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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of December 19, 2023 No. 178

About the technological documents regulating information exchange in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of rules of proper production practice of the Eurasian Economic Union"

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

1. Approve enclosed:

Rules of information exchange in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union";

Regulations of information exchange between authorized bodies (organizations) of state members of the Eurasian Economic Union in the field of drug circulation which are carrying out pharmaceutical inspections and the Eurasian economic commission in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union";

Regulations of information exchange between authorized bodies (organizations) of state members of the Eurasian Economic Union in the field of drug circulation which are carrying out pharmaceutical inspections in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union";

Regulations of information exchange between the public authorities of state members of the Eurasian Economic Union authorized on implementation and (or) coordination of activities in the field of drug circulation and interested in receipt of data on results of pharmaceutical inspections for realization of the powers assigned to them and the Eurasian economic commission in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union";

The description of formats and structures of the electronic documents and data used for realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union";

Procedure for accession to general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union".

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

Chairman of Board of the Eurasian economic commission

M. Myasnikovich

Approved by the Decision of Board of the Eurasian economic commission of December 19, 2023 No. 178

Rules of information exchange in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union"

See Rules of information exchange in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union"

 

Approved by the Decision of Board of the Eurasian economic commission of December 19, 2023, No. 178

Regulations of information exchange between authorized bodies (organizations) of state members of the Eurasian Economic Union in the field of drug circulation which are carrying out pharmaceutical inspections and the Eurasian economic commission in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union"

See Regulations of information exchange between authorized bodies (organizations) of state members of the Eurasian Economic Union in the field of drug circulation which are carrying out pharmaceutical inspections and the Eurasian economic commission in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Exchange of data on results of inspection of production sites of producers of medicines for compliance to requirements of Rules of proper production practice of the Eurasian Economic Union"

 

Approved by the Decision of Board of the Eurasian economic commission of December 19, 2023, No. 178

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