of August 25, 2017 No. 1015
About approval of Rules of accreditation of the medical organizations on the right of performing clinical trials of biomedical cellular products
According to part 7 of article 28 of the Federal law "About Biomedical Cellular Products" Government of the Russian Federation decides:
Approve the enclosed Rules of accreditation of the medical organizations on the right of performing clinical trials of biomedical cellular products.
Russian Prime Minister
D. Medvedev
Approved by the Order of the Government of the Russian Federation of August 25, 2017 No. 1015
1. These rules establish procedure for accreditation of the medical organizations on the right of performing clinical trials of biomedical cellular products (further - accreditation) for the purpose of:
a) establishments of safety and (or) portability of biomedical cellular products, including identifications of side effects in case of their application;
b) establishments of safety and efficiency of biomedical cellular products, including matching of optimum quantity (amount, weight, the area) biomedical cellular product and courses of treatment, for patients with certain diseases;
c) detection of features of interaction of biomedical cellular products with medicines, medical products, foodstuff, other biomedical cellular products;
d) studying of possibility of extension of indications for application of the registered biomedical cellular products.
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The document ceased to be valid since April 1, 2024 according to Item 1 of the Order of the Government of the Russian Federation of October 14, 2023 No. 1709