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

There are two principal ways for obtaining a MA:

•  Centralised procedure (CP):
•  Non-centralised procedures:
• national procedure (NP)
• mutual recognition procedure (MRP)
• decentralised procedure (DCP)

Each system has its own legal provisions and responsibilities for the competent authority (EMA or national competent authorities) and MA holders.

Figure 4: EU EMA procedure

Legal Basis CP: Regulation EC No.726/2004/EC
Legal Basis non-

CP: Directive 2001/83/EC as amended