Glossary

BlueReg Group Glossary

ASMF

Active Substance Master File

ATMPs

Advanced Therapy Medicinal Products

ATU

Autorisation temporaire d’utilisation (Temporary authorisation for use)

ATUc

Autorisation temporaire d’utilisation de cohorte (Cohort Temporary Authorisation for Use)

ATUn

Autorisation temporaire d’utilisation nominative (Named-patient Temporary Authorisation for Use)

BfArM

Federal Institute for Drugs and Medical Devices

CAT

Committed for Advanced Therapies

CHMP

Committee for Medicinal Products for Human Use

CMA

Conditional Marketing Authorisation

CMS

Concerned Member State

COA

Change of Ownership Application

COMP

Committee for Orphan Medicinal Products

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