Changes to Medicinal Products Registration Rules in the EAEU

August 25, 2025

In accordance with Decision No. 34 of the EAEU Council dated May 22, 2025, entered into force on June 21, 2025, amendments have been introduced to Decision No. 78 of the Eurasian Economic Commission Council dated November 3, 2016, concerning the “Rules for the Registration and Examination of Medicinal Products for Medical Use”.

Extension of Validity for National Registration Certificates

According to said amendments, the validity of national Registration Certificates may be extended if an application for bringing the registration dossier into compliance with the EAEU regulations is submitted to the Reference Member State by December 31, 2025, and the procedure is not yet completed.

The validity shall be extended for not more than three years from the date of submission of the application to the Authority of Reference Member State.

Extension of Validity in Concerned Member States

Additionally, the validity may be extended for the period of the expertise conducted in the Concerned Member State, but for not more than two years from the date of submission of the application to the Concerned Member State. In this case, the application must be submitted to the Concerned Member State within three years of the application being submitted to the Reference Member State.

The validity of Registration Certificates, for which the procedure for bringing the registration dossier into compliance with the EAEU regulations is completed in the Reference Member State by December 31, 2025, shall be extended in the Concerned Member States for the duration of this procedure, but may not exceed two years from the mentioned date.

Requirements for EAEU GMP Certificates

The last, but not least, referring to the above-mentioned amendments, if a valid EAEU GMP certificate is not available, the applicant may submit a set of documents for registration procedure or bringing the registration dossier into compliance with the EAEU regulations, including the documents for organization of EAEU GMP inspection along with a written commitment to undergo the inspection either during the expert evaluation process or within three years following the issuance of the Registration Certificate.

For more detailed information on associated costs, lists of required documents, etc. please contact our specialists from the Regulatory Affairs Department