PHV-6

VERSION 4 in force from: 31.01.2025

NAME: SÚKL requirements for reporting changes in the PSMF, for appointing the qualified person for pharmacovigilance and for appointing the contact person for pharmacovigilance issues in the Czech Republic

Introduction

1. Definition of terms

Definition of terms

2. Changes to the Pharmacovigilance System Master File which need to be reported to SÚKL

Changes to the Pharmacovigilance System Master File which need to be reported to SÚKL

3. Requirements for the qualified person for pharmacovigilance and reporting of appointment/change of the QPPV to SÚKL

Requirements for the qualified person for pharmacovigilance and reporting of appointment/change of the QPPV to SÚKL

4. Appointment/change of the contact person for pharmacovigilance issues in the Czech Republic

Appointment/change of the contact person for pharmacovigilance issues in the Czech Republic