Update of the PHV-4 Guideline

Information on SUKL’s update of the PHV-4 Guideline    

From 20 December 2016 the updated guideline PHV-4 version 5: Electronic reporting of the adverse drug reactions has been in force. Amendments in this Guideline follow up on the revision of the Guideline KLH-21 – version 6 in which the obligation of clinical trial adverse drug reports (SUSAR) parallel submission to SÚKL has been cancelled.

The following obligations of the CT sponsors are cancelled by this version of the Guideline PHV-4:

  • registration with SÚKL for ICSR electronic interchange
  • testing with SÚKL for ICSR electronic interchange
  • registration form up-date

Marketing authorisation holders’ obligations remain unchanged.

Pharmacovigilance Department

20.12.2016