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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

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

Rules of accreditation of the medical organizations on the right of performing clinical trials of biomedical cellular products

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) shipping 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 dosages of 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.

2. Accreditation can be performed as concerning all purposes specified in Item 1 of these rules and concerning one of them.

3. Accreditation is carried out by the Ministry of Health of the Russian Federation (further - accreditation body) for the purpose of recognition of possibility of the medical organization to conduct clinical trials of biomedical cellular products on profile of disease (condition) for which treatment the biomedical cellular product is intended.

4. Requirements to the medical organization for receipt of accreditation are:

a) availability of the license for implementation of medical activities;

b) availability of department (chamber) of intensive therapy and resuscitation - in case of performing clinical trials of the biomedical cellular products for the purpose of provided by subitems "an" and "b" of Item 1 of these rules;

c) availability of copies of the regulatory legal acts regulating questions of the organization and performing clinical trials of biomedical cellular products;

d) ensuring confidentiality of personal data of the patients participating in performing clinical trials of biomedical cellular products;

e) observance of rules of proper clinical practice of the biomedical cellular products approved in accordance with the established procedure.

5. For receipt of accreditation the medical organization submits to accreditation body the following documents (on paper or in electronic form):

a) the statement for provision of the certificate on accreditation on the right of performing clinical trials of biomedical cellular products (further - the certificate on accreditation) in the form approved by accreditation body signed by the head of the medical organization or its authorized representative and certified by seal of the medical organization (in the presence of seal);

b) extract from the Unified State Register of Legal Entities;

c) copy of the license for implementation of medical activities;

d) copies of the documents confirming availability at the medical organization of department (chamber) of intensive therapy and resuscitation - in case of performing clinical trials of the biomedical cellular products for the purpose of provided by subitems "an" and "b" of Item 1 of these rules;

e) the copy of the document approved by the head of the medical organization establishing operating procedure with personal data of the patients participating in performing clinical trials of biomedical cellular products.

6. The accreditation body has no right to demand from the medical organization of submission of the documents provided by subitems "b" and "v" of Item 5 of these rules. If the medical organization did not submit such documents on own initiative, the accreditation body according to the procedure of interdepartmental information exchange requests:

a) at the Federal Tax Service - information on the fact of entering of information about the applicant into the Unified State Register of Legal Entities;

b) at the Federal Service on supervision in health sector - information on availability at the medical organization of the license for implementation of medical activities (according to the unified register of licenses for implementation of medical activities which maintaining is performed by the Federal Service on supervision in health sector).

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