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DECISION OF BOARD OF THE EUROASIAN ECONOMIC COMMISSION

of June 30, 2017 No. 78

About Requirements to electronic type of statements and the documents of the registration file submitted when implementing registration and examination of safety, quality and efficiency of medical products

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 safety, quality and efficiency of medical products approved by the Decision of Council of the Euroasian economic commission of February 12, 2016 No. 46 (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 safety, quality and efficiency of medical products (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. 78

Requirements to electronic type of statements and the documents of the registration file submitted when implementing registration and examination of safety, quality and efficiency of medical products

I. General provisions

1. These Requirements are developed for the purpose of creation of equal conditions for business entities of state members of the Eurasian Economic Union (further respectively – state members, the Union) on submission of data in electronic form to authorized bodies of state members (the expert organizations) in case of performing procedures of registration and examination of safety, quality and efficiency of medical products.

2. The concepts used in these Requirements are applied in the values determined by 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 safety, quality and efficiency of medical products approved by the Decision of Council of the Euroasian economic commission of February 12, 2016 No. 46 (further – Rules of registration).

3. These Requirements determine structure and rules of filling of the documents in electronic form submitted by the applicant to authorized bodies of the state members in case of performing procedures provided by Rules of registration.

4. Structure of the document in electronic form "Data on the statement on carrying out registration of medical product within the Eurasian Economic Union" (R. 018) it is intended for electronic submission of the following types of statements:

a) the statement for conducting examination of medical product within the Union – according to appendix No. 2 to Rules of registration (further – the statement for examination);

b) the statement for carrying out registration of medical product within the Union represented according to appendix No. 3 to Rules of registration (further – the statement for registration);

c) the statement for modification of the registration file of medical product within the Union represented according to appendix No. 7 to Rules of registration (further – the statement for change);

d) the statement for cancellation (cancellation) of the registration certificate of the medical product represented according to appendix No. 10 to Rules of registration (further – the plea of nullity);

e) the statement for issue of the duplicate of the registration certificate of the medical product represented according to appendix No. 11 to Rules of registration (further – the statement for issue of the duplicate).

5. Structure of the document in electronic form "Data on the documents of the registration file of medical product or documents processed by consideration of the registration file of medical product" (R. 020) it is intended for electronic submission of documents of the registration file of medical product according to appendices No. 4 and 8 to Rules of registration, and also the documents processed by consideration of the registration file of medical product.

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