Authorisation and supervision

Medicines must be authorised by either the Danish Health and Medicines Authority or the European Commission before they can be sold in Denmark.

The Danish Health and Medicines Authority grants company authorisations, e.g. authorisations to manufacture and import medicines and intermediates.

Supervision of companies that manufacture medicines – both before and after the medicine has entered the market.

Authorisation of sale or dispensing of medicines that are not marketed in Denmark.

Find out how the Danish Health and Medicines Authority distinguishes between the various types of healthcare products.

Fees payable for medicines and company authorisations.

Declarations based on a manufacturing authorisation for a Danish company, an issued marketing authorisation for a specific medicinal product or a requested inspection.

If your company changes its name or address, the company authorisations will need to be renewed.