DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of June 30, 2020 No. 86

About modification of Item 5 of Requirements to research of stability of medicines and pharmaceutical substances

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 2 of Article 3 and article 6 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 the Board of the Eurasian economic commission solved:

1. The paragraph of the sixth of Item 5 of Requirements to research of stability of the medicines and pharmaceutical substances approved by the Decision of Board of the Eurasian economic commission of May 10, 2018 No. 69, to state in the following edition:

"date of production of series" - date of accomplishment of the first transaction, including mixing of active pharmaceutical substance with other components of medicine. For the medicines consisting of one pharmaceutical substance in primary package, initial date of packing (filling of primary package) is considered date of production;".

2. This Decision becomes effective after 30 calendar days from the date of its official publication.

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