The Natural Health Products Directorate of Health Canada (NHPD) will be meeting its goal and completing the assessments of the entire backlog of applications by Feb. 4, 2013. They’ve worked their way down from approximately 11,000 submissions to fewer than 150 as of today’s date, and will finish the remaining submissions as scheduled. They considered their backlog to be all submissions applied for prior to April 4, 2010.
Although they have been working on current applications, all assessors can now focus all their attention to current applications since the backlog is behind them. Their present turnaround time is approximately 60 to 120 days, depending on the complexity of the submission. However, since they are now being inundated with new applications, new product submissions could still take up to 180 days to get a licence as application assessment is on a first come first served basis.
There were a specific set of regulations (Natural Health Products–Unprocessed Product Licence Applications Regulations) known as UPLAR, in which any files that the NHPD had over 180 days were given an “EN” designation, which meant for all intents and purposes that the product was temporarily legal for sale and advertising, until a final decision was made. The NHPD has now revised the way they process applications, enabling them to make decisions in up to 180 days. Therefore, these regulations are no longer required and are repealed as of February 4, 2013.
The implementation of the laws and regulations are reaching their final stages and should be in complete effect by the end of next year (2014).
What this means:
1. On Feb. 4, 2013, NHP-UPLAR will be repealed. Products with submissions in place will not be acted against. They should have their licences in ample time to not be affected. New products will not receive exemption numbers (ENs) and will have to wait until an NPN licence is issued in order to be legally manufactured, imported or sold.
2. By Dec. 1, 2013 no product can be manufactured by a Canadian manufacturer or be imported without holding an NPN licence.
3. By Sept. 1, 2014, no retailer can have a product on their shelves that does not have a legal NPN licence.