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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

I

Incident for Medical Device (MEDDEV definition)

Any malfunction or deterioration in the characteristics and/or performance of a device, including use-error due…

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R

Risk-benefit balance

An evaluation of the positive therapeutic effects of the medicinal product in relation to the…

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