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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

e

eTMF/ TMF: electronic Trial Master File / Trial Master File

Electronic or paper filing system which must contains all study documents and at least essential…

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I

Innovative Medicine

A medicine that contains an active substance or combination of active substances that has not…

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