Marketing authorisation holders (MAH) are required to inform the Medical Products Agency if their approved medicinal products are available on the Swedish market or not.
Pursuant to Section 8 f of the Medicinal Products Act (1992:859) the following demands apply for medicinal products from 1 May, 2006:
”Section 8 f: After a marketing authorisation has been granted, the holder of the authorisation shall inform the 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 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.”
If an authorised product is not placed on the Swedish market within three years of its granting, the Medical Products Agency will 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. For a generic medicinal product approved for marketing before the data protection period of the reference medicinal product has expired, this period is counted from and including the day on which the data protection ends. The same applies if the protection period for a reference medicinal product is valid at the time of the approval, from the time the medicinal product was authorised for marketing to start. The Medical Products Agency may in exceptional circumstances and on public health or animal health grounds 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.
Forms regarding application for marketing authorisation and application for a waiver from the regulation on ending marketing authorisation (the Sunset clause) which are available on the MPA web site, see link in the right margin.
Please note that application of withdrawal of marketing authorisation for a medicinal product must be notified in a separate letter to the Medical Products Agency.
The Medical Products Agency continuously sends out information about medicinal products which have not been placed on the Swedish market within three years from approval, approximately six months prior to the marketing authorisation ceasing to be valid.
See the FAQ for more detailed information.