Sunset Clause


The sunset clause was introduced by the EMA in accordance with Regulation (EC) No. 726/2004, Article 14(4-6) to monitor the marketing status of the centrally authorized medicinal products within the European Union (EU) and the European Economic Area (EEA). This leads to the validity of the marketing authorisation expiring in cases where:

  • the medicinal product isn’t in the market within three years of the MA being granted, or
  • a medicinal product previously on the market is no longer present in the market for three consecutive years

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

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.

Freyr Expertise

  • 01

    Interpretation of EMA guidance and national health authority expectations regarding sunset clauses in the European countries

  • 02

    Strategic support in HA interactions related to sunset clauses, including timing considerations

  • 03

    Advice on sunset clause exemptions

  • 04

    End-to-end Regulatory strategy consultation in MAA submission

  • 05

    Regulatory experts with 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 in accordance with country-specific guidelines

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