Definition of a medicinal product
The Medicines Act No 93/1994 as amended, defines a medicinal product as “Any substance or compound claimed to have properties which can be used for treating diseases in humans or animals or preventing diseases or any substance or compound which can be used by humans or in animals or given to them either for the purpose of restoring, rectifying or amending a physiological function through pharmaceutical or immunological action or influencing the metabolism or for confirming a diagnosis of a disease”.
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.