By Monica Banach, MSc.
NHP, Drug, Scientific & Regulatory Affairs Associate
The Natural Health Product Directorate (NHPD) has set February 4, 2013 as the date when the Natural Health Product – Unprocessed Product Licence Applications Regulations is to be repealed, and which will officially end the granting of exemption numbers (ENs) for natural health products.
On August 4, 2010, the NHPD authorized the assignment of ENs for natural health products (NHPs), by specific provisions by the NHPD, under the Unprocessed Product Licence Applications Regulations (UPLAR). An EN is granted to a low risk product licence applications (PLA) that is in queue with the NHPD but has not yet received a Natural Product Number (NPN). The EN serves as a temporary means for which to allow NHPs to go to market while they await their licenses to be issued. Thus, an EN allows for the exemption to the probation on sale, set in the NHP Regulations, provided that the NHPD has not made a decision to refuse or issue a licence and finds that the product has met certain safety standards.
Under the Regulations, an EN would be assigned to products 180 days after the product licence application submission number is issued. Thus, if you are looking to submit a PLA and obtain an EN number for a natural health product, PLAs must be submitted to the NHPD by July of this year, 2012, as it will take 7 months to obtain an EN. The 7 month timeframe takes into account the following, once a PLA has been submitted: a) a 4 week turnaround time for the NHPD to provide a submission number; and b) the 180 day turnaround time for the NHPD to provide an EN. These timeframes constitute the performance standards set by the NHPD.
Once an EN is issued by the NHPD, it will remain operational until a decision to issue or refuse a licence is made, or until February 4, 2013, when the NHP-UPLAR are repealed. At this point, all current ENs will expire. February 4, 2013 will mark the 30 months after which these Regulations came into force, which was originally set in the NHP-UPLAR.
What does this mean for PLAs that are submitted after July 2012? This means that there will be no guarantee that an EN will be provided for a product, when taking into consideration the performance standards for timeframes set by the NHPD.
What happens after February 2013? As per the NHPD, once UPLAR expires, all products will require a licence to be on the market and the current practice of going to market with submission or exemption numbers will no longer be acceptable. The NHPD have committed themselves to clearing all applications currently in queue, i.e. either by issuing a Natural Product Number (NPN) or by issuing a refusal by the expiration of UPLAR.
Any files submitted after July, 2012 run the risk of not being licenced come February 2013 and may have a period of time during which they are exposed to enforcement while waiting for their application assessment to be completed. As per the NHPD, their internal performance standard for reviewing an application is 180 days.
If you have any questions or require assistance with filing PLAs, dicentra can provide advice and support with the preparation of high quality submissions of your NHPs.
References:
Natural Health Products (Unprocessed Product Licence Applications) Regulations P.C. 2010-958. The Food and Drug Act SOR/2010-171. August 4, 2010, http://gazette.gc.ca/rp-pr/p2/2010/2010-08-18/html/sor-dors171-eng.html.
Management of Product Licence Applications (PLA) for Natural Health Products. August 2010, http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/pol/pla-dlmm_manage-gestion-eng.php
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