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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

P

Paediatric Investigation Plan (PIP)

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary…

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E

Expedited Criteria

Criteria that should be fulfilled for expedited reporting. The four minimum information required for expedited…

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