EU Marketing Authorization Application - Overview
Registration of a single Marketing Authorization Application (MAA) for medicinal products enables Marketing Authorization Holders (MAHs)/pharmaceutical manufacturers to manufacture and distribute their products in all the EU member states.
Although the harmonized Regulatory requirements of all the EU member states ease the development and documents generation activity for pharmaceutical manufacturers, the complexity of the procedural requirements will need a Regulatory expert with a complete understanding of the EU country-specific requirements, Health Authority (HA) interactions, and Marketing Authorization Application registration activities (MAA submissions) to avoid validation rejections, major clock-stops which will delay the marketing authorization approval process, and go-to-market timelines.
Freyr, having established offices in multiple EU countries, assists pharmaceutical manufacturers in handling all the legal and administrative requirements along with registration support for medicinal products through Article 8(3) (for innovator products) and Article 10(1) routes (for generic medicinal products), which offers manufacturers and/or MAHs - Marketing Authorization Holders assurance on legal and procedural compliance for registration and distribution of their products in the EU countries.
EU Marketing Authorization Application
- Guidance in the selection of test products and Reference Medicinal Product (RMP) bio-batch lots for bio-equivalence studies.
- Provide support in the selection of dissolution parameters/multimedia for the performance of dissolution for test products and RMP.
- Support in the preparation of the Product Development Report (discriminatory nature of media).
- Finalization of the specifications for finished products, in-process/intermediates, and review of protocols/reports for exhibit batches/stability study.
- Advice in the selection of MAA Regulatory submission procedure, i.e., Centralized Procedure (CP), National Procedure (NP), Decentralized Procedure (DCP), or Mutual Recognition Procedure (MRP).
- Slot booking for MAA submissions.
- Liaise with specific countries to act as RMS for DCP Marketing Authorization Application (MAA) filing.
- To provide advice in the appointment of a Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV).
- To provide advice in batch release testing site and batch control site testing.
- Technical gap analysis of source documents/data for adequacy against EU countries’ specific requirements.
- The compilation, technical review, finalization, and publishing of the MAA submission in the eCTD format.
- Regular follow-ups with HAs.
- Handling HA queries with strategies and preparation of response package for the submission of the EU MAA.
- Translation support during the national phase of the registration in all the EU languages.
- Marketing Authorization Application (MAA) submissions.
- Supporting Marketing Authorization Holders (MAHs).
- Expertise in MAA Filing.
- Submission of Marketing Authorization Application (MAA) EMA.
- Submission of Marketing Authorization Application (MAA) FDA.
