ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of January 23, 2018 No. 49

About approval of Rules of realization of biomedical cellular products

According to part 8 of article 35 of the Federal law "About Biomedical Cellular Products" Government of the Russian Federation decides:

Approve the enclosed Rules of realization of biomedical cellular products.

Approved by the Order of the Government of the Russian Federation of January 23, 2018 No. 49

Rules of realization of biomedical cellular products

1. These rules determine procedure for realization of biomedical cellular products.

2. The realization of biomedical cellular products is enabled by producers of biomedical cellular products on paid and (or) non-paid basis to the following subjects of the address of biomedical cellular products:

a) other producers of biomedical cellular products - for production of biomedical cellular products;

b) the scientific organizations, the educational organizations - for carrying out scientific research;

c) the organizations performing medical activities.

3. The realization of biomedical cellular products is enabled based on the agreements signed according to the Civil code of the Russian Federation producers of biomedical cellular products with the subjects of the address of biomedical cellular products specified in Item 2 of these rules.

4. In case of realization of biomedical cellular product the producer of biomedical cellular product represents to the subject of the address of biomedical cellular products specified in Item 2 of these rules, on paper or in electronic form:

a) the specification on biomedical cellular product;

b) data on state registration of biomedical cellular product;

c) instruction for application of biomedical cellular product.

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