the pharmacologic
p.(None): awareness, established under Art. 56, Para. 1, letter "aa" of Regulation (EC) N 726/2004 of the European Parliament and
p.(None): of the Council, BDA recommends to the relevant holder of marketing authorisation to conduct a mutual safety
p.(None): research with the other concerned holders of authorisation;
p.(None): 2. post-marketing efficiency research, where the knowledge about the illness or the used clinic methodology gives
p.(None): ground for revision of the efficiency assessment, the conclusions about which have been made on the date of issuance of
p.(None): the authorisation.
p.(None): (2) The BDA shall notify in writing the owner of the marketing authorisation/registration certificate for the
p.(None): obligation under Para. 1, by grounding the reasons and indicating the objectives of the research and the terms for its
p.(None): conducting.
p.(None): (3) Within 30-day term after receiving the notification under Para. 2, the owner of the marketing
p.(None): authorisation/registration certificate may request from BDA granting a possibility for providing information about the
p.(None): obligations under Para. 1.
p.(None):
p.(None): (4) After receiving the request under Para. 3, the BDA shall set a term for provision of the information by the
p.(None): authorisation/registration certificate holder.
p.(None): (5) The BDA after information analysis under Para. 3, may:
p.(None): 1. confirm the obligation under Para. 1, or
p.(None): 2. repeal it.
p.(None): (6) The BDA shall notify the holder about the decision, taken under Para. 5.
p.(None): (7) In the cases under Para. 5, p. 1, the BDA executive director shall officially amend the issued marketing
p.(None): authorisation/registration certificate of the medicinal product by including in it the obligation under Para. 1 as a
p.(None): condition.
p.(None): (8) The grounds for imposing the obligations under Para. 1, p. 2 shall be determined by a delegated instrument under
p.(None): Art. 22b of Directive 2001/83/EC.
p.(None):
p.(None):
p.(None): Art. 56b (new – SG 102/2012, in force from 21.12.2012) (1) The holder of the marketing authorisation/registration
p.(None): certificate shall include in his/her risk management system all the conditions under Art. 551,56 and 56a.
...

p.(None): (2) The BDA internet site under Para. 1 shall be connected with the internet site of the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 234b (new – SG, 102/2012, in force from 02.01.2013) The BDA shall participate in information campaigns, organised
p.(None): by the European Commission and the European Medicines Agency about the danger of falsified medicinal products.
p.(None):
p.(None): Art. 235. (1) The authorisation to carry out retail trade with medicinal products shall be cancelled with the
p.(None): termination of the activity of the persons according to Art. 222.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The executive director of BDA shall cancel the authorisation for
p.(None): retail trade with medicinal products:
p.(None): 1. according to an application by the person who has received authorisation for carrying out retail trade with
p.(None): medicinal products:
p.(None): 2. wherever it has been established that the manager of the pharmacy does not comply with the requirements laid down in
p.(None): Art. 224 and 225.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 222 and 225 shall notify the BDA in
p.(None): writing within 14 days of the termination of the activity according to para 1.
p.(None):
p.(None):
p.(None): Art. 236. (1) The pharmacy cannot be closed for more than 30 days within a calendar year due to the absence of the
p.(None): manager.
p.(None): (2) (suppl. – SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011, amend. – SG,
p.(None): 60/2011, in force from 5. 8. 2011) Where the manager of the pharmacy is not in a position to fulfil his
p.(None): obligations due to a leave for temporary incapacity of work due to an illness, pregnancy and birth, or adoption and
p.(None): leave for breeding of a little child, as per Labour Code, the pharmacy can operate under the management of another
p.(None): master of pharmacy, respectively another assistant pharmacist, in the cases to Art. 225 complying with the requirements
p.(None): of Art. 224 for not more than two years. In all these cases a permission of the executive director of BDA shall be
p.(None): issued.
p.(None): (3) The permission according to 2 shall be issued within 30 days.
p.(None):
p.(None):
p.(None): Art. 237. Upon termination of the activity of the person who received authorisation to retail trade with medicinal
p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
...

Health / Pregnant

Searching for indicator pregnant:

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p.(None): clinical trials is permitted provided that:
p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
...

Health / Unconscious People

Searching for indicator unconscious:

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p.(None): 5. Committee for radiopharmaceuticals.
p.(None): 6. (new – SG, 71/2008, in force from 12.08.200) Commission for medicinal products with application in podiatry;
p.(None): 7. (amend. – SG, 71/2008, in force from 12.08.200) Commission for medicinal products for modern therapies;
p.(None): 8. (new - SG, 71/2008, in force from 12.08.200) commission for risk assessment at
p.(None):
p.(None): pharmaco-vigilance medicinal safety.
p.(None): (2) In case of necessity, the executive director of the BDA may also establish specialised committees other than those
p.(None): mentioned in para 1.
p.(None): (3) The specialised committees shall involve medical and other specialists with scientific achievements and practical
p.(None): experience in the respective fields of application of the medicinal products.
p.(None): (4) External specialists with scientific achievements and practical experience in the field of a specific group of
p.(None): medicinal products may be involved in the standing staff of the committees.
p.(None): (5) The executive director of the BDA shall appoint by an order the composition of the committees for a period of three
p.(None): years, the amount of their remuneration and shall approve a regulation on the conditions and order of their work.
p.(None): (6) Not later than 30 January of each year, the executive director of the BDA shall approve lists of the
p.(None): experts outside the composition of the committees according to para 1 after receiving the approval of the Minister of
p.(None): Health.
p.(None): (7) The executive director of the BDA may ahead of term dismiss a member of a specialised committee on
p.(None): his own request, in case of failure to fulfil his obligations for a period of more than three months, or in case of
p.(None): unconscious conduct of his functions.
p.(None): (8) The composition of the committees and the list of experts according to para 6 shall be published on the internet
p.(None): site of the BDA.
p.(None):
p.(None):
p.(None): Art. 48. (1) The members of the specialised committees according to Art. 47, para 1, and the experts according to Art.
p.(None): 47, para 4, shall sign a declaration to the effect of their obligation:
p.(None): 1. not to disclose data and circumstances, which have become known to them during or on the occasion of the conduct of
p.(None): their activities;
p.(None): 2. not to be involved in activities associated with the manufacture of or wholesale or retail trade in medicinal
p.(None): products.
p.(None): (2) In case the persons according to para 1 have been involved in the stages or preparation of the
p.(None): documentation necessary for the marketing authorisation of a medicinal product, they shall not participate
p.(None): in the sessions of the respective specialised committee according to Art. 47.
p.(None): (3) The persons according to para 1 shall not vote during making of a decision on issues in which they or members of
p.(None): their families have commercial, financial, or other interests.
p.(None):
p.(None):
p.(None): Art. 49. (1) (amend. – SG, 102/2012, in force from 21.12.2012) Within 200 days from the receipt of a valid
p.(None): documentation, the BDA, jointly with the respective committee according to Art. 47, Para. 1, shall assess the quality,
p.(None): safety, and efficacy of the medicinal product and shall establish an assessment report, with comments of the result of
p.(None): the pharmaceutical an pre-clinic tests, clinic studies of the system for risk management and of the system for safety
p.(None): vigilance of the relevant medicinal product.
...

Health / breastfeeding

Searching for indicator breastfeeding:

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p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
...

Health / ill

Searching for indicator ill:

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p.(None): Medicine Act;
p.(None): 4. a verified copy of the employment contract with the manager of the pharmacy – where such is required;
p.(None): 5. a declaration by the persons as per Art. 222, para 1 that the requirements under which is granted the authorisation
p.(None): for retail trade in medicinal products to persons under para 1, have been met;
p.(None): 6. a document issued by the mayor of the respective municipality verifying the number of citizens in the respective
p.(None): populated area;
p.(None): 7. a document for paid fee amounting to 100 BGN.
p.(None):
p.(None):
p.(None): § 5. Within three months from the entry into force of this Act the Minister of Health shall make the respective
p.(None): amendments in the ordinance as per Art. 219, para 2.
p.(None):
p.(None):
p.(None): § 6. The Act shall enter into force from the date of its promulgation in the State Gazette.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE MEDICAL ESTABLISHMENTS ACT
p.(None):
p.(None): (PROM. – SG 59/10, IN FORCE FROM 31.07.2010)
p.(None):
p.(None): § 77. The Act shall enter into force from the day of its promulgation in the State Gazette, except for:
p.(None): 1. paragraphs 9 (regarding Art. 19, para. 4), 53, 60 and 66 (regarding Art. 98, para 5 and 6), which shall enter into
p.(None): force from 1 January 2011;
p.(None): 2. paragraph 75, which shall enter into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT ON THE BUDGET OF THE NATIONAL HEALT HINSURANCE FUND FOR YEAR 2011
p.(None):
p.(None): (PROM. – SG 98/2010, IN FORCE FROM 01.01.2011)
p.(None):
p.(None): § 5. (1) In year 2011 activities on diagnosing and treatments of malignant illnesses and of ill of renal insufficiency
p.(None): treated with dialysis, including provision of the medical products and articles, as well as the other medical
p.(None): activities, which in 2010 has been funded through the budget of the Ministry of Health and through the
p.(None): assigned by the state activities to the
p.(None):
p.(None): municipalities, shall be paid with the funds envisaged in Art. 1, Para 2, line 5.
p.(None): (2) Activities, medical products and articles envisaged in Para 1 shall be paid under a procedure and method,
p.(None): determined by the Minister of Health.
p.(None): (3) Funds envisaged in Art.1, Para 2, line 5 shall be transferred monthly the end of the current month.
p.(None):
p.(None):
p.(None): § 7. Supervising Board of the National Health Insurance Fund shall be entitled to execute internal compensated changes
p.(None): of the credits between the elements of the expenses and of the transfers envisaged in Art.1, Para 2, which shall be
p.(None): within the frames of the approved budged.
p.(None):
p.(None):
p.(None): § 8. Supervising Board of the National Health Insurance Fund, on the grounds of Art. 26, Para 2 of the Health
p.(None): Insurance Act, shall be entitled to spend the funds of the reserve for unexpected and urgent expenditures
p.(None): envisaged in Art.1, Para 2, line 3.
p.(None): ………….
p.(None):
p.(None):
p.(None): § 15. This Act shall enter into force from 1st of January 2011, except for § 10, which shall enter into force from the
p.(None): day of its promulgation in the State Gazette.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE HEALTH ACT
p.(None):
p.(None): (PROM. - SG 98/2010, IN FORCE FROM 01.01.2011)
p.(None):
p.(None): § 106. In the Medicinal Products in Human Medicine Act (prom. – SG 31/2007; amend.
...

Social / Access to Social Goods

Searching for indicator access:

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p.(None): the Regional health inspectorates (RHI) in the field of the control on the medicinal products.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The implementation of this act measures, related to
p.(None): prevention of entering and dissemination of falsified medicinal products shall be carried out in cooperation
p.(None): between the Bulgarian Drug Agency and the customs authorities.
p.(None):
p.(None): Art. 17a (New – SG, 60/2011, in force from 05.08. 2011) The Regional health inspectorates shall issue
p.(None): authorisations for registration of drug stores.
p.(None):
p.(None):
p.(None): Art. 17b. (new – SG 18/14) (1) Expert drug retail trade council shall be set up subordinated to the
p.(None): Managing Director of the BDA including three representatives of Bulgarian Pharmaceutical Association, one
p.(None): representative of every Pharmaceutical department of Higher Medicinal Schools and four representatives of the BDA. The
p.(None): members of the council shall be appointed by an order of the Managing Director of BDA agreed by the Minister of Health.
p.(None): (2) The council referred to in par. 1 is a consultancy unit, which shall:
p.(None): 1. issue opinions on the submitted to the BDA applications and documents under Art. 228, par. 1 and 5 which they are
p.(None): submitting to the Managing Director of BDA;
p.(None): 2. make justified proposals to the Minister of Health through the Managing Director of BDA for improvement of the
p.(None): access of individuals to drugs.
p.(None): (3) The organization and the activity of the expert council under par. 1 shall be regulated by regulations issued by
p.(None): the Managing Director of BDA upon council’s proposal.
p.(None): (4) The members of the expert council referred to in par. 1 shall not get paid for the participation in council
p.(None): meetings.
p.(None): (5) The expert council referred to in par. 1 shall report on their activity on an annual basis to the Minister of
p.(None): Health.
p.(None):
p.(None):
p.(None): Art. 17c. (new – SG 18/14) Cannot be members of the expert council referred to in Art.
p.(None): 17b, par.1 persons who are:
p.(None): 1. owners, members of managing and supervisory bodies of business companies or sole traders with a scope of business
p.(None): production, import, wholesale or retail trade with drugs;
p.(None): 2. partners or shareholders holding more than 5 per cent of the equity of business companies with a scope
p.(None): of business production, import, wholesale or retail trade with drugs or working under a full time employment agreement
p.(None): in such companies.
p.(None):
p.(None): Section II. Registers
p.(None):
p.(None): Art. 18. (Repealed - SG, 60/2011, in force from 05.08. 2011)
p.(None):
p.(None):
p.(None): Art. 19. (1) The Bulgarian Drug Agency shall keep registers of:
p.(None): 1. (amend. – SG, 102/2012, in force from 21.12.2012) manufacturers and importers of medicinal products on the territory
p.(None): of the Republic of Bulgaria and qualified persons according to Art. 148, point 2,and Art. 161, Para. 2, p. 1;
p.(None): 2. (amend. – SG, 102/2012, in force from 21.12.2012) the manufacturers, importers and the wholesale traders of active
p.(None): substances;
p.(None): 3. authorised/registered medicinal products on the territory of the Republic of Bulgaria;
...

p.(None): the procedure shall be terminated and the clinical test shall no be conducted.
p.(None):
p.(None):
p.(None): Art. 119. (1) Within 60 days of the date of submission of an application for a clinical test with the medicinal
p.(None): products according to Art. 109, point 2,, the executive director of the BDA shall:
p.(None): 1. issue authorisation for the conduct of the clinical test, or
p.(None): 2. issue a motivated refusal.
p.(None): (2) The refusal according to para 1, point 2, shall be subject to appeal under the terms of the Administrative
p.(None): Procedure Code.
p.(None):
p.(None):
p.(None): Art. 120. (1) In case of medicinal products according to Art. 109, point 2, letters "a" - "c" the time limit according
p.(None): to Art. 119, para 1, for the issue of authorisation by the BDA for the conduct of a clinical test can be extended by 30
p.(None): days.
p.(None): (2) Provided that the BDA should consult the expert commission according to Art. 112, para 3, which is to assess the
p.(None): safety of the medicinal products according to para 1, the extended time limit according to para 1 can be extended by
p.(None): another 90 days.
p.(None):
p.(None):
p.(None): Art. 121. The executive director of the BDA shall refuse to issue authorisation for the conduct of a clinical test of
p.(None): medicinal products for gene therapy where there is a risk of modifying the genome of the reproductive cells of a study
p.(None): subject.
p.(None):
p.(None):
p.(None): Art. 122. (1) In case of a multicentre clinical test in the Republic of Bulgaria and in a third
p.(None):
p.(None): state, the BDA shall request the contracting authority to submit a declaration that he shall provide access to
p.(None): representatives of the BDA for inspection aimed at the establishment of compliance with the requirements and principles
p.(None): of Good Clinical Practice and Good Manufacturing Practice.
p.(None): (2) Provided that the contracting authority should not submit the declaration according to para 1, the BDA shall not
p.(None): review the submitted application.
p.(None):
p.(None):
p.(None): Art. 123. The contracting authority shall declare that the documentation submitted to the BDA and the ethics committee
p.(None): contains the same information.
p.(None):
p.(None):
p.(None): Art. 124. (1) The procedures in the ethics committee and in the BDA can be carried out simultaneously or consecutively
p.(None): at the discretion of the contracting authority.
p.(None): (2) The time limit for documentation review according to Art. 118, para 1, shall not cease to run in case of lack of
p.(None): decision of the ethics committee.
p.(None):
p.(None):
p.(None): Art. 125. The clinical test shall be conducted in compliance with the study protocol, which has received positive
p.(None): opinion of the respective ethics committee according to Art. 103 and under the conditions set out in the submitted
p.(None): documentation.
p.(None):
p.(None): Section V. Amendments
p.(None):
p.(None): Art. 126. (1) The contracting authority can at any time make amendments in the study protocol different from the
...

p.(None): 1. ensure the performance of the manufacturing operations in compliance with the requirements of the Good
p.(None): Manufacturing Practice and in compliance with the information according to Art. 27, Para. 1, points 7
p.(None): and 8 approved from the BDA, and in the cases of medicinal products for clinical trials – in compliance with
p.(None): the information according to Art. 110, Para. 1, point 4 submitted to the agency by the contracting authority.
p.(None): 2. (amend. – SG, 102/2012, in force from 02.01.2013) use only active substances, which have been manufactured in
p.(None): compliance with the requirements of the Good Manufacturing Practice for active substances;
p.(None): 2a. (new – SG, 102/2012, in force from 02.01.2013) be certain that the assisting substances, put in the
p.(None): medicinal products are manufactured in compliance with the appropriate Good manufacturing practices for assisting
p.(None): substances, determined on the basis of an official risk assessment in compliance with the applicable directives,
p.(None): adopted by the European Commission;
p.(None): 3. ensure on a permanent basis qualified personnel for the production and control according to the
p.(None): requirements the regulation according to Art. 152;
p.(None): 4. (amend. – SG 12/11, in force from 08.02.2011) only dispose of medicinal products, which have marketing authorisation
p.(None): fulfilling the requirements of this Act;
p.(None): 5. (revoked – SG 12/11, in force from 08.02.2011);
p.(None): 6. immediately notify the control bodies in case of substitution of the qualified person according to Art. 148, point
p.(None): 2;
p.(None): 7. ensure access of the control bodies to the premises and the documentation at any
p.(None): time;
p.(None): 8. ensures to the qualified person according to Art. 148, point 2 the required condition
p.(None): to fulfill his obligations.
p.(None): 9. (new – SG, 102/2012, in force from 02.01.2013) inform immediately the BDA and the use authorisation holder, if
p.(None): information is received that the medicinal products, which fall in the scope of hi/her manufacture automation, are
p.(None): falsified or there are suspects for falsification, notwithstanding of the fact whether these medicinal products
p.(None): have been disseminated within the
p.(None):
p.(None): frames of the legal supply or an illegal way, including through illegal sale through the services of the information
p.(None): society;
p.(None): 10 (new – SG, 102/2012, in force from 02.01.2013) check if the manufacturers, importers or traders, from whom he/she
p.(None): receives active substances have been register by the competent body of the Member state in which they are established;
p.(None): 11. (new – SG, 102/2012, in force from 02.01.2013) check up the authenticity and quality of the active and assisting
p.(None): substances.
p.(None): (2) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall perform audits in
p.(None): the production sites and trade with active substances for observation of the Good manufacturing practice
p.(None): and the Good distribution practice. The manufacture authorisation holder may sign a contract with a third person
p.(None): to carry out the audit on his/her behalf and on his/her account.
p.(None): (3) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall document the undertaken
...

p.(None): which shall contain:
p.(None): 1. certificate number and date;
p.(None): 2. number of the authorisation for wholesale of medicinal products and the issuing body;
p.(None): 3. name, place of business and address of management of the person who has received the certificate;
p.(None): 4. data for the person according to Art. 199, para 2, p. 2;
p.(None): 5. date of deletion of the certificate from the register and reason therefore;
p.(None): 6. remarks relating to the inscribed circumstances.
p.(None): (3) Data from the register shall be published on the internet site of the BDA.
p.(None): (4) (new – SG, 102/2012, in force from 02.01.2013) The BDA shall introduce to the data base under Art. 147
p.(None): information about the issued authorisations for wholesale trade with medicinal products.
p.(None): (5) (new – SG, 102/2012, in force from 02.01.2013) Upon request by the European Commission or by a Member State,
p.(None): BDA shall provide information about an issued authorisation for wholesale trade with medicinal products.
p.(None):
p.(None):
p.(None): Art. 206. (1) In case of change of the circumstances associated with the issued wholesale authorisation,
p.(None): its holder shall summit to the BDA an application under the terms of Art. 199 and append the documentation associated
p.(None): with the change.
p.(None): (2) The change authorisation shall be issued under the conditions and under the terms of Art. 200-202. In case of
p.(None): change of the premises for storage, the term according to Art. 202 shall apply and for the other cases the term shall
p.(None): be 14 days.
p.(None):
p.(None): Art. 207. (1) The wholesale authorisation holder who conducts his activity on the territory of the Republic of Bulgaria
p.(None): shall be obliged to:
p.(None): 1. at any time ensure access of the control bodies to the premises for storage of the medicinal products;
p.(None): 2. only trade in medicinal products authorised to the order of this Act;
p.(None): 3. trade in medicinal products, whose packaging and leaflets of which are in compliance with the issued marketing
p.(None): authorisation and under the terms of this Act and the expiry term of which has not elapsed;
p.(None): 4. only supply medicinal products from manufacturers, importers, and wholesalers of medicinal products who have
p.(None): received authorisation to perform such activity under the terms of this Act;
p.(None): 4a (new – SG, 102/2012, in force from 02.01.2013) check whether the received medicinal products from the
p.(None): persons under p. 4 have been falsified by a checkup of the safety indicators on the secondary packing;
p.(None): 5. supply medicinal products to other wholesale authorisation holders, pharmacies, and drugstores, opened under the
p.(None): terms of this Act;
p.(None): 6. supply medicinal products to physicians and physicians in dental medicine where a settlement has no pharmacy under
p.(None): the conditions and order laid down in a regulation of the Minister of Health;
p.(None): 6a (new – SG, 102/2012, in force from 02.01.2013) enter in the documents for supply the lot number of the supplied
p.(None): medicinal products;
p.(None): 6b (new – SG, 102/2012, in force from 02.01.2013) have an action plan in extraordinary situations, which shall contain
p.(None): effective measures for drawing out a medicinal product from the market upon an order of BDA or upon initiative of the
p.(None): manufacturer or the marketing authorisation holder of the relevant medicinal product;
p.(None): 6c (new – SG 18/14) provide for the supply of sufficient quantities of medicinal products for satisfying of health care
p.(None): needs of the individuals of the Republic of Bulgaria;
...

p.(None): Art. 269b. (new – SG, 102/2012, in force from 21.12.2012) (1) Where as a result of carried out inspections under Art.
p.(None): 269, Para. 3 compliance with the Good manufacturing practice is found, or the Good distribution practices where
p.(None): applicable, BDA shall issue to the manufacturer, importer or wholesale trader a certificate for Good
p.(None): manufacturing practice or certificate for Good distribution practice within the term of 90 days from the inspection.
p.(None): (2) Where as a result of a carried out inspection under Art. 269, Para. 3 it is found that the manufacturer, importer
p.(None): or wholesale trader of medicinal products or active substances fails to observe the requirements of the act and/or
p.(None): principles and directives of Good manufacturing practice and/or Good distribution practice, BDA shall issue an
p.(None): incompliance opinion.
p.(None): (3) The BDA shall introduce to the data base under Art. 147 the issued certificates under Para. 1 and information under
p.(None): Para. 2.
p.(None):
p.(None):
p.(None): Art. 269c. (new – SG, 102/2012, in force from 21.12.2012) (1) Where as a result of an inspection under Art. 270, Para.
p.(None): 1, p. 5 it is found that the marketing authorisation holder fails to observe the requirements of Chapter Eight,
p.(None): BDA shall give prescriptions for removal of the incompliance.
p.(None): (2) In the cases under Para. 1, BDA shall notify the Member States, the European
p.(None):
p.(None): medicines Agency and the European Commission.
p.(None):
p.(None):
p.(None): Art. 270. (1) Within the framework of their competence, the officials according to Art. 267, Para. 3, shall be entitled
p.(None): to:
p.(None): 1. (amend. - SG, 102/2012, in force from 21.12.2012) Access to all documents, connected to the subject
p.(None): of the inspection, as well as documents, connected directly and indirectly with violation of this Act or
p.(None): of legislation of the Member States, implementing requirements of Directive 2001/83/EC of the European
p.(None): Parliament and the Council for approval of the Community code concerning medicinal products for human use, as
p.(None): last amended by Directive 2004/27/EC of the European Parliament and the Council, independently from the form of the
p.(None): document;
p.(None): 2. order of each person to present information for violations according to point 1, which are familiar to him;
p.(None): 2a (new - SG, 102/2012, in force from 21.12.2012) inspect the manufacture and trade sites of manufacturers of
p.(None): medicinal products, active or auxiliary substances, as well as the laboratories, used by manufacture or import
p.(None): authorisation holders;
p.(None): 3. at any time inspect the sites subject to control and require, check, or make copies of all documents relating to the
p.(None): overall activity of the controlled site;
p.(None): 4. take samples of medicinal products, active substances, and percipients for laboratory
p.(None): tests;
p.(None): 5. (amend. - SG, 102/2012, in force from 21.12.2012) inspect the premises, archives,
p.(None): records, and documents and the basic documentation of the pharmaco-vigilance of the marketing authorisation
p.(None): holder or persons, who have been assigned to carry out the activities under Chapter Eight;
p.(None): 6. (new - SG, 102/2012, in force from 21.12.2012) carry out inspection about the observation of
p.(None): confirmed prices, limit prices or registered prices during sale of medicinal products;
...

p.(None):
p.(None):
p.(None): § 75. Within the term of up to 3 months from the enforcement of this Act the Council of Ministers shall select a staff
p.(None): of the Commission on prices and reimbursement.
p.(None):
p.(None): § 76. Within the term of up to 3 months from the enforcement of this Act:
p.(None): 1. The Minister of Health shall amend and supplement the ordinances under Art. 82, Para. 3, Art. 219, Para. 2 and Art.
p.(None): 243 in compliance with this Act.
p.(None): 2. The Council of Ministers shall adopt the Ordinance under Art. 258, Para. 5 and shall amend the tariff under Art. 21,
p.(None): Para. 2 and the Rules of procedure of the Ministry of Health in compliance with this Act.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 84. This Act shall come into force from the day of its publication in the State Gazette, with the exception of § 65,
p.(None): which shall come into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.(None):
p.(None): (PROM. - SG 38/12, IN FORCE FROM 01.07.2012)
p.(None):
p.(None): § 84. (In force from 18.05.2012) Within one month after the promulgation of this Act in the State Gazette:
p.(None): 1. The Council of Ministers shall adjust the Classified of positions in administration to the provision of this Act;
p.(None): 2. the competent bodies shall adjust the structural acts of the respective administration to the provisions of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 85. (1) The legal relationships with the persons from administrations under the Radio and Television Act, Independent
p.(None): Financial Audit Act, Electronic Communications Act, Financial Supervision Commission Act, Act on Access to and
p.(None): Disclosure of the Documents and Announcing Affiliation of Bulgarian Citizens with the State Security Service and
p.(None): the Intelligence Services of the Bulgarian Popular Army, Act on Seizure in Favour of the State of
p.(None): Property, Acquired through Criminal Activity Act on Prevention and Findings of Conflict of Interests, Code of Social
p.(None): Insurance, Health Insurance Act, Agricultural Producers Assistance Act, Roads Act shall be regulated subject to
p.(None): compliance with the provisions and following the procedure of § 36 of the Transitional and Conclusive Provisions of the
p.(None): Act amending and supplementing the Civil Servants Act (SG 24/06).
p.(None): (2) By the act of appointment of a civil servant:
p.(None): 1. the minimum rank for the occupied position shall be conferred, as determined in the Classified of positions in the
p.(None): administration, unless the servant hold a higher rank;
p.(None): 2. individual monthly salary shall be fixed.
p.(None): (3) Additionally required funds for insurance contributions of the persons under par. 2 shall be provided within the
p.(None): cost of salaries, remunerations and insurance contributions within the budgets of the respective administrators of
p.(None): budget credits.
p.(None): (4) Council of Ministers must make necessary adjustments in the out-of-budget account of State Fund "Agriculture",
p.(None): arising out of this Act.
p.(None): (5) Managing bodies of National Social Insurance Institute and of National Health Insurance Fund must make
p.(None): necessary adjustments in the respective budgets, arising out of this
p.(None):
p.(None): Act.
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Social / Age

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p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
p.(None): contain contact details of an independent person for additional information.
p.(None):
p.(None): Section .
p.(None): Clinical Trials in Vulnerable Patient Groups
p.(None):
p.(None): Art. 100. A clinical test in minor or underage persons can be undertaken provided that:
p.(None): 1. the study protocol has been approved by the respective ethics committee after discussion of the
p.(None): clinical, moral, and psycho-social aspects of childhood age in which at least two paediatricians have participated;
p.(None): 2. there is an anticipated direct benefit of the clinical test for the patient group, which is to be included;
p.(None): 3. the study is directly associated with the clinical condition from which the minor or underage person is suffering;
p.(None): 4. the study medicinal product is designated for the diagnosis, treatment, or prophylaxis of diseases, which are
p.(None): specific for minor or underage persons;
p.(None): 5. the study is designated to be conducted in minor or underage persons;
p.(None):
p.(None): 6. the study purpose is to check data obtained in clinical trials in persons who are capable of giving
p.(None): informed consent or of data obtained by other research methods;
p.(None): 7. the results obtained from clinical trials in adults and the interpretation thereof cannot be considered also valid
p.(None): for minor or underage persons;
p.(None): 8. the study is planned in a manner that pain, inconvenience, fear, and other disease- associated foreseeable risks are
p.(None): minimised and the risk threshold and physical pain degree have been determined in advance and shall be incessantly
p.(None): controlled throughout the clinical test;
p.(None): 9. the study has been planned and shall be conducted in compliance with the guidelines of the European Medicines
p.(None): Agency;
p.(None): 10. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
...

p.(None): contraindications, and warnings, which result from new information associated with the safe use of a medicinal product.
p.(None): 71. "Spontaneous report" shall mean a voluntarily report for a suspected adverse reaction during the use of
p.(None): a medicinal product forwarded to the marketing authorisation holder, to the bodies for supervision on the medicinal
p.(None): products, or to other organisations, which is not originating from a study or another organised system for data
p.(None): capturing.
p.(None): 72. "Expiry period of a medicinal product" shall mean the interval of time during which, if a medicinal product is
p.(None): stored under the prescribed conditions, it shall comply with the specification developed on the grounds of
p.(None): stability tests of several batches of the finished form.
p.(None): 73. (Amen. - SG 71/2008, in force from 12.08.2008) "Medicinal product equivalent to a herbal medicinal product"
p.(None): shall mean a product containing the same active substances irrespective of the composition of the excipients
p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
...

p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
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Social / Child

Searching for indicator child:

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p.(None):
p.(None):
p.(None): Art. 234b (new – SG, 102/2012, in force from 02.01.2013) The BDA shall participate in information campaigns, organised
p.(None): by the European Commission and the European Medicines Agency about the danger of falsified medicinal products.
p.(None):
p.(None): Art. 235. (1) The authorisation to carry out retail trade with medicinal products shall be cancelled with the
p.(None): termination of the activity of the persons according to Art. 222.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The executive director of BDA shall cancel the authorisation for
p.(None): retail trade with medicinal products:
p.(None): 1. according to an application by the person who has received authorisation for carrying out retail trade with
p.(None): medicinal products:
p.(None): 2. wherever it has been established that the manager of the pharmacy does not comply with the requirements laid down in
p.(None): Art. 224 and 225.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 222 and 225 shall notify the BDA in
p.(None): writing within 14 days of the termination of the activity according to para 1.
p.(None):
p.(None):
p.(None): Art. 236. (1) The pharmacy cannot be closed for more than 30 days within a calendar year due to the absence of the
p.(None): manager.
p.(None): (2) (suppl. – SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011, amend. – SG,
p.(None): 60/2011, in force from 5. 8. 2011) Where the manager of the pharmacy is not in a position to fulfil his
p.(None): obligations due to a leave for temporary incapacity of work due to an illness, pregnancy and birth, or adoption and
p.(None): leave for breeding of a little child, as per Labour Code, the pharmacy can operate under the management of another
p.(None): master of pharmacy, respectively another assistant pharmacist, in the cases to Art. 225 complying with the requirements
p.(None): of Art. 224 for not more than two years. In all these cases a permission of the executive director of BDA shall be
p.(None): issued.
p.(None): (3) The permission according to 2 shall be issued within 30 days.
p.(None):
p.(None):
p.(None): Art. 237. Upon termination of the activity of the person who received authorisation to retail trade with medicinal
p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
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p.(None): substance.
p.(None):
p.(None):
p.(None): Art. 32. The marketing authorisation holder of a medicinal product may authorise the use of the pharmaceutical,
p.(None): preclinical and clinical documentation contained in the dossier of the medicinal product for the assessment of
p.(None): subsequent applications for medicinal products with the same qualitative and quantitative composition with respect to
p.(None): the active substances and with the same pharmaceutical form.
p.(None):
p.(None):
p.(None): Art. 33. Conducting the necessary studies and tests for the purpose of preparing the documentation for marketing
p.(None): authorisation and the subsequent practical requirements in connection with the authorisation to market of
p.(None): medicinal products according to Art. 28 and Art. 29 shall not be regarded as breach of patent rights or to
p.(None): supplementary protection certificates of medicinal products.
p.(None):
p.(None):
p.(None): Art. 34. (1) The summary of product characteristics shall contain the following information:
p.(None):
p.(None): 1. name of the medicinal product, quantity of the active substance in a dose unit, and pharmaceutical form;
p.(None): 2. qualitative and quantitative composition in terms of the active substances and constituents of the
p.(None): excipient, the information of which is essential for proper administration of the medicinal product. The usual common
p.(None): name or chemical description shall be used;
p.(None): 3. pharmaceutical form;
p.(None): 4. clinical particulars:
p.(None): a) therapeutic indications,
p.(None): b) posology and method of administration for adults and, where necessary, for children,
p.(None): c) contra-indications,
p.(None): d) special warnings and precautions for use and, in the case of immunological medicinal products, any special
p.(None): precautions to be taken by persons handling such products and administering them to patients, together with
p.(None): any precautions to be taken by the patient,
p.(None): e) interaction with other medicinal products and other forms of interactions,
p.(None): f) use during pregnancy and lactation,
p.(None): g) effects on ability to drive and to use machines,
p.(None): h) undesirable effects,
p.(None): i) overdose (symptoms, antidotes, emergency measures).
p.(None): 5. pharmacological properties:
p.(None): a) pharmacodynamic properties,
p.(None): b) pharmacokinetic properties,
p.(None): c) preclinical safety data.
p.(None): 6. pharmaceutical particulars:
p.(None): a) list of excipients,
p.(None): b) major incompatibilities,
p.(None): c) shelf life, where necessary after reconstitution of the medicinal product or where the immediate packaging is opened
p.(None): for the first time,
p.(None): d) special precautions for storage,
p.(None): e) nature and contents of container,
p.(None): f) special precautions for disposal of unused medicinal product or waste materials from such medicinal product.
p.(None): 7. marketing authorisation holder.
p.(None): 8. registration number.
p.(None): 9. date of the first marketing authorisation or renewal of the marketing authorisation.
p.(None): 10. date of a variation in the summary of product characteristics.
p.(None): 11. for radiopharmaceuticals, full details of internal radiation dosimetry.
p.(None): 12. for radiopharmaceuticals, detailed instructions for extemporaneous preparation and quality control and, where
p.(None): appropriate, maximum storage time during which any intermediate preparation such as an eluate or the
...

p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
...

Social / Incarcerated

Searching for indicator restricted:

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p.(None): (2) (new - SG, 102/2012, in force from 01.03.2012; suppl. – SG 18/14) Where a medicinal product,
p.(None): permitted for use under this act, is not intended for direct supply to the patient or is not available on the market in
p.(None): the Republic of Bulgaria, BDA may permit its use, where some of the data, determined by the ordinance under
p.(None): Para. 1 has not been placed on the package or in the leaflet.
p.(None): (3) (new - SG, 102/2012, in force from 01.03.2012) In the cases under Para. 2, the information on the packing and in
p.(None): the leaflets may not be provided in the Bulgarian language.
p.(None): (4) (new - SG, 102/2012, in force from 01.03.2012) The conditions and procedure for supply of medicinal products under
p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
...

Social / Infant

Searching for indicator infant:

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p.(None): authorisation or refusal shall be delivered to the person who has submitted the application.
p.(None): (3) (Amend. - SG, 60/2011, in force from 5. 8. 2011) Where discrepancies with or omissions in the
p.(None): submitted documentation have been established, within 15 day term from filing the documentation under Art. 228, Para.
p.(None): 6, the BDA shall perform a check up of the produced documents and shall notify the candidate in writing about the found
p.(None): discrepancies and omissions. In these cases the term according to para 2 shall cease to run as from the date of the
p.(None): notification till the elimination of the defects.
p.(None): (4) (New SG. 71/2008, in force from 12. 08. 2008) In case that within 60 day term after the notification date, under
p.(None): para 3, the applicant fails to remove the established irregularities or incompleteness, the procedure for issuing
p.(None): authorisation for retail trade in medicinal products or for change of an issued authorisation shall be terminated.
p.(None): (5) (Former para 4 – SG 71/2008, in force from 12, 08 2008, amend. – SG, 60/2011, in force from 5. 8. 2011). The
p.(None): refusal of the executive director of the BDA to issue an authorisation shall be subject to appeal under the terms of
p.(None): the Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 229a. (New – SG. 23/2009, in force from 30. 03. 2009) (1) (amend. and suppl. - SG.
p.(None):
p.(None): 41/2009, in force from 02.06.2009; amend. – SG 98/10, in force from 01.01.2011, amend. – SG, 60/2011, in force from 5.
p.(None): 8. 2011) The BDA shall officially submit to RHI on the location of the relevant pharmacy with an authorisation, issued
p.(None): under Art. 229, para 2, including retail trade with food supplements, dietetic foods for special medical purposes,
p.(None): Infant formulas and transitional foods, copy of the authorisation for registering into the register under Art.
p.(None): 14, para 1 of the Foodstuffs Act.
p.(None): (2) (Amen. And suppl. – SG. 41/2009, in force from 02.06.2009) The pharmacies which perform retail trade with food
p.(None): supplements, dietetic foods for special medical purposes, Infant formulas and reansitional foods shall be subject to
p.(None): control according to the Foodstuffs Act;
p.(None):
p.(None):
p.(None): Art. 230. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011) The BDA shall keep a register of the issued
p.(None): authorisations for retail trade with medicinal products under Art. 229, para 2, which shall contain:
p.(None): 1. authorisation number and date;
p.(None): 2. name, place of business and address of management of the person who has received the authorisation;
p.(None): 3.(amend. – SG 12/11, in force from 08.02.2011) name and UCN of the manager of the pharmacy;
p.(None): 4. address of the pharmacy;
p.(None): 5. activities, which will be conducted in the pharmacy;
p.(None): 6. date of cancelling the authorisation and its deletion from the register and reason therefore;
p.(None): 7. remarks relating to the inscribed circumstances.
p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011) Data from the register shall be published on the
p.(None): internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 231. (1) In case of change of the circumstances inscribed in the register according to Art. 230, para 1, points
p.(None): 2-5, the person who has received authorisation to carry out retail trade with medicinal products shall submit an
p.(None): application under the terms of Art. 228, para 1, and shall append the documents associated with the change.
p.(None): (2) (New – SG, 60/2011, in force from 5. 8. 2011) In case of a change of the name and type of the trader, address of
p.(None): the pharmacy and manager of the pharmacy, a new application shall be submitted under Art. 228, Para. 1 and the charge
p.(None): for issuance a new authorisation for retail trade with medicinal products in a pharmacy shall be paid, determined by
p.(None): the tariff under Art. 21, Para. 2.
...

p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
...

p.(None): and 43, which shall come into force from 26 July 2008.
p.(None):
p.(None): Concluding provisions
p.(None): TO THE ACT AMENDING THE MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT
p.(None): (PUBL. - SG 10/2009, IN FORCE FROM 29.01.2009)
p.(None):
p.(None): § 2. The Act shall come into force from 29 January 2009.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT
p.(None):
p.(None): (PUBL. - SG 23/2009, IN FORCE FROM 30.03.2009)
p.(None):
p.(None): § 4. Persons, who have received by the time this Act comes into force authorisation under Art. 229, para 2, including
p.(None): performing trade with food supplements, may perform retail trade with dietetic foods for special medical purposes.
p.(None):
p.(None):
p.(None): § 5. Within 2 months after this Act comes into force, the Ministry of Health shall officially sent to the relevant
p.(None): RIPCPH of the locality of the pharmacies for listing into the register under
p.(None):
p.(None): Art. 14, para 1 of the Foodstuffs Act, a copy of the authorisations under Art. 229, para 2, issued by this Act comes
p.(None): into force.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 7. This Act shall come into force from 30 March 2009.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE HEALTH ACT
p.(None):
p.(None): (PUBL. - SG 41/2009, IN FORCE FROM 02.06.2009)
p.(None):
p.(None): § 92. (1) Persons, who have received by the time this Act comes into force authorisation under Art. 229, para 2 of the
p.(None): Medicinal Products in Human Medicine Act, including performing trade with food supplements, may perform retail trade
p.(None): also with Infant formulas and transitional foods.
p.(None): (2) Within the term of 2 months after this Act comes into force, the Ministry of Health shall officially submit in the
p.(None): relevant RIPCPH on the locality of the pharmacies, which perform retail trade with Infant formulas and transitional
p.(None): foods under Art. 1 for listing into the register under Art. 14, para 1 of the Foodstuffs Act copy of the authorisations
p.(None): under Art. 229, para 2 of the Medicinal Products in Human Medicine Act issued by the time this Act comes into force.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 96. This Act shall come into force from the day of its publication in the State Gazette, with the exception of:
p.(None): 1. para 3, 5, 6 and 9, which shall come into force from 1 January 2009;
p.(None): 2. para 26, 36, 38, 39, 40, 41, 42, 43, 44, 65, 66, 69, 70, 73, 77, 78, 79, 80, 81, 82, 83,
p.(None): 88, 89 and 90, which shall come into force from 1 July 2009;
p.(None): 3. para 21, which shall come into force from 1 June 2009.
p.(None):
p.(None): Concluding provisions
p.(None): TO THE ACT SUPPLEMENTING THE MEDICINAL PRODUCTS IN THE HUMANE MEDICINE ACT
p.(None): (PUBL. - SG 88/2009 IN FORCE FROM 06.11.2009)
p.(None):
p.(None): § 2. The Act shall enter into force from the day of its promulgation in the State Gazette.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT
p.(None):
p.(None): (PROM. - SG 102/09, IN FORCE FROM 22.12.2009)
p.(None):
p.(None): § 4. (1) Master-pharmacists and assistant pharmacists who, prior to the entry into force of this Act, have been granted
p.(None): permissions to open a pharmacy in populated areas referred to in Art. 228, para 4 according to the revoked Act on
p.(None): Medicines and Pharmacies for the Human Medicine, and who have not submitted an application for re-registration within
p.(None): the term fixed in
p.(None):
p.(None): § 66, para 3 of the Act on Amendment and Supplementation of the Medicinal Products in Human Medicine Act (SG 71/08),
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Social / Linguistic Proficiency

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p.(None):
p.(None):
p.(None): Art. 11. (1) The Minister of Health may, due to reasons relating to the protection of the health of the population,
p.(None): instruct by way of order the Executive Director of the BDA to authorise the use of a medicinal product, which has not
p.(None): been authorised for use on the territory of the Republic of Bulgaria and for which no application for issuing
p.(None): of an authorisation has been submitted but which has been authorised in another Member State.
p.(None): (2) In the cases under para 1, the director of BDA, or his authorised representative shall:
p.(None): 1. inform the holder of the marketing authorisation for the medicinal product on the
p.(None):
p.(None): initiation of a procedure for the authorisation of the medicinal product for use;
p.(None): 2. register the person referred to in point 1 as a holder of the issued authorisation;
p.(None): 3. demand from the regulatory body of the Member State that has issued the marketing authorisation a copy of the
p.(None): assessment report and a copy of the marketing authorisation.
p.(None): (3) (suppl. – SG, 102/2012, in force from 21.12.2012) The Bulgarian Drug Agency shall be obliged to ensure
p.(None): compliance of the label, patient information leaflet, classification, advertising, and follow-up of the
p.(None): safety of the medicinal product released on the market according to Para. 1 with the requirements of this Act.
p.(None): The information on the packing and in the leaflet of the medicinal product under Para. 1 shall not be obligatorily in
p.(None): the Bulgarian language.
p.(None): (4) The Executive Director of BDA shall inform the European Commission about the authorisation issued according to para
p.(None): 1, the name and address of the authorisation holder, as well as about the date of termination of the validity thereof.
p.(None):
p.(None):
p.(None): Art. 12. (1) The official pharmacopoeia of the Republic of Bulgaria shall be the European Pharmacopoeia
p.(None): (2) The official pharmacopoeia may be supplemented with the requirements of the Bulgarian pharmacopoeia.
p.(None): (3) The Minister of Health shall determine by way of order the dates of entry into effect of the current edition of the
p.(None): official pharmacopoeia and the annexes thereof.
p.(None): (4) The order according to para 3 shall be promulgated in the State Gazette and published on the internet
p.(None): site of BDA.
p.(None):
p.(None):
p.(None): Art. 13. (1) The monographs of the European Pharmacopoeia shall be obligatory for all substances, preparations, and
p.(None): pharmaceutical forms contained therein. In the cases where there is no monographs in the European Pharmacopoeia, the
p.(None): requirements of the current editions of the pharmacopoeias of the Member States, the U.S.A, and Japan provided that
p.(None): these are in compliance with the general rules of the European Pharmacopoeia.
p.(None): (2) Where the specification contained in a monograph of the European Pharmacopoeia or other national pharmacopoeia
p.(None): is insufficient to ensure the quality of the substance or pharmaceutical form, the Bulgarian Drug
p.(None): Agency can require supplementation of the specification by the applicant/marketing authorisation holder.
p.(None):
p.(None): Chapter two.
p.(None): MANAGING AND FINANCING BODIES
p.(None):
...

p.(None): 21. copy of a refusal for a marketing authorisation in a Member State or a third state accompanied by motives;
p.(None): information for temporary suspension or termination of the effect of the marketing authorisation;
p.(None): 22. copy of the proposed package leaflet accompanied by a summary of the results of the assessment of the level of
p.(None): comprehensibility of the contents of the package leaflet by a target patient group selected by the applicant or a copy
p.(None): of a leaflet approved by a regulatory authority in a Member State, which has already issued a marketing authorisation;
p.(None): 23. document of paid fee in amounts up in the tariff according to Art. 21, para 2.
p.(None): (2) (suppl. – SG 18/14) The documents according to para 1, item 18 and 18a, relating to the Member States, and point
p.(None): 19, respectively, shall only be submitted in the procedures according to section VII.
p.(None): (3) To radionuclide generators, the following documents shall be added to the data according to para 1:
p.(None): 1. description of the system together with a detailed description of its components, which may affect the composition
p.(None): or quality of the daughter radionuclides;
p.(None): 2. qualitative and quantitative particulars of the eluate or the sublimate.
p.(None): (4) The documents and data from pharmaceutical tests, preclinical and clinical trials shall be accompanied by
p.(None): summarised reports prepared by experts with the required technical and professional qualification. To the reports a
p.(None): curricula vitae report of the experts shall be applied.
p.(None): (5) The dossier of the medicinal product shall be submitted in the Bulgarian and/or English language.
p.(None): (6) (new – SG, 102/2012, in force from 21.12.2012) The risk management system under Para. 1, p. 13 should be
p.(None): proportional to the identified and to the potential risks of the medicinal product and to the need of collecting safety
p.(None): data of post-marketing researches.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The holder of the authorisation for use shall update the data of the
p.(None): file under Para. 1. For each change in the file the provisions of Chapter Three Section VI shall apply, where
p.(None): applicable.
p.(None):
p.(None):
p.(None): Art. 28. (1) The person according to Art. 26, para 1, insofar as he does not infringe industrial and commercial
p.(None): property rights, shall not submit to the BDA the data according to Art.
p.(None):
p.(None): 27, para 1, point 10, letters "b" and "c" provided that he can prove that the medicinal product indicated in the
p.(None): application is generic of a reference medicinal product, which is or has been authorised to market for not less than 8
p.(None): years in a Member State or in a state member of the European Economic Area.
p.(None): (2) The marketing authorisation holder of a generic product according to para 1 may not place it to market until 10
p.(None): years from the initial marketing authorisation of the reference medicinal product have elapsed.
p.(None): (3) Under observance of the conditions of para 1 and 2, the person according to Art. 26, para 1, may submit to the BDA
p.(None): an application for marketing authorisation of a medicinal product, which is generic of a reference medicinal product,
p.(None): even where the reference product has never had marketing authorisation on the territory of the Republic of Bulgaria.
...

p.(None): following data for the certificate:
p.(None): 1. registration number;
p.(None): 2. number and date of the marketing authorisation/registration certificate of the medicinal product;
p.(None): 3. name of the medicinal product;
p.(None): 4. international non-proprietary name of any active substance;
p.(None): 5. name and address of the holder of the marketing authorisation/registration certificate; 5a (new - SG, 102/2012, in
p.(None): force from 21.12.2012) the conditions of Art. 55a, 56 and
p.(None): 56a, entered in the authorisation for use/registration certificate;
p.(None): 6. date of variation of the marketing authorisation/registration certificate;
p.(None): 7. date of termination of the marketing authorisation/registration certificate;
p.(None): 8. other data.
p.(None): (2) The marketing authorisation/registration certificate of the medicinal product shall be delivered to the person
p.(None): according to Art. 26, Para. 1, and shall enter into effect as from the date
p.(None):
p.(None): of its inscription in the register according to Art. 19, Para. 1, point 3.
p.(None):
p.(None):
p.(None): Art. 53. (1) (amend. – SG, 102/2012, in force from 21.12.2012) The BDA shall publish on its internet site data
p.(None): according to Art. 52, Para.1 for the marketing authorisation of the medicinal product granted and the
p.(None): approved summary of product characteristics and the datas of the leaflet.
p.(None): (2) The BDA shall publish o its internet site the assessment report under art. 49, Para. 1 with the motives of the
p.(None): decision taken while deleting the data, representing commercial secret.
p.(None): (3) The report under Para. 2 shall be accompanied by a summary in understandable by the public language. The summary
p.(None): shall contain a section, related to the conditions for use of the medicinal product.
p.(None):
p.(None):
p.(None): Art. 54. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of a marketing authorisation/registration
p.(None): certificate of a medicinal product shall notify the BDA in writing about the date of actual placing on the market of
p.(None): the medicinal product in the Republic of Bulgaria.
p.(None): (2) (amend. – SG 18/14) The holder of a marketing authorisation/registration certificate of a medicinal product shall
p.(None): notify the BDA in writing within minimum two months prior to any discontinuation of the sales of a medicinal product
p.(None): irrespective temporary or permanent.
p.(None): (3) (amend. – SG 18/14) The holder of a marketing authorisation/registration certificate of a medicinal product shall
p.(None): indicate the reasons for the discontinuation of the sales subject to compliance with the provision of Art. 68, par. 1,
p.(None): item 6 and shall declare whether the measures under par. 2 undertaken by them are because of any of the grounds
p.(None): referred to in Art. 276 and Art. 277.
p.(None): (4) (amend. – SG 18/14) In case of discontinuation of the sales of a medicinal product as a result of unforeseen
p.(None): circumstances, the holder of a marketing authorisation/registration certificate of a medicinal product shall notify the
p.(None): BDA in writing within 7 days of the establishment of the circumstances.
p.(None):
p.(None):
p.(None): Art. 54a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG 18/14) With receiving a signal at the
p.(None): Executive Agency on Medicines (EAM) for termination of sales of a medicinal product, with the exception of the cases
p.(None): under Art. 54, Para. 2 and 4, the Agency shall perform a check within the term of 30 days after receiving the signal.
...

p.(None): been fulfilled:
p.(None): 1. the manufacturing authorisation holder, before partially or thoroughly removes or closes the safety
p.(None): indicators, shall check whether the relevant medicinal product is authentic or it has been faked;
p.(None): 2. the manufacturing authorisation holder while observing the requirements of Art. 168, Para. 8 may replace the safety
p.(None): indicators with ones, equal to them in relation to the possibility for guaranteeing the authenticity,
p.(None): identification and provision of evidences for faking the medicinal product.
p.(None): (3) The safety indicators shall be considered as equal, if:
p.(None): 1. they meet the requirements, determined by the delegated acts under Art. 54a, Para. 2 of Directive 2001/83/EC and
p.(None): 2. they are so effected that they allow the check of authenticity and identification of the medicinal products and
p.(None): provide evidences for their being faked.
p.(None): (4) The replacement under Para. 2, p. 2 shall be made without opening the initial packing of the medicinal product and
p.(None): in compliance with the Good manufacturing practice for medicinal products.
p.(None): (5) The BDA shall carry out supervision on the replacement of the safety indicators.
p.(None):
p.(None):
p.(None): Art. 169. (1) The information of the packaging and the medicinal product leaflet must be in full compliance with the
p.(None): data in the summary of product characteristics approved by the BDA upon the issue of the marketing authorisation and
p.(None): must comply with the requirements set out in the regulation according to Art. 170.
p.(None): (2) The information on the packaging and leaflet can be in several languages but one of these must obligatorily be
p.(None): Bulgarian language. The content of the information in various languages must be identical.
p.(None): (3) The name of the medicinal product shall obligatorily be written in the Bulgarian language and the
p.(None): international non-proprietary name of the medicinal substance shall be written according to the
p.(None): Anatomic-Chemical-Therapeutic Classification of the WHO. The name
p.(None): and address of the marketing authorisation holder can be written in Latin.
p.(None): (4) The information of the packaging and leaflet must be in a language comprehensible for the patient and must be
p.(None): readable and indelible.
p.(None): (5) (new – SG 18/14) The leaflet must be produced so that to be clear and understandable, and to allow
p.(None): the patient to undertake adequate actions, where required, with the assistance of the health care specialists.
p.(None):
p.(None): Art.170. (1) (former text of Art. 170 – SG, 102/2012, in force from 01.03.2012) The requirements relating
p.(None): to the packaging and leaflets of medicinal products shall be determined by an ordinance of the Minister of Health.
p.(None): (2) (new - SG, 102/2012, in force from 01.03.2012; suppl. – SG 18/14) Where a medicinal product,
p.(None): permitted for use under this act, is not intended for direct supply to the patient or is not available on the market in
p.(None): the Republic of Bulgaria, BDA may permit its use, where some of the data, determined by the ordinance under
p.(None): Para. 1 has not been placed on the package or in the leaflet.
p.(None): (3) (new - SG, 102/2012, in force from 01.03.2012) In the cases under Para. 2, the information on the packing and in
p.(None): the leaflets may not be provided in the Bulgarian language.
p.(None): (4) (new - SG, 102/2012, in force from 01.03.2012) The conditions and procedure for supply of medicinal products under
p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
...

p.(None):
p.(None):
p.(None): Art. 215. (1) (Amen. And suppl. - SG 71/2008, in force from 12.08.2008) To obtain authorisation to
p.(None): perform parallel import on the territory of the Republic of Bulgaria, the person according to Art. 213, para 1 shall
p.(None): submit to the executive director of BDA an application stating the Member State from which the parallel import of the
p.(None): medicinal product is to be effected from.
p.(None): (2) The following data and documents shall be appended to the application:
p.(None): 1. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product authorised for
p.(None): use in the Republic of Bulgaria;
p.(None): 2. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product intended for
p.(None): parallel import;
p.(None): 3. (suppl. – SG 12/11, in force from 08.02.2011) name of the marketing authorisation holder and the manufacturer if a
p.(None): person different from the marketing authorisation holder, name of the medicinal product intended for parallel import;
p.(None): 4. number of the marketing authorisation of the medicinal product in the Republic of Bulgaria and number of the
p.(None): marketing authorisation of the medicinal product in the Member State where the parallel import is to be effected from;
p.(None): 5. declaration for establishment of circumstances pursuant 217, issue 1;
p.(None): 6. copy of the patient information leaflet and a sample of the medicinal product in the form in which it is sold in the
p.(None): Member State where the parallel import is to be effected from,
p.(None):
p.(None): translation of the patient information leaflet in the Bulgarian language accompanied by a declaration that
p.(None): the translation is in compliance with the original of the leaflet;
p.(None): 7. proposal for patient information leaflet of the parallel imported medicinal product accompanied by a
p.(None): declaration that the content of the leaflet is identical with the content of the medicinal product authorised in the
p.(None): Republic of Bulgaria except for the following data:
p.(None): a) name and address of management of the person effecting the parallel import;
p.(None): b) name of manufacturer where it is different for both products;
p.(None): c) stability period where it is different for both products;
p.(None): d) excipients where these are different in both products;
p.(None): 8. in case of repackaging:
p.(None): a) sample of the parallel import product;
p.(None): b) copy of the contract between the person carrying out parallel import and the persons performing partial
p.(None): manufacturing activity – packaging, labelling;
p.(None): c) certificate of Good Manufacturing Practice where the repackaging processes are performed outside the
p.(None): territory of the Republic of Bulgaria;
p.(None): d) where repackaging is performed by the person according to Art. 213, para 1, copy of the manufacturing
p.(None): authorisation issued by the regulatory body of the Member State where repackaging is to be performed;
p.(None): 9. document for paid fee, in the amount as laid down in the tariff according to Art. 21,
p.(None): para 2.
p.(None): (3) (Amen. - SG 71/2008, in force from 12.08.2008) Where there are differences (in the
p.(None): composition of the excipients or other) between the parallel imported medicinal product and the product authorised for
p.(None): use on the territory of the Republic of Bulgaria, the person according to para 1 shall submit evidence that these do
p.(None): not affect the therapeutic qualities of the parallel imported medicinal product.
p.(None): (4) In the cases according to para 3 the person according to para 1 shall point out the differences on the packaging
p.(None): and in the patient information leaflet of the parallel imported medicinal product.
p.(None): (5) Where the person according to Art. 213, para 1, is repackaging and/or labelling the medicinal product in the
p.(None): Bulgarian language on the territory of the Republic of Bulgaria, it must possess a manufacturing authorisation issued
p.(None): by the executive director of the BDA.
p.(None): (6) The parallel imported product shall be used according to the conditions of the issued marketing authorisation for
p.(None): the use of the medicinal product on the territory of the Republic of Bulgaria.
p.(None):
p.(None):
p.(None): Art. 216. (1) The authorisation for parallel import on the territory of the Republic of Bulgaria shall be
p.(None): issued within 45 days of the date of submission of the documentation to the BDA.
p.(None): (2) Where the BDA shall request additional documentation from the applicant, the term according to para 1 shall cease
p.(None): to run until receipt of the requested information.
p.(None): (3) Where the BDA shall require information relating to the issue of the marketing authorisation of the
p.(None): imported medicinal product from the regulatory body of the Member State where the parallel import is to be effected
p.(None): from, the term according to para 1 shall be extended by 45 days.
p.(None): (4) If the BDA does not receive the requested documentation within the term according to para 3, the procedure for the
p.(None): issue of a parallel import authorisation for the territory of the Republic of Bulgaria shall be terminated.
p.(None): (5) The issued parallel import authorisations for the territory of the Republic of Bulgaria
p.(None):
p.(None): shall be published on the internet site of the BDA.
p.(None): (6) The parallel import authorisation shall be valid for 5 years. New authorisation shall be issued under the terms of
p.(None): Art. 215.
p.(None): (7) The parallel import authorisation shall not be automatically cancelled where the marketing authorisation
...

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p.(None): characteristics, labelling and package leaflet;
p.(None): e) all variations in the group are changes to the Active Substance Master File, Vaccine Antigen Master File or Plasma
p.(None): Master File;
p.(None): f) all variations in the group relate to a project intended to improve the manufacturing process and the quality of the
p.(None): medicinal product concerned or its active substance(s);
p.(None): g) all variations in the group are changes affecting the quality of a human pandemic influenza vaccine;
p.(None): h) all variations in the group are changes to the pharmaco-vigilance system referred to in Chapter Eight;
p.(None): i) all variations in the group are consequential to a given urgent safety restriction and are submitted in accordance
p.(None): with Art. 66;
p.(None): k) all variations in the group relate to the implementation of a given class labelling;
p.(None): l) all variations of the group are consequential to the assessment of a given periodic update report on the safety;
p.(None): m) all variations in the group are consequential to a given post-authorisation study conducted under the
p.(None): supervision of the holder of the marketing authorisation;
p.(None): n) all variations in the group are consequential to a specific obligation carried out pursuant to Art. 56;
p.(None): 3. the declared variations to the terms of the same marketing authorisation do not fall within one of the cases
p.(None): specified in item 2, provided that the BDS agrees to subject those variations to the same procedure.
p.(None): (4) Where variations as per Para 3, items 2 and 3 are grouped, holder of the marketing authorisation shall submit to
p.(None): the BDA:
p.(None): 1. a single notification, where at least one of the variations is a variation of type IB and all variations are of type
p.(None): IA or of type IB;
p.(None): 2. a single application, if the main variation is of type II and none of the rest of variations is an extension of the
p.(None): marketing authorisation;
p.(None): 3. a single application, where the main variation is extension of the marketing authorisation.
p.(None): (5) Attached to the application, respectively to the notification, the holder of the marketing
p.(None): authorisation shall submit:
p.(None): 1. documentation, related to the variations, as determined by the regulation envisaged in Art. 42;
p.(None): 2. a document, certifying that the fee, in an amount as per Tariff under Art. 21, Para 2,
p.(None): is paid.
p.(None): (6) The Executive Director of the BDA shall approve form of the application, respectively
p.(None): of notification, envisaged in Para 1 and 4, which shall be published on the Internet site of the BDA.
p.(None):
p.(None): Art. 62. (amend. – SG 12/11, in force from 08.02.2011) (1) The holder of marketing authorisation shall submit a
p.(None): notification of variations of type IA within 12 months following the implementation of the variation, except for
p.(None): the cases where variations require immediate notification.
p.(None): (2) Variations of type IA requiring immediate notification shall be specified in the regulation envisaged
p.(None): in Art. 42.
p.(None): (3) In the cases of Para 2, holder of marketing authorisation shall submit notification for the variation of type IA
p.(None): immediately after its implementation.
p.(None): (4) Within 30 days following receipt of the notification per Para 1, respectively per Para 3, the BDA shall notify the
p.(None): marketing authorisation holder:
p.(None): 1. if the variation(s) is/are accepted or not; in the cases where the variation(s) concerned is/are not accepted,
p.(None): reasons for that shall be stated; and
p.(None): 2. if variation(s) concerned lead(s) to amendment of the data in the issued marketing authorisation; where amendment of
p.(None): the issued marketing authorisation is needed, Art. 64a shall be applied.
...

p.(None): (2) The BDA shall pass a judgment regarding the measures within 24 hours of the notification.
p.(None): (3) Where the BDA has not passed a judgment within the term according to para 2, it shall be presumed that the measures
p.(None): have been approved.
p.(None): (4) Where the BDA has established that there is a risk for the health of the population from the use of medicinal
p.(None): product, it shall order the marketing authorisation holder to immediately undertake limiting measures.
p.(None): (5) In the cases according to para 1 and 4, the marketing authorisation holder of the medicinal product shall
p.(None): coordinate the method and term of implementation of the undertaken measures with the BDA.
p.(None): (6) Marketing authorisation holder of the medicinal product shall submit to the executive director of The BDA a
p.(None): variation application under the terms Art. 64 not later than 15 from the date undertaking the measures.
p.(None):
p.(None):
p.(None): Art. 66. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of the marketing authorisation of a medicinal
p.(None): product shall submit an application for enlargement of the scope of the granted marketing authorisation in case of:
p.(None): 1. change of the active substance(s):
p.(None): a. replacement of a chemical active substance by a different by a different salt/ester, complex/derivative, including
p.(None): the same therapeutic moiety, where the efficacy/safety characteristics are not significantly different.
p.(None): b. replacement by a different isomer, mixture of isomers, of a mixture by an isolated isomer (e.g. racemate with single
p.(None): enantiomer), where the efficacy/safety characteristics are not significantly different;
p.(None): c. replacement of a biological active substance with one of a slightly different molecular structure where the
p.(None): efficacy/safety characteristics are not significantly different, with the exception of changes to the active
p.(None): substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
p.(None):
p.(None): d. modification of the vector used to produce the antigen of the source material, including a new master cell bank from
p.(None): a different source, where the efficacy/safety characteristics are not significantly different;
p.(None): e. a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy/safety
p.(None): characteristics are not significantly different
p.(None): f. change to the extraction solvent of the ration of herbal drug to herbal drug preparation where the efficacy/safety
p.(None): characteristics are not significantly different.
p.(None): 2. Changes to strength, pharmaceutical form and route of administration:
p.(None): a. change of bioavailability;
p.(None): b. change of pharmacokinetics e.g. change in rate of release;
p.(None): c. change or addition of a new strength/potency;
p.(None): d. change or addition of a new pharmaceutical form; e.g. change or addition of a new route of administration– for
p.(None): parenteral application to differentiate between intraarterial, intravenous, intramuscular, subcutaneous and
p.(None): other routs of administration.
...

p.(None): equipment and control laboratories.
p.(None):
p.(None):
p.(None): Art. 149. The managers of manufacture and quality control of medicinal products in the manufacturing enterprises shall
p.(None): be:
p.(None): 1. persons with educational qualification master’s degree in pharmacy, chemistry, or biology and at least two-year
p.(None): practical experience in the pharmaceutical manufacture;
p.(None): 2. for the manufacture of radiopharmaceuticals or medicinal products subjected to ionizing radiation –
p.(None): persons who comply with the requirements according to point 1 and have an additionally recognised specialty in
p.(None): radiobiology or radiochemistry.
p.(None): 3. for the manufacture of immunological medicinal products including vaccines, toxins, sera, biotechnological products,
p.(None): and medicinal products obtained from human plasma or human blood – persons with recognised speciality in medical
p.(None): haematology, medical microbiology, virology, or immunology.
p.(None):
p.(None):
p.(None): Art. 150. (1) The person according to Art. 146 shall submit to the BDA a formal application as approved
p.(None): by the director of the Agency.
p.(None): (2) Together with the application according to para 1 the applicant shall also submit:
p.(None): 1. diploma, document for acquired speciality, document for length of service, certificate of clean court record, and
p.(None): employment contract for the persons according to Art. 148, point 2, and Art. 149;
p.(None): 2. copies of contracts of assignment of the manufacture and/or control of the products ordered for manufacture – in the
p.(None): cases according to Art. 151;
p.(None): 3.(amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code
p.(None):
p.(None): of the trader or cooperation from the Trade register, and for the companies, registered in a EU Member State or in a
p.(None): state – party on the Agreement for the EEA – a document for updated registration under the national legislation, issued
p.(None): by a competent body of the relevant state;
p.(None): 4. (amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 02.01.2013)) a list of
p.(None): the production activities and the medicinal forms, which will be manufactured;
p.(None): 5. schemes of the premises for the manufacture, control, and storage and a dossier of the manufacturing capacity;
p.(None): 6. assessment of the environmental impact during the manufacture of the medicinal products for the cases
p.(None): stipulated in the Environmental Protection Act;
p.(None): 7. authorisation by the Nuclear Regulatory Agency where the application concerns manufacture of
p.(None): radiopharmaceuticals or medicinal products subjected to ionised radiation during their manufacture;
p.(None): 8. authorisation for the use of the premises for manufacture, control, and storage issued according to order of the
p.(None): Spatial Development Act or another substituting document;
p.(None): 9. (amend., - SG 98/10, in force from 01.01.2011, repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 10. document for paid fee, in amount determined in the tariff to Art. 21, para 2.
p.(None): (3) For the manufacturing of narcotic substances and pharmaceutical forms containing such substances, the
p.(None): requirements of the Control on Drugs and Precursors Act shall be observed.
p.(None):
p.(None):
...

p.(None): 3. address of the premises for the control and storage of the medicinal products;
p.(None): 4. (amend. – SG, 102/2012, in force from 02.01.2013) the medicinal products, and forms for which the authorisation has
p.(None): been obtained;
p.(None): 5. name of the person according to Art. 161, para 2, point 1;
p.(None): 6. date of deletion of the import authorisation from the register and reason thereof.
p.(None): (2) Data from the register shall be published on the internet site of the BDA.
p.(None):
p.(None): Section III.
p.(None): PRODUCTION, IMPORT AND WHOLESALE TRADE WITH ACTIVE SUBSTANCES (NEW – SG, 102/2012, IN FORCE FROM 02.01.2013)
p.(None):
p.(None): Art. 167a. (new – SG, 102/2012, in force from 02.01.2013) Manufacture, import or wholesale trade with
p.(None): active substance may be carried out by natural or legal persons, registered as traders under the legislation of an EU
p.(None): Member State and entered in to the register under Art. 167.
p.(None):
p.(None):
p.(None): Art. 167b. (new – SG, 102/2012, in force from 02.01.2013) (1) For entering into the register under Art. 167d, the
p.(None): applicant shall submit to BDA an application according to a form, confirmed by the BDA executive director, which shall
p.(None): contain:
p.(None): 1. name, management central office of the person under Art. 167a;
p.(None): 2. a list of the active substances, which will be imported, manufactured or traded;
p.(None): 3. the activities, which the person under Art. 167a will carry out;
p.(None):
p.(None): 4. Premise addresses for the technical equipment for realizing the activity of the persons under Art. 167a;
p.(None): (2) The application under Para. 1 shall have attached:
p.(None): 1. data about the single identification code (SIC) of the trader and for the companies, registered in an EU Member
p.(None): State p a document for current registration under the national legislation, issued by a competent body of the
p.(None): relevant state;
p.(None): 2. document for a paid fee under Art. 21, Para. 2.
p.(None): (3) Within the term of 60 days after the application and the documents under Para. 1 and 2 are received, BDA, on the
p.(None): basis of the risk assessment shall:
p.(None): 1. enter the person under Art. 167a in the register under Art. 167d, for which shall notify,
p.(None): or
p.(None): 2. notify about the date of the inspection, carried out for establishing the compliance of
p.(None): the conditions for the activities under Art. 167a with the requirements of the Good manufacturing practice under Art.
p.(None): 152, Para. 1 and of the Good distribution practices of active substances under Art. 198.
p.(None): (4) Where as a result of the inspection under Para. 3, p. 2, BDA finds out compliance with the Good manufacturing
p.(None): practice under Art. 152, Para. 1 and of the Good distribution practices of active substances under Art. 198,
p.(None): it shall enter the applicant in the register under art. 167d, for which it shall notify him/her.
p.(None): (5) The expenses for performing the inspection under Para. 3, p. 2 shall be on the account of the
p.(None): applicant.
p.(None): (6) For the inspection under Para. 3, p. 2 the applicant shall pay a fee in the amount, determined by the tariff under
p.(None): Art. 21, Para. 2.
p.(None): (7) In the cases under Para. 3, p. 1 and Para. 4 the applicant may start to carry out his/her activity after
p.(None): registering in the register under Art. 167d.
p.(None):
p.(None):
...

p.(None): containing substances specified in the list under Art. 3, para 2, item 2 of the Control on Drugs and Precursors Act –
p.(None): with two blue strips. The packaging shall obligatorily contain a notice that the medicinal product shall only be
p.(None): dispensed by special medical prescription.
p.(None): (3) (amend. – SG, 102/2012, in force from 21.12.2012) The leaflet of the medical products, included in
p.(None): the list under Art. 23 of Regulation (EC) N 7262004 of the European Parliament and of the Council
p.(None): contains information with the following text: "This medicinal product is subject to additional observation".
p.(None): Before the text a sign is placed in black cooler under Art. 23, Para. 5 of Regulation (EC) N 7262004 of the European
p.(None): Parliament and of the Council, accompanied by an explanatory note.
p.(None): (4) (amend. – SG, 102/2012, in force from 21,12,2012) The leaflet of the medicinal products shall included
p.(None): a standard text, by which the patients are invited to report to the medical specialists or directly to BDA about every
p.(None): suspected unwilling medicinal reaction according to the samples in Art. 185, Para. 2, p. 4.
p.(None): (5) Where a medicinal product is to be authorised for use on the territory of the Republic of Bulgaria, a marking for
p.(None): separate collection and recycling according to the Waste Management Act and the acts for the application thereof shall
p.(None): be placed in its secondary packaging.
p.(None): (6) Where a medicinal product is to be authorised for use, its name on the secondary packaging, pharmaceutical form,
p.(None): and content of active substance in a single dose shall also be printed in the Braille’s alphabet.
p.(None): (7) The requirements of para 6 are not applied for vaccines and medicinal products in hospital’s packages.
p.(None): (8) (new – SG, 102/2012, in force from 21.12.2012) On the secondary package (if there is no such) on the initial
p.(None): package of the medicinal products, with the exception of radio- pharmaceutics, the following shall be placed:
p.(None): 1. individual identification sign for indicators of safety, which gives opportunity for the wholesale and retail
p.(None): traders to:
p.(None): a) check up the authenticity of the medicinal product;
p.(None): b) to identify separate packages.
p.(None): 2. a means, which may check up the package of the medicinal product if it has been
p.(None): faked.
p.(None):
p.(None):
p.(None): Art. 168a. (new – SG, 102/2012, in force from 21.12.2012) (1). On the package of the medicinal product, which is
p.(None): prescribed by a doctor’s prescription, safety indicators shall be placed under Art. 168, Para. 8 with the
p.(None): exception of the cases, in which the medicinal product has been included in the list, determined by the European
p.(None): Commission by a delegated act under Art. 168b.
p.(None): (2) On the package of a medicinal product, which does not need doctor’s prescription, no safety indicators shall be
p.(None): placed under Art. 168, Para. 8, with the exception of the cases, in which the medicinal product is included in the
p.(None): list, determined by the European Commission by a delegated act under Art. 168b, after it has been assessed, that it may
p.(None): be put to a risk to be faked.
p.(None): (3) The BDA shall notify the European Commission:
...

p.(None): the Republic of Bulgaria, BDA may permit its use, where some of the data, determined by the ordinance under
p.(None): Para. 1 has not been placed on the package or in the leaflet.
p.(None): (3) (new - SG, 102/2012, in force from 01.03.2012) In the cases under Para. 2, the information on the packing and in
p.(None): the leaflets may not be provided in the Bulgarian language.
p.(None): (4) (new - SG, 102/2012, in force from 01.03.2012) The conditions and procedure for supply of medicinal products under
p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
p.(None): 3. are intended for treatment of out-patients but their use can cause serious adverse drug reactions, which can require
p.(None): specialist prescribing and monitoring in the course of treatment.
p.(None):
p.(None):
p.(None): Art. 176. (1) The BDA can refuse to approve the dispensing regime of a medicinal product requested by the
p.(None): applicant according to Art. 26, para 1, on the grounds of assessment of:
p.(None): 1. the maximum single dose, maximum daily dose, quantity of the active substance in one dose unit, pharmaceutical
p.(None): form, specific appearance of the primary product packaging, and/or
p.(None): 2. other specific conditions of use.
p.(None): (2) The BDA can refuse to indicate the exact category of a medicinal product according to Art. 172 but pursuant to the
p.(None): criteria according to Art. 174 and Art. 175 shall determine whether a medicinal product shall be classified as a
p.(None): product dispensed only on medical prescription.
p.(None):
p.(None):
p.(None): Art. 177. Medicinal products, which do not meet the requirements according to Art. 173, 174, and 175 and the criteria
p.(None): laid down in the regulation according to Art. 178, shall be dispensed without medical prescription.
p.(None):
p.(None):
p.(None): Art. 178. The criteria for classification of medicinal products and the requirements to the documentation for changing
p.(None): the classification shall be determines by a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 179. (1) The BDA shall draw and publish on its internet site a list of the medicinal products, which shall be
p.(None): dispensed on the territory of the Republic of Bulgaria on medical prescription.
p.(None): (2) The list according to para 1 shall be updated annually.
p.(None):
p.(None): Art. 180. Should new data of a medicinal product, which has a marketing
p.(None): authorisation/registration certificate issued, become available, the BDA shall reconsider and if necessary change the
p.(None): classification in accordance with the requirements of Art. 173 and the criteria laid down in the regulation according
p.(None): to Art. 178.
p.(None):
p.(None):
...

p.(None): under Art. 56a, Para. 1. P. 1 by:
p.(None): 1.The Committee on Medicinal Products for human use – where at least on of the marketing authorisations
p.(None): for medicinal products, containing the relevant active substance has been provided in compliance with the centralised
p.(None): procedure, provided in Title II, Chapter 1 of Regulation (EC) N 726/2004 of the European Parliament and of the Council,
p.(None): or
p.(None): 2. the coordination group under Art. 77, Para. 2 – for cases, different from the ones, indicated in p. 1.
p.(None): (4) The list with the reference dates of the EU of the medicinal products under Art. 194l and the harmonised frequency
p.(None): for submitting their periodic updated vigilance reports shall be published on the European internet portal under Art.
p.(None): 68, Para. 1, p. 4.
p.(None): (5) The marketing authorisation holder after publication of the data under Para. 4 shall produce to BDA an
p.(None): application for change of the marketing authorisation of the relevant medicinal product. Each change of the
p.(None): dates of submitting the frequency of submission of the periodic updated safety reports, defined in the marketing
p.(None): authorisation, shall come into force 6 months after the date of their publication.
p.(None):
p.(None):
p.(None): Art. 194o. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall assess the periodic updated safety reports
p.(None): fpr the medicinal products, in order to define whether there are new risks or change of the established risks or change
p.(None): of the correlation benefit/risk.
p.(None): (2) The BDA shall carry out single assessment of the periodic updated safety reports of the medicinal products for
p.(None): which the Republic of Bulgaria has fulfilled the functions of a reference state in the meaning of Art. 76 and has been
p.(None): defined by the coordination group under art. 77, Para. 2.
p.(None): (3) A reporter from the Republic of Bulgaria shall participate in the single assessment of the periodic updated safety
p.(None): reports of medicinal products, where one of the products has been permitted for use under Regulation (EC) N 726/2004 of
p.(None): the European Parliament and of the Council and has been defined as such by the committee under Art. 56a, Para. 1, p. 1.
p.(None):
p.(None): Art. 194p. (new – SG, 102/2012, in force from 21.12.2012) (1) In the cases under Art. 194o, Para. 2 and 3, BDA or the
p.(None): reporter from the Republic of Bulgaria within the term of 60 days from the date of receiving the periodic updated
p.(None): safety report shall draw up n assessment report and shall submit it electronically to the European Medicines Agency and
p.(None): to the regulatory bodies of the Member States. The marketing authorisation holder shall receive the assessment report
p.(None): from the European Medicines Agency.
p.(None): (2) Within the term of up to 30 days from receiving the report under Para. 1, the marketing
p.(None): authorisation holder or the regulatory bodies of the Member States may produce their comments to the European medicines
p.(None): Agency and to BDA.
p.(None): (3) Within the term of up to 15 days from the date of receiving the comments under Para. 2, BDA shall update the
p.(None): assessment report y taking into consideration all produced objections and shall submit it to the committee under
p.(None): Art. 56a, Para. 1, p. 1 for approval and recommendation.
p.(None): (4) The European Medicines agency shall include the adopted assessment report and the recommendation of the committee
p.(None): under Art. 56a, Para. 1, p. 1 to the register under Art. 194h, Para. 3 and shall submit it to the marketing
p.(None): authorisation holder.
p.(None):
p.(None):
p.(None): Art. 194q. (new – SG, 102/2012, in force from 21.12.2012). Where the Republic of Bulgaria is not a
p.(None): reporter in the procedure under Art. 194o, Para. 2, BDA may produce comments within the term under Art. 194p, Para. 2
p.(None): to the European Medicines Agency and to the regulatory body of the Member State, which has drawn up the report.
p.(None):
p.(None):
p.(None): Art. 194r. (new – SG, 102/2012, in force from 21.12.2012). (1) In case of a single assessment of
p.(None): periodic updated safety reports of medicinal product under Art. 194l and where neither of the marketing authorisations
p.(None): of these products has been issued under Regulation (EC) 726/2004 of the European Parliament and of the Council, the
p.(None): coordination group under Art. 77, Para. 2 within the term of up to 30 days from the date of receiving the
p.(None): recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping, change, termination
p.(None): of the relevant marketing authorisations, including a schedule for implementation of the opinion.
p.(None): (2) Where the represented Member States in the coordination group under Art. 77, Para. 2 reach agreement about the
p.(None): action to be undertaken, BDA shall fulfill the adopted decision.
p.(None): (3) Where the opinion under Para. 1 is for interruption or termination of the marketing authorisation, the BDA
p.(None): executive director shall issue the order.
p.(None): (4) Where the opinion under Para. 1 recommends changes in the issued marketing authorisation, the marketing
p.(None): authorisation holder shall submit to BDA an application for change, including an updated short characteristics of the
p.(None): product and a leaflet, within the frames of the defined implementation schedule.
p.(None): (5) Where no agreement can be reached in the coordination group under Art. 77, Para. 2, the position of the majority
p.(None): Member States shall be produced to the European Commission, which shall adopt a decision for change, interruption or
p.(None): termination of the marketing authorisation, issued by the relevant regulatory bodies of the Member States.
p.(None): (6) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 5.
p.(None):
p.(None):
p.(None): Art. 194s. (new – SG, 102/2012, in force from 21.12.2012).(1) In case of single assessment of periodic
p.(None): updated safety reports of medicinal products under Art. 194l and where
p.(None):
p.(None): at least one of the marketing authorisations has been issued under Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council, the Committee of the medicinal products for human use within the term of 30 days from
p.(None): receiving the recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping,
p.(None): changing, termination or interruption of the validity of the relevant marketing authorisations, including a schedule
p.(None): for the opinion implementation.
p.(None): (2) Where the opinion under Para. 1 expresses a position for undertaking regulatory actions in relation to the
p.(None): marketing authorisations, the European Commission shall:
p.(None): 1. adopt as decision for change, termination or interruption of the marketing authorisations,
p.(None): issue under Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt decision with a recommendation for change, termination or interruption of the marketing authorisations, issued
p.(None): by the relevant Member States regulatory bodies.
p.(None): (3) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 2, p. 2.
p.(None):
p.(None): Section IV.
p.(None): Urgent Procedure at European Union Level. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194t. (new – SG, 102/2012, in force from 21.12.2012) (1) Urgent procedure at the level of the European Union may
...

p.(None): the BDA.
p.(None):
p.(None):
p.(None): Art. 196. (1) Manufacturer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued manufacturing authorisation for.
p.(None): (2) Importer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued import authorisation for.
p.(None):
p.(None):
p.(None): Art. 197. The persons according to Art. 195 shall dispose of:
p.(None): 1. suitable premises, equipment and outfits, and transport vehicles ensuring correct storage, distribution,
p.(None): and transportation of the medicinal products in compliance with the requirements of the Good Distribution
p.(None): Practice;
p.(None): 2. personnel and responsible master-pharmacist with at least two years length of service in his speciality and whose
p.(None): obligations shall be laid down in the regulation according to Art. 198.
p.(None):
p.(None):
p.(None): Art. 198. (amend. – SG, 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.(None): Distribution Practice of medicinal products and of active substances shall be adopted by an ordinance of the Minister
p.(None): of Health and by directives, adopted by the European Commission.
p.(None):
p.(None):
p.(None): Art. 199. (1) The persons according to Art. 195, para 2, shall submit to the BDA:
p.(None): 1. application containing name, place of business and address of management of the trader; address and description of
p.(None): the premises and equipment for the storage of the medicinal products;
p.(None): 2. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification
p.(None):
p.(None): code of the trader of cooperation from the Trade Register and for the companies, registered in a EU Member State or
p.(None): a state – party on the EEA Agreement – a document for updated registration according to the national
p.(None): legislation, issued by a competent body of the relevant state;
p.(None): 3. name, certificate of clean court record, diploma for higher education and length of service for the responsible
p.(None): master - pharmacist according to Art. 197, point 2, and a copy of his/her employment contract;
p.(None): 4. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 5. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 6. document certifying the legal grounds for the use of the premises;
p.(None): 7. (amend., - SG 98/10, in force from 01.01.2011) conclusion of the Regional Health Inspectorates after inspection on
p.(None): the spot evidencing that the health requirements in the whole sale premises according to the regulation according to
p.(None): Art. 198.
p.(None): 8. document for paid fee as laid down in the tariff Art. 21, para 2.
p.(None): (2) The persons according to Art. 195, para 1, shall submit to the BDA an application accompanied by the following
p.(None): documents:
p.(None): 1. copy of the wholesale authorisation issued by a regulatory body of a Member State;
p.(None): 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.(None): 3. address of the premises for the storage of the medicinal products on the territory of the Member State.
p.(None): (3) In case of wholesale of narcotic substances, as well as pharmaceutical forms containing such
p.(None): substances, the requirements of the Control on Drugs and Precursors Act shall also be applied.
...

p.(None): perform the following activities : storage and selling without doctor’s prescription permitted for use in the Republic
p.(None): of Bulgaria medicinal products, medical items, diet food for special medical purposes and food for babies and
p.(None): transitional food, as well as food supplements, cosmetic and sanitary-hygienic articles.
p.(None):
p.(None):
p.(None): Art. 226. (1) Pharmacies for selling medicinal products to citizens can be opened on the territory of healthcare
p.(None): establishments for outpatient care.
p.(None): (2) Pharmacies for selling medicinal products to citizens cannot be opened on the territory of healthcare
p.(None): establishments to Art. 21, para 2 of the Health Act, therapeutic establishments for hospital care, and
p.(None): healthcare establishments according to Art. 10 of the Medical Establishments Act.
p.(None):
p.(None):
p.(None): Art. 227. (1) (Prev. text of Art. 227 – SG 102/09, in force from 22.12.2009) The requirements relating
p.(None): to the location and to the premises of the pharmacy shall be laid down in the regulation according to Art. 219, para 2.
p.(None): (2) (New – SG 102/09, in force from 22.12.2009, amend. – SG, 60/2011, in force from
p.(None): 5. 8. 2011) The requirements to the structure and the premises of pharmacies as per Art. 228, para. 5 shall be set
p.(None): forth in an ordinance mentioned in para. 1.
p.(None):
p.(None):
p.(None): Art. 228. (Amen. - SG 71/2008, in force from 26.07.2008) (1) (amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Authorisation for retail trade with medicinal product shall be issued by the executive director of BDA, on the grounds
p.(None): of a formal application accompanied with the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 222, Para. 1;
p.(None): 2. labour contract or a contract for managing a pharmacy, signed with a Master of Pharmacy or assistant
p.(None): Pharmacist;
p.(None): 3. copy of the act for establishing the persons under Art. 222, para 4;
p.(None): 4. documents, evidencing that the requirements of Art. 224 have been observed;
p.(None): 5. certificate of court record of the Master of Pharmacy, respectively of the assistant pharmacist indicated as manager
p.(None): of the pharmacy;
p.(None): 6. medical certificate of the Master of Pharmacy or the assistant pharmacist, manager of the pharmacy;
p.(None): 7. (suppl. – SG, 60/2011, in force from 5. 8. 2011; revoked - SG 48/15)
p.(None): 7a. (new - SG, 60/2011, in force from 5. 8. 2011) hygiene conclusion, issued by the relevant RHI;
p.(None): 8. document for paid state fee in the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (2) (New - SG, 60/2011, in force from 5. 8. 2011) While issuing an authorisation for retail trade with medicinal
p.(None): products a check up shall be performed if the produced diploma of the Master Pharmacist /Assistant Pharmacist has been
p.(None): issued by the relevant competent institution.
p.(None): (3) (Former Para. 2, amend. - SG, 60/2011, in force from 5. 8. 2011) The pharmacies of
p.(None):
p.(None): the therapeutic establishments according to Art. 222, para 4 and 6 shall be opened and closed according to the request
p.(None): of the person representing the healthcare establishment;
...

p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
p.(None): Art. 239. (1) (amend. – SG, 60/2011, in force from 5. 8. 2011) Drugstores shall be opened after
p.(None): registration at the relevant RHI.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 238,
p.(None):
p.(None): para 2, shall submit to the RHI a registration application accompanied by the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
p.(None): In the cases, where it is found that the requirements of the Ordinance under Art. 243 have not been observed,
p.(None): within 7 day term after the inspection the RHI shall give instructions and shall determine term for removing them.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011). Within 14 day term from receiving the application and the
p.(None): documents under Para. 2, the director of RHI shall notify in writing the persons for finding irregularities
p.(None): in them and shall determine a term for their removal.
...

p.(None): (3) Investment projects for construction of new and/or refurbishment of existing sites associated with the manufacture
p.(None): of medicinal products in compliance with the rules for Good Manufacturing Practice of medicinal products shall be
p.(None): coordinated with the BDA.
p.(None):
p.(None):
p.(None): Art. 268a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Donations of medicinal products from holders authorisation
p.(None): for use, producers, wholesale and retail traders and from the Bulgarian red cross may be done only after coordination
p.(None): of the donator with the BDA through producing an application according to a form, confirmed by the Minister of Health
p.(None): upon proposal of the executive director of BDA.
p.(None): (2) The donations shall be done while observing the rules for Good donation practice of the World Health Organisation.
p.(None): (3) Where within 10 day term from receiving the application under Para. 1, BDA fails to respond in writing to the
p.(None): donator, it shall be accepted, that there is a silent agreement for the donation.
p.(None): (4) The medical establishments and the Bulgarian red cross shall inform BDA for the received donations of medicinal
p.(None): products within 7 day term from their receiving.
p.(None): (5) At the end of each quarterly, the BDA shall send information to the Ministry of Health about the donations under
p.(None): Para, 4.
p.(None): (6) For a performed donation of a medicinal product upon request of a medical establishment, intended for
p.(None): treatment of a concrete patient in a lifesaving situation, the donator shall inform the BDA within 7 day term from the
p.(None): donation.
p.(None): (7) The donations under Para. 6 shall not exceed the quantity, needed for a single course of treatment.
p.(None):
p.(None):
p.(None): Art. 269. (1) The control according to Art. 267 shall be exercised through inspections and laboratory tests.
p.(None): (2) The inspections and laboratory tests according to Para. 1 shall be conducted:
p.(None): 1. in connection with issuing marketing, manufacture, and import authorisations and certificates under the
p.(None): terms of this Act;
p.(None): 2. in connection with exercising surveillance on the medicinal products market;
p.(None): 3. in case of application on the part of the European Commission, the European Medicines Agency, or on the
p.(None): part of a competent body of another Member State;
p.(None): 4. in case of application on the part of a manufacturer, importer, or marketing authorisation holder
p.(None): outside the cases according to point 1.
p.(None): (3) (amend. – SG, 102/2012, in force from 21.12.2012) The BDA shall conduct inspections:
p.(None): 1. of manufacturers of medicinal products, placed on the territory of the Republic of Bulgaria of a Member
p.(None): State or in third states;
p.(None): 2. of importers and wholesale traders of medicinal products;
p.(None): 3. of the manufacturers, importers and wholesale traders of active substances premises, placed on the territory of the
p.(None): Republic of Bulgaria;
p.(None): 4. of premises of manufacturers or wholesale traders of active substances, placed in third states, as well as of
p.(None): manufacturers or importers of auxiliary substances;
p.(None):
p.(None): 5. of premises of marketing authorisation holders of medicinal products and of intermediaries in the area of
p.(None): medicinal products, registered under Art. 212a;
p.(None): 6. as a part of the certification procedure, which in connection with European Pharmacopoeia monographs.
...

p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
p.(None): 34. "Medical specialists" shall mean medical doctors, doctors in dental medicine, masters of pharmacy,
p.(None): nurses, midwives, medical laboratory assistants, medical auxiliaries and pharmacy assistants.
p.(None): 35. "Medical trade representative" shall mean a person who has passed special training and possessing scientific
p.(None): knowledge for the presentation of accurate and comprehensive information about the medicinal product he is
p.(None): advertising.
p.(None): 35a. (new – SG 1/14, in force from 03.01.2014)”Medical prescription” shall mean a prescription of a
p.(None): medicinal product, issued by a person who exercises a regulated medical profession within the meaning of § 1,
p.(None): item 1 of the Additional Provisions of the Recognition of Professional Qualifications Act and who is legally entitled
p.(None): to do so in the Member State in which the medical prescription is issued.
p.(None): 36. "Multicentre clinical test" shall mean a clinical test, which is conducted according to a single protocol but in
p.(None): more than one site and by more than one researcher. Researcher sites can be situated in the territory of one Member
p.(None): State, more than one Member State, and/or in Member States and third states.
p.(None): 37. "Name of a medicinal product" shall mean the name given to a medicinal product, which can be:
p.(None): a) a freely selected name (trade name);
p.(None): b) (amend. – SG 12/11, in force from 08.02.2011) a common name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation;
p.(None): c) (amend. – SG 12/11, in force from 08.02.2011) scientific name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation.
p.(None): 38. "Scientific literature" shall mean publication(s) of results from scientific research in specialised international
p.(None): scientific editions.
p.(None):
p.(None): 39. "New active substance" shall mean:
p.(None): a) chemical, biological, or radiopharmaceutical substance, which has not been authorised to market in
p.(None): the European Union as a medicinal product;
p.(None): b) isomer, mixture of isomers, complex or derivative or salt of a chemical substance, which has been authorised to
p.(None): market in the European Union as a medicinal product but is different with respect to safety and efficacy from
p.(None): a formerly authorised substance;
...

p.(None): provided by the Act on the Medicines and Pharmacies in the Human Medicine shall perform their activity as
p.(None): provided by their issued authorisations.
p.(None): (2) By this Act comes into force, the filed applications for issuing authorisation for retail
p.(None):
p.(None): trade with medicinal products shall be examined under the terms and conditions, provided by it.
p.(None): (3) Apart from the cases under para 1, the persons, status quo at the time of this Act comes into force, who have
p.(None): received authorisation for opening a pharmacy, shall comply their activity with its requirements within 1 year after
p.(None): its coming into force.
p.(None): (4) The persons under para 3 shall file in the Ministry of Health an application for re- registration, which shall
p.(None): contain:
p.(None): 1. application for issuing authorisation for retail trade with medicinal products by the persons under Art. 222, para
p.(None): 1, according to a form, approved by the Minister of Health;
p.(None): 2. updated certificate for listing into the trade register, correspondingly a document for updated registration of the
p.(None): person under Art. 222, para 1;
p.(None): 3. copy of the issued authorisation for opening a pharmacy, as provided by the Act on the Medicines and Pharmacies in
p.(None): the Human Medicine
p.(None): 4. certified copy of the employment contract or a contract for assignment of management of the head of the pharmacy –
p.(None): in the cases, where such is required;
p.(None): 5. declaration of the persons under Art. 222, para 1, that the conditions have been met for issuing the authorisation
p.(None): for retail trade with medicinal products of the persons under para 2;
p.(None): 6. document for a single paid fee in the amount of BGN 100.
p.(None):
p.(None):
p.(None): § 67. The persons, who have filed by this Act comes into force application for re- registration as
p.(None): provided by the repealed § 16 of the Transitional and Final Provisions, who will perform their activity as provided by
p.(None): the requirements of this Act, shall file in the Ministry of Health within 3 months after its coming into force, the
p.(None): following documents:
p.(None): 1. application, according to a form, approved by the Minister of Health;
p.(None): 2.updated certificate for listing in the trade register, or a document for updated registration or a
p.(None): certified copy of a similar document according to the national legislation of an EU Member State or the legislation of
p.(None): another Member- State – party of the EEA, under Art. 222, para 1;
p.(None): 3. employment contract or a contract for management of the pharmacy, signed with a Master of Pharmacy of Assistant
p.(None): Pharmacist.
p.(None):
p.(None):
p.(None): § 68. (1) Master of Pharmacy of Assistant Pharmacist, who has received authorisation for opening a pharmacy, as
p.(None): provided by the repealed § 16 of the Transitional and Final Provisions may transfer the issued authorisation
p.(None): to a person under Art. 222, para 1.
p.(None): (2) For performing the transfer, the persons under para 1 shall file in the Ministry of Health an application, which
p.(None): shall contain:
p.(None): 1. an application for issuing authorisation for retail trade with medicinal products by the persons under Art. 222,
p.(None): para 1, according to a form, approved by the Minister of Health;
p.(None): 2. an updated certificate for listing in the trade register, or a document for updated registration of
p.(None): the persons under Art. 22, para 1;
...

Social / Mothers

Searching for indicator mothers:

(return to top)
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
p.(None): (2) The committees according to para 1 shall include at least two persons of non-medical education, representatives of
...

Social / Property Ownership

Searching for indicator property:

(return to top)
p.(None): keep and maintain public registers for the issued by them authorisations for registration of drug
p.(None): stores.
p.(None): (2) Within 7-day term from the issuance of an authorisation for registration of a drug store, the relevant RHI shall
p.(None): submit information to the Ministry of Health about the issued act.
p.(None): (3) The Ministry of Health shall keep and maintain on its internet site a public national register of the issued
p.(None): authorisations for registration of a drug store.
p.(None):
p.(None): Section III. Financing
p.(None):
p.(None): Art. 20. (1) The activity of the Bulgarian Drug Agency is financed from the budget funds and its own activity.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) Budget funds shall be ensured by a subsidy from the state budget
p.(None): through the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 21. (1) The Bulgarian Drug Agency shall be the administrator of the revenues of its own activity, namely:
p.(None): 1. chemico-pharmaceutical examinations;
p.(None): 2. laboratory analyses and tests;
p.(None): 3. assessment of documentation and issue of authorisations, certificates, and other documents set forth in
p.(None): this Act;
p.(None): 4. evaluation by the renewal, variation and cease of marketing authorisation approval and certificate for registration
p.(None): of medicinal product;
p.(None): 5. maintenance of marketing authorisations of medicinal products;
p.(None): 6. fines and property sanctions imposed by penal ordinances issued for infringements of this Act;
p.(None): 7. consulting, publishing, and research activities in the field of the drug sector;
p.(None): 8. coordination of investment projects for the construction of new and/or refurbishing of existing sites relating to
p.(None): the manufacture of medicinal products;
p.(None): 9. conduct of inspections in connection with assessment of compliance of the manufacturing conditions with
p.(None): the requirements of Good Manufacturing Practice;
p.(None): 10 other sources.
p.(None): (2) During the execution of the activities according to para 1, points 1 – 5, points 7 – 9 the Bulgarian Drug Agency
p.(None): shall collect fees to the amounts as defined in a tariff adopted by the
p.(None):
p.(None): Council of Ministers.
p.(None): (3) (New - SG 71/2008, in force from 12.08.2008) The tariff under para 2 shall have determined lower and various in
p.(None): amount fees for realisation of the procedures on permission for usage, production and import of medicinal products for
p.(None): small and medium enterprises in the pharmaceutical sector in the meaning of the Small- and Medium-Size Enterprises Act.
p.(None):
p.(None):
p.(None): Art. 22. (1) The funds according to Art. 21 shall be spent for:
p.(None): 1. control activity of the BDA;
p.(None): 2. Payment of the activities according to Art. 21, Para. 1, p. 1 and 2, when The BDA is assigned their execution of
p.(None): another persons by contract;
p.(None): 3. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 4. establishment and maintenance and update of the registers according to Art. 19, Para.
p.(None): 1;
p.(None): 5. maintenance of systems for electronic data exchange with the regulatory bodies of
...

p.(None): (2) (suppl. – SG 18/14) The documents according to para 1, item 18 and 18a, relating to the Member States, and point
p.(None): 19, respectively, shall only be submitted in the procedures according to section VII.
p.(None): (3) To radionuclide generators, the following documents shall be added to the data according to para 1:
p.(None): 1. description of the system together with a detailed description of its components, which may affect the composition
p.(None): or quality of the daughter radionuclides;
p.(None): 2. qualitative and quantitative particulars of the eluate or the sublimate.
p.(None): (4) The documents and data from pharmaceutical tests, preclinical and clinical trials shall be accompanied by
p.(None): summarised reports prepared by experts with the required technical and professional qualification. To the reports a
p.(None): curricula vitae report of the experts shall be applied.
p.(None): (5) The dossier of the medicinal product shall be submitted in the Bulgarian and/or English language.
p.(None): (6) (new – SG, 102/2012, in force from 21.12.2012) The risk management system under Para. 1, p. 13 should be
p.(None): proportional to the identified and to the potential risks of the medicinal product and to the need of collecting safety
p.(None): data of post-marketing researches.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The holder of the authorisation for use shall update the data of the
p.(None): file under Para. 1. For each change in the file the provisions of Chapter Three Section VI shall apply, where
p.(None): applicable.
p.(None):
p.(None):
p.(None): Art. 28. (1) The person according to Art. 26, para 1, insofar as he does not infringe industrial and commercial
p.(None): property rights, shall not submit to the BDA the data according to Art.
p.(None):
p.(None): 27, para 1, point 10, letters "b" and "c" provided that he can prove that the medicinal product indicated in the
p.(None): application is generic of a reference medicinal product, which is or has been authorised to market for not less than 8
p.(None): years in a Member State or in a state member of the European Economic Area.
p.(None): (2) The marketing authorisation holder of a generic product according to para 1 may not place it to market until 10
p.(None): years from the initial marketing authorisation of the reference medicinal product have elapsed.
p.(None): (3) Under observance of the conditions of para 1 and 2, the person according to Art. 26, para 1, may submit to the BDA
p.(None): an application for marketing authorisation of a medicinal product, which is generic of a reference medicinal product,
p.(None): even where the reference product has never had marketing authorisation on the territory of the Republic of Bulgaria.
p.(None): (4) In the cases according to para 3, the person according to Art. 26, para 1, shall indicate in the
p.(None): application according to Art. 27, para 1, the Member State where the reference product is or has been authorised to
p.(None): market.
p.(None): (5) In the cases according to para 3, the BDA shall request from the regulatory authority of the Member State indicated
p.(None): in the application according to Art. 27, para 1, a confirmation of the information according to para 4, the qualitative
p.(None): and quantitative composition of the reference product and, if necessary, additional documentation.
p.(None): (6) At the request of a regulatory authority of a Member State where the application for a medicinal product generic to
...

p.(None): supplemented. All these authorisations shall be considered belonging to a general marketing authorisation of the
p.(None): medicinal product for the purposes of application of this Article.
p.(None):
p.(None):
p.(None): Art. 29. (1) The person according to Art. 26, para 1, shall submit to the BDA the results of the required preclinical
p.(None): and/or clinical trials in the cases where the medicinal product indicated in the application:
p.(None): 1. cannot be defined as generic or
p.(None): 2. the bioavailability tests do not prove bioequivalence, or
p.(None): 3. there is a change in the active substance(s), therapeutic indications, pharmaceutical form, and/or posology compared
p.(None): with the reference medicinal product, or
p.(None): 4. is offered in dosage units, which are different compared with the reference medicinal product.
p.(None): (2) Where a biological medicinal product indicated in the application as similar to a reference biological
p.(None): medicinal product does not comply with the conditions to be determined as
p.(None):
p.(None): a generic medicinal product due to different method of manufacture or different starting materials compared with the
p.(None): reference product, or for other reasons, the applicant shall submit to the BDA the results of the required preclinical
p.(None): and/or clinical trials associated with these conditions.
p.(None): (3) In the cases according to para 1 and 2 the documentation as laid down in the regulation according
p.(None): to Art. 42 shall also be submitted.
p.(None):
p.(None):
p.(None): Art. 30. (1) The person according to Art. 26, para 1, insofar as he does not infringe the industrial and commercial
p.(None): property, shall not submit to the BDA the data according to Art. 27, para 1, point 10, letters "b" and "c" provided
p.(None): that he can prove that the conditions laid down in the regulation according to Art. 42 to the effect that the
p.(None): active substance included in the composition of the medicinal product applied for marketing authorisation has a
p.(None): well-established use in the medical practice and possesses acknowledged efficacy and acceptable safety level. In these
p.(None): cases, the results from the tests and tests may be replaced by the relevant scientific publications.
p.(None): (2) The person according to para 1 shall submit the results from the required preclinical and clinical trials in
p.(None): case that the medicinal product containing active substances with well- established use, which have not been
p.(None): used for therapeutic use in the proposed combination. In this case, the documentation relating to each active substance
p.(None): shall not be submitted.
p.(None): (3) Where an active substance within the meaning of para 1 has a proven new therapeutic indication on the
p.(None): basis of significant preclinical or clinical data associated with the new indication, the next applicant may not refer
p.(None): to the data for the new indication of the active substance more than once in a year.
p.(None):
p.(None):
p.(None): Art. 31. In case, when medicinal product containing active substances used in the composition of
p.(None): authorised medicinal products but which are not used in the proposed combination for therapeutic purposes,
...

p.(None): of Regulation N 726/2004 (EC) of the European Parliament and of the Council.
p.(None):
p.(None):
p.(None): Art. 89. (1) A clinical test in human subjects shall be conducted with medicinal products, which are manufactured,
p.(None): maintained, and stored in compliance with the rules for Good Manufacturing Practice for medicinal products
p.(None): under development and research.
p.(None): (2) The rules for Good Manufacturing Practice for medicinal products under development and research
p.(None): shall be laid down in the regulation according to Art. 152.
p.(None): (3) A medicinal product can be proposed for a clinical test where pharmacological and toxicological studies have
p.(None): been conducted in accordance with the requirements for Good Laboratory Practice.
p.(None):
p.(None):
p.(None): Art. 90. The clinical test can be started and conducted provided that:
p.(None): 1. the anticipated therapeutic benefits for the study subjects, for current and future patients and the
p.(None): benefits for the healthcare justify the foreseen risks;
p.(None): 2. the physical and mental immunity of the study subjects, their right of immunity of their private life and the
p.(None): right of personal data protection have been guaranteed pursuant to the Protection of Personal Data Act;
p.(None): 3. insurance or indemnity for covering researcher or contracting authority liability has been provided.
p.(None):
p.(None):
p.(None): Art. 91. The contracting authority and the principal researcher shall make insurance covering their liability
p.(None): for property or non-property damages to the study subjects caused in or on the occasion of the conduct of the clinical
p.(None): test.
p.(None):
p.(None):
p.(None): Art. 92. (1) The contracting authority shall be responsible in case of injury of the health or death caused by or in
p.(None): the occasion of the conduct of the clinical test where the clinical test has been conducted in compliance with the
p.(None): requirements and procedures of the study protocol as approved by the ethics committee.
p.(None): (2) The principal researcher shall be responsible in case of injury of the health or death caused by or in the occasion
p.(None): of the conduct of the clinical test where the clinical test has not
p.(None):
p.(None): been conducted in compliance with the requirements and procedures of the study protocol as approved by the ethics
p.(None): committee.
p.(None):
p.(None):
p.(None): Art. 93. (1) Contracting authority of a clinical test shall be a person established on the territory of a Member State.
p.(None): (2) Contracting authority and researcher can be the same person.
p.(None):
p.(None):
p.(None): Art. 94. The contracting authority shall gratuitously provide the study medicinal product(s) and any device
p.(None): required for the administration thereof.
p.(None):
p.(None):
p.(None): Art. 95. (1) The contracting authority shall develop the labelling of the study medicinal product in compliance with
p.(None): the rules for Good Manufacturing Practice for medicinal products under development and research.
...

p.(None): which has received an authorisation for retail trade with medicinal products under terms and conditions,
p.(None): determined by the Ordinance under Art. 219, Para. 2.
p.(None): (6) (Repealed., former para 4, amen. - SG 71/2008, in force from26.07.2008, former Para. 5, amend. – SG, 60/2011,
p.(None): in force from 5. 8. 2011) Pharmacies of therapeutic establishments for outpatient care at the Ministry of
p.(None): Defence and Ministry of Interior can be managed from assistant pharmacist after proposal by the corresponding
p.(None): administration and after issued approval from the executive director of BDA.
p.(None):
p.(None):
p.(None): Art. 223. (1) Master - pharmacist and assistant pharmacist can be manager of only one pharmacy and shall obligatorily
p.(None): work in it.
p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011) Master of pharmacy or assistant pharmacist who is the manager of a
p.(None): pharmacy cannot be hired to work upon agreement with sole trader or trade company having as its objectives manufacture,
p.(None): import, wholesale or retail trade in medicinal products.
p.(None): (3) The person, envisaged in Para 1, who have received authorisation to retail trade with medicinal products cannot be
p.(None): an owner or participate in trade companies that have as their objectives manufacture, import, or wholesale trade in
p.(None): medicinal products including companies of related persons within the meaning of the Commerce Act.
p.(None):
p.(None):
p.(None): Art. 224. The manager of a pharmacy must:
p.(None): 1. be a Master in Pharmacy, respectively assistant pharmacist in the cases stipulated by the law;
p.(None): 2. not be deprived of the right to practice the profession;
p.(None): 3. not to be convicted for crimes associated with practicing his profession, for crimes against property and economy,
p.(None): or for intentional crimes against personality;
p.(None): 4. have at least one year practice like the person obtaining a master in pharmacy.
p.(None):
p.(None):
p.(None): Art. 225. (1). (Amen. - SG 71/2008, in force from 26.07.2008) In settlement on the territory, which does
p.(None): not have another pharmacy, right for retail trade with medicinal products, shall have a person under Art. 222, para 1,
p.(None): who has signed an employment contract or contract for managing of the pharmacy with an Assistant Pharmacist or Master
p.(None): of Pharmacy with less than a year of work experience.
p.(None): (2) The assistant pharmacist who has authorisation for retail trade with medicinal products according to
p.(None): para 1 is the manager of the pharmacy and he/she shall obligatory work in it.
p.(None):
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011) Assistant – pharmacist – manager of the pharmacy under Para. 1 may
p.(None): perform the following activities : storage and selling without doctor’s prescription permitted for use in the Republic
p.(None): of Bulgaria medicinal products, medical items, diet food for special medical purposes and food for babies and
p.(None): transitional food, as well as food supplements, cosmetic and sanitary-hygienic articles.
p.(None):
p.(None):
p.(None): Art. 226. (1) Pharmacies for selling medicinal products to citizens can be opened on the territory of healthcare
p.(None): establishments for outpatient care.
p.(None): (2) Pharmacies for selling medicinal products to citizens cannot be opened on the territory of healthcare
p.(None): establishments to Art. 21, para 2 of the Health Act, therapeutic establishments for hospital care, and
p.(None): healthcare establishments according to Art. 10 of the Medical Establishments Act.
p.(None):
p.(None):
...

p.(None): leave for breeding of a little child, as per Labour Code, the pharmacy can operate under the management of another
p.(None): master of pharmacy, respectively another assistant pharmacist, in the cases to Art. 225 complying with the requirements
p.(None): of Art. 224 for not more than two years. In all these cases a permission of the executive director of BDA shall be
p.(None): issued.
p.(None): (3) The permission according to 2 shall be issued within 30 days.
p.(None):
p.(None):
p.(None): Art. 237. Upon termination of the activity of the person who received authorisation to retail trade with medicinal
p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
p.(None): Art. 239. (1) (amend. – SG, 60/2011, in force from 5. 8. 2011) Drugstores shall be opened after
p.(None): registration at the relevant RHI.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 238,
p.(None):
p.(None): para 2, shall submit to the RHI a registration application accompanied by the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
...

p.(None): including information about the groups, which the advertising is intended for, about the method of its realisation, as
p.(None): well as the starting date of the advertising campaign;
p.(None): 3. guarantee the training of the medical trade representatives;
p.(None): 4. accurately and timely fulfil the instructions of the persons responsible for the control of advertising.
p.(None): (3) The medical trade representatives must report to the scientific units according to para 1 any information about the
p.(None): use of the advertised medicinal products, particularly with respect of the information of adverse drug reactions
p.(None): communicated to them by the medical specialists.
p.(None):
p.(None):
p.(None): Art. 245a. (New – SG. 71/2008, in force from 12. 08. 2008) Advertisement shall be admitted only of
p.(None): medicinal products, for which an authorisation has been issued under this Act.
p.(None):
p.(None):
p.(None): Art. 246. (1) The content of the advertising must comply with the data of the approved during the marketing
p.(None): authorisation procedure summary of product characteristics and only present the indications approved therein.
p.(None): (2) Advertising of a medicinal product must only bear on its correct use by objectively presenting the therapeutic
p.(None): indications of the medicinal product without exaggerating its therapeutic, prophylactic, and diagnostic
p.(None): capacities.
p.(None): (3) The advertising must not contain misleading information.
p.(None):
p.(None): (4) (New – SG. 71/2008, in force from 12.08.2008) The advertisement shall not contain proposal and/or promise for a
p.(None): gift and/or another property or non-property benefit.
p.(None): (5) (New – SG. 71/2008, in force from 12.08.2008) A medical specialist or a person, representing himself/herself as
p.(None): a medical specialist shall not perform direct or indirect advertisement of medicinal products in the printed
p.(None): and/or electronic media, as well as in internet.
p.(None):
p.(None):
p.(None): Art. 247. Advertising to the population shall only be allowed for medicinal products dispensed without
p.(None): medical prescription.
p.(None):
p.(None):
p.(None): Art. 248. Besides the cases according to Art. 247, advertising campaigns carried out by marketing authorisation
p.(None): holders in connection with vaccination shall be permitted provided observation of the requirements of Art. 251,
p.(None): and under terms and procedure, provided for in the Ordinance under Art. 249.
p.(None):
p.(None):
p.(None): Art. 248a. (New – SG. 71/2008, in force from 12.08.2008) Advertising in internet shall be prohibited of medicinal
p.(None): products, which are prescribed by doctor’s prescription, with the e exception of advertisement campaigns of
p.(None): vaccination, performed as provided by Art. 248, and approved by the competent authorities.
p.(None):
p.(None):
p.(None): Art. 249. The requirements to the advertising of medicinal products shall be paid down in a regulation of the Minister
p.(None): of Health.
p.(None):
p.(None):
p.(None): Art. 250. Application for authorisation of advertising of medicinal product shall be submitted by the
p.(None): marketing authorisation holder of the medicinal product or a duly empowered person.
p.(None):
p.(None):
p.(None): Art. 251. (1) For advertising authorisation the person according to Art. 250 shall submit to the BDA a formal
p.(None): application as approved by the executive director of the agency accompanied by:
p.(None): 1. design of the advertising;
...

p.(None): (2) Whoever breaks the primary/secondary packaging or sells/provides medicinal products with broken
p.(None): primary/secondary packaging shall be penalised with a fine from BGN 750 to BGN 1500 and in case of a repeated
p.(None): infringement with a fine from BGN 1,500 to BGN 3,000.
p.(None):
p.(None):
p.(None): Art. 284. (1) Whoever manufactures, imports, or conducts wholesale with medicinal products, or sells without
p.(None): respective authorisation or in infringement of an issued authorisation shall be penalised with a fine from BGN 50,000.
p.(None): (2) amend. – SG, 102/2012, in force from 02.01.2013) Whoever manufactures, imports, or conducts wholesale with
p.(None): medicinal products, or sells without respective authorisation or in infringement, or sell, storage or provides
p.(None): medicinal products, which of uncertain origin, shall be penalised with a fine from BGN 25,000 to BGN 50,000.
p.(None): (3) In the cases according to Para. 1 the bodies of the state control shall stop the operation of the
p.(None): site by an order.
p.(None): (4) The order according to Para. 3 shall be subject to appeal under the terms of the Administrative Procedure Code;
p.(None): however, the appeal shall not stop its execution.
p.(None):
p.(None):
p.(None): Art. 284a (new – SG, 102/2012, in force from 02.01.2013) Anyone, who manufactures, imports, exports, keeps, sells or
p.(None): provides false medicinal products, as well as intermediates in selling and buying falsified medicinal products, shall
p.(None): be punished by a fine of BGN 25 000 to BGN 50 000.
p.(None):
p.(None):
p.(None): Art. 284b (new – SG, 102/2012, in force from 02.01.2013) Any marketing authorisation holder, who fails to fulfill
p.(None): his/her obligation under Art. 160, shall be punished by a property sanctions of BGN 5000 to 10 000 and in a
p.(None): repeated violation – by a property sanction of BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 284c (new – SG, 102/2012, in force from 02.01.2013) Any wholesale authorisation holder of medicinal products, who
p.(None): fails to fulfill his/her obligation under Art. 207 shall be punished by a property sanction of BGN 2000 to 5000 and in
p.(None): a repeated deed of the same violation 0 by
p.(None):
p.(None): a property sanction of BGN 5000 to 10000.
p.(None):
p.(None):
p.(None): Art. 285. (1) Whoever trades in medicinal products without certificate of batch release shall be penalised with a
p.(None): fine from BGN 5,000 to BGN 10,000 and in case of repeated perpetration of the same infringement – with a
p.(None): fine from BGN 10,000 to BGN 20,000.
p.(None): (2) (Amend. – SG, 60/2011, in force from 5. 8. 2011) A wholesaler who supplies drugstores with medicinal
p.(None): products upon doctor's prescription, outside the lists approved by the Minister of Health shall be penalised with a
p.(None): property sanction from BGN 2500 to 5000 and in case of repeated infringement with a fine from BGN 5,000 to BGN 10,000.
p.(None): (3) A qualified person who has permitted sale of batches of medicinal products without certificate of batch release of
p.(None): any separate batch shall be penalised with a fine from BGN 2,500 to BGN 5,000.
p.(None):
p.(None):
p.(None): Art. 285a. (New – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012) Holder of an authorisation for use, who
p.(None): fails to notify the Minister of health for termination of the sales under Art. 264 shall be punished by a property
p.(None): sanction of BGN 25 000 to 50 000.
p.(None):
p.(None):
p.(None): Art. 285b. (new – SG, 102/2012, in force from 21.12.2012) Anyone, who manufactures, imports, exports, sells or keeps
p.(None): active substances in violation of this act, shall be punished by a fine BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 285c. (new – SG 18/14) A holder of a permit for wholesale of medicinal products failing to notify BDA of carrying
p.(None): out export of medicinal products under Art. 217a, par. 4 shall be punished with a fine, respectively with a proprietary
p.(None): sanction from BGN50 000 to BGN100 000, and in case of repeated the same violation – from BGN100 000 to BGN200 000.
p.(None):
p.(None):
p.(None): Art. 286. (1) In case of clinical trials conducted in infringement of this Act, provided no crime has been committed,
p.(None): the guilty persons shall be penalised with a fine from BGN 5,000 to BGN 10000 and in case of repeated permission or
p.(None): commitment of the same infringement – with a fine from BGN 10000 to BGN 20000.
p.(None): (2) Medial specialists who have permitted or committed infringements according to para 1 can be imposed the penalty of
p.(None): "deprived of the right to exercise the profession" for a term from 6 months to two years.
p.(None): (3) The measure according to para 2 shall be imposed by the Minister of Health according to a proposal by
p.(None): the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 287. (1) (Supl.. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Whoever conducts retail trade in medicinal products without having respective authorisation/certificate, or
p.(None): works in violation of his/her issued authorisation/certificate, shall be penalised by a fine from BGN 5,000 to BGN
p.(None): 10,000.
...

p.(None): registration of the drug store will be deprived of.
p.(None): (4) In the cases according to para 1 and 2, the bodies of the state control on the medicinal products
p.(None): shall stop the operation of the site by an order.
p.(None): (5) The order according to para 4 shall be subject to appeal under the terms of the Administrative Procedure Code;
p.(None): however, the appeal shall not stop its execution.
p.(None): (6) (Repealed - SG 71/2008 in force from 12.08.2008).
p.(None):
p.(None):
p.(None): Art. 287a. (New - SG 71/2008 in force from 12.08.2008). (1) Medical specialist, who works with persons,
p.(None): performing retail trade with medicinal products, without having authorisation/certificate for this, shall
p.(None): be punished by a fine of BGN 2500 to 5000
p.(None): (2) The punishment under para 1 shall be imposed on a person under para 1, who works in a pharmacy or a drugstore after
p.(None): termination of the action of the authorisation/certificate.
p.(None): (3)In case of established more than 2 violations under para 1 and 2, the Minister of Health may deprive the medical
p.(None): specialist of the right to exercise his/her profession for the term of up to 2 years.
p.(None):
p.(None):
p.(None): Art. 287b. (new – SG, 102/2012, in force from 02.01.2013) Anyone, who carries out trade with medicinal products on
p.(None): internet in violation of this act and the ordinance under Art. 234, Para. 5 shall be punished by a fine of BGN 5000 to
p.(None): 10 000.
p.(None):
p.(None):
p.(None): Art. 288. (1) A retailer in medicinal products who has permitted an incapable person to exercise activities, pointed
p.(None): out in Art. 219, shall be penalised with a property sanction from BGN 5,000 to BGN 10,000 and in case of repeated
p.(None): perpetration of the infringement the issued retail trade authorisation shall be bereaved.
p.(None): (2) In the cases according to para 1 the bodies of the state control shall stop the operation of the
p.(None): site by an order.
p.(None):
p.(None):
p.(None): Art. 289. (1) (prev. text of Art. 289 – SG 60.12, in force from 07.08.2012) Whoever sells medicinal products on prices
p.(None): different from those formed under the terms of this law shall be penalised with a fine from BGN 5,000 to BGN 10,000 and
p.(None): in case of repeated perpetration of the same infringement – with a fine from BGN 6,000 to BGN 12,000.
p.(None): (2) (new – SG 60.12, in force from 07.08.2012, amend. – SG, 102/2012, in force from 21.12.2012) A marketing
p.(None): authorisation holder who fails to fulfill an obligation set out by the Ordinance under Art. 261a, Para. 5,
p.(None): shall be punishable by property sanction amounting from BGN 5000 to BGN 10 000, and in case of repeated offence – by a
p.(None): property sanction amounting from BGN 10 000 to BGN 20 000.
p.(None): (3) (new - SG, 102/2012, in force from 21.12.2012). The violations under Para. 1 and 2 shall be found out by acts,
p.(None): drawn up by officials, determined by the Council chairperson under Art. 258, Para. 1, and the penal decrees shall be
p.(None): issued by the Council chairperson under Art. 258, Para. 1 or a council member, authorised by him/her.
p.(None):
p.(None): Art. 289a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG, 102/2012, in force from 21.12.2012) whoever
p.(None): works in violation of the confirmed pharmaco-therapeutic guides or performs assessment of the efficiency of the
p.(None): therapy not in the criteria under Art. 259, Para. 1, p. 4, shall be punished by a fine of BGN 1000 to 2000, and in a
p.(None): repeated violation – by a fine of BGN 2000 to 3000.
p.(None): (2) The violations under Para. 1 shall be established by acts, drawn out by officials, determined by the executive
p.(None): director of the Executive agency Medical Audit, and the penal orders shall be issued by the executive director
p.(None): of the Executive agency Medical Audit
p.(None):
p.(None):
p.(None): Art. 290. (1) (Amend. - SG 71/2008 in force from 12.08.2008) Whoever advertises medicinal products, which
p.(None): are not authorised under the terms of this Act, shall be penalised by a fine from BGN 10000 to BGN 20000.
p.(None): (2) (New - SG 71/2008 in force from 12.08.2008) Whoever advertises medicinal products describing and/or directing to
p.(None): properties, related to prophylactics, diagnosis or treatment of human illnesses, shall be penalised by a fine
p.(None): from BGN 10000 to BGN 20000.
p.(None): (3) (Former para 2 - SG 71/2008 in force from 12.08.2008) Whoever advertises medicinal products in
p.(None): violation of this Act shall be punished by a fine from BGN 10 000 to 20 000.
p.(None): (4) (Former para 3, amen. - SG 71/2008 in force from 12.08.2008) The penalties according to para 1-3
p.(None): shall also be imposed on persons who have permitted the emission, publication, and proliferation of the
p.(None): advertisement.
p.(None):
p.(None):
p.(None): Art. 290a. (New - SG 71/2008 in force from 12.08.2008) Any medical specialist or person representing himself/herself
p.(None): for a medical specialist, who performs direct or indirect advertisement of medicinal products in the
p.(None): printed and/or in electronic media, as well as in the internet, shall be punished by a fine from BGN 1000 to 5000, and
p.(None): in a repeated violation – from BGN 3000 to 10 000.
p.(None):
p.(None):
p.(None): Art. 290b. (New – SG, 60/2011, in force from 5. 8. 2011) Whoever performs a donation of medicinal products in violation
p.(None): of Art. 268a, Para. 1 shall be punished by a fine of BGN 1000 to 3000, and in repeated violation – by a fine of BGN
p.(None): 3000 to 5000.
p.(None):
p.(None):
p.(None): Art. 290c. (new – SG, 102/2012, in force from 21.12.2012) Any marketing authorisation holder, who holds
p.(None): non-interventional studies in violation of this act shall be punished by a property sanction of BGN 5000 to
p.(None): 10 000 and in a repeated deed of the same violation – by a property sanction of BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 290d. (new – SG, 102/2012, in force from 21.12.2012) Any marketing authorisation holder, who fails to fulfill the
p.(None): provision of Art. 55a, 56a and 56b shall be punished by a property sanction of BGN 5000 to 10 000 and in a repeated
p.(None): deed of the same violation – by a property sanction of BGN 10000 to 20000.
p.(None):
p.(None):
p.(None): Art. 290e. (new – SG, 102/2012, in force from 21.12.2012) Any marketing authorisation holder, who fails to fulfill the
p.(None): obligations under Art. 190 – 192, 194b, 194c, 194h and 194i shall
p.(None):
p.(None): be punished by a property sanction of BGN 5 000 to 10 000 and in a repeated deed of the same violation 0 by a property
p.(None): sanction of BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 290f. (new – SG, 102/2012, in force from 21.12.2012) Any marketing authorisation holder, who fails to fulfill the
p.(None): obligation under Art. 193 and 194 shall be punished by a property sanction of BGN 2000 to 5000 and in a repeated deed
p.(None): of the same violation – by a property sanction of BGN 5000 to 10 000.
p.(None):
p.(None):
p.(None): Art. 291. (1) (Suppl. SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012 in force from 21.12.2012) Property
p.(None): sanctions shall be imposed in case the infringements according to Art. 281-284a, 285, 285b, Art. 286, Para. 1 and 287b,
p.(None): Art. 289, Para. 1, Art. 289a, Art. 290, 290b, 292 and 294 have been committed by legal persons or sole traders in
p.(None): amount of the property sanction cannot be less than the triple amount of the respective fines and cannot be more than
p.(None): the triple amount of the stipulated maximum amounts of the respective fines.
p.(None): (2) (suppl. – SG 60.12, in force from 07.08.2012) For infringements according to Art. 289, para 1 the property
p.(None): sanction shall be the nine-fold amount of the overdrawn amount provided that it exceeds the maximum amount of
p.(None): the sanction according to para 1.
p.(None): (3) The imposing of a property sanction shall not exclude fining of the guilty officials.
p.(None): (4) The imposing of property sanctions shall not exclude the imposing of the stipulated measures regarding the right of
p.(None): the medical specialists and qualified persons.
p.(None):
p.(None):
p.(None): Art. 292. (1) Whoever shall not execute an order, directions, or instruction of the bodies of the state control, except
p.(None): in the cases pursuant to Art. 270, para 1, issue 2 and para 3 shall be penalised with a fine from BGN 1,500 to BGN
p.(None): 3,000.
p.(None): (2) For failure to execute an order, pursuant Art. 270, para 1, issue 2 and 3, the blamed persons shall be penalised
p.(None): with a fine of from BGN 500 to BGN1000.
p.(None):
p.(None):
p.(None): Art. 293. (1) (amend. – SG, 102/2012, in force from 02.01.2013)In cases according Art. 281, Para. 1-3, Art. 283, Para.
p.(None): 1, as and of non-observance of the condition under which the authorisations to retail trade with medicinal products in
p.(None): a pharmacy, the BDA executive director shall issue an order for the bereavement thereof.
p.(None): (2) In case of non-observance of the conditions under which the
p.(None): authorisations/certificates for registration of a drug store as well as in the cases under 287, Para. 3, the director
p.(None): of the BDA shall issue an order for the bereavement thereof.
p.(None): (3) In case of non-observance of the obligation to notify according to Art. 204, Para. 3, for the termination of the
p.(None): activity on the part of a wholesaler of medicinal products, the executive director of the BDA shall issue an order for
p.(None): the bereavement the issued authorisation.
p.(None): (4) (amend. – SG, 102/2012, in force from 02.01. 2013) In case of non-observance of the obligation to notify according
p.(None): to Art. 235, Para. 3, for the termination of the activity on the part of a holder of an authorisation to retail trade
...

p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
...

p.(None): 243 in compliance with this Act.
p.(None): 2. The Council of Ministers shall adopt the Ordinance under Art. 258, Para. 5 and shall amend the tariff under Art. 21,
p.(None): Para. 2 and the Rules of procedure of the Ministry of Health in compliance with this Act.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 84. This Act shall come into force from the day of its publication in the State Gazette, with the exception of § 65,
p.(None): which shall come into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.(None):
p.(None): (PROM. - SG 38/12, IN FORCE FROM 01.07.2012)
p.(None):
p.(None): § 84. (In force from 18.05.2012) Within one month after the promulgation of this Act in the State Gazette:
p.(None): 1. The Council of Ministers shall adjust the Classified of positions in administration to the provision of this Act;
p.(None): 2. the competent bodies shall adjust the structural acts of the respective administration to the provisions of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 85. (1) The legal relationships with the persons from administrations under the Radio and Television Act, Independent
p.(None): Financial Audit Act, Electronic Communications Act, Financial Supervision Commission Act, Act on Access to and
p.(None): Disclosure of the Documents and Announcing Affiliation of Bulgarian Citizens with the State Security Service and
p.(None): the Intelligence Services of the Bulgarian Popular Army, Act on Seizure in Favour of the State of
p.(None): Property, Acquired through Criminal Activity Act on Prevention and Findings of Conflict of Interests, Code of Social
p.(None): Insurance, Health Insurance Act, Agricultural Producers Assistance Act, Roads Act shall be regulated subject to
p.(None): compliance with the provisions and following the procedure of § 36 of the Transitional and Conclusive Provisions of the
p.(None): Act amending and supplementing the Civil Servants Act (SG 24/06).
p.(None): (2) By the act of appointment of a civil servant:
p.(None): 1. the minimum rank for the occupied position shall be conferred, as determined in the Classified of positions in the
p.(None): administration, unless the servant hold a higher rank;
p.(None): 2. individual monthly salary shall be fixed.
p.(None): (3) Additionally required funds for insurance contributions of the persons under par. 2 shall be provided within the
p.(None): cost of salaries, remunerations and insurance contributions within the budgets of the respective administrators of
p.(None): budget credits.
p.(None): (4) Council of Ministers must make necessary adjustments in the out-of-budget account of State Fund "Agriculture",
p.(None): arising out of this Act.
p.(None): (5) Managing bodies of National Social Insurance Institute and of National Health Insurance Fund must make
p.(None): necessary adjustments in the respective budgets, arising out of this
p.(None):
p.(None): Act.
p.(None): (6) The non-used leaves regulated in the employment agreement shall be kept and shall
p.(None): not be compensated with a financial benefit.
p.(None):
p.(None):
p.(None): § 86. (1) Within one month after entering of this Act into force the individual basic monthly salary of the employee
p.(None): shall be determined in such a way that the salary after the due tax and the obligatory insurance contributions
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Social / Soldier

Searching for indicator armed forces:

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p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
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Searching for indicator army:

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p.(None): 1. The Minister of Health shall amend and supplement the ordinances under Art. 82, Para. 3, Art. 219, Para. 2 and Art.
p.(None): 243 in compliance with this Act.
p.(None): 2. The Council of Ministers shall adopt the Ordinance under Art. 258, Para. 5 and shall amend the tariff under Art. 21,
p.(None): Para. 2 and the Rules of procedure of the Ministry of Health in compliance with this Act.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 84. This Act shall come into force from the day of its publication in the State Gazette, with the exception of § 65,
p.(None): which shall come into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.(None):
p.(None): (PROM. - SG 38/12, IN FORCE FROM 01.07.2012)
p.(None):
p.(None): § 84. (In force from 18.05.2012) Within one month after the promulgation of this Act in the State Gazette:
p.(None): 1. The Council of Ministers shall adjust the Classified of positions in administration to the provision of this Act;
p.(None): 2. the competent bodies shall adjust the structural acts of the respective administration to the provisions of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 85. (1) The legal relationships with the persons from administrations under the Radio and Television Act, Independent
p.(None): Financial Audit Act, Electronic Communications Act, Financial Supervision Commission Act, Act on Access to and
p.(None): Disclosure of the Documents and Announcing Affiliation of Bulgarian Citizens with the State Security Service and
p.(None): the Intelligence Services of the Bulgarian Popular Army, Act on Seizure in Favour of the State of
p.(None): Property, Acquired through Criminal Activity Act on Prevention and Findings of Conflict of Interests, Code of Social
p.(None): Insurance, Health Insurance Act, Agricultural Producers Assistance Act, Roads Act shall be regulated subject to
p.(None): compliance with the provisions and following the procedure of § 36 of the Transitional and Conclusive Provisions of the
p.(None): Act amending and supplementing the Civil Servants Act (SG 24/06).
p.(None): (2) By the act of appointment of a civil servant:
p.(None): 1. the minimum rank for the occupied position shall be conferred, as determined in the Classified of positions in the
p.(None): administration, unless the servant hold a higher rank;
p.(None): 2. individual monthly salary shall be fixed.
p.(None): (3) Additionally required funds for insurance contributions of the persons under par. 2 shall be provided within the
p.(None): cost of salaries, remunerations and insurance contributions within the budgets of the respective administrators of
p.(None): budget credits.
p.(None): (4) Council of Ministers must make necessary adjustments in the out-of-budget account of State Fund "Agriculture",
p.(None): arising out of this Act.
p.(None): (5) Managing bodies of National Social Insurance Institute and of National Health Insurance Fund must make
p.(None): necessary adjustments in the respective budgets, arising out of this
p.(None):
p.(None): Act.
p.(None): (6) The non-used leaves regulated in the employment agreement shall be kept and shall
p.(None): not be compensated with a financial benefit.
p.(None):
p.(None):
p.(None): § 86. (1) Within one month after entering of this Act into force the individual basic monthly salary of the employee
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Searching for indicator military:

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p.(None): Art. 198, as well as if he has authorisation for wholesale trade;
p.(None): 13. (new – SG, 102/2012, in force from 02.01.2013) check up whether the manufacturer or importer, from whom the
p.(None): medicinal product is received, has authorisation for manufacture/import;
p.(None): 14. (new – SG, 102/2012, in force from 02.01.2013) check up whether the intermediary, through whom the medicinal
p.(None): product is received, meets the requirements of this Chapter.
p.(None): (2) The documentation according to Para. 1, points 7 and 8 shall be kept for at least 5 years and shall be provided to
p.(None): the control bodies upon request.
p.(None):
p.(None):
p.(None): Art. 208. (amend. – SG, 102/2012, in force from 02.01.2013) The obligations according to Art. 207, Para. 1, point 2,
p.(None): and Art. 209a shall also apply to the wholesalers according to Art. 203, as well as to the importers and manufacturers
p.(None): trading in medicinal products manufactured by them.
p.(None):
p.(None):
p.(None): Art. 209. The requirements of the special provisions of other laws shall also apply to the wholesale of medicinal
p.(None): products containing narcotic substances or obtained from blood, or immunological products, or
p.(None): radiopharmaceuticals.
p.(None):
p.(None):
p.(None): Art. 209a. (New - SG 71/2008, in force from 12.08.2008) (1) The wholesale traders with medicinal products may deliver
p.(None): medicinal products to:
p.(None): 1. other wholesale traders with medicinal products;
p.(None): 2. pharmacies and drugstores;
p.(None): 3. the Ministry of Defence and the Ministry of Interior for own needs, with the exception of their medical
p.(None): institutions, as well as the State Reserve and Military time Reserve State Agency;
p.(None): 4. the Ministry of Health with:
p.(None): a) vaccines, tocsins and serums, needed for implementation of the Immunisation calendar of the Republic of
p.(None): Bulgaria, as well as during emergency epidemical situations;
p.(None): b) medicinal products, intended for treatment of illnesses, which are paid as provided by the Health Act, as well as
p.(None): for providing the implementation of national programmes in the area of healthcare;
p.(None): 5. (new – SG 60/12, in force from 07.08.2012) outpatient health care institutions which have signed an agreement with
p.(None): the National Health Insurance Fund, with medicinal products required for performance of health activities under Art.
p.(None): 82, para 2, item 3 of the Health Act.
p.(None): (2) Doctors and Dental doctors in the populated areas, where there are no pharmacies may be supplied with medicinal
p.(None): products by wholesale traders, as provided by the ordinance under Art. 207, para 1, p. 6.
p.(None):
p.(None):
p.(None): Art. 209b. (new – SG, 102/2012, in force from 02.01.2013) (1) In wholesale trade of medicinal products in third states
p.(None): the requirements of Art. 207, Para. 1, p. 2, 5 and 6 shall not apply, as well as the requirements of Chapter Nine "a".
p.(None):
p.(None): (2) Where the medicinal product is received directly from a third state, but jas not been imported on the territory of
p.(None): the Republic of Bulgaria, the requirements of Art. 207, Para. 1, p. 4 and 4a shall not apply.
p.(None): (3) (new – SG 18/14) In cases referred to in par. 1 the wholesalers shall certify by relevant documents
p.(None): that the medicinal products are received from persons holding a permit or have got the right to supply medicinal
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Social / Threat of Stigma

Searching for indicator threat:

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p.(None): the safety of the subjects, the scientific value of the clinical test, and/or the observation of the rules for Good
p.(None): Clinical Practice.
p.(None): (2) Essential amendment in the conduct of the clinical test shall be any amendment in the study protocol and/or in the
p.(None): information and the documentation according to Art. 110 and 116, which can affect:
p.(None): 1. the safety or the physical and mental immunity of the study subjects;
p.(None): 2. the scientific value of the clinical test;
p.(None): 3. the conduct or the organisation of the clinical test;
p.(None): 4. the quality or the safety of any study medicinal products.
p.(None):
p.(None):
p.(None): Art. 128. (1) The contracting authority can also implement planned study essential protocol and
p.(None): documentation amendments according to Art. 110 and 116 wherever:
p.(None): 1. the ethics committee has given a written positive opinion;
p.(None): 2. the executive director of the BDA has issued a written authorisation as to clinical trials with medicinal products
p.(None): according to Art. 109, point 2, or
p.(None):
p.(None): 3. the contracting authority has not been notified by the BDA about refusal of the proposed amendment in
p.(None): the clinical test with medicinal products according to Art. 109, point 3.
p.(None): (2) The provision of para 1 shall not apply to changes in an approved protocol, which are imperative to protect the
p.(None): subjects from immediate threat in case of occurrence or new information associated with the conduct of
p.(None): the clinical test or the development of the study medicinal product.
p.(None): (3) In the cases according to para 2, the contracting authority shall immediately notify the ethics committee
p.(None): according to para 1, point 1, and the BDA about the available new information, the measures taken, and the
p.(None): applied changes in the protocol.
p.(None):
p.(None):
p.(None): Art. 129. (1) While planning essential amendments to the clinical test and the documentation according to
p.(None): Art. 110 and 116, the applicant shall submit a formal written application to the BDA and the respective
p.(None): ethics committee.
p.(None): (2) The application shall be accompanied by documentation, which is necessary for grounding the amendments
p.(None): and certifies that after the implementation of the amendment the assessment of the benefit/risk ratio according to Art.
p.(None): 90, para 1, shall remain unchanged.
p.(None): (3) The requirements relating to the application and the documentation for the amendment shall be determined
p.(None): in the regulation according to Art. 82, para 3.
p.(None):
p.(None):
p.(None): Art. 130. (1) Within 35 days of receipt of an application for amendment, the ethics committee shall
p.(None): notify the contracting authority of its decision by issuing:
p.(None): 1. positive opinion on the requested amendment or
...

p.(None):
p.(None): to protect the study subjects from suddenly occurred risks for their safety and health.
p.(None): (2) In the cases according to para 1 the contracting authority shall immediately notify the BDA and the respective
p.(None): ethics committee about the undertaken actions and the reasons, which have raised these.
p.(None):
p.(None):
p.(None): Art. 133. (1) Where the clinical test is to be conducted under conditions different from those determined at the issue
p.(None): of the authorisation or there is information vitiating the scientific validity of the clinical test or the safety of
p.(None): the study subjects, the BDA can temporarily stop the conduct of the test or put a ban on it.
p.(None): (2) The ban can be imposed for a specific centre or for all centres in a multicentre clinical test on the territory of
p.(None): the Republic of Bulgaria.
p.(None): (3) In case of termination of the clinical test in all centres on the territory of the Republic of Bulgaria, the BDA
p.(None): shall, prior to undertaking actions according to para 1, notify the contracting authority and the principal researcher
p.(None): or the coordinating researcher in writing.
p.(None): (4) Within 7 days of the receipt of the notification the contracting authority and/or the principal researcher can
p.(None): express an opinion on the undertaken measures by the BDA.
p.(None): (5) The provision of para 3 shall not apply provided that there is an immediate threat for the health and safety of the
p.(None): study subjects.
p.(None):
p.(None):
p.(None): Art. 134. In the cases according to Art. 133, para 1, the BDA shall immediately notify the respective ethics
p.(None): committee, the regulatory bodies of the Member States, the European Medicines Agency, and the European
p.(None): Commission about the undertaken measures and the reasons therefore.
p.(None):
p.(None): Section V. Pharmaco-vigilance
p.(None):
p.(None): Art. 135. (1) The principal researcher shall immediately report in writing or by word of mouth any serious adverse
p.(None): event that has occurred in the course of the clinical test in a study subject at the centre he is responsible for.
p.(None): (2) A detailed written report shall be submitted after the report according to para 1.
p.(None): (3) At the notification according to para 1 and in the report according to para 2 the study subject shall be identified
p.(None): by a unique code number as defined in the study protocol.
p.(None): (4) The provisions of para 1 and 2 shall not apply provided that the protocol of the clinical test or the researcher’s
p.(None): brochure explicitly states that there is no requirement for an urgent report of a specific serious adverse event.
p.(None): (5) The researcher shall report to the contracting authority any adverse events or laboratory aberrations,
p.(None): which are defined in the study protocol as critical with respect to safety, within the timelines and format as required
p.(None): by the protocol.
p.(None):
p.(None):
p.(None): Art. 136. Where the outcome of an adverse event during the conduct of a clinical test is death, the researcher shall
...

p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
...

p.(None): (6) The parallel imported product shall be used according to the conditions of the issued marketing authorisation for
p.(None): the use of the medicinal product on the territory of the Republic of Bulgaria.
p.(None):
p.(None):
p.(None): Art. 216. (1) The authorisation for parallel import on the territory of the Republic of Bulgaria shall be
p.(None): issued within 45 days of the date of submission of the documentation to the BDA.
p.(None): (2) Where the BDA shall request additional documentation from the applicant, the term according to para 1 shall cease
p.(None): to run until receipt of the requested information.
p.(None): (3) Where the BDA shall require information relating to the issue of the marketing authorisation of the
p.(None): imported medicinal product from the regulatory body of the Member State where the parallel import is to be effected
p.(None): from, the term according to para 1 shall be extended by 45 days.
p.(None): (4) If the BDA does not receive the requested documentation within the term according to para 3, the procedure for the
p.(None): issue of a parallel import authorisation for the territory of the Republic of Bulgaria shall be terminated.
p.(None): (5) The issued parallel import authorisations for the territory of the Republic of Bulgaria
p.(None):
p.(None): shall be published on the internet site of the BDA.
p.(None): (6) The parallel import authorisation shall be valid for 5 years. New authorisation shall be issued under the terms of
p.(None): Art. 215.
p.(None): (7) The parallel import authorisation shall not be automatically cancelled where the marketing authorisation
p.(None): holder of the medicinal product launched on the market on the territory of the Republic of Bulgaria would withdraw it
p.(None): for reasons, which are not associated with a threat for the health of the population.
p.(None):
p.(None):
p.(None): Art. 217. The parallel import authorisation holder shall be obliged to:
p.(None): 1. notify the marketing authorisation holder of the medicinal product launched on the territory of the Republic of
p.(None): Bulgaria of his intention to effect parallel import and provide a sample of the parallel imported medicinal product
p.(None): upon request;
p.(None): 2. keep the following information for 5 years: name and address of the person whom the parallel imported medicinal
p.(None): product is to be delivered to, date of delivery, delivered quantity, and batch number;
p.(None): 3. submit in BDA:
p.(None): a) actualised patient’s leaflet of parallel imported product according with the variations in issued marketing
p.(None): authorisation of the approved medicinal product in Republic of Bulgaria;
p.(None): b)(Amen. - SG 71/2008, in force from 12.08.2008) declaration that the content of the leaflet according to letter "a"
p.(None): shall be identical with the content of the product leaflet, approved in Republic of Bulgaria except of the data
p.(None): according to Art. 215, para 2, point 7, letters "a" – "d";
p.(None): 4. document and report to the marketing authorisation holder and the BDA all reports of adverse drug reactions of the
p.(None): imported medicinal product.
p.(None):
p.(None): Chapter nine.
p.(None): "B" EXPORT OF MEDICINAL PRODUCTS (NEW – SG 18/14)
p.(None):
p.(None): Art. 217a. (new – SG 18/14) (1) Export of medicinal products from the territory of the Republic of Bulgaria may be done
p.(None): by a natural person or a legal entity holding a permit for wholesale with medicinal products or by a holder of a
p.(None): production license.
p.(None): (2) Holders of a production license may carry out export only of the medicinal products manufactured by them.
...

p.(None): 40. "Adverse event" shall mean any untoward unfavorable change the health condition observed during the administration
p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
p.(None): disability, and innate anomalies;
p.(None): d) combination of reactions according to subsections "a", "b", and "c".
p.(None): 42. "Common name" shall mean the international non-proprietary name (INN) of a medicinal substance or
p.(None): excipient recommended by the World Health Organisation; if not any, the name in the European Pharmacopoeia shall be
p.(None): used; if there is no such name there, another pharmacopoeia name shall be used; if there is no pharmacopoeia name, the
p.(None): common name shall be used.
p.(None): 42a (new – SG, 102/2012, in force from 21.12.2012) "Basic documentation of a system of pharmaco-vigilance" is a detail
p.(None): description of the pharmaco-vigilance system, used by the marketing authorisation holder in relation or one or more
p.(None): authorised for use medicinal products.
p.(None): 42b. (new - SG48/15) "Health technology assessment" shall mesn:
p.(None): a) a form of policy on research that examines the short- and long-term outcomes related to the implementation of
p.(None): health technologies and aims to provide information concerning alternative health strategies;
p.(None): b) multidisciplinary activity that systematically evaluates technical specifications, safety, clinical efficacy and
p.(None): effectiveness, cost, cost effectiveness, organizational, social, legal and ethical consequences of
p.(None): administration of medicinal products in health care and focuses on value - clinical and economic, provided
p.(None): that the analysis is comparative to existing or best alternative at the time;
p.(None):
...

p.(None): calculation of the probability of this positive result.
p.(None): 46. (amend. – SG, 102/2012, in force from 02.01.2013) "Auxiliary substance" is any component of a medicinal product,
p.(None): different for the active substance and the packing material.
p.(None): 47. "Post marketing study" shall mean any study conducted during the use of a medicinal product within the approved
p.(None): summary of product characteristics during the period after the authorisation to market.
p.(None): 47a (new - SG, 102/2012, in force from 02.01.2013) "Mediation in the area of medicinal products" are all the
p.(None): activities, which aim at signing contract for buying or selling of medicinal products with the exception of wholesale
p.(None): trade, which do not include physical keeping and which are expressed in negotiating independent and on behalf of
p.(None): another legal or natural person.
p.(None): 48. "Post marketing safety study" shall mean any study, related to an authorised for use medicinal product, conducted
p.(None): with the purpose of identification, characterisation of defining the risk level in relation of safety, to confirm the
p.(None): safety profile of the medicinal product or to assess the effectiveness of the measures for risk management.
p.(None): 49. "Potential serious risk for the population" shall exist where there is a high probability a medicinal product to
p.(None): cause irremovable, irremediable, and irreversible consequences. The assessment process shall identify the threat of
p.(None): causing damages to the health of the population and its actual exposition during wide use of the product. The serious
p.(None): risk for the health in the context of the use of a given medicinal can be assessed under the following conditions:
p.(None): a) efficacy – the submitted therapeutic efficacy data with regard to the proposed indication(s), the
p.(None): proposed target group, and the proposed dosage mentioned in the proposed patient information leaflet do not
p.(None): scientifically defend to the full extent the efficacy claims;
p.(None): b) safety – the assessment of the data for preclinical toxicity/pharmacological safety and clinical safety cannot
p.(None): convincingly defend the conclusion that all potential safety aspects with regard to the target patient group(s) have
p.(None): been accurately and comprehensively reflected in the proposed patient information leaflet or the absolute risk degree
p.(None): is unacceptable;
p.(None): c) quality – the proposed method of manufacture and control methods cannot guarantee the lack of an essential defect in
p.(None): the quality of the product, which can affect the product safety and/or efficacy;
p.(None): d) benefit/risk ratio: the assessment of the benefit/risk ratio and the potential benefit for the proposed
p.(None): indication(s) and the patient group(s).
p.(None): 50. "Representative of the person according to Art. 26, Para. 1, or of a marketing authorisation holder"
p.(None): shall mean a person residing on the territory of the Republic of Bulgaria appointed by the person according to Art. 26,
...

p.(None): population.
p.(None): 63. "Reference medicinal product" shall mean a medicinal product authorised under the terms of Art. 23 in compliance
p.(None): with the requirements of Art. 27.
p.(None): 64. "Reference value of a defined daily dose" on an international non-proprietary name with the corresponding
p.(None): pharmaceutical for according to the anatomo-therapeutic classification of medicinal products shall mean the lowest
p.(None): value of a defined daily dose determined on the basis of the values of a defined daily dose for various medicinal
p.(None): products for the international non-proprietary with the corresponding pharmaceutical form according to the
p.(None): anatomo- therapeutic classification of medicinal products.
p.(None): 65. "Reference value of a therapeutic course" shall be the lowest value of a therapeutic course determined on the basis
p.(None): of the values of a therapeutic course of the medicinal products according to international non-proprietary name with
p.(None): the corresponding pharmaceutical form.
p.(None): 66. "Risk during the use of a medicinal product" shall mean:
p.(None): a) risk for the health of the patient or risk for the health of the population, which is associated
p.(None): with the quality, safety, or efficacy of a medicinal product;
p.(None): b) risk of undesirable effects on the environment.
p.(None): 67. "Serious adverse event" shall mean any unfavorable change in the health condition,
p.(None):
p.(None): which has become the cause of lethal outcome, immediate threat to life, hospitalisation or extension of
p.(None): hospitalisation, significant or durable injury, disability, and innate anomalies.
p.(None): 68. "Batch release certificate" shall mean a document issued for each batch by the qualified person of the
p.(None): manufacturer or importer and shall include the requirements according to the specification, as well as all results from
p.(None): the tests for the release of the batch.
p.(None): 69. "Additional protection certificate" shall mean a document, which shall provide additional patent
p.(None): protection for a medicinal product of maximum 5 years after the lapse date of the main patent.
p.(None): 69a (new – SG, 102/2012, in force from 21.12.2012) "Risk management system" is a system of measures and
p.(None): activities for pharmaco-vigilance, intended for identification, characteristics, prevention or setting to
p.(None): minimum risks, related to the medicinal product, including effectiveness assessment of these activities and measures.
p.(None): 69b (new – SG, 102/2012, in force from 21.12.2012) "Pharmaco-vigilance system" is a system, used by the marketing
p.(None): authorisation holder and BDA for implementation of the tasks and responsibilities under Chapter Eight, intended for
p.(None): observation of vigilance of the permitted for use medicinal products and for finding every change in the benefit/risk
p.(None): ratio.
p.(None): 70. "Urgent limitation safety measures" shall mean temporary changes in the product information with respect of one
...

Social / Threat of Violence

Searching for indicator violence:

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p.(None): last amended by Directive 2004/27/EC of the European Parliament and the Council, independently from the form of the
p.(None): document;
p.(None): 2. order of each person to present information for violations according to point 1, which are familiar to him;
p.(None): 2a (new - SG, 102/2012, in force from 21.12.2012) inspect the manufacture and trade sites of manufacturers of
p.(None): medicinal products, active or auxiliary substances, as well as the laboratories, used by manufacture or import
p.(None): authorisation holders;
p.(None): 3. at any time inspect the sites subject to control and require, check, or make copies of all documents relating to the
p.(None): overall activity of the controlled site;
p.(None): 4. take samples of medicinal products, active substances, and percipients for laboratory
p.(None): tests;
p.(None): 5. (amend. - SG, 102/2012, in force from 21.12.2012) inspect the premises, archives,
p.(None): records, and documents and the basic documentation of the pharmaco-vigilance of the marketing authorisation
p.(None): holder or persons, who have been assigned to carry out the activities under Chapter Eight;
p.(None): 6. (new - SG, 102/2012, in force from 21.12.2012) carry out inspection about the observation of
p.(None): confirmed prices, limit prices or registered prices during sale of medicinal products;
p.(None): 7. (former Art. 6 - SG, 102/2012, in force from 21.12.2012) draw up statements of administrative
p.(None): infringements.
p.(None): (2) (repealed - SG, 102/2012, in force from 21.12.2012).
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011) The Executive Director of BDA of the corresponding director of
p.(None): RHI, depending of the administrative person, who determined the violence, has right to:
p.(None): 1. order in written form to the violator to cease the violation according to Para. 1, point
p.(None): 1;
p.(None): 2. requires from the violator to declare that it will cease the violation according to Para.
p.(None): 1, point 1 and when it is necessary to makes the declaration matter publicly available.
p.(None): 3. to order cease or prohibition of each violation according to Para. 1, point 1 and when it is necessary to order for
p.(None): cease or prohibition of violation matter publicly available.
p.(None): (4) (new - SG, 102/2012, in force from 21.12.2012). The Council chairperson under Art. 258, Para. 1 shall have the
p.(None): right to order in writing to the violator to stop the violation, found during the inspection under Para. 1, p. 6.
p.(None):
p.(None):
p.(None): Art. 271. (1) (amend., - SG 98/10, in force from 01.01.2011) The regional health inspectorates shall be
p.(None): entitled to:
p.(None): 1. stop construction and issue directions where violations of hygienic norms and requirements have been
p.(None): established in the course of construction; notify the Directorate for
p.(None):
p.(None): National Construction Control or the municipal technical office in case of illegal construction of sites and
p.(None): equipment for manufacture, storage, and sale of medicinal products shall be established;
p.(None): 2. prohibit the commissioning and stop the operation of sites and equipment in case of violation of the hygienic norms
p.(None): for the manufacture, storage, and sale of medicinal products – until the elimination of the violations;
p.(None): 3. block medicinal products in case of available documented information of discrepancies with the
...

Social / Trade Union Membership

Searching for indicator union:

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p.(None): implemented by the Minister of Health.
p.(None): (2) The Minister of Health shall:
p.(None): 1. be the national coordinator for the problems of medicinal product;
p.(None): 2. take part in international bodies and organisations carrying out activities in the domain of the medicinal products;
p.(None): 3. (repealed – SG, 60/2011, in force from 05.08.2011 new – SG, 102/2012, in force from 21.12.2012) organize provision
p.(None): of public information to the patient organisations and to the
p.(None):
p.(None): consumers organisations about the actions, undertaken against falsification of medicinal products.
p.(None): 4. Carry out other activities set out by a law.
p.(None): When activities according para 2, point 3 carried out, the Ministry of Health collect taxes in amount, determined in
p.(None): tariff according to Art. 21, para 2.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None):
p.(None):
p.(None): Art. 15. (1) Pharmacopoeia Committee shall be established with the Minister of Health as a consulting body on issues
p.(None): relating to the current pharmacopoeia.
p.(None): (2) The Minister of Health shall, on the grounds of a proposal of the Executive Director of the BDA determine by an
p.(None): order the composition of the Pharmacopoeia Committee and the expert groups thereto and shall approve the regulation
p.(None): relating to their activity.
p.(None): (3) The activity of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 16. (1) Higher Council of Pharmacy shall be established to the Minister of Health as a consulting body on issues
p.(None): relating to pharmacy. It shall be composed by five representatives appointed by the Minister of Health, five
p.(None): representatives from Bulgarian Pharmaceutical Union, two representatives from National Health Insurance Fund (NHIF) and
p.(None): one representative from Faculty of pharmacy of the high medicinal schools. The Minister of Health is a chairman of the
p.(None): council without right of vote.
p.(None): (2) The Higher Council of Pharmacy is consultative body, which discuss and provide statements for:
p.(None): 1. Basic approaches and priorities in the pharmaceutical area;
p.(None): 2. Ethical problems of the pharmacy;
p.(None): 3. Projects for normative acts, related with the pharmacy;
p.(None): 4. The scientific priorities in the area of pharmacy;
p.(None): 5. Programs for organisation of social educational campaign in the area of medicinal products.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None): (4) The organisation and the activity of the Higher Council of Pharmacy are settled with ordinance issued by the
p.(None): Minister of Health, after proposal of Higher Council of Pharmacy.
p.(None):
p.(None):
p.(None): Art. 17. (1) The Bulgarian Drug Agency shall be a specialised body at the Minister of Health for the surveillance on
p.(None): the quality, safety, and efficacy of the medicinal products.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) The Bulgarian Drug Agency shall be a legal entity budget financed with
p.(None): registered office in the city of Sofia with the Minister of Health.
p.(None): (3) The Bulgarian Drug Agency shall be managed and represented by an Executive Director who shall be appointed under
p.(None): the terms of the Administration Act.
...

p.(None): types of medicinal products and medicinal products intended for clinical trials can only be performed on the
p.(None): territory of the Republic of Bulgaria by natural or legal persons registered as traders on the territory of a
p.(None): Member State which have received manufacturing authorisation issued by the director of the BDA.
p.(None): (2) Manufacturing authorisation shall also be required in the cases where the products according to para 1 are intended
p.(None): for export only.
p.(None):
p.(None): (3) Manufacturing authorisation shall also be required for persons who perform simultaneously of separately
p.(None): one of the following activities: packaging, retail packaging, repackaging, labelling of medicinal products, and
p.(None): medicinal products intended for clinical trials.
p.(None): (4) Manufacturing authorisation shall also be required for persons who perform simultaneously or separately
p.(None): one of the following activities: complete or partial manufacture of active substances intended for the manufacture of
p.(None): medicinal products and various processes of packaging, retail packaging, repackaging, and re-labelling of active
p.(None): substances.
p.(None): (5) No manufacturing authorisation shall be required where the processes of retail packaging, mixing, or
p.(None): packaging are performed according to magisterial or pharmacopoeia recipe in a pharmacy.
p.(None):
p.(None):
p.(None): Art. 147. (amend. – SG, 102/2012, in force from 02.01.2013) The BDA shall introduce information about the issued
p.(None): manufacturing authorisations of medicinal products and certificates for good production practice to be entered in the
p.(None): European Union database.
p.(None):
p.(None):
p.(None): Art. 148. To obtain manufacturing authorisation the person according to Art. 146 must possess:
p.(None): 1. personnel with adequate qualification depending on the specificity of the manufactured types of
p.(None): medicinal products and pharmaceutical forms;
p.(None): 2. always at least one qualified person, who correspond to the condition of Art. 159 at any time;
p.(None): 3. manufacturing, control, and storage facilities for the medicinal products equipped with the required technical
p.(None): equipment and control laboratories.
p.(None):
p.(None):
p.(None): Art. 149. The managers of manufacture and quality control of medicinal products in the manufacturing enterprises shall
p.(None): be:
p.(None): 1. persons with educational qualification master’s degree in pharmacy, chemistry, or biology and at least two-year
p.(None): practical experience in the pharmaceutical manufacture;
p.(None): 2. for the manufacture of radiopharmaceuticals or medicinal products subjected to ionizing radiation –
p.(None): persons who comply with the requirements according to point 1 and have an additionally recognised specialty in
p.(None): radiobiology or radiochemistry.
p.(None): 3. for the manufacture of immunological medicinal products including vaccines, toxins, sera, biotechnological products,
p.(None): and medicinal products obtained from human plasma or human blood – persons with recognised speciality in medical
p.(None): haematology, medical microbiology, virology, or immunology.
p.(None):
p.(None):
p.(None): Art. 150. (1) The person according to Art. 146 shall submit to the BDA a formal application as approved
p.(None): by the director of the Agency.
p.(None): (2) Together with the application according to para 1 the applicant shall also submit:
...

p.(None): 1. name management address of the person under Art. 167a;
p.(None): 2. list of the active substances to be imported, manufactured or traded;
p.(None): 3. the activities, which the person under Art. 167a will carry out;
p.(None): 4. 4. Premise address in which the activities will be carried out;
p.(None): 5. 5. Notes on the entered circumstances.
p.(None): (2) The BDA shall enter in the data base under Art. 147 the information about the registered importers,
p.(None): manufacturers and wholesale traders of active substances.
p.(None):
p.(None):
p.(None): Art. 167e. (new – SG, 102/2012, in force from 02.01.2013) (1) The person under Art. 167a shall submit to BDA yearly by
p.(None): 31 January a notification about changes in the information, entered in the register under Art. 167d.
p.(None): (2) In case of changes, which may influence the quality or safety of the active substances, which are manufactured,
p.(None): imported or disseminated, the person under Art. 167a shall notify the
p.(None):
p.(None): BDA immediately
p.(None):
p.(None):
p.(None): Art. 167f. (1) (new – SG, 102/2012, in force from 02.01.2013) The manufacture, import and wholesale trade of active
p.(None): substances on the territory of the Republic of Bulgaria, including active substances, intended for export, shall
p.(None): be carried out in compliance with the Good manufacturing practice and the Good dissemination practices for
p.(None): active substances.
p.(None): (2) The importers may import active substances only if the following conditions have been observed:
p.(None): 1. the active substances are manufactured in compliance with standards for Good manufacturing practice,
p.(None): which are at least equivalent to the ones, established in the European Union and
p.(None): 2. (in force from 02.07.2013) the active substances are accompanied by a written confirmation by the
p.(None): competent body of the state-importer, that:
p.(None): a) the standards for good manufacturing practice, applicable to the object for manufacture of the
p.(None): exported active substances are at least equivalent to the ones, established by the European Union;
p.(None): b) The relevant object for manufacture shall be subject to a regular control and in it effectively is applied the
p.(None): Good manufacturing practice, where this includes multiple and immediate inspections in view to guaranteeing
p.(None): protection of the public health, at least equal to the one in the European Union, and
p.(None): c) in case of a found failure to observe the requirements, the state exporter shall inform immediately the BDA.
p.(None): (3) (in force from 02.07.2013) The requirement of Para. 2, p. 2 shall not apply if the state exporter is included in
p.(None): the list under Art. 111b of Directive 2001/83/EC
p.(None):
p.(None):
p.(None): Art. 167g. (new – SG, 102/2012, in force from 02.07.2013) (1) As an exception, where it is needed to be provided
p.(None): availability of medicinal products, the importer may import the active substance without a written confirmation under
p.(None): Art. 167f, Para. 2, p. 2 for the term, not longer than the validity term of the certificate for Good manufacturing
p.(None): practice, where the object for manufacture of an active substance in the state exporter has been inspected by a regular
p.(None): body of a Member State and it has been found, that it observes the principle and directives for Good manufacturing
p.(None): practice.
p.(None): (2) In the cases of Para. 1, BDA shall notify the European Commission.
p.(None):
p.(None):
p.(None): Art. 167h. (new – SG, 102/2012, in force from 02.01.2013) manufacturing authorisation holders, including those, who
p.(None): fulfill the activities under Art. 168b, Para. 2 shall be considered as manufacturers in the meaning of § 13, p. 3 of
p.(None): the Additional Provisions of the Act on Consumer Protection and shall bare responsibility for harms, caused by goods
p.(None): defects, provided in it.
p.(None):
p.(None): Chapter six.
p.(None): PACKAGING AND LEAFLETS OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 168 (1) Medicinal product packaging consists of primary and/or secondary packaging and patient
p.(None): information leaflet.
...

p.(None): traders to:
p.(None): a) check up the authenticity of the medicinal product;
p.(None): b) to identify separate packages.
p.(None): 2. a means, which may check up the package of the medicinal product if it has been
p.(None): faked.
p.(None):
p.(None):
p.(None): Art. 168a. (new – SG, 102/2012, in force from 21.12.2012) (1). On the package of the medicinal product, which is
p.(None): prescribed by a doctor’s prescription, safety indicators shall be placed under Art. 168, Para. 8 with the
p.(None): exception of the cases, in which the medicinal product has been included in the list, determined by the European
p.(None): Commission by a delegated act under Art. 168b.
p.(None): (2) On the package of a medicinal product, which does not need doctor’s prescription, no safety indicators shall be
p.(None): placed under Art. 168, Para. 8, with the exception of the cases, in which the medicinal product is included in the
p.(None): list, determined by the European Commission by a delegated act under Art. 168b, after it has been assessed, that it may
p.(None): be put to a risk to be faked.
p.(None): (3) The BDA shall notify the European Commission:
p.(None): 1. about medicinal products, which do not need doctor’s prescription, for which it has found that there is a risk to be
p.(None): faked;
p.(None): 2. about medicinal products, for which it has found that there is not risk to be fakes, while
p.(None):
p.(None): accounting the following criteria:
p.(None): a) price and volume of the sales of the medicinal product;
p.(None): b) number and frequency of cases of faked medicinal products, registered in the frames of the European Union and in
p.(None): third states and change in the number and frequency of similar cases in historical plan;
p.(None): c) specific characteristics of the relevant medicinal products;
p.(None): d) stage of the sicknesses, whose treatment is aimed;
p.(None): e) other potential risks for public health.
p.(None):
p.(None):
p.(None): Art. 168b. (new – SG, 102/2012, in force from 21.12.2012) (1) The rules about the safety indicators under Art. 168,
p.(None): Para. 8 shall be determined by the European Commission with the delegated acts under Art. 54a, Para. 2 of Directive
p.(None): 2001/83/EC.
p.(None): (2) The safety indicators shall not be removed nor closed partially or thoroughly, unless the following conditions have
p.(None): been fulfilled:
p.(None): 1. the manufacturing authorisation holder, before partially or thoroughly removes or closes the safety
p.(None): indicators, shall check whether the relevant medicinal product is authentic or it has been faked;
p.(None): 2. the manufacturing authorisation holder while observing the requirements of Art. 168, Para. 8 may replace the safety
p.(None): indicators with ones, equal to them in relation to the possibility for guaranteeing the authenticity,
p.(None): identification and provision of evidences for faking the medicinal product.
p.(None): (3) The safety indicators shall be considered as equal, if:
p.(None): 1. they meet the requirements, determined by the delegated acts under Art. 54a, Para. 2 of Directive 2001/83/EC and
p.(None): 2. they are so effected that they allow the check of authenticity and identification of the medicinal products and
p.(None): provide evidences for their being faked.
p.(None): (4) The replacement under Para. 2, p. 2 shall be made without opening the initial packing of the medicinal product and
p.(None): in compliance with the Good manufacturing practice for medicinal products.
...

p.(None):
p.(None):
p.(None): Art. 194. (amend. – SG, 102/2012, in force from 21,12,2012) (1) The marketing authorisation holder shall
p.(None): simultaneously or before providing for the public new information about concerns, related to pharmaco-vigilance of a
p.(None): certain medicinal product, permitted for use on the territory of the Republic of Bulgaria, shall notify the BDA, the
p.(None): European Medicines Agency and the European Commission.
p.(None): (2) The information under Para. 1 shall be objective and not misleading.
p.(None): (3) before disseminating information, related to pharmaco-vigilance, the marketing authorisation holder shall
p.(None): coordinate it in advance with BDA with the exception of the cases under Para. 1.
p.(None): (4) For carrying out assessment of the information under Para. 3, a fee shall be paid in the amount, determined by the
p.(None): tariff under Art. 21, Para. 2.
p.(None):
p.(None): Art. 194a. (new – SG, 102/2012, in force from 21.12.2012) (1) The principles and requirements of the Good
p.(None): pahrmaco-vigilance practice shall be defined by a manual, issued by the European Medicines Agency.
p.(None): (2) While carrying out the pharmaco-vigilance activities, the marketing authorisation holder shall observe the
p.(None): good practice under Para. 1.
p.(None):
p.(None): Section II.
p.(None): Collecting and Announcing Information about Suspected Adverse Reactions. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194b. (new – SG, 102/2012, in force from 21.12.2012) The marketing authorisation holder in fulfilling his/her
p.(None): duties under Art. 190, shall be obliged to document all reports for suspected adverse medicinal reactions,
p.(None): observed on the territory of the European Union or in third states, reported spontaneously by medical specialists or
p.(None): patients or occurred in the process of conducting post-marketing studies.
p.(None):
p.(None):
p.(None): Art. 194c. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder shall
p.(None): submit electronically to the data base "Eudra Vigilance" under Art. 24 of Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council reports about suspected adverse medicinal reactions, occurred on the territory of the EU
p.(None): and in third states within the term of 15 days from the date of receiving the report.
p.(None): (2) The marketing authorisation holder shall submit electronically to the database "Eudra Vigilance" reports, about
p.(None): all suspected adverse medicinal reactions, different form the ones, indicated in Para. 1, occurred on the territory
p.(None): of the EU within the term of 90 days from the date of receiving the report.
p.(None): (3) The marketing authorisation holder shall follow the publications in the specialised medicinal literature and
p.(None): shall report in the database "Eudra Vigilance" every described in it suspected adverse medicinal reaction
p.(None): with the exception of suspected adverse medicinal reactions of medicinal products, containing active substances,
p.(None): indicated in the list of Art. 27 of Regulation (EC) N 726/2004 of the European Parliament and of the Council and
p.(None): described in the literature sources of pharmaco-vigilance of the European Medicines Agency.
p.(None): (5) The form and contents of the reports under Para. 1 – 3 shall be provided by Implementation
p.(None): Regulation (EU) 520/2012.
p.(None):
p.(None):
p.(None): Art. 194d. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall register in the system under Art. 183 all
...

p.(None): request by BDA.
p.(None):
p.(None):
p.(None): Art. 194e. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall submit electronically to the Eudra
p.(None): Vigilance database reports about all serious suspected adverse
p.(None):
p.(None): medicinal reactions, occurred on the territory of the Republic of Bulgaria within the term of up to 15 days from the
p.(None): date of their receiving;
p.(None): (2) The BDA shall submit electronically to the Eudra Vigilance database reports about all serious suspected adverse
p.(None): medicinal reactions, different from the ones, indicated in Para. 1, occurred on the territory of the Republic of
p.(None): Bulgaria within the term of 90 days from the date of receiving the report.
p.(None): (3) The BDA shall submit electronically to the Eudra Vigilance database reports about suspected adverse medicinal
p.(None): reactions, occurred on the territory of the Republic of Bulgaria as a result of incorrect use of the medicinal
p.(None): product. The BDA shall inform about this fact the Ministry of Health and the professional organisations of the
p.(None): medical specialists.
p.(None): (4) Each body or institution, to which information has been received about suspected medicinal adverse reaction on the
p.(None): territory of the Republic of Bulgaria, shall inform the BDA about this fact.
p.(None): (5) The contents and form of the announcements and reports under Para. 1 – 3 shall be provided by the Implementation
p.(None): Regulation (EU) N 520/2012.
p.(None):
p.(None):
p.(None): Art. 194f. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall receive the submitted information by the
p.(None): marketing authorisation holder about serious suspected adverse medicinal reactions, occurred on the territory of the
p.(None): European Union, or in a third state through the Eudra Vigilance database.
p.(None): (2) The requirements for monitoring of the information in the Eudra Vigilance database shall be provided by the
p.(None): Implementation Regulation (EU) N 520/2012.
p.(None):
p.(None):
p.(None): Art. 194g. (new – SG, 102/2012, in force from 21.12.2012). In the process of the information exchange,
p.(None): BDA, the marketing authorisations holders and the European Medicines Agency shall cooperate about finding duplicated
p.(None): reports about suspected adverse medicinal reactions.
p.(None):
p.(None): Section III.
p.(None): Periodic updated reports for vigilance. (new – SG, 102/2012, in force from 21.12.2012).
p.(None):
p.(None): Art. 194h. (new – SG, 102/2012, in force from 21.12.2012). (1) The marketing authorisation holder shall be
p.(None): obliged to provide electronically to the European Medicines agency periodic updated safety reports, which shall
p.(None): contain:
p.(None): 1. summarised data about the relation benefit/risk of the medicinal product, including the results from all studies in
p.(None): view to their potential reflection on the marketing authorisation;
p.(None): 2. scientific assessment of the correlation benefit/risk of the medicinal product; the assessment shall be
p.(None): based on all available data, including data from clinical tests for non- permitted indications and for
p.(None): target groups, which have not been included in the product short characteristics;
p.(None): 3. all the data about the volume of the sales of the medicinal product and any other information, which the marketing
p.(None): authorisation holder has about the volume of the prescriptions, including the approximate number of the persons, having
...

p.(None): where the frequency of submission of the reports is a condition for issuance of the marketing
p.(None): authorisation/registration certificate or it has been determined in compliance with Art. 194l, 194m and 194n:
p.(None): 1. every 6 months from the date of issuance of the marketing authorisation/registration certificate of a medicinal
p.(None): product till the date of its placement on the market;
p.(None): 2. every 6 months during the first 2 years from the date of placement on the market of the medicinal product;
p.(None): 3. once a year during the following 2 years;
p.(None): 4. once every 3 years after the 4th year from the date of placement on the market of the medicinal product;
p.(None): (4) Apart from the cases under Para. 3, the periodic updated safety reports shall be submitted immediately upon request
p.(None): of BDA or a regulatory body of a Member State.
p.(None):
p.(None):
p.(None): Art. 194l. (new – SG, 102/2012, in force from 21.12.2012) Where the medicinal products, which contain one and the same
p.(None): active substance, or combination lf one and the same active substances, have received separate marketing
p.(None): authorisations/ registration certificates, the frequency and the date of submitting of the periodic updated safety
p.(None): reports may be changed and harmonised in view to performing one assessment of these reports.
p.(None):
p.(None):
p.(None): Art. 194m. (new – SG, 102/2012, in force from 21.12.2012) (1) The dates of submission of the periodic updated
p.(None): safety reports for the medicinal products under art. 194l shall be calculated according to the reference date
p.(None): of the European Union.
p.(None): (2) The reference date of the EU under Para. 1 is:
p.(None): 1. the ate of the first marketing authorisation in the European Union of the medicinal
p.(None):
p.(None): product, containing the relevant active substance or the relevant combination of the active substances, or
p.(None): 2.the earliest of the known dates of the marketing authorisations of the medicinal product, containing the relevant
p.(None): active substance or the relevant combination of active substances, if the date, indicated in p. 1 cannot be found.
p.(None):
p.(None):
p.(None): Art. 194n. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder of
p.(None): medicinal products under Art. 194l may submit a motivated request to the Committee of Medicinal Products for human use
p.(None): or to the coordination group under Art. 77, Para. 2 for defining the reference date of the EU or for change of the
p.(None): frequency of submitting periodic updated vigilance reports on one of the following grounds:
p.(None): 1. reasons, related to public health;
p.(None): 2. in order to be avoided duplicating of an assessment;
p.(None): 3. in order to be reached international harmonisation.
p.(None): (2) The Committee on Medicinal Products for human use, or the coordination group under Art. 77, Para. 2 after
p.(None): consultations with the committee under Art. 56a, Para. 1, p. 1 shall approve the request or shall make a motivated
p.(None): refusal.
p.(None): (3) The frequency of submitting and the reference ate of the EU shall be defined after consultation with the committee
p.(None): under Art. 56a, Para. 1. P. 1 by:
p.(None): 1.The Committee on Medicinal Products for human use – where at least on of the marketing authorisations
...

p.(None): 5.
p.(None):
p.(None):
p.(None): Art. 194s. (new – SG, 102/2012, in force from 21.12.2012).(1) In case of single assessment of periodic
p.(None): updated safety reports of medicinal products under Art. 194l and where
p.(None):
p.(None): at least one of the marketing authorisations has been issued under Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council, the Committee of the medicinal products for human use within the term of 30 days from
p.(None): receiving the recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping,
p.(None): changing, termination or interruption of the validity of the relevant marketing authorisations, including a schedule
p.(None): for the opinion implementation.
p.(None): (2) Where the opinion under Para. 1 expresses a position for undertaking regulatory actions in relation to the
p.(None): marketing authorisations, the European Commission shall:
p.(None): 1. adopt as decision for change, termination or interruption of the marketing authorisations,
p.(None): issue under Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt decision with a recommendation for change, termination or interruption of the marketing authorisations, issued
p.(None): by the relevant Member States regulatory bodies.
p.(None): (3) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 2, p. 2.
p.(None):
p.(None): Section IV.
p.(None): Urgent Procedure at European Union Level. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194t. (new – SG, 102/2012, in force from 21.12.2012) (1) Urgent procedure at the level of the European Union may
p.(None): be initiated by the European Commission, by the European Medicines Agency or by a Member State.
p.(None): (2) (amend. – SG 18/14) The BDA shall initiate an urgent procedure under this section by notification of the regulatory
p.(None): bodies of the other Member States, the European Medicines Agency and the European Commission where upon
p.(None): considerations, related with pharmaco- vigilance considers, that for a certain medicinal product, placed on the
p.(None): Bulgarian market, one of the following measures are needed to be undertaken:
p.(None): 1. termination or interruption of the marketing authorisation;
p.(None): 2. prohibition of distribution of the medicinal product;
p.(None): 3. issuing a refusal for renewing the marketing authorisation.
p.(None): (3) (amend. – SG 18/14) The BDA shall initiate the procedure under Para. 2 where they are advised by the marketing
p.(None): authorisation holder that, for reasons related to tracing of drug safety, they terminate the distribution of the
p.(None): medicinal product or they have undertaken or they intend to undertake actions for its withdrawal from the market, or
p.(None): will not undertake actions for the renewal of the issued marketing authorisation.
p.(None): (4) (amend. – SG 18/14) The BDA may initiate the procedure under par. 2 in the cases where they consider that for
p.(None): reasons, related to tracing of drug safety, regarding a particular medicinal product new counter-indications may be
p.(None): added or the recommended dose should be reduced, or the indications shall be limited.
p.(None): (5) (amend. – SG 18/14) The BDA shall submit to the European Medicines Agency and to the regulatory authorities of the
...

p.(None): Bulgaria of his intention to effect parallel import and provide a sample of the parallel imported medicinal product
p.(None): upon request;
p.(None): 2. keep the following information for 5 years: name and address of the person whom the parallel imported medicinal
p.(None): product is to be delivered to, date of delivery, delivered quantity, and batch number;
p.(None): 3. submit in BDA:
p.(None): a) actualised patient’s leaflet of parallel imported product according with the variations in issued marketing
p.(None): authorisation of the approved medicinal product in Republic of Bulgaria;
p.(None): b)(Amen. - SG 71/2008, in force from 12.08.2008) declaration that the content of the leaflet according to letter "a"
p.(None): shall be identical with the content of the product leaflet, approved in Republic of Bulgaria except of the data
p.(None): according to Art. 215, para 2, point 7, letters "a" – "d";
p.(None): 4. document and report to the marketing authorisation holder and the BDA all reports of adverse drug reactions of the
p.(None): imported medicinal product.
p.(None):
p.(None): Chapter nine.
p.(None): "B" EXPORT OF MEDICINAL PRODUCTS (NEW – SG 18/14)
p.(None):
p.(None): Art. 217a. (new – SG 18/14) (1) Export of medicinal products from the territory of the Republic of Bulgaria may be done
p.(None): by a natural person or a legal entity holding a permit for wholesale with medicinal products or by a holder of a
p.(None): production license.
p.(None): (2) Holders of a production license may carry out export only of the medicinal products manufactured by them.
p.(None): (3) Within the meaning of this Chapter, export shall also be an intra-Community supply within the European Union.
p.(None): (4) Export of medicinal products included in the Positive Medicines List referred to in Art. 262, par. 1 from the
p.(None): territory of the Republic of Bulgaria shall take place upon notification of BDA in every individual case, where the
p.(None): export is being carried out by the holder of a permit for wholesale of drugs.
p.(None):
p.(None):
p.(None): Art. 217b. (new – SG 18/14) The notification referred to in Art. 217a, par. 4 shall be send to the Managing Director of
p.(None): BDA and shall contain the following information:
p.(None): 1. name and registered address of the person under Art. 217a, par. 1;
p.(None): 2. name, pharmaceutical form and active substance quantity in a dose unit of the medicinal product
p.(None): intended for export;
p.(None): 3. reference number of the permit for wholesale of medicinal products;
p.(None): 4. number of packages of the medicinal product intended for export;
p.(None):
p.(None): 5. the state of destination of the export.
p.(None):
p.(None):
p.(None): Art. 217c. (new – SG 18/14; declared anti-constitutional CCD No 1 of 2015 - SG 12/2015) (1) Upon receipt
p.(None): of a notification under Art. 217b, BDA shall request information about the medicinal product intended for export for a
p.(None): period of the last 6 months as from the day of the notification:
p.(None): 1. about the consumption of the respective medicinal product from the National Health Insurance Fund and/or from the
p.(None): Ministry of Health;
p.(None): 2. about the supplied quantities of the respective medicinal product to the Republic of Bulgaria by the holder of the
p.(None): marketing authorisation.
p.(None): (2) The persons referred to in par. 1 shall provide the information requested by BDA within 15 days after the request.
...

p.(None): vaccination, performed as provided by Art. 248, and approved by the competent authorities.
p.(None):
p.(None):
p.(None): Art. 249. The requirements to the advertising of medicinal products shall be paid down in a regulation of the Minister
p.(None): of Health.
p.(None):
p.(None):
p.(None): Art. 250. Application for authorisation of advertising of medicinal product shall be submitted by the
p.(None): marketing authorisation holder of the medicinal product or a duly empowered person.
p.(None):
p.(None):
p.(None): Art. 251. (1) For advertising authorisation the person according to Art. 250 shall submit to the BDA a formal
p.(None): application as approved by the executive director of the agency accompanied by:
p.(None): 1. design of the advertising;
p.(None): 2. notarised power of attorney issued by the marketing authorisation holder where the application shall be submitted by
p.(None): another person;
p.(None): 3. bibliographical references of the used quotations, tables, or other materials, if any;
p.(None): 4. document for paid fee to the amount as paid down in the tariff according to Art. 21,
p.(None): para 2.
p.(None): (2) The presented advertising drafts - designs to Art. 1 issue 1 must be clear and if there
p.(None): is text, it must be understandable providing possibility to assess all of its elements - text and illustrations.
p.(None): (3) Expert Council of Advertising shall be established to the BDA. It shall involve physicians and
p.(None): specialists with practical experience in the field of advertising. The executive director of the BDA shall appoint
p.(None): by an order the composition of the council, where a representatives of the Professional Ethic Commission
p.(None): of the Bulgarian Medical Association, Bulgarian Dental Association and Bulgarian Pharmacists Union, the amount of
p.(None): the remuneration
p.(None):
p.(None): of its members, and shall approve rules for the condition and order for its work. In the Council representatives of
p.(None): patients organisations may be included.
p.(None): (4) The council according to para 3 shall prepare examination to the advertising design and shall establish an opinion
p.(None): for the executive director of the BDA.
p.(None): (5) In case of establishment of discrepancies between the advertising and the requirements of this Act,
p.(None): the BDA shall, within 7 days of the submission of the application according to para 1, give written
p.(None): instructions for their elimination by the applicant within one month of the notification date. This decision term shall
p.(None): cease to run as from the notification date till the elimination of the discrepancies.
p.(None): (6) If the applicant shall not fulfil the instructions within one month of the notification date according to para 5,
p.(None): the authorisation procedure shall be terminated.
p.(None):
p.(None):
p.(None): Art. 252. (1) The executive director of the BDA shall authorise or issue a motivated refusal of the
p.(None): advertising by an order within one month of the submission of the documentation according to Art. 251, para 1, on the
p.(None): grounds of the opinion according to Art. 251, para 4, and shall notify the marketing authorisation holder.
p.(None): (2) (New – SG, 60/2011, in force from 5. 8. 2011) Where within the term under Para. 1 the executive director of BDA
p.(None): does not permit by an order the advertisement or fails to make a grounded refusal, it shall be accepted, that there is
...

p.(None): (4) The marketing authorisation holder shall have the obligation to effect the notification under par. 1 not later than
p.(None): 18 months prior to the date of discontinuation of the sales, and in the cases under par. 2 - not later than three
p.(None): months prior to the date of discontinuation of the sales.
p.(None): (5) (suppl. - SG No. 18/14) Prior to the discontinuation of the sales under Paragraphs 1 and 2, the marketing
p.(None): authorisation holder shall be obliged to secure sufficient quantities of the respective medicinal product for
p.(None): satisfying the health needs, except for in cases where
p.(None):
p.(None): discontinuation is based on any of the grounds referred to in Art. 276, or Art. 277 of this Act.
p.(None): (6) Upon expiration of the terms under par. 4, the marketing authorisation holder shall file an application with the
p.(None): relevant document for deletion of the medicinal product from the Positive Medicines List.
p.(None): (7) Where after the discontinuation of the sales of the medicinal product the marketing authorisation holder has failed
p.(None): to fulfil his obligation under par. 6, the Council under Art. 258, par. 1 shall delete it ex officio from the Positive
p.(None): Medicines List.
p.(None):
p.(None):
p.(None): Art. 265. (1) (Suppl. – SG, 60/2011, in force from 5. 8. 2011) The Council of Ministers shall establish a Transparency
p.(None): Commission.
p.(None): (2) The composition of the Transparency Commission shall be determined by the Council of Ministers according
p.(None): to a proposal by the Minister of Health. In it representatives of the Ministry of Health, the Ministry of Labour and
p.(None): Social Policy, the BDA, the NHIF, the Bulgarian Medical Association, Bulgarian Dental Association, Bulgarian
p.(None): Pharmacists Union, the professional organisation of the pharmacists, and organisations of the patients
p.(None): and the pharmaceutical industry are obligatory included.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) A person, who is
p.(None): a member of the Transparency Commission shall not be a member of the Council.
p.(None): (4) The Council of Ministers determines with Rules the condition and the order for work of the Transparency Commission.
p.(None):
p.(None):
p.(None): Art. 266. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) The
p.(None): Transparency Commission shall be a body before which decisions of the Council may be appealed.
p.(None): (2) The decisions of the Transparency Commission shall be taken by a majority of two thirds of its members.
p.(None): (3) The decisions of Para. 2 could be appealed under the terms of the Administrative Procedure Code and the appeal has
p.(None): no suspense effect.
p.(None):
p.(None):
p.(None): Art. 266a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Where the treatment of a relevant sickness is without
p.(None): alternative in the country, for a concrete patient may be applied a medicinal products, which is authorised for use in
p.(None): an EU Member State, authorised for use under this Act, but is not sold on the Bulgarian market.
p.(None): (2) Annually, upon proposal of the medical establishments for hospital assistance after an opinion of the relevant
p.(None): national consultant on the profile of the sickness, the Minister of Health shall confirm a list of the medicinal
p.(None): products under Para. 1, which shall contain the following information:
p.(None): 1. code on the anatomy-therapeutic – chemical classification;
...

p.(None): that their effects with respect to efficacy and safety are essentially similar.
p.(None): 3. "Bioavailability" shall mean the rate and degree at which an active substance or its therapeutically active part is
p.(None): absorbed from the pharmaceutical form and it becomes available at its site of action. Where the medicinal substance is
p.(None): intended to exert a systemic therapeutic effect, bioavailability shall mean the rate and degree at which the medicinal
p.(None): substance or its therapeutically active part is released from the pharmaceutical form and passes into the total
p.(None): circulation.
p.(None): 4. "Researcher’s brochure" shall mean the aggregate of clinical and non clinical data of tests of medicinal product(s),
p.(None): which are relevant to the clinical test of the product(s) in man.
p.(None): 5. "Valid documentation" shall mean any documentation which is compliant with the requirements laid down in
p.(None): a give procedure pursuant to this Act both with respect to content and
p.(None):
p.(None): completeness.
p.(None): 6. "Substance with well established use in medical practice" shall mean a substance to which the following criteria can
p.(None): be applied:
p.(None): a) the period for proving the well established use in medical practice is not less than 10 years from the date of
p.(None): the first systematised and documented use of the substance as a medicinal product in the European Union or in
p.(None): the European Economic Area;
p.(None): b) quantitative aspects of the use of the substance, taking into consideration the degree of use in medical practice,
p.(None): the degree of use on geographical principle, and the degree of follow- up through the pharmaco-vigilance system
p.(None): including pre- and post marketing studies and published scientific literature for epidemiological studies
p.(None): and comparative epidemiological studies in particular;
p.(None): c) high degree of scientific interest in the use of the substance (number of scientific publications) and coherence
p.(None): in scientific assessments.
p.(None): 7. "Outer packaging" shall mean the packaging, which does not come in immediate contact with the medicinal
p.(None): product.
p.(None): 8. "Contracting authority" shall mean a natural or legal person, institution, or organisation responsible for the
p.(None): start-up, management, and/or financing of a clinical test.
p.(None): 9. "Generic medicinal product" shall mean a medicinal product, which has the same qualitative and quantitative
p.(None): composition as regards the active substances and the same pharmaceutical form as the reference medicinal
p.(None): product and its bioequivalence compared to the reference medicinal product has been proven in adequate
p.(None): bioavailability studies. Various immediate release oral pharmaceutical forms shall be regarded as the same
p.(None): pharmaceutical form. Various salts, esters, ethers, isomers, mixtures of isomers, complexes, or derivatives of an
p.(None): active substance shall be regarded as the same active substance except if these are significantly
p.(None): different in respect of safety and/or efficacy.
p.(None): 10. "Principal researcher" shall mean an appointed by the contracting authority medical doctor or doctor in dental
p.(None): medicine who is managing the overall conduct of a clinical test in compliance with an approved protocol and the rules
p.(None): for Good Clinical Practice and is responsible for the work of the researchers.
p.(None): 11. "Defined daily dose" shall be the mean daily maintenance dose of a given medicinal product, which administered to
p.(None): adults according to the main indication of a medicinal product.
p.(None): 12. "Good clinical practice" shall mean the aggregate of internationally recognised ethical and scientific
p.(None): quality requirement, which shall be observed during the planning, conduct, accounting, and reporting of clinical
p.(None): trials.
p.(None): 13. "Good laboratory practice" shall mean a system of rules in respect if the conditions for planning, processes of
p.(None): organizing, conduct, follow up, and documenting of laboratory tests.
p.(None): 14. "Good manufacturing practice" shall mean a system of rules encompassing all aspects of manufacture:
p.(None): personnel, premises, equipment, materials, documentation, and quality control and has the purpose of ensuring safety,
p.(None): efficacy, and compliance with a specification.
p.(None): 15.. (Suppl. - SG 71/2008 in force from 12.08.2008) "Member State" shall mean a State Member of the European Union, or
p.(None): a State, party of the Agreement of the EEA.
p.(None): 16. "Labeling" shall mean information on the immediate or outer packaging of a medicinal product.
p.(None): 17. "Immunological medicinal product" shall mean a medicinal product, which contains vaccines, toxins, sera, or
p.(None): allergens. Agents used to create active immunity or establish a condition of immunity or invoke passive
p.(None): immunity shall be involved in the scope of vaccines, toxins, and sera. Allergens shall mean medicinal products,
p.(None): which are intended to identify or stimulate specific purposeful change in the immunological response to an allergens
p.(None): agent.
p.(None): 18. "Bioequivalence study" shall mean a clinical test aimed at proving that two medicinal
p.(None):
p.(None): products are bioequivalent provided that they are pharmaceutically equivalent or pharmaceutical alternatives and
p.(None): provided that their bioavailability after administration of the same molar dose are similar to a degree, which is a
p.(None): condition for equivalence in respect of efficacy and safety.
p.(None): 19. "Bioavailability study" shall mean a clinical test aimed at showing what is the rate and degree which an active
p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
...

p.(None): advertising.
p.(None): 35a. (new – SG 1/14, in force from 03.01.2014)”Medical prescription” shall mean a prescription of a
p.(None): medicinal product, issued by a person who exercises a regulated medical profession within the meaning of § 1,
p.(None): item 1 of the Additional Provisions of the Recognition of Professional Qualifications Act and who is legally entitled
p.(None): to do so in the Member State in which the medical prescription is issued.
p.(None): 36. "Multicentre clinical test" shall mean a clinical test, which is conducted according to a single protocol but in
p.(None): more than one site and by more than one researcher. Researcher sites can be situated in the territory of one Member
p.(None): State, more than one Member State, and/or in Member States and third states.
p.(None): 37. "Name of a medicinal product" shall mean the name given to a medicinal product, which can be:
p.(None): a) a freely selected name (trade name);
p.(None): b) (amend. – SG 12/11, in force from 08.02.2011) a common name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation;
p.(None): c) (amend. – SG 12/11, in force from 08.02.2011) scientific name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation.
p.(None): 38. "Scientific literature" shall mean publication(s) of results from scientific research in specialised international
p.(None): scientific editions.
p.(None):
p.(None): 39. "New active substance" shall mean:
p.(None): a) chemical, biological, or radiopharmaceutical substance, which has not been authorised to market in
p.(None): the European Union as a medicinal product;
p.(None): b) isomer, mixture of isomers, complex or derivative or salt of a chemical substance, which has been authorised to
p.(None): market in the European Union as a medicinal product but is different with respect to safety and efficacy from
p.(None): a formerly authorised substance;
p.(None): c) biological substance, which has been authorised to market in the European Union as a medicinal product but has
p.(None): different molecular structure, different origin with respect to the starting material, or has been obtained
p.(None): through a different manufacturing process;
p.(None): d) radiopharmaceutical substance the radionuclides or molecular bonds (ligands) of which have not been
p.(None): authorised in the European Union as a medicinal product or the mechanism of bonding in a couple of the molecules
p.(None): and radionuclides has not been authorised in the European Union.
p.(None): 40. "Adverse event" shall mean any untoward unfavorable change the health condition observed during the administration
p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
...

p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
...

p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
p.(None): § 3. The Council of Ministers shall determine the conditions and order for the supply, storage and renewal of the
p.(None): medicinal products kept in the State Agency "State Reserve and War-time Reserves".
p.(None):
p.(None):
p.(None): § 4. (suppl. – SG 18/14) This Act shall implement the provisions of Directive 2001/83/EC of the European Parliament
p.(None): and the Council on the Community code relating to medicinal products for human use subsequently amended
p.(None): by Directive 2004/27/EC of the European Parliament and the Council and of Directive 2012/26/EU of the European
p.(None): Parliament and of the Council of 25 October 2012.
p.(None):
p.(None):
p.(None): § 5. The data protection periods for reference medicinal products shall be applied according to the
p.(None): provisions of Art. 89 of Regulation (EC) № 726/2004 of the European Parliament and the Council and Art. 2 of Directive
p.(None): 2004/27/EC of the European Parliament and the Council
p.(None):
p.(None):
p.(None): § 5a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG, 102/2012, in force from 21.12.2012) The Ministry
p.(None): of Health, the National Council on prices and reimbursement of medicinal products, the BDA and the Regional health
...

p.(None): No 10 of the Constitutional Court from 1996; amended, State Gazette No 38 from 1998, No 30 from 1999, No 10 from 2000,
p.(None): No 37 from 2000 - Decision No 3 of the Constitutional Court from 2000; amended, State Gazette No 59 from 2000, No 78
p.(None): from 2000 - Decision № 7 of the Constitutional Court from 2000; amended, State Gazette No 41 from 2001, No 107 and 120
p.(None): from 2002; amended, State Gazette No 2 from
p.(None): 2003; amended, State Gazette No 56, 71 and 112 from 2003, No 70 and 111 from 2004,
p.(None): No 37, 76, 85, 87, 99 and 105 from 2005, No 30, 31, 34, 75 and 105 from 2006) is repealed, with exception of the
p.(None): Regulation of Art. 10, para 2, which is applied for term to one year since the day of the coming in the force of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 7. (1) The marketing authorisations for medicinal products published before the entering into force of
p.(None): this Act under national procedure, which are authorised also in a Member States under centralised procedure shall cease
p.(None): to be valid as from 1 January 2007.
p.(None): (2) The marketing authorisations for medicinal products issued up to the entering into force of this Act under national
p.(None): procedure shall be brought into line with the requirements at the date of their renewal.
p.(None): (3) The marketing authorisations for medicinal products falling within the scope of Regulation (EC) 726/2004
p.(None): of the European Parliament and the Council and which have issued marketing authorisation under the terms of the
p.(None): repealed Medicines and Pharmacies in Human Medicine Act as materially similar products, but which have no
p.(None): marketing authorisation in European Union under the centralised procedure shall cease to be valid.
p.(None): (4) The medicinal products which have been issued marketing authorisation in the European Union under the
p.(None): centralised procedure, which national marketing authorisation is ceased under the terms of para 1, can be sold
p.(None): on the territory of Republic of Bulgaria in packages and with leaflets according to the ceased national marketing
p.(None): authorisation for a time limit not longer than one year since the date of its cessation.
p.(None):
p.(None):
p.(None): § 8. (1) The setting up of ceiling prices and the registered prices under the terms of the repealed Medicines and
p.(None): Pharmacies in Human Medicine Act of the medicinal product, which have marketing authorisation in the European Union
p.(None): according to the centralised procedure, which national marketing authorisation is suspended under the terms of
p.(None):
p.(None):
p.(None): § 7, para 1, remain in force for a time limit of one year from the date of its cessation.
p.(None): (2) The setting up of ceiling prices and registered prices under the terms of the repealed Medicines and Pharmacies in
p.(None): Human Medicine Act of the medicinal products, other than those according to para 1 remain in force for a time limit
p.(None): expiring on 31 December 2007.
p.(None):
p.(None): § 9. (1) The applications for marketing authorisation, renewal, modification of the published authorisation,
p.(None): which are submitted up to the entering into force of this Act are reviewed and closed according to the terms and the
p.(None): conditions provided for herein.
p.(None): (2) The submitted applications and documentations for marketing authorisation for medicinal products falling
p.(None): within the scope of the procedure provided for in Art. 74 and also according to Art. 75 shall be brought into
p.(None): line with the requirements of this Act within three months from its entering into force.
p.(None): (3) When in the case provided for in para 2, the application and the documentation under para 2 have not been brought
p.(None): into line with the requirements of this Act, the procedure of their review shall be terminated.
p.(None):
p.(None):
p.(None): § 10. (1) The clinical trials which were approved before this Act comes in force shall be finished according to under
p.(None): the conditions prevailing hitherto.
p.(None): (2) The applications for conduction of the clinical trial on the territory of Republic of Bulgaria are
p.(None): submitted, reviewed and closed according to the terms and conditions of this Act after the regulation according Art.
p.(None): 82, para 3 comes in force.
...

Social / Unemployment

Searching for indicator unemployed:

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p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
...

Social / Victim of Abuse

Searching for indicator abuse:

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p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
...

Social / Women

Searching for indicator women:

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p.(None): clinical trials is permitted provided that:
p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
...

Social / Youth/Minors

Searching for indicator minor:

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p.(None): (3) The informed consent according to para 1, point 3, and para 2 can only be given by a capable person who
p.(None): understands the essence, importance, scope, consequences, and eventual risks of the clinical test. Informed
p.(None): consent to participate in a clinical test can be withdrawn at any time.
p.(None): (4) The informed consent according to para 1, point 3, of an incapable major person shall be given by his/her
p.(None): legal representative. The consent of the legal representative must represent the supposed will of the subject
p.(None): and can be withdrawn at any time without negative consequences for the subject.
p.(None): (5) In the cases according to Art. 162, para 3 of the Health Act, informed consent shall be given by the person
p.(None): appointed by the court.
p.(None): (6) An incapable person shall be given information about the clinical test, eventual risks, and benefits in accordance
p.(None): with his/her capability to understand.
p.(None): (7) The explicit will of an incapable major person to refuse to participate in or to withdraw from the clinical test at
p.(None): any time must be taken into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None):
p.(None): Art. 97. (1) A clinical test in a minor person shall be conducted after obtaining written informed consent by both
p.(None): subject’s parents or guardians with observation of Art. 96, para 1 and 3.
p.(None): (2) Parents’ or guardians’ consent must represent the supposed will of the minor person and can be withdrawn at any
p.(None): time without negative consequences for the minor person.
p.(None): (3) The express will of the minor person to participate or to at any time withdraw from the clinical test must be taken
p.(None): into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (4) A clinical test in a minor person shall be conducted after obtaining written informed consent by both parents and
p.(None): the guardian in compliance of Art. 96, para 1 and 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, the written informed consent shall be given
p.(None): by the parent who is exercising the parental rights.
p.(None): (5) Minor’s, parents’ and guardian’s’ consent can be withdrawn at any time without negative consequences
p.(None): for the minor person.
p.(None): (6) The express will of the minor person to at any time withdraw from the clinical test must be taken into
p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
p.(None): contain contact details of an independent person for additional information.
p.(None):
p.(None): Section .
p.(None): Clinical Trials in Vulnerable Patient Groups
p.(None):
p.(None): Art. 100. A clinical test in minor or underage persons can be undertaken provided that:
p.(None): 1. the study protocol has been approved by the respective ethics committee after discussion of the
p.(None): clinical, moral, and psycho-social aspects of childhood age in which at least two paediatricians have participated;
p.(None): 2. there is an anticipated direct benefit of the clinical test for the patient group, which is to be included;
p.(None): 3. the study is directly associated with the clinical condition from which the minor or underage person is suffering;
p.(None): 4. the study medicinal product is designated for the diagnosis, treatment, or prophylaxis of diseases, which are
p.(None): specific for minor or underage persons;
p.(None): 5. the study is designated to be conducted in minor or underage persons;
p.(None):
p.(None): 6. the study purpose is to check data obtained in clinical trials in persons who are capable of giving
p.(None): informed consent or of data obtained by other research methods;
p.(None): 7. the results obtained from clinical trials in adults and the interpretation thereof cannot be considered also valid
p.(None): for minor or underage persons;
p.(None): 8. the study is planned in a manner that pain, inconvenience, fear, and other disease- associated foreseeable risks are
p.(None): minimised and the risk threshold and physical pain degree have been determined in advance and shall be incessantly
p.(None): controlled throughout the clinical test;
p.(None): 9. the study has been planned and shall be conducted in compliance with the guidelines of the European Medicines
p.(None): Agency;
p.(None): 10. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 101. (1) Clinical trials in the persons according to Art. 96, para 4 and 5, who are not capable of giving informed
p.(None): consent, shall be conducted in compliance with the requirements of Art. 90.
p.(None): (2) Except for the requirements of para 1, inclusion of major persons who are not capable of giving informed consent in
p.(None): clinical trials is permitted provided that:
p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
...

p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
p.(None): (2) The committees according to para 1 shall include at least two persons of non-medical education, representatives of
p.(None): both genders, who are financially and administratively independent of the healthcare establishment where the clinical
p.(None): test is to be conducted.
p.(None): (3) The committees according to para 1 can involve external specialists for the needs of their work.
p.(None): (4) In clinical trials in minor or underage persons the respective ethics committee at the healthcare establishment can
p.(None): involve external experts in order to facilitate its work.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): years.
p.(None): Art. 105. (1) The mandate of the ethics committee members shall have duration of 4
p.(None):
p.(None): (2) One half of the composition of the ethics committees shall be renewed every 2 years.
p.(None): (3) A member of an ethics committee cannot be appointed in the same committee for
p.(None): more than two consecutive mandates.
p.(None):
p.(None):
p.(None): Art. 106. (1) The ethics committees according to Art. 103, para 1 and 2, shall draw written standard operating
p.(None): procedures in compliance with the rules for Good Clinical
p.(None): Practice, which shall determine the conditions and order for their work within one month from its establishment.
p.(None): (2) The standard operating procedures of the ethics committees shall be approved by the executive director of the BDA.
p.(None): (3) The sessions of the ethics committees shall be held in camera. In case of necessity, the chairman of the ethics
p.(None): committee can invite the contracting authority or the principal researcher to participate.
...

Social / education

Searching for indicator education:

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p.(None): 6. precautions and safety measures during storage of the medicinal product, its administration to patients
p.(None): and for the disposal of waste products together with an indication of potential risks for the environment;
p.(None): 7. description of the method of manufacture;
p.(None): 8. description of the control methods employed by the manufacturer;
p.(None): 8a (new – SG, 102/2012, in force from 02.01.2013) declaration, that the audit results under Art. 160, Para. 2,
p.(None): conducted by the manufacturer of the medicinal product confirm that the active substance has been produced in
p.(None): compliance with the principles and directives for good production practice; the declaration shall indicate the date on
p.(None): which the audit is conducted;
p.(None): 9. assessment of the potential risks presented by the medicinal product for the environment for every
p.(None): individual case and measures for the limitation thereof;
p.(None): 10. results of:
p.(None): a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.(None): b) preclinical (toxicological and pharmacological) tests;
p.(None): c) clinical trials;
p.(None): 11. declaration that the ethic principles of the Good Manufacturing Practice have been complied with in the clinical
p.(None): trials conducted outside the territory of the Member States;
p.(None): 12. (amend. – SG, 102/2012, in force from 21.12.2012) a summary of the system
p.(None): a) for vigilance the medicinal safety, which shall include the following elements:
p.(None): b) which is to be implemented and, where appropriate, description of the risk management system;
p.(None): c) name of the qualified person under Art. 191, a CV – education, acquired professional experience in the area of
p.(None): vigilance the medicinal safety and qualification for performing his/her duties under Chapter Eight;
p.(None): d) each Member state in which the qualified person fulfils his/her duties;
p.(None): e) address, tel. fax, e-amil address of the person under letter "a";
p.(None): f) address, at which the basic document is kept of the system for vigilance medicinal
p.(None): safety;
p.(None): 12a. (new - SG, 102/2012, in force from 21.12.2012) declaration by the applicant that
p.(None): he/she has the needed means for fulfilling the obligations under Chapter Eight;
p.(None): 13. (amend. -SG, 102/2012, in force from 21.12.2012) plan for risk management with a description of the system for risk
p.(None): management, which the applicant will introduce for the relevant medicinal product with the plan summary;
p.(None): 14. summary of product characteristics according to Art. 34;
p.(None): 15. mock-up of the immediate and outer packaging of the product and a proposed package leaflet in
p.(None): compliance with the requirements of chapter six;
p.(None): 16. copy of the manufacturing authorisation issued by the regulatory authority of the
p.(None):
p.(None): country where manufacture is performed accompanied by a Good Manufacturing Practice certificate or a
p.(None): certificate evidencing that the manufacture of the medicinal product and the active substances contained in its
p.(None): composition has been performed in compliance with standards, which are at least equivalent to the standards of
p.(None): the Good Manufacturing Practice;
p.(None): 17. copy of a document evidencing that the medicinal product is designated for treatment, prophylaxis, or diagnostics
...

p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
p.(None): (2) The committees according to para 1 shall include at least two persons of non-medical education, representatives of
p.(None): both genders, who are financially and administratively independent of the healthcare establishment where the clinical
p.(None): test is to be conducted.
p.(None): (3) The committees according to para 1 can involve external specialists for the needs of their work.
p.(None): (4) In clinical trials in minor or underage persons the respective ethics committee at the healthcare establishment can
p.(None): involve external experts in order to facilitate its work.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): years.
p.(None): Art. 105. (1) The mandate of the ethics committee members shall have duration of 4
p.(None):
p.(None): (2) One half of the composition of the ethics committees shall be renewed every 2 years.
p.(None): (3) A member of an ethics committee cannot be appointed in the same committee for
p.(None): more than two consecutive mandates.
p.(None):
p.(None):
p.(None): Art. 106. (1) The ethics committees according to Art. 103, para 1 and 2, shall draw written standard operating
p.(None): procedures in compliance with the rules for Good Clinical
p.(None): Practice, which shall determine the conditions and order for their work within one month from its establishment.
p.(None): (2) The standard operating procedures of the ethics committees shall be approved by the executive director of the BDA.
...

p.(None):
p.(None):
p.(None): Art. 197. The persons according to Art. 195 shall dispose of:
p.(None): 1. suitable premises, equipment and outfits, and transport vehicles ensuring correct storage, distribution,
p.(None): and transportation of the medicinal products in compliance with the requirements of the Good Distribution
p.(None): Practice;
p.(None): 2. personnel and responsible master-pharmacist with at least two years length of service in his speciality and whose
p.(None): obligations shall be laid down in the regulation according to Art. 198.
p.(None):
p.(None):
p.(None): Art. 198. (amend. – SG, 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.(None): Distribution Practice of medicinal products and of active substances shall be adopted by an ordinance of the Minister
p.(None): of Health and by directives, adopted by the European Commission.
p.(None):
p.(None):
p.(None): Art. 199. (1) The persons according to Art. 195, para 2, shall submit to the BDA:
p.(None): 1. application containing name, place of business and address of management of the trader; address and description of
p.(None): the premises and equipment for the storage of the medicinal products;
p.(None): 2. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification
p.(None):
p.(None): code of the trader of cooperation from the Trade Register and for the companies, registered in a EU Member State or
p.(None): a state – party on the EEA Agreement – a document for updated registration according to the national
p.(None): legislation, issued by a competent body of the relevant state;
p.(None): 3. name, certificate of clean court record, diploma for higher education and length of service for the responsible
p.(None): master - pharmacist according to Art. 197, point 2, and a copy of his/her employment contract;
p.(None): 4. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 5. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 6. document certifying the legal grounds for the use of the premises;
p.(None): 7. (amend., - SG 98/10, in force from 01.01.2011) conclusion of the Regional Health Inspectorates after inspection on
p.(None): the spot evidencing that the health requirements in the whole sale premises according to the regulation according to
p.(None): Art. 198.
p.(None): 8. document for paid fee as laid down in the tariff Art. 21, para 2.
p.(None): (2) The persons according to Art. 195, para 1, shall submit to the BDA an application accompanied by the following
p.(None): documents:
p.(None): 1. copy of the wholesale authorisation issued by a regulatory body of a Member State;
p.(None): 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.(None): 3. address of the premises for the storage of the medicinal products on the territory of the Member State.
p.(None): (3) In case of wholesale of narcotic substances, as well as pharmaceutical forms containing such
p.(None): substances, the requirements of the Control on Drugs and Precursors Act shall also be applied.
p.(None): (4) In case of wholesale of radiopharmaceuticals, an opinion of the Nuclear Regulatory Agency shall also be submitted.
p.(None):
p.(None):
p.(None): Art. 200. The BDA shall assess the documentation the documentation and conduct an inspection on the spot of the sites
p.(None): mentioned in the application to certify their compliance with the requirements of the Good Distribution Practice.
p.(None):
p.(None):
...

p.(None): (4) (new – SG 18/14) Where the wholesalers supply medicinal products to persons in third countries, they certify by
p.(None): relevant documents that the supplies are solely for persons, holding a permit or having got the right to
p.(None): receive medicinal products intended for wholesaling or for supplying to individuals subject to compliance with the
p.(None): applicable national laws of the third country.
p.(None): (5) (prev. par. 3 – SG 18/14) A wholesale trader, who delivers medicinal products to persons from third states, which
p.(None): have the right under the relevant national legislation to deliver medicinal products to the consumers, shall issue a
p.(None): document ,which shall certify:
p.(None): 1. date of delivery;
p.(None): 2. name and form of the medicinal product;
p.(None): 3. delivered quantity;
p.(None): 4. name and address of the person, to whom the medicinal product has been delivered;
p.(None): 5. lot number.
p.(None):
p.(None):
p.(None): Art. 210. (Amend. – SG, 60/2011, in force from 5. 8. 2011) (1) The holder of the authorisation for use
p.(None): and the person under Art. 26, Para. 2 may provide samples of authorised medicinal products to:
p.(None): 1. physicians and physicians in dental medicine;
p.(None): 2. higher medical schools and medical colleges;
p.(None): (2) In the cases according to para 1, the packaging of the medicinal products shall bear an inscription "Sample".
p.(None): (3) The persons according to para 1, point 1, maid be supplied not more than two pieces of the same pharmaceutical form
p.(None): of a medicinal product in one calendar year in the smallest existing pack of a manufacturer, and the higher medical
p.(None): schools and medical colleges – only in quantities required for the purposes of the education.
p.(None): (4) The holder of the authorisation for use and the person under Art. 26, Para. 2 shall keep record of all persons whom
p.(None): they have delivered samples to, about the type, quantity, and time of delivery and shall provide this data to the
p.(None): control bodies upon request.
p.(None):
p.(None):
p.(None): Art. 211. (1) The wholesalers must have a system for blocking and recall of medicinal products, which have shown
p.(None): discrepancies with the requirements relating to quality, safety, and efficacy.
p.(None): (2) The holder of approval for wholesale is duty to freeze and draw out medicinal product, which showed discrepancies
p.(None): with the requirement for quality, safety and efficacy based on the order, determined in the regulation according Art
p.(None): 274, para 1.
p.(None):
p.(None):
p.(None): Art. 212. (1) The executive director of the BDA shall notify the European Commission, the regulatory bodies of the
p.(None): other Member States, and the European Medicines Agency for the issued wholesale authorisations, temporarily
p.(None): stopped, or bereaved authorisations and the
p.(None):
p.(None): reasons therefore.
p.(None): (2) (amend. – SG, 102/2012, in force from 02.01.2013) Where the executive director of the BDA has established that
p.(None): the person according to Art. 195, Para. 1, does not fulfill its obligations according to Art. 207, Para. 1,
p.(None): points 2-14, he shall notify the regulatory body of the Member State, which has issued the wholesale
p.(None): authorisation, as well as the European Commission.
p.(None): (3) Where the regulatory body according to para 2 has temporarily stopped or bereaved the wholesale authorisation of
p.(None): the person according to Art. 195, para 1, it shall notify the executive director of the BDA and the
p.(None): European Commission.
p.(None):
p.(None):
...

p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
p.(None): Art. 239. (1) (amend. – SG, 60/2011, in force from 5. 8. 2011) Drugstores shall be opened after
p.(None): registration at the relevant RHI.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 238,
p.(None):
p.(None): para 2, shall submit to the RHI a registration application accompanied by the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
p.(None): In the cases, where it is found that the requirements of the Ordinance under Art. 243 have not been observed,
p.(None): within 7 day term after the inspection the RHI shall give instructions and shall determine term for removing them.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011). Within 14 day term from receiving the application and the
p.(None): documents under Para. 2, the director of RHI shall notify in writing the persons for finding irregularities
p.(None): in them and shall determine a term for their removal.
p.(None): (5) (New – SG, 60/2011, in force from 5. 8. 2011). For submitting a registration application for a drug
p.(None): store or for performing a change under Art. 242, the relevant RHI shall collect charges in the amount, determined by
p.(None): the tariff under Art. 21, Para. 2.
p.(None):
p.(None):
p.(None): Art. 240 (Amend. - SG, 60/2011, in force from 5. 8. 2011). Within 14 day term after the inspection under Art. 239,
p.(None): Para. 3 or after removing the irregularities under Art. 239, Para. 4, the director of the RDA shall issue a
...

p.(None): within the validity of its marketing authorisation.
p.(None): (2) Where there have been variations in the marketing authorisation of a medicinal product resulting in
p.(None): changes of an authorised advertising of this product, the marketing authorisation holder shall submit to the
p.(None): BDA an application for change.
p.(None):
p.(None):
p.(None): Art. 254. In case of change in the authorised advertising, the person according to Art.
p.(None): 250 shall submit an application under the terms of Art. 251.
p.(None):
p.(None):
p.(None): Art. 254a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) The advertisement, intended for the medical specialists
p.(None): shall not be permitted under Art. 250 – 252.
p.(None): (2) The advertisement under Para. 1 shall be disseminated after submitting a notification to BDA, which shall contain
p.(None): an advertisement draft, while observing the requirements of this Chapter and the Ordinance under Art. 249.
p.(None):
p.(None):
p.(None): Art. 255. (1) The proliferation of samples of medicinal products containing narcotic substances within the
p.(None): meaning of the Control on Drugs and Precursors Act shall be prohibited.
p.(None): (2) The direct provision of samples of medicinal products to the population by medical trade representatives according
p.(None): to Art. 244, para 1, point 3 shall be prohibited.
p.(None):
p.(None): Art. 256. Samples of medicinal products shall be provided to medical specialists under the conditions and order laid
p.(None): down in the regulation according to Art. 249.
p.(None):
p.(None):
p.(None): Art. 257. (1) The medical trade representatives according to Art. 245, para 2, point 3, must have passed special
p.(None): education organised by the marketing authorisation holder who has employed them and must possess scientific knowledge
p.(None): about the presented medicinal product.
p.(None): (2) During any visit, the medical trade representatives must dispose of the summary of the product characteristics and
p.(None): price data of the medicinal product and about the conditions of its payment and shall provide these upon request.
p.(None): (3) While presenting medicinal products before medical specialists, the medical trade representatives cannot offer
p.(None): gifts and other material and immaterial benefits.
p.(None):
p.(None): Chapter twelve.
p.(None): REGULATION OF PRICES OF MEDICINAL PRODUCTS (TITLE, AMEND. – SG 102/2012)
p.(None):
p.(None): Section I.
p.(None): National Council on Prices and Reimbursement of Medicinal Products (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 258. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) (1)
p.(None): (amend. – SG 43/16) Under the Minister of Health shall be established National Council on Prices and
p.(None): Reimbursement of medicinal products, called hereinafter "The Council". The Council shall be a legal
p.(None): persons, a second level budget administrator. Its status is of a state commission with a central office in Sofia.
p.(None): (2) The Council activity shall be funded by the state budget through the budget of the Ministry of Health.
p.(None): (3) The Council shall be a college body and shall consist of a Chairperson and 6 members of whom 3 shall
p.(None): be medical doctors or Master-Pharmacists, 2 layers and 2 economists, all with at least 5 years professional
p.(None): practical experience. The chairperson and the Council members shall be elected and discharged by a decision of
...

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p.(None): When activities according para 2, point 3 carried out, the Ministry of Health collect taxes in amount, determined in
p.(None): tariff according to Art. 21, para 2.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None):
p.(None):
p.(None): Art. 15. (1) Pharmacopoeia Committee shall be established with the Minister of Health as a consulting body on issues
p.(None): relating to the current pharmacopoeia.
p.(None): (2) The Minister of Health shall, on the grounds of a proposal of the Executive Director of the BDA determine by an
p.(None): order the composition of the Pharmacopoeia Committee and the expert groups thereto and shall approve the regulation
p.(None): relating to their activity.
p.(None): (3) The activity of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 16. (1) Higher Council of Pharmacy shall be established to the Minister of Health as a consulting body on issues
p.(None): relating to pharmacy. It shall be composed by five representatives appointed by the Minister of Health, five
p.(None): representatives from Bulgarian Pharmaceutical Union, two representatives from National Health Insurance Fund (NHIF) and
p.(None): one representative from Faculty of pharmacy of the high medicinal schools. The Minister of Health is a chairman of the
p.(None): council without right of vote.
p.(None): (2) The Higher Council of Pharmacy is consultative body, which discuss and provide statements for:
p.(None): 1. Basic approaches and priorities in the pharmaceutical area;
p.(None): 2. Ethical problems of the pharmacy;
p.(None): 3. Projects for normative acts, related with the pharmacy;
p.(None): 4. The scientific priorities in the area of pharmacy;
p.(None): 5. Programs for organisation of social educational campaign in the area of medicinal products.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None): (4) The organisation and the activity of the Higher Council of Pharmacy are settled with ordinance issued by the
p.(None): Minister of Health, after proposal of Higher Council of Pharmacy.
p.(None):
p.(None):
p.(None): Art. 17. (1) The Bulgarian Drug Agency shall be a specialised body at the Minister of Health for the surveillance on
p.(None): the quality, safety, and efficacy of the medicinal products.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) The Bulgarian Drug Agency shall be a legal entity budget financed with
p.(None): registered office in the city of Sofia with the Minister of Health.
p.(None): (3) The Bulgarian Drug Agency shall be managed and represented by an Executive Director who shall be appointed under
p.(None): the terms of the Administration Act.
p.(None): (4) The structure, functions, and work organisation of the Bulgarian Drug Agency shall be regulated by statutes adopted
p.(None): by the Council of Ministers.
p.(None): (5) The Bulgarian Drug Agency shall:
p.(None): 1. issue manufacture authorisation for medicinal products;
p.(None): 2. issue marketing authorisations and registration certificated for medicinal products;
p.(None): 3. issue authorisations for wholesale of medicinal products;
p.(None): 4. issue authorisations for parallel import of medicinal products;
p.(None):
p.(None): 5. (amend. – SG, 60/2011, in force from 05.08.2011), issue, refuse or terminate authorisations for retail
p.(None): trade with medicinal products;
...

p.(None): medicinal products intended for clinical trials.
p.(None): (4) Manufacturing authorisation shall also be required for persons who perform simultaneously or separately
p.(None): one of the following activities: complete or partial manufacture of active substances intended for the manufacture of
p.(None): medicinal products and various processes of packaging, retail packaging, repackaging, and re-labelling of active
p.(None): substances.
p.(None): (5) No manufacturing authorisation shall be required where the processes of retail packaging, mixing, or
p.(None): packaging are performed according to magisterial or pharmacopoeia recipe in a pharmacy.
p.(None):
p.(None):
p.(None): Art. 147. (amend. – SG, 102/2012, in force from 02.01.2013) The BDA shall introduce information about the issued
p.(None): manufacturing authorisations of medicinal products and certificates for good production practice to be entered in the
p.(None): European Union database.
p.(None):
p.(None):
p.(None): Art. 148. To obtain manufacturing authorisation the person according to Art. 146 must possess:
p.(None): 1. personnel with adequate qualification depending on the specificity of the manufactured types of
p.(None): medicinal products and pharmaceutical forms;
p.(None): 2. always at least one qualified person, who correspond to the condition of Art. 159 at any time;
p.(None): 3. manufacturing, control, and storage facilities for the medicinal products equipped with the required technical
p.(None): equipment and control laboratories.
p.(None):
p.(None):
p.(None): Art. 149. The managers of manufacture and quality control of medicinal products in the manufacturing enterprises shall
p.(None): be:
p.(None): 1. persons with educational qualification master’s degree in pharmacy, chemistry, or biology and at least two-year
p.(None): practical experience in the pharmaceutical manufacture;
p.(None): 2. for the manufacture of radiopharmaceuticals or medicinal products subjected to ionizing radiation –
p.(None): persons who comply with the requirements according to point 1 and have an additionally recognised specialty in
p.(None): radiobiology or radiochemistry.
p.(None): 3. for the manufacture of immunological medicinal products including vaccines, toxins, sera, biotechnological products,
p.(None): and medicinal products obtained from human plasma or human blood – persons with recognised speciality in medical
p.(None): haematology, medical microbiology, virology, or immunology.
p.(None):
p.(None):
p.(None): Art. 150. (1) The person according to Art. 146 shall submit to the BDA a formal application as approved
p.(None): by the director of the Agency.
p.(None): (2) Together with the application according to para 1 the applicant shall also submit:
p.(None): 1. diploma, document for acquired speciality, document for length of service, certificate of clean court record, and
p.(None): employment contract for the persons according to Art. 148, point 2, and Art. 149;
p.(None): 2. copies of contracts of assignment of the manufacture and/or control of the products ordered for manufacture – in the
p.(None): cases according to Art. 151;
p.(None): 3.(amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code
p.(None):
p.(None): of the trader or cooperation from the Trade register, and for the companies, registered in a EU Member State or in a
p.(None): state – party on the Agreement for the EEA – a document for updated registration under the national legislation, issued
...

Social / employees

Searching for indicator employees:

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p.(None): 3. 30 days where an application has been submitted for confirmation, change or deletion of a price under Art. 261a,
p.(None): Para. 2;
p.(None): 4. 30 days, where an application has been submitted for registration, change or deletion of a price under Art. 161a,
p.(None): Para. 3;
p.(None):
p.(None): 5. 30 days for confirmation/registration of a price of medicinal products, for which authorisation for
p.(None): parallel import has been received;
p.(None): 6. (new - SG 48/15) ninety days where an application is filed for inclusion in the Positive Medicine List of a
p.(None): medicinal product with a new international non-proprietary name;
p.(None): 7. (new - SG 48/15) sixty days where an application is filed for maintaining the the reimbursement
p.(None): status of a medicinal products included in the Positive Medicine List.
p.(None): (2) For the medicinal products under Art. 262, Para. 5, the Council shall pronounce within the term of up to 30 days
p.(None): where an application has been submitted for confirmation of a price under Art. 261a, Para. 1 and including the product
p.(None): in the Positive medicine list.
p.(None): (3) The terms under Para. 1 and 2 start to run from the date of submitting an application under the ordinance under
p.(None): Art. 261a, Para. 5.
p.(None):
p.(None):
p.(None): Art. 259c. (New – SG, 60/2011, in force from 5. 8. 2011, repealed – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None):
p.(None): Art. 259d. (New – SG, 60/2011, in force from 5. 8. 2011, repealed – SG, 102/2012, in force from 21.12.2012).
p.(None):
p.(None):
p.(None): Art. 260. (Amend. - SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) The state
p.(None): bodies, officials and applicants on this Chapter shall be obliged to give assistance to the Council and the employees
p.(None): in it while fulfilling their assigned obligations.
p.(None):
p.(None):
p.(None): Art. 261. (Amend. - SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) (1) The
p.(None): Council members and its employees shall be obliged not to announce circumstances and facts, known to them during
p.(None): fulfilling their official duties under this act, unless upon a written request by a state body, where this is provided
p.(None): by an act.
p.(None): (2) In relation to their duties under Para. 1 the persons shall sign a declaration according to a form, confirmed by
p.(None): the Council chairperson.
p.(None):
p.(None): Section II.
p.(None): Regulation and registration of prices of medicinal products. Algorithms for treatment with medicinal products (new –
p.(None): SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 261a (New – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) (1) The
p.(None): council shall regulate the prices of medicinal products, included in the Positive Medicines List under Art. 262, Para.
p.(None): 1 and paid by public means in compliance with the lowest reference prices in the Member States.
p.(None): (2) The Council shall regulate the limit prices of the medicinal products, which are sold after doctor’s prescription
p.(None): apart from those under Para. 1 in compliance with the lowest reference prices of the Member States.
p.(None): (3) The Council shall register maximum selling prices for retail trade of the medicinal products, which are sold
p.(None): without doctor’s prescription.
p.(None): (4) The price, defined under Para. 1 shall also be the limit price of the medicinal products at their retail trade.
p.(None):
p.(None): (5) The Council of Ministers upon proposal of the Minister of Health shall determine by an ordinance the conditions and
p.(None): rules for regulation of prices of medicinal products under Para. 1 for regulation of the limit prices of medicines,
p.(None): sold after doctor’s prescription under Para. 2 at their retail trade, as well as the conditions and procedure for
...

p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
...

Social / gender

Searching for indicator gender:

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p.(None): 71. "Spontaneous report" shall mean a voluntarily report for a suspected adverse reaction during the use of
p.(None): a medicinal product forwarded to the marketing authorisation holder, to the bodies for supervision on the medicinal
p.(None): products, or to other organisations, which is not originating from a study or another organised system for data
p.(None): capturing.
p.(None): 72. "Expiry period of a medicinal product" shall mean the interval of time during which, if a medicinal product is
p.(None): stored under the prescribed conditions, it shall comply with the specification developed on the grounds of
p.(None): stability tests of several batches of the finished form.
p.(None): 73. (Amen. - SG 71/2008, in force from 12.08.2008) "Medicinal product equivalent to a herbal medicinal product"
p.(None): shall mean a product containing the same active substances irrespective of the composition of the excipients
p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
...

Social / orphan

Searching for indicator orphan:

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p.(None): plasma
p.(None): COUNCIL DIRECTIVE 87/18/EEC OF 18 DECEMBER 1986 on the harmonisation of laws, regulations and administrative provisions
p.(None): relating to the application of the principles of good laboratory practice and the verification of their
p.(None): applications for trials on chemical substances.
p.(None): COUNCIL DIRECTIVE 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates
p.(None): and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the
p.(None): right of establishment relating to certain activities in the field of pharmacy
p.(None): SECOND COUNCIL DIRECTIVE 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or
p.(None): Administrative Action relating to proprietary medicinal products
p.(None): DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.(None): of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
p.(None): REGULATION (EC) NO 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE
p.(None): COUNCIL of 31 March 2004 laying down Community procedures for the authorisation and supervision of
p.(None): medicinal products for human and veterinary use and establishing a European Medicines Agency.
p.(None): COMMISSION REGULATION (EC) NO 1084/2003 of 3 June 2003 concerning the examination of variations to the terms
p.(None): of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a
p.(None): competent authority of a Member State.
p.(None): REGULATION (EC) NO 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE
p.(None): COUNCIL of 16 December 1999 on orphan medicinal products.
p.(None): COMMISSION REGULATION (EC) NO 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of
p.(None): marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ, L 334/7 of
...

Social / parents

Searching for indicator parent:

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p.(None): subject’s parents or guardians with observation of Art. 96, para 1 and 3.
p.(None): (2) Parents’ or guardians’ consent must represent the supposed will of the minor person and can be withdrawn at any
p.(None): time without negative consequences for the minor person.
p.(None): (3) The express will of the minor person to participate or to at any time withdraw from the clinical test must be taken
p.(None): into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (4) A clinical test in a minor person shall be conducted after obtaining written informed consent by both parents and
p.(None): the guardian in compliance of Art. 96, para 1 and 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, the written informed consent shall be given
p.(None): by the parent who is exercising the parental rights.
p.(None): (5) Minor’s, parents’ and guardian’s’ consent can be withdrawn at any time without negative consequences
p.(None): for the minor person.
p.(None): (6) The express will of the minor person to at any time withdraw from the clinical test must be taken into
p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
...

Searching for indicator parents:

(return to top)
p.(None): understands the essence, importance, scope, consequences, and eventual risks of the clinical test. Informed
p.(None): consent to participate in a clinical test can be withdrawn at any time.
p.(None): (4) The informed consent according to para 1, point 3, of an incapable major person shall be given by his/her
p.(None): legal representative. The consent of the legal representative must represent the supposed will of the subject
p.(None): and can be withdrawn at any time without negative consequences for the subject.
p.(None): (5) In the cases according to Art. 162, para 3 of the Health Act, informed consent shall be given by the person
p.(None): appointed by the court.
p.(None): (6) An incapable person shall be given information about the clinical test, eventual risks, and benefits in accordance
p.(None): with his/her capability to understand.
p.(None): (7) The explicit will of an incapable major person to refuse to participate in or to withdraw from the clinical test at
p.(None): any time must be taken into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None):
p.(None): Art. 97. (1) A clinical test in a minor person shall be conducted after obtaining written informed consent by both
p.(None): subject’s parents or guardians with observation of Art. 96, para 1 and 3.
p.(None): (2) Parents’ or guardians’ consent must represent the supposed will of the minor person and can be withdrawn at any
p.(None): time without negative consequences for the minor person.
p.(None): (3) The express will of the minor person to participate or to at any time withdraw from the clinical test must be taken
p.(None): into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (4) A clinical test in a minor person shall be conducted after obtaining written informed consent by both parents and
p.(None): the guardian in compliance of Art. 96, para 1 and 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, the written informed consent shall be given
p.(None): by the parent who is exercising the parental rights.
p.(None): (5) Minor’s, parents’ and guardian’s’ consent can be withdrawn at any time without negative consequences
p.(None): for the minor person.
p.(None): (6) The express will of the minor person to at any time withdraw from the clinical test must be taken into
p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
p.(None): contain contact details of an independent person for additional information.
p.(None):
p.(None): Section .
p.(None): Clinical Trials in Vulnerable Patient Groups
p.(None):
...

Social / philosophical differences/differences of opinion

Searching for indicator opinion:

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p.(None): d) each Member state in which the qualified person fulfils his/her duties;
p.(None): e) address, tel. fax, e-amil address of the person under letter "a";
p.(None): f) address, at which the basic document is kept of the system for vigilance medicinal
p.(None): safety;
p.(None): 12a. (new - SG, 102/2012, in force from 21.12.2012) declaration by the applicant that
p.(None): he/she has the needed means for fulfilling the obligations under Chapter Eight;
p.(None): 13. (amend. -SG, 102/2012, in force from 21.12.2012) plan for risk management with a description of the system for risk
p.(None): management, which the applicant will introduce for the relevant medicinal product with the plan summary;
p.(None): 14. summary of product characteristics according to Art. 34;
p.(None): 15. mock-up of the immediate and outer packaging of the product and a proposed package leaflet in
p.(None): compliance with the requirements of chapter six;
p.(None): 16. copy of the manufacturing authorisation issued by the regulatory authority of the
p.(None):
p.(None): country where manufacture is performed accompanied by a Good Manufacturing Practice certificate or a
p.(None): certificate evidencing that the manufacture of the medicinal product and the active substances contained in its
p.(None): composition has been performed in compliance with standards, which are at least equivalent to the standards of
p.(None): the Good Manufacturing Practice;
p.(None): 17. copy of a document evidencing that the medicinal product is designated for treatment, prophylaxis, or diagnostics
p.(None): of rare diseases accompanied by a copy of the opinion of the European Medicines Agency;
p.(None): 18. copies of all marketing authorisations issued in other Member States or in a third state of the medicinal product
p.(None): applied for marketing authorisation;
p.(None): 18a. (new -SG, 102/2012, in force from 21.12.2012) a copy of summary of the safety data, including the data,
p.(None): contained in the periodical updated safety reports and if any – the signals for suspected unacceptable
p.(None): medicinal reactions;
p.(None): 19. list of the Member States where an application for marketing authorisation the medicinal product has
p.(None): been submitted;
p.(None): 20. copy of the summary of product characteristics proposed by the person according to Art. 26, para 1, or a copy of
p.(None): the summary of product characteristics approved by a regulatory authority of a Member State/ states members of
p.(None): the European Economic Area, which has already issued a marketing authorisation;
p.(None): 21. copy of a refusal for a marketing authorisation in a Member State or a third state accompanied by motives;
p.(None): information for temporary suspension or termination of the effect of the marketing authorisation;
p.(None): 22. copy of the proposed package leaflet accompanied by a summary of the results of the assessment of the level of
p.(None): comprehensibility of the contents of the package leaflet by a target patient group selected by the applicant or a copy
p.(None): of a leaflet approved by a regulatory authority in a Member State, which has already issued a marketing authorisation;
p.(None): 23. document of paid fee in amounts up in the tariff according to Art. 21, para 2.
p.(None): (2) (suppl. – SG 18/14) The documents according to para 1, item 18 and 18a, relating to the Member States, and point
...

p.(None): 1. the data according to Art. 27, para 1, points 1 – 9 and point 10, letter "a";
p.(None): 2. summary of product characteristics without the data according to Art. 34, para 1, point
p.(None): 4;
p.(None): 3. in case of a herbal medicinal product according to Art. 37, para 2, or of a combined
p.(None): herbal medicinal product – the information according to Art. 37, para 1, point 5 for the combination;
p.(None): where the individual active substances of the combined product are not sufficiently known, data on the traditional use
p.(None): of each shall be provided;
p.(None):
p.(None): 4. a copy of the marketing authorisation or registration certificate of the herbal medicinal product granted by a
p.(None): Member State or a third country and/or a copy of a refusal accompanied by the motives of the decision;
p.(None): 5. bibliographical or expert evidence to the effect that the medicinal product in question or a corresponding product
p.(None): has been in medicinal use throughout a period of at least 30 years preceding the date of the application including at
p.(None): least 15 years within a Member State or country of the European Economic Area preceding the date the application;
p.(None): 6. bibliographical evidence of the safety the product accompanied by an expert report for the product accompanied by an
p.(None): expert report;
p.(None): 7. a copy of the manufacturing authorisation accompanied by a Good Manufacturing Practice certificate or by a
p.(None): certificate evidencing that the product is manufactured under conditions equivalent to the requirements of the
p.(None): Good Manufacturing Practice.
p.(None): (2) The BDA may request additional information from the applicant for the assessment of the safety of the medicinal
p.(None): product according to para 1.
p.(None): (3) The BDA may request an opinion of the Committee for Herbal Medicinal Products at the European Medicines Agency
p.(None): relating to the adequacy of the data according to para 1, point 5, by submitting the necessary parts of the dossier of
p.(None): medicinal product.
p.(None): (4) The data submitted according to para 1, point 5 shall also be valid in the cases where throughout the period of 30
p.(None): years of use in the medical practice:
p.(None): 1. the medicinal product, which is similar to the product which is applied for registration, has been marketed without
p.(None): authorisation or registration or
p.(None): 2. where the number of the components or the strength of the medicinal product, which is applied for registration, is
p.(None): decreased.
p.(None):
p.(None):
p.(None): Art. 39. (1) Where the product has been used in the Community for less than 15 years, but is otherwise eligible for
p.(None): simplified registration Art. 37, para 1, the BDA shall submit the documentation according to Art. 38, para
p.(None): 1, to the Committee on Herbal Medicinal Products for opinion.
p.(None): (2) The BDA shall make the final decision following the establishment of the monograph of the Committee according to
p.(None): para 1 on the compliance or the product with the criteria for registration for traditional use.
p.(None): (3) In the cases according to para 1 the term according to Art. 44 shall cease to run.
p.(None):
p.(None):
p.(None): Art. 40. The BDA may request from the applicant for herbal medicinal product to submit the documentation according to
p.(None): Art. 27 - 32 or according to Art. 35.
p.(None):
p.(None):
p.(None): Art. 41. (1) The BDA shall publish on its internet site a list of the herbal substances, preparations, or
p.(None): combinations thereof used in the traditional herbal medicinal products established by the Committee on Herbal
p.(None): Medicinal Products of the European Evaluation Agency. The list shall contain therapeutic indications, strength,
p.(None): posology and method of administration as well as other information, which is necessary for the safe use of the herbal
p.(None): substance as a traditional medicinal product.
p.(None): (2) Where the product proposed in the application for registration for traditional use contains herbal
p.(None): substance, preparation, or combination of products included in the list according to para 1, the applicant shall not
p.(None): submit the data according to Art. 38, para 1, points 4 - 6.
p.(None): (3) Where the herbal substance, preparation, or combination thereof are excluded from
p.(None):
p.(None): the list according to para 1, the holder of the registration certificate of a herbal medicinal product must submit to
p.(None): the BDA the full documentation according to Art. 38 within three months from the amendment.
...

p.(None): in the sessions of the respective specialised committee according to Art. 47.
p.(None): (3) The persons according to para 1 shall not vote during making of a decision on issues in which they or members of
p.(None): their families have commercial, financial, or other interests.
p.(None):
p.(None):
p.(None): Art. 49. (1) (amend. – SG, 102/2012, in force from 21.12.2012) Within 200 days from the receipt of a valid
p.(None): documentation, the BDA, jointly with the respective committee according to Art. 47, Para. 1, shall assess the quality,
p.(None): safety, and efficacy of the medicinal product and shall establish an assessment report, with comments of the result of
p.(None): the pharmaceutical an pre-clinic tests, clinic studies of the system for risk management and of the system for safety
p.(None): vigilance of the relevant medicinal product.
p.(None): which shall be submitted to the of the. The assessment report shall be updated upon receipt of new information relating
p.(None): to the quality, safety and efficacy of the product. The drawn up assessment report shall be produced to the BDA
p.(None): executive director.
p.(None): (2)(new – SG, 102/2012, in force from 21.12.2012) The report under Para. 1 shall be updated in case that new
p.(None): information appears, important for the quality assessment, safety and efficiency of the medicinal product.
p.(None): (3) (former Para. (2) – SG, 102/2012, in force from 21.12.2012) Where a medicinal product contains
p.(None): genetically modified organisms, the BDA shall submit to the Ministry of
p.(None):
p.(None): Environment and Waters the necessary documentation of the dossier of the medicinal product and request an opinion with
p.(None): respect to the potential risk to the environment established within 60 days. The sixty-day period shall be within the
p.(None): frames of the period according to Para. 1.
p.(None): (4) (former Para. (3) – SG, 102/2012, in force from 21.12.2012) In the cases of radiopharmaceuticals, the
p.(None): BDA shall submit the necessary documentation of the dossier of the medicinal product to the Nuclear Regulatory
p.(None): Agency request an opinion with respect to the quality and safety of the product established within 60 days. The
p.(None): sixty-day period shall be within the frames of the period according to Para. 1.
p.(None): (5) (former Para. (4) – SG, 102/2012, in fore rom 21.12.2012) Where the Ministry of Environment and the Nuclear
p.(None): Regulatory Agency do not pass a judgment within the terms according to Para. 3 and 4, it shall be presumed
p.(None): that their opinion is positive.
p.(None):
p.(None):
p.(None): Art. 50. (1) Where the BDA establishes incompliance of the dossier with the requirements for
p.(None): granting marketing authorisation or registration certificate according to this Act, it shall notify the applicant
p.(None): in writing to submit additional information associated with the documentation according to Art. 27-32 or
p.(None): according to Art. 35, para 3, or according to Art. 38, and or to present an oral or written explanation of
p.(None): the established incompleteness and discrepancies within 180 days of the notification date.
p.(None): (2) In the cases according to para 1, the term according to Art. 44 shall cease to run as from the notification date
p.(None): until the presentation of the requested information.
p.(None): (3) The executive director of the BDA shall terminate the procedure for granting a marketing authorisation
p.(None): or authorisation for registration of a medicinal product where:
p.(None): 1. the applicant has not submitted the information according to para 1 within the required time limit;
p.(None): 2. the persons according to Art. 26, para 1, request its termination in writing.
p.(None):
p.(None):
p.(None): Art. 51. Within 10 days of the establishment of the assessment report according to Art. 49, para 1, the executive
p.(None): director of the BDA shall issue a marketing authorisation/registration certificate of the medicinal product or make a
p.(None): motivated refusal.
p.(None):
p.(None):
p.(None): Art. 52. (1) (amend. – SG, 102/2012, in force from 21.12.2012) Within 5 days of granting, the marketing
p.(None): authorisation/registration certificate in the register according to Art. 19, Para. 1, point 3, which shall contain the
p.(None): following data for the certificate:
p.(None): 1. registration number;
...

p.(None): withdrawn authorisations for use, as well as the made refusals for renewal of issued authorisations for use of
p.(None): medicinal products within 7 day term from issuance of the relevant act.
p.(None):
p.(None): Section VI.
p.(None): Variations in Granted Marketing Authorisation
p.(None):
p.(None): Art. 60. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of a marketing authorisation of the medicinal
p.(None): product shall be obliged to notify the BDA about any change in the conditions under which the permit has been granted.
p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011)Variations may be of type IA, of type IB, of type II, extension of the
p.(None): marketing authorisation and urgent restricting measures of safety.
p.(None): (3) (amend. – SG 12/11, in force from 08.02.2011) Terms and criteria of classification of the variation shall be laid
p.(None): down in the regulation envisaged in Art. 42.
p.(None): (4) (amend. – SG 12/11, in force from 08.02.2011) Any variation, which is not an extension and whose
p.(None): classification is undetermined after application of the terms and criteria stipulated in the envisaged in Art. 42
p.(None): regulation, shall be considered a variation of type IB by default.
p.(None): (5) (new – SG 12/11, in force from 08.02.2011) As an exception from Para 4, and whose classification is undetermined
p.(None): after application of the terms and criteria stipulated in the envisaged in Art. 42 regulation, shall be
p.(None): considered, shall be considered a variation of type II in the following cases:
p.(None): 1. upon a request of the holder of the marketing authorisation, entered in the application for variation;
p.(None): 2. where the BDA, after an assessment of the validity of the notification under Art. 63, comes to the opinion that the
p.(None): change could have significant impact on the quality, safety or on the efficacy of the medicinal product.
p.(None):
p.(None):
p.(None): Art. 61. (amend. – SG 12/11, in force from 08.02.2011) (1) Holder of the marketing authorisation of
p.(None): the medicinal product shall submit separate notifications, respectively applications to the BDA for each
p.(None): variation of type IA, type IB or type II or for extension of the range.
p.(None): (2) If a concrete variation leads to a change in the data of the summary characteristic of the product, of the
p.(None): labelling or of the leaflet, these changes shall be assumed as a part of the declared variation and about them separate
p.(None): application shall not be submitted.
p.(None): (3) Holder of the marketing authorisation may arrange the variations in groups, where:
p.(None): 1. notifies simultaneously of one and the same variations of type IA in the conditions of
p.(None):
p.(None): one or several marketing authorisations;
p.(None): 2. declares simultaneously several variations in the conditions of the marketing authorisations, belonging to
p.(None): a global marketing authorisation for the medicinal products as per Art. 28, Para 8, provided that the envisaged
p.(None): variations fall under one of the following cases:
p.(None): a) one of the variations in the group constitutes extension of the marketing authorisation;
p.(None): b) one of the variations in the group constitutes a variation of type II, and all the other variations appear as a
p.(None): consequence of the variation of type II;
p.(None): c) one of the variations in the group constitutes variation of type IB, and all the other variations appear as a
p.(None): consequence of the variation of IB
p.(None): d) all variations in the group relate solely to changes of administrative nature to the summary product
...

p.(None): authorisation shall submit:
p.(None): 1. documentation, related to the variations, as determined by the regulation envisaged in Art. 42;
p.(None): 2. a document, certifying that the fee, in an amount as per Tariff under Art. 21, Para 2,
p.(None): is paid.
p.(None): (6) The Executive Director of the BDA shall approve form of the application, respectively
p.(None): of notification, envisaged in Para 1 and 4, which shall be published on the Internet site of the BDA.
p.(None):
p.(None): Art. 62. (amend. – SG 12/11, in force from 08.02.2011) (1) The holder of marketing authorisation shall submit a
p.(None): notification of variations of type IA within 12 months following the implementation of the variation, except for
p.(None): the cases where variations require immediate notification.
p.(None): (2) Variations of type IA requiring immediate notification shall be specified in the regulation envisaged
p.(None): in Art. 42.
p.(None): (3) In the cases of Para 2, holder of marketing authorisation shall submit notification for the variation of type IA
p.(None): immediately after its implementation.
p.(None): (4) Within 30 days following receipt of the notification per Para 1, respectively per Para 3, the BDA shall notify the
p.(None): marketing authorisation holder:
p.(None): 1. if the variation(s) is/are accepted or not; in the cases where the variation(s) concerned is/are not accepted,
p.(None): reasons for that shall be stated; and
p.(None): 2. if variation(s) concerned lead(s) to amendment of the data in the issued marketing authorisation; where amendment of
p.(None): the issued marketing authorisation is needed, Art. 64a shall be applied.
p.(None): (5) Marketing authorisation holder shall stop implementation of the respective variation(s) of type
p.(None): IA, immediately after a notification of unfavourable opinion under Para 4, item 1 is received.
p.(None):
p.(None):
p.(None): Art. 63. (amend. – SG 12/11, in force from 08.02.2011)(1) In event that the notification for variation of type IB meets
p.(None): the requirements of Art. 61, the BDA shall inform the holder of marketing authorisation that the notification is valid,
p.(None): and shall state the date from which the term as per Para 2 starts running.
p.(None): (2) Within 30 days following the receipt of a valid notification, the BDA shall assess the submitted documentation and
p.(None): shall notify the holder of marketing authorisation:
p.(None): 1. whether it accepts or rejects the variation concerned; in the cases where the notification cannot be
p.(None): accepted, the grounds on which its unfavourable opinion is based shall be stated, and
p.(None): 2. if variation concerned leads to change in the data of the issued marketing authorisation; where
p.(None): amendment of the issued marketing authorisation is needed, Art. 64a shall be applied.
p.(None): (3) Where, within the term laid down in Para 2, the BDA finds that the submitted documentation does not
p.(None): fulfil the requirements of the Law and of the regulation envisaged in Art. 42, it shall notify of this the holder of
p.(None): the marketing authorisation.
p.(None): (4) Within 30 days, following the receipt of the notification per Para 3, the holder of the marketing authorisation may
p.(None): amend or supplement the notification.
p.(None): (5) Where, within the term per Para 4, the holder of the marketing authorisation does not submit amended or
p.(None): supplemented documentation, the BDA shall terminate the procedure and notify of this the holder of the marketing
p.(None): authorisation.
p.(None): (6) Within 30 days from the receipt of the amended documentation envisaged in Para 4, the BDA shall notify the holder
p.(None): of the marketing authorisation:
p.(None): 1. whether it accepts or rejects the variation concerned; in the cases where the notification cannot be
p.(None): accepted, the grounds on which its unfavourable opinion is based shall be stated, and
p.(None): 2. if variation concerned leads to change in the data of the issued marketing authorisation; where
p.(None): amendment of the issued marketing authorisation is needed, Art. 64a shall be applied.
p.(None):
p.(None): (7) The holder of the marketing authorisation shall apply the approved variation of type IB only after a notification
p.(None): of approval as per Para 2, item 1, respectively notification as per Para 6, item 1 is received.
p.(None):
p.(None):
p.(None): Art. 64. (amend. – SG 12/11, in force from 08.02.2011)(1) Where the application for variation of type II fulfils
p.(None): the requirements of Art. 61, the BDA shall notify the holder of the marketing authorisation about receipt
p.(None): of a valid application and by stating the date from which the period envisaged in Para 2 starts.
p.(None): (2) Within 60 days from the receipt of a valid application, BDA shall prepare an assessment report.
p.(None): (3) The period referred to in Para 2 may be:
p.(None): 1. reduced, having regard to the urgency of the matter of safe use of the medicinal product, or
p.(None): 2. extended to 90 days for variations concerning a change to or addition of therapeutic indications.
p.(None): (4) In event that the BDA finds that the submitted documentation does not fulfil the requirements of the
p.(None): Law and of the regulation envisaged in Art. 42, it shall notify the holder of the marketing authorisation of this
p.(None): and shall set a time limit within which supplementary information and documentation shall be provided.
p.(None): (5) In the cases under Para 4, the time period envisaged in Para 2 shall be suspended until the requested supplementary
p.(None): information and documentation has been provided.
...

p.(None): Art. 103, para 1 and 2, the BDA, or by contracting authorities.
p.(None): (5) The Central Ethics Committee shall carry out the methodical guidance with respect to the ethics committees
p.(None): according to Art. 103, para 1 and 2.
p.(None): (6) The sessions of the Central Ethics Committee shall be held in camera. In case of necessity, the chairman of the
p.(None): Central Ethics Committee can invite the contracting authority or the principal researcher to participate.
p.(None): (7) The Council of Ministers, according to a proposal of the Minister of Health, shall determine the conditions and
p.(None): order for the work of the Central Ethics Committee by a regulation.
p.(None):
p.(None):
p.(None): Art. 108. (1) A member of the Central Ethics Committee cannot be appointed in the same committee for more than two
p.(None): consecutive mandates. The duration of a mandate shall be 4 years.
p.(None): (2) Half of the composition of the Central Ethics Committee shall be renewed every 2
p.(None): years.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): met:
p.(None): Section V.
p.(None): Authorisation to Conduct a Clinical Test
p.(None):
p.(None): Art. 109. A clinical test can be started provided that the following conditions have been
p.(None):
p.(None): 1. the respective ethics committee has given a positive opinion and
p.(None): 2. the executive director of BDA has issued a written authorisation for the conduct
p.(None): thereof where one of the study medicinal products is either:
p.(None): a) a medicinal product for gene therapy;
p.(None): b) a medicinal product for somato-cellular therapy;
p.(None): c) a medicinal product, which contains genetically modified organisms;
p.(None): d) a high technology medicinal product described in the Annex to Regulation (EC) 726/2004 of the European
p.(None): Parliament and the Council;
p.(None): e) a medicinal product, which contains biological substance(s) of human or animal origin or contains biological
p.(None): components of human or animal origin or the manufacturing process of which involves such components, or
p.(None): 3. the contracting authority has not been notified by the BDA in writing that the clinical test cannot be conducted
p.(None): within the time limit as set out by the law; for medicinal products outside those according to 2.
p.(None):
p.(None):
p.(None): Art. 110. (1) For obtaining opinion, the principal researcher or the coordinating researcher shall submit to
p.(None): the respective ethics committee according to Art. 103 the following documentation:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (2) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 111. (1) The ethics committee shall establish an opinion taking into consideration the following:
p.(None): 1. importance of the clinical test;
p.(None): 2. positive assessment of the ratio between the anticipated benefits and risks according to Art. 90, para 1, and the
p.(None): motivation of the conclusions;
p.(None): 3. protocol of the clinical test;
p.(None): 4. to what extent the principal researcher and the study team are adequate for the conduct of the
p.(None): clinical test;
p.(None): 5. researcher’s brochure;
p.(None): 6. availability of the required equipment and its adequate quality;
p.(None): 7. compliance and completeness of the written information, which is to be given, as well as the procedure for obtaining
p.(None): informed consent and the validity of the clinical test in human subjects incapable of giving informed consent in the
p.(None): cases according to Art. 100 and 101;
p.(None): 8. provided indemnity or recovery in case of injury or death, which could result from the clinical test;
p.(None): 9. insurance covering researcher or contracting authority liability;
p.(None): 10. where necessary, the conditions and order for remuneration or indemnification of study researchers and subjects
p.(None): and the elements of the contract between the contracting authority and the healthcare establishment;
p.(None): 11. conditions and order for subject recruitment.
p.(None): (2) The ethics committee shall:
p.(None): 1. give positive opinion;
p.(None): 2.. refuse in a motivated manner, or
p.(None): 3. request amendment of a part of the documentation as a condition for obtaining a positive opinion.
p.(None):
p.(None):
p.(None): Art. 112. (1) Within 60 days from the submission of an application, the ethics committee shall pass resolution with an
p.(None): opinion, which shall be sent to the applicant and the BDA.
p.(None): (2) Where the clinical test involves a medicinal product for gene therapy or somato- cellular therapy or a medicinal
p.(None): product containing genetically modified organisms, the time limit according to para 1 shall be extended by 30 days.
p.(None): (3) Where for the review of a clinical test involving a medicinal product for gene therapy or somato-0-cellular therapy
p.(None): or a medicinal product containing genetically modified organisms it shall be imperative to consult a specially
p.(None): established for the purpose expert committee by an order to the director of the BDA, the time limit for drawing an
p.(None): opinion shall be 180 days.
p.(None):
p.(None):
p.(None): Art. 113. (1) During assessment of the documentation, the ethics committee can once request additional written
p.(None): documentation from the applicant. The time limits according to Art. 112 shall cease to run until submission of the
p.(None): requested documentation.
p.(None): (2) The review procedure of the study shall be terminated if the applicant should not submit the additional
p.(None): documentation required by the committee within 30 days of the receipt of the request for additional information.
p.(None):
p.(None):
p.(None): Art. 114. (1) Where the clinical test is to be conducted in more than one centre on the territory of the Republic of
p.(None): Bulgaria, the application shall be submitted to the ethics committee
p.(None):
p.(None): for multicentre tests according to Art. 103, para 1.
p.(None): (2) Where the clinical test is to be conducted in only one centre on the territory of the Republic of Bulgaria, the
p.(None): application can be submitted to the ethics committee according to Art. 103, para 1 or 2 at applicant’s discretion.
p.(None): (3) The opinion of the ethics committee according to Art. 103, para 1, shall be valid for all centres on the territory
p.(None): of the Republic of Bulgaria.
p.(None): (4) (new – SG 12/11, in force from 08.02.2011) For submission of applications to obtain opinion by the Ethics
p.(None): Committee, the Ministry of Health shall collect a fee in amount as determined by the Tariff envisaged in
p.(None): Art. 21. Para 2.
p.(None):
p.(None):
p.(None): Art. 115. (1) Where the opinion of the respective ethics committee according to Art. 103 is negative, the applicant can
p.(None): appeal before the Central Ethics Committee within 90 days of the date of notification.
p.(None): (2) Where the negative opinion of the respective ethics committee according to Art. 103 is established without taking
p.(None): into consideration the opinion of the expert commission according to Art. 112, para 3, the contracting authority can,
p.(None): within 14 days of the date of notification, request in writing that the committee revise its opinion.
p.(None): (3) The expert committee according to Art. 112, para 3, shall, within 60 days of the date of receipt of a written
p.(None): application of the applicant, pass a resolution on the negative opinion of the respective committee and can either
p.(None): challenge or support it, wherefore it shall notify the ethics committee in writing. The ethics committee shall take
p.(None): final decision and send it to the applicant.
p.(None): (4) Where the expert commission according to Art. 112, para 3, supports the negative opinion, the contracting authority
p.(None): can, within 14 days of the date of notification, appeal against the decision before the Central Ethics Committee.
p.(None): (5) The opinion of the Central Ethics Committee shall be final and binding on the respective ethics
p.(None): committee.
p.(None):
p.(None):
p.(None): Art. 116. (1) The applicant shall submit to the BDA an application after the pattern for the conduct of the clinical
p.(None): test.
p.(None): (2) Where the applicant for the clinical test is not the contracting authority, the application shall be accompanied by
p.(None): documentation certifying that the person has been empowered by the contracting authority.
p.(None): (3) Where the contracting authority has not been registered as a natural person or legal entity on the territory of
p.(None): Bulgaria, the application shall be accompanied by a document evidencing the data of his empowered
p.(None): representative on the territory of the Republic of Bulgaria.
p.(None): (4) The following documents shall be appended to the application:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (5) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 117. (1) During assessment of the documentation, the BDA can once request additional written
p.(None): documentation from the applicant.
...

p.(None): subject.
p.(None):
p.(None):
p.(None): Art. 122. (1) In case of a multicentre clinical test in the Republic of Bulgaria and in a third
p.(None):
p.(None): state, the BDA shall request the contracting authority to submit a declaration that he shall provide access to
p.(None): representatives of the BDA for inspection aimed at the establishment of compliance with the requirements and principles
p.(None): of Good Clinical Practice and Good Manufacturing Practice.
p.(None): (2) Provided that the contracting authority should not submit the declaration according to para 1, the BDA shall not
p.(None): review the submitted application.
p.(None):
p.(None):
p.(None): Art. 123. The contracting authority shall declare that the documentation submitted to the BDA and the ethics committee
p.(None): contains the same information.
p.(None):
p.(None):
p.(None): Art. 124. (1) The procedures in the ethics committee and in the BDA can be carried out simultaneously or consecutively
p.(None): at the discretion of the contracting authority.
p.(None): (2) The time limit for documentation review according to Art. 118, para 1, shall not cease to run in case of lack of
p.(None): decision of the ethics committee.
p.(None):
p.(None):
p.(None): Art. 125. The clinical test shall be conducted in compliance with the study protocol, which has received positive
p.(None): opinion of the respective ethics committee according to Art. 103 and under the conditions set out in the submitted
p.(None): documentation.
p.(None):
p.(None): Section V. Amendments
p.(None):
p.(None): Art. 126. (1) The contracting authority can at any time make amendments in the study protocol different from the
p.(None): essential amendments according to Art. 127, para 2.
p.(None): (2) In the cases according to para 1 the contracting authority shall keep the documentation relating to
p.(None): the amendments and shall provide it to the BDA and the ethics committee upon request.
p.(None):
p.(None):
p.(None): Art. 127. (1) Amendment in the conduct of a clinical test can be required by the BDA wherever necessary to guarantee
p.(None): the safety of the subjects, the scientific value of the clinical test, and/or the observation of the rules for Good
p.(None): Clinical Practice.
p.(None): (2) Essential amendment in the conduct of the clinical test shall be any amendment in the study protocol and/or in the
p.(None): information and the documentation according to Art. 110 and 116, which can affect:
p.(None): 1. the safety or the physical and mental immunity of the study subjects;
p.(None): 2. the scientific value of the clinical test;
p.(None): 3. the conduct or the organisation of the clinical test;
p.(None): 4. the quality or the safety of any study medicinal products.
p.(None):
p.(None):
p.(None): Art. 128. (1) The contracting authority can also implement planned study essential protocol and
p.(None): documentation amendments according to Art. 110 and 116 wherever:
p.(None): 1. the ethics committee has given a written positive opinion;
p.(None): 2. the executive director of the BDA has issued a written authorisation as to clinical trials with medicinal products
p.(None): according to Art. 109, point 2, or
p.(None):
p.(None): 3. the contracting authority has not been notified by the BDA about refusal of the proposed amendment in
p.(None): the clinical test with medicinal products according to Art. 109, point 3.
p.(None): (2) The provision of para 1 shall not apply to changes in an approved protocol, which are imperative to protect the
p.(None): subjects from immediate threat in case of occurrence or new information associated with the conduct of
p.(None): the clinical test or the development of the study medicinal product.
p.(None): (3) In the cases according to para 2, the contracting authority shall immediately notify the ethics committee
p.(None): according to para 1, point 1, and the BDA about the available new information, the measures taken, and the
p.(None): applied changes in the protocol.
p.(None):
p.(None):
p.(None): Art. 129. (1) While planning essential amendments to the clinical test and the documentation according to
p.(None): Art. 110 and 116, the applicant shall submit a formal written application to the BDA and the respective
p.(None): ethics committee.
p.(None): (2) The application shall be accompanied by documentation, which is necessary for grounding the amendments
p.(None): and certifies that after the implementation of the amendment the assessment of the benefit/risk ratio according to Art.
p.(None): 90, para 1, shall remain unchanged.
p.(None): (3) The requirements relating to the application and the documentation for the amendment shall be determined
p.(None): in the regulation according to Art. 82, para 3.
p.(None):
p.(None):
p.(None): Art. 130. (1) Within 35 days of receipt of an application for amendment, the ethics committee shall
p.(None): notify the contracting authority of its decision by issuing:
p.(None): 1. positive opinion on the requested amendment or
p.(None): 2. motivated refusal of the amendments in the clinical test.
p.(None): (2) Within 35 days of the date of receipt of an application with positive opinion of the ethics committee, the BDA
p.(None): shall:
p.(None): 1 approve the amendments in a clinical test of medicinal products according to Art. 109, point 2, or
p.(None): 2. disapprove the amendments with explicit motivation.
p.(None): (3) Provided that within 35 days of the submission of the documentation for amendments in clinical trials of medicinal
p.(None): products according to Art. 109, point 3, the applicant does not receive notification for disapproval of the amendment,
p.(None): the proposed amendments can be implemented.
p.(None):
p.(None):
p.(None): Art. 131. (1) In the cases according to Art. 130, para 2, point 2, the contracting authority can submit alteration of
p.(None): the proposed amendments consistent with the motives not later than 14 days prior to the implementation of the
p.(None): amendments.
p.(None): (2) Within 14 days of the date of receipt of the amended documentation according to para 1, the BDA shall issue and
p.(None): amendment of its authorisation for the clinical test of medicinal products according to Art. 109, point 2, or shall
p.(None): issue a refusal, which shall not be subject to appeal.
p.(None): (3) The refusal according to para 2 shall not be subject to appeal.
p.(None):
p.(None): Section V. Cessation of the Clinical Test
p.(None):
p.(None): Art. 132. (1) The contracting authority or the researcher can undertake urgent measures
p.(None):
p.(None): to protect the study subjects from suddenly occurred risks for their safety and health.
p.(None): (2) In the cases according to para 1 the contracting authority shall immediately notify the BDA and the respective
p.(None): ethics committee about the undertaken actions and the reasons, which have raised these.
p.(None):
p.(None):
p.(None): Art. 133. (1) Where the clinical test is to be conducted under conditions different from those determined at the issue
p.(None): of the authorisation or there is information vitiating the scientific validity of the clinical test or the safety of
p.(None): the study subjects, the BDA can temporarily stop the conduct of the test or put a ban on it.
p.(None): (2) The ban can be imposed for a specific centre or for all centres in a multicentre clinical test on the territory of
p.(None): the Republic of Bulgaria.
p.(None): (3) In case of termination of the clinical test in all centres on the territory of the Republic of Bulgaria, the BDA
p.(None): shall, prior to undertaking actions according to para 1, notify the contracting authority and the principal researcher
p.(None): or the coordinating researcher in writing.
p.(None): (4) Within 7 days of the receipt of the notification the contracting authority and/or the principal researcher can
p.(None): express an opinion on the undertaken measures by the BDA.
p.(None): (5) The provision of para 3 shall not apply provided that there is an immediate threat for the health and safety of the
p.(None): study subjects.
p.(None):
p.(None):
p.(None): Art. 134. In the cases according to Art. 133, para 1, the BDA shall immediately notify the respective ethics
p.(None): committee, the regulatory bodies of the Member States, the European Medicines Agency, and the European
p.(None): Commission about the undertaken measures and the reasons therefore.
p.(None):
p.(None): Section V. Pharmaco-vigilance
p.(None):
p.(None): Art. 135. (1) The principal researcher shall immediately report in writing or by word of mouth any serious adverse
p.(None): event that has occurred in the course of the clinical test in a study subject at the centre he is responsible for.
p.(None): (2) A detailed written report shall be submitted after the report according to para 1.
p.(None): (3) At the notification according to para 1 and in the report according to para 2 the study subject shall be identified
p.(None): by a unique code number as defined in the study protocol.
p.(None): (4) The provisions of para 1 and 2 shall not apply provided that the protocol of the clinical test or the researcher’s
p.(None): brochure explicitly states that there is no requirement for an urgent report of a specific serious adverse event.
p.(None): (5) The researcher shall report to the contracting authority any adverse events or laboratory aberrations,
p.(None): which are defined in the study protocol as critical with respect to safety, within the timelines and format as required
p.(None): by the protocol.
p.(None):
p.(None):
...

p.(None): (2) The marketing authorisation holder shall announce to BDA about each new information, which could
p.(None): influence the correlation benefit-risk for the medicinal product.
p.(None): (3) The obligation under Para. 2 shall not liberate the marketing authorisation holder from the requirements of Art.
p.(None): 194h for providing the information under Para. 2 and through the periodic updated safety reports.
p.(None):
p.(None):
p.(None): Art. 145c. (new – SG, 102/2012, in force from 21.12.2012) (1) Where the study is conducted only on the
p.(None): territory of the Republic of Bulgaria in implementation of the obligation under Art. 56a, the holder of the marketing
p.(None): authorisation shall produce a draft protocol of the study to BDA. The draft protocol, with a written consent
p.(None): under Art. 145a, Para. 2 shall be produced also to the commissions under Art. 103, Para. 1 or 2, where
p.(None): applicable.
p.(None): (2) The BDA executive director, within the term of up to 60 days from the date of receiving the
p.(None): documentation under Para. 1, the marketing authorisation holder shall submit a notification of the study or shall give
p.(None): a grounded refusal.
p.(None): (3) The BDA executive director shall refuse conducting of the study with one or more of the grounds under Art. 145f,
p.(None): Para. 2, p. 2.
p.(None): (4) The commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2 within the term of up to 60 days
p.(None): from the date of receiving the documentation under Para. 1 shall submit to the marketing authorisation holder a
p.(None): positive or negative opinion.
p.(None): (5) Conducting of the study may start after receiving approval by BDA and a positive opinion by the commission under
p.(None): Art. 103, Para. 1 or by the commissions under Art. 103, Para. 2.
p.(None): (6) For assessment of the documentation under Para. 1, BDA shall collect a fee in the amount, determined by the tariff
p.(None): under Art. 21,Para. 2.
p.(None):
p.(None):
p.(None): Art. 145d. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder shall
p.(None): apply planned substantial changes in the protocol in the cases under Art. 145c, Para. 1 after their prior approval by
p.(None): BDA and by the commission under art. 103, Para. 1, or the commissions under Art. 103, Para. 2.
p.(None): (2) The marketing authorisation holder shall produce to BDA and to the commission under Art. 103, Para. 1 or the
p.(None): commissions under Art. 103, Para. 2 the documentation, related to the changes and thee motives for that.
p.(None): (3) The BDA executive director within the term of 30 days after receiving the documentation under Para. 2
p.(None): shall approve the changed protocol or shall issue a motivated refusal and shall notify the marketing authorisation
p.(None): holder.
p.(None): (4) The commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2
p.(None):
p.(None): within the term of 30 days from the date of receiving the documentation under Para. 2 shall submit to the marketing
p.(None): authorisation holder a positive or negative opinion.
p.(None): (5) The BDA executive director shall refuse the changes under Para. 1 with one or more of the grounds, indicated in
p.(None): Art. 145f, Para. 2, p. 2.
p.(None): (6) The marketing authorisation holder may apply the changes under Para. 1 after receiving an approval by
p.(None): BDA and a positive opinion by the commission under Art. 103, Para. 1 or by the commissions under Art. 103, Para. 2.
p.(None): (7) BDA shall collect fee in the amount, defined by the tariff under Art. 21, Para. 2 for assessment of the
p.(None): documentation under Para. 1.
p.(None):
p.(None):
p.(None): Art. 145e. (New – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder shall
p.(None): produce to BDA a final report of the study within the term of up to 12 months after finalisation of the data
p.(None): collecting. The report shall have attached a study result summary.
p.(None): (2) The marketing authorisation holder may submit a grounded request to BDA for postponing the term under
p.(None): Para. 1 at least 3 months before the date for producing the final report, indicated in the protocol.
p.(None): (3) The BDA shall approve or refuse grounded the request under Para. 2 and shall notify the marketing authorisation
p.(None): holder.
p.(None): (4) Where the marketing authorisation holder, based on the report of Para. 1, considers that a change in the
p.(None): marketing authorisation is needed, he/she shall submit to BDA an application for a change under Chapter Three,
p.(None): Section VI.
p.(None): (5) The BDA executive director by an order shall interrupt the action or shall terminate the marketing authorisation,
p.(None): where BDA on the basis of the report under Para. 1 after consultation with the marketing authorisation
p.(None): holder considers that interruption or termination of marketing authorisation is needed.
p.(None):
p.(None):
p.(None): Art. 145f. (new – SG, 102/2012, in force from 21.12.2012) (1) Where the study is conducted on the
p.(None): territory of the Republic of Bulgaria, also on the territory of other EU Member States, for medicinal products,
p.(None): permitted under Regulation (EC) N 726.2004 of the European Parliament and of the Council or under Chapter Three,
p.(None): Section VII in implementation of the obligations under Art. 55a or Art. 56a, the marketing authorisation holder shall
p.(None): submit the draft protocol to the committee under Art. 56a, Para. 1, p. 1.
p.(None): (2) Within the term of up to 60 days from the date of receiving the documentation under Para. 1, the committee under
p.(None): Art. 56a, Para. 1, p. 1. Shall draw up an opinion and shall submit to the marketing authorisation holder:
p.(None): 1. a approval notification, or
p.(None): 2. grounded refusal, where:
p.(None): a) it finds, that the study conducting encourages the use of the medicinal product, and/or
p.(None): b) considers, that the design of the study will not achieve the objectives, laid down in the protocol, and/or
p.(None): c) the study has nature of a clinic study.
p.(None): (3) In the cases under Para. 2, p. 1 the marketing authorisation holder shall produce the notification to BDA and to
p.(None): the commissions under Art. 103, Para. 1 or 2, where applicable.
p.(None): (4) The commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2, within the term of up to 15 days
p.(None): from the date of receiving the notification under Pra. 3 shall submit to the marketing authorisation holder a positive
p.(None): or negative opinion.
p.(None):
p.(None): (5) The study conducting may start after receiving a positive opinion by the commission under Art. 103, Para. 1 or a
p.(None): commission under art. 103, Para. 2.
p.(None): (6) The contents and the form of the protocol under Para. 1 shall be determined by Commission Implementing Regulation
p.(None): (EU) No 520/2012 of 19 June 2012 on the performance of pharmaco-vigilance activities provided for in Regulation (EC) No
p.(None): 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the
p.(None): Council (OJ, L 159/5 of 20 June 2012), called hereinafter "Implementing Regulation (EU) N 520/2012".
p.(None):
p.(None):
p.(None): Art. 145g. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder in the
p.(None): cases under art. 154f, Para. 1 shall apply planned substantial changes in the study protocol after their prior approval
p.(None): by the committee under Art. 56a, Para. 1, p. 1.
p.(None): (2) The marketing authorisation holder shall produce to the committee under Art. 56a, Para. 1, p. 1 the documentation,
p.(None): related to the changes and grounds for that.
p.(None): (3) Where the committee under Art. 56a, Para. 1 approves the protocol changes, the marketing authorisation holder shall
p.(None): notify the BDA and the commission under Art. 103, Para. 1 or the commissions under Art. 103. Para. 2.
p.(None): (4) The marketing authorisation holder may apply the changes under Para. 1 after receiving a positive
p.(None): opinion by the commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2.
p.(None):
p.(None):
p.(None): Art. 145h. (new – SG, 102/2012, in force from 21.12.2012) The marketing authorisation holder shall submit in electronic
p.(None): way to the committee under Art. 56a, Para. 1, p. 1 a final report, with a study result summary within the term of up to
p.(None): 12 months after finalisation of data collecting.
p.(None): (2) The marketing authorisation holder may submit a grounded request to the committee under Art. 56.a, Para. 1, p. 1
p.(None): for postponing the term under Para. 1 at least 3 months before the date for producing the final report, indicated in
p.(None): the protocol.
p.(None): (3) The committee under Art. 56a, Para. 1, p. 1 shall approve or refuse groundedly the request under Para. 2 and shall
p.(None): notify the marketing authorisation holder.
p.(None): (4) The contents and form of the report under Para. 1 shall be determined by Implementing Regulation (EU)
p.(None): N 520/2012.
p.(None):
p.(None):
p.(None): Art. 145i. (new – SG, 102/2012, in force from 21.12.2012) (1) The committee under Art. 56a, Para. 1, p. 1 based on the
p.(None): report under Art. 145h, Para. 1 and after consultation with the marketing authorisation holder shall issue a grounded
p.(None): recommendation about the marketing authorisation of the medicinal product and shall submit it to:
p.(None): 1. The committee of the medicinal product for human use under Art. 5 of Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council or
p.(None): 2. The coordination group under art. 77, Para. 2.
p.(None): (2) In the cases under Para. 1. P. 2 where the committee under Art. 56a, Para. 1, p. 1 has recommended a change,
p.(None): interruption or termination of the marketing authorisation, the coordination group, represented by the Member
p.(None): States, in which the study has been conducted, shall issue an opinion about the needed actions, to be undertaken in
p.(None): relation to the marketing authorisation, including a schedule for its implementation.
p.(None): (3) Where the represented member States in the coordination group reach consensus about the opinion under Para. 2,
p.(None): it shall be published on the European internet portal for
p.(None):
p.(None): medicinal products under Art. 68, Para. 1, p. 4 and shall be submitted to the marketing authorisation
p.(None): holder.
p.(None): (4) The BDA executive director in compliance with the opinion under Para. 2 shall interrupt or terminate
p.(None): the action of the marketing authorisation.
p.(None): (5) Where in the opinion under Para. 2 changes have been recommended in the issued marketing authorisation, the
p.(None): marketing authorisation holder within the frames of the determined implementation schedule shall submit to BDA an
p.(None): application for change under Chapter Three, Section VI, including an updated short characteristic of the product and a
p.(None): leaflet.
p.(None): (6) Where it is impossible an agreement to be reached within the frames of the coordination group, the
p.(None): position of the majority Member States shall be produced to the European Commission, which shall adopt a
p.(None): decision for change, interruption or termination of the marketing authorisation, issued by the relevant regulatory
p.(None): bodies of the Member States.
p.(None): (7) The decision under Para. 6 shall be published on the European internet portal for medicinal products under Art.
p.(None): 68, Para. 1, p. 4 and shall be submitted to the marketing authorisation holder.
p.(None): (8) The BDA shall apply the temporary and/or final measures of the decision under Para. 6 and shall inform the European
p.(None): Medicines Agency and the European Commission.
p.(None): (9) In the cases under Para. 1, the Committee on medicinal products for human use in compliance with the
p.(None): recommendations of the committee under art. 56a, Para. 1, p. 1 shall issue an opinion about storage, change,
p.(None): termination or interruption of the validity of the marketing authorisation, including a schedule for
p.(None): implementation of the opinion. The opinion shall be published on the European internet portal for medicinal
p.(None): products under Art. 68, Para. 1, p. 4 and shall be submitted to the marketing authorisation holder.
p.(None): (10) Where in the opinion under Para. 9 a position is expressed for undertaking regulatory actions in
p.(None): relation to the marketing authorisations, the European Commission shall undertake a decision for a change, termination
p.(None): or interruption of the marketing authorisation, issued under Regulation (EC) N 726/2004 of the European Parliament and
p.(None): of the Council.
p.(None):
p.(None):
p.(None): Art. 145j. (new – SG, 102/2012, in force from 21.12.2012) (1) Non-interventional studies on the territory of the
p.(None): Republic of Bulgaria shall be conducted under Art. 145c – 145e.
p.(None): (2) During conducting non-interventional studies under Para. 1 the financing source shall ne indicated
p.(None):
p.(None): Chapter five.
p.(None): MANUFACTURING AND IMPORT OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES (TITLE. AMEND. – SG, 102/2012, IN FORCE FROM
p.(None): 02.01.2013)
p.(None):
p.(None): Section .
p.(None): Manufacture
p.(None):
p.(None): Art. 146. (1) (amend. – SG, 102/2012, in force from 02.01.2013)Within the meaning of this Act manufacture of all
p.(None): types of medicinal products and medicinal products intended for clinical trials can only be performed on the
p.(None): territory of the Republic of Bulgaria by natural or legal persons registered as traders on the territory of a
p.(None): Member State which have received manufacturing authorisation issued by the director of the BDA.
p.(None): (2) Manufacturing authorisation shall also be required in the cases where the products according to para 1 are intended
p.(None): for export only.
p.(None):
p.(None): (3) Manufacturing authorisation shall also be required for persons who perform simultaneously of separately
p.(None): one of the following activities: packaging, retail packaging, repackaging, labelling of medicinal products, and
p.(None): medicinal products intended for clinical trials.
...

p.(None): medicinal products, placed on the market of the Republic of Bulgaria:
p.(None): 1. monitoring of the result of the measures for decreasing the risk for a medical products, contained in the risk
p.(None): management plan;
p.(None): 2. monitoring of the result of implementation of conditions, indicated in Art. 55a, 56, or
p.(None):
p.(None): 56a;
p.(None):
p.(None): 3. assessment of the updating of the risk management system;
p.(None): 4. monitoring of the data base of Eudra Vigilance", created in compliance with Art. 24 of
p.(None): Regulation (EC) N 726/2004 of the European Parliament and of the Council for new risks or for change of already
p.(None): established and for change of the correlation benefit/risk.
p.(None):
p.(None):
p.(None): Art. 187. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall inform the European Medicines Agency
p.(None): and the marketing authorisation holder at identification of signals for new risks or change of found risks or in
p.(None): case of change of the correlation benefit/risk of a medicinal products.
p.(None): (2) The committee under Art. 56a, Para. 1, p. 1 shall analyze and prioritize the valid signals for new risks or for
p.(None): change of already found and for change of the correlation benefit/risk.
p.(None): (3) Where the Committee under Art. 56a, Para. 1, p. 1 recommends follow up actions, the coordination group under Art.
p.(None): 77, Para. 2 or the Committee on Medicinal Products for Human Use shall draw up an opinion for regulatory actions
p.(None): related to the authorisation for use within the
p.(None):
p.(None): frames of a schedule, drawn up in compliance with the seriousness and level of danger.
p.(None): (4) The BDA shall apply the recommended in the opinion of the coordination group under Art. 77, Para. 2 or in the
p.(None): decision of the European Commission temporary and/or final measures.
p.(None):
p.(None):
p.(None): Art. 188. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall inform the European Medicines Agency, the
p.(None): regulatory bodies of the other EU Member States and the European Commission at least 24 hours before the public
p.(None): announcement of the information about suspects, related to vigilance of safety of the medicinal product, unless in the
p.(None): cases, where protection of public health required immediate announcement of the information.
p.(None): (2) The BDA shall publish information, related to active substances, contained in medicinal products,
p.(None): permitted for use and in other Member States by using harmonised draft announcement and schedule of the publication,
p.(None): proposed by the European Medicines Agency.
p.(None): (3) In the cases under Para. 1 and 2 the information, containing personal data or trade secret, shall be deleted,
p.(None): unless the publication of this data is needed for protection of public health.
p.(None):
p.(None):
p.(None): Art. 189. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA may delegate some of the rights and duties
p.(None): under this Chapter to a regulatory body of another Member State by signing an agreement.
p.(None): (2) In the cases under Para. 1, BDA shall inform the European Commission, the European Medicines Agency
p.(None): and the regulatory bodies of the other Member States for the delegation of the authorisations and shall
p.(None): publish and announcement on the internet portal under Art. 185, Para. 1 or on its internet site.
p.(None):
p.(None):
...

p.(None): authorisation holder or the regulatory bodies of the Member States may produce their comments to the European medicines
p.(None): Agency and to BDA.
p.(None): (3) Within the term of up to 15 days from the date of receiving the comments under Para. 2, BDA shall update the
p.(None): assessment report y taking into consideration all produced objections and shall submit it to the committee under
p.(None): Art. 56a, Para. 1, p. 1 for approval and recommendation.
p.(None): (4) The European Medicines agency shall include the adopted assessment report and the recommendation of the committee
p.(None): under Art. 56a, Para. 1, p. 1 to the register under Art. 194h, Para. 3 and shall submit it to the marketing
p.(None): authorisation holder.
p.(None):
p.(None):
p.(None): Art. 194q. (new – SG, 102/2012, in force from 21.12.2012). Where the Republic of Bulgaria is not a
p.(None): reporter in the procedure under Art. 194o, Para. 2, BDA may produce comments within the term under Art. 194p, Para. 2
p.(None): to the European Medicines Agency and to the regulatory body of the Member State, which has drawn up the report.
p.(None):
p.(None):
p.(None): Art. 194r. (new – SG, 102/2012, in force from 21.12.2012). (1) In case of a single assessment of
p.(None): periodic updated safety reports of medicinal product under Art. 194l and where neither of the marketing authorisations
p.(None): of these products has been issued under Regulation (EC) 726/2004 of the European Parliament and of the Council, the
p.(None): coordination group under Art. 77, Para. 2 within the term of up to 30 days from the date of receiving the
p.(None): recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping, change, termination
p.(None): of the relevant marketing authorisations, including a schedule for implementation of the opinion.
p.(None): (2) Where the represented Member States in the coordination group under Art. 77, Para. 2 reach agreement about the
p.(None): action to be undertaken, BDA shall fulfill the adopted decision.
p.(None): (3) Where the opinion under Para. 1 is for interruption or termination of the marketing authorisation, the BDA
p.(None): executive director shall issue the order.
p.(None): (4) Where the opinion under Para. 1 recommends changes in the issued marketing authorisation, the marketing
p.(None): authorisation holder shall submit to BDA an application for change, including an updated short characteristics of the
p.(None): product and a leaflet, within the frames of the defined implementation schedule.
p.(None): (5) Where no agreement can be reached in the coordination group under Art. 77, Para. 2, the position of the majority
p.(None): Member States shall be produced to the European Commission, which shall adopt a decision for change, interruption or
p.(None): termination of the marketing authorisation, issued by the relevant regulatory bodies of the Member States.
p.(None): (6) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 5.
p.(None):
p.(None):
p.(None): Art. 194s. (new – SG, 102/2012, in force from 21.12.2012).(1) In case of single assessment of periodic
p.(None): updated safety reports of medicinal products under Art. 194l and where
p.(None):
p.(None): at least one of the marketing authorisations has been issued under Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council, the Committee of the medicinal products for human use within the term of 30 days from
p.(None): receiving the recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping,
p.(None): changing, termination or interruption of the validity of the relevant marketing authorisations, including a schedule
p.(None): for the opinion implementation.
p.(None): (2) Where the opinion under Para. 1 expresses a position for undertaking regulatory actions in relation to the
p.(None): marketing authorisations, the European Commission shall:
p.(None): 1. adopt as decision for change, termination or interruption of the marketing authorisations,
p.(None): issue under Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt decision with a recommendation for change, termination or interruption of the marketing authorisations, issued
p.(None): by the relevant Member States regulatory bodies.
p.(None): (3) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 2, p. 2.
p.(None):
p.(None): Section IV.
p.(None): Urgent Procedure at European Union Level. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194t. (new – SG, 102/2012, in force from 21.12.2012) (1) Urgent procedure at the level of the European Union may
p.(None): be initiated by the European Commission, by the European Medicines Agency or by a Member State.
p.(None): (2) (amend. – SG 18/14) The BDA shall initiate an urgent procedure under this section by notification of the regulatory
p.(None): bodies of the other Member States, the European Medicines Agency and the European Commission where upon
p.(None): considerations, related with pharmaco- vigilance considers, that for a certain medicinal product, placed on the
p.(None): Bulgarian market, one of the following measures are needed to be undertaken:
p.(None): 1. termination or interruption of the marketing authorisation;
p.(None): 2. prohibition of distribution of the medicinal product;
p.(None): 3. issuing a refusal for renewing the marketing authorisation.
...

p.(None): and shall contain one or more of the following conclusions:
p.(None): 1.it is not needed additional study or undertaking actions at Community level;
p.(None): 2. the marketing authorisation holder shall have to carry out an additional study and data analysis;
p.(None): 3. the marketing authorisation holder shall have to conduct safety post-marketing study with a follow up assessment of
p.(None): the results from it;
p.(None): 4. the Member State or the marketing authorisation holder shall apply measures for decreasing the risk;
p.(None): 5. the marketing authorisation shall have to be terminated, interrupted or a refusal for its renewal has to be issued;
p.(None): 6 the marketing authorisation shall have to be changed.
p.(None): (4) The concrete measures under Para. 3, p. 4, as well as the conditions and restrictions, which are to be included in
p.(None): the marketing authorisation, shall be indicated in the recommendation.
p.(None):
p.(None): (5) In the cases under Para. 3, p. 6, where the changes are related to change or addition of information in the short
p.(None): characteristics, on the packing or leaflet of the medicinal product, the recommendation shall contain the formulation
p.(None): of the changes or added information and the place, where it has to be put.
p.(None):
p.(None):
p.(None): Art. 194x. (new – SG, 102/2012, in force from 21.12.2012) (1) Where in the scope of the procedure under Art. 194t no
p.(None): medicinal product has been included, permitted for use under Regulation (EC) N 726/2004 of the European Parliament
p.(None): and of the Council, the coordination group under Art. 77, Para. 2 on the basis of the recommendation under Art. 194v
p.(None): within the term of up to 30 days from the date of its receiving shall issue an opinion about the keeping, change,
p.(None): termination, interruption of the validity of the relevant decisions for use or refusal of their renewal, including a
p.(None): schedule for implementation of the opinion.
p.(None): (2) Where the opinion recommends undertaking measures under Art. 194v, Para. 3, p. 5, the BDA executive director
p.(None): shall interrupt by an order the action or shall terminate the marketing authorisation or shall refuse its
p.(None): renewal.
p.(None): (3) Where the opinion under Para. 1 recommends changes in the issuance of a marketing authorisation, the
p.(None): marketing authorisation holder shall submit an application and a leaflet to BDA for a change, including an updated
p.(None): short characteristics of the product and a leaflet, within the frames of the schedule for implementation.
p.(None): (4) Where the opinion under Para. 1 recommends undertaking measures under Art. 194v, Para. 3, p. 2 – 4, the
p.(None): marketing authorisation holder shall undertake the needed actions and shall inform BDA and the regulatory bodies of the
p.(None): other Member States.
p.(None): (5) Where within the frames of the coordination group under Art. 77, Para. 2 no agreement can be reached,
p.(None): the position of the majority of the Member States shall be given to the European Commission, which shall adopt a
p.(None): decision with a recommendation for a change, termination or interruption of the marketing authorisation, issued
p.(None): by the relevant regulatory bodies of the Member States.
p.(None): (6) The BDA shall apply the temporary or final measures, recommended in the decision.
p.(None):
p.(None):
p.(None): Art. 194y. (new – SG, 102/2012, in force from 21.12.2012) (1) Where in the scope of the procedure under Art. 194t a
p.(None): medicinal products has been included, permitted for use under Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council, the Committee of the medicinal products for human medicine on the basis of the
p.(None): recommendation under Art. 194v, Para. 3 within the term of 30 days from the date of its receiving, shall issue an
p.(None): opinion about keeping, change, termination, interruption of the validity of the relevant marketing authorisations or
p.(None): refusal for their renewal, including a schedule for implementation of the opinion.
p.(None): (2) Where the opinion under Para. 1 expresses a position for undertaking regulatory action in relation to the marketing
p.(None): authorisations, the European Commission shall:
p.(None): 1. adopt a decision for change, termination or interruption the validity of the marketing authorisations, issued under
p.(None): Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt a decision with a recommendation for a change, termination or interruption of the validity of the
p.(None): marketing authorisations, issued by the relevant regulatory bodies of the Member States.
p.(None): (3) The BDA shall apply the recommended temporary and/or final measures in the decision of the European
p.(None): Commission under Para. 2, p. 2.
p.(None):
p.(None): Art. 194z. (new – SG, 102/2012, in force from 21.12.2012) The recommendation under Art. 194v, Para. 1, the opinion
p.(None): under Art. 194x, Para. 1 and the decision of the European Commission under Art. 194w, Para. 5 and Art. 194x,
p.(None): Para. 2 shall be published on the European internet portal under Art. 68, Para. 1, p. 4.
p.(None):
p.(None): Chapter nine.
p.(None): WHOLESALE TRADE OF MEDICINAL PRODUCTS AND intermediation IN THE AREA OF THE MEDICINAL PRODUCTS (TITLE, AMEND. – SG,
p.(None): 71/2008, IN FORCE FROM 12.08.2008, TITLE, AMEND. – SG, 102/2012, IN FORCE FROM 02.01.2013)
p.(None):
p.(None): Section .
p.(None): Wholesale Trade of Medicinal Products
p.(None):
p.(None): Art. 195. (1) Wholesale of medicinal products can perform natural and legal persons registered as traders pursuant to
p.(None): the national legislation of a Member State and possessing authorisation for such activity issued by a regulatory body
p.(None): of the respective Member State.
p.(None): (2) Where the person according to para 1 is in possession of warehouse premises on the territory of the Republic of
p.(None): Bulgaria, he can perform wholesale of medicinal products after receipt of authorisation from the executive director of
p.(None): the BDA.
p.(None):
p.(None):
p.(None): Art. 196. (1) Manufacturer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued manufacturing authorisation for.
p.(None): (2) Importer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued import authorisation for.
p.(None):
p.(None):
p.(None): Art. 197. The persons according to Art. 195 shall dispose of:
p.(None): 1. suitable premises, equipment and outfits, and transport vehicles ensuring correct storage, distribution,
...

p.(None): a state – party on the EEA Agreement – a document for updated registration according to the national
p.(None): legislation, issued by a competent body of the relevant state;
p.(None): 3. name, certificate of clean court record, diploma for higher education and length of service for the responsible
p.(None): master - pharmacist according to Art. 197, point 2, and a copy of his/her employment contract;
p.(None): 4. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 5. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 6. document certifying the legal grounds for the use of the premises;
p.(None): 7. (amend., - SG 98/10, in force from 01.01.2011) conclusion of the Regional Health Inspectorates after inspection on
p.(None): the spot evidencing that the health requirements in the whole sale premises according to the regulation according to
p.(None): Art. 198.
p.(None): 8. document for paid fee as laid down in the tariff Art. 21, para 2.
p.(None): (2) The persons according to Art. 195, para 1, shall submit to the BDA an application accompanied by the following
p.(None): documents:
p.(None): 1. copy of the wholesale authorisation issued by a regulatory body of a Member State;
p.(None): 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.(None): 3. address of the premises for the storage of the medicinal products on the territory of the Member State.
p.(None): (3) In case of wholesale of narcotic substances, as well as pharmaceutical forms containing such
p.(None): substances, the requirements of the Control on Drugs and Precursors Act shall also be applied.
p.(None): (4) In case of wholesale of radiopharmaceuticals, an opinion of the Nuclear Regulatory Agency shall also be submitted.
p.(None):
p.(None):
p.(None): Art. 200. The BDA shall assess the documentation the documentation and conduct an inspection on the spot of the sites
p.(None): mentioned in the application to certify their compliance with the requirements of the Good Distribution Practice.
p.(None):
p.(None):
p.(None): Art. 201. (1) Provided that the BDA establishes omissions in the submitted documentation, it
p.(None): shall notify the applicant in writing.
p.(None): (2) In the cases according to para 1 the term according to Art. 202, para 1, shall cease
p.(None): to run.
p.(None):
p.(None):
p.(None): Art. 202. (1) In a period of 90 days of the date of submission of the application according to Art. 199, para 1, the
p.(None): executive director of the BDA shall issue a wholesale authorisation or make a motivated refusal.
p.(None): (2) The refusal according to para 1 shall be subject to appeal under the terms of the Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 203. In a period of 15 days of the date of submission of the documentation according to Art. 199, para 2, the
p.(None): executive director of the BDA shall issue a registration certificate for wholesale on the territory of the Republic of
p.(None): Bulgaria to the person according to Art. 195, para 1.
p.(None):
p.(None): Art. 204. (1) The wholesale authorisation for medicinal products shall be timeless.
p.(None): (2) The authorisation according to Art. 202 or the certificate according to Art. 203 shall be cancelled provided that
p.(None): its holder requests so from the executive director of the BDA in writing.
p.(None): (3) The person according to Art. 195 shall be obliged to notify the BDA in writing within 7 days of the termination of
p.(None): its activities relating the wholesale of medicinal products. In such cases, the executive director of the BDA shall
...

p.(None): for retail trade in medicinal products at a pharmacy, opened in a populated area with not more than 10 000 citizens,
p.(None): shall be issued on the grounds of a submitted request in a form, to which shall be attached the following documents:
p.(None): 1. (amend. - SG, 60/2011, in force from 5. 8. 2011) the documents referred to in para 1, items 1, - 7a and a document
p.(None): issued by the mayor of the respective municipality, certifying the number of citizens in the respective populated area;
p.(None): 2. (amend. – SG, 102/2012, in force from 02.01.20120 document for paid fee amounting to 50% of the fee, defined by the
p.(None): tariff under Art. 21, Para. 2 for issuance of a permit for retail sale with medicinal products under Art. 222, Para. 1.
p.(None): (6) (prev. text of para 4, suppl. – SG 102/09, in force from 22.12.2009; amend., - SG 98/10, in force from 01.01.2011,
p.(None): former Para. 5, amend. – SG, 60/2011, in force from 5. 8. 2011) The application and the documents under para 1 and 5
p.(None): shall be filed to the BDA.
p.(None): (7) (prev. text of para 5, amend. – SG 102/09, in force from 22.12.2009; amend., - SG 98/10, in force from 01.01.2011,
p.(None): former Para. 6, amend. – SG, 60/2011, in force from 5. 8. 2011) The RHI shall issue hygiene resolution up to 14 days
p.(None): from the date of filing the application about this.
p.(None): submit the documents under para 5 to the Ministry of Health within 3 days from issuing
p.(None): the
p.(None):
p.(None):
p.(None): Art. 229. (1) (Repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): (2) (amend. – SG 102/09, in force from 22.12.2009, amend. – SG, 60/2011, in force from
p.(None): 5. 8. 2011; suppl. – SG 18/14) Within the term of 1 month after receiving the documentation under Art. 228, Para. 6,
p.(None): the executive director of BDA upon an issued opinion by the Expert Council for Retail Sale of Medicinal Products shall
p.(None): issue authorisation for retail with medicinal products or make a motivated refusal to issue an authorisation. The
p.(None): authorisation or refusal shall be delivered to the person who has submitted the application.
p.(None): (3) (Amend. - SG, 60/2011, in force from 5. 8. 2011) Where discrepancies with or omissions in the
p.(None): submitted documentation have been established, within 15 day term from filing the documentation under Art. 228, Para.
p.(None): 6, the BDA shall perform a check up of the produced documents and shall notify the candidate in writing about the found
p.(None): discrepancies and omissions. In these cases the term according to para 2 shall cease to run as from the date of the
p.(None): notification till the elimination of the defects.
p.(None): (4) (New SG. 71/2008, in force from 12. 08. 2008) In case that within 60 day term after the notification date, under
p.(None): para 3, the applicant fails to remove the established irregularities or incompleteness, the procedure for issuing
p.(None): authorisation for retail trade in medicinal products or for change of an issued authorisation shall be terminated.
p.(None): (5) (Former para 4 – SG 71/2008, in force from 12, 08 2008, amend. – SG, 60/2011, in force from 5. 8. 2011). The
p.(None): refusal of the executive director of the BDA to issue an authorisation shall be subject to appeal under the terms of
p.(None): the Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 229a. (New – SG. 23/2009, in force from 30. 03. 2009) (1) (amend. and suppl. - SG.
p.(None):
p.(None): 41/2009, in force from 02.06.2009; amend. – SG 98/10, in force from 01.01.2011, amend. – SG, 60/2011, in force from 5.
p.(None): 8. 2011) The BDA shall officially submit to RHI on the location of the relevant pharmacy with an authorisation, issued
...

p.(None): marketing authorisation holder of the medicinal product or a duly empowered person.
p.(None):
p.(None):
p.(None): Art. 251. (1) For advertising authorisation the person according to Art. 250 shall submit to the BDA a formal
p.(None): application as approved by the executive director of the agency accompanied by:
p.(None): 1. design of the advertising;
p.(None): 2. notarised power of attorney issued by the marketing authorisation holder where the application shall be submitted by
p.(None): another person;
p.(None): 3. bibliographical references of the used quotations, tables, or other materials, if any;
p.(None): 4. document for paid fee to the amount as paid down in the tariff according to Art. 21,
p.(None): para 2.
p.(None): (2) The presented advertising drafts - designs to Art. 1 issue 1 must be clear and if there
p.(None): is text, it must be understandable providing possibility to assess all of its elements - text and illustrations.
p.(None): (3) Expert Council of Advertising shall be established to the BDA. It shall involve physicians and
p.(None): specialists with practical experience in the field of advertising. The executive director of the BDA shall appoint
p.(None): by an order the composition of the council, where a representatives of the Professional Ethic Commission
p.(None): of the Bulgarian Medical Association, Bulgarian Dental Association and Bulgarian Pharmacists Union, the amount of
p.(None): the remuneration
p.(None):
p.(None): of its members, and shall approve rules for the condition and order for its work. In the Council representatives of
p.(None): patients organisations may be included.
p.(None): (4) The council according to para 3 shall prepare examination to the advertising design and shall establish an opinion
p.(None): for the executive director of the BDA.
p.(None): (5) In case of establishment of discrepancies between the advertising and the requirements of this Act,
p.(None): the BDA shall, within 7 days of the submission of the application according to para 1, give written
p.(None): instructions for their elimination by the applicant within one month of the notification date. This decision term shall
p.(None): cease to run as from the notification date till the elimination of the discrepancies.
p.(None): (6) If the applicant shall not fulfil the instructions within one month of the notification date according to para 5,
p.(None): the authorisation procedure shall be terminated.
p.(None):
p.(None):
p.(None): Art. 252. (1) The executive director of the BDA shall authorise or issue a motivated refusal of the
p.(None): advertising by an order within one month of the submission of the documentation according to Art. 251, para 1, on the
p.(None): grounds of the opinion according to Art. 251, para 4, and shall notify the marketing authorisation holder.
p.(None): (2) (New – SG, 60/2011, in force from 5. 8. 2011) Where within the term under Para. 1 the executive director of BDA
p.(None): does not permit by an order the advertisement or fails to make a grounded refusal, it shall be accepted, that there is
p.(None): a silent agreement with the project of the advertisement under Art. 251, Para. 1, p. 1 and it may be disseminated.
p.(None): (3) (Former, Para. 2 – SG, 60/2011, in force from 5. 8. 2011) The refusal of the executive director of the BDA shall be
p.(None): subject to appeal under the terms of the Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 253. (1) The issued advertising authorisation to Art. 252, para 1 shall refer to a concrete medicinal product
p.(None): within the validity of its marketing authorisation.
p.(None): (2) Where there have been variations in the marketing authorisation of a medicinal product resulting in
p.(None): changes of an authorised advertising of this product, the marketing authorisation holder shall submit to the
p.(None): BDA an application for change.
p.(None):
p.(None):
p.(None): Art. 254. In case of change in the authorised advertising, the person according to Art.
p.(None): 250 shall submit an application under the terms of Art. 251.
p.(None):
p.(None):
p.(None): Art. 254a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) The advertisement, intended for the medical specialists
p.(None): shall not be permitted under Art. 250 – 252.
p.(None): (2) The advertisement under Para. 1 shall be disseminated after submitting a notification to BDA, which shall contain
p.(None): an advertisement draft, while observing the requirements of this Chapter and the Ordinance under Art. 249.
p.(None):
p.(None):
...

p.(None): to a proposal by the Minister of Health. In it representatives of the Ministry of Health, the Ministry of Labour and
p.(None): Social Policy, the BDA, the NHIF, the Bulgarian Medical Association, Bulgarian Dental Association, Bulgarian
p.(None): Pharmacists Union, the professional organisation of the pharmacists, and organisations of the patients
p.(None): and the pharmaceutical industry are obligatory included.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) A person, who is
p.(None): a member of the Transparency Commission shall not be a member of the Council.
p.(None): (4) The Council of Ministers determines with Rules the condition and the order for work of the Transparency Commission.
p.(None):
p.(None):
p.(None): Art. 266. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) The
p.(None): Transparency Commission shall be a body before which decisions of the Council may be appealed.
p.(None): (2) The decisions of the Transparency Commission shall be taken by a majority of two thirds of its members.
p.(None): (3) The decisions of Para. 2 could be appealed under the terms of the Administrative Procedure Code and the appeal has
p.(None): no suspense effect.
p.(None):
p.(None):
p.(None): Art. 266a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Where the treatment of a relevant sickness is without
p.(None): alternative in the country, for a concrete patient may be applied a medicinal products, which is authorised for use in
p.(None): an EU Member State, authorised for use under this Act, but is not sold on the Bulgarian market.
p.(None): (2) Annually, upon proposal of the medical establishments for hospital assistance after an opinion of the relevant
p.(None): national consultant on the profile of the sickness, the Minister of Health shall confirm a list of the medicinal
p.(None): products under Para. 1, which shall contain the following information:
p.(None): 1. code on the anatomy-therapeutic – chemical classification;
p.(None): 2. international non-patent name, to which the product belongs; 3.sickness according to international code of
p.(None): sicknesses; 4.medicinal form and quantity active substance;
p.(None): 5. additional information.
p.(None): (3) The list under Para. 2 shall be published on the internet site of the Ministry of Health.
p.(None): (4) The terms and conditions for inclusion, changes or exclusion of medicinal products in the list under Para. 2 shall
p.(None): be determined by the Ordinance under Art. 9, Para. 1.
p.(None):
p.(None): (5) The medicinal product under Para. 1 shall be supplied upon a special order of a medical establishment for hospital
p.(None): assistance under terms and conditions, determined by the Ordinance under Art. 9, Para. 1.
p.(None): (6) The head of the medical establishment under Para. 5 shall bear responsibility for applying the treatment under
p.(None): Para. 1.
p.(None):
p.(None): Chapter thirteen.
p.(None): STATE CONTROL ON THE MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 267. (1) (amend., - SG 98/10, in force from 01.01.2011, suppl. – SG 102/2012, in force from 21.12.2012) The
p.(None): Ministry of Health shall exercise the state control on the medicinal products. The immediate management shall be
p.(None): executed by the chief state health inspector, the Council chairperson under Art. 258, Para. 1, the executive director
p.(None): of the BDA, and the directors of the regional health inspectorates (RHI) who shall be state inspectors for the control
p.(None): of the medicinal products.
...

p.(None): (8) (new – SG, 102/2012, in force from 21.12.2012) The BDA shall cooperation with the European Medicines Agency in
p.(None): coordination of inspections in third states.
p.(None):
p.(None):
p.(None): Art. 269a. (new - SG, 102/2012, in force from 21.12.2012) (1) The officials under Art. 267, Para. 3 shall draw up a
p.(None): report for each carried out inspection under Art. 269, Para. 3 and 4 for observing the principles and directions
p.(None): for Good manufacturing practice or for Good distribution practices or for observation of the requirements of
p.(None): Chapter Eight, as well as the requirements of this act.
p.(None): (2) The report under Para. 1 shall be given to the checked person, who can provide notes on it.
p.(None): (3) with receiving a grounded request, BDA shall submit electronically the reports under Para. 1 to the competent body
p.(None): of another Member State or to the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 269b. (new – SG, 102/2012, in force from 21.12.2012) (1) Where as a result of carried out inspections under Art.
p.(None): 269, Para. 3 compliance with the Good manufacturing practice is found, or the Good distribution practices where
p.(None): applicable, BDA shall issue to the manufacturer, importer or wholesale trader a certificate for Good
p.(None): manufacturing practice or certificate for Good distribution practice within the term of 90 days from the inspection.
p.(None): (2) Where as a result of a carried out inspection under Art. 269, Para. 3 it is found that the manufacturer, importer
p.(None): or wholesale trader of medicinal products or active substances fails to observe the requirements of the act and/or
p.(None): principles and directives of Good manufacturing practice and/or Good distribution practice, BDA shall issue an
p.(None): incompliance opinion.
p.(None): (3) The BDA shall introduce to the data base under Art. 147 the issued certificates under Para. 1 and information under
p.(None): Para. 2.
p.(None):
p.(None):
p.(None): Art. 269c. (new – SG, 102/2012, in force from 21.12.2012) (1) Where as a result of an inspection under Art. 270, Para.
p.(None): 1, p. 5 it is found that the marketing authorisation holder fails to observe the requirements of Chapter Eight,
p.(None): BDA shall give prescriptions for removal of the incompliance.
p.(None): (2) In the cases under Para. 1, BDA shall notify the Member States, the European
p.(None):
p.(None): medicines Agency and the European Commission.
p.(None):
p.(None):
p.(None): Art. 270. (1) Within the framework of their competence, the officials according to Art. 267, Para. 3, shall be entitled
p.(None): to:
p.(None): 1. (amend. - SG, 102/2012, in force from 21.12.2012) Access to all documents, connected to the subject
p.(None): of the inspection, as well as documents, connected directly and indirectly with violation of this Act or
p.(None): of legislation of the Member States, implementing requirements of Directive 2001/83/EC of the European
p.(None): Parliament and the Council for approval of the Community code concerning medicinal products for human use, as
p.(None): last amended by Directive 2004/27/EC of the European Parliament and the Council, independently from the form of the
p.(None): document;
p.(None): 2. order of each person to present information for violations according to point 1, which are familiar to him;
p.(None): 2a (new - SG, 102/2012, in force from 21.12.2012) inspect the manufacture and trade sites of manufacturers of
p.(None): medicinal products, active or auxiliary substances, as well as the laboratories, used by manufacture or import
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General/Other / Incapacitated

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p.(None): violation of the ordinance under Art. 234, Para. 5.
p.(None): (2) The BDA internet site under Para. 1 shall be connected with the internet site of the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 234b (new – SG, 102/2012, in force from 02.01.2013) The BDA shall participate in information campaigns, organised
p.(None): by the European Commission and the European Medicines Agency about the danger of falsified medicinal products.
p.(None):
p.(None): Art. 235. (1) The authorisation to carry out retail trade with medicinal products shall be cancelled with the
p.(None): termination of the activity of the persons according to Art. 222.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The executive director of BDA shall cancel the authorisation for
p.(None): retail trade with medicinal products:
p.(None): 1. according to an application by the person who has received authorisation for carrying out retail trade with
p.(None): medicinal products:
p.(None): 2. wherever it has been established that the manager of the pharmacy does not comply with the requirements laid down in
p.(None): Art. 224 and 225.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 222 and 225 shall notify the BDA in
p.(None): writing within 14 days of the termination of the activity according to para 1.
p.(None):
p.(None):
p.(None): Art. 236. (1) The pharmacy cannot be closed for more than 30 days within a calendar year due to the absence of the
p.(None): manager.
p.(None): (2) (suppl. – SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011, amend. – SG,
p.(None): 60/2011, in force from 5. 8. 2011) Where the manager of the pharmacy is not in a position to fulfil his
p.(None): obligations due to a leave for temporary incapacity of work due to an illness, pregnancy and birth, or adoption and
p.(None): leave for breeding of a little child, as per Labour Code, the pharmacy can operate under the management of another
p.(None): master of pharmacy, respectively another assistant pharmacist, in the cases to Art. 225 complying with the requirements
p.(None): of Art. 224 for not more than two years. In all these cases a permission of the executive director of BDA shall be
p.(None): issued.
p.(None): (3) The permission according to 2 shall be issued within 30 days.
p.(None):
p.(None):
p.(None): Art. 237. Upon termination of the activity of the person who received authorisation to retail trade with medicinal
p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
...

p.(None): to a medicinal product, which has already received marketing authorisation.
p.(None): 26. "Coordinating researcher" shall mean a researcher appointed for the purpose of coordinating the researchers or
p.(None): various sites participating in a multicentre test.
p.(None): 27. "Patient information leaflet" shall mean a leaflet accompanying a medicinal product and containing information for
p.(None): the customer.
p.(None): 27a. (New - SG 71/2008 in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) "Medicinal product
p.(None): for modern therapy" is a medicinal product, determined in Art. 2 of Regulation (EC) N 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on the medicinal products for modern therapy and amending Directive
p.(None): 2001/83/EC and Regulation (EC) № 726/2004.
p.(None): 28. "Medicinal product obtained from human plasma or human blood" shall mean a medicinal product produced
p.(None): from human blood constituents and by a method involving industrial process. The following shall be ascribed to this
p.(None): group: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, and other plasma
p.(None): fractions and combinations thereof.
p.(None): 29. "Medicinal product intended for treatment, prophylaxis, and diagnostics of rare
p.(None):
p.(None): diseases" shall mean a product, which:
p.(None): a) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases or chronic diseases taking
p.(None): progressive course, which affect not more than 5 of 10,000 people on the territory of a state or
p.(None): b) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases and severely health damaging
p.(None): chronic disease (diseases with high percentage of disease-related incapacity of work or disability) and are there is
p.(None): evidence appended that the sale of the product does ensure satisfactory return, which can justify the required
p.(None): investment for scientific research and development without having stimuli for the creator of the product, and
p.(None): c) where the is no satisfactory method of diagnostics, prophylaxis, or treatment of a given condition or where there is
p.(None): such method the proposed medicinal product has significantly more advantages and benefits for the people affected by
p.(None): this condition.
p.(None): 30. "Pharmaceutical form" shall mean an adequate for intake structure containing active substance(s), which can
p.(None): include or cannot include excipients and which is obtained through application of certain technological operations
p.(None): ensuring the desired healing effect and stability at storage within the expiry term.
p.(None): 31.. (Amen. - SG 71/2008 in force from 12.08.2008) "Any person, established on the territory of a Member State shall
p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
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p.(None): authorisation and the subsequent practical requirements in connection with the authorisation to market of
p.(None): medicinal products according to Art. 28 and Art. 29 shall not be regarded as breach of patent rights or to
p.(None): supplementary protection certificates of medicinal products.
p.(None):
p.(None):
p.(None): Art. 34. (1) The summary of product characteristics shall contain the following information:
p.(None):
p.(None): 1. name of the medicinal product, quantity of the active substance in a dose unit, and pharmaceutical form;
p.(None): 2. qualitative and quantitative composition in terms of the active substances and constituents of the
p.(None): excipient, the information of which is essential for proper administration of the medicinal product. The usual common
p.(None): name or chemical description shall be used;
p.(None): 3. pharmaceutical form;
p.(None): 4. clinical particulars:
p.(None): a) therapeutic indications,
p.(None): b) posology and method of administration for adults and, where necessary, for children,
p.(None): c) contra-indications,
p.(None): d) special warnings and precautions for use and, in the case of immunological medicinal products, any special
p.(None): precautions to be taken by persons handling such products and administering them to patients, together with
p.(None): any precautions to be taken by the patient,
p.(None): e) interaction with other medicinal products and other forms of interactions,
p.(None): f) use during pregnancy and lactation,
p.(None): g) effects on ability to drive and to use machines,
p.(None): h) undesirable effects,
p.(None): i) overdose (symptoms, antidotes, emergency measures).
p.(None): 5. pharmacological properties:
p.(None): a) pharmacodynamic properties,
p.(None): b) pharmacokinetic properties,
p.(None): c) preclinical safety data.
p.(None): 6. pharmaceutical particulars:
p.(None): a) list of excipients,
p.(None): b) major incompatibilities,
p.(None): c) shelf life, where necessary after reconstitution of the medicinal product or where the immediate packaging is opened
p.(None): for the first time,
p.(None): d) special precautions for storage,
p.(None): e) nature and contents of container,
p.(None): f) special precautions for disposal of unused medicinal product or waste materials from such medicinal product.
p.(None): 7. marketing authorisation holder.
p.(None): 8. registration number.
p.(None): 9. date of the first marketing authorisation or renewal of the marketing authorisation.
p.(None): 10. date of a variation in the summary of product characteristics.
p.(None): 11. for radiopharmaceuticals, full details of internal radiation dosimetry.
p.(None): 12. for radiopharmaceuticals, detailed instructions for extemporaneous preparation and quality control and, where
p.(None): appropriate, maximum storage time during which any intermediate preparation such as an eluate or the
p.(None): ready-to-use pharmaceutical will conform to its specifications.
p.(None): (2) The summary of product characteristics of medicinal products according to Art. 28- 33, those parts of the summary
p.(None): of product characteristics of the reference medicinal product referring to indications or dosage forms which were still
p.(None): covered by patent law at the time when a generic medicine was marketed shall not be included.
p.(None): (3) The requirements relating to the form and content of the summary of product characteristics shall be
p.(None): laid down in the regulation according to Art. 42.
...

p.(None): medicinal product is received, has authorisation for manufacture/import;
p.(None): 14. (new – SG, 102/2012, in force from 02.01.2013) check up whether the intermediary, through whom the medicinal
p.(None): product is received, meets the requirements of this Chapter.
p.(None): (2) The documentation according to Para. 1, points 7 and 8 shall be kept for at least 5 years and shall be provided to
p.(None): the control bodies upon request.
p.(None):
p.(None):
p.(None): Art. 208. (amend. – SG, 102/2012, in force from 02.01.2013) The obligations according to Art. 207, Para. 1, point 2,
p.(None): and Art. 209a shall also apply to the wholesalers according to Art. 203, as well as to the importers and manufacturers
p.(None): trading in medicinal products manufactured by them.
p.(None):
p.(None):
p.(None): Art. 209. The requirements of the special provisions of other laws shall also apply to the wholesale of medicinal
p.(None): products containing narcotic substances or obtained from blood, or immunological products, or
p.(None): radiopharmaceuticals.
p.(None):
p.(None):
p.(None): Art. 209a. (New - SG 71/2008, in force from 12.08.2008) (1) The wholesale traders with medicinal products may deliver
p.(None): medicinal products to:
p.(None): 1. other wholesale traders with medicinal products;
p.(None): 2. pharmacies and drugstores;
p.(None): 3. the Ministry of Defence and the Ministry of Interior for own needs, with the exception of their medical
p.(None): institutions, as well as the State Reserve and Military time Reserve State Agency;
p.(None): 4. the Ministry of Health with:
p.(None): a) vaccines, tocsins and serums, needed for implementation of the Immunisation calendar of the Republic of
p.(None): Bulgaria, as well as during emergency epidemical situations;
p.(None): b) medicinal products, intended for treatment of illnesses, which are paid as provided by the Health Act, as well as
p.(None): for providing the implementation of national programmes in the area of healthcare;
p.(None): 5. (new – SG 60/12, in force from 07.08.2012) outpatient health care institutions which have signed an agreement with
p.(None): the National Health Insurance Fund, with medicinal products required for performance of health activities under Art.
p.(None): 82, para 2, item 3 of the Health Act.
p.(None): (2) Doctors and Dental doctors in the populated areas, where there are no pharmacies may be supplied with medicinal
p.(None): products by wholesale traders, as provided by the ordinance under Art. 207, para 1, p. 6.
p.(None):
p.(None):
p.(None): Art. 209b. (new – SG, 102/2012, in force from 02.01.2013) (1) In wholesale trade of medicinal products in third states
p.(None): the requirements of Art. 207, Para. 1, p. 2, 5 and 6 shall not apply, as well as the requirements of Chapter Nine "a".
p.(None):
p.(None): (2) Where the medicinal product is received directly from a third state, but jas not been imported on the territory of
p.(None): the Republic of Bulgaria, the requirements of Art. 207, Para. 1, p. 4 and 4a shall not apply.
p.(None): (3) (new – SG 18/14) In cases referred to in par. 1 the wholesalers shall certify by relevant documents
p.(None): that the medicinal products are received from persons holding a permit or have got the right to supply medicinal
p.(None): products subject to compliance with the applicable national laws of the third country.
p.(None): (4) (new – SG 18/14) Where the wholesalers supply medicinal products to persons in third countries, they certify by
p.(None): relevant documents that the supplies are solely for persons, holding a permit or having got the right to
...

General/Other / Relationship to Authority

Searching for indicator authority:

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p.(None): trials conducted outside the territory of the Member States;
p.(None): 12. (amend. – SG, 102/2012, in force from 21.12.2012) a summary of the system
p.(None): a) for vigilance the medicinal safety, which shall include the following elements:
p.(None): b) which is to be implemented and, where appropriate, description of the risk management system;
p.(None): c) name of the qualified person under Art. 191, a CV – education, acquired professional experience in the area of
p.(None): vigilance the medicinal safety and qualification for performing his/her duties under Chapter Eight;
p.(None): d) each Member state in which the qualified person fulfils his/her duties;
p.(None): e) address, tel. fax, e-amil address of the person under letter "a";
p.(None): f) address, at which the basic document is kept of the system for vigilance medicinal
p.(None): safety;
p.(None): 12a. (new - SG, 102/2012, in force from 21.12.2012) declaration by the applicant that
p.(None): he/she has the needed means for fulfilling the obligations under Chapter Eight;
p.(None): 13. (amend. -SG, 102/2012, in force from 21.12.2012) plan for risk management with a description of the system for risk
p.(None): management, which the applicant will introduce for the relevant medicinal product with the plan summary;
p.(None): 14. summary of product characteristics according to Art. 34;
p.(None): 15. mock-up of the immediate and outer packaging of the product and a proposed package leaflet in
p.(None): compliance with the requirements of chapter six;
p.(None): 16. copy of the manufacturing authorisation issued by the regulatory authority of the
p.(None):
p.(None): country where manufacture is performed accompanied by a Good Manufacturing Practice certificate or a
p.(None): certificate evidencing that the manufacture of the medicinal product and the active substances contained in its
p.(None): composition has been performed in compliance with standards, which are at least equivalent to the standards of
p.(None): the Good Manufacturing Practice;
p.(None): 17. copy of a document evidencing that the medicinal product is designated for treatment, prophylaxis, or diagnostics
p.(None): of rare diseases accompanied by a copy of the opinion of the European Medicines Agency;
p.(None): 18. copies of all marketing authorisations issued in other Member States or in a third state of the medicinal product
p.(None): applied for marketing authorisation;
p.(None): 18a. (new -SG, 102/2012, in force from 21.12.2012) a copy of summary of the safety data, including the data,
p.(None): contained in the periodical updated safety reports and if any – the signals for suspected unacceptable
p.(None): medicinal reactions;
p.(None): 19. list of the Member States where an application for marketing authorisation the medicinal product has
p.(None): been submitted;
p.(None): 20. copy of the summary of product characteristics proposed by the person according to Art. 26, para 1, or a copy of
p.(None): the summary of product characteristics approved by a regulatory authority of a Member State/ states members of
p.(None): the European Economic Area, which has already issued a marketing authorisation;
p.(None): 21. copy of a refusal for a marketing authorisation in a Member State or a third state accompanied by motives;
p.(None): information for temporary suspension or termination of the effect of the marketing authorisation;
p.(None): 22. copy of the proposed package leaflet accompanied by a summary of the results of the assessment of the level of
p.(None): comprehensibility of the contents of the package leaflet by a target patient group selected by the applicant or a copy
p.(None): of a leaflet approved by a regulatory authority in a Member State, which has already issued a marketing authorisation;
p.(None): 23. document of paid fee in amounts up in the tariff according to Art. 21, para 2.
p.(None): (2) (suppl. – SG 18/14) The documents according to para 1, item 18 and 18a, relating to the Member States, and point
p.(None): 19, respectively, shall only be submitted in the procedures according to section VII.
p.(None): (3) To radionuclide generators, the following documents shall be added to the data according to para 1:
p.(None): 1. description of the system together with a detailed description of its components, which may affect the composition
p.(None): or quality of the daughter radionuclides;
p.(None): 2. qualitative and quantitative particulars of the eluate or the sublimate.
p.(None): (4) The documents and data from pharmaceutical tests, preclinical and clinical trials shall be accompanied by
p.(None): summarised reports prepared by experts with the required technical and professional qualification. To the reports a
p.(None): curricula vitae report of the experts shall be applied.
p.(None): (5) The dossier of the medicinal product shall be submitted in the Bulgarian and/or English language.
p.(None): (6) (new – SG, 102/2012, in force from 21.12.2012) The risk management system under Para. 1, p. 13 should be
p.(None): proportional to the identified and to the potential risks of the medicinal product and to the need of collecting safety
p.(None): data of post-marketing researches.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The holder of the authorisation for use shall update the data of the
p.(None): file under Para. 1. For each change in the file the provisions of Chapter Three Section VI shall apply, where
p.(None): applicable.
p.(None):
p.(None):
p.(None): Art. 28. (1) The person according to Art. 26, para 1, insofar as he does not infringe industrial and commercial
p.(None): property rights, shall not submit to the BDA the data according to Art.
p.(None):
p.(None): 27, para 1, point 10, letters "b" and "c" provided that he can prove that the medicinal product indicated in the
p.(None): application is generic of a reference medicinal product, which is or has been authorised to market for not less than 8
p.(None): years in a Member State or in a state member of the European Economic Area.
p.(None): (2) The marketing authorisation holder of a generic product according to para 1 may not place it to market until 10
p.(None): years from the initial marketing authorisation of the reference medicinal product have elapsed.
p.(None): (3) Under observance of the conditions of para 1 and 2, the person according to Art. 26, para 1, may submit to the BDA
p.(None): an application for marketing authorisation of a medicinal product, which is generic of a reference medicinal product,
p.(None): even where the reference product has never had marketing authorisation on the territory of the Republic of Bulgaria.
p.(None): (4) In the cases according to para 3, the person according to Art. 26, para 1, shall indicate in the
p.(None): application according to Art. 27, para 1, the Member State where the reference product is or has been authorised to
p.(None): market.
p.(None): (5) In the cases according to para 3, the BDA shall request from the regulatory authority of the Member State indicated
p.(None): in the application according to Art. 27, para 1, a confirmation of the information according to para 4, the qualitative
p.(None): and quantitative composition of the reference product and, if necessary, additional documentation.
p.(None): (6) At the request of a regulatory authority of a Member State where the application for a medicinal product generic to
p.(None): a referent medicinal product, which is or has been authorised to market on the territory of the Republic of
p.(None): Bulgaria, is submitted, the BDA shall submit the requested information according to para 5 within one month from
p.(None): the request date.
p.(None): (7) The ten-year period according to para 2 may be extended by maximum one year at the request of the marketing
p.(None): authorisation holder of the reference medicinal product provided that during the first 8 years from the issue
p.(None): of the marketing authorisation of the reference medicinal product its marketing authorisation holder has
p.(None): received authorisation for a new therapeutic indication the significant clinical advantages of which versus the
p.(None): existing therapeutic opportunities are scientifically well-grounded.
p.(None): (8) (new – SG 12/11, in force from 08.02.2011) Where for a medicinal product an initial marketing authorisation has
p.(None): been issued according to Art. 23, regarding each change of the strength of the active substance, in the pharmaceutical
p.(None): form, of the quantity per package, of the administrative route of the medicinal product, as well as regarding
p.(None): all other changes or extensions of the range of the marketing authorisation, an authorisation according
p.(None): to the requirements of this Act shall be also issued or the initial marketing authorisation shall be
p.(None): supplemented. All these authorisations shall be considered belonging to a general marketing authorisation of the
p.(None): medicinal product for the purposes of application of this Article.
p.(None):
p.(None):
...

p.(None):
p.(None):
p.(None): Art. 70. (1) Prior to the placement on the market of each batch of the product the marketing
p.(None): authorisation of a medicinal product obtained from human blood or human plasma shall submit to the BDA the following:
p.(None): 1. a sample of the finished product and/or a sample of the bulk/ unfinished product;
p.(None): 2. manufacturing and quality control protocols;
p.(None): 3. document for paid fee as laid down in the tariff according to Art. 21, para 2.
p.(None): (2) Within 60 days of the submission of the full set of documents, the BDA shall perform an assessment of the
p.(None): manufacturing and control protocols of the medicinal product obtained from human blood or human plasma and tests
p.(None): of the submitted samples in an accredited laboratory in order to establish whether the medicinal product
p.(None): according to para 1 is manufactured in compliance with the approved specifications.
p.(None): (3) In case of a positive result from the tests, the BDA shall issue a batch release certificate.
p.(None): (4) The conditions and order, as well as the