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

The Organisation for Professionals in Regulatory Affairs

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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.

The Organisation for Professionals in Regulatory Affairs

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