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Conditional Marketing Autorisation

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The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required.

The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future.

Other glossary definitions



Nonviable substance produced by or derived from microorganisms, which, when administered in adequate amount, confer…

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Development international birth date (DIBD)

Date of first approval (or authorization) for conducting an interventional clinical trial in any country…

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