Sunset Clause

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.

A 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 - Freyr Expertise

  • 01

    The interpretation of the EMA guidance and national HA expectations regarding sunset clauses in European countries.

  • 02

    Strategic support in HA interactions related to sunset clause for marketing authorizations, including timing considerations.

  • 03

    Advice on sunset clause exemptions.

  • 04

    End-to-end Regulatory strategy consultation in MAA submission.

  • 05

    Regulatory experts with a comprehensive understanding of HA requirements.

  • 06

    Preparation of Regulatory strategy for HA queries.

  • 07

    HA communication/interactions throughout the drug lifecycle.

  • 08

    Post-approval and LCM activities per country-specific guidelines.

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