Name of law Law amending and supplementing the law on medical devices Named Bill a bill amending and supplementing the law on medical devices date of acceptance 03/07/2012 number/year Official Gazette 54/2012 Decree No 260

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

I DECLARE:

To be published in the Official Gazette the law amending and supplementing the law on medical devices, adopted by the National Assembly of the HLI July 3, 2012.

Issued in Sofia on 9 July 2012.

The President of the Republic: Rosen Plevneliev

Stamped with the State seal.

Minister of Justice: Diana Kovatcheva

LAW

amending and supplementing the law on medical devices (official SG. 46 2007; amend., 110/2008, no. 41 and 82 from 2009, no. 98 of 2010 No. 39 and 60 by 2011)

§ 1. In art. 1, al. 1, item 5, the words "wholesale" shall be deleted.

§ 2. In art. 6 is hereby amended as follows:

1. In paragraph 3, the words "or certificates ' shall be deleted.

2. In paragraph 5, the words "wholesale" shall be deleted.

§ 3. Article 77 is amended as follows:

"Art. 77. (1) the wholesale trade of medical devices in the territory of the Republic of Bulgaria can perform natural or legal persons registered as traders under the commercial law or under the legislation of another Member State or of another State party to the agreement on the European economic area or Switzerland, the Swiss, who has been granted permission for the wholesale trade of medical devices by the FDA or other document certifying their right to trade with medical devices issued by the competent authority of the State concerned.

(2) manufacturers, established in the territory of the Republic of Bulgaria, may carry out commercial transactions with the products manufactured by them without the document referred to in paragraph 1. 1. "

§ 4. Article 78 is amended as follows:

"Art. 78. (1) the natural or legal persons, registered under the commercial law or under the legislation of another Member State or of another State party to the agreement on the European economic area or Switzerland, the Swiss, who want to get permission for the wholesale trade of medical devices, the FDA filed in the sample application, approved by the Executive Director of the BDA, which apply :

1. the UIC data of persons registered under the commercial law, and for persons registered in another Member State or in another State party to the agreement on the European economic area or Switzerland – the Swiss evidence commercial registration;

2. a list of the categories of medical devices in accordance with the nomenclature system BS EN ISO 15225 for categorization of medical devices and their respective manufacturers of paper and magnetic media;

3. a document for paid fee fixed by the tariff referred to in art. 7, para. 1.

(2) where the premises for the storage of medical products on the territory of the Republic of Bulgaria, the persons referred to in para. 1 as stated in the application and their address. In this case, to the documentation under para. 1 shall apply:

1. a declaration that:

a) premises for the storage of medical devices referred to in the list under para. 1, item 2, depending on the specificity and the manufacturer's instructions set out in the instructions for use, and

(b)) hold or have transport, ensuring their proper storage in distribution and transportation;

2. information on the name, permanent address and address for correspondence with the person assigned to the Manager of the storage facilities and marketing of medical devices, as well as a copy of the contract, on the basis of the relationship with the applicant. "

§ 5. Art is created. 78A:

"Art. 78. When the persons under art. 77 possess a document certifying their right to carry out the wholesale trade of medical devices issued by a competent authority of another Member State or of another State party to the agreement on the European economic area or Switzerland, the Swiss, and premises for storage of medical products on the territory of the Republic of Bulgaria, presented at the FDA:

1. form of notification in a form approved by the Executive Director of the BDA;

2. a copy of the document certifying their right to carry out wholesale, accompanied by a translation into Bulgarian language;

3. a list of the categories of medical devices in accordance with the nomenclature system BS EN ISO 15225 for categorization of medical devices and their respective manufacturers of paper and magnetic media;

4. the documentation referred to in art. 78, para. 2. "

§ 6. Article 79 shall be amended as follows:

"Art. 79. (1) the drug agency checks the documentation under art. 78 and 78a. Upon finding shortcomings in the FDA's documentation shall notify the applicant and give a time limit for their removal.

(2) the Executive Director of BDA, within 30 days of the date of submission of the documentation referred to in art. 78 issue permission for the wholesale trade of medical devices of the persons under art. 78, para. 1 the data on their premises for storage and trade and that the list of categories of medical devices shall be entered in the register under art. 81. (3) the time limit referred to in paragraph 1. 2 stops to run from the date of the notification under paragraph 1. 1 to remove the limitations.

(4) drug agency within 7 days of notification under art. 78 and entered in the register under art. 81 the data from notification. "

§ 7. Article 80 shall be amended as follows:


"Art. 80. (1) in the event of a change of address of the storage facilities and marketing of medical devices in the territory of the Republic of Bulgaria the persons under art. 78 submitted to the FDA application for change of authorization under art. 79, para. 2 a the persons under art. 78A – notification of the change. The application or notification shall apply the change documentation and document for paid fee for persons under art. 78 in the amount fixed by the tariff referred to in art. 7, para. 1. (2) the application or notification of change shall be submitted within 7 days after making the appropriate changes.

(3) the persons referred to in para. 1 notify the FDA within 7 days after making the change of legal status, registered office and/or address of the administrator and/or in the event of a change in the person of art. 78, para. 2, item 2, and/or change the list of types of medical devices, with whom he traded. To notification applies the associated with the change documentation.

(4) the Executive Director of the BDA issue permission to change the authorization under art. 79, para. 2 within 14 days from the date of submission of the documentation referred to in paragraph 1. 1.

(5) the drug agency recorded in the register under art. 81 change in circumstances under para. 1 and 3 in 7 days of the issuance of the authorization for change, respectively of the notification of the change. "

§ 8. Art is created. 80 and:

"Art. 80. (1) the persons under art. 78 and 78A within 10 days after the termination of its activities relating to the marketing of medical products on the territory of the Republic of Bulgaria shall inform in writing the Executive Director of the BDA.

(2) in the cases referred to in para. 1 BDA's Executive Director by order revoke the authorization under art. 79, para. 2. Drug Agency within 7 days of issuance of the order for termination of the authorisation entered in the register under art. 81 date of termination of the authorisation of the seller under art. 78.

(3) the drug agency recorded in the register under art. 81 date of termination of the activity of the persons under art. 78. "

§ 9. In art. 81 following amendments and supplements shall be made:

1. In the text before point 1, the words ' issued certificates or permits to wholesale medical products "shall be replaced by" persons under art. 78 and 78A ".

2. point 1 shall be amended as follows:

"1. the number and date of the authorization for wholesale trade of medical devices for the persons under art. 78; ".

3. In paragraph 2, the words "article. 77 "are replaced by" article. 78 and 78A ".

4. In paragraph 3 the words "permits or certificates referred to in paragraph 1" shall be replaced by "authorization under art. 79, para. 2. "

5. In paragraph 4, the words "and wholesale" are replaced by "of".

6. In paragraph 5, the words "paragraph 4" shall be replaced by ' section 2 '.

7. Point 6 is replaced by the following:

"6. a list of the categories of medical devices that carry trade; '.

8. a point 7:

7. changes in the scheduled circumstances. "

§ 10. In art. 82 following amendments and supplements shall be made:

1. In paragraph 8. 1:

and before that) the text shall be amended as follows: 1 "traders with medical devices that carry out trade in the territory of the Republic of Bulgaria, are required to deal only with medical devices, of which the expiration date has expired and have not:";

(b)) shall be item 1 (a):

"1a. the marked lot/serial number on the packaging, where appropriate;".

2. in the Al. 2, the words "under art. 78, para. 2 "are replaced by" medical devices storage when equipped with such ".

3. Paragraphs 3, 4 and 5 be amended thus:

"(3) wholesalers with medical devices provide and maintain a documented system for monitoring the safety of medical devices placed on the market, and for blocking and withdrawal from the market of medical devices, showed non-compliance with the safety requirements within the meaning of chapter seven.

(4) To the Al. 3 store the batch certificates of medical devices for a period of 5 years and shall be made available on request to the officials referred to in art. 86, para. 2.

(5) the persons referred to in para. 1 are obliged to store medical devices expired, blocked and/or medical devices withdrawn for a place with permanent alarm indication to the manufacturer or to their destruction. "

§ 11. Article 83 shall be amended as follows:

"Art. 83. (1) the persons under art. 77 may carry out commercial transactions with the medical devices subject to requirements for their storage and distribution with:

1. other wholesalers within the meaning of this Act;

2. medical institutions under the law on hospitals and veterinary hospitals under the animal health activities;

3. health establishments under art. 21, para. 2, item 1, 3 and 4 and al. 3 of the law on health;

4. the veterinary pharmacies;

5. drug stores;

6. persons engaged in the provision of assistive devices, gadgets and equipment, and medical devices for people with disabilities under the law on integration of people with disabilities;

7. holders of commercial sites that offer defined by order of the Minister of health or authorized by him Deputy Minister medical devices;

8. communities, public authorities and public institutions that carry out procedures for the award of public contracts for the supply of medical devices;

9. educational establishments;

10. persons who are in the process of building and equipping the future medical and health institutions, after receipt of a building permit in accordance with the law on spatial planning.

(2) the Minister of health shall determine by order the medical devices that can be sold in outlets under para. 1, item 7.

§ 12. Art is created. 83 (b):

"Art. 83 (b) (1) the persons under art. 78 and 78A support information and keep records of:


1. bought and sold quantity by type of medical device, date of purchase and sale, inventory, lot number and expiry date;

2. the name and address of the management of individuals, of which are bought and who sold medical devices;

3. the number and date of issue of the document certifying the right to carry out the wholesale of the persons under art. 77, and information identifying the authority which issued the document.

(2) the persons under art. 83, para. 1.3-5 and 7-10 support information for:

1. the quantity purchased by types of medical devices, date of purchase and sale, inventory, lot number and expiry date;

2. the name and address of the management of the person referred to in art. 77, of which have purchased medical devices and the data referred to in para. 1, item 3.

(3) the persons under art. 83, para. 1, 2, and 6 support information for:

1. the quantity purchased by types of medical devices, date of purchase, inventory, lot number and expiry date;

2. the name and address of the management of the person referred to in art. 77, of which have purchased medical devices and the data referred to in para. 1, item 3;

3. the person to whom they have granted/applied medical device/products. "

§ 13. Article 84 shall be amended as follows:

"Art. 84. (1) the officials under art. 86, para. 2 planned and carried out unannounced inspections at the premises for the storage and distribution of medical devices.

(2) officials under para. 1 may require, verified and make copies of the documentation referred to in art. 82, para. 3 and under art. 83 (b), and to take samples and samples of the products under the conditions set out in art. 93, para. 3. (3) where, on examination, it is established that medical devices do not meet the requirements of art. 82, para. 1, item 1, 1A, 2, or 3, or are expired, the Executive Director of the BDA ordering with order blocking and withdraw devices from the market and/or their destruction.

(4) in order to establish inconsistencies of the storage facilities and trading with the requirements laid down by the manufacturer for the product, officials at al. 1 give instructions and deadline for their removal.

(5) where, on examination, it is established that in the system of art. 82, para. 3 or in the documentation under art. 83 (b) there are gaps or inaccuracies, officials at al. 1 give instructions and deadline for their removal.

(6) where the discrepancies, incompleteness or inaccuracies not corrected within the time limits referred to in paragraph 1. 4 and 5, officials at al. 1 comment to the Executive Director of the BDA with proposal for withdrawal of the marketing authorisation for wholesale, for the persons under art. 78A – deletion from the register under art. 81 and the closure of their premises for storage and trade.

(7) the orders of the Executive Director of the BDA in al. 3 and 6 may be appealed pursuant to the administrative code, an appeal shall not suspend implementation. "

§ 14. Article 85 shall be replaced by the following:

"Art. 85. The Bulgarian drug agency shall inform the regulatory authority of the other Member State or of the other State party to the agreement on the European economic area or the Swiss Switzerland which issued the document certifying the right to carry out the wholesale trade of medical devices, for breaches in the wholesale trade of medical devices in the territory of the Republic of Bulgaria and provide information upon request to the persons under art. 78. "

§ 15. Article 89 shall be amended as follows:

"Art. 89. The persons under art. 86, para. 2 carry out checks at the premises of art. 83, para. 1, 2-7, as well as in the production premises and the premises for the storage and marketing of medical devices under art. 78, para. 2 and art. 78. "

§ 16. In art. 104, para. 1 the words "under art. 83, para. 1, 2 and 3 ' shall be replaced by "referred to in art. 83, para. 1, item 2 relating to medical institutions in the medial institutions act ".

§ 17. In art. 112, para. 2, item 2, the words "under art. 83, para. 1, 2 and 3 ' shall be replaced by "referred to in art. 83, para. 1, item 2 relating to medical institutions in the medial institutions act ".

§ 18. In art. 129 creates al. 3: "(3) the head of a medical or health institution that buys medical devices by persons without authorisation or other document certifying the right to carry out trade in medical products, issued by a competent authority of a Member State or of another State party to the agreement on the European economic area or the Swiss Switzerland, be fined 10 000 LV."

§ 19. In art. 131 words "wholesale" shall be deleted.

§ 20. In art. 132 words "wholesale" shall be deleted.

§ 21. Article 134 is amended as follows:

"Art. 134. Carrying out wholesale trade of medical devices without owning a document certifying his or her right to exercise this activity, shall be punished with a penalty amounting to EUR 10 000. "

§ 22. Art is created. 134 (a):

"Art. 134. Wholesaler with medical devices that does not fulfill the obligation of art. 78A, shall be punished with a penalty amounting to EUR 10 000. "

§ 23. In art. 135, after the words "para. 1 "insert" or 3 ".

§ 24. In art. 136 the words "art. 80, al. 5 ' shall be replaced by "art. 80 a, para. 1. "

§ 25. Article 138 shall be amended as follows:

"Art. 138. Who does the retail sale of medical devices outside health care facilities under art. 21, para. 2, item 4 and al. 3 of the Act on health and/or out of the objects of art. 83, para. 1, item 4-7, is punishable by a fine or penalty payment in the amount $10 000.

§ 26. Art is created. 138 (a):

"Art. 138. A medical device that violates the requirements of art. 83 (b), shall be punished with the penalty payment in the amount $1000. "

§ 27. In § 1 of the additional provisions so 36 and 37 shall be amended as:

"36." retail "means all activities by acquiring, storing and sale of medical devices.


37. "wholesale" means all activities to the acquisition, storage, supply, import or export of medical devices for the purpose of sale, except in the case of provision of medical devices directly to the population. "

Transitional and final provisions

§ 28. Applications for permits or certificates for the wholesale trade of medical devices submitted to the entry into force of this law shall be dealt with under the conditions and by the procedure provided for therein.

§ 29. 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 of 2011.) make the following changes and additions:

1. an art. 82 (b):

"Art. 82. (1) (b) tissue establishments for hospital care are required to provide the necessary treatment to patients for their medical devices.

(2) medical devices under para. 1 are provided through hospital pharmacies at the hospitals for hospital care.

(3) where the medical device under para. 1 shall not be paid by the national health insurance fund or from the State budget, patients must pay them at the prices at which the hospital has purchased them. "

2. In art. 86:

(a)) in the Al. 2 section 2 is amended as follows:

"2. on the security of the hospital for hospital care necessary for treating his medical devices when they are not paid for by the national health insurance fund or from the State budget;"

b) paragraph 3 shall be amended as follows:

"(3) in the cases referred to in para. 2, item 2 medical devices shall be provided and paid for by the procedure of art. 82 (b). "

The law was adopted by 41-Otto National Assembly on 3 July 2012 and is stamped with the official seal of the National Assembly.

President of the National Assembly Tsetska Tsacheva:

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