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Table 1 Summary of the three application procedures in the European Union

From: Unrealized potential of drug repositioning in Europe during COVID-19 and beyond: a physician's perspective

  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)