On February 8, 2013, Health Canada released an announcement to clarify the fate of advertising for products currently in-market under exemption numbers (“ENs”). The verdict? Advertising for such products will be allowed for an 18-month transition period.
The “Exemption Number” Stopgap
Since 2010, the Natural Health Products (Unprocessed Product Licence Applications) Regulations (“NHP-UPLAR”) permitted certain low-risk natural health products with pending product licence applications to be sold under ENs until a product licence was issued. This was intended to be a temporary measure to deal with the backlog of applications that had flooded the Natural Health Products Directorate. During this period, according to a Health Canada Position Statement dated September 10, 2010, preclearance agencies could rely on the product licence application, rather than a product licence, to review advertising and adjudicate complaints.
The life of the NHP-UPLAR ended on February 4, 2013, meaning that no more new ENs will be issued. Health Canada will work with the industry to phase out products sold under ENs, ultimately requiring that all products sold in Canada have a natural product number (“NPN”) or Homeopathic Medicine Number (“DIN-HM”). It is expected that, going forward, the majority of product licenses are to be processed within 180 days so the category of EN will no longer be necessary to facilitate entry of new products into the market.
What Happens Now
The recent Health Canada announcement provides an 18-month transition period for advertising of products previously issued an EN. The status quo will therefore remain for the preclearance of advertising and handling of disputes during this time period. This allows a measure of certainty for those still advertising products for which no product licence has been issued, and sets an expiry date of sorts by which companies will need to phase out such advertising, or transition to advertising based on the issued product licence.