Health Canada Departmental Statement regarding NAPRA Resolution on Unlicensed NHPs

February 1, 2010
Ottawa, ON

Health Canada is aware of the National Association of Pharmacy Regulatory Authorities (NAPRA) Position Statement on the sale of Non-Approved Marketed Health Products indicating that pharmacists should not sell a marketed health product without a Drug Identification Number (DIN), Natural Product Number (NPN) or Drug Identification Number for Homeopathic Medicine (DIN-HM). The position statement does not affect Health Canada's Compliance Policy for NHPs. The current policy will continue to be applied and actions will be taken where appropriate, based on the risk that a product represents.

Health Canada's compliance and enforcement efforts target primarily products that present an unacceptable risk to the health of Canadians. As such, the vast majority of natural health products have not been the target of compliance and enforcement actions.

Some products which had been labelled with Drug Identification Numbers (DINs) will now require Natural Health Product Numbers (NPN #) as of January 1, 2010. In most circumstances, manufacturers will still be able to sell NHPs with non-compliant labelling (still bearing the "DIN") for a period of 6 to 12 months. Provided that no significant risks have been identified, enforcement discretion will be applied so as not to cause a disruption to the market by allowing depletion of product still bearing a DIN.

For the most up to date information on authorized NHPs, Health Canada maintains a publicly-accessible database of all licensed NHPs which is updated daily on its website at : www.healthcanada.gc.ca/lnhpd.

Canadians can identify NHPs that have been authorized for sale by Health Canada by looking for the NPN, DIN-HM or DIN on the product label. Since 2004, Health Canada has issued over 18,000 product licences which represent approximately 23,000 NHPs. Although there are 23,000 licensed NHP products, an average retail location may carry less. (An average retail outlet carries up to 6,000 products).