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Glossary

Identified risk

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An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest.

Other glossary definitions

C

CIOMS I Form

A form used to notify the relevant authorities of the Individual Case Safety Report (ICSR)…

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E

European Union (EU) Legal Representative

Sponsors who are not based in the EU/EEA must appoint a legal representative based in…

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