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Glossary

Competent Authority

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Is responsible for the authorization of medicines / medical devices and for ensuring that medicines and medical devices work and are acceptably safe.

Its role is to authorize, monitor, control, inspect and inform.

Other glossary definitions

P

Post-Authorization Efficacy Study (PAES)

A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming…

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C

Core Reimbursement Dossier

A core reimbursement dossier is submitted during the late stage of development of a product,…

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