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The document ceased to be valid since  March 27, 2022 according to Appendix 3 to the Resolution of Council of Ministers of the Republic of Belarus of March 25, 2022 No. 175

RESOLUTION OF COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS

of August 6, 2015 No. 666

About entering of amendments into the resolution of Council of Ministers of the Republic of Belarus of February 17, 2012 No. 156

Council of Ministers of the Republic of Belarus DECIDES:

1. Bring in the single list of the ministerial procedures performed by state bodies and other organizations concerning legal entities and individual entrepreneurs, No. 156 approved by the resolution of Council of Ministers of the Republic of Belarus of February 17, 2012 "About approval of the single list of the ministerial procedures performed by state bodies and other organizations concerning legal entities and individual entrepreneurs, entering of amendment into the resolution of Council of Ministers of the Republic of Belarus of February 14, 2009 No. 193 and recognition voided some resolutions of Council of Ministers of the Republic of Belarus" (The national register of legal acts of the Republic of Belarus, 2012, No. 35, 5/35330; National legal Internet portal of the Republic of Belarus, 17.07. 2012, 5/35957; 16:04. 2013, 5/37100), following amendments:

1.1. in the column "The List of the Documents and (or) Data Represented by Interested Persons to Authorized Body for Implementation of Ministerial Procedure" of Item 10.22:

after the paragraph of the fifth to add the column with the paragraph of the following content:

"protocols of laboratory researches (testing) of food staples and foodstuff on compliance to the requirements established by the legislation of the Republic of Belarus in the field of sanitary and epidemiologic wellbeing of the population";

to consider the paragraph of the sixth the paragraph the seventh;

1.2. add the list with Items 10.22-1 and 10.22-2 of the following content:

 

"10.22-1. The state sanitary and hygienic examination of products of foreign production with issue of the sanitary and hygienic conclusion on products (except for products which are subject to state registration)

public institution "Republican center of hygiene, epidemiology and public health", regional centers of hygiene, epidemiology and public health, public institution "Minsk city center of hygiene and epidemiology", zone centers of hygiene and epidemiology

statement

the document confirming introduction platy15

list of products

the copy of the technical regulatory legal act establishing quality requirements and safety of products (technical codes of common practice, state standards, specifications), and technological documentation (compoundings, technical descriptions, technological instructions), the letter of the producer about sostave2

the document of the producer confirming safety and quality produktsii2

documents of the producer on application (use) of products (the instruction, the operation manual, regulations – in the presence) 2

label (packaging) or it makety2

protocols of laboratory researches (testing) for compliance to the requirements established by the legislation of the Republic of Belarus in the field of sanitary and epidemiologic wellbeing of the population, executed by the laboratories accredited in the National accreditation system of the Republic of Belarus

veterinary sertifikat2

the contract in foreign trade (agreement) and the documents confirming import and (or) acquisition produktsii2

15 days

on the processing equipment for production of food and perfumery and cosmetic products established on production – for operation in the conditions of the specified production

on products (except for processing equipment for the production of food and perfumery and cosmetic products established on production) imported into the Republic of Belarus – within expiration dates (storage) of the lot of products imported according to the contract in foreign trade (agreement)

service fee

10.22-2. Replacement (renewal, modification, issue of the duplicate) of the sanitary and hygienic conclusion by products

public institution "Republican center of hygiene, epidemiology and public health", regional centers of hygiene, epidemiology and public health, public institution "Minsk city center of hygiene and epidemiology", zone centers of hygiene and epidemiology

for replacement (renewal), modification – the statement in any form

the documents confirming need of replacement (renewal), introduction izmeneniy2

the document confirming introduction platy15

for issue of the duplicate – the statement in any form

the document confirming introduction platy15

15 days

on effective period of the sanitary and hygienic conclusion on products

service fee";

 

1.3. add the list with Item 10.36 of the following content:

 

"10:36. Issue (prolongation of effective period, modification, issue of the duplicate) of the certificate of conformity of production of medicine to requirements of the Proper production practice (GMP)

Ministry of Health

for issue, prolongation of effective period – the file of production site

the plan of elimination of discrepancies developed and approved by producer of medicine

the report on accomplishment of the plan of elimination of discrepancies approved by producer of medicine

for modification, issue of the duplicate – the statement in any form

the reference reasons of modification or issue of the duplicate of the certificate of conformity of production of medicine to requirements of the Proper production practice (GMP) with application of copies of the documents confirming need of modification

10 days

3 years (in case of modification, issue of the duplicate – on effective period of the certificate of conformity of production of medicine to requirements of the Proper production practice (GMP)

free of charge".

 

2. To the Ministry of Health to bring the regulatory legal acts into accord with this resolution and to take other measures for its realization.

3. This resolution becomes effective in 15 days after its official publication.

Prime Minister of the Republic of Belarus

A. Kobyakov

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