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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of October 8, 2021 No. 570

About state registration of strategically important medicines

Based on parts eight, the tenth and twenty fifth article 10 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation" and the subitem and) Item 3 of Rules of registration and examination of the medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78, Council of Ministers of the Republic of Belarus DECIDES:

1. Approve Regulations on procedure and conditions of implementation of state registration of strategically important medicines it (is applied).

2. Make changes to resolutions of Council of Ministers of the Republic of Belarus according to appendix.

3. To the Ministry of Health in three-months time to take measures for implementation of this resolution.

4. This resolution becomes effective after its official publication.

First Deputy Prime Minister of the Republic of Belarus

N. Snopkov

Appendix

to the Resolution of Council of Ministers of the Republic of Belarus of October 8, 2021 No. 570

The list of the changes made to resolutions of Council of Ministers of the Republic of Belarus

1. In 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:

in Item 8:

subitem 8.14 after words "the simplified procedure" to add with words "state registration of strategically important medicines,";

state subitem 8.14-1 in the following edition:

"8.14-1. determines:

procedure for carrying out complex of the preliminary technical works connected with conducting examinations, approbations of techniques of quality control of medicine and quality control of this medicine with use of such techniques, other researches, preceding state registration (confirmation of state registration) of medicines, conditional state registration (confirmation of conditional state registration) of medicines, state registration of medicines in the simplified procedure, to modification of the registration file;

procedure for carrying out complex of the examinations performed in case of registration (registration confirmation) and other procedures connected with registration of medicines within the Eurasian Economic Union;

procedure for technical supply of maintaining the State register of medicines of the Republic of Belarus;

procedure for carrying out complex of the preliminary technical works connected with conducting examinations for confirmation of conformity of strategically important medicine to safety requirements, efficiency and qualities and also determinations of possibility of the emergency use of strategically important medicine;

list of strategically important medicines;".

2. Add the single list of the ministerial procedures performed by state bodies and other organizations concerning legal entities and individual entrepreneurs, No. approved by the resolution of Council of Ministers of the Republic of Belarus of February 17, 2012 156, Item 10.13-1 of the following content:

"10.13-1. The state registration of strategically important medicine performed:

 

 

 

 

 

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