| 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 | ||
| Electronic Reporting of Adverse Drug Reactions | YES | 17.5.2019 | PHV-4 version 6 | ||
| PHV-6 version 2 | SÚKL requirements for reporting changes in PSMF and for appointing local contact person for pharmacovigilance in the Czech Republic | YES | 1.11.2019 | PHV-6 version 1 | |
| 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 |
Search
cz