Last month marked the end of the Natural Health Products (Unprocessed Product Licence Applications) Regulations. As of February 2013, Health Canada will no longer issue new Exemption Numbers (ENs) for Natural Health Products (NHPs).
In 2004, the Natural Health Products Regulations came into force, prohibiting the sale of unlicensed NHPs in Canada. At that time, there were an estimated 40,000 NHPs already on the market that did not comply with the new Regulations. As a result, Health Canada was flooded with NHP licence applications. By 2010, Health Canada had processed approximately 40,000 applications, but was still experiencing a sizable backlog.
The Unprocessed Product Licence Regulations, which came into force on August 4, 2010, were introduced as a temporary framework within which NHPs awaiting receipt of marketing authorization (i.e., unlicensed NHPs) could be sold safely and legally in Canada.
Under the Unprocessed Product Licence Regulations, manufacturers could be granted an EN and deemed to hold a valid product licence provided that certain filing requirements were fulfilled and safety criteria were met. Health Canada is now moving away from that temporary framework towards the requirement that by September 1, 2014, all NHPs sold in Canada must have a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM).
The new requirement will be implemented using a two-stage transition plan.
Stage 1 (March 1, 2013 to November 30, 2013)
During the first stage, Health Canada will focus on promoting awareness of the Natural Health Products Regulations and working with industry to ensure understanding of the new regime.
Businesses should use this time to review their products and phase out any NHPs at the retail level with non-compliant formulations, labelling or packaging.
Health Canada will prioritize its enforcement efforts during this stage, with less priority being given to NHPs that have an active submission number and products for which the labelling has not yet been updated to reflect minor modifications. These products will be subject to high priority enforcement measures, however, if risks to health or additional non-compliances are identified.
Stage 2 (December 1, 2013 to August 31, 2014)
During the second stage of the transition plan, NHPs at the importation and manufacturing levels will be expected to have received marketing authorization and comply with its terms, including with respect to formulations, packaging and labelling.
Businesses should continue to conduct an internal review of their NHPs during this stage to ensure compliance with the Natural Health Products Regulations.
Implementation Date (September 1, 2014)
By September 1, 2014, all NHPs imported into, manufactured or sold in Canada will be expected to have an NPN or DIN-HM. NHPs without marketing authorization may be subject to compliance and enforcement measures.