RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of August 14, 2020 No. 71

About change of resolutions of the Ministry of Health of the Republic of Belarus of March 1, 2010 No. 20 and of April 17, 2015 No. 49

Based on parts four and the seventh article 12 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation", Item 2 of the resolution of Council of Ministers of the Republic of Belarus of November 30, 2012 No. 1105 "About approval of the list of actions technical (technological, testing) nature", paragraphs two and third subitem 8.17 of Item 8 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, the Ministry of Health of the Republic of Belarus DECIDES:

1. Make changes to the following resolutions of the Ministry of Health of the Republic of Belarus:

1.1. in the resolution of the Ministry of Health of the Republic of Belarus of March 1, 2010 No. 20 "About approval of the Instruction about procedure and conditions of monitoring procedure of quality of the medicines registered in the Republic of Belarus before receipt in realization, and also the medicines which are in circulation in the territory of the Republic of Belarus, modification and amendments in the resolution of the Ministry of Health of the Republic of Belarus of January 15, 2007 No. 6 and recognition voided resolutions of the Ministry of Health of the Republic of Belarus of June 24, 2002 No. 37 and Item 14 of the resolution of the Ministry of Health of the Republic of Belarus of December 22, 2006 No. 117":

state the name in the following edition:

"About monitoring procedure of quality of medicines before receipt in realization, and also the medicines which are in circulation in the territory of the Republic of Belarus";

state preamble in the following edition:

"Based on part four of article 12 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation", Item 2 of the resolution of Council of Ministers of the Republic of Belarus of November 30, 2012 No. 1105 "About approval of the list of actions technical (technological, testing) nature", paragraphs two and third subitem 8.17 of Item 8 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, the Ministry of Health of the Republic of Belarus DECIDES:";

state Items 1 and 11 in the following edition:

"1. Establish the list of the test laboratories accredited in the National accreditation system of the Republic of Belarus for testing of medicines before receipt in realization and also the medicines which are in circulation in the territory of the Republic of Belarus according to appendix.

11. Approve the Instruction about procedure and conditions of monitoring procedure of quality of medicines before their receipt in realization, and also the medicines which are in circulation in the territory of the Republic of Belarus it (is applied).";

to be reworded as follows appendix to this resolution it (is applied);

To be reworded as follows the instruction about procedure and conditions of monitoring procedure of quality of the medicines registered in the Republic of Belarus before receipt in the realization, and also the medicines which are in circulation in the territory of the Republic of Belarus approved by this resolution it (is applied);

1.2. in the resolution of the Ministry of Health of the Republic of Belarus of April 17, 2015 No. 49 "About approval of the Instruction about procedure and conditions of quality control of the medicines made in drugstores":

state preamble in the following edition:

"Based on part seven of article 12 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation", the paragraph of third subitem 8.17 of Item 8 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, the Ministry of Health of the Republic of Belarus DECIDES:";

in Item 1:

"enclosed" to exclude the word;

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

in the Instruction about procedure and conditions of quality control of the medicines made in drugstores approved by this resolution:

state Item 3 in the following edition:

"3. For the purposes of this Instruction the main terms and their determinations in the values established by the Law of the Republic of Belarus of June 18, 1993 No. 2435-XII "About health care" and the Law of the Republic of Belarus "About drug circulation are used".";

"accredited in" to add Item 6 after words with the word "National";

part one of Item 9 to add with words ", and in case of medicine recognition low-quality - in public institution "The state pharmaceutical supervision in the field of drug circulation Gosfarmnadzor (further - GU "Gosfarmnadzor")";

add Item 24 with words ", and also pharmaceutical substances before receipt to the room of pharmaceutical production of medicines";

to be reworded as follows appendix 1 to this Instruction it (is applied);

in appendix 2 to this Instruction:

the word "address" shall be replaced with words "location";

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

after the word "initials" to add with words "(initial of own name)";

after the word "Initials" to add with words "(initial of own name)";

after the word" (" to add position with the word of "employee";

in appendix 3 to this Instruction:

the word "Address" shall be replaced with words "Location";

after the word "initials" to add with words "(initial of own name)";

the word "address" shall be replaced with words "location";

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