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Glossary

Occupational exposure to a medicinal product

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For the purpose of reporting cases of suspected adverse reactions, an exposure to a medicinal product as a result of one’s professional or non-professional occupation.

Other glossary definitions

P

Post-Authorization Efficacy Study (PAES)

A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming…

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R

Risk Management Plan (RMP)

A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise,…

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