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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

S

Summary of product characteristics (SmPC)

Part of the marketing authorization of a medicinal product setting out the agreed position of…

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I

In Vitro Diagnostic Medical Device (IVDMD)

Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,…

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