Sunset Clause

Secure your medicinal product's future in Europe with Freyr's sunset clause Regulatory services. We provide expert interpretation of EMA guidelines, strategic support for Health Authority engagement, and comprehensive lifecycle management to prevent invalidation of marketing authorization.

Sunset Clause - Overview

The sunset clause was introduced by the European Medicines Agency (EMA) per Regulation (EC) No. 726/2004, Article 14(4-6), to monitor the marketing status of centrally authorized medicinal products within the European Union (EU) and the European Economic Area (EEA). This leads to the invalidation of the Marketing Authorization (MA) in the following instances:

  • The medicinal product is not in the market within three (03) years of the MA being granted.
  • A medicinal product previously on the market is no longer available for three (03) consecutive years.

Exemptions to the sunset clause may be granted in certain cases, for example, for medicinal products that are used in emergencies in response to public health threats. Such exemptions must be justified by the Marketing Authorization Holder (MAH). For nationally approved products, the relevant Health Authority (HA) may apply specific criteria related to sunset clauses, particularly with extensions requested for products undergoing major reformulation activities and requiring significant development studies.

An MAH must remain aware of the sunset clause periods that may apply to their products to ensure the potential for continued product supply.

At Freyr, our Regulatory experts can provide support on queries related to the sunset clause and interpretation of the guidance related to it.

Sunset Clause - Expertise

  • The interpretation of the EMA guidance and national HA expectations regarding sunset clauses in European countries.
  • Strategic support in HA interactions related to sunset clause for marketing authorizations, including timing considerations.
  • Advice on sunset clause exemptions.
  • End-to-end Regulatory strategy consultation in MAA submission.
  • Regulatory experts with a comprehensive understanding of HA requirements.
  • Preparation of Regulatory strategy for HA queries.
  • HA communication/interactions throughout the drug lifecycle.
  • Post-approval and LCM activities per country-specific guidelines.
Sunset Clause

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​