DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of September 7, 2018 No. 151

About approval of the Management on creation of the regulating document on quality of medicine

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, articles 4 and 13 of the Agreement on the single principles and rules of drug circulation within Eurasian economic союзаот on December 23, 2014 the Board of the Eurasian economic commission solved:

1. Approve the enclosed Management on creation of the regulating document on quality of medicine.

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

Approved by the Decision of Board of the Eurasian economic commission of September 7, 2018 No. 151

Management on creation of the regulating document on quality of medicine

I. General provisions

1. The present manual is developed taking into account appendix No. 3 to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 (further - Rules), and establishes procedure for creation and execution of the regulating document on quality of medicine (further - the regulating document on quality).

2. The present manual extends to medicines for medical application irrespective of the nature of their active ingredients.

Concerning active pharmaceutical substance creation of the regulating document on quality is not required.

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