A marketing authorization (MA) granted by European Union (EU) competent authority is usually valid for 5 years. If the manufacturer is willing to continue, marketing authorization holder (MAH) will have to renew the MA Application (MAA) License by filing renewal application to MAA in accordance with Article 24 of Directive 2001/83/EC and Article 14 (1-3) of Regulation (EC) No 726/2004. The renewal application shall be submitted to competent EU member state’s Health Authority (HA) by MAH at least 9 months before its expiry and failing to which, the validity of MA will lapse.
Once the MAA is renewed, it shall remain valid for lifetime, unless the competent authority of EU member state decides to have one more renewal based on pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product and to process with one additional 5-year renewal. Even if the marketing authorization is valid for lifetime, MAH has to submit a Periodic Safety Update Report (PSUR) / a Periodic Benefit Risk Evaluation Report (PBRER) for every 3 years to HA.
The authority can be approached for MAA License renewal in one of the following ways depending upon the requirement of the case:
- Renewal through Centralized Procedure (CP): The renewal application submitted to European Medicines Agency (EMA) through CP shall be evaluated in about 120 days by Committee for Medicinal Products for Human Use (CHMP). If any changes are necessary to the Summary of Product Characteristics (SmPC) or Labeling arising from a PSUR/PEBRER evaluation or any other document, the MAH will have to submit an updated SmPC as part of renewal process.
The evaluation process and time table for renewal application for MAA filed through CP is depicted below:
- Renewal through Mutual Recognition Procedure (MRP) and Decentralized Procedure (DCP): The assessment of renewal application of MAA for the medicinal products approved by the MRP and DCP are the same as medicine approved by the CP. Only difference is that the evaluation is conducted by the national competent authorities of authorizing countries, instead of EMA.
The evaluation process and time table for renewal application for MAA filed through MRP or DCP is depicted below:
Either the way, the renewal application requires due attention to ensure documents are in line with current regulations. Any changes needed to the SmPC, Labeling or other Regulatory aspects will require professional Regulatory support.
Freyr’s expert Regulatory team is capable at handling renewal applications for MAA in large volume for EU member states. Freyr has a proven approach in filing renewals for MAA, catering to all documents in a structured manner. Freyr’s efficient tracking system ensures timely renewals and will prove beneficial for the clients.
- Tracking of renewal application due date
- Send the renewal initiation documents request to manufacturer
- Regulatory assessment of the supporting documents received for renewal application submission
- Request for additional documents/justification
- Compilation of renewal dossier and share with manufacturer for review
- Finalization of renewal dossier and submission to HA / country manager before renewal application due date