Closed consultation: Guidance document updates for Good Pharmacovigilance Practices (GVP) inspection
Current status: Closed
This consultation ran from September 15, 2025 to October 30, 2025.
Health Canada announced a 45-day consultation on the drafts of the updated GVP guidance documents. After consultation, the drafts will be finalized and replace the versions previously published in 2013:
- GUI-0102: Good pharmacovigilance practices (GVP) guidelines
- GUI-0063: Risk classification guide for good pharmacovigilance practices (GVP) observations
The deadline to provide comments was October 30, 2025.
Who was the focus of this consultation
This consultation invited feedback from all interested parties and stakeholders, in particular:
- market authorization holders marketing the following human drugs in Canada:
- pharmaceutical drugs, prescription and non-prescription
- biologics set out in Schedule D to the act, including:
- biotechnology products
- vaccines
- fractionated blood products
- radiopharmaceuticals set out in Schedule C of the Food and Drugs Act (act)
- medical gases
Key questions for discussion
Your ideas and input were sought around the proposed updates to the guidance documents related to GVP inspections. The updates provide additional information on GVP and regulations applicable to GVP inspections.
The documents for consultation included proposed updates to existing guidance documents:
- Draft GUI-0102: Good Pharmacovigilance Practices (GVP) guidelines
- Draft GUI-0063: Risk classification guide for Good Pharmacovigilance Practices (GVP) observations
These guidance documents are intended to promote stakeholder compliance, as well as promote consistency in inspections conducted by Health Canada.
The input gathered through this process will be considered when finalizing the guidance documents.
Related information
Contact us
Health Product Compliance Directorate
Regulatory Operations and Enforcement Branch
Health Canada
Email: gvp-bpv@hc-sc.gc.ca