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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

S

Safety concern

An important identified risk, an important potential risk, or important missing information.

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S

Signal

Information arising from one or multiple sources, including observations and experiments, which suggests a new…

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