CRED 8 Presentations

01/07/2024

Exceptional circumstances cf. conditional marketing authorisation

• Conditional marketing authorisation • 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

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

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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 • Pharmacovigilance system master file (PSMF)

Scientific advice

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PRIME

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Managing Internal/External Expectations

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The Organisation for Professionals in Regulatory Affairs

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