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 6

Electronic Reporting of Adverse Drug Reactions YES  5.12.2017 PHV-4 version 5  

PHV-4 version 5

Suspension of Electronic ICSR Exchange Testing with SUKL YES 20.9.2016   PHV-4

PHV-4 version 5

Electronic Adverse Drug Reaction Reports YES 9.6.2015    PHV-4

The electronic version of the form for EudraVigilance partner registration for electronic ICSR interchange

 What to do in case of system failure?

PHV-6 version 1 SÚKL requirements for reporting changes in PSMF and for appointing local contact person for pharmacovigilance in the Czech Republic YES 16.01.2017 PHV-6   

SÚKL´s requirements for producing, contents and distribution of educational materials intended for healthcare professionals and patients

YES 25.4.2014    

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