The NHPD UPLAR (Unprocessed Product License Application Regulations) was adopted in Canada August 4, 2010. As of this date, products require an Exemption Number (EN), Natural Product Number (NPN), or Homeopathic Drug Identification Number (DIN-HM) in order to be sold in Canada. As such, submission numbers are no longer considered to be lower priorities for NHPD enforcement actions. The next 6 months are considered to be a transition period for the compliance and enforcement policy. This means that the response to unauthorized products (those without an EN, NPN or DIN-HM) will focus on compliance promotion and education. Regulated parties who make an effort to come into compliance with the product licensing requirements will not be a high priority for enforcement unless their product poses a risk to health. Once the compliance promotion period has elapsed (anticipated February 1, 2011), products without an NPN, DIN-HM or EN will be subject to compliance and enforcement activities. As such, a stop sale and recall would be required, as only products with product licenses or ENs could legally be sold.
All applications that were granted submission numbers and have been in the queue for at least 180 days are now eligible to obtain ENs. You now have 60 days to opt-in to receive ENs for your eligible products. Opting-in is executed by sending the NHPD a particular fax-back form and ensuring that any submission numbers that do not meet eligibility criteria are outlined in this form.
Dicentra, a Canadian scientific & regulatory consulting firm, will be hosting a free webinar this Thursday, August 12, at 1:00 PM Eastern Time. The webinar should not last longer than 30 minutes. The webinar will cover everything important pertaining to the new regulations and will outline all necessary steps to obtain your ENs. We strongly encourage you to attend this session if you market natural health products/dietary supplements in Canada. To join the webinar please click on the following link several minutes prior to the starting time.
Topic: UPLAR Update Webinar
Date: Thursday, August 12, 2010
Time: 1:00 pm, Eastern Daylight Time (New York, GMT-04:00)
Meeting Number: 572 802 082
Meeting Password: Nhpd2010
To join the online meeting:
1. Go to https://dicentra.webex.com/dicentra/j.php?ED=153124192&UID=0&PW=NNzIxODBhZDIw&RT=NCMxMQ%3D%3D
2. If requested, enter your name and email address.
3. If a password is required, enter the meeting password: Nhpd2010
4. Click "Join".