DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 № 75

About approval of the Regulations on Expert committee on medicines

Astana

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 8 of article 7 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 90 of appendix №1 to the Regulations of work of the Euroasian 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 Regulations on Expert committee on medicines.

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. 

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 № 75

Regulations on Expert committee on medicines

I. General provisions

1. The expert committee on medicines (further – Committee) is created under the Eurasian economic commission (further – the Commission) according to Item 8 of article 7 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.

2. The committee 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.

3. The basic principles of activities of Committee are the principles of legality, voluntariness, openness, equality, competence and professionalism of participants, collective nature of decision making, orientation to world level of development of science and technology.

4. The committee based on appeals of public authorities of state members of the Union (further – state members), members of Board of the Commission and members of the committee performs development of offers on questions:

a) harmonization and standardization of the legislation of state members in the field of drug circulation;

b) harmonizations of the legislation of state members in the field of control (supervision) in the field of drug circulation and interaction of the authorized bodies performing control (supervising) functions in the field of drug circulation;

c) ensuring unity of mandatory requirements to safety, efficiency and quality of medicines in the territories of state members and their observance;

d) adoptions of single rules and requirements of regulation of drug circulation within the Union;

e) ensuring single approaches to creation of system of quality assurance of medicines.

5. For the purpose of ensuring realization of the single principles and regulations of drug circulation within the Union the Committee based on appeals of public authorities of the state members authorized on implementation and (or) coordination of activities in the field of drug circulation (further – authorized bodies), performs settlement in the field of drug circulation by preparation of recommendations, including the following questions:

a) settlement of disagreements of authorized bodies concerning registration and examination of safety, quality and efficiency of medicines, recognition of results of preclinical (not clinical), clinical and other trials (testing) of medicines, results of inspection of production, preclinical (not clinical), clinical trials (testing) of medicines, systems of pharmakonadzor on compliance to rules proper pharmaceutical the practician, and also to the requirements approved by the Commission;

b) consideration of cases of discrepancy in line items of authorized bodies concerning assessment of ratio of advantage and risk of the medicines which are in circulation in the territories of state members;

c) determination of need of conducting joint pharmaceutical inspection of the subject in the field of drug circulation on compliance to requirements of rules proper pharmaceutical the practician and pharmaceutical inspectorate of state member, responsible for the organization of inspection;

d) the choice of reference drug for performing preclinical (not clinical) and clinical trials (testing) of medicines in the cases provided by rules of carrying out researches of bioequivalence of medicines in the Eurasian Economic Union and rules of carrying out researches of biological medicines in the Eurasian Economic Union, names of new dosage form of the developed medicine in case of impossibility of use of the Nomenclature of dosage forms;

e) other questions carried to competence of Committee by the acts entering the right of the Union.

6. For the purpose of ensuring realization of the single principles and regulations of drug circulation within the Union the Committee based on statements of subjects of drug circulation considers the questions connected with development, preclinical (not clinical) trials and clinical trials (testing), quality assurance of medicines and activities of pharmaceutical inspectorates which are not settled by acts of the Commission and accepts the corresponding recommendations.

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