DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of February 28, 2023 No. 20

About modification of 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 Eurasian economic commission of February 12, 2016 No. 46 (further - Rules of registration), the Board of the Eurasian economic commission solved:

1. Bring in 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, No. approved by the Decision of Board of the Eurasian economic commission of June 30, 2017 78, of change according to appendix.

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

Appendix

to the Decision of Board of the Eurasian economic commission of February 28, 2023 No. 20

The changes made to 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

Requirements to state in the following edition:

"Are approved by the Decision of Board of the Eurasian 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 Eurasian economic commission of February 12, 2016 No. 46 (further - Rules of registration, the Commission).

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 modification of the registration file of the medical product in notifying procedure represented according to appendix No. 9 to Rules of registration (further - the statement for change in notifying procedure);

e) the statement for cancellation (cancellation) of the registration certificate of the medical product represented according to appendix No. 13 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. 10 to Rules of registration (further - the statement for issue of the duplicate);

g) the statement for carrying out approval of the expert opinion on the registered medical product represented according to appendix No. 11 to Rules of registration (further - the statement of accession).

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 appendix No. 4 to Rules of registration, and also the documents processed by consideration of the registration file of medical product.

6. The list of the documents submitted by the applicant in electronic form is determined by Rules of registration.

7. Specified in items 4 and 5 these Requirements documents in electronic form are created in XML format according to the Extensible Markup Language (XML) 1.0 (Fifth Edition) standard (it is published on the Internet to the address: http://www.w3.org/TR/REC-xml).

8. Specified in items 4 and 5 these Requirements of structure of documents in electronic form represent set of the details located in hierarchical type. Details of structures of documents in electronic form can include 1 or several enclosed details.

9. The description of structures of documents in electronic form and the rule of their filling is provided in tabular form with indication of complete rekvizitny structure taking into account hierarchy levels up to simple (atomic) details (table 1 - 7 and 10).

10. For specifying of obligation of filling of details the following designations in the column "Plurality" ("Mn".) in tables 2 are used - 7 and 10:

0 - the detail is not filled;

1 - the detail is obligatory;

0. 1 - props are optional, repeatings are not allowed;

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