Marketing Authorization Procedure in Europe - Overview
Marketing Authorization procedure in Europe plays a critical role and allows pharmaceutical companies to legally market and distribute their medicinal products within the European Union. To obtain marketing authorization for their generic products, sponsors must submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). The EMA evaluates the application and grants the marketing authorization. This authorization enables Marketing Authorization Holders (MAHs) access to all EU member states for manufacturing and distributing their products.
The marketing authorization procedure in Europe is highly regulated. The harmonized Regulatory requirements by all the EU member states ease the development and document-generation activity for pharmaceutical manufacturers. However, the complexity of the procedural requirements will need a Regulatory expert with a complete understanding of the EU country-specific requirements, expertise in Health Authority interactions, and MAA registration procedure activities (MAA submissions) to avoid rejections and major clock-stops in the marketing authorization approval process.
In the generic drug approval process, the manufacturer or the sponsor of a generic medicinal product should select a specific MAA procedure such as the Centralized Procedure (CP), National Procedure (NP), Mutual Recognition Procedure (MRP), and Decentralized Procedure (DCP) for registering and placing the medicinal product in the EU.
Freyr, having established offices in multiple EU countries, can be a cost-effective and trust-worthy Regulatory partner for pharmaceutical manufacturers to handle the generic drug approval process, including legal & administrative requirements and MAA registration procedure support for the medicinal products through Article 8(3) (for innovator products) and Article 10(1) routes (for generic medicinal products). Freyr supports pharmaceutical manufacturers and/or MAHs in achieving legal and procedural compliance in the registration and distribution of their products in EU countries.
Marketing Authorization Procedure in Europe - Freyr Expertise
- 01
Legal representation as a MAH for medicinal product manufacturers with no establishments in the European Economic Area (EEA).
- 02
Regulatory consultation/strategic support during the development of generic products.
- 03
Advise applicants in the selection of appropriate MAA registration procedures.
- 04
Advice for appointment/consultation of Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV) (if the applicant office is not in the EEA and they do not have their own QP and QPPV).
- 05
Guidance in the selection of test products and reference medicinal products bio-batch for bio-equivalence study.
- 06
To provide support in the selection of dissolution parameters/multimedia for the performance of the dissolution for test products and reference medicinal products.
- 07
Review support for manufacturers during the development stage of the product (discriminatory nature of media).
- 08
Finalization of the specifications for Finished Products (FPs), in-process/intermediates, and review of protocols/reports for exhibit batches/stability study.
- 09
Regulatory assessment/gap analysis of source documents/already-registered dossiers for their Regulatory adequacy.
- 10
Slot booking for MAA submission.
- 11
Liaise with specific countries to act as Reference Member State (RMS) for DCP MAA filing.
- 12
Compiling, technical reviewing, finalizing, publishing, and submission of MAA to the EU HAs.
- 13
Regulatory strategy in response to HA queries (RTQs).
- 14
Prepare responses to HA queries (HAQs) with supporting documents/data with the scientific rationale to avoid delay in approval.
- 15
Follow-up with Regulatory agencies throughout the generic drug approval process.
USA
UK
GERMANY
INDIA