Since the Natural Health Product Regulations came into force in 2004, all natural health products (NHPs) must have anatural product number (NPN) to be legally sold in Canada.   However, Health Canada developed an 18 month transition plan (March 1st, 2013 to September 1st, 2014) for companies to make the necessary adjustments to business practices and/or phase out products that are not in compliance.

The first 9 months of the transition period (March 1st, 2013 to November 30th, 2013) was on enhancing the awareness of theNatural Health Product (NHP) Regulations.  On December 1st, 2013, the first phase of the transition period ended.  As of December 1st, Manufacturers, Importers, Packagers, and Labellers are expected to be compliant with the NHP Regulations. Products without a product license will not be allowed for commercial importation into Canada and the sale of these products by Canadian Importers and Manufacturers will be subject to compliance and enforcement action.  Health Canada will continue to focus its post-market surveillance on products which may pose a risk to the health and safety of Canadians.  However, companies importing unlicensed products may receive a refusal letter for any commercial shipments of unlicensed natural health products found at the border and Manufacturers, Packagers, and Labellers may be requested to stop sale.

The second phase of transition and the end of the compliance transition is from December 1st, 2013 to August 31st, 2014.  As of Septembers 1st, 2014, NHPs without market authorization may be subject to compliance and enforcement activities.  During the 9 months of the transition period, companies should continue to phase out products at the retail level that do not have market authorization, or products with old, non-compliant formulations, labelling or packaging.  Products that have an active submission number or products with only minor modifications are considered lower priority for enforcement, unless there is a safety risk or additional non-compliances are identified.

DSA can assist your company in bringing your existing NHPs into compliance.

Contact us to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a health care product in Canada, click here.