Before a medicine can be sold in Denmark, it must be authorised by either the Danish Health and Medicines Authority or the European Commission. This is also the case for herbal medicines and strong vitamins and minerals.
Authorisation procedures
Companies can apply for authorisation to market medicines in Denmark and the EU/EEA in four ways:
The centralised procedure
The centralised procedure according to which medicines are authorised in the entire EU simultaneously.
The decentralised procedure
The decentralised procedure (DCP) according to which companies apply for authorisation in several EU or EEA countries simultaneously.
The mutual recognition procedure
The mutual recognition procedure (MRP) according to which a national marketing authorisation for a medicine in one EU or EEA country forms the basis for authorisation in another EU or EEA country.
The national procedure
The national procedure according to which the medicine is authorised in one EU or EEA country only.
Application for authorisation
An application for authorisation of a medicine must contain documentation for the medicine's effect, safety and quality. If the medicine is authorised, the company obtains approval in the form of a marketing authorisation.
Companies can find guidelines and forms for authorisation 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) details the most important information about the medicine, including its effect, 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.
The SPCs for medicines, authorised by the Danish Health and Medicines Authority, are available in Danish via the box to the right. The SPCs for centrally authorised medicines can be downloaded from the website of the European Medicines Agency (EMA).
Withdrawal of marketing authorisation
In special circumstances, the Danish Health and Medicines Authority may withdraw the marketing authorisation for a medicine, for example if the balance between a medicine's effect and side effects is no longer acceptable, or if the medicine has not kept pace with scientific development.
The Licensing Committee
The Licensing Committee advises the Danish Health and Medicines Authority on questions about the licensing of medicines.
