Regulatory Alert and Reminder: Kazakhstan, Kyrgyzstan, Armenia

We remind you that 31 December 2025 is the deadline for submitting applications for bringing national marketing authorisations into compliance with the requirements of the EAEU.

On 22 May 2025, by Decision of the Council of the Eurasian Economic Commission No. 34, amendments were introduced to the Rules for Registration and Expert Examination of Medicinal Products for Medical Use. These amendments establish a mechanism for a smooth transition from national marketing authorisations to the EAEU format without interruption of product circulation, provided that an application and dossier for alignment are submitted by 31 December 2025.

Key provisions of the amendments:

• National marketing authorisations may be converted into the EAEU format without any risk of suspension of product circulation if the procedure is initiated by 31 December 2025. The validity of such authorisations is automatically extended for the duration of the procedure, but not more than 3 years in each of the applied-for Member States, and an additional period of up to 2 years for the recognition procedure in the recognition states, starting from the date of submission of the application for alignment, and in any case not beyond 31 December 2027.
• Marketing authorisations for which no application for alignment with the EAEU rules is submitted in the reference state by 31 December 2025 inclusive remain valid only until the expiry date specified in the national authorisations of the EAEU Member States. However, no post-registration variations, re-registration, renewal, or subsequent applications for alignment with the EAEU rules may be submitted from 1 January 2026.
• Medicinal products that will be registered under a national procedure after 31 December 2025 (in countries where the national procedure is formally retained) will be valid exclusively as local registrations, applicable only within the domestic market of the respective country. They cannot be transitioned into the EAEU framework and will cease to be valid no later than 31 December 2027.
• The introduction of variations to the dossier in the reference state is permitted throughout the entire duration of the recognition procedure.
• The provision allowing temporary submission of a package of supporting documents instead of an EAEU GMP certificate, with an obligation to undergo inspection within three years after registration, becomes permanent. At the same time, the updated rules introduce significantly stricter consequences for failure to fulfil this obligation — up to and including suspension or cancellation of the registration.
• The procedure for introducing variations in the recognition states that do not affect the registration in the reference state has been clarified, enabling timely responses to local requirements, particularly with regard to labelling and the package leaflet.

The respective amendments have already been implemented into the national legislation of Armenia, Kazakhstan, and Kyrgyzstan.