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calendary January 2, 2024

Bringing the drug dossier into compliance with the requirements of the EAEU will become easier

We are talking about the entry into force of amendments 9 and 10 of the edition of Decision 78 “On the Rules for Registration and Examination of Medicines for Medical Use.”

All participants in the pharmaceutical industry were eagerly awaiting the entry into force of Decision No. 60 (Edition 9), according to which clause 30 of the Registration Rules was renewed until December 31, 2024. This paragraph allows to provide the documents confirming the compliance of the manufacturing site with GMP requirements in the absence of an EAEU GMP certificate. Such documents include:

  • GMP certificate of the country of origin;
  • A copy of the report on the results of the last inspection of the manufacturing site conducted by the authorized body of the manufacturing country within the last 3 years;
  • Information on the results of all GMP inspections of this manufacturing site carried out over the past 3 years;
  • Information about complaints regarding the quality of medicinal products produced at this manufacturing site over the past 3 years;
  • Consent to conduct a pharmaceutical inspection for compliance with the requirements of good manufacturing practice of the Union;
  • A copy of the master file (master file) of the manufacturing site(s).

It is important that clause 30 applies only to manufacturing sites located outside the EAEU.

In addition to the amendments from Decision No. 60, on December 20, 2023, the provisions of Decision No. 114 (Edition 10) will come into force, which significantly simplify the procedure for bringing the registration dossier for a medicinal product into compliance with EAEU requirements. In particular, the ability to make changes to the registration dossier simultaneously with the compliance procedure will be optimized.

Also, the amendments of Edition 10 change the procedure for issuing registration certificates. Now it will be possible to obtain an indefinite RU if the drug has been in circulation in the reference state for more than 5 years.

References:
  1. Decision of the EEC Council No. 60 of May 23, 2023
  2. Decision of the EEC Council No. 114 of October 20, 2023

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