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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

R

Risk Management Plan (RMP)

A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise,…

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S

Serious Adverse Device Effect (SADE)

Adverse Device Effect that has resulted in any of the consequences characteristic of a Serious…

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