Authorisation procedures

Medicines must be authorised by the Danish Medicines Agency or the European Commission before they can be sold in Denmark.

This is also the case for natural medicinal products and strong vitamins and minerals.

Authorisation procedures

Companies can apply for a marketing authorisation in four ways:

The national procedure

The medicine is authorised in one EU or EEA country only.

The centralised procedure

The medicine is authorised in the entire EU simultaneously.

The decentralised procedure (DCP)

Companies apply for authorisation in several EU or EEA countries simultaneously.

The mutual recognition procedure (MRP)

A national marketing authorisation for a medicine in one EU or EEA country forms the basis for authorisation in another EU or EEA country.

Application for authorisation

An application for authorisation of a medicine must contain documentation for the medicine's efficacy, safety and quality.

If the medicine is authorised, the company will be granted a marketing authorisation.

Companies can find guidelines and forms for marketing authorisation applications or parallel import of medicines in the left-hand menu.

Information about the medicine in the summary of product characteristics and package leaflet

The summary of product characteristics (SPC) contains the most important information about the medicine, including its efficacy, side effects, warnings, dosage, active substances, etc.

The SPC forms the basis for the instructions for the patient (package leaflet) which the company must formulate and supply with the medicine package. The SPC also sets the framework within which the company is allowed to advertise for the medicine.

SPCs for medicines authorised by the Danish Medicines Agency are available in Danish at produktresume.dk

SPCs for centrally authorised medicines are available at the website of the European Medicines Agency (EMA)

Withdrawal of marketing authorisation

In special circumstances, the Danish Medicines Agency may withdraw the marketing authorisation for a medicine

For example, if the risk/benefit balance of a medicine is no longer acceptable, or if the medicine has not kept pace with scientific development.

Authorised and deregistered medicinal products

List of authorised medicinal products (in Danish)

List of deregistered medicinal products (in Danish)

The Medicinal Products Committee replaces the Licensing Committee

By the Danish Parliament's adoption of act no. 605 of 18 June 2012 amending the Danish Medicines Act, the rules governing the Medicinal Products Committee were established.