URPL is Poland's national competent authority for medicinal products. Marketing-authorisation holders should use URPL for Poland-specific pharmacovigilance information and EMA/EudraVigilance for EU-wide ICSR and procedural requirements.
Core official resources
- URPL — national medicines authority and pharmacovigilance information.
- EMA GVP — EU pharmacovigilance framework.
- EudraVigilance — EU ICSR system.
Practical use
Check URPL for national safety communications, reporting routes, Polish-language requirements and local procedural updates before relying only on EU-level material.