Bringing the registration dossier in compliance with the requirements of the EAEU

Formation of the common market of medical drugs on the territory of countries that are members of the Eurasian Economic Union (EAEU) requires a unified approach to the requirements for the registration dossier for approval of the drug for medical use.

Already registered medicinal drugs which are in circulation must be brought into compliance with EAEU requirements by the end of 2025. A special procedure is provided for this purpose. Employees of X7Research Registration Department have great experience in reviewing dossiers and bringing them in compliance with the requirements outlined in the Rules for Registration and Examination of Medicinal Products for Medical Use.

X7 Research assists in compliance with the dossier with EAEU requirements. We accompany the whole registration process until the receipt of the new registration certificate.

REVIEW OF REGISTRATION DOSSIER FOR COMPLIANCE WITH EEA REQUIREMENTS

PREPARATION OF ADDITIONAL REVIEWS / JUSTIFICATIONS

SUBMISSION OF THE DOSSIER TO THE REGULATORY AUTHORITIES OF THE REFERENCE COUNTRY

X7 Research knows how to ensure that all stages of drug registration are passed without any claims from the regulatory authorities. For 10 years we have been successfully working with clients from different countries.

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