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 reference member state approves a medicinal product in a member state. Only one country is considered as the reference member state, where the product has already been registered and granted a national marketing authorization. The required documents are supposed to be submitted in Common Technical Document (CTD) format. A valid document assuring the compliance to Good Manufacturing Practice (GMP) has to be submitted. Non-clinical and clinical study must be conducted as per EEC approved Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), respectively. If any compliance-related concerns are raised from the submitted documents, the governing body of the reference member state will conduct an unscheduled audit on the manufacturing premises. A centralized database of registered medicinal products is maintained wherein information like the name of the product, active pharmaceutical substances, approved Summary of Product Characteristics (SmPC), patient leaflet and packaging mock-ups are made publicly available. The total duration for the approval of the medicinal product in reference member state is 210 days and once it gets approved in the reference member state, the applicant gets marketing authorization in the member states concerned within 90 days from the day when authorities of the member state concerned receive the marketing authorization application (MAA) and other documents. Marketing authorization in the member states concerned is granted based on the evaluation of the marketing authorization application and assessment report prepared by the reference member state. Communication between the applicant and the authority occurs via integrated systems and the documents have to be provided in the official language of the member state concerned. Detailed process steps and key milestones are outlined below. STEP 1: MARKETING AUTHORIZATION IN REFERENCE MEMBER STATE Applicant submits marketing authorization application (MAA) to reference member state (RMS). The RMS will validate document submission (within 14 days). Next, assessment of MAA begins (Day 0) – this involves evaluating product quality, safety and efficacy, and performing lab tests to verify quality. If non-compliance is found, it will trigger an inspection (180 days). The RMS can also request additional information during assessment of the MAA, and applicants will be given max. 90 days to respond to queries (the 90 days is not considered within the period of the grant of marketing authorization). A final assessment report will then be prepared, either granting marketing authorization or refusing it. If MA is granted, a certificate for marketing authorization is issued on Day 210 and this information is published in the common register. STEP 2: MARKETING AUTHORIZATION IN CONCERNED MEMBER STATE BY MUTUAL RECOGNITION PROCEDURE Applicant lodges request to submit MAA and assessment report via integrated system to reference member state (RMS). The applicant’s request will be accepted within 5 days. The applicant can then submit MAA and documents (day 0). The application will be shared with concerned member states (CMS). One of three things will then happen: (i) Request for any additional information (within 50 days) – query responses from applicants (max. 90 days – not considered within the period of the grant of MA); (ii) No requests sent – opinion on approvability (within 20 days); or (iii) Refusal to grant marketing authorization (within 14 days). If MA is granted, a certificate for marketing authorization will be issued (Day 90) and information will be published in the common register. .