01. How are products prescribed for compassionate use handled in Iceland?

Products prescribed for compassionate use are handled via the same procedure as products granted named-patient basis use exemptions (exemptions granted under exceptional circumstances to physicians to use a product which does not have a marketing authorisation in Iceland).

This is in accordance to Article 12 of the Medicinal Product Act No. 100/2020: „The Icelandic Medicines Agency may, in accordance with an application by a physician, in his or her own name or in the name of a healthcare institution, or by a dentist or veterinarian, grant an exemption from the provisions of the first paragraph of Article 11. Such an exemption shall only be granted if the following conditions are met:

a. Special circumstances, which are well substantiated with reasons, obtain which call for the use of a medicinal product for which no Icelandic marketing authorisation has been granted, or which has received Icelandic marketing authorisation but has not been marketed in Iceland.

b. The application states that the quantity for which the exemption is sought is limited to the requirements of those who are to use the medicinal product, and whether the use is intended for a specific individual or animal and whether it will take place in a healthcare institution or another specific location."

Products with Icelandic marketing authorisation but not marketed in Iceland are handled via the same procedure.


Last updated: December 17, 2021
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