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Glossary

Risk-benefit balance

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An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health. 

Other glossary definitions

A

Appropriately Reduce (risk)

The reduction of risk to an acceptable level as determined by the manufacturer and regulatory…

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Q

Qualified Person for PharmacoVigilance (QPPV)

Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.…

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