Good pharmacovigilance practices inspections
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- What are good pharmacovigilance practices
- What are good pharmacovigilance practices inspections
- Contact us
What are good pharmacovigilance practices
Pharmacovigilance is the science and activities to detect, assess, understand and prevent adverse events or any other drug-related problems. Good pharmacovigilance practices (GVP) are measures taken to facilitate pharmacovigilance activities. These practices ensure that safety data is generated in a consistent, reliable and verifiable manner. They also protect public health and patient safety by ensuring that drugs being sold comply with the legislation, such as section 9 of the Food and Drugs Act.
What are good pharmacovigilance practices inspections
Manufacturers or market authorization holders (MAHs) who sell drugs are responsible for post-market pharmacovigilance activities and good pharmacovigilance practices. When you sell a drug under a name you control, you meet the definition of a manufacturer under the Food and Drug Regulations.
Health Canada conducts post-market GVP inspections on manufacturers or MAHs. The inspections are used to verify compliance with the regulations and help ensure that drugs sold in Canada are safe.
Learn about the inspections we conduct:
We also developed guidance documents and policies to help industry comply with GVP:
- Good pharmacovigilance practices guidelines (GUI-0102)
- Risk classification guide for good pharmacovigilance practices observations (GUI-0063)
- Good pharmacovigilance practices inspection approach policy for human drugs (POL-0041)
Contact us
For questions about good pharmacovigilance practices, your regulatory obligations, and GVP inspections, email us at gvp-bpv@hc-sc.gc.ca.
Related links
Health Canada resources
- Food and Drugs Act
- Food and Drug Regulations
- Reports and publications – MedEffect Canada
- Compliance and enforcement policy (POL-0001)
- Guidance documents on applications and submissions for drug products