Snapshot

The EEU Decentralized 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 an abridged review (a reliance 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 decentralized procedure involves the simultaneous submission of the dossier to all states selected by the applicant. The total procedure duration in the reference state does not exceed 140 working days, and in the concerned states, 50 working days. This procedure is used less frequently, primarily when a simultaneous product launch in several countries is required. .