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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


CE-Marking Technical File

A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications,…

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Post-Market Clinical Follow-up (PMCF) plan

The documented, proactive, organized methods and procedures set up by the manufacturer to collect clinical…

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