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calendary August 30, 2023

Changes in the rules for registration of medicines 2023

In May 2023, Decision No. 60 “On Amendments to the Rules for Registration and Examination of Medicinal Products for Medical Use” was published on the legal portal of the Eurasian Economic Union. By this decision were approved a number of important changes that many members of the regulatory community were waiting for.

Firstly, as part of these changes, some terms related to high-tech, herbal and combined preparations were clarified and supplemented. Also, such terms as "major objection" and "insignificant remark" and corresponding changes in the procedure for examination and preparation of an expert report appeared.

"major objection" - an expert's remark that the data presented in the registration dossier by the applicant do not confirm the quality and (or) efficacy of the registered medicinal product for medical use or indicate that the "benefit-risk" ratio for the medicinal product is unacceptable and the risk causing harm to human health as a result of taking a medicinal product exceeds the effectiveness of the use of such a medicinal product, which makes its registration impossible;

"insignificant remark" – an expert’s remark that the documents submitted in the registration dossier on the quality, safety and efficacy of a medicinal product contain a deviation from the requirements of the relevant acts of the Union bodies in the field of circulation of medicines, which cannot lead to a risk of harm to human health due to taking a medicinal product;

Secondly, it became possible for the Commission to provide and restrict access to the regulatory document on quality to laboratories that carry out quality control: “if it is necessary to provide the Commission with access to the regulatory document on the quality of a medicinal product using the means of an integrated system, the authorized bodies (expert organizations) of the Member States send to the Commission an appropriate written request containing information about the laboratories that carry out quality control and the experts who need to be granted such access” The procedure for restricting access is similar to the above.

Thirdly, clarifications were made to the list of information included in the protocol of laboratory tests (Appendix 12).

And finally, the validity of paragraph 30 of the Rules on the possibility of providing documents confirming the readiness for inspection, instead of the missing GMP certificates of the EAEU / EAEU member country, has been extended until 12/31/2024. According to the current version of the Rules, this possibility existed until 12/31/2021.

Given the date of publication (June 22, 2023), the Decision will enter into force within 180 calendar days, that is, December 19, 2023.

References:
  1. https://www.consultant.ru/document/cons_doc_LAW_450208/df573f90349f9c291776a6f6224b01ec7059ce33/

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