After the Decision No. 78 of the Board Eurasian Economic Commission (EEC) oN November 3rd, 2016, the “Rules” for registration and expert review of drugs for medical use within the Eurasian Economic Union (EAEU) were approved and entered into force on May 6th, 2017.
With a view to theese forthcoming changes, medicines registered under the “Rules” can circulate and be offered for sale throughout the EAEU, in the territories of Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan without undergoing any registration procedures in each of these member states.
In particular, the “Rules” provide two procedures for registration of medicines:
1) Mutual recognition: the registration is first conducted in the reference state at the applicant’s choice, then in the states of recognition at the applicant’s request;
2) Decentralised procedure: the registration is conducted simultaneously in several member states in which an application has been filed, one of which is chosen as the reference state.
In addition, for registration dossiers of medicines registered in the member states under the national requirements before 31 December 2020, it is necessary to conduct the Bringing into Compliance procedure with the EAEU requirements until 31 December 2025.
In case the drug product was registered before 31.12.2020 and marketed in at least three member states for five years, an unlimited MA will be issued, after the approval of the above mentioned procedure.
Regulatory Pharma Net team and experts have years of experience in identifying the best solutions and are available to support companies with the preparation of the registration dossiers and to conduct the “Bringing into Compliance” procedure. We would be happy to respond to any of your inquiries.
For further information you are welcome to visit us at BOOTH B 37 at DIA Europe 2019 or sending your request to info@regulatorypharmanet.com we could arrange a dedicated meeting or teleconference.
Regulatory Pharma Net team is available to support companies to comply with this requirement.