Licensing of medicines

26 October 2020

Medicines in Denmark must meet very strict quality, safety and efficacy requirements before they can be authorised.

At the Danish Medicines Agency, we assess applications for new medicines from pharmaceutical companies to find out if the medicine in question can be made available to the general public. In addition, we contribute experts to the European Medicines Agency, EMA, which also assesses applications for authorisation of medicines from manufacturers wanting to make their products available to citizens in all EU member states including Denmark.

A medicine can only be authorised and made available to the public if major scientific studies have provided sufficient evidence of the medicine’s quality, efficacy and safety. You can read more about the clinical trial phases.

The Danish Medicines Agency also approves the scientific studies that are conducted prior to the potential authorisation of a new medicine, for companies applying for authorisation of a medicine in Denmark must naturally first test the medicine thoroughly.

Benefits must outweigh the risks

The documentation from these tests is submitted to the Danish Medicines Agency or to the EMA whereupon a team of specialised doctors, pharmacists and other professionals reviews the company’s documentation and user information. If the team of experts concludes that the medicine’s benefits outweigh its known risks, the product is authorised and can then be marketed.

The Danish Medicines Agency neither develops nor tests the medicine.

A medicine can be authorised via different routes. It can be authorised in a single country, authorised in more countries at once, or it can be authorised in all EU countries at once. Medicines/vaccines against infectious diseases are authorised at the EU level, which means the European Medicines Agency, EMA, assesses and possibly authorises the product on behalf of all EU members states.

Under normal circumstances, it takes 8 to 10 years from the first idea for a medicine to the medicine has been rigorously tested, authorised and made available to the public.

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