DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of July 17, 2018 № 113

About approval of the Management on validation of analytical techniques of carrying out testing of medicines

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 2 of article 3 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 Euroasian economic commission decided:

1. Approve the enclosed Management on validation of analytical techniques of carrying out testing of medicines.

2. This Decision becomes effective after 6 months from the date of its official publication.

Approved by the Decision of Board of the Euroasian economic commission of July 17, 2018 №113

Management on validation of analytical techniques of carrying out testing of medicines

I. General provisions

1. In the present manual rules of validation of analytical techniques of carrying out testing of medicines, and also the list of the characteristics which are subject to assessment in case of validation of the specified techniques and to inclusion in the registration files submitted to authorized bodies of state members of the Eurasian Economic Union are determined (further respectively – state members, the Union).

2. The purpose of validation of analytical technique of carrying out testing of medicines is documentary confirmation of its suitability for purpose.

II. Determinations

3. For the purposes of the present manual concepts which mean the following are used:

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