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:
”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 or, if the reference product is still under data protection, from the date it can be marketed, 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.
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 EMEA, as these are not comprised by the Swedish Medicinal Products Act.
In order for a medicinal product to be considered as available on the Swedish market, at least one package of a strength, pharmaceutical form or taste (i.e. mint, lemon) must be marketed. “Available on the Swedish market” means that the product must be available for the user it is intended for.
The holder of a marketing authorisation is obliged to continuously inform the Medical Products Agency when marketing begins, and no less than two months before actual marketing ends, preferably using a special form which is available on the MPA web site, see the 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.
At the end of 2008 the Medical Products Agency will inform the Marketing authorisation holders (MAH) who have approved medicinal products which have not been available on the Swedish market since 1 May 2006 that the marketing authorisation for these products may be withdrawn from 1 May 2009. The Medical Products Agency will continuously inform about medicinal products which have not been placed on the Swedish market within three years from approval. This will be provided approximately six months prior to the marketing authorisation is ceased to be valid.
Exemption from the regulation regarding withdrawal of marketing authorisation may be granted if there are particular reasons, e.g. if there is lack of suitable alternative suppliers or alternative treatments to the medicinal product which means that there is the potential for adverse impact on public or animal health. Or, the medicinal product is a medicine held as part of emergency preparedness arrangements, for example vaccines. If the medicinal product has been mutually recognised through the MR or DC procedure with Sweden as reference member state (RMS) and a valid authorisation is required to support continuity of supply in CMS or in third countries. A decision regarding exemption can be valid for a limited time or until further notice.
Application for exemption from “Sunset clause” should be made at least three months prior to the actual time for invalidation of the marketing authorisation, preferably by using a special form which is available on the MPA web site, see link in the right margin.