Marketing authorisation for a medicine

Updated 03 March 2016

Companies can apply for authorisation to market medicines in Denmark and the EU/EEA in four different ways.

The centralised procedure

The centralised procedure in which new and high-technology medicines are authorised in the entire EU simultaneously. The European Medicines Agency (EMA) is responsible for this procedure.

The individual member states are responsible for the scientific evaluation of applications on a rotational basis.

The centralised procedure is compulsory for biotechnological medicines, new medicines for the treatment of certain diseases and for orphan drugs.

The decentralised procedure

The decentralised procedure (DCP) in which companies can apply for authorisation in more than one EU or EEA country simultaneously and where no EU or EEA country has granted a national authorisation in advance.

The Reference Member State (RMS) is responsible for the procedure and the scientific evaluation of the application. The Reference Member State is also responsible for preparing the public assessment report which is available at the webiste of the Heads of Medicines Agencies

The mutual recognition procedure

The mutual recognition procedure (MRP) in which the marketing authorisation for a medicine, which has already been authorised in accordance with the national procedure in one EU or EEA country (the Reference Member State), forms the basis for authorisation in another EU or EEA country.

The Reference Member State is responsible for the procedure and the scientific evaluation of the application. The Reference Member State is also responsible for preparing the public assessment report which is available at the webiste of the Heads of Medicines Agencies

The national procedure

The national procedure in which the medicine is authorised in one EU or EEA country only.

This authorisation may later form the basis for approval under the mutual recognition procedure.

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