Name of law Law amending and supplementing the law on medicinal products for human use the Name Bill a bill amending and supplementing the law on medicinal products for human use date adopted 21/07/2011 number/year Official Gazette 60/2011 Decree No 186

On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria

I DECLARE:

To be published in the Official Gazette the law amending and supplementing the law on medicinal products for human use, adopted by the National Assembly of the HLI 21 July 2011.

Issued in Sofia on 29 July 2011.

The President of the Republic: Georgi Parvanov

Stamped with the State seal.

Minister of Justice: Margarita Popova

LAW

amending and supplementing the law on medicinal products for human use (official SG. 31 of 2007; amend., SG. 19 of 2008; Decision of the Constitutional Court No. 5 of 2008-65/2008; amend., no. 71 of 2008, no. 10, 23, 41, 88 and 102 of 2009, 59/98 and by 2010 and no. 9 and 12 by 2011.)

§ 1. In art. 14 is hereby amended as follows:

1. In paragraph 8. 2 item 3 shall be repealed.

2. Paragraph 3 shall be repealed.

§ 2. In art. 16 para. 3 is repealed.

§ 3. In art. 17, al. 5 item 5 is replaced by the following: "5. the issued, refused or suspended marketing authorisations of medicinal products at retail;".

§ 4. In chapter II, section I created art. 17A:

"Art. 17. the regional health inspections and issue certificates of registration of the drugstores. "

§ 5. Article 18 is hereby repealed.

§ 6. In art. 19, para. 1 item 5 is replaced by the following: "5. the permits issued for retail trade in medicinal products;".

§ 7. In chapter two, section II art is created. 19A:

"Art. 19. (1) the RZI lead and maintain public registers of their certificates of registration of drugstores.

(2) within 7 days of the issuance of the certificate of registration of the drugs the RZI sent to the Ministry of health information on the Act.

(3) the Ministry of health leads and maintains on its website a public national register of issued certificates of registration of drugs. "

§ 8. In art. 22 the following modifications are made:

1. In paragraph 8. 1.10 ' in size 40 "is replaced by" up to 25 ".

2. in the Al. 2:

and in the text) before item 1 the words "art. 14, para. 3, art. 114, para. 4, art. 260, para. 4 and art. 262, para. 7 ' shall be replaced by "art. 114, para. 4 and art. 261, para. 5 ";

b) point 1 shall be repealed;

c) in paragraph 3 the words "the Commission on the prices of medicinal products, the Commission in a positive list of medicines" are replaced by "the Committee on pricing and reimbursement;

d) in item 5, the words "up to 40 percent of the funds under art. 14, para. 3, art. 260, para. 4 and art. 262, para. 7 ' shall be replaced by ' up to 25 per cent of the resources under art. 114, para. 4 and art. 261, para. 5. "

§ 9. Art is created. 54A:

"Art. 54. (1) on receipt of a signal in the drug agency to suspend sales of the medicinal product, except in the cases under art. 54, para. 2 and 3, the Agency shall check, within 30 days of the receipt of a signal.

(2) in carrying out the verification referred to in paragraph 1. 1 the FDA may request information from the holder of the marketing authorisation for use and/or the person under art. 26, al. 2 concerning the suspension of sales of the medicinal product, as well as by wholesalers of medicinal products on the available quantities of the product.

(3) the drug agency published on your page on the Internet the results of checks carried out. "

§ 10. In chapter three, section V creates art. 59 in:

"Art. 59. Drug Agency shall inform the Directorate of the Ministry of health under art. 259, para. 11 for suspended and withdrawn permissions for use and for the failure to renew the permits issued for the use of medicinal products within 7 days of issuance of the relevant Act. "

§ 11. In art. 79 para. 4 and 5 are repealed.

§ 12. Art is created. 79A:

"Art. 79. (1) in the light of the decision of the European Commission after the completion of the arbitration procedure the FDA within 30 days of receipt of the notification:

1. issue, temporarily suspend or terminate permission to use, or

2. to carry out the required changes in the issued permission to comply with the decision of the European Commission.

(2) drug agency shall notify the European Commission and the European Medicines Agency for the issued act under para. 1. "

§ 13. In art. 87 para. 1 shall be amended as follows:

(1) a clinical trial may be conducted in hospitals for hospital care, mental health centres, centres for skin-venereal diseases, oncologic, complex centers centers, medical centers, dentists, and medical and dental centres authorised/registration certificate under the medial institutions act. "

§ 14. In art. 103 al. 1 shall be amended as follows:

"(1) to the Minister of health created the Commission on ethics for multi-centre trials, whose composition shall be determined by order of the Minister and includes regular and reserve members. Reserve members participate in meetings of the Commission and have a voice in the absence of regular members.

§ 15. In art. 150, para. 2 is hereby amended as follows:

1. Points 3 and 4 are hereby amended:

"3. the data for the single identification code of the trader or the cooperative from the commercial register, and for the companies registered in a Member State of the European Union or in a State party to the agreement on the European economic area – document for up-to-date registration under national law, issued by the competent authority of the country concerned;

4. list of production activities, medicinal forms and of active substances which will produce; ".

2. point 9 shall be repealed.

§ 16. In art. 155, para. 2 the words "medicinal products and forms" are replaced by "production activities and formulations".

§ 17. In art. 156 following amendments and supplements shall be made:

1. In paragraph 8. 1:

a) point 3 shall be repealed;

(b)) in item 5, the word "operations" shall be replaced by "activities";

in section 6) shall be replaced by the following:

"6. the active substances and formulations;"

d) in point 7, the word "Court" is replaced by "commercial".

2. a new paragraph. 3:

(3) within 14 days of the occurrence of a change of equipment holder of the manufacturing authorization shall notify the FDA. "

3. a para. 4:

"(4) the holder of the manufacturing authorisation filed with the FDA notification at the start of production for each new medicinal product authorized for use."

4. The current paragraph. 3 it al. 5.

§ 18. In art. 157 is hereby amended as follows:

1. In paragraph 8. 1, item 2 the number "90" is replaced by "30" and the words "item 3, 4, 5 and 6 ' shall be replaced by ' paragraph 4 – 6.

2. in the Al. 2 the words "item 3, 4, 5 and 6 ' shall be replaced by ' paragraph 4 – 6.

§ 19. In Chapter five, section I created art. 160:

"Art. 160. (1) the Executive Director of the BDA with order takes the manufacturing authorisation issued when there are no conditions under art. 148 and failure to comply with the requirements of good manufacturing practice laid down by the procedure of art. 152.

(2) the Executive Director of the BDA by order suspend the manufacturing authorisation:

1. at the written request of the holder;

2. upon termination of the activities for which it is issued;

3. where the registration of the trader;

4. upon the death of the natural person – sole proprietor.

(3) the order under paragraph 1. 1 may be appealed pursuant to the administrative code, an appeal shall not have suspensive effect.

§ 20. In art. 162, para. 2 paragraph 1 shall be replaced by the following:

' 1. data for Single identification code of the trader or the cooperative from the commercial register, and for the companies registered in a Member State of the European Union or in a State party to the agreement on the European economic area – document for up-to-date registration under national law, issued by the competent authority of the country concerned; ".

§ 21. In art. 193, para. 1, after the words "the holder" is added "persons authorised to parallel import and".

§ 22. In art. 199, para. 1 is hereby amended as follows:

1. point 2 shall be replaced by the following:

"2. the data for the single identification code of the trader or the cooperative from the commercial register, and for the companies registered in a Member State of the European Union or in a State party to the agreement on the European economic area – document for up-to-date registration under national law, issued by the competent authority of the country concerned;".

2. points 4 and 5 are repealed.

§ 23. Article 210 shall be replaced by the following:

"Art. 210. (1) the holder of the marketing authorisation for use and/or person under art. 26, al. 2 can provide samples of medicinal products authorised for use on:

1. physicians and dental practitioners;

2. higher medical schools and medical colleges.

(2) in cases under para. 1 on the packaging of medicinal products shall be labelled "sample".

(3) The persons referred to in para. 1, item 1 may be delivered no more than two samples of the same pharmaceutical form of the medicinal product in one calendar year in the smallest existing packaging and producer of higher medical schools and medical colleges – only in quantities necessary for training purposes.

(4) the holder of the marketing authorisation for use and/or person under art. 26, al. 2 keep records of all persons who have supplied samples, the type, quantity and timing of deliveries and, upon request, provide this information to the supervisory authorities.

§ 24. In art. 219 is hereby amended as follows:

1. In paragraph 8. 1 the words "on the list, determined by the Minister of health ' shall be deleted.

2. in the Al. 2, the words "and the list under para. 1.0 ' shall be deleted.

§ 25. In art. 222 following amendments and supplements shall be made:

1. a new paragraph. 5:


"(5) For the satisfaction of their own needs medical institutions under para. 4 who do not have an open pharmacy, may be supplied by the pharmacy of the hospital, licensed for retail trade in medicinal products under conditions and by an order determined by the Ordinance under art. 219, para. 2. "

2. The current paragraph. 5 it al. 6 and in her words "by the Minister of health ' shall be replaced by" by the Executive Director of BDA. "

§ 26. In art. 225 Al is created. 3:

"(3) the pharmacist Assistant pharmacy manager – under par. 1, may carry out the following activities: storing and dispensing without prescription of authorised medicinal products in the Republic of Bulgaria, medical devices, dietary foods for special medical purposes and infant formulae and follow-on formulae, as well as nutritional supplements, cosmetics and sanitary means. "

§ 27. In art. 227, para. 2 the words "para. 4 "shall be replaced by" para. 5. "

§ 28. In art. 228 following amendments and supplements shall be made:

1. In paragraph 8. 1:

and in the text) before item 1, the words "the Minister of health or authorized by him Deputy Minister" shall be replaced by the words "the Executive Director of the BDA";

b) point 1 shall be amended as follows:

' 1. data for Single identification code of the trader or the cooperative from the commercial register, and for the companies registered in a Member State of the European Union or in a State party to the agreement on the European economic area – document for up-to-date registration under national law, issued by the competent authority of the country of the persons under art. 222, para. 1; "

in point 7) at the end, add "as well as information concerning the penalties imposed pursuant to the Act on professional organization of master-pharmacists";

(d)) that is created: ' 7A. Hygienic conclusion issued by the RZI; ".

2. a new paragraph. 2:

"(2) when issuing an authorisation for retail trade in medicinal products that presented a diploma to pharmacists/Assistant pharmacist, issued by the competent authority."

3. The current paragraph. 2 it al. 3 and in her words "and 5 ' shall be replaced by" and 6 ".

4. The current paragraph. 3 it al. 4.

5. The current paragraph. 4 it al. 5 and in item 1, the words "item 1, 2, 3, 4, 5, 6 and 7 ' shall be replaced by ' paragraphs 1-7 and".

6. the Previous para. 5 and 6 become Al respectively. 6 and 7 are amended:

(6) the application and the documents referred to in para. 1 and 5 are submitted to the FDA.

(7) the regional health inspection issued hygienic conclusion within 14 days from the date of filing of the application for it. "

§ 29. In art. 229 the following modifications are made:

1. The first subparagraph of paragraph 1 shall be repealed.

2. in the Al. 2 the words "art. 228, para. 5 Health Minister "shall be replaced by" art. 228, para. 6, the Executive Director of BDA. "

3. Paragraph 3 is replaced by the following:

(3) within 15 days of receipt of the documentation referred to in art. 228, para. 6 the FDA carries out verification of the documents presented and notify the applicant of the discrepancies or gaps. In such cases, the period referred to in para. 2 stops to run from the date of notification to the removal of deficiencies. "

4. in the Al. 5, the words "Minister of health" shall be replaced by the words "the Executive Director of the BDA.

§ 30. In art. 229 a, para. 1 the words "Ministry of health" shall be replaced by the words "drug agency".

§ 31. In art. 230, para. 1 and 2, the words "Department of health" shall be replaced by the words "drug agency".

§ 32. In art. 231 following amendments and supplements shall be made:

1. a new paragraph. 2:

"(2) in the event of a change of both the name and the type of merchant, pharmacy and pharmacy manager shall submit a new application in accordance with art. 228, para. 1 and paid the fee for the issue of a marketing authorisation of medicinal products in the retail pharmacy, as defined in the tariff referred to in art. 21, para. 2. "

2. Al are created. 3 and 4:

"(3) a person authorized for the retail sale of medicinal products by the order of art. 228, para. 5, can make change under art. 230, para. 1, item 4 only in the village with a population of 10,000 inhabitants.

(4) where a person referred to in paragraph 1. 3 wishes to effect change under art. 230, para. 1, item 4 in the village with a population of over 10,000 inhabitants, it pays a fee for the granting of a marketing authorisation of medicinal products in the retail pharmacy, as defined in the tariff referred to in art. 21, para. 2. "

3. The current paragraph. 2 it al. 5.

§ 33. In art. 234 Al is created. 5:

(5) without prescription medicinal products can be sold over the Internet only by a pharmacy or drug store, authorized under the conditions and by the order of this law and of the Ordinance under art. 219, para. 2, respectively, under art. 243. "

§ 34. In art. 235 the following modifications are made:

1. In paragraph 8. 2 the words "Minister of health" shall be replaced by the words "the Executive Director of the BDA.

2. in the Al. 3 the words "Minister of health" are replaced by "BDA".

§ 35. In art. 236, para. 2, second sentence, the words "by the Minister of health or from authorized by him Deputy Minister" is replaced by "by the Executive Director of BDA."

§ 36. In art. 239 following amendments and supplements shall be made:

1. In paragraph 8. 1, the words "in the FDA" shall be replaced by "in the RZI".

2. in the Al. 2:

a), the words "in the FDA" shall be replaced by "in the RZI";

b) point 1 shall be amended as follows:

' 1. data for Single identification code of the trader or the cooperative from the commercial register, and for the companies registered in a Member State of the European Union or in a State party to the agreement on the European economic area – document for up-to-date registration under national law, issued by the competent authority of the country of the persons under art. 238, para. 1; "

in points 4 and 5) are repealed.

3. Al are created. 3, 4 and 5:

(3) within 14 days of receipt of the application referred to in paragraph 1. 2 check RZI on compliance with requirements of the Ordinance under art. 243. In cases where it is established that the requirements are not complied with the Ordinance under art. 243, within 7 days of completion of the examination regulations and gives RZI shall set a deadline for their removal.

(4) within 14 days of receipt of the application and the documents referred to in para. 2 the Director of RZI shall notify the person shortcomings in them and set a time limit for their removal.

(5) for an application for the registration of drugs or for making the change under art. 242 the RZI collects fees in an amount fixed by the tariff referred to in art. 21, para. 2. "

§ 37. Article 240 is amended as follows:

"Art. 240. (1) within 14 days of the completion of the inspection under art. 239, para. 3 or by removal of the limitations of art. 239, para. 4 the Director of RZI issue certificate for registration of drugs or makes a motivated refusal to issue.

(2) the refusal of the Director of RZI under para. 1 subject to appeal pursuant to the administrative code.

§ 38. In art. 241 is hereby amended as follows:

1. In paragraph 8. 1, the words "in the FDA" shall be replaced by "in the RZI".

2. in the Al. 2 the words "BDA" shall be replaced by ' of the RZI ".

§ 39. Art is created. 241:

"Art. 241. The national register of issued certificates of registration of drugs under art. 19A, para. 3 contains:

1. name of the RZI, issued a certificate of registration;

2. the number and date of the issued certificate;

3. seat and address of the person who has obtained a certificate of registration of drugs;

4. the name of the head of the drugstore;

5. the address of the Pharmacy;

6. date of termination of the registration and the basis for that. "

§ 40. In art. 252 following amendments and supplements shall be made:

1. a new paragraph. 2:

"(2) where, within the period referred to in paragraph 1. 1 Executive Director of BDA does not resolve with an ad or not make reasoned refusal, it is assumed that there was a tacit agreement with the draft advertising under art. 251, para. 1, item 1, and it can be distributed. "

2. The current paragraph. 2 it al. 3.

§ 41. Art is created. 254 (a):

"Art. 254. (1) the advertisement, designed for medical professionals, not permitted by the order of art. 250-252.

(2) advertising on al. 1 spread after submission of the notification to the FDA, to which the project applies to advertising, and in compliance with the requirements of this chapter and of the Ordinance under art. 249. "

§ 42. In art. 258 following amendments and supplements shall be made:

1. In paragraph 8. 1 the words "para. 4 "shall be replaced by" para. 5. "

2. Paragraphs 2 and 3 shall be read with the following adaptations:

"(2) the State shall register the maximum retail selling prices of medicinal products subject to medical prescription, outside those under para. 1, and of medicines without medical prescription.

(3) the price determined pursuant to para. 1, and the overall price of medicinal products when sold at retail. "

3. Al are created. 4 and 5:

"(4) the marginal price of a medicinal product, which is not included in the positive list, but with the same active substance in international non-proprietary name, which is included in the list, with the exception of the products referred to in art. 262, para. 5, item 2, shall regulate the conditions and procedures specified by the Ordinance of Pará. 5. (5) the Council of Ministers shall, on a proposal from the Minister of health shall determine by Decree the conditions and arrangements for regulating the prices of medicinal products under para. 1 and the terms and conditions for the registration of prices of medicinal products under para. 2. "

§ 43. Article 259 shall be amended as follows:

"Art. 259. (1) to the Minister of health created the Committee on pricing and reimbursement.

(2) the composition of the Commission for pricing and reimbursement shall be set by decision of the Council of Ministers, on a proposal from the Minister of health and includes: five representatives of the Ministry of health, five representatives of the national health insurance fund, a representative of the Ministry of finance, a representative of the Bulgarian medical association and a representative of the Bulgarian Dental Association.

(3) the representative of the Ministry of finance is the Chairman of the Commission.

(4) the members of the Commission shall be for a term of 4 years.

(5) every two years, one half of the composition of the Commission under para. 1 is updated.


(6) a person who is a member of the Committee on the pricing and reimbursement shall not be a member of the Committee on transparency.

(7) The members of the Committee on pricing and reimbursement may be appointed medical specialists, lawyers and economists with practical experience in the field of medicinal products and in the respective areas of their application.

(8) the methods of work of the Committee on the pricing and reimbursement shall be determined by the Ordinance under art. 258, para. 5.

(9) the activities of the Committee on pricing and reimbursement shall be ensured by the specialized administrations of the Ministry of health and the national health insurance fund. "

§ 44. Create art. 259 and 259 (b):

"Art. 259. (1) the Committee on pricing and reimbursement shall meet the Chairman, five representatives of the national health insurance fund, two representatives of the Ministry of health and a representative of the Bulgarian medical association or the Bulgarian Dental Association, when examining applications for medicinal products under art. 262, para. 5, item 1.

(2) the meetings of the Commission under para. 1 are considered to be valid if two thirds of the members are present.

(3) the decision of the Commission under para. 1 is taken by a two-thirds majority of its members.

(4) the Commission shall meet at prices and reimbursement in the Chairman, five representatives of the Ministry of health, two representatives of the national health insurance fund and a representative of the Bulgarian medical association or the Bulgarian Dental Association, when examining applications for medicinal products under art. 262, para. 5, item 3 and 4.

(5) meetings of the Commission under para. 4 are considered to be valid if two thirds of the members are present.

(6) the decision of the Commission under para. 4 is taken by a two-thirds majority of its members.

(7) the Committee on pricing and reimbursement shall meet at least once a month in the boards on the Al. 1 and 4.

(8) the Committee on pricing and reimbursement shall meet in its composition under art. 259, para. 2 when examining applications for medicinal products under art. 262, para. 5, item 2 and organisational in nature or related to the overall business.

(9) meetings of the Commission under para. 8 are considered to be valid if two thirds of the members are present.

(10) the decision of the Commission under para. 8 is taken by a two-thirds majority of its members.

Art. 259. (1) (b) the Chairman and the members of the Committee on the pricing and reimbursement shall be obliged not to disclose circumstances and facts which have become known to them in or on the occasion of the performance of their duties under this Act, except at the written request of a public body, where this is provided for by law.

(2) in connection with its obligations under paragraph 1. 1 the members of the Commission for pricing and reimbursement shall sign a declaration in a form approved by the President of the Commission. "

§ 45. Create art. 259 in and 259 (d):

"Art. 259. (1) the activities of the Committee on pricing and reimbursement is assisted by experts who have higher education in the fields of "medicine" or "Pharmacy", outside of its composition, established by order of the Minister of health. Requirements to experts shall be determined by the Ordinance under art. 258, para. 5.

(2) the Committee on reimbursement rates and publishes information on its activities on the website of the Ministry of health.

(3) the Commission shall draw up and reimbursement prices every six months, report on its activities to the Council of Ministers, which shall be published on the website under para. 2.

Art. 259. (1) the Chairman of the Committee on the pricing and reimbursement constitute, organize and manage the activities of the Commission.

(2) in the absence of the Chairman, he authorizes in writing, Member of the Committee on the pricing and reimbursement to replace him and to exercise his powers under para. 1. "

§ 46. Article 260 shall be amended as follows:

"Art. 260. (1) the members of the Committee on the pricing and reimbursement shall be released early or their powers shall terminate: 1. at their written request;

2. in the case of intentionally committed an indictable offence established by a final judgment;

3. failing to carry out their duties more than six months;

4. upon the entry into force of the Act, with established conflict of interest under the law for the prevention and detection of conflicts of interest.

(2) in the cases referred to in para. 1 or death Minister of health defines a new article for a period up to the end of the initial term. "

§ 47. Article 261 is replaced by the following:

"Art. 261. (1) the Committee on pricing and reimbursement:

1. approve, disapprove, amended or deleted the price of medicinal products under art. 258, para. 1;

2. register, refusing to register, amend, or delete the item price of medicinal products under art. 258, para. (2);

3. approve, disapprove, amended or deleted the price of medicinal products under art. 258, para. (4);

4. approve, revoke or amend the pharmaco-therapeutic guides, including criteria for assessing the effectiveness of the therapy, as well as recommendations for algorithms for treatment with medicinal products, offered by the national consultants, medical scientific societies and expert advice on terms and in accordance with procedures determined by the Ordinance under art. 258, para. 5;

5. includes, modify or exclude medicinal products from the positive list;

6. maintain and update the positive list.

(2) any application under subsection. 1, item 1 – 3 and 5 shall be legal, economic and medical evaluation of the Directorate in the specialized administration of the Ministry of health.

(3) the Committee on pricing and reimbursement results public records of the prices of medicinal products under art. 258, para. 2 and 4.

(4) the Commission and reimbursement prices published on the website of the Ministry of Health established pharmaco-therapeutic guides, recommendations for algorithms for treatment with medicinal products and criteria for the evaluation of the effectiveness of the therapy.

(5) for the submission of applications for the formation, registration or a change in the price of the produced or registered medicinal product, turn on or change included in the list under art. 262, para. 1 medicinal product Department of health collects levies fixed by the tariff referred to in art. 21, para. 2. "

§ 48. Art is created. 261:

"Art. 261. (1) the Committee on pricing and reimbursement shall take a decision within:

1. sixty days, when an application is submitted for the approval of the price under art. 258, para. 1 and the inclusion of a medicinal product in the positive list;

2. thirty days, when an application for modification or deletion of included in the positive list a medicinal product;

3. thirty days, when an application has been made for the establishment, alteration or deletion of the price under art. 258, para. (4);

4. thirty days, when an application for registration, change or cancellation of the price under art. 258, para. (2);

5. thirty days for approval/registration of the price of medicinal products, for which authorisation for parallel imports.

(2) For medicinal products under art. 262, para. 4 the Committee on pricing and reimbursement shall take a decision within 30 days, when an application is submitted for the approval of the price under art. 258, para. 1 and the incorporation of the product in the positive list.

(3) the time limits referred to in para. 1 and 2 shall run from the date of filing of the application in the order of the Ordinance under art. 258, para. 5. "

§ 49. Article 262 shall be amended as follows:

"Art. 262. (1) Positive drug list includes medicinal products subject to medical prescription, paid with funds from the budget of the NATIONAL HEALTH INSURANCE FUND from the State budget, beyond the scope of the compulsory health insurance and of the budget of establishments under art. 5 of the law on medical institutions, and from the budgets of the hospitals with State and/or municipal participation under art. 9 and 10 of the law on medical institutions.

(2) Positive drug list includes medicinal products classified in pharmacological groups under code anatomo-therapeutic-chemical classification, with relevant international non-proprietary names belonging to these designations, with the defined daily dose, price under art. 258, para. 1, the overall price of medicinal products when sold at retail, the reference value for defined daily dose, the value of the package, calculated on the basis of the reference value for defined daily dose and the level of pay, necessary for their treatment, as well as diseases in international code of diseases (ICD).

(3) medicinal products in a positive list of medicines shall be selected in accordance with the evidence for efficacy, therapeutic efficacy, safety and pharmaco-economic analysis of indicators.

(4) When one or more medicinal products with the same international non-proprietary name, pharmaceutical form and concentration of the active substance, with the exception of medicinal products under art. 29, are already included in the relevant part of the positive drug list evaluation under para. 3.

(5) Positive drug list includes:

1. medicinal products intended to treat diseases that are paid in accordance with the law on health insurance;

2. medicinal products, paid from the budget of establishments under art. 5 of the law on medical institutions and from the budgets of the hospitals with State and/or municipal participation under art. 9 and 10 of the law on medical institutions;

3. medicinal products intended for the treatment of AIDS, infectious diseases, diseases beyond the scope of the law on health insurance, paid by the procedure of art. 82, para. 1, item 8 of the Health Act, as well as vaccines for mandatory immunizations and vaccines, reimunizacii on special testimony and, in exceptional circumstances, specific serum immunoglobulins;

4. the marginal price of medicinal products under art. 258, para. 3 more items.

(6) the Ministry of health, the NATIONAL HEALTH INSURANCE FUND and the FDA can make reasoned proposals to the Commission by prices and reimbursement for a review of medicinal products included in the positive list under conditions and by an order determined by the Ordinance under art. 258, para. 5.


(7) the national health insurance fund pays for medicinal products referred to in paragraph 1. 5, item 1, under the conditions and by the order of the Ordinance under art. 45, para. 8 of the law on health insurance. "

§ 50. Art is created. 262:

"Art. 262. (1) upon suspension of sales under art. 54, para. 3 of a medicinal product, which is included in the positive list, and within the framework of the relevant international non-proprietary name not authorised under this Act another medicinal product, the holder of the authorisation shall notify in writing the Ministry of health.

(2) the holder of the marketing authorisation holder shall notify in writing the Ministry of health and, in the case of suspension of sales of the medicinal product, the price used to determine the reference value within the framework of the relevant international non-proprietary name and pharmaceutical form.

(3) where the product under para. 1 and 2 is intended for the treatment of diseases, to be paid under the Health Insurance Act, the holder of the authorisation shall notify, in writing, and the NATIONAL HEALTH INSURANCE FUND within the time limits under para. 4.

(4) the holder of the marketing authorisation is required to carry out the notification under paragraph 1. 1 not later than 18 months before the date of suspension of sales and, in the cases referred to in para. 2 – no later than three months before the date of suspension of sales.

(5) to the cessation of sales of Pará. 1 and 2, the holder of the authorisation for use is obliged to provide sufficient quantities of the medicinal product concerned to satisfy health needs.

(6) after the expiry of the time limits referred to in para. 4 the holder of the marketing authorisation holder shall submit an application for exemption and the relevant documents of the medicinal product in the positive list.

(7) where, after the suspension of sales of the medicinal product, the holder of the authorisation to use has not fulfilled its obligation under paragraph 1. 6, the Commission shall, at the prices and reimbursement officially excludes him from a positive list of medicines. "

§ 51. Article 263 shall be amended as follows: "Article. 263. With funds from the State budget out of the scope of mandatory health insurance can pay for medicinal products subject to medical prescription are not included in the list under art. 262, para. 1, necessary for the prevention or treatment of outbreaks, epidemics, pandemics, as well as in the presence of the suspected or confirmed spread of chemical or biological agents or nuclear radiation. "

§ 52. Article 264 is amended as follows:

"Art. 264. the conditions, rules and criteria for inclusion, amendments and/or exclusion of medicinal products from the positive list shall be determined by the Ordinance under art. 258, para. 5. "

§ 53. In art. 265 following amendments and supplements shall be made:

1. In paragraph 8. 2, second sentence, after the words "Ministry of health" insert "of the Ministry of labour and social policy" and a comma.

2. in the Al. 3 the words "commissions under art. 259 and art. 261 "are replaced by" the Committee on pricing and reimbursement.

§ 54. In art. 266, para. 1 the words "commissions under art. 259, para. 1 and art. 261, para. 1 "shall be replaced by" the Committee on pricing and reimbursement.

§ 55. In chapter twelve is created art. 266:

"Art. 266. (1) where the treatment of disease has no alternative in the country, for a specific patient may apply a medicinal product which has been authorised in a country member of the European Union, is authorised for use in accordance with this law, but is not distributed on the Bulgarian market.

(2) every year at the suggestion of the hospitals for hospital care and after consultation of the national consultant on the profile of the disease, Health Minister approve the list of medicinal products under para. 1, which contains the following information:

1. code of the anatomical therapeutic chemical classification;

2. international non-proprietary name to which the product belongs;

3. disease in international code of diseases;

4. pharmaceutical form and quantity of active substance;

5. additional information.

(3) the list under para. 2 is published on the website of the Ministry of health on the Internet.

(4) the conditions and procedures for inclusion, amendments or exclusion of medicinal products on the list under para. 2 shall be determined by the Ordinance under art. 9, para. 1.

(5) the medicinal product in the Al. 1 is supplied by special order of the medical establishment for hospital care under conditions and by an order determined by the Ordinance under art. 9, para. 1.

(6) the head of the hospital in al. 5 be responsible for the implementation of treatment under para. 1. "

§ 56. Art is created. 267:

"Art. 267. An Executive Agency "Medical audit" shall control observance of the established pharmaco-therapeutic guides and an evaluation of the effectiveness of therapy in accordance with the criteria set out in art. 261, para. 1, item 4. "

§ 57. Art is created. 268:

"Art. 268. (1) Donations of medicines from holders of permission for use, manufacturers, wholesalers and retailers and the Bulgarian Red Cross may only be carried out after consultation of the donor with the FDA through the presentation of an application in a form approved by the Minister of health, on a proposal from the Executive Director of the BDA.

(2) Donations shall be carried out subject to the rules of good donor practice to the World Health Organization.

(3) When within 10 days as of receipt of the application referred to in paragraph 1. 1 BDA does not respond in writing to the donor, it is assumed that there is an implied consent for making the donation.

(4) medical institutions and the Bulgarian Red Cross notified the FDA received donations of medicinal products within 7 days of receiving them.

(5) at the end of each quarter, the FDA sends information in the Ministry of health of the donations under para. 4. (6) for the donation of a medicinal product on application by the medical establishment, intended for the treatment of a specific patient in a life-threatening condition, the grantor shall notify the FDA within 7 days of the transfer.

(7) the donations under para. 6 may not exceed the quantity required for one course of treatment. "

§ 58. In art. 272, para. 1 the following endorsements are added:

1. an item 5 (b):

' 5b. carry out inspections on the donations of art. 268 a, para. 1; ".

2. point 7 is created:

"7. calls into foreclosure medicinal products and active substances in case of doubt the departure of their quality by placing the supporting characters in the objects of production."

§ 59. In art. 285, para. 2, after the word "produce" a comma and the words "outside the established by the Minister of health lists" are replaced by "awarded by prescription".

§ 60. Art is created. 285:

"Art. 285. The holder of the marketing authorisation, which notifies the Minister of health for the suspension of sales under art. 262 and is punishable by a fine of 25,000 to 50,000 EUR.

§ 61. In art. 287 following amendments and supplements shall be made:

1. In paragraph 8. 1 the words "respectively with penalty payment" shall be deleted.

2. in the Al. 3, after the word "sell" is added "or" store.

§ 62. Art is created. 289:

"Art. 289. (1) in violation of the established pharmaco-therapeutic guides or evaluate the effectiveness of therapy in deviation from criteria under art. 261, para. 1, item 4, shall be punished with fine from 1000 to 2000 BGN, and for engaging in the same violation – with a fine of 2000 to 3000 BGN.

(2) the offences referred to in paragraph 1. 1 shall be laid down by regulations drawn up by officials designated by the Executive Director of the Executive Agency "Medical audit" and the penal provisions shall be issued by the Executive Director of the Executive Agency "Medical audit". "

§ 63. Art is created. 290 (b):

"Art. 290 b. who committed a donation of medicines in violation of art. 268 a, para. 1, is punishable by a fine of 1000 to 3000 BGN, and for engaging in the same violation – with a fine of 3000 to 5000 LEVs. "

§ 64. In art. 291, para. 1, after the words "art. 289 "insert" art. 289 and "and after the words" art. 290 "is added" art. 290 b "and a comma.

§ 65. In the additional provisions § 5A is created:

"§ 5a. (1) the Ministry of health, the Committee on the pricing and reimbursement, drug agency and regional health surveys provide an opportunity for the provision of information and reception of applications and documents under this Act by electronic means, under the conditions and pursuant to the law on electronic document and electronic signature law on e-governance.

(2) the provision of information and the adoption of applications and documents by electronic transmission shall be carried out after providing the appropriate technical and organisational conditions, and the respective software products. "

Transitional and final provisions

§ 66. (1) producers under § 12 para. 2 of the transitional and final provisions shall comply with the requirements of art. 148 and of good manufacturing practice laid down by the procedure of art. 152, within 6 months of the entry into force of this law.

(2) after the expiry of the period referred to in para. 1 BDA checks on compliance with the requirements of art. 148 and of good manufacturing practice laid down by the procedure of art. 152.

(3) where, after the inspection referred to in paragraph 1. 2 the FDA finds that the conditions for the manufacture, control and storage of the starting material for the production and the finished medicinal product do not meet the requirements of this law and of good manufacturing practice, it shall inform in writing the person concerned referred to in paragraph 1. 1 and give written instructions.


(4) in the event that, within 60 days from the date of notification to the person concerned under para. 1 does not resolve the discrepancies, the Executive Director of the BDA takes issued under the revoked law for medicines and pharmacies in human medicine (official SG. 36 of 1995; Decision of the Constitutional Court No. 10 of the 1996 – 61/1996; amend., SG. 38 of 1998, no. 30 of 1999, no. 10 of 2000. Decision No 3 of the Constitutional Court from 2000 – issue 37 of 2000; amend. , PC. Since 2000, 59; Decision of the Constitutional Court No. 7 of 2000, PC. 78 since 2000; amend., SG. 41. Since 2001, PCs. 107 and 120 from 2002; Corr, PCs. 2 of 2003; amend., SG. 56, 71 and 112 since 2003, PCs. 70 and 111 in 2004, PCs. 37, 76, 85, 87, 99 and 105 by 2005, issue. 30, 31, 34, 75, 80 and 105 of 2006; OTM, PCs. 31 of 2007.) permission for production under the conditions of art. 160.

(5) where, after the inspection referred to in paragraph 1. 2 it is established that the person concerned referred to in paragraph 1. 1 shall not be enforced in accordance with the requirements of art. 148 and of good manufacturing practice referred to in art. 152, the FDA takes a manufacturing authorisation issued under the conditions of art. 160.

(6) where, after the inspection referred to in paragraph 1. 2 it is established that the person concerned referred to in paragraph 1. 1 shall be enforced in accordance with the requirements of art. 148 and of good manufacturing practice referred to in art. 152, the FDA issued a new authorisation for manufacture in accordance with this law, the following:

1. on application and documentation of art. 150 and 151, and

2. the presentation of a document for paid fee 1500 EUR

(7) where, within one month of the completion of the examination under paragraph 1. 2 person in the Al. 6 has not submitted an application and documentation of art. 150 and 151, a permit for production under the revoked law for drugs in human medicine and pharmacies shall be terminated.

§ 67. (1) Open and outstanding until the entry into force of this law or procedures change permissions for retail trade in medicinal products shall be considered and completed by the previous line without presentation of a proposal by the Supreme Council of pharmacy.

(2) within two months of the entry into force of this law, the Ministry of health provides the drug agency with Protocol archive of concluded proceedings.

(3) within two months of the entry into force of this Act, the Department of health provides a drug agency Protocol with its Department of health registry of permits issued for retail trade in medicinal products in the pharmacy.

(4) following the granting of the permission pursuant to para. 1 Department of health sent within three days, officially to the drug agency a copy thereof for entry in the register of permits issued for retail trade in medicinal products.

(5) after the completion of proceedings under para. 1 Department of health provides the drug agency with Protocol their archives.

§ 68. (1) applications for the issue or amendment of certificates of registration of drugstores, submitted to the entry into force of this law shall be dealt with under the conditions and by the procedure provided for therein.

(2) within one month from the entry into force of this law, the drug agency provides the regional health inspection protocol applications and documents submitted with regard to proceedings for the issue of certificates of registration of drugstores, as well as archive of concluded proceedings.

(3) within one month from the entry into force of this law, the drug agency shall provide the Ministry of health with the Protocol its BDA register of issued certificates of registration of drugs.

(4) within one month of the submission of the register under para. 3 the Ministry of health shall draw up and publish on your page national register of licences issued prior to the entry into force of this Act, certificates of registration of drugstores.

§ 69. (1) within three months of the entry into force of this law the procedures for validating or registering the prices of medicinal products shall be carried out in the previous row of the prices of medicinal products.

(2) after the expiry of the period referred to in para. 1 Commission on the prices of medicinal products submitted to the Commission on the prices and reimbursement with Protocol applications and documents submitted to the procedures under paragraph 1. 1, as well as the archives of the finalised procedures for approval or registration of the prices of medicinal products.

(3) After expiry of the period referred to in para. 1 Commission on the prices of medicinal products submitted to the Commission on the prices and reimbursement with the Protocol by the Commission registers of issued decisions on approval or registration of the prices of medicinal products.

§ 70. (1) within three months of the entry into force of this law the procedures for inclusion, exclusion and/or change of medicinal products of a positive list of medicines shall be carried out in the previous line of the Commission in a positive list of medicines.

(2) after the expiry of the period referred to in para. 1 Commission in a positive list of medicines shall forward to the Commission the prices and reimbursement with Protocol applications and documents submitted to the procedures under paragraph 1. 1, as well as the archives of the finalised procedures for inclusion, exclusion and/or change of medicinal products of a positive list of medicines.

§ 71. State fees, imported under the procedures provided for in § 69, para. 1 and § 70, para. 1 shall be expended for the provision of the relevant administrative proceedings, as well as for the activities of the Committee on transparency.

§ 72. (1) the prices laid down by the procedure of art. 258, para. 1 of the medicinal products to the entry into force of this Act are included in the positive list shall be considered and their price caps when sold at retail pursuant to art. 258, para. 3.

(2) within three months of the entry into force of this law, the Commission on the prices of medicinal products officially deleted from the register of price caps limit the prices of medicinal products under para. 1.

(3) until 31 December 2012, the holders of authorisations for use cannot alter the price of a medicinal product with the exception of the reduction for products which, on the entry into force of this law have had a price, but are not included in the positive list.

§ 73. (1) with the entry into force of this law the price caps of medicinal products subject to medical prescription and registered prices of medicines without medical prescription shall be deemed to be their registered prices under art. 258, para. 2.

(2) except in the cases referred to in paragraph 1. 1, with the entry into force of this law the price caps of medicinal products, which belong to the international non-proprietary name, which is included in the positive list, with the exception of the products listed in annex 2 of the list are considered and their price caps when sold at retail and may not be changed until the adoption of the Ordinance under art. 258, para. 5.

(3) within three months of the entry into force of this law, the Commission on the prices of medicinal products shall draw up the register under art. 261, para. 3, in which you enter prices under para. 1.

§ 74. Within three months of the entry into force of this law the Commission in a positive list of medicines brought a positive list of medicines in accordance with the requirements of art. 262, para. 5, item 1 – 3.

§ 75. Within three months of the entry into force of this law the Council of Ministers shall determine the composition of the Commission for pricing and reimbursement.

§ 76. Within three months of the entry into force of this Act:

1. Minister of health amended the Ordinances under art. 82, para. 3, art. 219, para. 2 and art. 243 in accordance with this law.

2. the Council of Ministers shall adopt Ordinance referred to in art. 258, para. 5 and amend the tariff referred to in art. 21, para. 2 and the rules of procedure of the Ministry of health in accordance with this law.

§ 77. In the medial institutions Act (promulgated, SG. 62 of 1999; amend., SG. 88 and 113 of 1999; Corr. 114/1999; amend., SG. 36, 65 and 108 of 2000; Decision of the Constitutional Court No. 11 of 2001 – issue 51 of 2001; amend., SG. 28 and 62 of 2002, no. 83, 102 and 114 from 2003. , PC. 70 by 2004, PCs. 46, 76, 85, 88, and 105 by 2005, issue. 30, 34, 59, 80 and 105, 2006, issue. 31, 53 and 59 since 2007, PCs. 110. Since 2008, PCs. 36, 41, 99 and 101 of 2009, PCs. 38, 59, 98 and 100 by 2010 and PC. 45 by 2011.) make the following changes and additions:

1. In art. 11:

a) a new para. 2:

(2) Medical Center, medical-dental Center and dental Center may be conducted clinical trials on medicinal products. ';

(b)) the previous para. 2, 3 and 4 shall become respectively al. 3, 4 and 5.

2. In art. 26, al. 1:

a) a new item 6:

"6. clinical trials on medicinal products;"

(b)) the current item 6, 7, 8 and 9 shall become item 7, 8, 9 and 10.

3. In art. 26 a, para. 1: a) a new paragraph 4:

4. clinical trials on medicinal products; "

(b)) the current item 4, 5, 6, 7 and 8 shall become item 5, 6, 7, 8 and 9.

4. In art. 26 (b), para. 1:

a) a new item 10:

"10. clinical trials on medicinal products;"

(b)) the former item 10, 11 and 12 shall become item 11, 12 and 13.

§ 78. In the law on the control of narcotic substances and precursors (promulgated, SG. 30 of 1999; amend., 63/2000, no. 74, 75 and 120 of 2002, no. 56 of 2003, issue 76, 79 and 103 by 2005, issue 30, 75 and 82 of 2006, no. 31 and 55 in 2007, issue 36, 43 and 69 since 2008. , PC. 41, 74, 82 and 93 from 2009, PCs. 22, 23, 29, 59 and 98 of 2010 and PC. 8 and 12 of 2011.) the following modifications are made:

1. In art. 32, para. 1 the words "and the order" shall be deleted.

2. In art. 32 and al. 3 and 4 are hereby amended:


"(3) in the 5 days of the filing of an application for a licence for wholesale trade in narcotic substances, the Ministry of Health officially required by the inspectors to the drugs the regional health inspection within the territory of which the buildings and spaces in which activities will be carried out wholesale, to conduct an inspection.

(4) the narcotic drugs inspectors carried out an on-the-spot check to establish conformity of actual conditions with the requirements of the law and the Ordinance under art. 32, para. 1 and shall draw up a protocol in duplicate. "

3. In art. 33, para. 1 the words "and the order" shall be deleted.

4. In art. 33A:

a) paragraphs 2 and 3 shall be amended like that:

"(2) in the 5 days of the filing of an application for a licence for retail and storage of medicinal products containing narcotic substances, the Ministry of Health officially required by the inspectors to the drugs the regional health inspection in the territory of which the pharmacy, to conduct an inspection.

(3) the narcotic drugs inspectors carried out an on-the-spot check to establish conformity of actual conditions with the requirements of the law and the Ordinance under art. 32, para. 1 and shall draw up a protocol in duplicate. ';

(b)) paragraph 7 shall be repealed;

in) in the Al. 8 the words "in accordance with the proposal of the Supreme Council of pharmacy ' shall be deleted.

§ 79. In the Health Act (promulgated, SG. 70 by 2004; amend., SG. 46, 76, 85, 88, 94 and 103 by 2005, issue 18, 30, 34, 59, 71, 75, 80, 81, 95 and 102 in 2006, issue 31, 41, 46, 53, 59, 82 and 95 (2007), no. 13, 102, and 110 in 2008, issue 36, 41 , 74, 82, 93, 99 and 101 of 2009, PCs. 41, 42, 50, 59, 62, 98 and 100 by 2010 and PC. 8, 9 and 45 from 2011) make the following changes and additions:

1. In art. 86:

(a)) in the Al. 2 creating a new item 2:

"2. the purchase of the medical establishment of necessary medical devices for his treatment when he asked for it and they are not paid for by the national health insurance fund or from the State budget;"

(b)) the current item 2, 3, 4 and 5 shall become paragraph 3, 4, 5 and 6;

in) a new para. 3:

"(3) in the cases referred to in para. 2, item 2 the patient paid medical devices on the prices at which the hospital has purchased them. ";

d) past al. 3 it al. 4.

2. In art. 116 (b), para. 1 creating item 4 (a):

"4A. verify compliance with the established pharmaco-therapeutic guides and an evaluation of the effectiveness of therapy in accordance with the criteria set out in art. 261, para. 1, item 4 of the law on medicinal products for human use. "

§ 80. In the law on health insurance (official SG. 70 of 1998; amend., SG. 93 and 153 of 1998, no. 62, 65, 67, 69, 110 and 113 in 1999, issue 1 and 64 in 2000, 41/2001, no. 1, 54, 74, 107, 112, 119 and 120 of 2002, no. 8, 50, 107 and 114 from 2003. , PC. 28, 38, 49, 70, 85 and 111 in 2004, PCs. 39, 45, 76, 99, 102, 103 and 105 of 2005, St. 17, 18, 30, 33, 34, 59, 80, 95 and 105, 2006, issue. 11 of 2007; Decision of the Constitutional Court No. 3 of 2007 – PCs. 26 of 2007; amend., SG. 31, 46, 53, 59, 97, 100 and 113 of 2007, PC. 37, 110 and 71 of 2008, PCs. 35, 41, 42, 93, 99 and 101 of 2009, PCs. 19, 26, 43, 49, 58, 59, 62, 96, 97, 98 and 100 by 2010 and PC. 9 of 2011.) the following modifications are made:

1. In art. 45: a) in the Al. 8 the words "art. 262, para. 4, paragraph 1 "are replaced by" article. 262, para. 5, item 1 ";

(b)) in the Al. 9 the words "art. 262, para. 4, paragraph 1 "are replaced by" article. 262, para. 5, item 1 ";

in) in the Al. 10 the words "art. 262, para. 4, paragraph 1 "are replaced by" article. 262, para. 5, item 1.

2. In art. 56, para. 1 the words "art. 262, para. 4, paragraph 1 "are replaced by" article. 262, para. 5, item 1.

§ 81. In the medical devices Act (promulgated, SG. 46 2007; amend., 110/2008, no. 41 and 82 from 2009, no. 98 of 2010 and 2011 39) made the following changes and additions:

1. In art. 27, al. 2 paragraph 1 shall be replaced by the following:

"1. the unified identification code of the company".

2. In art. 28, para. 2 paragraph 1 shall be replaced by the following:

"1. the unified identification code of the company".

3. In art. 61, para. 3 item 1 shall be amended as follows:

"1. the unified identification code, when a person is registered under the commercial law, or a copy of the Act of creation, where the person is established by law or by decision of the Council of Ministers;".

4. The title of chapter v shall be replaced by the following: "marketing of medical devices".

5. In art. 78, para. 1 paragraph 1 shall be replaced by the following:

"1. the unified identification code, when a person is registered under the commercial law or the relevant document on the national legislation of the Member State of the European Union or of a State party to the agreement on the European economic area;".

6. In art. 80: a) in the Al. 1:

AA) in point 2, the words ' and/or address "shall be deleted;

BB) points 3, 4 and 5 are repealed;

(b)) a new para. 2:

"(2) wholesalers with medical devices submitted to the FDA, apply to it-related change documents, change:

1. legal status, registered office and/or address of the administrator of the trader;

2. the list of the types of medical devices marketed, and of their respective manufacturers;

3. the name and/or address of the representative under art. 78, para. 5. ";

in the previous para.) 2, 3, 4 and 5 shall become, respectively, al. 3, 4, 5 and 6.

7. an art. 83 (a):

"Art. 83. (1) the hospitals for hospital care may carry out commercial transactions with medical devices only for the needs of their patients.

(2) medical devices, which may be the subject of commercial transactions at al. 1 shall be determined by the Ordinance under art. 30. "

8. In art. 136 the words "art. 80, al. 4 "shall be replaced by" art. 80, al. 5. "

§ 82. In the law on health and safety at work (official SG. 124 of 1997; amend., no. 86 of 1999 No. 64 and 92 of 2000, no. 25, and 111 since 2001, no. 18 and 114 from 2003, no. 70 by 2004, issue 76 of 2005, issue 33, 48, 102 and 105 of 2006. , PC. 40 since 2007, PCs. 102 and 108 from 2008, PCs. 93 by 2009 and PCs. 12, 58, 88 and 98 of 2010.) the following modifications are made:

1. In art. 25, para. 3 paragraph 2 shall be replaced by the following:

2. legal or natural persons registered under the commercial law, the law on cooperatives or under the law of non-profit legal entities, as well as by companies under the law of a Member State of the European Union or of a State party to the agreement on the European economic area, customer service workers. "

2. In art. 25 d, para. 1:

a) point 4 is replaced by the following:

4. data for single identification code of the company from the commercial register or cooperative or current certificate for registration of persons registered under the Act for non-profit legal entities and companies registered in a Member State of the European Union or in a State party to the agreement on the European economic area – document for up-to-date registration under national law, issued by the competent authority of the country concerned; "

(b) point 8) is repealed.

3. In art. 25 e al. 2 shall be amended as follows:

"(2) the Minister of health or his authorised representative official in 20 days of the filing of the notice of change of circumstance under art. 25 d, para. 1 on a proposal from the Commission for registration of occupational medicine services reflect the changes in the register of occupational medicine services, and in the cases under art. 25 d, para. 1, item 1, 3 and 5 and issue a certificate of registration or change makes reasoned refusal. "

§ 83. In the law on blood donation and blood transfusion, (official SG. 102 by 2003; amend., SG. 70 by 2004, no. 30 and 65 by 2006, no. 31 of 2007, no. 41 and 74 from 2009 and no. 59 and 98 of 2010) everywhere the words "National Center of Haematology and transfusiology" and "National Center of Haematology and transfusiology" shall be replaced by ' the national transfusion haematology Center and the National Center for blood establishments ".

§ 84. The law shall enter into force on the day of its publication in the Official Gazette with the exception of § 65, which shall enter into force on 30 September 2011.

The law was adopted by 41-Otto National Assembly on July 21, 2011 and is stamped with the official seal of the National Assembly.

President of the National Assembly Tsetska Tsacheva:

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