Medicines in the EU
Medicines in the European Union are authorised through one of two procedures, as described below. Only medicines that have been granted a marketing authorisation can be marketed in the European Economic Area (EEA).
1. Centralised authorisation procedure
This procedure results in a single marketing authorisation that is valid in all European Union countries, as well as in Iceland, Liechtenstein and Norway.
The centralised procedure is compulsory for new marketing-authorisation applications for:
- human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions, and 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;
- officially designated 'orphan medicines' (medicines used for rare human diseases);
- veterinary medicines for use as growth or yield enhancers.
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, if the medicine concerned represents a significant therapeutic, scientific or technical innovation, or if its authorisation through the centralised procedure would be in the interest of public health.
Applications through the centralised procedure are submitted directly to the European Medicines Agency. Evaluation by the Agency's scientific committees takes up to 210 days, at the end of which the relevant 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 European Union.
Once a marketing authorisation has been granted, the marketing-authorisation holder can begin to market the medicine in the EEA.
2. National authorisation procedures
Each EU Member State has its own procedures for the authorisation of medicines within their own territory that fall outside the scope of the centralised procedure. Information about these national procedures can normally be found on the website of the national medicines authority in the country concerned.
There are also two possible routes available to companies for the authorisation of these medicines in several countries simultaneously:
- the decentralised procedure, in which companies can apply for simultaneous authorisation in more than one EU country of a medicine that has not yet been authorised in any EU country and that does not fall within the mandatory scope of the centralised procedure;
- the mutual-recognition procedure, in which companies that have a medicine authorised nationally in one EU Member State can apply for that authorisation to be recognised in other EU countries. More information is available via the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary.
In some cases, disputes arising from these procedures can be referred to the European Medicines Agency for arbitration as part of a referral procedure.