Spring Intro 2023

16/02/2023

CONDITIONAL MA

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Why Important?

In the interest of public health, conditional MA may be granted where:  the benefit of immediate availability outweighs the risk of less comprehensive data than typically required

Eligibility

Requirements

Medicines must be: • aimed at treating, preventing or diagnosing seriously debilitating or life-threatening diseases ; • intended for use in emergency situations ; • designated as orphan medicines .

• Positive benefit-risk balance; • Likely that the applicant will be able to

provide comprehensive data ; • Fulfils unmet medical need ;

• Benefit to public health of product's immediate availability outweighs the risks due to need for further data.

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