Table 1 Summary of the three application procedures in the European Union
Central procedure | Decentral procedure | Mutual recognition procedure | |
|---|---|---|---|
Authorization authority | European commission | National | National |
Registration location | All 27 EU member states | One or more EU member state(s) | Multiple EU member states |
Application | Simultaneous in all states | Separately in each individual member state | Simultaneous at one or more concerned member states |
Existing approval | No existing approval in EU member state | No existing approval in EU member state | Existing approval by EU member state national market authority (Reference Member State) |
Compulsory | Yes, for innovative medicines (incl. orphan disease) | No | No |
Data exclusivity and market protection | 8 years data exclusivity + 2 years market protection (+ 1 year market protection for new indication) | ||