The Council of the Eurasian Economic Commission (EEC) approved Decision No. 34 of 22.05.2025 , which amends the Decision of the EEC Council No. 78 of 03.11.2016 “On the rules for registration and examination of medicines for medical use”.
The document states that registration certificates for medicines issued before December 31, 2025, remain valid until their expiration and after the specified period if a certain condition is met. For drugs registered under national rules, but with applications submitted for compliance with the EAEU requirements before December 31, 2025, the validity period of the certificates is extended:
for no more than three years - for the reference state (from the date of application);
for no more than two years - for states of recognition (from the date of filing an application in them).
If the alignment procedure is completed in the reference State before 31 December 2025, the certificates in the recognition States are extended for two years from 31 December 2025.
Applications for bringing the registration dossier into compliance with the EAEU standards must be submitted to the reference state by 31 December 2025. The reference state is obliged to notify the recognition states of such applications within five working days. If the application is rejected or withdrawn, the applicant must inform all interested states.
The decision also changes the deadline for the procedure for making changes to the registration dossier during the examination in the recognition states and introduces a new form of the expert report. The conditions for drugs from third countries are also changing: drugs imported before December 31, 2025, can be sold in the EAEU only in the country that issued the certificate, if an application for compliance with the union's standards has not been submitted.
The document will come into force on June 22, while a number of provisions apply to legal relations that arose from January 1, 2024. You can read it on the portal: https://pharmnewskz.com/ru/legislation/reshenie-soveta-eek-ot-22-maya-2025-goda--34_10242
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
The document states that registration certificates for medicines issued before December 31, 2025, remain valid until their expiration and after the specified period if a certain condition is met. For drugs registered under national rules, but with applications submitted for compliance with the EAEU requirements before December 31, 2025, the validity period of the certificates is extended:
for no more than three years - for the reference state (from the date of application);
for no more than two years - for states of recognition (from the date of filing an application in them).
If the alignment procedure is completed in the reference State before 31 December 2025, the certificates in the recognition States are extended for two years from 31 December 2025.
Applications for bringing the registration dossier into compliance with the EAEU standards must be submitted to the reference state by 31 December 2025. The reference state is obliged to notify the recognition states of such applications within five working days. If the application is rejected or withdrawn, the applicant must inform all interested states.
The decision also changes the deadline for the procedure for making changes to the registration dossier during the examination in the recognition states and introduces a new form of the expert report. The conditions for drugs from third countries are also changing: drugs imported before December 31, 2025, can be sold in the EAEU only in the country that issued the certificate, if an application for compliance with the union's standards has not been submitted.
The document will come into force on June 22, while a number of provisions apply to legal relations that arose from January 1, 2024. You can read it on the portal: https://pharmnewskz.com/ru/legislation/reshenie-soveta-eek-ot-22-maya-2025-goda--34_10242
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
