List of medicines jeopardised by Sunset clause

A list of medicinal products that may be affected by the sunset clause provision as of 31. 12. 2026 was published on 29. 4. 2026. Since 2021, the first list of medicinal products that may be affected by the sunset clause provision is published at the turn of April and May, and the updated list is published at the end of September.

These medicinal products could be subject to the sunset clause provision according to Section 34a (1) and Section 34a (2) of Act No. 378/2007 Coll., on pharmaceuticals, as amended.

The list is for information purposes only and shall not be binding.

The marketing authorisation number, name of the product, ATC code, marketing authorisation holder, MRP number and status of the marketing authorisation shall be stated in the overview for each medicinal product.

• Medicinal products jeopardised by the SC to 31. 12. 2026 (xlsx, 31 kB)

Queries regarding lists of medicinal products whose marketing authorisation has ceased to be valid or medicinal products jeopardised by sunset clause and the announcement that the 3 years period for placing of the generic medicinal product on the market begins to count ever since the market protection of the reference medicinal product expires (i.e. after 10 years from the first marketing authorisation of the reference medicinal product in any Member State or in the EU) should be sent to the following address: sunset@sukl.gov.cz. Do not use this address for submitting applications for exemption from the sunset clause, nor for the communication in the subsequent administrative proceedings regarding such application (you can use the electronic mailroom for those submissions: posta@sukl.gov.cz). 

Should you have any questions regarding issues of exceptions from sunset clause provision, please contact the following members of staff:

• Mgr. Eliška Vavřinová
  Tel: 272 185 121
  E-mail: eliska.vavrinova@sukl.gov.cz