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 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 version 1 |
SÚKL´s requirements for producing, contents and distribution of Direct Healthcare Professional Communication
|
NO
| 11.01.2023 | PHV-8 |
|
| GVP |
Guidelines on good pharmacovigilance practices (GVP)
|
YES
|
|
|
|
