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Concept information

clinical research > clinical trial > phase > marketing authorization > conditional marketing authorisation

Preferred term

conditional marketing authorisation  

Broader concept

Note

  • Conditional marketing authorisation is a pragmatic tool for the fast-track approval of a medicine that fulfils an unmet medical need. Despite earlier approval, it guarantees that the medicine meets rigorous EU standards for safety, efficacy and quality and that comprehensive data is still generated post-approval. European Medicines Agency. « Conditional marketing autorisation. » (Retrieved 02/01/2021, from https://www.ema.europa.eu/ )

Creator

  • Patricia Fener

URI

http://data.loterre.fr/ark:/67375/C0X-JX9VZM1D-T

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