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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

O

Off-label use

Situations where a medicinal product is intentionally used for a medical purpose not in accordance…

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D

Data Protection Representative (DPR)

The DPR is the EU representative of non- EU Sponsors that are not established in…

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