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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of September 22, 2015 №121

About Regulations on Pharmacopoeial committee of the Eurasian Economic Union

(as amended of the Decision of Board of the Eurasian economic commission of 27.12.2016 No. 170)

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 5 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 29 of appendix №2 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, 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" the Board of the Eurasian economic commission decided:

1. Approve the enclosed Regulations on Pharmacopoeial committee of the Eurasian Economic Union.

2. This Decision becomes effective from the effective date Agreements on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014.

Chairman of Board of the Eurasian economic commission

V. Khristenko

Approved by the Decision of Board of the Eurasian economic commission of September 22, 2015 №121

Regulations on Pharmacopoeia committee of the Eurasian Economic Union

I. General provisions

1. This Provision is developed according to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 5 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and the Decision of the Supreme Eurasian economic council of December 23, 2014 №108 also determines competence, procedure for activities and forming of Pharmakopeyny committee of the Eurasian Economic Union (further - Pharmacopoeial committee of the Union).

2. The Pharmacopoeia committee of the Union is created for the purpose of consideration and approval of general and private Pharmacopoeial clauses (monographs) of the Pharmacopoeia of the Eurasian Economic Union (further - the Pharmacopoeia of the Union), including Pharmacopoeia Articles (monographs) on veterinary medicines intended for inclusion in the Pharmacopoeia of the Union (further - Pharmacopoeia Articles (monographs)).

3. The Pharmacopoeia committee of the Union in the activities is guided by the Agreement on the Eurasian Economic Union of May 29, 2014, the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, the acts entering the right of the Eurasian Economic Union (further - the Union), and also this Provision.

4. The Pharmacopoeial committee of the Union performs the activities in interaction with authorized bodies of state members of the Union (further - state members), the international and regional organizations, public associations and other organizations.

5. The basic principles of activities of Pharmacopoeial committee of the Union are the principles of legality, voluntariness, openness, publicity, equality of participants, collective nature of decision making and accounting of interests of subjects of drug circulation.

II. Powers of Pharmacopoeiacommittee of the Union.

6. The Pharmacopoeia committee of the Union performs the following powers: 

a) development of model of harmonization of pharmacopeias of the states - members, determination of types and mechanisms of harmonization of requirements of Pharmacopoeial Articles (monographs), and also development of procedure for carrying out harmonization of pharmacopeias of state members;

b) determination of general approaches to development of Pharmacopoeial Articles (monographs) on different types of medicines (substance for pharmaceutical use, medicinal vegetable raw materials, medicines, etc.);

c) preparation of management on development and harmonization of Pharmacopoeial Articles (monographs);

d) establishment of forms of requests of need of development of Pharmacopoeial Articles (monographs), updating or introduction of amendments to pharmacopoeial articles (monographs);

e) determination of the list of the documents and materials attached to the draft of pharmacopoeial Article (monograph);

e) decision making about development of pharmacopoeial Articles (monographs), updating or introduction of amendments to pharmacopoeial articles (monographs);

g) forming annually work plan of pharmacopoeial committee of the Union;

h) determination according to offers of authorized bodies of state members of the list of test laboratories of the states - members for carrying out verification of drafts of pharmacopoeial Articles (monographs);

i) carrying out expert evaluation of drafts of pharmacopoeial Articles (monographs), drafts of quality manuals of medicines and the documents and materials attached to them;

j) consideration of drafts of pharmacopoeian Articles (monographs), drafts of quality manuals of medicines and the documents and materials attached to them and decision making about their approval or about refusal in approval (with indication of the reasons);

k) preparation and approval of the project of the Pharmacopoeia of the Union for its submitting for examination by the Eurasian economic commission (further - the Commission);

l) determination of the list of standard samples of the Pharmacopoeia of the Union;

m) implementation of the international sci-tech cooperation in the field of quality assurance of medicines.

III. Organization of activities

7. The structure of pharmacopoeial committee of the Union is created of representatives of state members.

 The number of members of Pharmacopoeia committee of the Union from each state member cannot exceed 7 people.

For the purpose of organizational and technical supply of activities of Pharmacopoeia committee by the head of department of the Commission which competence questions of regulation of drug circulation within the Union enter under pharmacopoeial committee the secretariat is created of officials and the staff of the Commission who is not part of members of pharmacopoeial committee and do not participate in vote.

 8. Modification of structure of Pharmacopoeia committee of the Union is performed based on offers of authorized bodies of state members.

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