February 4, 2013 will mark the repeal of the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLARs), which were introduced in 2010 as a temporary solution to the backlog of natural health products awaiting regulatory approval. After this date, Health Canada will phase out the sale, importation and manufacture of unlicensed NHPs in Canada.
The Natural Health Products Regulations (NHPR) were enacted in 2004 to create a regulatory framework for certain health products that made therapeutic claims but did not pose the same level of risk as traditional over-the-counter drugs.
At the time the NHPR came into force, approximately 40,000 products that met the definition of an NHP but that were unlicensed were available on the Canadian market. As a result, a large number of products needed an NHP licence to continue to be legally sold in Canada. The unintended consequence of the NHPR was a queue of applications for thousands of products.
In response to this backlog, Health Canada introduced the NHP-UPLARs in 2010 so that Canadians would have lawful access to NHPs that were still awaiting regulatory approval. An exemption number (EN) was issued for NHPs that had been in the application queue for more than 180 days and that met certain safety requirements. NHPs that were issued an EN were deemed to hold a product licence, which allowed them to be lawfully sold in Canada.
The NHP-UPLARs were meant to be a short-term solution and, to that end, were drafted to be repealed on February 4, 2013 (30 months after the day they came into force).
In anticipation of the repeal date, Health Canada has been steadily working toward clearing the NHP backlog. According to Health Canada’s most recent update on the progress of this backlog clearing process,1 93% of all 71,901 NHP licence applications received between January 1, 2004 and September 30, 2012 were either cleared or rejected.
Further, Health Canada has reviewed how it processes NHP licence applications in order to prevent another backlog. Health Canada has committed to reviewing all NHP licence applications within 180 days of submission. In particular, for those NHP products that pose a low to medium risk (i.e., known products making established claims or known products making new claims), Health Canada is targeting an application processing time of 30 days or less.2
Transition Process and Practical Considerations
Companies that are currently selling NHPs in Canada under an EN and do not obtain an NHP licence on or before February 4, 2013 will have an 18-month transition period to phase out any unauthorized NHPs from the Canadian market. The transition period will be split into two 9-month phases:
Phase I (March 1, 2013 to November 30, 2013). During this time, Health Canada will focus on compliance promotion to companies that sell NHPs in Canada. Health Canada will attempt to raise awareness among companies so that they understand what steps to take to comply with NHPR.
In particular, Health Canada will be encouraging companies to review their current NHP inventory and to start phasing out NHPs with old, non-compliant formulations, labelling and packaging. Health Canada has indicated that it will shortly be releasing a guidance document on the impact of the repeal of NHP-UPLARs on advertising and labelling.
Companies should also review their operations to ensure that only licensed NHPs are imported into Canada by the end of Phase I.
Phase II (December 1, 2013 to August 31, 2014). Companies will no longer be permitted to import or manufacture unlicensed NHPs as of December 1, 2013. Presumably, any NHPs that are not labelled with a valid licence number will be held at the Canadian border as of this date. However, companies will have until August 31, 2014 to continue selling any unlicensed NHPs that still remain available at the retail level in Canada.
After the last day of the transition period (August 31, 2014), only licensed NHPs may be imported, manufactured or sold in Canada.
Although the NHPD has previously taken a risk-based approach to compliance (i.e., taken action only if there is a perceived safety issue with an NHP), we expect that the NHPD will become more active in enforcement after August 31, 2014.