A special recording procedure for certain securities will be in effect until the end of 2025

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03.06.2025
THE RULES FOR REGISTRATION AND EXPERT EXAMINATION OF MEDICINES HAVE CHANGED

In particular, the deadline for submitting an application for confirmation of registration (re-registration) of a drug has changed. This must be done no earlier than 260 (not 140) working days before the expiry of the marketing authorisation in the reference member state, but no later than the expiry date of this period. 

It is envisaged to extend the validity of drug marketing authorisations for which applications for bringing marketing authorisation dossier into compliance with the requirements of the EAEU have been submitted to the authorised body (expert organisation) of the reference member state by December 31, 2025.

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