There are several different licensing procedures that a company may use to obtain a marketing authorisation for a medicine depending on which countries the product is going to be marketed in and the type of medicine.
In the European Union (EU), a company may submit an application via the centralised procedure to the European Medicines Agency (EMA) for a single marketing authorisation that is valid in all EU Member States plus Iceland, Liechtenstein and Norway. The use of this licensing procedure is mandatory for certain types of medicines including:
- medicines containing a new active substance intended for the treatment of certain conditions (including AIDS, cancer, diabetes and others)
- advanced-therapy medicines
- medicines derived from biotechnology processes
- medicines used for rare human diseases (also known as ‘orphan medicines’)
The use of the centralised procedure may be optional in certain other cases.
The EMA website
contains additional information about the centralised procedure and full details of its scope.
Decentralised and Mutual Recognition Procedures
A company may use the decentralised procedure (DCP) to apply for a marketing authorisation for a medicine that has not yet been authorised in any EU country and is not required to be approved via the centralised procedure.
The mutual recognition procedure (MRP) can be used if the medicine already has a marketing authorisation in one Member State and the company wishes to market it in other Member States.
The CMDh, the Co-ordination group for Mutual Recognition and Decentralised Procedures – Human - is responsible for the organisation of these procedures and provides a forum to discuss any issues that arise during these procedures.
For both the DCP and the MRP the company decides in which EU countries they wish to obtain a marketing authorisation. One of those countries acts as the Reference Member State (RMS) and takes the lead in the running of the procedure and the assessment of the marketing authorisation application on behalf of the other involved Member States. The other Member States are then referred to as Concerned Member States (CMSs) and may raise queries on the application during the procedure. If the application is approved at the end of the procedure, each of the Member States involved in the procedure issues a marketing authorisation to the company.
A company can submit an application for a marketing authorisation directly to the HPRA if the company only wishes to market a medicine in Ireland and the product in question is not required to be approved through the centralised procedure. If, at a future timepoint, the same company decides that they want to market the medicine in another EU Member State, the Mutual Recognition Procedure can be used.