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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 12, 2016 No. 30

About approval of the Procedure for forming and maintaining information system in the field of the address of medical products

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 9 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, Item 112 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission solved No. 109:

1. Approve the enclosed Procedure for forming and maintaining information system in the field of the address of medical products.

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 the address of medical products (products of medical prescription and medical equipment) 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.

Members of council of the Eurasian economic commission:

from the Republic of Armenia

 

V. Gabriyelyan

from the Republic of Belarus

V. Matyushevsky

from the Republic of Kazakhstan

B. Sagintayev

from the Kyrgyz Republic

O. Pankratov

from the Russian Federation

I. Shuvalov

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016, No. 30

Procedure for forming and maintaining information system in the field of the address of medical products

I. General provisions

1. This Procedure is developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014 and article 9 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014.

2. The information system in the field of the address of medical products (further - information system) is intended for creation of conditions on providing the address within the Eurasian Economic Union (further - the Union) safe, high-quality and effective medical products.

3. The information system is part of the integrated information system of the Union (further - the integrated system) and includes the following information resources:

a) the unified register of the medical products registered within the Union;

b) the unified register of the authorized organizations having the right to conduct researches (testing) of medical products for the purpose of their registration;

c) single information database of monitoring of safety, quality and efficiency of medical products.

4. General information resources of information system are created on the basis of information exchange of state members of the Union and the Eurasian economic commission (further respectively - state members, the Commission).

5. For the purposes of this Procedure concepts which mean the following are used:

"the reference state" - the state member chosen by the applicant which authorized body performs registration of medical product;

"authorized body" - the public authority of state member authorized on implementation and (or) coordination of activities in the field of the address of medical products in the territory of this state member;

"the expert organization" - the legal entity of state member to which the authorized body delegates separate functions in the field of the address of medical products and also is granted the right to access to the data containing in information system.

6. Authorized body with use of means of the integrated system:

a) represents to the Commission of the data, necessary for forming and maintaining information system;

b) supports information transferred to them for entering into general information resources of information system in urgent condition;

c) performs information exchange with authorized bodies of other interested state members concerning implementation of the procedures established by Rules of registration and examination of safety, quality and efficiency of medical products (further - Rules of registration of medical products).

7. The commission performs the publication of data of open part of information system on information portal of the Union on the Internet (further respectively - information portal of the Union, the Internet).

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

9. The technological documents regulating the information exchange realized within general processes by means of the integrated system including requirements to formats and structures of the electronic documents and data used in case of such interaction are developed and affirm the Commission.

10. Access to the data of general information resources which are subject to publication for interested persons is provided through information portal of the Union on a grant basis.

11. The integrated system for information exchange with authorized bodies (the expert organizations) of other state members and the Commission is used by authorized body (the expert organization) in the following purposes:

a) obtaining and information transfer about the facts and circumstances creating threat of life or to human health in case of use of medical product;

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