DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of May 29, 2024 No. 43

About modification of Rules of registration and examination of medicines for medical application

According to article 7 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and Item 84 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission solved:

1. Bring in the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78, of change according to appendix.

2. This Decision becomes effective after 30 calendar days from the date of its official publication and extends to the legal relationship which arose since March 1, 2024.

Members of council of the Eurasian economic commission:

Appendix

to the Decision of Council of the Eurasian economic commission of May 29, 2024 No. 43

The changes made to Rules of registration and examination of medicines for medical application

1. In Item 19:

a) after the paragraph of the twenty seventh to add with the paragraph of the following content:

"number of the version (sequence) of submission of documents of the electronic registration file" – number assigned by the applicant to documents of the registration file represented in electronic form according to the requirements to structure of the document established by the Commission together with the statement for modification and (or) in response to the request of authorized body (the expert organization) of state member representing data on each submission of the registration file in the form of 4 Arab figures (for primary submission of the registration file figures "0000" are specified);";

b) in paragraph 48 of the word of "changes in the registration file" shall be replaced with words "in the registration file of the changes exerting impact on earlier drawn conclusions".

2. In the paragraph the second Item 48 of the word "in the conditions of threat of origin, origin and liquidation of emergency situation and (or) in case of threat" shall be replaced with words "in case of origin threat, emergence of emergency situation and liquidation of its effects and (or) in case of threat".

3. State Item 62 in the following edition:

"62. The expert valuation report shall be updated by the expert organization of the reference state in case of new information which is important for quality evaluation, safety and (or) efficiency of medicine and (or) can affect ratio "advantage – risk" medicine, within the procedure of entering into the registration file of the changes exerting impact on earlier drawn conclusions and (or) to information containing in it.".

4. In the offer the first paragraph one of Item 66-1 of the word "according to appendices No. 19 and 20 to these rules" shall be replaced with words "according to appendix No. 19".

5. State Item 113 in the following edition:

"113. Updating of the expert report is performed according to Item 62 of these rules.".

6. State Item 144 in the following edition:

"144. Entering into the registration file of changes of IA of type, Ianutipa and (or) IB of type according to amendment of V to appendix No. 19 to these rules within the procedure of registration confirmation (re-registration) of medicine without additional filing of application about modification of the registration file is allowed.".

7. The paragraph one of Item 152 to state in the following edition:

"152. Modification of the registration file of the registered medicine and examination of the made changes are performed according to the classification of changes and rules of their introduction provided by appendix No. 19 to these rules.".

8. State Items 153 and 154 in the following edition:

"153. In case of the positive decision of authorized body (the expert organization) on modification of the registration file the new registration certificate of medicine at former number on remaining period of action of registration of medicine (for registration certificates of medicines with limited effective period) or without restriction of effective period (for termless registration certificates of medicines) is issued to the applicant if the made changes concern information containing in the registration certificate of medicine. Data on date of the decision of authorized body (the expert organization) for each approved change with indication of number (numbers) of the version (sequence) of submission of documents of the electronic registration file are provided in the unified register.

154. In case of entering into the registration file of medicine of changes of IA of type according to amendment of V to appendix No. 19 to these rules which are not mentioning information on medicine in 60 working days and before the end of action of less registration certificate of medicine introduction of such changes in the course of conducting examination of medicine in case of confirmation of its registration (re-registration) is allowed.".

9. In Item 155:

a) the paragraph one to state in the following edition:

"155. In case of filing of application about modification of the registration file of the medicine registered in the reference state and the states of recognition, the applicant shall provide to authorized body (the expert organization) of the reference state information on prior dates of giving and numbers of versions (sequences) of submission of documents on modification of the registration file of the states of recognition (in the presence).";

b) add paragraph two with words ", and also (if necessary) the document created by authorized body (the expert organization), confirming validity of the corresponding version (sequence) of submission of documents of the electronic registration file. Change of the holder of the registration certificate is considered according to amendment of V to appendix No. 19 to these rules".

10. In paragraphs one both third Item 172 and the paragraph the second Item 174 of the word "appendices No. 19 and 20" shall be replaced with words "appendix No. 19".

11. In appendix No. 19 to the specified Rules:

a) to state the text of appendix (except for amendments) in the following edition:

"Appendix No. 19

to Rules of registration and examination of medicines for medical application

(in edition of the Decision of Council of the Eurasian economic commission of May 29, 2024 No. 43)

Rules of modification of the registration file of the registered medicine for medical application

I. General provisions

1.1. Subject and scope of application

1.1.1. These rules establish procedure for modification of the registration file of the registered medicine (further – modification) according to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 (further – Rules of registration and examination), and procedure for modification of the registration file of the medicines which are exposed to the procedure of reduction of the registration file of the medicine registered according to the national procedure in state members of the Eurasian Economic Union (further – state members, the Union), in compliance with Rules of registration and examination (further – reduction in compliance), and also regulate rules of conducting examination in case of introduction of the specified changes.

Holders of registration certificates of medicines (further respectively – holders, registration certificates) or applicants have the right to address to authorized body (the expert organization) of the reference state for receipt of the recommendation about classification of changes which classification is not provided by these rules, according to Item 1.5.1 of these rules or on other questions connected with the procedure of modification. If necessary discussion of the specified questions with authorized bodies (the expert organizations) of the states of recognition can be organized.

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