If you plan to bring af new product onto the Danish market: Getting started
- A medicinal product may only be marketed or dispensed in Denmark when a marketing authorisation has been granted either by the Danish Medicines Agency pursuant to this Act or by the European Commission.
- Any manufacture, import, export, storage, resale, distribution, dispensing, splitting and packaging of medicinal products is subject to authorisation from the Danish Medicines Agency.
Cf. Sections 7 and 39 of the Danish Medicines Act
When the Danish Medicines Agency assesses a product, we first of all determine whether or not it is a medicinal product.
- If we determine that it is not a medicinal product, we refer the company to the relevant regulatory authority.
- If we determine that it is a medicinal product, we advise the company to apply for a marketing authorisation and a company authorisation.
- If the company is then granted these authorisations, the product becomes authorised as a medicinal product and can be sold in Denmark.
- If we give notice that the product is a medicinal product, but the company is not granted a marketing authorisation, it is illegal to sell it in Denmark.
Is your product a medicinal product?
It can be difficult to draw the line between food supplements and medicinal products, or between medicinal products and cosmetic products. In determining the status of a product, the Danish Medicines Agency uses the definition in section 2 of the Danish Medicines Act:
A product is a medicinal product if it satisfies either of the criteria in section 2(i)(a) and (i)(b) of the Danish Medicines Act:
- is presented as a suitable product for the treatment or prevention of disease in human beings or animals, or
- 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.
Section 2(i) of the Danish Medicines Act:
- The first limb of the definition is based on how the product is presented. See How to advertise your product
- The second limb of the definition is based on the product's function. See What is the function of your product?
When either limb of the definition is satisfied, the Danish Medicines Agency classifies the product a medicinal product.
What happens if a company sells a medicinal product without a marketing authorisation?
The Danish Medicines Agency is occasionally challenged by manufacturers or distributors that sell products without the required authorisations. In such cases, we must determine whether the product is a medicinal product – after it has been on sale for a while.
If the Danish Medicines Agency determines that the product is a medicinal product, it is illegal for the company to continue selling it without a marketing authorisation and a company authorisation from the Danish Medicines Agency. In order to obtain permission to sell the product, the company must satisfy the requirements in the Danish Medicines Act. If the product does not obtain a marketing authorisation, we order the company to stop selling and advertising the product and to withdraw any surplus stock.
In many of the cases, the Danish Medicines Agency has ordered the companies to stop selling a product. The Danish Medicines Agency has issued a guiding list of products that have been classed as medicinal products (in Danish only).
A company sells the product 'Cold-free', which contains thyme. The product is advertised in a newspaper, one of the claims being "Good for colds". The Danish Medicines Agency sees the advertisement and starts an investigation of the product.
The Danish Medicines Agency determines that 'Cold-free' is a medicinal product, because the product is described as being suitable for treatment of the disease cold. The company, which until then believed 'Cold-free' to be a food supplement, has not been authorised to market medicines and must therefore withdraw 'Cold-free' from the market. If the company wants to, it can subsequently seek authorisation from the Danish Medicines Agency.
Medicinal products in other EU member states
Even though a product might not be a medicinal product in another EU member state, it can still be a medicinal product in Denmark. This is because it is determined nationally whether each product is, or is not, at medicinal product.