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Guidelines and forms

  Name En. v. Valid. since Replaces Amends

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 8 Electronic Reporting of Adverse Drug Reactions YES 8.4.2022 PHV-4 version 7  
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