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Glossary

Module 3

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This is the quality (or CMC) module, which is a component of the common technical document used for the registration of pharmaceuticals for human use.

 

Other glossary definitions

C

Clinical Trial Application (CTA)

The conduct of clinical trials is subject to prior authorization from health authorities, to ensure…

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R

Reference safety information

In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the…

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