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RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of December 22, 2009 No. 1677

About procedure and storage conditions, transportations, suspensions of realization and medical application, retirement, return to the producer or supplier, destructions of medicines

(as amended on 29-09-2020)

The Council of Ministers of the Republic of Belarus DECIDES:

1. No. 256 is excluded according to the Resolution of Council of Ministers of the Republic of Belarus of 01.04.2015

2. Approve Regulations on procedure and storage conditions, transportations, suspensions of realization and medical application, retirement, return to the producer or supplier, destructions of medicines it (is applied).

3. Make additions and changes to the following resolutions of Council of Ministers of the Republic of Belarus:

3.1. ceased to be valid according to the Resolution of Council of Ministers of the Republic of Belarus of 28.10.2011 No. 1446

3.2. ceased to be valid according to the Resolution of Council of Ministers of the Republic of Belarus of 11.07.2012 No. 635

3.3. in the resolution of Council of Ministers of the Republic of Belarus of August 29, 2002 No. 1178 "About approval of the Regulations on procedure for storage of medicines, products of medical appointment and medical equipment and Regulations on procedure for destruction of medicines, products of medical appointment and medical equipment" (The national register of legal acts of the Republic of Belarus, 2002, No. 100, 5/11051):

from the name, preamble, Items 1 and 2 of the word of "medicines" to exclude;

in Regulations on the procedure for storage of medicines, products of medical appointment and medical equipment approved by this resolution:

from the name and Item 1 of the word of "medicines" to exclude;

from part two of Item 2 of the word of "medicines depending on their physical and chemical and toxicological properties, and also groups" to exclude;

exclude Item 3;

in Regulations on the procedure for destruction of medicines, products of medical appointment and medical equipment approved by this resolution:

from the name of the word of "medicines" to exclude;

to exclude from Item 1 of the word "medicines";

3.4. Ceased to be valid according to the Resolution of Council of Ministers of the Republic of Belarus of 01.04.2015 No. 256

3.5. in the resolution of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269 "About approval of the Regulations on state registration (re-registration) of medicines and pharmaceutical substances and Regulations on state registration (re-registration) of products of medical appointment and medical equipment" (The national register of legal acts of the Republic of Belarus, 2008, No. 213, 5/28269; 2009, No. 66, 5/29385):

3.5.1. in the Regulations on state registration (re-registration) of medicines and pharmaceutical substances approved by this resolution:

in item 4:

in subitem 4.1:

replace figures "5-9" with figures "16-20";

figures"; 2009, 53, 5/29302" to exclude No.;

"original" to exclude the word from subitem 4.4;

add subitem 4.5 with the offer of the following content: "At the same time approbation of methods of the analysis of the medicines and pharmaceutical substances for the first time declared for state registration in the Republic of Belarus is not carried out:

if the cost of the samples of medicine, pharmaceutical substance necessary for carrying out approbation of analysis methods, exceeds 1000 conventional units, equivalent 1000 US dollars at the rate of National Bank of the Republic of Belarus for date of submission of the registration file;

concerning drugs and psychotropic substances;

concerning radio pharmaceutical medicines;

concerning the medicines intended for treatment of patients with seldom found pathology;

concerning the medicines arriving from the international organizations to the Ministry of Health through humanitarian and technical assistance;";

"approved (signed)" to exclude from subitem 4.8 of the word;

in Item 7 part one:

"the expert (experts) of the Center of examinations and testing and" to exclude from word paragraph two;

word in paragraph three "the expert (experts) of the Center of examinations and testing and at least than one expert" shall be replaced with words "at least than two experts";

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