Voisin Consulting Life Sciences glossary icon
Glossary

Conditional Marketing Autorisation

Loading..
Click a letter to view all its definitions

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

C

CE-Marking Technical File

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

View definition
P

Post-Market Clinical Follow-up (PMCF) plan

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

View definition