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Current status of pharmacovigilance in Poland under Polish and EU provisions

Publication date: October 07, 2025

Pharmacovigilance under Polish law

The purpose of an inspection of the pharmacovigilance system for medicinal products intended for human use (pharmacovigilance inspection) is to verify how the marketing authorization holder for medicinal products is fulfilling its obligations regarding the pharmacovigilance system imposed by Polish and European Union law.

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