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of July 20, 2022 No. ZR-304
About introduction of amendments to the Law "About Medical Care and Servicing of the Population"
Accepted by National Assembly of the Republic of Armenia on July 6, 2022
Article 1. Items 50-60 of part 1 of article 2 of the Law of March 4, 1996 as No. ZR-42 "About medical care and servicing of the population" (further – the Law) to recognize invalid.
Article 2. To state Chapter 10 of the Law in the following edition:
"Chapter 10. State regulation of the address of medical products
Article 45. State regulation of the address of medical products
1. The address of medical products in the Republic of Armenia is regulated according to the Agreement "About the Eurasian Economic Union" of May 29, 2014, the Agreement "About the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union" (further – the Agreement), other international treaties entering the right of the Republic of Armenia, decisions of the Eurasian economic commission (further – the Commission), and also the legislation.
2. The concepts applied in this Chapter are used in the sense established by legal acts of the Eurasian Economic Union (further – the Union) in the field of the address of medical products.
3. Within the competence in the field of the address of medical products of the Republic of Armenia the authorized body performs regulation of the address of medical products, licensing of the types of activity provided by the law, state registration of medical products, accreditation of the imported medical products, the organization of examination and professional observations, ensuring collection, information analysis about unfavorable events (incidents) in the course of application (operation) of medical products) and the adoptions of relevant decisions and functions assigned to it by this Law and other laws of the Republic of Armenia.
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