Update of the PHV-6 Guideline

Information on SUKL’s update of the PHV-6 Guideline  

From 16 January 2017 the updated guideline PHV-6 version 1: SÚKL requirements for reporting changes in PSMF and for appointing local contact person for pharmacovigilance in the Czech Republic, is valid.

Amendments to the Guideline follow changes in reporting changes of QPPVs, their contact details and PSMF location – this information is reported directly to the database (XEVMPD) in accordance with the Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 from February 2016.

This version of the Guideline PHV-6 introduces new obligations of marketing authorization holders (who´s PSFM is located in the Czech Republic) to report change of the QPPV, change of the contact details of the QPPV and change of the PSMF location also to the Pharmacovigilance dpt of SÚKL.

Additionally, this version of the Guideline PHV-6 introduces new obligation of the contact person for pharmacovigilance in the Czech Republic – to be contactable on the phone number with the Czech country calling code.

 

Pharmacovigilance Department  
17. 1. 2017