Guidelines and forms, State Institute for Drug Control

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 5	Electronic Reporting of Adverse Drug Reactions	YES	20.12.2016	PHV-4 version 4
PHV-4 version 5	Suspension of Electronic ICSR Exchange Testing with SUKL Information on Suspension of Electronic ICSR Exchange Testing with SUKL.docx (19.85 kB)	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 Reg-Company-CZ.xls (90 kB) Reg-Company-EN.xls (118.5 kB)
	What to do in case of system failure? F-FV-033-01-1vydání_Oznámení o předložení fyzického média_templát.doc, soubor typu doc, (37 kB) F-FV-033-02-1vydání_Notification of Physical Media Sumbission_template.doc, soubor typu doc, (34.5 kB)
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
PHV-7	SÚKL´s requirements for producing, contents and distribution of educational materials intended for healthcare professionals and patients	YES	25.4.2014
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

State Institute for Drug Control