Medicine or not

Updated 11 July 2019

If a product is a medicine, this has a significant bearing on how it can be sold and produced. The Danish Medicines Agency determines if products are medicines or not.

If the product is classified as a medicine, you will both need a marketing authorisation and a company authorisation before you can sell it in Denmark. Medicines must be authorised so that the consumers can rest assured that the medicine works as intended and is safe to use.

  • A medicine can only be marketed or dispensed when a marketing authorisation has been granted either by the Danish Medicines Agency or 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

Typical borderline cases

In the figure below, you can see some of the product groups that border on medicines. Click on either product group to go to the responsible authority.

Before you start selling your product

If you are a company planning to bring a new product onto the Danish market, it is important to know if your product is classed as a medicine or not.

We have gathered information to guide you if you plan to sell a healthcare product in Denmark. Please see the menu to the left.

If you are not sure if your product is a medicine or not, the Danish Medicines Agency can make a specific individual assessment to find out if the product is classified as a medicine.

  • If your product is not a medicine, we will tell you which other authority is responsible for the product type in question.
  • If we determine that it is a medicine, your company must apply to the Danish Medicines Agency for a marketing authorisation and a company authorisation. It is illegal to sell the product in Demark before it has been authorised as a medicine.

What happens if a company sells a medicine without a marketing authorisation?

At the Danish Medicines Agency, we occasionally see manufacturers or distributors that sell products without the required authorisations. In such cases, we need to determine if the product is a medicine or not after the sale has started.

If the Danish Medicines Agency determines that the product is a medicine, 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 recall 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 an indicative list of products determined to be medicines.

Medicines in other EU member states

Even if a product is not a medicine in another EU member state, it can still be a medicine in Denmark. This is because it is determined nationally whether each product is, or is not, at medicine.

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