of November 3, 2016 №76
About approval of Requirements to marking of medicines for medical application and veterinary medicines
According to articles 30 and 56of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 14 of appendix №12 to the Agreement on the Eurasian Economic Union of May 29, 2014, article 8 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Items 57 and 97of appendix №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 № 98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 №108 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" Council of the Eurasian economic commission decided:
1. Approve the enclosed Requirements to marking of medicines for medical application and veterinary medicines (further – Requirements to marking).
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 drug circulation 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, except for provisions of the Requirements to marking approved by this Decision concerning marking of veterinary medicines. The provisions of Requirements to marking concerning marking of veterinary medicines become effective from the effective date regulations of the address of the veterinary medicines approved by Council of the Eurasian economic commission according to Item 57 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.
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 November 3, 2016 №76
1. These Requirements establish rules of the marking placed on packagings of medicines for medical application (further – medicines) and the veterinary medicines (further – veterinary means) released in the total market of medicines within the Eurasian Economic Union (further – the Union).
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