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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of June 14, 2017 No. 706

About approval of Rules of destruction of counterfeited biomedical cellular products, poor-quality biomedical cellular products and counterfeit biomedical cellular products

According to article 38 of the Federal law "About Biomedical Cellular Products" Government of the Russian Federation decides:

1. Approve the enclosed Rules of destruction of counterfeited biomedical cellular products, poor-quality biomedical cellular products and counterfeit biomedical cellular products.

2. This resolution becomes effective from the date of its official publication.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of June 14, 2017 No. 706

Rules of destruction of counterfeited biomedical cellular products, poor-quality biomedical cellular products and counterfeit biomedical cellular products

1. These rules determine procedure for destruction of the counterfeited biomedical cellular products withdrawn in accordance with the established procedure from circulation, poor-quality biomedical cellular products and counterfeit biomedical cellular products (further - the withdrawn biomedical cellular products).

2. The withdrawn biomedical cellular products which are physical evidences on criminal cases and (or) on cases on administrative offenses are liable to destruction according to the procedure, established respectively by the Code of penal procedure of the Russian Federation and (or) the Russian Federation Code of Administrative Offences.

The withdrawn biomedical cellular products which are under customs procedure of destruction are liable to destruction according to the procedure, the established legislation of the Russian Federation on customs affairs.

3. Destruction of the withdrawn counterfeited biomedical cellular products or poor-quality biomedical cellular products is performed based on the decision of the owner of biomedical cellular products and (or) the decision of the Federal Service on supervision in health sector or the judgments.

4. The withdrawn counterfeit biomedical cellular products are liable to destruction by a court decision.

5. The decision of the Federal Service on supervision about destruction of the withdrawn counterfeited biomedical cellular products and (or) poor-quality biomedical cellular products contains in health sector:

a) data on biomedical cellular products (name, series, unit of measure), on their quantity, and also on container or packaging;

b) basis of destruction of biomedical cellular products;

c) term of destruction of biomedical cellular products;

d) the information about the owner of biomedical cellular products (complete and (if is available) the abbreviated name, including trade name, form of business of the legal entity, the address of its location, and also phone numbers and the e-mail address (in the presence);

e) the information about the producer of biomedical cellular products (complete and (if is available) the abbreviated name, including trade name, form of business of the legal entity, the address of its location, and also phone numbers and the e-mail address (in the presence).

6. The owner of the withdrawn counterfeited biomedical cellular products and (or) poor-quality biomedical cellular products in time who is not exceeding 30 working days from the date of receipt of the decision of the Federal Service on supervision in health sector about their destruction shall perform this decision.

7. Destruction of the withdrawn biomedical cellular products is performed with observance of requirements of the legislation in the field of environmental protection, the legislation in the sphere of health protection, and also the legislation in the field of ensuring sanitary and epidemiologic wellbeing of the population.

8. The expenses connected with destruction of the withdrawn biomedical cellular products are compensated by their owner.

9. Destruction of the withdrawn biomedical cellular products is confirmed by the act of destruction of biomedical cellular products in which are specified:

a) data about the withdrawn biomedical cellular products of the organization performing destruction or the individual entrepreneur (complete and (if is available) the abbreviated name, including trade name, form of business of the legal entity, the address of its location or surname, name and middle name (in the presence) of the individual entrepreneur, details of the document proving his identity, the residential address, and also phone numbers and the e-mail address (in the presence) of the legal entity or the individual entrepreneur);

b) the basis of destruction of the withdrawn biomedical cellular products (the judgment or the decision of the Federal Service on supervision in health sector) with indication of details of the relevant document;

c) data on the destroyed withdrawn biomedical cellular products (the name, series, unit of measure), their quantity, and also on container or packaging;

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