Consultation of Good Pharmacovigilance Practices Guidance Documents

Posted Date: 23-September-2025

Updated Guidance for Industry on Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products, effective October 1, 2026

 

The Marketed Health Products Directorate (MHPD) released two documents for consultation, building on the previous versions.

 

  • GUI-0102 Good pharmacovigilance practices (GVP) guidelines and
  • GUI-0063 Risk classification guide for good pharmacovigilance practices (GVP) observations

 

The existing documents may be found on Health Canada’s website.  Participants wishing to be engaged in this consultation are directed to make an ask of Health Canada for the consultation documents.  In lieu of reaching out to them, we have provided them here:

 

GUI-0063 Risk Classification of GVP – EN/FR

 

GUI-0102 GVP Practices – EN/FR