06. Why does a product that contains CBD and is manufactured as food supplement have to fulfil same restrictions as a medicinal product in Iceland?

According to paragraph 3 of Article 2 of the Medicinal products Act No. 100/2020 the Icelandic Medicines Agency shall decide if there is a doubt as to whether individual substances or compounds are medicinal products. In case of doubt as to whether a product can, taking into account all its properties, fall within the terms of definition of a medicinal product, and the definition of a product subject to other legislation, the provisions of Medicinal products Act shall apply.

The medicinal product Sativex has a marketing authorization in Iceland and one of the two active ingredients is CBD.

If a product has an ingredient that is an active ingredient in a medicinal product which has a marketing authorization there is the abovementioned doubt and the product has to fulfil same restrictions as other medicinal products to be legal on the Icelandic market.


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