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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

I

Identified risk

An untoward occurrence for which there is adequate evidence of an association with the medicinal…

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M

Medical Device Software

A “medical device software”, refers to a computer application that meets the legal definition of…

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