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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

P

Potential risk

An untoward occurrence for which there is some basis for suspicion of an association with…

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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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