Product Classification

Definition of a medicinal product

The Medicines Act No 100/2020 as amended, defines a medicinal product as "All types of substance or combination of substances which: a. are said to have properties that are of use in the treatment of illnesses in humans or animals or in the prevention of illness, or b. which may be administered to humans or animals, or given to them, in order to restore, correct or modify physiological functions by means of pharmacophysiological or immunological action or through action on metabolism, or in order to confirm a diagnosis.”

Substance: Any substance, independent of origin from:

  • Humans, e.g. blood or blood products
  • Animals, e.g. microorganisms, animals, tissues, serum, toxic chemicals, extracts, substances processed from blood etc.
  • Herbs, e.g. microorganisms, plants or parts of plants, serum, extracts etc.
  • Other substances, e.g. elements, substances from nature and substances formed by chemical reactions or combinations

If in doubt IMA decides whether individual substances or compounds are to be regarded as medicines

Having considered all its properties, if a doubt still remains whether a product can fall under the definition of a medicinal product or a product belonging to a different legislation, the medicines legislation applies.

One of the major tasks of the Icelandic Medicines Agency (IMA) is to ensure consumer protection. IMA issues a list on classification of substances and compounds with respect to pharmaceutical activity and/or harmfulness of the substances, wherein it is stated which substances/compounds are banned/permitted in consumer products. Furthermore IMA issues a list on classification of claims banned/permitted in consumer products.

Classification of products/substances/claims

If substances/compounds/claims which is sought and is to be found in/on a product intended to be placed on the market in Iceland, but does not feature on any IMA list, the importer can apply for IMA to classify/assess whether the ingredients of the product are permitted or whether it contains pharmaceutically active substances or the claims indicates that the product may be a medicine.