Renewals Submissions - Overview
In accordance with Article 14(1-3) of Regulation (EC) No 726/2004, any Marketing Authorization (MA), except those granted under exceptional circumstances, is valid until five (5) years from the date of approval. To remain valid and/or to extend the validity, the renewal of the marketing authorization is required before the date of the expiry.
After the renewal, the validity of the MAA shall be for a fixed or indefinite period. Once the MAA license is renewed, it is valid for a lifetime unless the competent member authority of the EU member state decides to have one more renewal based on pharmacovigilance and to process with an additional 5-year renewal.
Hence, Marketing Authorization Holders (MAH) need to maintain the validity of the application to continue the distribution in the EU region. At Freyr, our Regulatory experts can assist the MAHs by handling and filing the license renewal application with a very efficient tracking system to manage the timely submission of renewals to HAs.
Renewals Submissions - Expertise
- Tracking of MAA license renewal application due date
- Send the renewal initiation documents request to the manufacturer
- Regulatory assessment of the supporting documents for renewal application submission
- Request for additional documents/justification
- Compilation and review of renewal dossier
- Finalization of renewal dossier and submission to Health Authority before the due date of the license renewal application
