of July 17, 2012 No. 101
About carrying out state registration of products constituting potential danger for life and health of the population
Based on the paragraph of the fourth subitem 8.32 of Item 8, of 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, of subitem 2.1 of Item 2 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" the Ministry of Health of the Republic of Belarus DECIDES:
1. Approve Regulations on procedure and conditions of carrying out state registration of products constituting potential danger for life and health of the population it (is applied).
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
1. This Provision establishes procedure and conditions of carrying out state registration of products for the first time made on customs area of the Eurasian Economic Union or for the first time the state member of the Eurasian Economic Union imported on customs area which is subject to registration according to acts of the Eurasian economic commission (further - state registration of products), including procedure and conditions of issue, renewal of the certificate on state registration of products 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. State registration of products is carried out by the bodies and organizations exercising the state sanitary inspection for the list according to appendix to the resolution which approved this Provision according to statements of the organizations and individual entrepreneurs. Financing of works on carrying out state registration of products is performed at the expense of means of the organizations and individual entrepreneurs if other is not established by acts of the legislation.
3. The legal entity or physical person as the individual entrepreneur which are the manufacturer or the seller (importer) or person authorized by the manufacturer registered in the territory of state member of the Eurasian Economic Union according to its legislation (further - applicants) can be the applicant when carrying out state registration of products.
4. State registration of products is performed according to the procedure and in case of observance of the conditions established by the international legal acts constituting the regulatory legal base of the Customs union and the Common economic space and (or) 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 other acts of the legislation.
5. The list of the documents necessary for carrying out state registration of products and issue of the certificate on state registration of products is determined by Regulations of the ministerial procedure performed concerning subjects of managing, by subitem 9.5.1 "Receipt of the certificate on state registration of products for the first time made on customs area of the Eurasian Economic Union or for the first time the state member of the Eurasian Economic Union imported on customs area which is subject to registration according to acts of the Eurasian economic commission", the approved resolution of the Ministry of Health of the Republic of Belarus of February 21, 2022 No. 13 (further - regulations of ministerial procedure according to subitem 9.5. 1).
The list of the documents necessary for renewal by replacement of the certificate on state registration of products is determined by Regulations of the ministerial procedure performed concerning subjects of managing, by subitem 9.5.2 "Renewal by replacement of the certificate on state registration of products", the approved resolution of the Ministry of Health of the Republic of Belarus of February 21, 2022 No. 13 (further - regulations of ministerial procedure according to subitem 9.5. 2).
6. The decision on refusal in state registration of products in writing or in the form of the electronic document with reasons for causes of failure within three working days is brought to the attention of the applicant, the deputy minister of health care - the Chief state health officer of the Republic of Belarus, bodies and organizations exercising the state sanitary inspection, authorized according to the legislation of state members of the Eurasian Economic Union of bodies (the organizations, organizations) of state members of the Eurasian Economic Union, Eurasian economic commission.
7. The document confirming safety of products regarding its compliance to requirements of the legislation in the field of sanitary and epidemiologic wellbeing of the population, to the sanitary and epidemiologic, hygienic requirements and procedures established by technical regulations of the Customs union, Eurasian Economic Union the certificate on state registration of products is.
The certificate on state registration of products is granted for the term established by part one of Item 3 of regulations of ministerial procedure according to subitem 9.5.1 and Item 3 of regulations of ministerial procedure according to subitem 9.5.2.
8. The certificate on state registration of products is subject to renewal by replacement 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.
Appendix
to the Resolution of the Ministry of Health of the Republic of Belarus of July 17, 2012 No. 101
1. Public institution "Baranovichi zone center of hygiene and epidemiology".
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