CRED ERP 25

01/07/2025

Exceptional circumstances cf. conditional marketing authorisation

• Conditional marketing authorisation

Exceptional circumstances • Comprehensive data cannot be provided (specific reasons foreseen in legislation) • Reviewed annually to reassess the risk-benefit balance • Will normally not lead to the completion of the dossier and "normal" MA

•

• Demonstrate positive benefit risk balance, based on scientific data, pending confirmation • MA valid for one year, on a renewable basis • Once pending studies are provided, converted to "normal" MA

The Organisation for Professionals in Regulatory Affairs

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Other EU Key Strategic Considerations

Orphan drug considerations

Risk Management Plan

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•

• Paediatric investigation plans (PIPs)

• Non-NCEs and legal basis of application

Scientific advice

• Pharmacovigilance system master file (PSMF)

•

PRIME

•

Managing Internal/External Expectations

•

The Organisation for Professionals in Regulatory Affairs

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