Sunset Clause

Marketing authorisation holders (MAH) are required to inform the Swedish Medical Products Agency if their approved medicinal products are available on the Swedish market or not.

Pursuant to Chapter 4 Section 18 of the Medicinal Products Act (2015:315) the following demands apply for medicinal products:

”Section 8 f: After a marketing authorisation has been granted, the holder of the authorisation shall inform the Swedish Medical Products Agency of the actual date when the product, including all approved strengths and forms, is placed on the Swedish market. The holder shall also notify the Swedish Medical Products Agency if the product ceases to be placed on the market, either temporarily or permanently. Such notification shall be made no less than two months before the interruption.”

A form regarding marketing information for medicinal products can be found in the right margin.

If an authorised product is not placed on the Swedish market within three years of its granting, the Swedish Medical Products Agency shall decide that the authorisation shall cease to be valid. Correspondingly, when an authorised product previously placed on the Swedish market is no longer actually present on the market for a period of three consecutive years, the authorisation for this product shall cease to be valid.

The Swedish Medical Products Agency may, for reasons relating to human or animal health, grant exemptions from what is stated in paragraph 2.

Medicinal products authorised within the Centralised procedure will be handled centrally by EMA, as these are not comprised by the Swedish Medicinal Products Act.

See the FAQ (link in the right margin) for more detailed information.

New management of Sunset Clause exemptions from October 2017

The Swedish Medical Products Agency has decided to consider payment of the annual fee to be a notification of the intention to market the product in Sweden. As a consequence, the marketing authorisation does not cease to be valid due to Sunset Clause, provided the annual fee is paid on time. No application for exemption from invalidation of a marketing authorisation due to Sunset Clause needs to be submitted.

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information