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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

Comparability Protocol

A comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change…

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C

CE-Marking Technical File

A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications,…

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