Guideline on the "sunset clause" - notification about initiation or cessation of marketing of medicinal products

Updated 01 September 2022


Section 28(1) of the Danish Medicines Act stipulates that a marketing authorisation ceases to be valid if the medicinal product has not been marketed for three consecutive years. 
The Danish Medicines Agency considers a medicinal product as being marketed if at least one package of the medicinal product has been notified to Medicinpriser (Medicine Prices) or if the annual fee has been duly paid for the concerned medicinal product.
The Danish Medicines Agency may in exceptional circumstances grant exemptions from section 28(1) of the Danish Medicines Act. A request for exemption can be sent to Danish Medicines Agency. Send an email

What medicinal products are comprised by the "sunset clause"?

The "sunset clause" contained in the Danish Medicines Act applies to all medicinal products for which the Danish Medicines Agency has issued a marketing authorisation. Parallel imported medicinal products are not comprised.
If medicinal products are authorised under the centralised procedure, we refer marketing authorisation holders to the guidelines of the European Medicines Agency (EMA)