Monitoring Regulatory Compliance

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Canadians trust that the health products they buy are safe and effective. However, protecting Canadians' health and safety doesn't end when regulations are put in place. Equally important in reducing health risks is monitoring compliance - Health Products and Food Branch (HPFB) actively oversees the marketplace so that anyone who makes, packages, imports or sells health products to retailers in Canada follows regulatory requirements.

Regulatory compliance

Products that HPFB regulates include pharmaceuticals, natural health products, medical devices, veterinary drugs, food and biologics. The HPFB Inspectorate is responsible for overseeing the compliance of all regulated products by monitoring establishment licensing, inspections, investigations, and laboratory analysis. The exception to this is with food, where the Canadian Food Inspection Agency is responsible for federal inspection and monitoring.

To obtain licences for any HPFB-regulated activity-and to renew licenses each year-companies must demonstrate to the Branch that all processes and procedures adhere to appropriate standards. Internationally recognized Good Manufacturing Practices must be followed at Canadian sites involved in the production of drug products. These sites are thoroughly inspected on a regular basis by highly trained professionals.

The Inspectorate also moves quickly to investigate any possible regulatory violations that it may learn of through complaints from competitors or tips from members of the public.

Sound scientific evidence

Each inspection and investigation conducted by the Inspectorate relies on sound scientific evidence provided by other directorates in the Branch. In addition, the Inspectorate operates two analytical laboratories to conduct a variety of tests on health products. These labs work closely with leading scientific experts within HPFB, and are certified to the world's highest standards.

International cooperation

The health products industry today operates in a global environment. HPFB works hand in hand with agencies in more than 20 countries, participating in activities to help harmonize global standards and practices. All manufacturers selling products to Canadians, wherever they are located, must follow and adhere to the strict standards and rules set by Health Canada.

HPFB is firmly committed to protecting the health and safety of Canadians. The work of the Inspectorate assures Canadians that they can have confidence in the health products they purchase.

Health Canada
Health Products and Food Branch
250 Lanark Avenue
Graham Spry Building
Address Locator: 3002A
Ottawa ON K1A 0K9
Telephone: 613-957-1806
Facsimile: 613-954-3957
Email: hpfb-dgpsa@hc-sc.gc.ca
Web site: www.healthcanada.gc.ca/hpfb

HPFB Inspectorate
250 Lanark Avenue
Address Locator: 3002A
Ottawa ON K1A 0K9
Toll Free: 1-800-267-9675
National Capital Region: 613-946-5095
Facsimile: 613-952-9805
Email: DGO-ADGO_BDG-BDGA/HC-SC/GC/CA
Web sites: www.healthcanada.gc.ca/compliance
www.healthcanada.gc.ca/inspectorate

Operational Centres

Atlantic
16^th floor, suite 1625
1505 Barrington Street
Halifax, Nova Scotia
B3J 3Y6
Telephone: 902-426-2160
Facsimile: 902-426-6676

Ontario
2301 Midland Avenue
Scarborough, Ontario
M1P 4R7
Telephone: 416-973-1600
Fax: 416-973-1954

Québec
1001 St-Laurent Street West
Longueuil, Québec
J4K 1C7
Telephone: 450-646-1353
Facsimile: 450-928-4455

Manitoba and Saskatchewan
510 Lagimodière Blvd
Winnipeg, Manitoba
R2J 3Y1
Telephone: 204-984-1341
Facsimile: 204-984-2155

Western
4^th Floor
4595 Canada Way
Burnaby, British-Colombia
V5G 1J9
Telephone: 604-666-3704
Facsimile: 604-666-3149