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Glossary

Important identified risk and Important potential risk

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An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for public health.

Other glossary definitions

C

Committee for Advanced Therapy (CAT)

The Committee for Advanced Therapies (CAT) is the European Medicines Agency’s (EMA) committee responsible for…

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S

Significant risk device

An investigational device that:  Is intended as an implant and presents a potential for serious…

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