SÚKL is Czechia's national competent authority for medicines. It provides pharmacovigilance information for healthcare professionals, patients and regulated companies alongside the EU GVP and EudraVigilance framework.
Core official resources
- SÚKL — national authority.
- Adverse-reaction reporting guidance — example of SÚKL reporting guidance and EudraVigilance routing.
- EMA GVP.
Practical use
For MAHs registered in EudraVigilance, Czech ICSRs generally follow the EU routing model. Use SÚKL for national instructions, contacts, safety communications and local procedural questions.