ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of October 3, 2018 No. 1184

About approval of the Regulations on licensing of activities for production of biomedical cellular products

According to the Federal Law "About Licensing of Separate Types of Activity" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on licensing of activities for production of biomedical cellular products.

2. This resolution is effective till September 1, 2030.

Approved by the Order of the Government of the Russian Federation of October 3, 2018 No. 1184

Regulations on licensing of activities for production of biomedical cellular products

1. This Provision determines procedure for licensing of activities for production of biomedical cellular products.

2. Licensing of activities for production of biomedical cellular products is performed by the Federal Service on supervision in the field of health care (further - the licensing body).

3. Activities for production of biomedical cellular products include works on the list according to appendix.

4. The licensed requirements imposed to the license applicant on implementation of activities for production of biomedical cellular products (further - the license), are:

a) availability at the license applicant of production facilities in the place of implementation of activities for production of the biomedical cellular products, technical means, the equipment and technical documentation belonging to it on the property right or other legal cause providing right of possession and right to use, the biomedical cellular products corresponding the stipulated in Article 35 Federal Laws "About Biomedical Cellular Products" to regulations of production and to rules of proper practice on work with biomedical cellular products;

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