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

1.2. Non-centralised procedures

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:

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.