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DECISION OF BOARD OF THE EUROASIAN ECONOMIC COMMISSION

of June 30, 2017 No. 79

About Requirements to electronic type of statements and the documents of the registration file submitted when implementing registration and examination of medicines for medical application

According to Item 11 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 the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Euroasian economic commission of November 3, 2016 No. 78 (further – Rules of registration), the Board of the Euroasian economic commission solved:

1. Approve the enclosed Requirements to electronic type of statements and the documents of the registration file submitted when implementing registration and examination of medicines for medical application (further – Requirements).

2. Determine that development of technical schemes of structures of the documents in electronic form provided by Requirements and ensuring their placement in the register of structures of electronic documents and data published on the official site of the Eurasian Economic Union (further – the Union), 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 Union.

3. Determine that in case of realization in state members of the Union of electronic form of interaction in case of performing procedures according to Rules of registration the documents in electronic form provided by Requirements according to the technical schemes of structures of such documents containing in the register of structures of electronic documents and data are applied.

4. 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 June 30, 2017 No. 79

Requirements to electronic type of statements and the documents of the registration file submitted when implementing registration and examination of medicines for medical application

see Requirements to electronic type of statements and the documents of the registration file submitted when implementing registration and examination of medicines for medical application (0.11Mb In original language)

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