Name of law
Law amending the Law on Medicinal Products in Human Medicine
Amendments to the Law on Medicinal Products in Human Medicine
Date of adoption
Number / year Official Gazette
DECREE № 30 Pursuant to Art. 101, para. 3 of the Constitution of the Republic of Bulgaria
To be published in the "Official Gazette" Law on Amending and Supplementing the Law on Medicinal Products for Human Use adopted by HLIІ National Assembly on January 16, 2014, readmitted on February 26, 2014
Released in Sofia on February 28, 2014
President of the Republic: Rosen Plevneliev
stamped with the state seal.
Minister of Justice: Zinaida Zlatanova
Law amending the Law on Medicinal Products for Human Use (prom. SG. 31 of 2007 .; amend., SG. 19 and 71 2008, pcs. 10, 23, 41, 88 and 102 of 2009, pcs. 59 and 98 in 2010, pcs. 9, 12, 60 and 61 of 2011, pcs. 38, 60 and 102 in 2012, pcs. 15 of 2013 and No.. 1 2014)
§ 1. In art. 1 created item. 5b:
"5b. export of medicinal products under Chapter Nine "b". "
§ 2. In art. 17, para. 5 following amendments and additions:
1. A t. 12:
"12a. issue certificates of Good Distribution Practice; ".
2. In item. 14 the word "agree" be replaced by "consulting".
§ 3. In Chapter II, Section I create art. 17b and 17c:
"Art. 17b. (1) The Executive Director of BDA create Expert Council on retail sales of medicinal products, which includes three representatives of the Bulgarian Pharmaceutical Union, one representative of pharmaceutical faculties of medical universities and four representatives of the BDA. The composition of the Board is determined by order of the Executive Director of BDA agreed with the Minister of Health.
(2) The Council under par. 1 is advisory unit which:
1. prepare statements submitted to the BDA applications and documents under Art. 228, para. 1 and 5, which presents the Executive Director of BDA;
2. make reasoned proposals to the Minister of Health, through the Executive Director of BDA to improve the population's access to medicines.
(3) The organization and activities of the expert council under par. 1 shall be governed by regulations issued by the BDA Executive Director at the proposal of the Board.
(4) The members of the expert council under par. 1 do not receive remuneration for attendance at meetings of the council.
(5) In its activities the expert council under par. 1 shall report annually to the Minister of Health.
Art. 17c. Can not be members of the expert council under Art. 17b para. 1 persons:
1. owners, members of management and supervisory bodies of companies or sole traders specializing in the manufacture, import, wholesale or retail trade in medicinal products;
2. partners or shareholders who hold more than 5 per cent of the capital of commercial companies specializing in the manufacture, import, wholesale or retail trade in medicinal products or work contract of employment in these companies. "
§ 4. In art. 19, para. 1 created item. 8:
"8. notifications for export of medicines under Chapter Nine "b". "
§ 5. In art. 27 para. 2 after the words "item. 18 "shall be added" and 18 ".
§ 6. In art. 54 is amended as follows:
1. Paragraph 2 is amended as follows:
"(2) The holder of the marketing authorization / registration certificate of a medicinal product shall notify the BDA in writing at least two months before the cessation of sales of a medicinal product, whether temporarily or permanently."
2. Paragraph 3 is amended as follows:
"(3) The holder of the marketing authorization / registration certificate of a medicinal product shall state the reasons for the suspension of sales in accordance with Art. 68, para. 1, p. 6 and declares that the action it has taken under par. 2 due on the grounds of Art. 276 or art. 277. "
third. In para. 4 the words "24 hours" are replaced by "seven days."
§ 7. In art. 54a para. 1 the words "and 3" are replaced by "and 4".
§ 8. In art. 68 be made the following amendments:
1. In para. 1 m are created. 6, 7, 8 and 9:
"6. inform BDA of any action taken by him, to suspend the marketing of a medicinal product withdrawal from the market of a medicinal product, a request for termination of the authorization or declared intention not to renew the authorization for use, and indicate the reasons why such action; in these cases, the holder of the marketing authorization declare whether his initiative are due on the grounds of Art. 276 or art. 277;
7. BDA informed if the actions under p. 6 were taken in a third country and are due on the grounds of Art. 276 or art. 277;
8. inform the European Medicines Agency, when actions under p. 6 and 7 are taken on the basis of Art. 276 and 277;
9. provide sufficient quantities of the medicinal product to meet the health needs of the population of the Republic of Bulgaria. "
2. In para. 2 t. 2 is amended as follows:
"2. Data on the volume of sales of the medicinal product and any other information which the holder of the marketing authorization has, on volume of medical prescriptions for the product; ".
§ 9. In art. 79b are made the following amendments:
1. Paragraph 3 is amended as follows:
"(3) The BDA procedure under Chapter Eight, Section IV, where necessary application of one of the measures referred to in Art. 194u, para. 2 and 3. "
2. Created al. 4 and 5:
"(4) Notwithstanding paragraph. 1-3 when urgent action is essential to protect public health at any stage of the arbitration procedure, the BDA may suspend the marketing authorization and prohibit the use of the medicinal product in the territory of the Republic of Bulgaria to the final decision.
(5) In the cases under par. 4 BDA inform the European Commission, European Medicines Agency and other Member States of the reasons for its decision no later than the next business day. "
§ 10. In art. 169 new para. 5:
"(5) The leaflet must be shaped in such a way that is clear and understandable, enabling the patient to take appropriate action, if necessary, with the help of medical professionals."
§ 11. In art. 170, para. 2 after the words "this Act" insert "is not intended to be delivered directly to the patient or".
§ 12. In art. 194u be made the following amendments:
1. In para. 2 the word "start" is replaced by "initiate".
2. Paragraphs 3-7 are amended as follows:
"(3) The BDA initiate the procedure under par. 2, as notified by the marketing authorization holder that, for reasons relating to pharmacovigilance, suspend distribution of a medicinal product or has taken or intends to take action to withdraw it or not to take action for renewal of the issued authorization.
(4) The BDA can initiate the procedure under par. 2 and in cases where it considers that, for reasons relating to pharmacovigilance, for a medicinal product must to add new contraindications or reduce the recommended dose or testimony be limited.
(5) The BDA provides the European Medicines Agency and the regulatory authorities of other Member States all relevant scientific information available, as well as an evaluation of the data and the reasons for initiating the procedure under this section .
(6) In the cases under par. 2-4 European Medicines Agency shall notify the BDA of initiation, when concerns about the safety concern to other medicinal products belonging to the same therapeutic group or contain the same active substance in the product referred to in items par. 5, or when this product is authorized in another or other Member States.
(7) In the cases under par. 4, where there is no need to take urgent measures BDA procedure under Art. 77 or 79b. "
Third. A par. 8:
"(8) The BDA inform the holder of the marketing authorization to initiate the procedure under this section."
§ 13. In art. 207, para. 1 created item. 6c:
"6c. ensure the supply of sufficient quantities of medicinal products to meet the health needs of the population of the Republic of Bulgaria ".
§ 14. In art. 209b be made the following amendments:
1. A new paragraph. 3:
"(3) In the cases under par. 1 wholesalers certified by relevant documents that medicinal products are obtained from persons who are authorized or entitled to supply medicinal products in accordance with applicable national law of the third country. "
2. A par. 4:
"(4) Where the wholesaler supply medicinal products to persons in third countries, it verifies with the relevant documents that supplies are only for persons who are authorized or entitled to receive medicinal products intended for wholesale or the delivery of the population in accordance with applicable national law of the third country. "
third. Former para. 3 becomes para. 5.
§ 15. In art. 212a para. 1, 'the territory of the Republic of Bulgaria "are deleted.
§ 16. A Chapter Nine "b" "Export of medicinal products' with art. 217a - 217g:
"Chapter Nine" b "
EXPORT OF DRUG PRODUCTS
Art. 217a. (1) Export of medicinal products from the Republic of Bulgaria can perform natural or legal person holding the license for wholesale trade in medicinal products or marketing authorization procedure.
(2) The holder of a manufacturing authorization can perform export only produced its medicines.
(3) For the purposes of this chapter exports and intra-Community supply within the European Union.
(4) Export of medicinal products included in the Positive drug list under Art. 262, para. 1 of the territory of the Republic of Bulgaria after a notification to BDA in each case when the export is carried out by the holder of the marketing authorization of medicinal products.
Art. 217b. Notification under Art. 217a para. 4 shall be submitted to the Executive Director of BDA and contains the following data:
1. name and address of the person under Art. 217a para. 1;
2. the name, dosage form and amount of active substance in the strength of the medicinal product intended for export; 3
. number of marketing authorization of medicinal products;
4. number of packages of medicinal product intended for export;
5. country in which it is planned to export.
Art. 217v. (1) Upon receipt of a notification pursuant to Art. 217b BDA requires information about the medicinal product intended for export for a period of six months ago from the date of notification:
1. consumption of the medicinal product by the National Health Insurance Fund and / or the Ministry of Health;
2. quantities delivered by the medicinal product in the Republic of Bulgaria by the holder of the marketing authorization.
(2) The persons under par. 1 BDA provide the requested information within 15 days of receiving the request.
(3) The BDA analyze the obtained under par. 2 information for the medicinal product by comparing data on the quantities used under par. 1 pt. 1 and quantities supplied under par. 1 pt. 2 of available data obtained pursuant to Art. 217b pt. 4 for the number of packages intended for export.
(4) If within 30 days from the date of receipt of the notification under Art. 217b, executive director of the BDA does not object in writing to carry out the exports, it is assumed that there is a tacit consent for export.
(5) The BDA Executive Director may, within the period under par. 4 refuse a reasoned order export performance when in the course of the analysis under par. 3 found that:
1. available at the time of submission of the notification under Art. 217b quantities of the medicinal product in the Republic of Bulgaria are not sufficient to meet the health needs of the population;
2. as a result of export may experience temporary shortages necessary to meet the health needs of the population quantities of the medicinal product; 3
. lack of sufficient quantities of the medicinal product to meet the health needs of the population could seriously jeopardize the life and health of the population.
(6) The refusal under par. 5 subject to appeal under the Administrative Code.
(7) Data on the performance of exports of medicinal products from the Republic of Bulgaria is posted on the BDA website.
Art. 217g. Export of medicinal products is carried out within three months of expiry of the term of art. 217v, para. 4. "
§ 17. In art. 229, para. 2 after the abbreviation "BDA" add "after the opinion of the Expert Council on retail sales of medicinal products".
§ 18. In art. 262 new para. 9:
"(9) The conditions, rules and criteria for inclusion, change and / or exclusion of medicinal products from the Positive drug list is determined by the ordinance under Art. 261A para. 5. "
§ 19. In art. 264 is amended as follows:
1. In para. 1 after the words "Ministry of Health" insert "and the National Council on prices and reimbursement of medicinal products."
2. In para. 2 after the words "Ministry of Health" insert "and the National Council on prices and reimbursement of medicinal products." 3
. In para. 5 after the words "health needs" a comma and add "except in cases where the termination is due to any of the grounds under Art. 276 or art. 277 ".
§ 20. A Art. 285v:
"Art. 285v. The holder of a marketing authorization of medicinal products which notifies the BDA to perform export of medicinal products under Art. 217a para. 4, shall be punished with fine or with proprietary sanction of 50 000 to 100 000 lev, while repeating the same offense - up from 100 000 to 200 000 Levs. "
§ 21. In § 4 the additional provisions finally adds "and Directive 2012/26 / EC of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83 / EC as regards pharmacovigilance (OJ, L 299/1 of 27 October 2012). "
§ 22. In the Health Insurance Act (prom. SG. 70 of 1998 .; amend. And suppl., SG. 93 and 153 in 1998, pcs. 62 65, 67, 69, 110 and 113 in 1999, pcs. 1, 31 and 64 of 2000, pcs. 41 2001 pcs. 1, 54, 74, 107, 112, 119 and 120 2002 pcs. 8, 50, 107 and 114 of 2003, pcs. 28, 38, 49, 70, 85 and 111 of 2004, pcs. 39, 45, 76, 99, 102, 103 and 105 2005 pcs. 17, 18, 30, 33, 34, 59, 80, 95 and 105 of 2006, pcs. 11 2007 .; Decision № 3 of the Constitutional Court from 2007 - No. . 26 2007 .; amend. and suppl., SG. 31, 46, 53, 59, 97, 100 and 113 in 2007, pcs. 37, 71 and 110 of 2008, pcs. 35, 41 , 42, 93 and 101 of 2009, pcs. 19, 26, 43, 49, 58, 59, 62, 96, 97 and 100 in 2010, pcs. 9, 60, 99 and 100 in 2011 No.. 38, 60, 94, 101 and 102 in 2012, pcs. 4, 15, 23 and 106 of 2013 pcs. 1 of 2014) the following amendments:
1 . In art. 15, para. 1 creates it. 14:
"14. Representatives of NHIF determined that agreed terms and conditions of art. 45, para. 15. "
2. In art. 19, para. 7 creates so. 18:
"18. published in the "Official Gazette" terms and conditions of art. 45, para. 15. "
third. In art. 45:
a) in para. 15 after the words "Law on Medicinal Products in Human Medicine" insert "of medical devices and dietary foods for special medical purposes";
B) a new paragraph. 16:
"(16) The terms and conditions under par. 15 are published in the "Official Gazette" by the Governor of the NHIF. "
C) the former para. 16, 17 and 18 become par. 17, 18 and 19.
law was adopted by the 42 th National Assembly on January 16, 2014 and February 26, 2014 and was affixed with the official seal of the National Assembly.
Chairman of the National Assembly Mihail Mikov