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Authorization authority
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European commission
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National
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National
|
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Registration location
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All 27 EU member states
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One or more EU member state(s)
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Multiple EU member states
|
|
Application
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Simultaneous in all states
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Separately in each individual member state
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Simultaneous at one or more concerned member states
|
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Existing approval
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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)
|
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Compulsory
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Yes, for innovative medicines (incl. orphan disease)
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No
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No
|
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Data exclusivity and market protection
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8 years data exclusivity + 2 years market protection (+ 1 year market protection for new indication)
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