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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 №93

About recognition of results of inspection of production of medicines

(as amended of the Decision of Council of the Eurasian economic commission of 04.09.2020 No. 66)

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 7 of article 7 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 Council of the Eurasian economic commission decided: Determine that:

1. Till December 31, 2020 (inclusive) authorized bodies of state members of the Eurasian Economic Union when implementing state registration (re-registration, registration confirmation, modification of the registration file of medicine) of medicines according to the legislation of state member of the Eurasian Economic Union mutually recognize the documents issued by authorized bodies of state members of the Eurasian Economic Union, confirming compliance of production of medicines to requirements of proper production practice of the Eurasian Economic Union or for the medicines made in state members of the Eurasian Economic Union - to requirements of proper production practice of state members of the Eurasian Economic Union.

From January 1, 2021 to December 31, 2025 (inclusive) authorized bodies of the states of members of the Eurasian Economic Union during the implementing of re-registration, registration confirmation, modification of the registration file of medicine according to the legislation of state member of the Eurasian Economic Union mutually recognize the documents issued by authorized bodies of the states of members of the Eurasian Economic Union, confirming compliance of production of medicines to requirements of proper production practice of the Eurasian Economic Union or for the medicines made in state members of the Eurasian Economic Union - to requirements of proper production practice of state members of the Eurasian Economic Union.

2. This Decision becomes effective 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

 

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

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