Marketing Authorization Application License Renewal, MAA Submissions, PSUR

Freyr helps pharma manufacturers in filing Market Authorization Application (MAA) License renewal, PSUR Submissions as per HAs requirement for EU by Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) & Centralized Procedure (CP)
A marketing authorization (MA) granted by European Union (EU) competent authority is usually valid for 5 years. If the manufacturer 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:
Know more at Freyr Page - Market Authorization Application (MAA) License renewal

Comments

Post a Comment

Popular posts from this blog

Medical Device Regulation Report, Morocco, Registration

This report provides information on regulations imposed on medical device in Morocco for product registration, import permit, validity & renewal process, variations filing, legal representative and labeling. Summary Product definition and governing regulations; Information on medical device registration; Explains the process of registration through flowcharts; Precise information on health authority fees & timelines for registration; Additional information on the validity of registration, renewal process and variation filing Presents the regulations applicable on labeling; and Describes the information on import regulations, and the requirement of a legal representative. Check out more details at  Medical Device Regulation Report, Morocco, Registration
Read more

Medical Device Registration in Germany, IVDs, CE marking, EU MDR

Freyr offer Regulatory services for Medical Device & IVDs that includes registration with EMA, licensing, EU-MDR Transition, Classification, Dossier Review, Compilation & Submission, CE mark & ISO 13485 certification, provides support to certify medical devices from TUV, DQS, DEKRA, SGS in Germany region – Freyr Webpage Link – Medical Device Registration in Germany Freyr Expertise European Medical Device Classification ISO 13485 Compliance CE Technical File or Design Dossier Review, Compilation and Submission EU-MDR Transition and Support Clinical Evaluation Reports (CER) for Medical Devices ISO 14971 Risk Management Consulting Medical Device Regulatory Strategy Report Testing Support- Biocompatibility, Electrical Safety and Mechanical & Performance Labeling and GMP Support Post-market Monitoring and Adverse Event Reporting European Authorized Representative Support
Read more

Health Authority Queries – Responses | Interactions

The appropriate and timely communication with Health Authorities (HAs) is a key factor for the speedy approval and uninterrupted commercialization of a medicinal product either during initial approval or during Life Cycle Management (LCM, i.e. through post approval changes submissions). When a  Marketing Authorization Holder (MAH)  or applicant submits an initial or post approval activity application, upon evaluating the submitted data HAs may revert with their concerns or recommendations, if the submitted data is insufficient or requires any further clarification or for any further commitments post approval to ensure quality, safety and efficacy of the product. Either the Information Requests (IRs), Refuse to Review (RTR), or Request for Further Information (RFI), the expertise lies in understanding the concerns, response compilation while answering, so that it avoids further queries and delays in the approval procedures. While responding to HA queries, the communication ...
Read more