Module 16 2024

22/10/2024

Limits of Precautionary Principle

The Anorectics Case

Precautionary measure ● If risk to human health is identified even if existence or extent is uncertain ● No need to wait until the reality/seriousness of the risk becomes fully apparent BUT ● Authorities must have new scientific data or information to justify reconsidering safety/efficacy ● A mere change in consensus on safety/efficacy does not justify withdrawal of an authorisation

No such information cited in CHMP opinion

CFI annulled the Commission decisions

The Organisation for Professionals in Regulatory Affairs

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Thank You

Questions?

The Organisation for Professionals in Regulatory Affairs

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