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Glossary

Competent Authority

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Is responsible for the authorization of medicines / medical devices and for ensuring that medicines and medical devices work and are acceptably safe.

Its role is to authorize, monitor, control, inspect and inform.

Other glossary definitions

N

New Drug Application (NDA)

A NDA is the final step formally taken by a drug sponsor, wherein it applies…

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C

Company Core Data Sheet (CCDS)

A document prepared by the marketing authorization holder containing, in addition to safety information, material…

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