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DECISION OF BOARD OF THE EURASIAN 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 Eurasian economic commission of February 12, 2016 No. 46 (further – Rules of registration), the Board of the Eurasian 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 Eurasian 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 Eurasian 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 Eurasian 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.

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 1 are used – 7 and 10:

0 – the detail is not filled;

1 – the detail is obligatory;

0. 1 – requisite is optional, repeatings are not allowed;

0.* – the requisite is optional, can repeat without restrictions;

1.* – the detail is obligatory, can repeat without restrictions;

n. m – the detail is obligatory, at least n of times of no more m of times (n> 1, of m> n shall repeat).

11. In the column "Name of Detail" are specified the name of detail, and also in brackets the name of the element of data corresponding to it in the technical scheme of structure of the document in electronic form with indication of namespace prefix.

II. Requirements to structure of the document in electronic form of "Data on the statement for carrying out registration of medical product within the Eurasian Economic Union" (R. 018)

12. For specifying of rules of filling of details depending on type of the statement the following designations are used:

"+" – the detail can be filled for this type of the statement according to its plurality;

"+ (n. m)" – the detail can be filled for this type of the statement and at least n of times of no more m of times (n > = 0, m> n shall repeat).

If designation is not specified, the detail is not filled for this type of the statement.

13. Structure of details of structure of the document in electronic form of "Data on statement for carrying out registration of medical product within Eurasian Economic Union" (R. 018) and general rules of their filling depending on type of the statement are provided in table 1.

14. Requirements to forming of XML documents according to structure of the document in electronic form "Data on the statement for carrying out registration of medical product within the Eurasian Economic Union" (R. 018) are given in table 9.

Table 1

Structure of details of structure of the document in electronic form of "Data on statement for carrying out registration of medical product within Eurasian Economic Union" (R. 018)

Name
detail

Rule of filling
detail

Statement for registration,


statement for examination

Statement for change

Plea of nullity



Statement for issue of the duplicate

Mn.

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