The Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) was repealed as of February 2013 as planned. This means that new natural health products (NHPs) will no longer be issued an exemption number (EN) and products currently operating under an EN will need to be brought into compliance with the Natural Health Product Regulations (NHPR) or phased out. With NHP-UPLAR phased out, EN’s no longer have the intended effect under NHP-UPLAR.
Health Canada has released details on the transition plan to address the repeal of NHP-UPLAR. The transition will take place over 18 months, divided into 2, 9-month phases. As of September 1, 2014 when the transition ends, all NHPs will be required to have natural product number (NPN) or a Homeopathic Medicine Number in order to be sold at the distributor/retail level or at the manufacturing/importer or packaging/labelling level.
Phase 1: March – November 2013
During Phase 1 of the transition period Health Canada will be focussed on promoting awareness of and compliance with the NHPR with manufacturers, importers, packagers, and labellers (“supply chain”). NHPs that have an active submission number or have been approved with minor modifications still to be reflected in the labelling will generally not be targeted for enforcement. Issues relating to risk will always bring about compliance action.
If you are a member of the supply chain and selling a product under an EN during this period because it is still being reviewed by Health Canada (i.e. has an active submission number) no action is likely required. If, as a supply chain member, you are selling a product under an EN because your NPN requires modification to the product label (including updating labels to indicate “NPN” rather than “EN”) you should begin the process of making these modifications so that they can be reflected on the next label run and you can begin distributing compliant products by the November 30, 2013 deadline. If, as a supply chain member, you have any other products that do not have an NPN, you should begin phasing them out, including winding down import and manufacturing activities, unless you feel by the end of November 2013 an NPN will be issued for the product. The key for this phase is that members of the supply chain should ensure that by December 1, 2013 only products that are issued an NPN are sold. It is expected that there will likely continue to be some latitude with respect to labelling as long as the product has been issued an NPN and the nature of the label deficiency does not give rise to a risk to the health of the consumer.
Phase 2: December 2013 – August 2014
When Phase 2 of the transition period begins in December 2013, supply chain members will no longer be permitted to sell NHPs without an NPN having been issued for the product. During Phase 2, NHPs without an NPN can still be sold from inventory of distributors or retailers. This 9-month period ending September 1, 2014 allows for distributors and retailers to sell-off existing inventory of products which have not received an NPN.
Full Compliance: September 1, 2014
Starting September 1, 2014 supply chain members, as well as distributors and retailers, will only be permitted to import, manufacture and sell NHPs which have been issued an NPN under the NHPR and are in compliance with the terms of the market authorization. It is suspected that the NHP Directorate will continue to work diligently to review those past backlog (August 2010) submissions that remain in the queue. This may further reduce the amount of products that will have to be withdrawn from the marketplace by September 1, 2014.