5. EU Regulatory procedures for a marketing authorisation (MA)

If a company wishes to request marketing authorisation (MA) for a medicine not eligible for or if the company does not opt for the centralised procedure it may use one of the following routes:

• National procedure (NP).
• Mutual recognition procedure (MRP), whereby a marketing authorisation granted in one Member State can be recognised in other EU countries
• Decentralised procedure (DCP), whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.

To note:  For all new MA applications in DCP, MRP and NP the eCTD format is mandatory. The data requirements and standards for the authorisation of medicines are the same in the EU, irrespective of the authorisation route.