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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of October 14, 2025 No. 148

About change of the resolution of the Ministry of Health of the Republic of Belarus of November 18, 2020 No. 103

Based on parts seven, the ninth article 20 of the Law of the Republic of Belarus of July 20, 2006 "About drug circulation" the Ministry of Health of the Republic of Belarus DECIDES: No. 161-Z

1. Bring in the resolution of the Ministry of Health of the Republic of Belarus of November 18, 2020 No. 103 "About procedure for certification, forming and maintaining registers of authorized persons of producers of medicines, pharmaceutical inspectors" the following changes:

to exclude from preamble of the word "and 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,";

in the Instruction about requirements imposed to authorized persons of producers of medicines and procedure for their certification approved by this resolution:

in the paragraph the second Item 2 of the word "special permission (license) for the right of implementation of pharmaceutical activities regarding industrial production of medicines and (or) pharmaceutical substances and their wholesale" shall be replaced with words "licenses for implementation of pharmaceutical activities regarding industrial production of medicines and their wholesale";

state Item 3 in the following edition:

"3. Certification is carried out with use of the automated information system "Certification of UL" based on the agreement signed between the republican unitary enterprise "LOTIOS Scientific and Practical Center" (further - the state company "NPTs LOTIOS") and producer of medicines which authorized person is subject to certification.";

in Item part one 5, parts one and the fourth Item 13, of part one of Item 21 of the word "NPTs "LOTIOS" shall be replaced with words "the state company "NPTs LOTIOS" in the corresponding case;

in Item 11:

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