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 Under this procedure, the applicant can submit the marketing authorization application in multiple member states simultaneously and get approval by following steps: • Evaluation of application and approval in the reference member state. • Assessment report prepared by the reference member state is reviewed and accepted by the member states concerned. If no major objections are raised, they proceed to grant marketing authorization in their respective states. First the applicant has to submit the following documents to the authorized authority of reference member state and then to the authority of the member states concerned within 14 days: • Application form (paper/electronic format). • Proof of fee payment. • Marketing authorization application (electronic format). Module 1 is to be submitted in paper format except for documents of Risk Management Plan, manufacturing site master file and pharmacovigilance master file. • Finished product samples. • Testing materials to be provided in enough quantity to perform three rounds of testing to the expert organization of RMS. • SmPC, patient leaflet, packaging mock-ups of the medicinal product (if required). Any disagreement between the reference member state and the member states concerned during the assessment period will be resolved by an expert committee within 60 days from the day the dispute is raised. An expert committee for medicinal products has been formed whose responsibilities are to address disagreements between member states, ensure adherence to the principles of common market for medicinal products, and provide recommendations related to various issues like inspections, regulatory gaps, development of advisory groups. Detailed process steps and key milestones are outlined below. 1. Applicant chooses RMS and CMS 2. MAA and documents submission (Day 0). Documents to be submitted include application, module 1 of MAA, proof of payment, SmPC, patient leaflet, mock-ups of packaging (if needed). 3. Verification of application completeness (within 14 days). If any additional information is required, it will be requested, and applicants have max. 90 days to respond – assessment period will be put on hold. 4. Draft assessment report submission. (Day 90) 5. Requests raised by CMS sent to RMS (within 30 days) 6. RMS gathers all the requests from CMS. 7. Preparation of a single request. 8. Complete draft assessment report (Day 155) 9. Consultation by member states (Day 165) 10. Finalization of assessment (Day 175) 11. Issuance of certificate of marketing authorization by RMS (Day 205) 12. Issuance of certificate of marketing authorization by agreeing member states (Day 210) 13. Information published in common register. .