Authorisation of medicines
All medicines must be authorised before they can be marketed and made available to patients. In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route.
Centralised authorisation procedure
Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing-authorisation application to EMA.
This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.
EMA's Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not.
Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
Scope of the centralised authorisation procedure
The centralised procedure is compulsory for:
- human medicines containing a new active substance to treat:
- human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);
- neurodegenerative diseases;
- auto-immune and other immune dysfunctions;
- viral diseases.
- medicines derived from biotechnology processes, such as genetic engineering;
- advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;
- orphan medicines (medicines for rare diseases);
- veterinary medicines for use as growth or yield enhancers.
It is optional for other medicines:
- containing new active substances for indications other than those stated above;
- that are a significant therapeutic, scientific or technical innovation;
- whose authorisation would be in the interest of public or animal health at EU level.
Today, the great majority of new, innovative medicines pass through the centralised authorisation procedure in order to be marketed in the EU.
National authorisation procedures
The majority of medicines available in the EU were authorised at national level, either because they were authorised before EMA's creation or they were not in the scope of the centralised procedure.
Each EU Member State has its own national authorisation procedures. Information about these can normally be found on the websites of the national competent authorities:
- the mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries;
- the decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.
For more information see:
- Coordination Group for Mutual Recognition and Decentralised Procedures – Human
- Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary
The data requirements and standards governing the authorisation of medicines are the same in the EU, irrespective of the authorisation route.