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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of December 21, 2016 №141

About approval of the Procedure for use by authorized bodies of state members of the Eurasian Economic Union of measures for suspension or prohibition of use of the medical products posing hazard to life and (or) human health, poor-quality, counterfeit or counterfeited medical products and to their withdrawal from the address in the territories of state members of the Eurasian Economic Union

Moscow

According to article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 3 of article 8 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, Item 93 of appendix №1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Euroasian economic council of December 23, 2014 № 98, and for the purpose of execution of the Decision of the Supreme Eurasian economic council of December 23, 2014 №109 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission decided:

1. Approve the enclosed Procedure for use by authorized bodies of state members of the Eurasian Economic Union of measures for suspension or prohibition of use of the medical products posing hazard to life and (or) human health, poor-quality, counterfeit or counterfeited medical products and to their withdrawal from the address in the territories of state members of the Eurasian Economic Union.

2. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Members of council of the Eurasian economic commission:

From the Republic of Armenia

 

V. Gabriyelyan

From the Republic of Belarus

V. Matyushevsky

From the Republic of Kazakhstan

A. Mamin

From the Kyrgyz Republic

O. Pankratov

From the Russian Federation

I. Shuvalov

Approved by the Decision of Council of the Eurasian economic commission of December 21, 2016 №141

Procedure for use by authorized bodies of state members of the Eurasian Economic Union of measures for suspension or prohibition of use of the medical products posing hazard to life and (or) human health, poor-quality, counterfeit or counterfeited medical products and to their withdrawal from the address in the territories of state members of the Eurasian Economic Union

1. This Procedure is developed for the purpose of implementation of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 3 of article 8 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014 (further - the Agreement) and establishes rules of acceptance of the states of members of the Eurasian Economic Union by authorized bodies (further respectively - state members, the Union) measures for suspension or prohibition of use of the medical products posing hazard to life and (or) human health, poor-quality, counterfeit or counterfeited medical products and also their withdrawal from the address in the territories of state members.

2. For the purposes of this Procedure concepts which mean the following are used:

"counterfeit medical product" - the medical product issued or which is in circulation with violation of requirements of the legislation of state member of the Eurasian Economic Union in the field of intellectual property;

"the poor-quality medical product" - medical product which does not conform to general requirements of safety and efficiency of medical products to requirements to their marking, technical and operational documentation on them and cannot be safely used for designated purpose, established by the producer;

"counterfeited medical product" - the medical product intentionally accompanied with false information about its structure, characteristics and (or) the producer.

3. The authorized body of state member makes the decision on suspension or will lock uses and retirement in the territory of the state of the medical product posing hazard to life and (or) human health, poor-quality, counterfeit or counterfeited medical product based on the results received during implementation of the state control (supervision) in the sphere of the address of medical products or revealed within the monitoring of safety, quality and efficiency of medical products performed according to the Rules of carrying out monitoring of safety, quality and efficiency of medical products approved by the Decision of Board of the Eurasian economic commission of December 22, 2015 №174.

4. The term for which use of medical product stops shall not exceed 180 calendar days from the date of adoption of the relevant decision. The specified term can be extended by authorized body of state member in case of need of conducting additional examination of safety, quality and efficiency of medical product in connection with the revealed negative effects of its use for conducting such examination.

5. Suspension of use of medical product can be performed by authorized body of state member based on the medical product provided by the producer or its authorized representative of the statement (with reasons) for the term specified in the statement.

6. The authorized body of state member within 1 working day from the date of decision making about suspension of use of medical product or about prolongation of term of suspension of use of medical product posts it on the official site on the Internet.

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