CRED 8 Presentations

01/07/2024

Conditional approvals (1)

• Conditional approval is MA granted on less than complete clinical data package • Legal basis: Article 14 (7) of Regulation (EC) No 726/2004 • Valid for 1 year (renewable) • Expectation is that a full development package will be completed and submitted

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Conditional approvals (2)

• All following requirements should be met: • Positive risk-benefit balance • Likely that the applicant will be in a position to provide comprehensive clinical data; • Unmet medical needs will be fulfilled; • The benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.

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