As of February 4, 2013, the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) will no longer be in effect. What this means is that no new Exemption Numbers (ENs) for NHPs will be issued, and Health Canada will be transitioning toward the requirement that all NHPs sold in Canada have natural product numbers (NPNs),or Homeopathic Medicine Number (DIN-HM) on the label.
The end of UPLAR does not not signal an immediate change in compliance and enforcement for NHPs. Compliance and enforcement efforts will continue to be risk based. Health Canada’s focus will continue to be on those products for which steps have not been taken to bring them into compliance and/or that pose a higher risk to consumers. Using input from stakeholders, Health Canada has developed a transition plan which provides time for companies to make necessary adjustments to business practices and/or phase out products that are not in compliance. Following the transition period, the expectation is that all products will have an NPN or DIN-HM. There will be an 18 month transition period starting March 1, 2013, that is further broken down into two 9-month phases, as follows:
1) First 9-month Period (March 1, 2013 – November 30, 2013)
The main focus of these first 9 months will be on compliance. During this period, unless a risk to health or additional non-compliances are identified, NHPs that have an active submission number with the Natural Health Products Directorate (NHPD) or approved NHPs that have undergone minor modifications during the licensing process which are not yet reflected in the current labelling, will be a lower priority for enforcement at all levels of the distribution chain.
During this 9-month phase companies should use this time to review their product(s) status and supply, and should begin to phase out products without market authorisation and authorised products with old, non-compliant formulations, labelling or packaging.
2) Second 9-month Period (December 1, 2013 – August 31, 2014)
During these 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 with the NHPD or products that have undergone minor modifications which are not reflected in the current labelling, will be considered a lower priority for enforcement, unless a risk to health or additional non-compliances are identified. At the importation and manufacturing level, NHPs will be expected to have market authorisation and respect the terms of their market authorisations, including formulation and labelling.
Following the transition period, as of September 1, 2014, Health Canada’s expectation is that all NHPs will have an NPN or DIN-HM before coming onto the market. This applies to all levels of the supply chain, including retail. Companies must only import, manufacture and sell NHPs with market authorisation (NPN or DIN-HM) and respect the terms of their market authorisation. NHPs without market authorisation may be subject to compliance and enforcement activities.
For further assistance or information on how DSA Consultants can help your company ensure its products are sold in Compliance with the NHP Regulations and to find out how your company can avoid enforcement action from Health Canada, contact us for more information.