- Licensing of medicines
Medicines must be authorised by either the Danish Health and Medicines Authority or the European Commission before they can be sold in Denmark.
- Company authorisations and registrations
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.
- Compassionate use
Authorisation of sale or dispensing of medicines that are not marketed in Denmark.
- Definition of a medicine
Find out how the Danish Health and Medicines Authority distinguishes between the various types of healthcare products.
Fees payable for medicines and company authorisations.
- Export certificates
Declarations based on a manufacturing authorisation for a Danish company, an issued marketing authorisation for a specific medicinal product or a requested inspection.
- Name/address changes
If your company changes its name or address, the company authorisations will need to be renewed.