September 1 has passed and for the natural health product (NHP) industry in Canada this is quite a significant date. As of this date no NHPs on the market in Canada are to be sold without first receiving market authorization. In addition to receiving their market authorization, NHPs must also be compliantly labeled indicating their NPN or DIN-HM on the principal display panel. This is the license number Health Canada provides to a company to indicate that a product has market authorization.
In Canada, natural health products (NHPs) are subject to the Natural Health Products Regulations (NHPR) which came into effect January 1, 2004. NHPs must undergo pre-market assessment and approval prior to being sold in Canada. When the Regulations first came into effect NHPs could not be sold until they received market authorization (NPN or DIN-HM). However, due to an overwhelming number of applications submitted to the NHPD, a backlog of unprocessed applications quickly ensued resulting in exorbitant review times and a delay in market access for Industry. To address this issue the NHPD enacted the Unprocessed Product License Applications Regulations (UPLAR) on August 10, 2010 to allow NHPs backlogged in the queue for premarket review temporary market access until their market authorization was received. Products granted this temporary license status received a preliminary assessment for safety and efficacy and were assigned an exemption number (EN) while they awaited full review. With an EN a company could sell their NHP products while awaiting a decision on their in-queue submission.
This temporary market access through ENs expired on February 4, 2013, when the NHPD completed the review and rendered a decision (licensing or refusal) of all NHP applications received prior to UPLAR. While the backlog from UPLAR was cleared, many products submitted after the EN temporary market access period were left wondering if the NHPD would still allow them to sell with a only a submission number while awaiting full pre-market review.
In response to this question the NHPD informed the industry of the Two Phase NHP Compliance and Enforcement Transition period. In the First Phase manufacturers, packagers, and labelers were given nine months (from March 1, 2013 to December 1, 2013) to continue producing, packaging/labeling and importing NHPs into Canada with only a submission number while the review of their applications was underway. After December 1, 2013 no products should have been manufactured, packaged, labeled or imported without a NPN or DIN-HM and site licensed importer.
Following December 1, 2013 the Industry entered Phase 2 of the Compliance and Enforcement Transition period which provided an additional nine months (until September 1, 2014) for retailers to finish selling their stock of non–market authorized products that had received a submission number and were imported into Canada prior to December 1, 2013, the end of the Phase 1 transition. After September 1, 2014 it is the NHPD’s expectation that no NHPs on the market in Canada will be sold without first receiving market authorization. In addition to receiving their market authorization NHPs must also be compliantly labeled indicating their NPN or DIN-HM on the principal display panel.
The NHPD has informed Industry that the end of Phase 2 of the NHP Compliance and Enforcement Transition Period does not signal an overnight rush of Inspectors to seize NHPs, but that compliance and enforcement will continue to focus on post-market surveillance of NHPs that pose risks to the health and safety of Canadians, or products making unsubstantiated claims. Moreover, Health Canada intends to expand the current scope of their compliance promotion activities to include transparency initiatives, including opportunities for Industry to promote their compliance with the Regulations. Furthermore, the NHPD has been actively working to streamline their review process by instituting a 3 Class system to stream NHP submissions for review. Under this 3 Class system an NPN is received in either 10 (business days), 30 or 210 days from the date of submission such that Industry will have a faster path to market.
For companies that have diligently worked with the NHPD process, as flawed as the process has been at times, at the end of the tunnel will be marketplace fairness, and those that comply with the Regulations and produce high-quality NHPs will be rewarded for their patience. In turn, Canadian consumers will receive products that they know to be safe and effective—a good image for our industry.
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