Procedures to obtain a licence (marketing authorisation) for a medicine
A company may use one of several procedural routes to obtain a marketing authorisation for a medicine for Ireland. The procedure chosen depends on the type of product and the country(ies) in Europe in which the product/medicine will be marketed. Three routes are described below.
Centralised Procedure
A company may submit a centralised application to the European Medicines Agency (EMA). This will result in a single marketing authorisation that is valid in all EU Member States plus Iceland, Liechtenstein, and Norway. The use of this authorisation procedure is mandatory for certain types of medicines including:
- medicines containing a new active substance intended for the treatment of certain conditions (including HIV, cancer, diabetes, and others)
- medicines derived from biotechnology processes.
- advanced-therapy medicines
- 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.
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 company requests a country to act as the Reference Member State (RMS). For an MRP the reference member state will be the MS which has already authorised the product. The RMS takes the lead in the administration and the assessment of the marketing authorisation application on behalf of the other involved Member States.
The other Member States are referred to as Concerned Member States (CMSs). The CMSs 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 issue a national marketing authorisation to the company.
The CMDh, the Co-ordination group for Mutual Recognition and Decentralised Procedures – Human is responsible for the organisation of the MR and DCP procedures and provides a forum to discuss any issues that arise during these procedures and their website contains additional procedural information
National Procedure
A company can apply for a marketing authorisation directly to the HPRA if the company wishes to market a medicine in Ireland only. This route applies where the product is not already authorised in another member state and is not required to be approved through the centralised procedure.
If, in the future, the same company decides that they want to market the medicine in another EU Member State, the Mutual Recognition Procedure can be used as detailed above.
In case of further queries on the submission and approval of national licensing procedures, please contact the HPRA’s Customer Services section at info@hpra.ie.