The Low-Risk Veterinary Health Product (LRVHP) program enables companies to speed the licensing process of veterinary natural health products. A third party program administrator is in place to activate this voluntary pilot program on your behalf, and issues Notification Numbers (NNs) for products registered through their system.
Currently, the LRVHP pilot is a voluntary program where applicants can apply for Notification Numbers (NNs) from this third party program administrator. Health Canada’s policy is that NN products are not enforced; meaning, they are for the most part safe from enforcement action. The alternative to the NN system for natural pet supplements would be to achieve a Drug Identification Number (DIN), and while the DIN is a full legal authorization, it is very costly, time consuming, and requires product-specific clinical data. The NN program provides a quick way to allow the sale of natural animal supplements in Canada.
Some additional updates to watch for….
New product license applications are now required when filing with the NNHPD. The new application form is a web-based license application. It is designed to be completed online and saved where it can be retrieved and /or amended at any time. The form can automatically access the Natural Health Products Ingredients Database (NHPID). e-PLA 2.3.1
A Company Code is now mandatory on the new application form
The company code is a unique number which is assigned to an individual company by the NNHPD. On the Applicant page, the company code must be the one assigned to the applicant/licensee.
NNHPD Performance timelines to issue an NPN have been updated with extended wait times:
Class I is for products that are supported entirely by Individual NNHPD Monograph – now 60 days
Class II is for supported entirely by a combination of Individual NNHPD Monographs – now 90 days
Class III is for products without any ingredients not supported by an NNHPD Monograph – now 210 days or 6 months
Part of this new proposal is to introduce a cost to file a license application.
Did you know that filing a natural health product application is still free?
Use of Cannabis and CBD in natural health products is to be announced in late October 2019
CBD, or cannabidiol, is one of a group of chemical substances called cannabinoids and are found in the flowers and leaves of the cannabis plant, Cannabis sativa. Unlike the more widely known cannabinoid, delta-9-tetrahydrocannabinol or THC, CBD does not produce a high or intoxication.
CBD is popular and used for a number of conditions and illnesses such as anxiety, pain relief, as an inflammatory to mention a few. Though CBD is used therapeutically, with the exception of specific CBD products for epilepsy, there much debate about the evidence supporting these claims
Until recently, like other cannabis containing products, those containing CBD were regulated as controlled substances. This changed with the passing of the Cannabis Act in 2018 and under the act, the CBD oil is available and can be purchased dependent on provincial and territorial legislation. In these cases, the CBD is largely unchanged from that found in the plant and the product itself cannot make any therapeutic claim. In addition, health products both containing CBD and making a therapeutic claim are considered to be prescriptions drugs in Canada.
Pet Supplement Licensing
Registering your Veterinary Health Products in Canada:
Previously, the VHP notification program was voluntary, but as of November 2017, the new formal notification program was put in place. It is important to first classify the product properly as a VHP because veterinary drugs and animal feed products are not regulated under the VHP framework.
By identifying the dosage form, the recommended use, or claims being made, all ingredients must be listed in the Permitted Substance List. Any ingredients that are not listed or do not reflect the recommended use, can be added or amended via a PSL Notification. This must be done before filing the VHP notification.
Selling a Veterinary Health Product (VHP) in Canada requires a Notification Number (NN), allowing for the sale of this product type without a Drug Identification Number (DIN).
There are fees payable to Health Canada associated with the notification. Currently, the fee is $503.00 It is possible your company may qualify for a reduction or a waived fee based on the first application or company size. The standard timeline for Health Canada to review your product is approximately 2 months, based on recently submitted applications.
To obtain a Notification Number, the pilot program requires an application form, where applicants attest their products meet certain ingredient requirements, have adequate safety and efficacy data to support their product, and prove they are manufacturing the product in accordance with Goods and Manufacturing Practices. Our company can assist with this application process.