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DECISION OF BOARD OF THE EUROASIAN ECONOMIC COMMISSION

of August 30, 2016 No. 94

About the technological documents regulating information exchange in case of realization by means of the integrated information system of foreign and mutual trade of general process "Forming, maintaining and use of the single information database of monitoring of safety, quality and efficiency of medical products"

According to Item 30 of the Protocol on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 3 to the Agreement on the Eurasian Economic Union of May 29, 2014) and being guided by the Decision of Board of the Euroasian economic commission of November 6, 2014 No. 200, the Board of the Euroasian economic commission solved:

1. Approve enclosed:

Rules of information exchange in case of realization by means of the integrated information system of foreign and mutual trade of general process "Forming, maintaining and use of the single information database of monitoring of safety, quality and efficiency of medical products";

Regulations of information exchange between authorized bodies of state members of the Eurasian Economic Union and the Euroasian economic commission in case of realization by means of the integrated information system of foreign and mutual trade of general process "Forming, maintaining and use of the single information database of monitoring of safety, quality and efficiency of medical products";

The description of formats and structures of the electronic documents and data used for realization by means of the integrated information system of foreign and mutual trade of general process "Forming, maintaining and use of the single information database of monitoring of safety, quality and efficiency of medical products";

Procedure for accession to general process "Forming, maintaining and use of the single information database of monitoring of safety, quality and efficiency of medical products".

2. Determine that development of technical schemes of structures of the electronic documents and data provided by the Description approved by this Decision, and ensuring their placement in the register of structures of the electronic documents and data used in case of realization of information exchange in the integrated information system of foreign and mutual trade are performed by department of the Euroasian economic commission which competence includes coordination of works on creation and development of the integrated information system of the Eurasian Economic Union.

3. This Decision becomes effective after 30 calendar days from the date of its official publication.

Chairman of Board of the Euroasian economic commission

T. Sargsyan

 

Approved by the Decision of Board of the Euroasian economic commission of August 30, 2016 No. 94

Rules of information exchange in case of realization by means of the integrated information system of foreign and mutual trade of general process "Forming, maintaining and use of the single information database of monitoring of safety, quality and efficiency of medical products"

I. General provisions

1. These rules are developed according to the following acts entering the right of the Eurasian Economic Union (further - the Union):

The agreement on the Eurasian Economic Union of May 29, 2014;

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;

The decision of the Supreme Euroasian economic council of December 23, 2014 No. 109 "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";

The decision of Council of the Euroasian economic commission of February 12, 2016 No. 30 "About approval of the Procedure for forming and maintaining information system in the sphere of the address of medical products";

The decision of Board of the Euroasian economic commission of November 6, 2014 No. 200 "About the technological documents regulating information exchange in case of realization by means of the integrated information system of foreign and mutual trade of general processes";

The decision of Board of the Euroasian economic commission of January 27, 2015 No. 5 "About approval of Rules of electronic data exchange in the integrated information system of foreign and mutual trade";

The decision of Board of the Euroasian economic commission of April 14, 2015 No. 29 "About the list of general processes within the Eurasian Economic Union and modification of the Decision of Board of the Euroasian economic commission of August 19, 2014 No. 132";

The decision of Board of the Euroasian economic commission of June 9, 2015 No. 63 "About the Analysis technique, optimization, harmonizations and descriptions of general processes within the Eurasian Economic Union";

The decision of Board of the Euroasian economic commission of September 28, 2015 No. 125 "About approval of the Regulations on exchange of electronic documents in case of cross-border interaction of public authorities of state members of the Eurasian Economic Union among themselves and with the Euroasian economic commission";

The decision of Board of the Euroasian economic commission of December 22, 2015 No. 174 "About approval of Rules of carrying out monitoring of safety, quality and efficiency of medical products".

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