MAA Registration

Freyr offers comprehensive support for Marketing Authorization procedures in Europe, guiding pharmaceutical companies through complex Regulatory pathways. Our expertise spans legal representation, strategic consultation, and end-to-end MAA submission support to expedite generic drug product approvals across the EU.

MAA Registration - 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.

MAA Registration - Expertise

  • Legal representation as an MAH for medicinal product manufacturers with no establishments in the European Economic Area (EEA).
  • Regulatory consultation/strategic support during the development of generic products.
  • Advise applicants in the selection of appropriate MAA registration procedures.
  • Advice for appointment/consultation of Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV) (if the applicant's office is not in the EEA and they do not have their own QP and QPPV).
  • Guidance in the selection of test products and reference medicinal products bio-batch for bio-equivalence study.
  • To provide support in the selection of dissolution parameters/multimedia for the performance of the dissolution for test products and reference medicinal products.
  • Review support for manufacturers during the development stage of the product (discriminatory nature of media).
  • Finalization of the specifications for Finished Products (FPs), in-process/intermediates, and review of protocols/reports for exhibit batches/stability study.
  • Regulatory assessment/gap analysis of source documents/already-registered dossiers for their Regulatory adequacy.
  • Slot booking for MAA submission.
  • Liaise with specific countries to act as Reference Member State (RMS) for DCP MAA filing.
  • Compiling, technical reviewing, finalizing, publishing, and submission of MAA to the EU HAs.
  • Regulatory strategy in response to HA queries (RTQs).
  • Prepare responses to HA queries (HAQs) with supporting documents/data with the scientific rationale to avoid delay in approval.
  • Follow-up with Regulatory agencies throughout the generic drug approval process.
MAA Registration

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​