Information to Marketing Authorisation Holders - Sunset Clause

The Sunset Clause in Directive 2001/83/EC was implemented in Article 7 of the Pharmaceutical Act No 93/1994


“The marketing authorisation is invalidated if the medicinal product for which the marketing authorisation is granted has not been placed on the market within three years of the granting of the authorisation, or if a medicinal product for which authorisation has been granted, and which has been placed on the market, has not in fact been on the market for a continuous period of three years. The Medicines Agency may grant exemptions from this provision in special circumstances, and for reasons relating to public health. Such exemptions shall be supported by valid reasons.”

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.

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