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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

R

Real World Study (RWS)

Studies investigating health interventions whose design does not follow the design of a highly-controlled RCT…

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E

Ethics Committee (EC)

The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European…

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