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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of November 28, 2014 No. 1120

About questions of state registration of biomedical cellular products

(as amended of the Resolution of Council of Ministers of the Republic of Belarus of 25.03.2022 No. 175)

Based on part two of article 39-1 of the Law of the Republic of Belarus of June 18, 1993 "About health care" the Council of Ministers of the Republic of Belarus DECIDES: No. 2435-XII

1. Approve Regulations on procedure for state registration of biomedical cellular products it (is applied).

2. Determine the list of the biomedical cellular products which are not subject to state registration according to appendix.

3. Authorize the Ministry of Health on acceptance of regulatory legal act about approval of procedure and amount of carrying out clinical testing of biomedical cellular products.

4. No. 175 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 25.03.2022

5. This resolution becomes effective since December 27, 2014, except for Item 3, of the official publication of this resolution which is becoming effective later.

Prime Minister of the Republic of Belarus

M. Myasnikovich

Approved by the Resolution of Council of Ministers of the Republic of Belarus of November 28, 2014 No. 1120

Regulations on procedure for state registration of biomedical cellular products

Chapter 1. General provisions

1. This Provision determines procedure for state registration of biomedical cellular products in the Republic of Belarus.

2. Requirements of this provision are obligatory for the legal entities and individual entrepreneurs including performing import, realization, medical application of biomedical cellular products and their state registration.

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