Source: https://www.global-regulation.com/translation/bulgaria/3356685/law-amending-and-supplementing-the-law-on-medicinal-products-for-human-use.html
Timestamp: 2019-12-11 01:24:51
Document Index: 614298893

Matched Legal Cases: ['§ 2', 'art. 8', '§ 3', 'Art. 8', '§ 4', 'art. 11', '§ 5', 'art. 14', '§ 6', 'art. 17', '§ 7', 'art. 19', 'art. 148', 'art. 161', '§ 8', 'art. 22', 'art. 261', 'art. 259', '§ 9', 'art. 27', 'art. 160', 'art. 191', '§ 10', 'art. 34', 'art. 23', 'art. 23', 'art. 185', '§ 11', 'art. 47', '§ 12', 'art. 49', 'art. 47', '§ 13', 'art. 52', 'art. 19', 'art. 55', '§ 14', 'Art. 53', 'art. 52', 'art. 49', '§ 15', 'art. 55', 'art. 59', '§ 16', 'art. 55', 'art. 194', '§ 17', '§ 18', 'art. 56', 'art. 56', 'art. 22', 'Art. 56', 'art. 55', 'Art. 56', 'art. 55', '§ 19', 'art. 59', 'art. 55', '§ 20', 'art. 59', 'art. 259', '§ 21', 'art. 27', 'art. 27', '§ 22', '§ 23', 'art. 79', '§ 24', 'Art. 79', 'art. 79', 'art. 56', 'art. 194', '§ 25', 'art. 139', 'art. 191', 'art. 82', '§ 26', 'art. 140', 'art. 191', 'art. 82', '§ 27', 'art. 145', '§ 28', 'art. 145', 'Art. 145', 'art. 55', 'Art. 145', 'art. 145', 'art. 145', 'art. 194', 'Art. 145', 'art. 56', 'art. 145', 'art. 145', 'art. 103', 'art. 103', 'art. 103', 'art. 103', 'art. 21', 'Art. 145', 'art. 145', 'art. 103', 'art. 103', 'art. 103', 'art. 103', 'art. 103', 'art. 103', 'art. 145', 'art. 103', 'art. 103', 'art. 21', 'Art. 145', 'Art. 145', 'art. 55', 'art. 56', 'art. 56', 'art. 56', 'art. 103', 'art. 103', 'art. 103', 'art. 103', 'art. 103', 'Art. 145', 'art. 145', 'art. 56', 'art. 56', 'art. 56', 'art. 103', 'art. 103', 'art. 103', 'art. 103', 'Art. 145', 'art. 56', 'art. 56', 'art. 56', 'Art. 145', 'art. 56', 'art. 145', 'art. 5', 'art. 77', 'art. 56', 'art. 68', 'art. 68', 'art. 56', 'art. 68', 'Art. 145', 'art. 145', '§ 29', '§ 30', 'art. 146', '§ 31', '§ 32', 'art. 150', '§ 33', 'Art. 152', '§ 34', 'art. 155', '§ 35', 'art. 156', '§ 36', 'art. 158', '§ 37', 'art. 159', 'art. 168', '§ 38', 'art. 160', '§ 39', '§ 40', 'art. 161', 'art. 159', 'art. 159', '§ 41', 'art. 162', '§ 42', 'art. 165', '§ 43', 'art. 167', '§ 44', 'art. 167', 'Art. 167', 'art. 167', 'Art. 167', 'art. 167', 'art. 167', 'art. 167', 'art. 167', 'art. 21', 'art. 167', 'art. 167', 'art. 167', 'art. 152', 'art. 198', 'art. 152', 'art. 198', 'art. 167', 'art. 21', 'art. 167', 'Art. 167', 'art. 167', 'Art. 167', 'art. 147', 'Art. 167', 'art. 167', 'art. 167', 'art. 167', 'Art. 167', 'art. 111', 'Art. 167', 'art. 167', 'Art. 167', 'art. 168', '§ 13', '§ 45', 'art. 168', 'art. 23', 'art. 185', '§ 46', 'art. 168', 'art. 168', 'art. 168', 'art. 168', 'art. 168', 'art. 168', 'Art. 168', 'art. 168', 'art. 168', '§ 47', 'art. 170', 'art. 198', '§ 48', '§ 49', 'Art. 183', '§ 50', 'Art. 184', '§ 51', 'Art. 185', 'art. 68', 'art. 53', '§ 52', 'Art. 186', 'art. 55', '§ 53', 'Art. 187', 'art. 56', 'art. 56', 'art. 77', 'art. 77', '§ 54', 'Art. 188', '§ 55', 'Art. 189', 'art. 185', '§ 56', 'Art. 190', '§ 57', 'Art. 191', 'art. 27', '§ 58', 'Art. 192', 'art. 55', 'art. 190', '§ 59', 'Art. 193', '§ 60', 'Art. 194', 'art. 21', '§ 61', 'Art. 194', '§ 62', 'art. 194', 'Art. 194', 'art. 190', 'Art. 194', 'art. 24', 'Art. 194', 'art. 183', 'Art. 194', 'Art. 194', 'Art. 194', '§ 63', 'art. 194', 'Art. 194', 'Art. 194', 'art. 28', 'art. 55', 'Art. 194', 'art. 194', 'art. 194', 'Art. 194', 'Art. 194', 'art. 194', 'Art. 194', 'art. 194', 'art. 77', 'art. 77', 'art. 56', 'art. 56', 'art. 77', 'art. 194', 'art. 68', 'Art. 194', 'art. 76', 'art. 77', 'art. 56', 'Art. 194', 'art. 194', 'art. 56', 'art. 56', 'art. 194', 'Art. 194', 'art. 194', 'art. 194', 'Art. 194', 'art. 194', 'art. 77', 'art. 56', 'art. 77', 'art. 77', 'Art. 194', 'art. 194', 'art. 56', '§ 64', 'art. 194', 'Art. 194', 'Art. 194', 'art. 194', 'art. 194', 'Art. 194', 'art. 185', 'art. 68', 'art. 194', 'Art. 194', 'art. 56', 'art. 68', 'Art. 194', 'art. 194', 'art. 77', 'art. 194', 'art. 194', 'art. 194', 'art. 77', 'Art. 194', 'art. 194', 'art. 194', 'Art. 194', 'art. 194', 'art. 194', 'art. 194', 'art. 194', 'art. 68', '§ 65', '§ 66', '§ 67', 'art. 205', 'art. 147', '§ 68', 'art. 207', 'art. 148', 'art. 161', 'art. 69', 'art. 198', '§ 69', 'art. 208', '§ 70', 'art. 209', 'art. 207', 'art. 207', '§ 71', 'art. 212', '§ 72', 'art. 212', 'art. 212', 'art. 21', 'Art. 212', 'art. 212', 'art. 198', 'art. 198', '§ 73', 'art. 220', 'art. 219', '§ 74', 'art. 228', 'art. 21', 'art. 222', '§ 75', 'art. 234', 'art. 85', '§ 76', 'art. 234', 'art. 234', 'art. 234', 'Art. 234', '§ 77', 'art. 240', 'art. 238', 'art. 239', 'art. 239', 'art. 29', '§ 78', 'Art. 240', 'art. 238', 'art. 238', '§ 79', '§ 80', 'art. 258', '§ 81', 'Art. 258', 'art. 19', '§ 82', 'Art. 259', 'art. 261', 'art. 261', 'art. 261', 'art. 261', 'art. 261', 'art. 261', 'art. 261', 'art. 21', 'art. 262', '§ 83', 'Art. 259', '§ 84', 'Art. 259', 'art. 261', 'art. 261', 'art. 261', 'art. 262', 'art. 261', 'art. 261', '§ 85', '§ 86', '§ 87', 'Art. 260', '§ 88', 'art. 261', '§ 89', 'art. 261', '§ 90', 'Art. 261', 'art. 262', '§ 91', 'Art. 262', 'art. 5', 'art. 9', 'art. 261', 'art. 29', 'art. 5', 'art. 9', 'art. 82', 'art. 261', 'art. 258', 'art. 261', 'art. 45', '§ 92', '§ 93', 'Art. 264', 'art. 54', 'art. 258', '§ 94', 'art. 265', '§ 95', 'art. 266', '§ 96', 'art. 267', 'art. 258', 'art. 258', 'art. 258', '§ 97', 'art. 267', 'art. 261', 'art. 259', '§ 98', 'art. 268', '§ 99', 'art. 269', 'art. 212', '§ 100', 'art. 269', 'Art. 269', 'art. 267', 'art. 269', 'Art. 269', 'art. 269', 'art. 269', 'art. 147', 'Art. 269', 'art. 270', '§ 101', 'art. 270', 'art. 258', '§ 102', 'art. 272', 'art. 212', '§ 103', 'Art. 272', 'art. 52', '§ 104', 'art. 276', 'art. 55', 'art. 27', 'art. 27', '§ 105', 'art. 277', '§ 106', 'art. 281', '§ 107', 'art. 284', '§ 108', 'art. 284', 'Art. 284', 'Art. 284', 'art. 160', 'Art. 284', 'art. 207', '§ 109', 'art. 285', 'art. 262', 'art. 264', '§ 110', 'art. 285', '§ 111', 'art. 287', 'art. 234', '§ 112', 'art. 289', 'art. 258', 'art. 261', 'art. 258', 'art. 258', '§ 113', 'art. 289', 'art. 261', 'art. 259', '§ 114', 'art. 290', 'Art. 290', 'Art. 290', 'art. 55', 'Art. 290', 'art. 190', 'Art. 290', 'art. 193', '§ 115', 'art. 291', 'art. 281', 'art. 286', 'art. 287', '§ 116', 'art. 293', 'art. 281', 'art. 283', 'art. 287', '§ 117', 'art. 290', '§ 118', '§ 119', 'art. 167', 'art. 167', '§ 120', 'art. 212', '§ 121', '§ 122', 'art. 192', '§ 123', 'art. 192', '§ 124', '§ 125', 'art. 2', '§ 126', 'art. 194', 'art. 194', '§ 127', 'art. 194', 'art. 194', '§ 128', 'art. 234', 'art. 234', 'art. 85', '§ 129', 'art. 183', '§ 130', '§ 131', 'art. 21', '§ 132', '§ 133', 'art. 21', 'art. 261', '§ 134', 'art. 159', 'art. 168', 'art. 168', 'art. 54', '§ 135', 'art. 45', 'art. 262', 'art. 262', 'art. 262', 'art. 262', 'art. 262', 'art. 262', 'art. 262', 'art. 56', 'art. 262', 'art. 262', '§ 136', 'art. 116', 'art. 261', 'art. 259', '§ 137', 'art. 16', 'art. 17', 'art. 32', 'art. 33', 'art. 47', 'art. 48', 'art. 59', 'art. 65', 'art. 65', 'art. 65', 'art. 65', 'art. 65', 'art. 66', 'art. 77', 'art. 95', '§ 138', '§ 36', '§ 29', '§ 44', 'art. 167', 'art. 167', '§ 167', '§ 98', '§ 101', '§ 102', '§ 1', 'art. 167', 'art. 167']

Machine Translation of "Law Amending And Supplementing The Law On Medicinal Products For Human Use" (Bulgaria)
Law Amending And Supplementing The Law On Medicinal Products For Human Use
Original Language Title: Закон за изменение и допълнение на Закона за лекарствените продукти в хуманната медицина
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 11/12/2012 number/year Official Gazette 101/2012 Decree No 433
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 11 December 2012.
Issued in Sofia on 18 December 2012.
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 – No. 65 of 2009; amend., no. 71 of 2008, no. 10, 23, 41, 88 and 102 of 2009, 59/98 and by 2010. , PC. 9, 12, 60 and 61 by 2011, issue. 38 and 60 by 2012.)
1. In paragraph 2, the words "and the active substances ' shall be deleted.
2. paragraph 2 shall be inserted: ' 2A. production, import and wholesale trade with active substances; ".
3. item 5 shall be inserted: ' 5a. brokerage in the field of medicinal products; ".
§ 2. In art. 8, t. 7, the word "high-tech" is replaced by "modern".
§ 3. Art is created. 8A:
"Art. 8. In the manufacture of medicinal products intended only for export, of intermediate products, active substances and excipients shall apply the relevant provisions of Chapter five. "
§ 4. In art. 11, para. 3 creating the second sentence: "the information on the packaging and in the package leaflet of the medicinal product as al. 1 may not necessarily be of Bulgarian language ".
§ 5. In art. 14, para. 2 creates a new paragraph 3:
3. arrange the provision of public information on the patient organisations and consumer organisations concerning the actions taken against the counterfeiting of medicinal products. "
§ 6. In art. 17 the following amendments and supplements: 1. Al. 5:
(a)) shall be so 5A and 5b:
' 5a. Enter manufacturers, importers and wholesalers of active substances;
5b. keep a register of persons engaged in mediation in the field of medicinal products; "
b) item 10 shall be (a): "10A. carries out the functions of the competent authority for pharmacovigilance; "
in point 11) shall be replaced by the following:
"11. organizes and maintains a pharmacovigilance system;"
(d)) shall be so 18 and 18B:
"18. participated in the international harmonization and standardization of technical measures relating to the monitoring of drug safety, under the coordination of the European Medicines Agency;
18B. establish and maintain a national Internet portal for medicinal products; ".
2. a para. 7: "(7) the implementation of the measures referred to in this law relating to the prevention of the introduction and spread of counterfeit medicinal products is carried out in collaboration between the FDA and the Customs authorities. '
§ 7. In art. 19, para. 1 make the following amendments and additions:
1. Points 1 and 2 shall be read with the following adaptations:
1. manufacturers and importers of medicinal products on the territory of the Republic of Bulgaria and of qualified persons under art. 148, item 2, and in art. 161, para. 2, item 1;
2. manufacturers, importers and wholesalers with active substances; ".
"4A. medicinal products;".
§ 8. In art. 22 is made the following changes and additions:
1. In paragraph 8. 1, item 6, after the word "products" are added "and pharmacovigilance.
and in the text) before item 1 the words "art. 261, para. 5 ' shall be replaced by "art. 259, para. 5 ";
b) in paragraph 3 the words "the Committee on pricing and reimbursement" are deleted.
§ 9. In art. 27 the following amendments and supplements shall be made:
and so is created) 8A: "8A. a statement that the results of the audit referred to in art. 160, para. 2, carried out by the manufacturer of the medicinal product, confirms that the active substance is manufactured in conformity with the principles and guidelines of good manufacturing practice; in the Declaration shall indicate the date on which the audit was carried out; "
b) point 12 shall be replaced by the following: 12. summary the system of pharmacovigilance, which includes the following elements:
a) name of the qualified person referred to in art. 191, CV-education gained professional experience in the field of pharmacovigilance and the qualification for the performance of his duties pursuant to chapter eight;
(b) each Member State), in which the qualified person perform his duties;
in) address, phone, fax, e-mail address of the person referred to in paragraph (a);
d) address where the main document is stored on the system for tracking drug safety; "
in item is created) 12A: 12 a. Declaration by the applicant that it has the necessary means to fulfil its obligations under Chapter eight; "
d) point 13 shall be replaced by the following: ' 13. risk management plan with a description of the risk-management system which the applicant will introduce for the medicinal product, together with a summary of the plan; "
(e)) is created that 18A: ' 18A. a copy of the summary of safety data, including data contained in the periodic safety update reports, and where these are present, reports of suspected side effects; ".
2. Al are created. 6 and 7: (6) risk management system under para. 1, item 13 should be proportionate to the identified and potential risks of the medicinal product and of the need to collect safety data from post-marketing studies.
(7) the holder of the marketing authorisation dossier update of data under para. 1. For any change in the file is applied the order of chapter three, section VI, where applicable. "
§ 10. In art. 34 create al. 4 and 5: "(4) the summary of medicinal products included in the list under art. 23 of Regulation (EC) No 726/2004 of the European Parliament and the Council, contains the following information: "this medicinal product is subject to additional monitoring. In front of text placed a sign in the color black in accordance with art. 23 (5) of Regulation (EC) No 726/2004 of the European Parliament and the Council, accompanied by an explanatory note.
(5) summary of medicinal products contain a standard text that encourages medical professionals to report any suspected adverse drug reaction according to the models referred to in art. 185, para. 2, item 4. "
§ 11. In art. 47, para. 1 make the following amendments and additions:
1. In paragraph 7, the word "high-tech" is replaced by "modern".
2. item 8 shall be inserted:
"8. the Commission on risk assessment in pharmacovigilance.
§ 12. In art. 49 following amendments and supplements shall be made: 1. a paragraph 1 shall be amended as follows:
(1) within 200 days from the date of receipt of valid documentation jointly with the BDA Committee under art. 47, para. 1 assess the quality, safety and efficacy of the medicinal product and shall draw up an assessment report with comments on the results of the pharmaceutical and pre-clinical tests and clinical trials, the risk management system and the system for monitoring the safety of the medicinal product concerned. The assessment report shall be submitted to the Executive Director of BDA. "
"(2) the report referred to in paragraph 1. 1 is updated when there are new information important for the evaluation of the quality, safety and efficacy of the medicinal product. "
3. the Previous para. 2 and 3 become respectively al. 3 and 4.
4. The current paragraph. 4 it al. 5 and in her words "para. 2 and 3 ' shall be replaced by "para. 3 and 4 ".
§ 13. In art. 52, para. 1 make the following amendments and additions:
1. the text before point 1 shall be replaced by the following: "within 5 days from the date of issue of the authorisation/certificate of registration in the register under art. 19, para. 1, item 3 is entered the following data for the authorisation/certificate: ".
"5. the conditions under art. 55, 56 and 56A, entered in the authorisation/certificate of registration; ".
§ 14. Article 53 shall be amended as follows:
"Art. 53. (1) the drug agency publishes on its website within 14 days of the issue of the marketing authorisation/registration certificate data under art. 52, para. 1 the approved summary of product characteristics and package leaflet data.
(2) drug agency publishes on its website the assessment report under art. 49, para. 1 the reasons for the decision, as deleted data, representing a trade secret.
(3) the report under para. 2 shall be accompanied by a summary in plain language for the public. The summary contains a section relating to the conditions for the use of the medicinal product. "
§ 15. In art. 55 al. 5 shall be amended as follows:
"(5) the existence of reasonable grounds relating to pharmacovigilance, including due to the exposure of the medicinal product on the insufficient number of patients, the FDA may require a marketing authorisation holder to submit an application for its renewal for another five years by the procedure of art. 59A. "
§ 16. Art is created. 55: "art. 55. (1) the Executive Director of the FDA may issue a permission to use/certificate of registration of a medicinal product to be included one or more of the following conditions:
1. to take certain measures to ensure the safe use of the medicinal product to be included in the risk management system;
2. to conduct post-marketing safety studies;
3. to comply with the more stringent than those laid down in chapter eight obligations for recording or reporting suspected side effects;
4. to comply with any other conditions or restrictions with regard to the safe and effective use of the medicinal product;
5. the existence of an adequate pharmacovigilance system;
6. to conduct post-marketing studies for efficacy, when there is a concern related to the efficacy of the medicinal product, which may be permitted only after the medicinal product is placed on the market.
(2) the authorisation/certificate of registration shall state the deadlines for fulfilment of the conditions under paragraph 1. 1, when applicable.
(3) the grounds for the imposition of the condition under paragraph 1. 1, item 6 shall be determined by a delegated Act referred to in article 22 (b) of Directive 2001/83/EC, taking into account the scientific guidelines, developed in the direction of art. 194. (4) the requirements for conducting post-marketing studies to determine efficacy in the Guide issued by the European Medicines Agency. "
§ 17. Article 56 shall be amended as follows: "Article. 56. (1) in exceptional cases, after consultation with the applicant, the Executive Director of the BDA may grant permission to use/registration certificate under the condition when the applicant can prove that he has not provided comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use for any of the following reasons: 1. the indications for which the medicinal product is intended, are so rare that the applicant is unable to provide full evidence, or
2. the State of scientific knowledge at the time was such that it could not provide comprehensive data, or
3. the collection of such data is contrary to generally accepted principles of medical ethics.
(2) the marketing authorisation/certificate of registration referred to in paragraph 1. shall be issued in one of the following conditions:
1. the applicant/holder to perform a programme of studies for the period referred to in paragraph 1. 3, the results of these studies serve as a reassessment of the benefit-risk;
2. the medicinal product has a scheme only on prescription, as in certain cases may be used only under strict medical supervision in hospital for hospital care and, in the case of a radiopharmaceutical – only under the control of the authorized person;
3. the package leaflet, as well as in any medical information that came with the medicinal product, shall be provided for text, which draws the attention of medical experts that some of the data available for the medicinal product are subject to further studies.
(3) the authorisation/certificate of registration referred to in paragraph 1. shall be issued for a period of one year and for each subsequent year may be extended on the basis of an assessment of the fulfilment of the conditions laid down in para. 2. "
§ 18. Create art. 56A, 56B, and 56 in: "art. 56. (1) after the issue of the marketing authorisation/registration certificate for the FDA may require the holder of the authorisation/certificate to conduct: 1. postmarketingovo safety study if there are concerns identified or potential risks or missing information relating to pharmacovigilance of the medicinal product concerned; When the same risks apply to other medicinal products, in consultation with the Committee for risk assessment in the area of pharmacovigilance, set up by article 56, paragraph 1, point (AA) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, recommends that the FDA the holder of an authorisation for use to carry out a joint study for safety with other holders of authorisation;
2. postmarketingovo study of efficacy, when knowledge of the disease or the clinical methodology provides the basis for the revision of estimates of efficacy, the conclusions of which have been made on the date of issue of the authorization.
(2) drug agency shall notify in writing the holder of the marketing authorisation/certificate of registration of the obligation under paragraph 1. 1, and shall give reasons demonstrating the reasons and indicate the purpose of the survey and the terms for the meeting.
(3) within 30 days of receipt of the notification under paragraph 1. 2 the holder of the marketing authorisation/certificate of registration may be requested by the FDA providing the opportunity to submit information on the obligations under para. 1. (4) After receipt of a request under paragraph 1. 3 the FDA set a time limit for the submission of information by the holder of the marketing authorisation/certificate of registration.
(5) the drug agency after an analysis of the information referred to in para. 3 may:
1. to affirm the obligation under paragraph 1. 1, or
(6) drug agency shall inform the holder of the decision taken under paragraph 1. 5. (7) in the cases referred to in para. 5, item 1, the Executive Director of BDA officially amended the issued permission to use/certificate of registration of the medicinal product, by including in it as a condition to the obligation under paragraph 1. 1.
(8) the reasons for the imposition of obligations under para. 1, item 2 shall be determined by a delegated act under art. 22 (b) of Directive 2001/83/EC.
Art. 56 (b) (1) the holder of the marketing authorisation/certificate of registration includes in its risk management system all the conditions under art. 55, 56 and 56A.
(2) in the cases referred to in para. 1 the holder of the marketing authorisation/registration certificate submitted to the FDA notification of change in the system of risk management.
Art. 56. the drug agency sends information to the European Medicines Agency for permits issued under art. 55, 56 and 56A. "
§ 19. In art. 59 and al. 1 shall be amended as follows: ' (1) in the cases under art. 55, para. 2 and 5, but not later than nine months before the expiry of the authorisation/certificate of registration, the holder submits to the FDA application for renewal, together with the summary dossier in respect of quality, safety and efficacy, including the evaluation of the data contained in the reports of suspected adverse reactions and the periodic safety update reports submitted in accordance with Chapter 8. , and all approved changes following the granting of the marketing authorisation/certificate of registration. "
§ 20. In art. 59 in the words "Directorate of the Ministry of health under art. 259, para. 11 "shall be replaced by" National Council on pricing and reimbursement of medicinal products ".
§ 21. Article 68 shall be amended as follows: "Article. 68. (1) the holder of an authorisation for use/certificate of registration of a medicinal product shall:
1. acknowledges the achievements of scientific and technical progress and introduce any necessary changes in the documentation under art. 27, al. 1, item 7 and 8 in order that the medicinal product to be produced and controlled in accordance with the generally accepted scientific methods; changes are made by the order of the chapters third and fifth;
2. submit immediately to the FDA any new information which might entail the amendment of the particulars and documents referred to in art. 27-32 and in the summary of product characteristics;
3. immediately inform the FDA of any prohibition or restriction imposed by the regulatory authorities of other States in which the medicinal product is placed on the market, for reasons that have imposed such measures and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product concerned; the information includes both positive and negative results of clinical trials or other studies of all indications and populations, whether they are included in the marketing authorisation, as well as data on the use of the medicinal product, when such use is outside the conditions of the permit for use;
4. store and update information about the medicinal product with current scientific knowledge, including of the evaluation conclusions and recommendations published on the European Internet portal for medicinal products established in accordance with article 26 of Regulation (EC) No 726/2004 of the European Parliament and of the Council;
5. spread the medicinal product with the latest approved summary of product characteristics and package leaflet for the patient.
(2) the holder of the marketing authorisation/registration certificate is obliged at the request of the FDA to submit:
1. data in support of a positive benefit/risk ratio for the medicinal product;
2. data relating to the volume of sales of the medicinal product and medical prescriptions issued for the product, if it has any;
3. a copy of the master system pharmacovigilance.
(3) the holder of the marketing authorisation holder shall provide the FDA the Al. 2, item 3 within 7 days of receipt of the request. "
§ 22. Article 72 shall be repealed.
§ 23. In art. 79 is hereby amended as follows: 1. (2) is hereby repealed.
§ 24. Art is created. 79 (b):
"Art. 79 (b). (1) in cases where the interests of the European Union before deciding on the issue of the authorisation of the medicinal product, for a temporary suspension, termination or for changing it, the FDA, the applicant or the holder of an authorisation for use may refer the matter to the Committee referred to in art. 79, para. 1 for the application of the arbitration procedure.
(2) in the cases referred to in para. 1, when referral is the result of the assessment of data related to the pharmacovigilance of authorised medicinal product the matter shall be referred to the Committee under art. 56 a, para. 1, item 1, and shall apply the procedure laid down in art. 194 194 h or w.
(3) where it is necessary to take urgent action, apply the procedure laid down in Chapter 8, section V. "
§ 25. In art. 139, para. 3 the words "art. 191, para. 1 "shall be replaced by" art. 82, para. 3. "
§ 26. In art. 140, para. 2 the words "art. 191, para. 1 "shall be replaced by" art. 82, para. 3. "
§ 27. In art. 145 al. 2, 3, 4, 5 and 6 are repealed.
§ 28. In chapter four, "and" create art. 145 a-145 k:
"Art. 145. (1) Neintervencionalni post-marketing safety studies are carried out on the initiative of the holder of the marketing authorisation or in the fulfilment of the conditions under art. 55 and 56 and are related to the collection of data on drug safety of patients and medical professionals.
(2) where a survey is planned the collection of data from patients should be obtained their consent. Personal data of patients are processed in compliance with the requirements of the data protection act.
(3) medical professionals do not receive financial or other incentives for participation in neintervencionalnite safety studies in addition to compensation for the time spent and money.
Art. 145. (1) (b) at the time of the survey under art. 145 in, al. 1 and art. 145, para. 1 the holder of the marketing authorisation shall monitor the data received and take account of their impact on the risk-benefit balance of the medicinal product.
(2) the holder of the authorisation shall notify the FDA any new information which might influence the risk-benefit balance of the medicinal product.
(3) the obligation under paragraph 1. 2 does not exempt the holder of the authorization for use of the requirement of art. 194 (h) for the provision of the information referred to in para. 2 and by the periodic safety update reports.
Art. 145 in. (1) where the survey is carried out only on the territory of the Republic of Bulgaria in implementation of an obligation under art. 56a, the holder of the marketing authorisation shall submit the draft of the Protocol the FDA study. The draft Protocol, accompanied by a written consent under art. 145, para. 2, is presented in the article. 103, para. 1 or 2, as applicable.
(2) the Executive Director of the BDA within 60 days from the date of receipt of the documentation referred to in paragraph 1. 1 shall send to the holder of the authorization to use notification of approval of the study or makes a reasoned refusal.
(3) the Executive Director of the BDA refuses the survey with one or more of the grounds under art. 145, para. 2, item 2.
(4) the Commission under art. 103, para. 1, according to the art. 103, para. 2, within 60 days from the date of receipt of the documentation referred to in paragraph 1. 1 shall send to the holder of the authorization to use positive or negative opinion.
(5) the conduct of the study could begin after receipt of approval from the FDA and a favourable opinion from the Commission under art. 103, para. 1, respectively, of the commissions referred to in art. 103, para. 2.
(6) for the evaluation of the documentation referred to in paragraph 1. 1 BDA collects the fee specified in the tariff referred to in art. 21, para. 2.
Art. 145. (1) the holder of the marketing authorisation for use apply planned significant changes in the Protocol in the cases under art. 145 in, al. 1 after the prior approval by the FDA and by the Commission under art. 103, para. 1, according to the art. 103, para. 2. (2) the holder of the marketing authorisation holder shall submit to the Commission and the FDA under art. 103, para. 1, respectively, in the art. 103, para. 2 the documentation relating to the changes and the reasons for it.
(3) the Executive Director of the BDA within 30 days of receipt of the documentation referred to in paragraph 1. 2 approve the modified Protocol or issue a reasoned refusal and shall inform the holder of the marketing authorisation.
(4) the Commission under art. 103, para. 1, according to the art. 103, para. 2, within 30 days from the date of receipt of the documentation referred to in paragraph 1. 2 sent to the holder of the authorization to use positive or negative opinion.
(5) the Executive Director of the BDA refuses the changes under para. 1 with one or more of the reasons set out in art. 145, para. 2, item 2.
(6) the holder of the marketing authorisation may apply changes under para. 1 after receiving approval from the FDA and a favourable opinion from the Commission under art. 103, para. 1, according to the art. 103, para. 2. (7) for the evaluation of the documentation referred to in paragraph 1. 1 BDA collects the fee specified in the tariff referred to in art. 21, para. 2.
Art. 145 e. (1) the holder of the marketing authorisation holder shall submit a final report of the study to the FDA within 12 months after the completion of data collection. The report shall be applied and a summary of the results of the study.
(2) the holder of the marketing authorisation holder may submit a reasoned request to the FDA for delaying the deadline referred to in para. 1 at least three months before the date of presentation of the final report referred to in the Protocol.
(3) the drug agency approves or motivated refusal of the request made under paragraph 1. 2 and shall inform the holder of the marketing authorisation.
(4) where the holder of the marketing authorisation on the basis of the report referred to in paragraph 1. 1 consider that a change is needed in the marketing authorisation, he submitted to the FDA application pursuant to chapter three, section VI.
(5) the Executive Director of the BDA by order suspend or terminate the authorisation for use when the FDA on the basis of the report referred to in paragraph 1. 1 and after consultation with the holder of the marketing authorisation holder considers it necessary suspension or termination of the permission for use.
Art. 145. (1) where the examination is conducted both on the territory of the Republic of Bulgaria and in the territory of other Member States, for medicinal products authorised under Regulation (EC) No 726/2004 of the European Parliament and of the Council or under Chapter three, section VII in the performance of their obligations under art. 55 or under art. 56A, the holder of the marketing authorisation submitted to the Committee under art. 56 a, para. 1, item 1 of the draft Protocol.
(2) within 60 days from the date of receipt of the documentation referred to in paragraph 1. 1 the Committee under art. 56 a, para. 1, item 1 shall issue an opinion and shall send to the holder of the marketing authorisation for use: 1. notice of approval, or
2. where reasoned refusal:
a) finds that the conduct of the study promotes the use of the medicinal product, and/or
b) considers that the design of the study will not achieve the objectives set forth in the Protocol objectives, and/or
in the study) has the character of a clinical trial.
(3) in the cases referred to in para. 2, paragraph 1 the holder of the marketing authorisation shall submit notification to the BDA and the commissions under art. 103, para. 1 or 2, as applicable.
(4) the Commission under art. 103, para. 1, according to the art. 103, para. 2, within 15 days from the date of receipt of the notification under paragraph 1. 3 send the holder of the authorisation to use positive or negative opinion.
(5) the conduct of the study could begin after receiving a favourable opinion from the Commission under art. 103, para. 1, respectively, by the Commission under art. 103, para. 2.
(6) the content and form of the Protocol on al. 1 shall be determined by Commission implementing Regulation (EC) No 520/2012 of 19 June 2012 on the conduct of activities in the field of pharmacovigilance laid down in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (OJ L 157/5 of 20 June 2012.) , hereinafter referred to as the "Commission implementing Regulation (EC) No 520/2012".
Art. 145. (1) the holder of an authorisation for use in the cases under art. 145, para. 1 apply planned significant changes in the Protocol of the study after the prior approval by the Committee under art. 56 a, para. 1, item 1.
(2) the holder of the marketing authorisation holder shall submit to the Committee referred to in art. 56 a, para. 1.1 the documentation relating to the changes and reasons for it.
(3) where the Committee under art. 56 a, para. 1, item 1 changes in the approved Protocol, the holder of the authorisation shall inform the BDA and the Commission under art. 103, para. 1, according to the art. 103, para. 2.
(4) the holder of the marketing authorisation may apply changes under para. 1 after receiving a favourable opinion from the Commission under art. 103, para. 1, according to the art. 103, para. 2. Art. 145. (1) the holder of the marketing authorisation holder shall submit electronically to the Committee under art. 56 a, para. 1 1 final report, accompanied by a summary of the survey results, within 12 months after the completion of data collection.
(2) the holder of the marketing authorisation holder may submit a reasoned request to the Committee under art. 56 a, para. 1, item 1 to postpone the time limit referred to in paragraph 1. 1 at least three months before the date of presentation of the final report referred to in the Protocol.
(3) the Committee under art. 56 a, para. 1, item 1 shall approve or make the request reasoned refusal under para. 2 and shall inform the holder of the marketing authorisation.
(4) the content and format of the report referred to in para. 1 shall be determined by Commission implementing Regulation (EC) No 520/2012.
Art. 145. (1) the Committee under art. 56 a, para. 1, item 1 on the basis of the report referred to in art. 145 (h), para. 1 and, after consulting with the holder of the permit for use issued a reasoned recommendation concerning the authorisation for the use of the medicinal product and send it to:
1. the Committee for medicinal products for human use under art. 5 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, or
2. the coordination group referred to in art. 77, para. 2. (2) in the cases referred to in para. 1, item 2, where the Committee under art. 56 a, para. 1, item 1 is the recommended change, suspension or discontinuance of the marketing authorisation, coordination group, represented by Member States surveyed, issued an opinion on the appropriate action to be taken in respect of the authorisation holder, including a timetable for its implementation.
(3) where Member States submitted to the coordinating group reach consensus on the opinion referred to in paragraph 1. 2, it is published on the European Internet portal for medicinal products under art. 68, para. 1, item 4 and sent to the holder of the marketing authorisation.
(4) the Executive Director of the BDA in accordance with the opinion of Pará. 2 suspend or terminate permission to use.
(5) where, in the opinion of Pará. 2 recommended changes in the issued permission for use, the holder of the marketing authorisation for use within the specified timetable submitted to the FDA application pursuant to chapter three, section VI, including an updated summary of product characteristics and package leaflet.
(6) where no agreement is reached within the coordinating group, the position of the majority of Member States provide the European Commission, which shall adopt a decision on the modification, suspension or discontinuance of the permit for use issued by the relevant regulatory authorities of the Member States.
(7) the decision referred to in paragraph 1. 6 shall be published on the European Internet portal for medicinal products under art. 68, para. 1, item 4 and sent to the holder of the marketing authorisation.
(8) the drug agency apply temporary and/or definitive measures of the decision referred to in paragraph 1. 6, and shall inform the European Medicines Agency and the European Commission.
(9) in the cases referred to in para. 1, item 1, the Committee for medicinal products for human use in accordance with the recommendation of the Committee under art. 56 a, para. 1, item 1 shall issue an opinion on the suspension or termination of the validity of the marketing authorisation for use, including a timetable for the implementation of the opinion. The opinion shall be published on the European Internet portal for medicinal products under art. 68, para. 1, item 4 and sent to the holder of the marketing authorisation.
(10) where in the opinion of Pará. 9 position was expressed to take regulatory action in respect of authorisations to use the European Commission adopts a decision on the modification, suspension or discontinuance of use, issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council.
Art. 145 HP (1) Neintervencionalni studies in the territory of the Republic of Bulgaria shall take place in accordance with art. 145 in-145 (e).
(2) in carrying out the surveys referred to in paragraph neintervencionalni. 1 shall indicate the source of funding. "
§ 29. The title of chapter v shall be replaced by the following: "the manufacture and import of medicinal products and active substances".
§ 30. In art. 146, para. 1, the words "of the active substances used as starting materials" shall be deleted.
§ 31. Article 147 is amended as follows: "Article. 147. Drug Agency introduces information on permits issued for the manufacture of medicinal products and certificates of good manufacturing practice in the database of the European Union. "
§ 32. In art. 150, para. 2 item 4 shall be amended as follows:
"4. a list of production activities and medicinal forms that will produce;".
§ 33. Article 152 shall be amended as follows:
"Art. 152. (1) the principles and requirements for good manufacturing practice for all kinds of medicinal products, medicinal products for clinical trial and on active substances shall be determined by an Ordinance of the Minister of health and with acts and guides adopted by the European Commission.
(2) the principles and requirements for a formal risk assessment to establish good manufacturing practice for excipients are determined by the Ordinance under para. 1 and with manuals, adopted by the European Commission. "
§ 34. In art. 155, para. 2 the words ' active substances ' shall be deleted.
§ 35. In art. 156, para. 1, item 6, the words "active substances and ' shall be deleted.
§ 36. In art. 158, para. 1, item 4, the words "active substances" and the comma after them are deleted.
§ 37. In art. 159 following amendments and supplements shall be made: 1. a new paragraph. 4:
"(4) the qualified person shall be responsible for the fact that the packaging of the medicinal product are the safety features referred to in art. 168, para. 8. "
2. the Previous para. 4, 5 and 6 become Al respectively. 5, 6 and 7.
3. The current paragraph. 7 it al. 8 and in her words "para. 6 ' shall be replaced by "para. 7. "
4. the Previous para. 8 and 9 become Al respectively. 9 and 10.
§ 38. In art. 160 make the following amendments and supplements: 1. Al. 1:
a) point 2 is replaced by the following: "2. uses only active substances which have been manufactured in accordance with the requirements of good manufacturing practice for active substances;"
b) item 2 shall be:
' 2A. shall ensure that auxiliary substances used in medicinal products are manufactured in accordance with the appropriate good manufacturing practices for excipients, determined on the basis of a formal risk assessment in accordance with the applicable guidelines, adopted by the European Commission; "
in t. created) 9-11:
"9. The FDA and immediately inform the holder of the marketing authorisation, if it receives information that the medicinal products falling within the scope of its authorisation for production are counterfeit or suspect fraud, regardless of whether these products have been distributed within the legal supply chain or illicitly, including through illegal sales through the services of the information society;
10. Verify that manufacturers, importers or traders of which receives active substances are registered by the competent authority of the Member State where they are established;
11. verify the authenticity and quality of the active and the excipients. "
2. Create a new para. 2 and 3: (2) the holder of the manufacturing authorization shall carry out audits in the objects for the production and marketing of active substances for the observance of good manufacturing practice and Good distribution practice. The holder of the manufacturing authorization may enter into a contract with a third party to carry out the audit in his name and for his account.
(3) the holder of the manufacturing authorization shall record the measures taken under paragraph 1. 1, item 2 and 2 and measures. "
3. the Previous para. 2, 3, 4, 5, 6 and 7 shall become al. 4, 5, 6, 7, 8 and 9.
4. The current paragraph. 8 it al. 10 and in her words "active and ' shall be deleted.
§ 39. In Chapter five in the title of section II, the words ' and active substances ' shall be deleted.
§ 40. In art. 161 the following modifications are made:
1. In paragraph 8. 1, the words "of the active substances used as starting materials" and the comma after them are deleted.
a) in paragraph 1 the words "art. 159, para. 2 and 9 ' shall be replaced by "art. 159, para. 2 and 10 ";
b) in paragraph 2, the words "of the active substances and auxiliary ' shall be deleted.
§ 41. In art. 162, para. 2, item 2, the words ' active substances ' shall be deleted.
§ 42. In art. 165, para. 1, item 2, the words ' active substances ' shall be deleted.
§ 43. In art. 167, para. 1, item 4, ' active substances ' shall be deleted.
§ 44. In Chapter five establishes the section III, with art. 167 – 168 h: section III
Production, import and wholesale of active substances
Art. 167. Production, import or wholesale of active substances may be carried out only natural or legal persons registered as traders under the legislation of a Member State and entered in the register under art. 167.
Art. 167. (1) (b) for entry in the register under art. 167 (d) the applicant shall submit in BDA sample application, approved by the Executive Director of the BDA, which contains:
1. the name, seat and address of management of the person referred to in art. 167;
2. the list of active substances which will be imported, manufactured or marketed;
3. the activities which the person under art. 167 (a) will be carried out;
4. address of premises and technical equipment for the carrying out of the activities of the persons under art. 167. (2) an application under subsection. 1 shall apply:
1. data for single identification code of the merchant and for the companies registered in a Member State – document for up-to-date registration under national law, issued by the competent authority of the country concerned;
2. a document for paid fee under art. 21, para. 2.
(3) within 60 days of receipt of the application and the documentation referred to in paragraph 1. 1 and 2 on the basis of the FDA risk assessment:
1. Enter the person under art. 167 in the register under art. 167 d, for which it shall inform, or
2. notify the date of inspection for compliance with the conditions for carrying out the activities under art. 167 and with the requirements of good manufacturing practice referred to in art. 152, para. 1 and good distribution practices of active substances under art. 198. (4) where, as a result of inspection under paragraph 1. 3, item 2 the FDA has established according to the requirements of good manufacturing practice referred to in art. 152, para. 1 and good distribution practices of active substances under art. 198, it shall enter in the register the applicant under art. 167 (d) inform him.
(5) the cost of carrying out the inspection referred to in paragraph 1. 3, item 2 shall be borne by the applicant.
(6) for carrying out the inspection referred to in paragraph 1. 3, item 2, the applicant shall pay the fee set out in the tariff referred to in art. 21, para. 2.
(7) in the cases referred to in para. 3, item 1 and al. 4 the applicant may begin to operate after entry in the register under art. 167.
Art. 167 in. By the deadline referred to in art. 167 b, para. 3 the FDA notifies that the inspection is to be carried out, the applicant may begin the implementation of the activity.
Art. 167. (1) the drug agency leads a public register of importers, manufacturers and wholesalers with active substances that contains:
2. the list of active substances which are imported, manufactured or marketed;
4. the address of the premises where the activities are carried out;
5. remarks on the scheduled circumstances.
(2) drug agency introduces the database under art. 147 information for registered importers, manufacturers and wholesalers with active substances.
Art. 167 (1) the person referred to in art. 167 and filed in by 31 January each year the FDA notification of changes in the information entered in the register under art. 167 (2) in case of changes that may affect the quality or safety of active substances that are manufactured, imported or distributed, the person under art. 167 and notify the FDA immediately.
Art. 167. (1) the manufacture, importation and wholesale of active substances on the territory of the Republic of Bulgaria, including active substances, intended for export shall be carried out in accordance with good manufacturing practice and good distribution practices for active substances.
(2) importers may import active substances only if the following conditions are met:
1. active substances have been manufactured in accordance with standards of good manufacturing practice at least equivalent to those laid down by the European Union, and
2. active substances shall be accompanied by written confirmation from the competent authority of the exporting country:
a) good manufacturing practice standards applicable to the facility for the production of the exported active substance are at least equivalent to those laid down by the European Union;
(b) the production entity) is subject to regular control and effectively applies good manufacturing practice, as this includes repeated and unannounced inspections, in order to ensure protection of public health, at least equivalent to that in the European Union, and
c) in the case of non-compliance found the exporting country will immediately inform the FDA.
(3) the requirement of paragraph 6. 2, item 2 shall not apply if the exporting country is included in the list under art. 111 (b) of Directive 2001/83/EC.
Art. 167. (1) in exceptional cases, when it is necessary to ensure the availability of medicinal products, the importer can import the active substance without the written confirmation referred to in art. 167, para. 2, item 2 for no longer than the period of validity of the certificate of good manufacturing practice, when the object of production of active substance in the exporting country has been inspected by the regulatory authority of a Member State and found to comply with the principles and guidelines of good manufacturing practice.
(2) in the cases referred to in para. 1 notify the FDA, the European Commission.
Art. 167. The holders of permits for the manufacture, including those which carry out activities under art. 168 b, para. 2, are considered as producers within the meaning of § 13, item 3 of the additional provisions of the law on consumer protection and responsibility for damage caused by a defect of the goods referred to therein. "
§ 45. In art. 168 make the following amendments and supplements: 1. Paragraphs 3 and 4 shall be amended as: "(3) the package leaflet of medicinal products included in the list under art. 23 of Council Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains the following information: "this medicinal product is subject to additional monitoring. In front of text placed a sign in black under article 23 (5) of Regulation (EC) No 726/2004 of the European Parliament and the Council, accompanied by an explanatory note.
(4) in the package leaflet of medicinal products include standard text with which patients are invited to report to the medical professionals or directly to the FDA any suspected adverse drug reaction according to the models referred to in art. 185, para. 2, item 4. "
2. a para. 8: "(8) On the secondary packaging and where there is none – on the immediate packaging of the medicinal products, with the exception of radiopharmaceuticals shall be entered:
1. an individual identification mark for safety indicators, which enables traders to wholesale and retail:
a) verify the authenticity of the medicinal product;
b) identify individual packages;
2. the means by which to carry out a check on the packaging of the medicinal product if it has been tampered with. "
§ 46. Create art. 168 and 169 (b): "art. 168. (1) on the packaging of a medicinal product is granted by prescription, safety indicators under art. 168, para. 8, with the exception of cases in which the medicinal product is included in the list specified by the European Commission with delegated act under art. 168 (b). (2) on the packaging of a medicinal product, which is available without prescription, not mapped safety indicators under art. 168, para. 8, with the exception of cases in which the medicinal product is included in the list specified by the European Commission with delegated act under art. 168 (b) after it is assessed that is exposed to the risk of counterfeiting.
(3) the drug agency shall notify the Commission:
1. for medicinal products which are available without prescription, for whom it is established that there is a risk of counterfeiting;
2. for medicinal products has established that there is no risk of counterfeiting, taking into account the following criteria:
(a)) price and volume of sales of the medicinal product;
(b)) number and frequency of cases of falsified medicinal products registered in the framework of the European Union and in third countries, and the change in the number and frequency of such plan;
the characteristics of the relevant) specific medicinal products;
d) burden of the diseases whose treatment goals;
e) other potential risks to public health.
Art. 168. (1) (b) the rules on the safety features referred to in art. 168, para. 8 shall be laid down by the European Commission with the delegated acts referred to in article 54 (a) (2) of Directive 2001/83/EC.
(2) the safety features are not removed or obscured in part or in full, unless the following conditions are met:
1. the holder of the manufacturing authorization, before partially or completely to remove or close the safety features, check whether the medicinal product is authentic and whether it has been tampered with;
2. the holder of the manufacturing authorisation subject to compliance with the requirements of art. 168, para. 8 can replace the safety features with equivalent to them in terms of the ability to ensure the authentication, identification and securing of evidence for the medicinal product.
(3) the safety features are considered equivalent if:
1. comply with the requirements laid down in the delegated acts referred to in article 54 (a) (2) of Directive 2001/83/EC, and
2. are equally effective in allowing verification of authenticity and identification of the medicinal products and the provision of evidence of tampering.
(4) Replace under para. 2, item 2 shall be carried out without opening the immediate packaging of a medicinal product in accordance with good manufacturing practice for medicinal products.
(5) the drug agency shall supervise the replacement of safety indicators. "
§ 47. In art. 170 following amendments and supplements shall be made: 1. The current text becomes paragraph. 1.
"(2) where a medicinal product authorised in accordance with this Act, is not available on the market in the Republic of Bulgaria, the FDA may allow its use when some of the data set out in the Ordinance referred to in para. 1, are not mapped on the packaging or in the package insert.
(3) in the cases referred to in para. 2 the information on the packaging and in the leaflet could not be provided and the Bulgarian language.
(4) the detailed rules for the supply of medicinal products under para. 2 shall be determined by the Ordinance under art. 198. "
§ 48. In Chapter 8 establishes the name: "Section I General provisions".
§ 49. Article 183 shall be replaced by the following:
"Art. 183. (1) the drug agency organizes and maintains a pharmacovigilance system for the performance of their obligations under this chapter.
(2) the system under paragraph 1. 1 is used to collect information on the risks of medicinal products for patients ' health or public health. The information covers the reports of adverse reactions when use of the medicinal product in accordance with the summary, as well as information about abuse and use, which is not in accordance with the approved summary of product characteristics, including information on adverse reactions observed in the performance of professional duties.
(3) the drug agency validates, processes and classifies information under para. 2, make a scientific analysis of the data collected in order to assess the opportunities for risk reduction and prevention and take appropriate action in terms of the marketing authorisation for the medicinal product.
(4) drug agency carried out audits of the system under paragraph 1. 1 and every two years, send a report to the European Commission with their results.
(5) the drug agency apply adequate and effective quality system to ensure compliance of the system under paragraph 1. 1 with the requirements of this Act. The minimum requirements for the quality system shall be determined by Commission implementing Regulation (EC) No 520/2012. "
§ 50. Article 184 shall be replaced by the following:
"Art. 184. (1) the medical professionals are required to report without delay to the holder of the marketing authorisation or of the FDA for any suspected serious adverse drug reaction and to provide, upon request, additional information on the follow-up of the case.
(2) patients may report adverse reactions anytime of medical specialists or BDA.
(3) in the cases referred to in para. 1 and 2, where the message relates to biological medicinal product prescribed, distributed or sold on the territory of the Republic of Bulgaria, it must be clearly identified by the reporter, with its trade name and lot number or that information to be provided in the additional track ".
§ 51. Article 185 is amended as follows:
"Art. 185. (1) the drug agency maintains a national Internet portal for medicinal products associated with European Internet portal for medicinal products under art. 68, para. 1, item 4.
(2) drug agency provided through the portal in the Al. 1 at least the following information: 1. the public assessment reports under art. 53, para. 2 and their resumes;
2. Summary of products and package inserts;
3. Summary of risk management plans for medicinal products authorised in the territory of the Republic of Bulgaria;
4. examples of standardized forms for reporting of suspected adverse reactions by health professionals and patients, drawn up in accordance with the requirements of article 25 of Regulation (EC) No 726/2004 of the European Parliament and of the Council;
5. the updated list of the medicinal products referred to in article 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council;
6. messages, providing information to the general public for concerns about the safety of the use of a medicinal product;
7. instructions for all the ways and forms for reporting suspected adverse reactions by health professionals and patients. "
§ 52. Article 186 is amended as follows:
"Art. 186. The Bulgarian drug agency performs the following activities of medicinal products placed on the market of the Republic of Bulgaria: 1. monitoring of the effects of measures to reduce the risk of a medicinal product contained in the risk management plan;
2. monitoring of the outcome of the implementation of the conditions set out in art. 55A, 56 or 56A;
3. evaluating the update of the risk management system;
4. monitoring of the EudraVigilance database ' ', established in accordance with article 24 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, for new risks or for a change in the already established and the change in the benefit/risk ratio. "
§ 53. Article 187 shall be amended as follows:
"Art. 187. (1) the drug agency inform the European Medicines Agency and the holder of an authorisation for use in the identification of signals for new risks or to change the risks identified, or in the event of a change in the risk-benefit balance of a medicinal product.
(2) the Committee referred to in art. 56 a, para. 1, item 1 analyze and prioritize signals for validated new risks or for a change in the already established and to change the benefit/risk ratio.
(3) where the Committee under art. 56 a, para. 1, item 1 recommended follow-up, coordination group, under art. 77, para. 2 or, respectively, the Committee for medicinal products for human use shall also draw up an opinion on the regulatory action with regard to authorisation for use within the timetable drawn up in accordance with the seriousness and extent of the danger.
(4) the drug agency recommended applied in the opinion of the coordination group referred to in art. 77, para. 2 or in the decision of the European Commission temporary and/or definitive measures. "
§ 54. Article 188 shall be amended as follows:
"Art. 188. (1) the drug agency inform the European Medicines Agency, regulatory authorities of other Member States and the European Commission at least 24 hours prior to the communication to the public of information about concerns related to the tracking of safety of the medicinal product concerned, except in cases where the protection of public health requires immediate disclosure of the information.
(2) drug agency publishes information relating to active substances contained in medicinal products authorised in other Member States, using a harmonised draft of communication and publication schedule, proposed by the European Medicines Agency.
(3) in the cases referred to in para. 1 and 2 information containing personal or commercially sensitive data, is deleted, unless the publication of these data is necessary for the protection of public health. "
§ 55. Article 189 shall be amended as follows:
"Art. 189. (1) the drug agency may delegate any of the rights and obligations under this chapter, the regulatory authority of another Member State through the conclusion of the agreement.
(2) in the cases referred to in para. 1 the FDA informed the European Commission, the European Medicines Agency and the regulatory authorities of the other Member States of any delegation of powers and post a message on the Internet portal under art. 185, para. 1 or on its website. "
§ 56. Article 190 shall be amended as follows:
"Art. 190. (1) the holder of an authorisation for use is bound to have its pharmacovigilance system for the performance of his duties under this chapter.
(2) the holder of an authorisation for use by the system under paragraph 1. 1 make a scientific evaluation of the information collected on the safety of medicinal products, evaluate the opportunities to minimize or prevent the risk and take the appropriate measures.
(3) the holder of an authorisation for use apply adequate and effective quality system to ensure compliance of the system under paragraph 1. 1 with the requirements of this Act. The minimum requirements for the quality system shall be determined by Commission implementing Regulation (EC) No 520/2012.
(4) the holder of an authorisation for use carry out a regular audit of the system under paragraph 1. 1. information on the main findings of the audit shall be recorded in the system, and serves for the preparation of a plan for the implementation of appropriate corrective action. This information may be deleted after full implementation of corrective action. "
§ 57. Article 191 shall be replaced by the following:
"Art. 191. (1) the holder of an authorisation for use determine the qualified person with appropriate qualifications, responsible for pharmacovigilance.
(2) the person referred to in paragraph 1. 1 is found in the territory of a Member State and has permanently and continuously at the disposal of the holder of the marketing authorisation.
(3) to support the activities of the qualified person shall be the holder of the authorisation to use determines the person established in the territory of the Republic of Bulgaria. The appointment of such a person shall not relieve the qualified person referred to in paragraph 1. one of his responsibilities under this chapter.
(4) the holder of the marketing authorisation holder shall submit to the FDA data under art. 27, al. 1 12 c "and"-"in" to the persons referred to in para. 1 and 3.
(5) the holder of the authorisation shall notify the FDA when any change in the particulars referred to in para. 4.
(6) the holder of the marketing authorisation shall provide the data referred to in para. 4 for the qualified person of the European Medicines Agency. "
§ 58. Article 192 shall be amended as follows:
"Art. 192. (1) the holder of the marketing authorisation is required to: 1. maintain and make available, at the request of the FDA main document system pharmacovigilance;
2. apply a risk management system for each medicinal product;
3. monitor the outcome of the measures contained in the risk management plan, or 4. monitor the outcome of the implementation of the conditions under art. 55A, 56 or 56A;
5. update the risk management system;
6. monitor the system data under art. 190, para. 1 to identify new risks or change of the risks identified, and to determine whether changes have occurred in the benefit/risk ratio of the observed product.
(2) the content and the procedure for maintenance of the system for pharmacovigilance shall be determined by Commission implementing Regulation (EC) No 520/2012. "
§ 59. Article 193 shall be amended as follows:
"Art. 193. The holder of the authorisation shall inform the FDA and the European Medicines Agency in case of identification of signals for new risks or to change the risks identified, or in the event of a change in the risk-benefit balance of the medicinal product concerned. "
§ 60. Article 194 shall be amended as follows:
"Art. 194. (1) the holder of an authorisation for use at the same time or before to give the public new information about concerns related to tracking the safety of a medicinal product authorised in the territory of the Republic of Bulgaria shall inform the FDA, the European Medicines Agency and the European Commission.
(2) the information referred to in para. 1 must be objective and not misleading.
(3) to disseminate information relating to pharmacovigilance, the holder of the authorization to use it consistent with the FDA in advance except in the cases referred to in paragraph 1. 1.
(4) for the evaluation of the information referred to in para. 3 fee in the amount set out in the tariff referred to in art. 21, para. 2. "§ 61. In chapter eight article is created. 194:
"Art. 194. (1) the principles of good practice and pharmacovigilance are defined in the Guide issued by the European Medicines Agency.
(2) in carrying out the activities under the pharmacovigilance the holder of an authorisation for use observe good practice under para. 1. "
§ 62. In chapter eight creates section II "harvesting and the communication of information on suspected adverse reactions" with art. 194 b-194 (g):
"Art. 194 (b). The holder of the authorisation for use in the performance of his duties under art. 190 is required to record all suspected adverse reactions occurring within the European Union or in third countries, his reported spontaneously by medical professionals or patients or arose in the process of conducting post-marketing studies.
Art. 194. (1) the holder of the marketing authorisation shall submit electronically to the database "EudraVigilance" under art. 24 of Regulation (EC) No 726/2004 of the European Parliament and of the Council reports of serious suspected adverse reactions, occurring in the territory of the European Union and in third countries, within 15 days from the date of receipt of the message.
(2) the holder of the marketing authorisation shall submit electronically to the database "EudraVigilance" messages for all suspected side effects, other than those referred to in paragraph 1. 1, occurred in the territory of the European Union, within 90 days from the date of receipt of the message.
(3) the holder of the marketing authorisation for use in specialized publications monitored medical literature and report in the database "EudraVigilance" each described in her suspected adverse drug reactions with the exception of suspected adverse reactions to medicinal products containing active substances specified in the list referred to in article 27 of Regulation (EC) No 726/2004 of the European Parliament and of the Council and described in literary sources , followed by the European Medicines Agency.
(4) the holder of the marketing authorisation holder shall establish procedures for the collection of accurate and reliable data, enabling scientific assessment reports for suspected side effects. The holder of the authorisation to use collect subsequent information relating to these messages and provides updated data in "EudraVigilance".
(5) the form and content of the reports referred to in paragraph 1. 1 – 3 are defined by Commission implementing Regulation (EC) No 520/2012.
Art. 194. (1) the drug agency register in the system of art. 183 all suspected adverse reactions occurring in the territory of the Republic of Bulgaria, by medical professionals and patients, and requires, where necessary, additional information from the follow-up of the case.
(2) when messages of suspected adverse reactions, occurring in the territory of the Republic of Bulgaria shall be submitted by the holder of the marketing authorisation, it shall provide additional information on the follow-up of the case at the request of the FDA.
Art. 194 (1) drug agency filed electronically in a database "EudraVigilance" messages for all serious suspected adverse reactions, occurring in the territory of the Republic of Bulgaria, within 15 days from the date of their receipt.
(2) drug agency filed electronically in a database "EudraVigilance" messages for all suspected side effects, other than those referred to in paragraph 1. 1, occurred in the territory of the Republic of Bulgaria, within 90 days from the date of receipt of the message.
(3) the drug agency filed electronically in a database "EudraVigilance" reports of suspected adverse reactions, occurring in the territory of the Republic of Bulgaria, as a result of improper use of the medicinal product. Drug agency shall inform the Ministry of health and professional organizations of medical professionals.
(4) any body or institution that has received information on suspected adverse drug reactions occurring in the territory of the Republic of Bulgaria shall inform the FDA about this.
(5) the content and form of messages and reports referred to in paragraph 1. 1 – 3 are defined by Commission implementing Regulation (EC) No 520/2012.
Art. 194. (1) the drug agency receives information submitted by the holder of the authorization to use information on serious suspected adverse reactions, occurring in the territory of the European Union or in a third country, by means of the database "EudraVigilance".
(2) the requirements for the monitoring of the information in the database "EudraVigilance" shall be determined by Commission implementing Regulation (EC) No 520/2012.
Art. 194. In the process of exchange of information, the FDA authorisation holders and the European Medicines Agency cooperate to detect duplicate messages for suspected side effects. "
§ 63. In chapter eight creates section III periodic safety update reports ' with art. 194 h-194 t:
"Art. 194. (1) the holder of the marketing authorisation is required to submit electronically to the European Medicines Agency periodic safety update reports containing: 1. Summary of the data on the risk-benefit balance of the medicinal product, including the results of all studies, with a view to their potential impact on the marketing authorisation;
2. the scientific assessment of the risk-benefit balance of the medicinal product; the assessment is based on all available data, including data from clinical trials for indications of unauthorized and target groups that are not included in the summary of product characteristics;
3. all data on the volume of sales of the medicinal product and any other information that the holder of the authorisation has, on volume of prescriptions, including the approximate number of persons having used medicinal product or exposed to him for another reason.
(2) the content and format of electronic periodic safety update reports shall be determined by Commission implementing Regulation (EC) No 520/2012.
(3) the information referred to in para. 1 is collected and stored in the registry, set up by article 25 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, and is available to the FDA.
Art. 194. The holders of the authorisations of use/certificates for registration of medicinal products under art. 28, 30, 35 and 37 shall submit periodic safety update reports only in cases when: 1. submission of the report is provided under art. 55 or 56, entered in the authorisation/certificate of registration, or
2. Drug Agency or a regulatory authority of another Member State requires on the basis of considerations for the safety of the medicinal product or in the absence of periodic safety update reports concerning the active substance contained in the medicinal product has been granted permission to use/certificate of registration.
Art. 194 hp. (1) the authorisation/certificate of registration is determined the frequency of submission of periodic safety update reports.
(2) the dates of submission of reports depending on the frequency of Pará. 1 shall be calculated from the date of issue of the authorisation/certificate of registration.
(3) periodic safety update reports shall be submitted in the following time intervals, with the exception of cases where the frequency of submission of the reports is a condition for the granting of the marketing authorisation/certificate of registration or determined in accordance with art. 194 l, m and n 194 194:1. every six months from the date of issue of the permit for use/certificate of registration of the medicinal product and the date of placing it on the market;
2. every 6 months during the first two years of the date of marketing of the medicinal product;
3. once a year over the next two years;
4. every three years after the fourth year from the date of the placing on the market of the medicinal product.
(4) except in the cases referred to in paragraph 1. 3, periodic safety update reports shall be submitted immediately upon request by the FDA or the regulatory authority of a Member State.
(5) paragraphs 3 and 4 shall also apply to medicinal products authorised for use on the territory of the Republic of Bulgaria, which do not fall within the scope of art. 194 l.
Art. 194 l. where medicinal products containing the same active substance or combination of active substances the same have received separate authorisation/registration certificate, the frequency and dates of submission of periodic safety update reports can be modified and harmonized with a view to the carrying out of a uniform assessment of these reports.
Art. 194 m. (1) dates of submission of periodic safety update reports for medicinal products under art. 194 l shall be calculated in accordance with the reference date of the European Union.
(2) reference date of the European Union at the Pará. 1 is:
1. date of first authorisation for use in the European Union of the medicinal product containing the active substance or combination of active substances concerned, or
2. the earliest of the known dates of authorisations for the use of the medicinal product containing the active substance or combination of active substances concerned if the date referred to in paragraph 1 may not be established.
Art. 194. (1) the holder of the marketing authorisation of medicinal products under art. 194 l may submit a reasoned request to the Committee for medicinal products for human use, according to the coordination group referred to in art. 77, para. 2 to determine the reference date of the European Union, or to change the frequency of submission of periodic safety update reports in one of the following grounds: 1. reasons relating to public health;
2. in order to avoid duplication of assessment;
3. in order to achieve international harmonisation.
(2) the Committee for medicinal products for human use, respectively, the coordination group referred to in art. 77, para. 2 after consulting the Committee referred to in art. 56 a, para. 1, item 1 shall approve the request or makes a reasoned refusal.
(3) the frequency of filing and the reference date of the European Union shall be determined after consultation with the Committee referred to in art. 56 a, para. 1, item 1 of: 1. The Committee for medicinal products for human use – where at least one of the marketing authorisations for the use of medicinal products containing the active substance concerned has been granted in accordance with the centralised procedure, provided for in title II, Chapter 1 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, or 2. the coordination group referred to in art. 77, para. 2 – for cases other than those referred to in paragraph 1.
(4) the list of the reference dates of the European Union of medicinal products under art. 194 l and harmonized frequency for the submission of their periodic safety update reports shall be published on the European Internet portal under art. 68, para. 1, item 4.
(5) the holder of an authorisation for use after the publication of data under para. 4 submit the FDA application for change of the marketing authorisation of the medicinal product concerned. Any change of the dates of submission and frequency of submission of periodic safety update reports, set permissions for use, shall enter into force six months after the date of their publication.
Art. 194. (1) o drug agency assess periodic safety update reports for medicinal products in order to determine whether there are new risks, or changes in the risks identified, or change the benefit/risk ratio.
(2) drug agency carried out a single assessment of periodic safety update reports for medicinal products to which the Republic of Bulgaria was performing the functions of the reference Member State within the meaning of art. 76, and is defined by the coordinating group under art. 77, para. 2. (3) the Rapporteur by the Republic of Bulgaria participates in the single assessment of periodic safety update reports for medicinal products where at least one of the products is authorised under Regulation (EC) No 726/2004 of the European Parliament and of the Council, and is scheduled for a Committee under art. 56 a, para. 1, item 1.
Art. 194 p. (1) in the cases under art. 194 Oh, al. 2 and 3, respectively, of the FDA, the rapporteur Republic of Bulgaria within 60 days from the date of receipt of the periodic safety update report shall draw up an assessment report and send it electronically to the European Medicines Agency and the regulatory authorities of the Member States. The holder of the marketing authorisation obtained assessment report by the European Medicines Agency.
(2) within 30 days of receipt of the report referred to in paragraph 1. 1 the holder of the marketing authorisation or regulatory authorities of Member States may submit their comments to the European Medicines Agency and BDA.
(3) within 15 days from the date of receipt of the comments under para. 2 update the BDA assessment report taking into account all presented objections, and shall forward it to the Committee under art. 56 a, para. 1, item 1 for approval and recommendation.
(4) the European Medicines Agency includes an evaluation report and recommendation adopted by the Committee under art. 56 a, para. 1, item 1 in the register under art. 194 h, para. 3 and sends it to the holder of the marketing authorisation.
Art. 194. The Republic of Bulgaria When p is not the rapporteur in the procedure under art. 194 Oh, al. 2, the FDA may submit comments within the time limit under art. 194 p, al. 2 to the European Medicines Agency and to the regulatory authority of the home State, prepared the assessment report.
Art. 194 (1) in the case of a single assessment of periodic safety update reports for medicinal products under art. 194 l and when none of the permissions for the use of these products has not been issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council, the coordination group referred to in art. 77, para. 2 within 30 days from the date of receipt of the recommendation from the Committee under art. 56 a, para. 1, item 1 shall issue an opinion on the maintenance, variation, suspension or termination of the appropriate permissions for use, including a timetable for the implementation of the opinion.
(2) where the Member States in the coordination group referred to in art. 77, para. 2 agree on action to be taken, the FDA implements the adopted decision.
(3) where the opinion referred to in paragraph 1. 1 is for the suspension or withdrawal of a marketing authorisation, the Executive Director of the BDA issue the command.
(4) where, in the opinion of Pará. 1 recommended changes in the issued permission for use, the holder of the marketing authorisation submitted to the FDA application, including an updated summary of product characteristics and package leaflet, within the timetable for implementation.
(5) where no agreement is reached within the coordinating group under art. 77, para. 2, the position of the majority of Member States provide the European Commission, which shall adopt a decision on the modification, suspension or discontinuance of use issued by the relevant regulatory authorities of the Member States.
(6) drug agency apply temporary and/or definitive measures of the decision referred to in paragraph 1. 5. Art. 194 (1) in the case of a single assessment of periodic safety update reports for medicinal products under art. 194 l and where at least one of the permission for use has been issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council, the Committee for medicinal products for human use within 30 days of receipt of the recommendation from the Committee under art. 56 a, para. 1, item 1 shall issue an opinion on the suspension or termination of the validity of the relevant permissions to use, including a timetable for the implementation of the opinion.
(2) where, in the opinion of Pará. 1 position was expressed to take regulatory action in respect of authorisations to use the European Commission: 1. adopt a decision for a change, suspension or termination of the permission for use granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council;
2. adopt a decision with recommendation for modification, suspension or discontinuance of use issued by the relevant regulatory authorities of the Member States.
(3) the drug agency apply temporary and/or definitive measures of the decision referred to in paragraph 1. 2, item 2. "
§ 64. In Chapter 8 section IV is created "an emergency procedure at the level of the European Union" with art. 194-194 at will:
"Art. 194. (1) an emergency procedure at the level of the European Union may be initiated by the European Commission, the European Medicines Agency or the Member State concerned.
(2) Drug Agency launched an emergency procedure under this section by notifying the regulatory authorities of the other Member States, the European Medicines Agency and the European Commission, when for reasons connected with pharmacovigilance, considers that for a given medicinal product placed on the market, it is necessary to take any of the following measures: 1. suspension or termination of the permission for use;
2. Prohibition of the distribution of the medicinal product;
3. the issue of refusal to renew authorisation for use.
(3) the drug agency may initiate the procedure referred to in para. 2 in cases where: 1. it considers that the medicinal product must be added new contraindications or reduced the recommended dose, or testimony to be limited;
2. the marketing authorisation holder has notified the FDA that the considerations relating to pharmacovigilance, suspended distribution of the medicinal product or terminate permission to use, or intend to terminate or not renew a permit for use.
(4) drug agency provides to the European Medicines Agency the scientific information available, as well as the evaluation of the data.
(5) the European Medicines Agency will notify the FDA to expand the scope of the procedure with the medicinal products covered by the same safety considerations and belong to the same therapeutic group or contain the same active substance, or where the medicinal product in respect of which the procedure was initiated under para. 2 or 3, and is authorised in another Member State.
(6) except in the cases referred to in paragraph 1. 5 the procedure under this section shall not apply.
(7) in the cases referred to in para. 2 or 3 BDA shall inform the holder of the marketing authorisation.
Art. 194. (1) in the cases under art. 194, at para. 2, when it considers that it is necessary to take emergency measures to protect public health, the FDA may temporarily suspend the authorisation to use and to prohibit the use of the medicinal product in the territory of the Republic of Bulgaria to the adoption of the final decision under art. 194 194 h or w.
(2) drug agency notified the European Medicines Agency, the European Commission and the regulatory authorities of the other Member States of the measures taken under paragraph 1. 1 within one working day of their application and shall indicate the reasons therefor.
(3) when the drug agency participates in the procedure under this section shall, at the request of the FDA, the European Commission shall take provisional measures prescribed in respect of the authorisation for the use of the medicinal product or when the medicinal product is authorised under Regulation (EC) No 726/2004 of the European Parliament and the Council – in terms of the product itself, to the end of the procedure.
Art. 194 x. Drug Agency issued a national Internet portal under art. 185, para. 1 for the manner in which interested parties may provide information to the European Internet portal under art. 68, para. 1, item 4 of the medicinal product, subject to the procedure referred to in art. 194 at, and for the opportunity to participate in public discussion, if it is announced.
Art. 194. (1) the Committee under art. 56 a, para. 1.1 within 60 days from the date of announcement of the procedure of the European Internet portal shall prepare a reasoned recommendation.
(2) the holder of the marketing authorisation may, within the period referred to in paragraph 1. 1 to provide written comments.
(3) the recommendation in para. 1 shall be published on the European Internet portal under art. 68, para. 1, item 4 and contains one or more of the following conclusions: 1. does not need further investigation or action at Community level;
2. the holder of the marketing authorisation must carry out an additional survey and data analysis;
3. the holder of the marketing authorisation should conduct a safety survey postmarketingovo with subsequent evaluation of the results thereof;
4. the Member State or the holder of the authorisation to implement risk mitigation measures;
5. marketing authorisation should be suspended, cancelled or refused renewal;
6. permission for use must be changed.
(4) the specific measures referred to in paragraph 1. 3, paragraph 4, as well as the conditions and restrictions that should be included in the permit for use shall be set out in the recommendation.
(5) in the cases referred to in para. 3, t. 6, when the changes are related to amendment or addition to the information in the summary, on the packaging or in the package leaflet of the medicinal product, shall be included in the wording of the changed or added information and where should it be done.
Art. 194 (1) where, in the scope of the procedure under art. 194 at not included medicinal product authorised pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, the coordination group referred to in art. 77, para. 2 on the basis of the recommendation referred to in art. 194 c within 30 days from the date of receipt issued an opinion on the maintenance, variation, suspension, termination of validity of the authorisation or refusal to renew certificates, including the timetable for the implementation of the opinion.
(2) where, in the opinion recommended taking measures under art. 194 c, para. 3, item 5, the Executive Director of the BDA by order suspend or terminate permission to use, or its renewal refused.
(3) where, in the opinion of Pará. 1 recommended changes in the issued permission for use, the holder of the marketing authorisation submitted to the FDA application, including an updated summary of product characteristics and package leaflet, within the timetable for implementation.
(4) where, in the opinion of Pará. 1 recommended taking measures under art. 194 c, para. 3, item 2 – 4, the holder of the marketing authorisation shall take the necessary measures and inform the FDA and regulatory authorities of the other Member States.
(5) where, in the framework of the coordination group referred to in art. 77, para. 2 cannot be reached, the position of the majority of Member States provide the European Commission, which shall adopt a decision with recommendations for change, suspension or discontinuance of the permit for use issued by the relevant regulatory authorities of the Member States.
(6) the drug agency recommended applied in the decision referred to in paragraph 1. 5 temporary and/or definitive measures.
Art. 194. (1) where, in the scope of the procedure under art. 194 at included medicinal product authorised pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, the Committee for medicinal products for human use on the basis of the recommendation referred to in art. 194 c, para. 3 within 30 days from the date of receipt issued an opinion on the maintenance, variation, suspension, termination of validity of the authorisation or refusal to renew certificates, including the timetable for the implementation of the opinion.
(2) where, in the opinion of Pará. 1 position was expressed to take regulatory action in respect of authorisations for use: 1. The European Commission shall adopt a decision to change, suspend or terminate the validity of authorisations for use issued under Regulation (EC) No 726/2004 of the European Parliament and of the Council;
2. adopt a decision with recommendations for change, suspension or termination of the validity of authorisations for use issued by the relevant regulatory authorities of the Member States.
(3) the drug agency recommended applied in the decision of the European Commission under para. 2, item 2 temporary and/or definitive measures.
Art. 194. The recommendation referred to in art. 194 c, para. 1 opinion of art. 194 s, al. 1 and decision of the European Commission under art. 194 h, para. 5 and art. 194 s, al. 2 is published on the European Internet portal under art. 68, para. 1, item 4. "
§ 65. The title of Chapter 9 shall be replaced by the following: "wholesale trade in medicinal products and mediation in the field of medicinal products".
§ 66. Article 198 shall be amended as follows: "Article. 198. the principles and requirements for good distribution practice of medicinal products or of active substances shall be adopted by a decree of the Minister of health and with the guidelines adopted by the European Commission. "
§ 67. In art. 205 Al are created. 4 and 5: "(4) drug agency introduces the database under art. 147 information on permits issued for wholesale trade in medicinal products.
(5) at the request of the Commission or of a Member State provides information about the FDA granted permission for the wholesale trade in medicinal products. "
§ 68. In art. 207, para. 1 make the following amendments and supplements: 1. an item 4 (a):
"4A. examine whether the medicinal products obtained from the persons referred to in paragraph 4 are not forged by checking of the safety features on the packaging;".
2. Create t 6a and 6B:
"6a. delivery documents entered in the batch number of medicinal products supplied;
6B. is there a contingency plan, which contains the effective measures to withdraw a medicinal product from the market by the FDA or on the initiative of the producer or holder of the marketing authorisation of the medicinal product concerned; ".
7. store data for every transaction with received, delivered or disposed of through the mediation of medicinal products in the form of a sale/purchase invoices or in electronic form, or in any other form, as follows:
a) date of receipt and delivery;
(b)) name of the medicinal product;
c) received, delivered or disposed of through mediation;
d) name and address of the person from whom it was obtained or supplied medicinal product;
(e) the lot number) and number of the certificate for the release of the batch released by the qualified person referred to in art. 148, paragraph 2, of the qualified person referred to in art. 161, para. 2, paragraph 1, and the number of the certificate for the release of the batch, issued by the FDA – in the cases under art. 69 and 70; ".
4. Create t. 10, 11, 12, 13 and 14:
10. maintain a quality system, responsibilities, processes and risk management measures related to its activities;
11. shall inform the authorisation holder and the FDA for use when it is discovered or suspected that the medicinal product that is received or offered, was forged;
12. check that the retailer from whom it has received medicinal product, comply with the principles and guidelines of Good distribution practices under art. 198, and whether it has permission to wholesale;
13. check that the manufacturer or importer, from whom he received the medicinal product has authorisation to manufacture/import;
14. check that the intermediary through whom has received medicinal product complies with the requirements of this chapter. "
§ 69. In art. 208 words ' 2-9 ' shall be replaced by ' 2-14 '.
§ 70. Art is created. 209 (b): "art. 209 (b). (1) in the wholesale trade in medicinal products in third countries do not apply the requirements of art. 207, para. 1, 2, 5 and 6, as well as the requirements of chapter nine.
(2) where a medicinal product is obtained directly from a third country, but is not being imported into the territory of the Republic of Bulgaria shall not apply the requirements of art. 207, para. 1, item 4 and 4A.
(3) the wholesaler that supplies of medicinal products to persons of third countries which are entitled under the relevant national law to supply medicinal products to the customers, issued a document, stating:
1. date of grant;
2. the name and form of the medicinal product;
3. the quantity supplied;
4. name and address of the person to whom the product is delivered;
5. lot number. "
§ 71. In art. 212, para. 2 the words ' 2-9 ' shall be replaced by ' 2-14 '.
§ 72. In chapter nine to create art. 212 and 212 (b): "art. 212. (1) Mediation in the field of medicinal products on the territory of the Republic of Bulgaria can perform physical and legal persons registered as commercial firms within the meaning of the commercial code of the Republic of Bulgaria, which are registered for performing this activity by the FDA.
(2) the persons referred to in para. 1 who want to be registered as intermediaries, submitted to the FDA notification in a form approved by the Executive Director of the BDA, which contains:
1. the name, seat and address of management;
(3) The notification under paragraph 1. 2 shall apply:
1. data for single identification code;
2. a document for paid fee in the amount set out in the tariff referred to in art. 21, para. 2.
(4) drug agency recorded in the public register persons engaged in mediation in the field of medicinal products.
(5) the persons referred to in para. 1 may carry out mediation in the field of medicinal products after submission of the notification referred to in para. 2 in the BDA.
(6) the persons referred to in para. 1 notify the FDA within 7 days of the occurrence of a change in any of the circumstances referred to in paragraph 1. 2.
Art. 212 (b). (1) the persons under art. 212A, al. 1 are required: 1. to operate only with authorised medicinal products;
2. to have a contingency plan, which contains the effective measures to withdraw a medicinal product from the market by the FDA or on the initiative of the producer or holder of the marketing authorisation of the medicinal product concerned;
3. to store data, including the following information for each transaction made via mediation medicinal products:
a) settlement date;
the marketed quantity through mediation);
d) name and address of the beneficiaries and delivered the medicinal product;
(e) the batch number;)
4. to comply with the requirements of good distribution practice adopted by the Ordinance under art. 198;
5. to maintain a quality system, responsibilities, processes and risk management measures related to its activities;
6. immediately inform the authorisation holder and the FDA for use when it is discovered or suspected that the medicinal product – the subject of the mediation, was forged;
7. check whether the trader has permission for the wholesale trade of medicinal products;
8. to verify that the manufacturer or importer holds a production permit/import;
9. to store the data in item 2 for at least 5 years and make them available upon request of the control authorities.
(2) the requirements for mediation activities in the field of medicinal products shall be determined by the Ordinance under art. 198 and the guides of the European Commission. "
§ 73. In art. 220 al. 3 shall be amended as follows:
"(3) the pharmacist Assistant may perform all activities under art. 219, para. 1 under the supervision of a master pharmacist with the exception of: granting of medicinal products prescription and control consultations relating to medicinal products. "
§ 74. In art. 228, para. 5, paragraph 2, the words "EUR 1000" shall be replaced by "50 percent of the fee set out in the tariff referred to in art. 21, para. 2 for issue of permission for retail trade in medicinal products under art. 222, para. 1. "
§ 75. In art. 234 Al are created. 6 and 7:
(6) Pharmacy and drogeriite in al. 5 published on the Internet site through which carry out trading of medicinal products without prescription, a common logo, recognizable for the entire European Union.
(7) the requirements for the common logo under para. 6 shall be determined by a delegated act under art. 85 c (3) of Directive 2001/83/EC. "
§ 76. Create art. 234 a and 234 (b): "art. 234. (1) the drug agency publishes and maintains on its website:
1. information on the national legislation applicable to the supply of medicinal products for sale over the Internet, including information about the fact that there may be differences between Member States as regards the classification of the medicinal product and of the conditions of delivery;
2. information concerning the purpose of the common logo;
3. a list of persons offering products for sale over the Internet, as well as the addresses of their websites;
4. General information regarding the risks associated with medicinal products delivered to customers over the Internet in violation of the Ordinance under art. 234, para. 5.
(2) the website of the FDA under para. 1 is associated with the website of the European Medicines Agency.
Art. 234 b. drug agency participates in the European Commission and the European Medicines Agency information campaigns about the dangers of counterfeit medicinal products. "
§ 77. In art. 240 following amendments and supplements shall be made:
"(2) the Director of RZI reasoned refuse to issue a certificate of registration of the person as per art. 238, para. 2 when:
1. not presented any of the documents referred to in art. 239, para. (2);
2. within the time limit under art. 239, para. 4 the applicant has not eliminated the shortcomings. "
"(3) where, within the time limit referred to in paragraph 1. 1 the Director of the RZI is issued a certificate of registration of the drugs or did not make reasoned refusal, it is assumed that there is a tacit agreement.
(4) in the cases referred to in para. 3 the applicant may start performing the requested operations in accordance with the art. 29 of the Act on restricting administrative regulation and administrative control over the economic activity. "
3. The current paragraph. 2 it al. 5.
§ 78. Art is created. 240:
"Art. 240. (1) the Director of the RZI terminated by order the registration of drugs:
1. at the request of the person who has obtained a certificate of registration of drugs;
2. with the termination of the person's activities under art. 238, para. 2, for which it shall inform the RZI.
(2) within 14 days of the termination of the activity of al. 1, item 2 the person under art. 238, para. 2 notify the RZI. "
§ 79. The title of chapter twelve is replaced by the following: "regulating the prices of medicinal products".
§ 80. In chapter twelve prior art. 258 name: is created "section I National Council on pricing and reimbursement of medicinal products".
§ 81. Article 258 shall be replaced by the following:
"Art. 258. (1) to the Minister of health shall set up a National Council on pricing and reimbursement of medicinal products, hereinafter referred to as "the Council". The Council is a legal entity on budgetary allowance – secondary authorising officer. It has the status of a State Commission based g. Sofia.
(2) the activities of the Council are financed from the State budget through the budget of the Ministry of health.
(3) the Council's College and consists of a Chairman and six members, three of whom are doctors or masters-pharmacists, two lawyers and two economists, all with experience of not less than 5 years. The Chairman and the members of the Council shall be elected or dismissed by decision of the Council of Ministers, on a proposal from the Minister of health. The President shall direct the work of the Council and represents it.
(4) the members of the Council may not hold a position or to operate under art. 19, para. 6 of the law on the administration.
(5) the activity of the Council is assisted by the Administration, the structure and organization of the work shall be determined by the rules of procedure adopted by the Council of Ministers. "
§ 82. Article 259 shall be amended as follows.
"Art. 259. (1) the Council shall:
1. approve, disapprove, amended or deleted the price of medicinal products under art. 261, para. 1;
2. approve, disapprove, amended or deleted the overall price of medicinal products under art. 261, para. (2);
3. register, refusing to register, amend, or delete prices of medicines without prescription under art. 261, para. 3;
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. 261, para. 5;
5. includes, modify or exclude medicinal products from the positive list;
6. maintain and update the positive list.
(2) the Council shall keep public records of:
1. the prices of medicinal products authorised under art. 261, para. 1;
2. the approved limit prices of medicinal products under art. 261, para. (2);
3. the prices recorded for the medicinal products referred to in art. 261, para. 3.
(3) the Council shall supervise the sale of medicinal products with an established price, price and price limit registered.
(4) the Council shall adopt a written application for approval or registration of price or for inclusion, exclusion and changes of medicinal products from the positive list under this chapter, carry out inspections and studies on them and give reasoned decisions.
(5) the Council collects fees in the amounts set out in the tariff referred to in art. 21, para. 2, for the submission of applications for:
1. approval, registration or change in the established or registered price of a medicinal product;
2. turn on or change included in the list under art. 262, para. 1 medicinal product. "
§ 83. Article 259 (a) shall be replaced by the following:
"Art. 259. (1) the meetings of the Council are regular, if they attend more than half of the total number of its members.
(2) the Council shall act by a majority of more than half of the total of their members.
(3) The meetings of the Council may be invited to attend the parties concerned, which shall be informed of the date and time of the meeting, which will consider the request. "
§ 84. Article 259 b shall be amended as follows:
"Art. 259 (b). (1) the Council shall take a decision within:
1. sixty days, when an application is submitted for the approval of the price under art. 261, 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;
3. thirty days, when an application is submitted for approval, modification or deletion of the price under art. 261, para. (2);
4. thirty days, when an application for registration, change or cancellation of the price under art. 261, para. 3;
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. 5 the Council shall take a decision within thirty days, when an application is submitted for the approval of the price under art. 261, 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. 261, para. 5. "
§ 85. Article 259 shall be repealed.
§ 86. Article 259 (d) is repealed.
§ 87. Article 260 shall be amended as follows:
"Art. 260. The State bodies, officials and applicants under this chapter shall be obliged to provide assistance to the Council and to the employees in the performance of their assigned duties. "
§ 88. Article 261 is replaced by the following: "art. 261. (1) the members of the Council and its employees are 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 persons signed a declaration in a form approved by the President of the Council. "
§ 89. In chapter twelve after art. 261 creates a name: "Section II the regulation and registration of the prices of medicinal products. Algorithms for treatment with medicinal products ".
§ 90. Article 261 (a) shall be replaced by the following:
"Art. 261. (1) the Council regulates the prices of medicinal products included in the positive list under art. 262, para. 1 and paid with public funds, in accordance with the lowest reference price of Member States.
(2) the Council regulates the marginal prices of medicinal products, which shall be granted subject to prescription than those under para. 1 in accordance with the lowest reference price of Member States.
(3) the Council shall register the maximum retail selling prices of medicinal products which are available without prescription.
(4) the price determined pursuant to para. 1, and the overall price of medicinal products when sold at retail.
(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, for the regulation of the limit granted prices on prescription medicines under para. 2 when sold at retail, as well as the conditions and procedures for the registration of the prices of medicinal products which are available without prescription. "
§ 91. Article 262 shall be amended as follows:
"Art. 262. (1) a Positive list shall be drawn up and maintained by the Council and includes medicinal products subject to medical prescription and paid with funds from the budget of the NATIONAL HEALTH INSURANCE FUND from the State budget, beyond the scope of the statutory health insurance, 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/therapeutic course price under art. 261, para. 1, the overall price of medicinal products when sold at retail, the reference value for defined daily dose/therapeutic rate value on the package, calculated on the basis of the reference value/therapeutic course 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 for which there is no specific defined daily dose, the reference value is determined on the basis of the therapeutic course, concentration or volume.
(4) 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.
(5) where 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. 4.
(6) 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. 261, para. 4 more items.
(7) the Ministry of health and the NATIONAL HEALTH INSURANCE FUND can make proposals to the Council under art. 258, para. 1 for a review of medicinal products included in the positive list under conditions and by an order determined by the Ordinance under art. 261, para. 5.
(8) the national health insurance fund pays for medicinal products referred to in paragraph 1. 6, item 1, under the conditions and by the order of the Ordinance under art. 45, para. 9 of the law on health insurance. "
§ 92. Article 262 (a) is repealed.
§ 93. Article 264 is amended as follows:
"Art. 264. (1) upon suspension of sales under art. 54, para. 3 of a medicinal product, which is included in the positive list, and when within 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 the sales of the medicinal product, the holder of the authorisation to use has not fulfilled its obligation under paragraph 1. 6, the Council, under art. 258, para. 1 officially excludes him from a positive list of medicines. "
§ 94. In art. 265, para. 3 the words "the Committee on pricing and reimbursement" is replaced by "National Council on pricing and reimbursement of medicinal products".
§ 95. In art. 266, para. 1 the words "the Committee on pricing and reimbursement" is replaced by "National Council on pricing and reimbursement of medicinal products".
§ 96. In art. 267 the following endorsements are added:
1. In paragraph 8. 1, second sentence, after the words "main State health inspector" is added "by the President of the Council under art. 258, para. 1 "and a comma.
2. in the Al. 2, after the words "medicinal products are" added "the Council under art. 258, para. 1 "and a comma.
3. in the Al. 3, after the words "the commandments" is added "the President of the Council under art. 258, para. 1 "and a comma.
§ 97. In art. 267 and the words "art. 261, para. 1, item 4 "shall be replaced by" art. 259, para. 1, item 4.
§ 98. In art. 268, para. 1 make the following amendments and additions:
1. In paragraph 1, after the words "trading of medicinal products" shall be inserted, and "active substances".
"2. the activities of the holders of an authorisation for use, manufacturers, importers and wholesalers of medicinal products and active substances of the medicinal products in pharmacies and drogeriite;".
"6. the system for tracking drug safety of holders of an authorisation for use and to comply with the requirements of good practice for tracking of drug safety."
§ 99. In art. 269 following amendments and supplements shall be made:
"(3) drug agency carries out inspections:
1. medicinal products manufacturers located on the territory of the Republic of Bulgaria, of a Member State or in third countries;
2. the importers and wholesalers of medicinal products;
3. the premises of producers, importers and wholesalers of active substances, situated on the territory of the Republic of Bulgaria;
4. the premises of producers or wholesalers of active substances located in third countries, as well as the manufacturers or importers of excipients;
5. the premises of holders of authorisations for the use of medicinal products and medicinal products registered in accordance with art. 212A;
6. as part of the certification procedure, which is in conjunction with the monographs of the European Pharmacopoeia;
7. the producers of source materials at the written request of the manufacturer. "
2. Paragraphs 5, 6 and 7 shall be read with the following adaptations:
"(5) Inspections under paragraph 1. 3 and 4 shall be carried out in accordance with guidelines adopted by the European Commission.
(6) the drug agency is involved at the request of the European Commission, the European Medicines Agency or Member State concerned in carrying out inspections under paragraph 1. 3 in the European Union or in third countries.
(7) drug agency cooperates and exchanges information with the European Medicines Agency in planning and carrying out inspections under paragraph 1. 3. "
"(8) drug agency cooperates with the European Medicines Agency in coordinating the inspections in third countries."
§ 100. Create art. 269 and 270, (b) and 269 in:
"Art. 269. (1) the officials under art. 267, para. 3 prepare a report on each inspection carried out under art. 269, para. 3 and 4, for the observance of the principles and guidelines of good manufacturing practice or good distribution practices, or to comply with the requirements of chapter eight, as well as the requirements of this Act.
(2) the report referred to in paragraph 1. 1 shall provide the inspected person may submit comments on it.
(3) on receipt of a reasoned request the FDA sent electronically the reports referred to in para. 1 to the competent authority of another Member State or of the European Medicines Agency.
Art. 269 (b). (1) where, as a result of inspection under art. 269, para. 3 conformity with good manufacturing practice, good distribution practices, respectively, where applicable, the BDA issue to the manufacturer, importer or wholesaler a certificate for good manufacturing practice, respectively good distribution practice certificate within 90 days of the completion of the inspection.
(2) where, as a result of inspection under art. 269, para. 3 it is established that the manufacturer, the importer or the retailer of medicinal products or of active substances does not conform to the requirements of the law and/or the principles and guidelines of good manufacturing practice and/or good distribution practices, the FDA issued an opinion of non-compliance.
(3) the drug agency introduces the database under art. 147 certificates issued under para. 1 and information under para. 2. Art. 269 in. (1) where, as a result of inspection under art. 270, para. 1, item 5, it is established that the holder of the authorisation for use does not conform to the requirements of chapter eight, gives the FDA requirements for the removal of disparities.
(2) in the cases referred to in para. 1 Member States notify the FDA, the European Medicines Agency and the European Commission. "
§ 101. In art. 270 following amendments and supplements shall be made:
"1. the access to all documents relating to the subject matter of the inspection, as well as documents related directly or indirectly to the violation of this law or the laws of the Member States implementing the requirements of Directive 2001/83/EC, regardless of the form of the document;"
"2. to inspect manufacturing and trading establishments of manufacturers of medicinal products, active or excipients, as well as the laboratories used by holders of a permit to manufacture or import;"
in point 5) shall be replaced by the following:
"5. to inspect the premises, records and documents system pharmacovigilance of the holder of the marketing authorisation or persons carrying out the assigned activities under Chapter eight;"
d) a new item 6:
"6. to carry out a check on compliance with the approved prices, marginal prices or the prices recorded on the sale of medicinal products;"
(e)) the current item 6 becomes item 7.
"(4) the President of the Council under art. 258, para. 1 has the right to order in writing to the offender to cease the infringement established in the examination under paragraph 1. 1, item 6. "
§ 102. In art. 272, para. 1 make the following amendments and additions:
1. In paragraph 1, after the words "medicinal products" "is added and the active substances, as well as of good distribution practices.
2. paragraph 2 shall be inserted: ' 2A. deleted from the register persons engaged in brokerage activity with medicinal products, in the event of non-observance of the obligations under art. 212 b. "
3. In item 5 and the word "false" is replaced by "falsified".
§ 103. Art is created. 272:
"Art. 272. (1) with delegated acts under art. 52 (b) (2) of Directive 2001/83/EC shall lay down the necessary measures to prevent the putting into circulation of medicinal products entering the European Union, but not intended for placing on the market of the European Union, for which there are reasonable grounds for suspicion that they are counterfeit.
(2) the drug agency will take the necessary measures in accordance with the delegated acts referred to in para. 1 to prevent the putting into circulation of medicinal products entering the European Union, but not intended for placing on the market of the European Union, for which there are reasonable grounds for suspicion that they are counterfeit.
(3) the Customs authorities shall notify the FDA about the entry into the territory of the Republic of Bulgaria of medicinal products under para. 1 with a view to the adoption of measures referred to in paragraph 1. 2. "
§ 104. In art. 276 following amendments and supplements shall be made:
1. Create? 6 a and 6 b: ' 6a. does not fulfil the conditions under art. 55A, 56A or 56, or 6 (b). the manufacture of the medicinal product has not been made in accordance with the production method described under art. 27, al. 1, item 7, or ".
7. control tests have not been carried out or they are not carried out in accordance with the methods referred to in art. 27, al. 1, item 8, or ".
§ 105. In art. 277, para. 1 is hereby amended as follows:
1. In paragraph 1 the words "proper use" are deleted.
2. In paragraph 3 the words ' proper use ' shall be deleted.
§ 106. In art. 281, para. 1, the words ' counterfeit medicinal products or "shall be deleted.
§ 107. In art. 284, para. 2 the words "false as well as medicinal products" shall be deleted.
§ 108. Create art. 284, 284 b and 284 in:
"Art. 284. To produce, import, export, store, sell or provide falsified medicinal products and mediate in the purchase and sale of counterfeit medicinal products is punishable by a fine of 25 000 to 50 000.
Art. 284 (b). The holder of the manufacturing authorization that does not fulfill his obligations under art. 160, is punished with a proprietary sanction from 5000 to 10 000 BGN, and for engaging in the same violation – with a proprietary sanction from 10 000 to 20 000.
Art. 284. the holder of the authorisation for wholesale trade in medicinal products, which do not comply with its obligations under art. 207, is punished with a penalty from 2000 to 5000 BGN, and for engaging in the same violation – with a proprietary sanction from 5000 to 10 000 LEVs. "
§ 109. In art. 285 and the words "art. 262 (a) ' shall be replaced by "art. 264 "and the word" fine "is replaced by" penalty ".
§ 110. Art is created. 285 (b): "art. 285 b. who produced, imported, exported, sold, or kept active substances in violation of the requirements established by this Act, is punishable by a fine of 10 000 to 20 000 LV. "
§ 111. Art is created. 287 (b): "art. 287 b. Who does the trading of medicinal products over the Internet in violation of the requirements of this law and of the Ordinance under art. 234, para. 5, is punishable by a fine of 5000 to 10 000 LEVs. "
§ 112. In art. 289 following amendments and supplements shall be made:
1. In paragraph 8. 2 the words "art. 258, para. 5 ' shall be replaced by "art. 261, para. 5. "
"(3) Offences under paragraph 1. 1 and 2 shall be laid down by legislation, made up of officials appointed by the President of the Council under art. 258, para. 1, and the penal provisions shall be issued by the President of the Council under art. 258, para. 1 authorized by him or a member of the Council. "
§ 113. In art. 289, para. 1 the words "under art. 261, para. 1, item 4 "shall be replaced by" art. 259, para. 1, item 4.
§ 114. Create art. 290 c, 290, 290 (d) (e) and 290 is:
"Art. 290. the holder of a permit for use, which held neintervencionalni studies in violation of this law, shall be punished with a proprietary sanction from 5000 to 10 000 BGN, and for engaging in the same violation – with a proprietary sanction from 10 000 to 20 000.
Art. 290. The holder of an authorisation for use, which does not fulfil the conditions under art. 55A, 56A and 56B, is punished with a proprietary sanction from 5000 to 10 000 BGN, and for engaging in the same violation – with a proprietary sanction from 10 000 to 20 000.
Art. 290 e. Holder for permission to use that does not comply with the obligations under art. 190-192, 193, 194, b in 194 h and 194 and is punishable with a proprietary sanction from 5000 to 10 000 BGN, and for engaging in the same violation – with a proprietary sanction from 10 000 to 20 000.
Art. 290. The holder of an authorisation for use, which does not fulfil the obligations referred to in art. 193 and 194, is punished with a penalty from 2000 to 5000 BGN, and for engaging in the same violation – with a proprietary sanction from 5000 to 10 000 LEVs. "
§ 115. In art. 291 words "art. 281-287 "are replaced by" article. 281-284, 285, 285 (b), art. 286, para. 1, art. 287 and 288 (b) ".
§ 116. In art. 293 the following modifications are made: 1. Paragraphs 1 and 2 shall be read with the following adaptations:
(1) failure to comply with the conditions under which the authorisations are issued/production, import certificates, parallel import, wholesale and retail trade in medicinal products in the pharmacy, as well as in the cases under art. 281, para. 1 – 3 and art. 283, para. 1 Executive Director of BDA issued an order for their withdrawal.
(2) upon failure to comply with the conditions under which a certificate for registration of drugs, as well as in the cases under art. 287, para. 3 Director of the RZI issued an order for the revocation of the certificate. "
2. in the Al. 4, the words "Minister of health" shall be replaced by the words "the Executive Director of the BDA.
§ 117. In the additional provisions the following amendments and additions:
1. In paragraph 1: (a)) point 1 shall be replaced by the following: "1." active substance "means any substance or mixture of substances intended for use in the manufacture of a medicinal product, which when used in its production are becoming an active ingredient in this product, intended for the exercise of the pharmacological, immunological or metabolic action in order to restore, correct or modify physiological functions or to making a medical diagnosis. ';
(b) in item 27) and the word "high-tech" is replaced by "modern";
in) point 41 shall be replaced by the following: "41." Adverse drug reaction "means any unforeseen and unintended responses to a medicinal product. In the case of a clinical trial – each unwanted and unexpected responses to an investigational medicinal product, regardless of the applied dose. The types of adverse drug reactions are:
a) "unexpected" adverse drug reaction – which is not mentioned in the summary of product characteristics or the nature, severity or outcome of which comply with those set out not in the summary of product characteristics; in the case of a clinical trial is a side effect, whose nature, severity or outcome does not match the information for testing medicinal product referred to in the investigator's brochure;
(b)) "suspected" – a side effect of which s″obŝitelât or the holder of the authorisation to use suggests that there is a possible causal relation to acceptances medicinal product;
c) "serious" – any adverse effect on health status, that has become the cause of mortal issue, immediate danger to the life, hospitalization or extension of hospitalization, significant or permanent damage, disability and congenital abnormalities;
d) combinations of reactions in letters "a", "b" and "c". ";
d) 42 t. is created:
"42." the system of pharmacovigilance "is a detailed description of the pharmacovigilance, used by the holder of the permit for use in respect of one or more authorised medicinal products. ';
(e)) is created that 43A: "43." Risk management plan "means a detailed description of the risk management system.";
is) point 46 is amended as follows:
"46." excipient "means any ingredient of the medicinal product, other than active substance and packaging material.";
(g)) is created that 47A:
"47A." Mediation in the field of medicinal products ': means all activities aimed at the conclusion of a contract for the purchase or sale of medicinal products, with the exception of wholesale trade that do not involve physical holding, which are expressed in bargaining and independently on behalf of another legal or natural person. ";
h) section 48 is amended as follows: ' 48. " Postmarketingovo study for safety "is any study related to authorised medicinal product conducted in order to identify, characterize, or determine the degree of risk in terms of safety, to confirm the safety profile of the medicinal product or to assess the effectiveness of risk management measures.";
and so on are created) 69 and 69 (b): "69." Risk management system "is a system of measures and activities for pharmacovigilance, designed to identify, characterise, prevent or minimise risks relating to medicinal product, including an assessment of the effectiveness of those activities and measures.
69 b. "pharmacovigilance system" is the system used by the holder of an authorisation for use and implementation by the FDA of the tasks and responsibilities under Chapter eight, designed for carrying out surveillance of the safety of medicinal products authorised for use and to detect any change in the risk-benefit balance. ";
(k)) is created that 75 and:
"75." substantial change in the Protocol of the study ' postmarketingovo neintervencionalno are changes that affect the safety, physical or mental integrity of patients or study results and their interpretation. ";
(l) paragraph 81) (a) shall be replaced by the following: "81." Falsified medicinal product: any medicinal product which are presented false: a) its identity, including the data on the primary or the secondary packaging, its name or the content with respect to any of its ingredients, including excipients, and the quantity of the active substance in the unit dose;
(b)), its source, including the manufacturer, the country where it was produced, the State in which it is placed on the market or the holder of the authorisation for use, or in history), including the records and documents relating to the supply chain.
It is not considered falsified medicinal product with such unintentional admitted tolerances in quality, as well as medicinal pordukt which is placed on the market in violation of the rights of intellectual property. ";
m) that is created: 92
"92." delegated Act "is an act within the meaning of art. 290 of the Treaty on the functioning of the European Union. "
2. In paragraph 5 (a), para. 1 the words "the Committee on pricing and reimbursement" are replaced by "the National Council for pricing and reimbursement of medicinal products".
§ 118. This law introduces the requirements of Directive 2010/84/EC of the European Parliament and of the Council of 15 December 2010, amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OB, L 348/74 of 31 December 2010) and directive 2011/62/EC of the European Parliament and of the Council of 8 June 2011, amending Directive 2001/83/EC on the code on the Community code relating to medicinal products for use in preventing the entry into the legal supply chain (OB, L 174/74 from 1 July 2011).
§ 119. (1) After 2 January 2013. manufacturers, importers and wholesalers of active substances submitted to the FDA by March 2, 2013 applications and documents for recording in accordance with art. 167 (b).
(2) producers and importers that are produced or imported active substances on the basis of the licences issued to 2 January 2013 manufacturing/importation, do not pay a fee for entry in the register under art. 167.
(3) to 2 March 2013 persons under para. 2 carry out activities of production and import of active substances on the basis of their issued permits to manufacture/import.
§ 120. The persons who conduct mediation in the field of medicinal products and had 2 January 2013, register under the conditions and by the procedure of art. 212A within March 2, 2013.
§ 121. Initiated prior to the entry into force of this law, the procedures for the authorisation of use is completed under the conditions and by the procedure provided for therein.
§ 122. (1) the holders of the authorisations of use do not apply the risk management system referred to in art. 192, para. 1, item 2, in the case of medicinal products which have been granted permissions for use before 21 July 2012, except in the cases referred to in para. 2. (2) the drug agency may impose an obligation on the holder of the permit for use to create and implement a risk management system, when it considers that for a given medicinal product there is a concern that may affect the benefit/risk ratio. In this case, the FDA required by the marketing authorisation holder to submit a detailed description of the risk management system, which intends to introduce for the medicinal product concerned.
(3) in the cases referred to in para. 2 notify the FDA the holder of the marketing authorisation, stating the grounds for the imposition of the obligation and the deadline for submission of the detailed description of the risk management system.
(4) within 30 days of receipt of the notification under paragraph 1. 3 the holder of a marketing authorisation may request the FDA providing the opportunity for the presentation of information concerning the obligation under paragraph 1. 2. (5) After receipt of a request under paragraph 1. 4 the FDA set a time limit for the submission of information by the holder of the marketing authorisation.
(6) on the basis of the information the FDA can confirm the obligation under paragraph 1. 2 or to cancel it.
(7) drug agency shall inform the holder of the decision taken under paragraph 1. 6. (8) When the FDA confirmed the obligation, Executive Director officially issued change in permission to use by including it as a condition imposed obligation under para. 2. § 123. Holders of authorisations for the use of medicinal products issued before 21 July 2012, to comply with the obligation under art. 192, para. 1. with effect from 1 July 21, 2015 or the date of the renewal of the authorisation for the use of the medicinal product concerned, depending on which of the two dates will occur earlier.
§ 124. Initiated prior to the entry into force of this law shall be in neintervencionalni survey completed current order.
§ 125. (1) until the time limit under art. 2, item 3 of Directive 2010/84/EU authorisation holders send reports of serious adverse reactions occurring in the territory of the Republic of Bulgaria, to the FDA and the European Medicines Agency within 15 days of receipt.
(2) drug agency checks the fulfilment of the obligation under paragraph 1. 1. (3) where the message relates to a serious adverse drug reaction occurring in the territory of a third State, holders of authorisations for use within the time limit referred to in paragraph 1. 1 shall communicate to the European Medicines Agency.
§ 126. (1) the holders of the authorisations of use submitted to FDA periodic safety update reports in accordance with the time intervals under art. 194 k, al. 3 for medicinal products, which use permits issued before 21 July 2012 and for which the frequency and dates of submission of periodic safety update reports are not listed as conditions in the authorization for use.
(2) the provisions of para. 1 applies to the determination of another frequency or other dates of submission of the reports in the authorisation or the determination of dates and frequency according to art. 194 l – 194.
§ 127. (1) the holders of the authorisations of use provide periodic safety update reports referred to in art. 194 h, para. 1 in the register under art. 194 h, para. 3 after the expiry of 12 months from the date on which the European Medicines Agency announced its operation.
(2) until the time limit referred to in paragraph 1. 1 authorisation holders submit periodic safety update reports to the FDA and regulatory authorities of the other Member States in which the medicinal product is authorised.
§ 128. Holders of a permit/certificate for retail trade in medicinal products in the pharmacy or drug store under art. 234, para. 5 fit the website logo under art. 234, para. 6 within one year from the date of publication of the Act referred to in art. 85 c (3) of Directive 2001/83/EC.
§ 129. Drug agency carried out the first audit of the system under art. 183, para. 1 and sent to the European Commission a report with the results no later than 21 September 2013.
§ 130. (1) until March 20, 2013 ongoing and outstanding procedures before the Committee on pricing and reimbursement of completed her on previous row.
(2) After 1 April 2013 nepriklûčilite procedures before the Committee on pricing and reimbursement is completed by the National Council for pricing and reimbursement of medicinal products under the conditions and in accordance with this law.
(3) no later than 31 March 2013 Committee on pricing and reimbursement grants to National Council on pricing and reimbursement of medicinal products with a protocol applications and documents submitted to the procedures under paragraph 1. 1, as well as the archives of closed procedures.
(4) no later than 31 March 2013 Committee on pricing and reimbursement grants to National Council on pricing and reimbursement of medicinal products with the Protocol by the Commission registers.
§ 131. (1) until March 20, 2013. the fees for the submission of applications for the approval of prices/price caps, registering the prices of medicinal products for inclusion, exclusion or modification of medicinal products in a positive list of medicines are collected by the Ministry of health at the rates set out in the tariff referred to in art. 21, para. 2.
(2) data collected up to March 20, 2013 funds under para. 1 is spent on the activities of the Committee on the pricing and reimbursement of the transparency.
§ 132. Within three months of the entry into force of this law the Council of Ministers shall, on a proposal from the Minister of health:
1. determine the President and members of the National Council on pricing and reimbursement of medicinal products;
2. adopts the rules of procedure of the National Council on pricing and reimbursement of medicinal products.
§ 133. (1) within two months of the entry into force of this law the Council of Ministers amended the tariff referred to in art. 21, para. 2.
(2) no later than 1 April 2013, the Council of Ministers shall adopt Ordinance referred to in art. 261, para. 5.
§ 134. Obligations under art. 159, para. 4, art. 168, para. 8, art. 168A and 168 (b) begin to be implemented three years after the date of publication of the delegated acts referred to in art. 54 (a) of Directive 2001/83/EC in the official journal of the European Union.
§ 135. 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, PC. 9, 60, 99 and 100 by 2011, issue. 38, 60 and 94 by 2012.) the following modifications are made:
1. In art. 45:
(a)) in the Al. 9 the words "art. 262, para. 5, item 1 "shall be replaced by" art. 262, para. 6, item 1 ";
(b)) in the Al. 10 the words "art. 262, para. 5, item 1 "shall be replaced by" art. 262, para. 6, item 1 ";
in) in the Al. 15, the words "article. 262, para. 5, item 1 "shall be replaced by" art. 262, para. 6, item 1 ";
(d)) in the Al. 18, item 1 the words "art. 262, para. 5, paragraph 2 "shall be replaced by" art. 262, para. 6, item 2. "
2. In art. 56, para. 1 the words "art. 262, para. 5, item 1 "shall be replaced by" art. 262, para. 6, item 1.
§ 136. 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, PC. 8, 9, 45 and 60 by 2011, and St. 38, 40, 54, 60 and 82 by 2012.) in art. 116 (b), para. 1, item 4 and the words "art. 261, para. 1, item 4 "shall be replaced by" art. 259, para. 1, item 4.
§ 137. 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 of 2010; Corr, PCs. 23 of 2010; amend., SG. 29, 59 and 98 of 2010 and PC. 8, 12, 60 and 61 by 2011 and PCs. 83 by 2012.) the following modifications are made:
1. In art. 16, al. 3 the words "Directorate" narcotic drugs "which is a link in the ' shall be deleted.
2. In art. 17, al. 1 the words "drugs" shall be replaced by "in the specialized administration of the Ministry of health.
3. In art. 32A:
(a)) in the Al. 6 the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ";
(b)) in the Al. 8 the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ";
in) in the Al. 10 the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
4. In art. 33 a, para. 5, the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
5. In art. 47, para. 1 the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
6. In art. 48, para. 2 the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
7. In art. 59:
(a)) in the Al. 2 the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration of the Ministry of health ";
(b)) in the Al. 3 in the text before item 1 the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
8. In art. 65 words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
9. in art. 65 and the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
10. In art. 65 b, para. 2 and 4, the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
11. in art. 65 in the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
12. in art. 65 (d), the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
13. in art. 66 words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
14. In art. 77 words "Directorate" drugs ", acting as a special administration" shall be replaced by the "specialized administration".
15. in art. 95, para. 3 the words "Directorate" narcotic drugs "shall be replaced by the" specialized administration ".
§ 138. The law shall enter into force on the day of its publication in the Official Gazette with the exception of:
1. paragraph 9, item 1 (a), § 36, § 29 – 38 – 43, § 44 on art. 167, 167 b, c, d 167 167 167, (e), art. 167, para. 1 and al. 2, paragraph 1 and article. § 167 h, 65-76, § 98, paragraphs 1 and 2, § 101, paragraph 1, letters "a" and "b", § 102, 103, 106-108, 111, 116, 117, § 1, letter "a", "e", "g" and "l", which shall apply from 2 January 2013;
2. paragraphs 20 and 117, paragraph 2, which shall apply from 1 April 2013;
3. paragraph 44 on art. 167, para. 2, item 2, and para. 3 and art. 167 (g), which shall enter into force on 2 July 2013.
The law was adopted by 41-Otto National Assembly on 11 December 2012 and is stamped with the official seal of the National Assembly.
2011 Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsi