Name | En. v. | Valid. since | Replaces | Amends | |
Non-Interventional Post-Authorisation Safety Studies of Medicinal Products for Human Use | YES | 11.1.2016 | PHV-3 version 3 | ||
PHV-4 version 9 |
Electronic Reporting of Adverse Drug Reactions |
YES | 1.9.2023 | PHV-4 version 8 | |
PHV-6 version 3 |
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 |
YES | 8.4.2022 | PHV-6 version 2 | |
PHV-7 version 2 |
SÚKL´s requirements for producing, contents and distribution of educational materials intended for healthcare professionals and patients |
YES | 15.07.2019 | PHV-7 version 1 | |
PHV-8 |
SÚKL´s requirements for producing, contents and distribution of Direct Healthcare Professional Communication |
NO | 4.7.2014 | ||
GVP | Guidelines on good pharmacovigilance practices (GVP) | YES |