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Glossary

Overdose

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Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose according to the authorized product information.

Other glossary definitions

P

Pharmacovigilance System Master File (PSMF)

A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the…

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Q

Qualified Person for PharmacoVigilance (QPPV)

Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.…

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