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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of July 17, 2012 No. 101

About some questions of carrying out state registration of products constituting potential danger for life and health of the population

(as amended on 20-12-2016)

Based on the paragraph of the fourth subitem 8.32 of Item 8, 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 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360", subitem 2. 1, parts two of subitem 2.2 of Item 2, of the paragraph of third Item 3 of the resolution of Council of Ministers of the Republic of Belarus of July 11, 2012 No. 635 "About some questions of sanitary and epidemiologic wellbeing of the population" DECIDES: the Ministry of Health of the Republic of Belarus

1. Approve the enclosed Regulations on procedure and conditions of carrying out state registration of products constituting potential danger for life and health of the population.

2. Establish the list of the bodies and organizations exercising the state sanitary inspection, authorized on carrying out state registration of products according to appendix.

3. This resolution becomes effective after its official publication.

Minister

V.I.Zharko

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of July 17, 2012 No. 101

Regulations on procedure and conditions of carrying out state registration of products constituting potential danger for life and health of the population

1. This Provision establishes procedure and conditions of carrying out state registration of products constituting potential danger for life and health of the population including procedure and conditions of issue, renewal, suspension, renewal, cancellation of the certificate on state registration (further - state registration) if other is not established by the international legal acts constituting the regulatory legal base of the Customs union and the Common economic space and (or) the acts constituting the right of the Eurasian Economic Union including the technical regulations of the Customs union, Eurasian Economic Union containing sanitary and epidemiologic, hygienic requirements and procedures.

2. For the first time made and for the first time the products imported on the territory of the Republic of Belarus included in the list of products constituting potential danger for life and health of the population, No. 57 established by the resolution of the Ministry of Health of the Republic of Belarus of June 5, 2012 "About establishment of the list of products constituting potential danger for life and health of the population, and recognition voided some resolutions of the Ministry of Health of the Republic of Belarus" (The national register of legal acts of the Republic of Belarus, 2012, No. 70, 8/26009) are subject to state registration (further - products).

3. State registration is carried out by the bodies and organizations exercising the state sanitary inspection for the list according to appendix to the resolution approving this Provision (further - the organizations authorized on carrying out state registration), according to statements of the organizations and individual entrepreneurs. Financing of works on carrying out state registration is performed at the expense of means of the organizations and individual entrepreneurs if other is not established by acts of the legislation of the Republic of Belarus.

4. Applicants for carrying out state registration are manufacturers (producers) or suppliers (importers) of products.

5. Products are not subject to state registration in the cases established by the international legal acts constituting the regulatory legal base of the Customs union and the Common economic space and (or) the acts constituting the right of the Eurasian Economic Union including the technical regulations of the Customs union, Eurasian Economic Union containing sanitary and epidemiologic, hygienic requirements and procedures and based on the documents confirming them.

6. When carrying out state registration the service fee (works) rendered when implementing this ministerial procedure proceeding from economically reasonable costs according to the legislation of the Republic of Belarus is levied.

7. State registration includes:

acceptance and registration of a statement;

consideration of the submitted documents;

the conclusion of the contract for performance of works (services) rendered when implementing state registration;

entering of data on products into the Register of certificates on state registration of the Republic of Belarus on the goods which are subject to sanitary and epidemiological surveillance (control) on customs border and customs area of the Eurasian Economic Union (further - the Register) which maintaining is performed by the Ministry of Health of the Republic of Belarus;

registration and issue of the certificate on state registration.

The documents provided for state registration of the dietary supplements to food including intended for food of athletes are in accordance with the established procedure submitted for consideration of the commission on determination of order of registration and realization of dietary supplements to food of the Ministry of Health.

8. The list of the documents necessary for carrying out state registration of products (goods) and issue of the certificate on state registration, renewals of the certificate on state registration in case of change of indicators of safety, structure, and also terms of its carrying out are determined by Item 10.21 of the single list of the ministerial procedures performed by state bodies and other organizations concerning legal entities and individual entrepreneurs, the Council of Ministers of the Republic of Belarus approved by the resolution of February 17, 2012 No. 156 "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) (further - the single list).

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