5. EU Regulatory procedures for a marketing authorisation (MA)
1. EU Regulatory procedures for a marketing authorisation (MA)
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There are two principal ways for obtaining a MA:
- Centralised procedure (CP):
- Non-centralised procedures:
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