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Glossary

Market Protection

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The protection of an approved medicine against competition from generic medicines that extends beyond the protection conferred by data exclusivity. During this period, applications for generics can be accepted and authorised, but the generic medicines cannot be placed on the market.

Other glossary definitions

C

Company Core Safety Information (CCSI)

All relevant safety information contained in the company core data sheet prepared by the Marketing…

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N

Non-substantial Amendment

A non-substantial amendment is a change to the conduct of the clinical trial that does…

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