NOTICE – Deadline for Transfer of DINs to NPNs

- July 20, 2009

The December 31st, 2009 deadline is approaching, bringing an end to the six-year transition period for product licensing of natural health products (NHPs). As per section 108 of the Natural Health Products Regulations, all NHPs with Drug Identification Numbers (DINs) issued under the Food and Drug Regulations must obtain a product licence by this deadline.

Health Canada encourages all DIN holders whose products meet the definition of a NHP to submit a Transitional DIN application by September 1, 2009 in order to allow sufficient review time and to avoid any interruption to product sales. Applications, which meet the required criteria, will be authorized for sale and issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Applications received subsequent to the December 31st, 2009 deadline will be subject to the Natural Health Products Directorate’s (NHPD) full licence application process, including but not limited to the provision of safety and efficacy data required under Section 5 of the Natural Health Products Regulations.

DIN holders must ensure the DIN is valid at the time of filing their application with the NHPD in order to be eligible under the Trans-DIN stream. No DIN fee will be charged for the upcoming year if the DIN holder chooses to discontinue their DIN while returning the Annual Notification. However, if DIN holders choose to discontinue during the Annual Notification, they will still be eligible to apply under the Trans-DIN stream. This only applies if they clearly indicate in their application to NHPD that the discontinuation occurred during the annual process. If the DIN holder chooses to keep the DIN active they will be responsible for paying the annual DIN fee in full for the upcoming year, their DINs will be discontinued on December 31st, 2009, and they will not be eligible for refunds.

The Natural Health Products Ingredients Database (NHPID) is a useful reference for DIN holders to refer to for assistance in determining whether your product is an NHP, although it is not an exhaustive list. Further inquiries as to product classification can be submitted using the Natural Health Products Ingredients Database Issue Form.

Count on dicentra to help you meet this looming deadline, and ensure all of your NHPs with DINs are properly licenced with no interruption to sales. For more information please contact us.