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

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There are two principal ways for obtaining a MA:

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