When the Danish Health and Medicines Authority determines whether a product is, or is not, a medicinal product, we look at the aspects below, cf. section 2 of the Danish Medicines Act:
- claims made about the product
- text and images on the package
- comparison to already approved medicinal products
- the name of the product
- the product form
- the active substances contained in the product
- the product is for making a medical diagnosis.
We assess the product based on how it is presented and its function, corresponding to section 2(i) of the Danish Medicines Act, which states that it is a medicinal product when the product:
(a) is presented as a suitable product for the treatment or prevention of disease in human beings or animals, or
(b) may be used in or administered to humans or animals to recover, change or affect physiological functions by having a pharmacological, immunological and metabolic effect, or to make a medical diagnosis.
When we have completed our assessment based on the above, we assess overall whether or not the product is a medicinal product. If we give notice that it is a medicinal product, the company may then apply for authorisation to the Danish Health and Medicines Authority.
If it is not a medicinal product, we advise the company to contact the responsible authority that regulates the concerned product group, e.g. the Danish Veterinary and Food Administration.
You can read more about the assessment of products under Licensing of medicines.