Snapshot

The EEU Mutual Recognition Procedure pathway has been developed by the Eurasian Economic Union of EEU Eurasia Economic Union.

This pathway can be used where medicinal products.

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Armenia Belarus Kazakhstan Kyrgyzstan Russia

When relevant, the agency relies on prior decisions from Armenia Belarus Kazakhstan Kyrgyzstan Russia

Target time assessment is The EAEU rules for marketing authorization establish two main procedures for bringing new medicines to the EAEU market: the mutual recognition procedure and the decentralized procedure. The applicant has the autonomy to select the reference state and, where necessary, the concerned states. The reference state is the lead country that conducts the primary scientific evaluation of the dossier, and the concerned states are other EAEU countries in which the applicant seeks approval. The application and dossier are submitted electronically with an electronic signature. The mutual recognition procedure involves sequential dossier submission: first to the reference state, and then to the concerned states. Marketing authorization in the reference state is granted within 140 working days. If additional materials are requested, the applicant has up to 90 working days to respond, with a possible extension (the total response period must not exceed 180 working days). In the concerned states, provided there are no disagreements, marketing authorization is granted no later than 60 working days from the date of access to the expert report. In practice, the mutual recognition procedure is the more commonly used procedure, and the reference state is typically Russia. .