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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