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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of December 29, 2014 No. 116

About some measures for implementation of the resolution of Council of Ministers of the Republic of Belarus of November 28, 2014 No. 1120

(The last edition from 03-04-2018)

Based on Item 3 of the resolution of Council of Ministers of the Republic of Belarus of November 28, 2014 No. 1120 "About some questions of state registration of biomedical cellular products", of subitem 8.24-3 of Item 8, of subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360" the Ministry of Health of the Republic of Belarus DECIDES: parts one of item 4 and part two of Item 9 of the Regulations on procedure for state registration of biomedical cellular products approved by the resolution of Council of Ministers of the Republic of Belarus of November 28, 2014 No. 1120 "About some questions of state registration of biomedical cellular products"

1. Approve enclosed:

1.1. The instruction about procedure for the organization and carrying out complex of the preliminary technical works preceding submission of documents for state registration (confirmation of state registration) of biomedical cellular products, modification of the registration file on the biomedical cellular products which are earlier registered in the Republic of Belarus;

1.2. The instruction about procedure and amount of carrying out clinical testing of biomedical cellular products;

1.3. Regulations on the commission on biomedical cellular products.

2. This resolution becomes effective after its official publication.

Minister

V.I.Zharko

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of December 29, 2014 No. 116

The instruction about procedure for the organization and carrying out complex of the preliminary technical works preceding submission of documents for state registration (confirmation of state registration) of biomedical cellular products, modification of the registration file on the biomedical cellular products which are earlier registered in the Republic of Belarus

1. This Instruction determines procedure for the organization and carrying out by the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further - the Company) complex of the preliminary technical works connected with conducting examinations, inspections, testing, including the clinical, and other researches preceding submission of documents for state registration (confirmation of state registration) of biomedical cellular products, modification of the registration file on the biomedical cellular products which are earlier registered in the Republic of Belarus (further - preliminary technical works).

2. This Instruction is obligatory for the legal entities and individual entrepreneurs including performing production and import of biomedical cellular products, and also carrying out preliminary technical works.

3. In this Instruction the main terms and their determinations in the values established by the Law of the Republic of Belarus of June 18, 1993 "About health care" are used (Vyarkho¸naga Savet's Vedamastsi of Respubliki Belarus, 1993, No. 24, Art. 290; The National register of legal acts of the Republic of Belarus, 2008, No. 159, 2/1460) and the Regulations on procedure for state registration of biomedical cellular products approved by the resolution of Council of Ministers of the Republic of Belarus of November 28, 2014 No. 1120 "About some questions of state registration of biomedical cellular products" (The national legal Internet portal of the Republic of Belarus, 03.12. 2014, 5/39767).

4. Preliminary technical works are carried out based on the agreement signed between the Company and the applicant.

5. Essential terms of the contract, in addition to other conditions established according to the legislation are:

provision by the applicant of the documents necessary for state registration (confirmation of state registration) of biomedical cellular products and containing data confirming safety and quality of biomedical cellular products, including technical regulatory legal acts on biomedical cellular products, the analytical passport, the document containing the description of technological production phases, instructions for application, prototype of graphic design of the label (further if other is not established, - documents for registration (confirmation);

procedure for acceptance of preliminary technical works with issue of the conclusion about compliance or discrepancy of biomedical cellular products to requirements for safety and quality (further - the conclusion of the Company).

6. The complex of preliminary technical works includes:

6.1. for state registration (confirmation of state registration) of biomedical cellular products:

6.1.1. conducting examination of the documents submitted by the applicant for registration (confirmation) (further - examination of documents).

When conducting examination of documents it is performed:

check of completeness and correctness of their registration;

check of completeness and relevance of information specified in them;

completion and fitting with their applicant (if necessary);

refining of the list and names of biomedical cellular products taking into account the similar biomedical cellular products registered in the Republic of Belarus.

The term of conducting examination of documents shall not exceed 15 calendar days;

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