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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

Periodic Summary Reporting

Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for…

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V

Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU…

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