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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of April 1, 2020 No. 191

About measures for implementation of the Presidential decree of the Republic of Belarus of December 31, 2019 No. 499

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

In pursuance of Item 5 of the Presidential decree of the Republic of Belarus of December 31, 2019 "About drug circulation" the Council of Ministers of the Republic of Belarus DECIDES: No. 499

1. Approve:

The regulations on procedure for conducting inspection on compliance to Rules of proper distributor practice within the Eurasian Economic Union and issue of the conclusion by its results (are applied);

The regulations on the simplified procedure of state registration of medicines (are applied).

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

3. This resolution becomes effective in the following procedure:

paragraphs the ninth, the twelfth or fifteenth, nineteenth and twentieth Item 1, paragraphs the fourth, the fifth, twelfth and thirteenth Item 2, appendix item 4 - since May 1, 2020;

paragraph two of Item 1 of this resolution, paragraphs of the sixth or eighth of Item 2, paragraphs the eleventh and twelfth Item 3 appendices - since December 1, 2020;

other provisions of this resolution - after its official publication.

Prime Minister of the Republic of Belarus

S. Rumas

Appendix

to the Resolution of Council of Ministers of the Republic of Belarus of April 1, 2020 No. 191

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

1. In the resolution of Council of Ministers of the Republic of Belarus of December 22, 2009 No. 1677 "About approval of the Regulations on procedure for storage, transportation, retirement, return to the producer or the supplier, destructions of medicines, amendment, change and recognition voided some resolutions of Council of Ministers of the Republic of Belarus":

from the name of the word", amendment, change and recognition voided some resolutions of Council of Ministers of the Republic of Belarus" to exclude;

in Item 2:

exclude the word "enclosed";

add Item with the word "(is applied)";

in Regulations on the procedure for storage, transportation, retirement, return to the producer or the supplier, destructions of medicines approved by this resolution:

in Item 2 of the word of "2006" on medicines" (The national register of legal acts of the Republic of Belarus, 2006, No. 122, 2/1258)" shall be replaced with words "2006 No. 161-Z "About medicines";

in part one of Item 10 of the word of "the measuring instruments of the Republic of Belarus entered in the State register" shall be replaced with words "undergone the state checking";

in the paragraph the second Item 16 of the word "Republican control and analytical laboratory of the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further - RUP "TsEIZ")" shall be replaced with words "public institution" the state pharmaceutical supervision in the sphere of drug circulation Gosfarmnadzor (further - GU "Gosfarmnadzor")";

in Item 17:

after the words "accredited in" to add Item with the word "National";

words "Republican control and analytical laboratory of RUP "TsEIZ" shall be replaced with words "GU "Gosfarmnadzor";

Item in paragraph three 18, the paragraph the sixth Item 20 of the word "Republican control and analytical laboratory of RUP "TsEIZ" shall be replaced with words "GU "Gosfarmnadzor";

in Item 19:

in word part one "Republican control and analytical laboratory of RUP "TsEIZ" shall be replaced with words "GU "Gosfarmnadzor";

in part two:

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