In July 2021, the Eurasian Economic Commission issued an update that from July 1, 2021, medicinal products should be registered according to the unified rules of the EAEU. These rules were approved by the Decision of the Council of the Economic Commission dated 03.01.2017 No. 78 “On the rules for registration and examination of medicines for medical use”. At the same time, for the Russian Federation, the establishment of compulsory registration under the EAEU Rules was carried out from January 1, 2021.
The main features of the above rules for the registration of medicines on the territory of the EAEU include:
prior to filing an application for registration of a medicinal product, the authorized bodies or expert organizations of the Member States have the right, at the request of the applicant, to conduct scientific and pre-registration consultations in accordance with the legislation of the Member States on issues related to analytical trials, preclinical and clinical trials;
- when submitting an application for registration, confirmation of registration (re-registration), bringing the medicinal product into compliance with the EAEU requirements, the applicant must submit a valid document as part of the registration dossier confirming compliance with the EAEU Good Manufacturing Practice requirements;
- preclinical drug safety studies conducted in non-EAEU states are considered during the examination of drugs, provided that they are planned, performed and described in the preclinical study report in accordance with the requirements of good laboratory practice, equivalent to those of the EAEU;
- period for registration and examination of a medicinal product in the reference state should not exceed 210 calendar days from the date of filing an application for registration of a medicinal product until the day of issuance of a registration certificate.
Recall that until July 1, 2021, at the choice of the applicant, the registration of a medicinal product could be carried out either in accordance with the EAEU Rules, or in accordance with the legislation of a member state.
From July 1, 2021, the first stage of the transition to a single registration has been completed in all EAEU countries.
At the same time, medicines already registered and in national registries will be in circulation until the end of 2025. The registration dossier of such medicinal products, if the manufacturer plans to circulate them on the territory of the EAEU after 2025, must be brought in line with the rules for registration and examination of medicinal products of the EAEU. Thus, participants in the union market should take into account that all registration certificates issued according to the national rules of the member states are valid until their expiration, but no later than December 31, 2025.
August 11, 2021