of May 19, 2022 No. 84
About modification of Rules of registration and examination of safety, quality and efficiency of medical products
According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Items 2 and 4 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014, Item 92 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission solved:
1. Paragraph two of Item 1 of Rules of registration and examination of safety, quality and efficiency of the medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 46, to state in the following edition:
"Requirements of these rules can not be applied to medical products which address is regulated by the legislation of state members of the Union (further - state members) and which are intended for application in the conditions of military operations, origin, liquidation and the prevention of emergency situations, threat of spread of the epidemic diseases constituting danger to people around, prevention, diagnostics and treatment of the diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors and in case of threat of absence or lack of medical products in the markets of state members in the conditions of introduction of rationing economic arrangements concerning at least one of state members. Non-use of requirements of these rules is allowed only during action of the specified conditions.".
2. This Decision becomes effective after 10 calendar days from the date of its official publication.
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