March 2, 2025
When will the procedure for bringing the dossier in line with the requirements of the EAEU be completed?
The situation with the dossier harmonization with the requirements of the EAEU region in the pharmaceutical industry has only become more dynamic in the last few years. However, the pace of bringing registration dossiers in line with the new requirements is still insufficient.
According to current regulatory requirements, the harmonization procedure must be initiated before 31.12.2025. However, in Russia, only 78% of all registered medicines have passed or have already launched the necessary changes. In Kyrgyzstan, this figure did not reach even 4%, in Armenia – 6%.
In October 2024, the EEC Council proposed to simplify the transition period of the harmonization if this process is not completed by the end of 2025. In particular, the authors of the document propose to extend the validity period of the RC for drugs for which the harmonization procedure has already been initiated as follows:
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In the reference State – for no more than 3 years.
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In the States of recognition – for an additional period of no more than 2 years.
The sale of such medicines in the EAEU member States will be allowed until their expiration date.
The end of the transition period is also complicated by the lack of an extension of paragraph 30 of Decision 78, according to which pharmaceutical companies can provide a number of other documents instead of the EAEU GMP certificate. This clause ended on 12/31/2024 and so far no amendments have been adopted to allow the application to be submitted in more lenient conditions.
Due to these difficulties, the largest pharmaceutical associations of the EAEU asked to speed up the consideration of the draft decision of the EEC Council in order to relieve the burden on the industry as much as possible and avoid possible disruptions to the supply of medicines in the EAEU member states.
According to the Vedomosti newspaper, the appeal is under consideration in the "relevant department."
