RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of July 6, 2023 No. 441

About change of resolutions of Council of Ministers of the Republic of Belarus

Based on subitem 1-1.1 of Item 11 of the Presidential decree of the Republic of Belarus of May 5, 2006 No. 289 "About structure of the Government of the Republic of Belarus", parts ten, the twelfth 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. Make changes to the following resolutions of Council of Ministers of the Republic of Belarus:

1.1. preamble of the resolution of Council of Ministers of the Republic of Belarus of April 14, 2011 No. 497 "About approval of the Regulations on procedure for carrying out survey of physical persons regarding identification of the alcohol intoxication and (or) condition caused by consumption of drugs, psychotropic substances, their analogs, the toxic or other stupefying substances" to state in the following edition:

"Based on paragraph two of Article 19 and part two of article 35 of the Law of the Republic of Belarus of July 23, 2008 "About Council of Ministers of the Republic of Belarus" the Council of Ministers of the Republic of Belarus DECIDES: No. 424-Z";

1.2. in the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About questions of the Ministry of Health of the Republic of Belarus":

"state" to exclude the word from Item 1-1;

in Regulations on the Ministry of Health of the Republic of Belarus approved by this resolution:

add Item 2 with part of the following content:

"In the Ministry of Health for the purpose of ensuring its activities and maintenance other structural divisions are created, as a rule.";

"state" to exclude the word from subitem 4.6 of item 4;

"state" to exclude the word from Item 5;

to exclude the word "state" from the paragraph of the fifth Item 7;

in Item 8:

the fifth subitem 8.14-1 to state the paragraph in the following edition:

"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, determinations of possibility of the emergency use of strategically important medicine, preceding state registration (confirmation of state registration) of strategically important medicines, modification of the registration file;";

the fifth subitem 8.27 to add the paragraph with words ", state registration (confirmation of state registration) of strategically important medicine";

from subitems 8. 8.66, 8.76, 8.80 the word "state" in the corresponding case to exclude 54,;

"state" to exclude the word from subitem 9.5 of Item 9;

in part two of Item 10 of the word "in accordance with the established procedure" shall be replaced with words "Council of Ministers of the Republic of Belarus in coordination with the President of the Republic of Belarus";

in appendix to this resolution:

"state" to exclude the word from the name;

state Item 15 in the following edition:

"15. Public institution "University dental clinic", Minsk.";

state Item 45 in the following edition:

"45. Trade and production republican unitary enterprise "Minsk Pharmacy", Minsk district, Mr. Zaslavl.";

1.3. in the resolution of Council of Ministers of the Republic of Belarus of April 1, 2015 No. 254 "About state registration (confirmation of state registration) of medicines":

in Regulations on the procedure and conditions of implementation of state registration (confirmation of state registration) of medicines approved by this resolution:

the fourth to state the paragraph to part two of Item 1 in the following edition:

"implementation of state registration (confirmation of state registration) of strategically important medicines, modification of the registration file, and also suspension, cancellation of the registration certificates issued on strategically important medicines.";

the second Item 10 to state part in the following edition:

"The decision specified in part one of this Item is drawn up by the order of the Ministry of Health.";

from Items 12 and 13 of the word", modification of the registration file" to exclude;

the fourth Item 17 to exclude part;

in part two of Item 19 of the word "is accepted by the Ministry of Health in the form of the order" shall be replaced with words "it is drawn up by the order of the Ministry of Health";

to state part one of Item 24 in the following edition:

"24. The decision on renewal of action of the registration certificate with indication of date of renewal is drawn up by the order of the Ministry of Health.";

to state part one of Item 25 in the following edition:

"25. The decision on cancellation of the registration certificate in the cases provided in part of the twenty fourth article 10 of the Law of the Republic of Belarus "About drug circulation" except for of the case provided in the paragraph the second the specified part is drawn up by the order of the Ministry of Health.";

state Item 26 in the following edition:

"26. After effective period of the registration certificate on the medicine which did not undergo the procedure of confirmation of state registration (conditional state registration) data on date of cancellation of the registration certificate are entered in the State register.";

to be reworded as follows appendices 2-4 to this Provision (are applied);

To be reworded as follows the regulations on structure, procedure for forming and maintaining the State register of medicines of the Republic of Belarus approved by this resolution it (is applied);

1.4. in Regulations on the procedure and conditions of implementation of state registration of strategically important medicines approved by the resolution of Council of Ministers of the Republic of Belarus of October 8, 2021 No. 570:

state Item 1 in the following edition:

"1. This Provision determines procedure and conditions of implementation of state registration (confirmation of state registration) of strategically important medicines, modification of the registration file, and also suspensions, cancellation of the registration certificates issued on strategically important medicines.";

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