DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 № 86

About the Order of interaction of state members of the Eurasian Economic Union on identification of counterfeited, counterfeit and (or) substandard medicines

Astana

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 13 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 91 of appendix №1 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" Council of the Euroasian economic commission decided :

1. Approve the enclosed Order of interaction of the states – members of the Eurasian Economic Union on identification of counterfeited, counterfeit and (or) substandard 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 №86

Order of interaction of state members of the Eurasian Economic Union on identification of counterfeited, counterfeit and (or) substandard medicines

1. This Procedure is developed according to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 13 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and determines the procedure of interaction of state members of the Eurasian Economic Union (further respectively – state members, the Union) and the Eurasian economic commission (further – the Commission) by identification of counterfeited, counterfeit and (or) substandard medicines.

2. Information exchange concerning counteraction to the address of counterfeited, counterfeit, and (or) substandard medicines is performed between "contact points" of authorized bodies (authorized organizations) of state members which competence includes the state control (supervision) of drug circulation (further – authorized bodies), and the Commission with use of means of the integrated information system of the Union (further – the integrated system).

If necessary information exchange can be performed on e-mail addresses of "contact points".

3. With use of means of the information system of the Union in the field of drug circulation which is part of the integrated system the following general information resources are created:

a) the single information database of the medicines which are not conforming to quality requirements and also the counterfeited and (or) counterfeit medicines revealed in the territories of state members;

b) the single information database of medicines which registration certificates are suspended, and also the medicines withdrawn from the market and prohibited to medical application in the territories of state members;

c) the unified register of the registered medicines of the Union.

4. General information resources are created on the basis of information exchange of state members and the Commission.

5. Authorized body with use of the integrated system:

a) performs information exchange with authorized bodies of other state members and the Commission;

b) supports information provided to them for inclusion in general information resources in urgent condition.

6. Information exchange between authorized bodies, and also between authorized bodies and the Commission in the course of forming, maintaining and use of general information resources is performed by means of realization of general processes within the Union by means of the integrated system.

7. The data containing in general information resources are provided according to the procedure, established by the Commission.

8. Authorized bodies have the right to use means of the integrated system for information exchange with each other and the Commission in the following cases:

a) receipt of information on the facts and circumstances creating threat of life and (or) to health of the person in case of use of medicines;

b) identification of the fact of the address in the territory of state member of counterfeited, counterfeit and (or) substandard medicines during implementation of actions on control of drug circulation and carrying out monitoring of safety, quality and efficiency of medicines;

c) implementation of measures for suspension of action of registration certificates of medicines, response and prohibition to medical application of medicines.

9. In case of exchange of information about the revealed counterfeited, counterfeit and (or) substandard medicines, containing the data carried by the legislation of state members to data of limited distribution, the authorized body of state member provides the address with such information and its protection according to the legislation of the state.

Authorized bodies notify each other that information on the revealed counterfeited, counterfeit and (or) substandard medicines belongs to data of limited distribution.

10. Information exchange is performed in the following modes:

a) the operational notification (the operational notification shall contain data on identification counterfeited and (or) counterfeit medicinal means according to the list according to appendix №1, about identification of substandard medicine – according to the list according to appendix №2);

b) information request.

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