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Glossary

Risk minimization measure

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Interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. 

Other glossary definitions

C

Critical Quality Attribute (CQA)

A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate…

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E

Emerging Safety Issue

A safety issue considered by a marketing authorization holder to require urgent attention by the…

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