In the European Union (EU), medicines can be authorised by the centralised authorisation procedure or national authorisation procedures.
Centralised authorisation procedure
The European Medicines Agency is responsible for the centralised authorisation procedure for human and veterinary medicines.
This procedure results in a single marketing authorisation that is valid in all EU countries, as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
The centralised procedure is compulsory for:
- human medicines for the treatment of human immunodeficiency virus (HIV) or acquired immune deficiency sydnrome (AIDS), cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases;
- veterinary medicines for use as growth or yield enhancers;
- medicines derived from biotechnology processes, such as genetic engineering;
- advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;
- officially designated 'orphan medicines' (medicines used for rare human diseases).
For medicines that do not fall within these categories, companies have the option of submitting an application for a centralised marketing authorisation to the Agency. This is possible for medicines:
- that are a significant therapeutic, scientific or technical innovation, or;
- whose authorisation would be in the interest of public or animal health.
Applications through the centralised procedure are submitted directly to the Agency. Evaluation by the Agency's Scientific committees takes up to 210 active days plus 'clock stops', at the end of which the committee adopts an opinion on whether the medicine should be marketed or not.
This opinion is then transmitted to the European Commission, which has the ultimate authority for granting marketing authorisations in the EU.
Once a marketing authorisation has been granted, the marketing-authorisation holder can legally begin to market the medicine in all EEA countries.
More information is available in:
National authorisation procedures
Each EU Member State has its own national authorisation procedures for the authorisation, within their own territory, of medicines that fall outside the scope of the centralised procedure.
Information about these national procedures can normally be found on the website of the national medicine authority in the country concerned:
There are also two possible routes available to companies for the authorisation of these medicines in several countries simultaneously:
Companies can apply for the simultaneous authorisation of a medicine in more than one EU country if it has not yet been authorised in any EU country and it does not fall within the mandatory scope of the centralised procedure.
Companies that have a medicine authorised in one EU Member State can apply for this authorisation to be recognised in other EU countries.
More information is available on:
- Coordination Group for Mutual Recognition and Decentralised Procedures – Human
- Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary
In some cases, disputes arising in these procedures can be referred to the Agency for arbitration as part of Referral procedures.