| PHV-3 version 4 | 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 4 | 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 | 31. 1. 2025 | PHV-6 version 3 |
|
| PHV-7 version 2 | SÚKL´s requirements for producing, contents and distribution of educational materials intended for healthcare professionals and patients | YES | 15. 7. 2019 | PHV-7 version 1 |
|
| PHV-8 version 1 | SÚKL´s requirements for producing, contents and distribution of Direct Healthcare Professional Communication | NO | 11. 1. 2023 | PHV-8 |
|
| GVP |
Guidelines on good pharmacovigilance practices (GVP)
| YES | | |
|
