Tuesday, December 18, 2012
On August 4, 2010 the Natural Health Products Directorate (NHPD) of Health Canada informed the natural health products industry of new legislation – the Unprocessed Product Licence Applications Regulations (UPLAR) – to address the ongoing issue of unlicenced products as a consequence of the backlog. This legislation was enacted, ostensibly, to ensure that Canadian consumers had access to safe natural health products within a reasonable time frame. This was accomplished by assigning Exemption Numbers (ENs) to products that had received a preliminary assessment for safety and efficacy so that they could be legally sold while awaiting full review. UPLAR was created as a temporary solution and is set to expire on February 4, 2013, when the legislation is repealed.
Any new submission or amendment received by the NHPD prior to August 5, 2010 is considered pre-UPLAR. Of the 10,885 pre-UPLAR submissions, 86% have been completed as of October 2012. This means they have been approved, refused or withdrawn by the applicant. As we approach the end of UPLAR there still remains 1,534 applications to be assessed. Although this number sounds quite large there is good news for companies with pre-UPLAR applications in queue. The NHPD is working steadfastly towards meeting its goal of clearing the backlog, with 1,593 applications assessed in October of this year alone. Furthermore, the NHPD is meeting its 180 day and 60 day review time performance targets 70% (for non-traditional, traditional and homeopathic applications) and 99% (for Compendial and labeling standards applications) of the time, respectively. A Regulatory Affairs Associate at dicentra, Manushvi Chadha Gupta has indicated that in her experience “The NHPD has been actively meeting its target dates for reviewing all streams of applications. We are witnessing a very quick turnaround on assessments, with compendials getting licenced within days and IRNs coming through within the first couple of weeks. It appears as though the NHPD takes its deadlines seriously and frequently completes their review before their target timelines”.
This can be accredited to a number of initiatives at the NHPD including the publication of 30 new monographs in 2012, triaging applications for assessment based on risk and completing application assessments by “batching” (where products and/or ingredients of the same type are assessed in batches to expedite review time and provide reviewer decision consistency).
In the interim, what do you need to know about the NHPD’s assessment process with respect to completing their backlog? Expect to receive clarification requests (CRs) and information request notices (IRNs) in batches where you will be requested to either modify the claims, ingredient presentation and/or risk statements to conform to Pre-Cleared Information (PCI) requirements or provide additional evidence to substantiate the safety of an ingredient. It has been our experience that applications that are either voluntarily changed to meet PCI through Unsolicited Revisions or at the request of an IRN are reviewed and licensed quickly.
Furthermore, do not expect to receive an EN for any applications submitted after July, 2012. After this date applications are only given submission numbers and it is important for companies to understand the difference, as it is legal to go to market with an EN but not a submission number. With that in mind we suggest that industry does not look at this as a negative, but as an opportunity to carefully and thoughtfully plan out your product licence applications so that you meet the NHPD’s expectations when you first submit.
As the NHPD appears to be on track with clearing its backlog by February 4, 2013 this may leave you questioning what the industry should expect in the way of compliance and enforcement. The NHPD has clearly indicated that they will maintain their compliance and enforcement risk-based approach and are quick to emphasize that the end of UPLAR does not signal a change in their approach to compliance and enforcement activities. When asked about what type of compliance and enforcement we can expect from the Inspectorate on February 5, 2013, the day after UPLAR expires, dicentra’s Director of Quality & Compliance, William Morkel, indicated the following “Some in the industry believe that there are hoards of inspectors poised to strike at midnight, the moment UPLAR expires. In reality, when it comes to enforcement, it will be business as usual – Health Canada will continue to follow their current compliance and enforcement policy, at least for the first nine months of the proposed transition period”.
Currently, the NHPD is proposing to consult with the industry and review feedback from December 2012 through to January 2013 to determine appropriate transition time lines. At this time the NHPD plans to begin phasing out products without market authorization starting on March 1, 2013. On December 1, 2013 (9 months from the start of the transition) the NHPD will expect that all manufacturers, packagers and labelers will have completed stock turn over and should not be selling unlicensed products. Retailers and distributors will be provided with an additional 9 months from this time, until September 1, 2014, to complete sale of stock of non-market authorized products. After this time the Natural Health Products Regulations and the Compliance and Enforcement Policy will come into full effect and products without market authorization should not be sold. However, it is important to note that the transition period for compliance and enforcement is still under construction and may change based on industry feedback.
Although full-scale compliance and enforcement is set to begin in 2014 we would take this as a good sign. For all of us who have been working diligently to satisfy NHPD standards, as flawed as the process has been at times, at the end of the tunnel will be marketplace fairness, where those that comply with the Regulations and produce high quality natural health products for the public will be rewarded for their patience. This reward will be passed on to the Canadian consumer in that they will receive products that they know will be safe and effective – a good image for our industry.
dicentra is an international leader in regulatory and scientific affairs within the dietary supplement, natural health product (NHP), food, beverage, cosmetic and OTC industries. For more information please visit http://dicentra.com.