Does your product need an authorisation from the Danish Health and Medicines Authority?
If your product is a medicinal product, it must be authorised by the Danish Health and Medicines Authority. One way of finding out is by looking at its function.
By definition, a medicinal product is any product that may be used in or administered to humans or animals to restore, change or modify physiological functions by having a pharmacological, immunological or metabolic effect or to make a medical diagnosis.
Section 2(i)(b) of the Danish Medicines Act.
The product is a medicinal product if it is used to improve bodily functions in humans or animals by:
- affecting functions of organs or cells,
- affecting the immune system,
- affecting the metabolism.
or if the product is to be used for making a medical diagnosis.
Are there special areas to be aware of
In most cases, there is no doubt when a substance is classed as a medicinal product. But there may be borderline cases, which call for an assessment by the Danish Health and Medicines Authority to determine whether the substance is to be classed as a medicinal product because of its affect in humans or animals.
Mr Bent Jørgensen sells herbal medicines. He has been offered to represent an American product for jetlag. Mr Jørgensen believes that there is a potential for the product in Denmark because there are no such products for jetlag on the market just yet.
Mr Jørgensen calls the Danish Health and Medicines Authority for advice on the rules in the area. The Danish Health and Medicines Authority investigates the product and returns that this particular type of pills would be covered by the Danish Medicines Act because they contain the active substance melatonin. In other words, Bent Jørgensen must apply to the Danish Health and Medicines Authority for a marketing authorisation for the product.
Active substances in medicinal products
The Danish Health and Medicines Authority has indicated examples of active substances that generally decide that a product is a medicinal product. If your product contain one or more of the active substances on the list, it is most likely a medicinal product, which requires a marketing authorisation from the Danish Health and Medicines Authority.