If you plan to bring a new product onto the Danish market, you will first of all need to know if the product is classed as a medicinal product.
If the product is a medicinal product, you will both need a marketing authorisation and a company authorisation before you are allowed to sell it in Denmark. When a medicinal product has a marketing authorisation, consumers are assured that the medicine works as intended and is safe to use.
- A medicinal product may only be marketed or dispensed in Denmark when a marketing authorisation has been granted either by the Danish Health and Medicines Authority 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 Health and Medicines Authority.
Cf. Sections 7 and 39 of the Danish Medicines Act
When the Danish Health and Medicines Authority 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 Health and Medicines Authority 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.
When either limb of the definition is satisfied, the Danish Health and Medicines Authority classifies the product a medicinal product.
What happens if a company sells a medicinal product without a marketing authorisation?
The Danish Health and Medicines Authority 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 Health and Medicines Authority 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 Health and Medicines Authority. 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 Health and Medicines Authority has ordered the companies to stop selling a product. The Danish Health and Medicines Authority 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 Health and Medicines Authority sees the advertisement and starts an investigation of the product.
The Danish Health and Medicines Authority 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 Health and Medicines Authority.
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.