The Sunset Clause in Directive 2001/83/EC was implemented in Article 15 of the Pharmaceutical Act No 100/2020: “Marketing authorisation shall lapse if the medicinal product for which it was granted has not in fact been placed on the market within three years of the granting of the authorisation or if the medicinal product for which it was granted has not in fact been on the market for an unbroken period of three years. The Icelandic Medicines Agency may grant exemptions from this provision under special circumstances or for reasons concerning public health. Reasons for such exemptions shall be stated.”
The Icelandic Medicines Agency, IMA, is of the opinion that applying the sunset clause could counteract the necessary increase of marketed medicinal products in Iceland. Hence IMA has decided not to enforce the sunset clause for the time being. Marketing authorisation holders will be informed should this decision be amended.