Prior to 2012, all health products for pets were regulated by either the Veterinary Drugs Directorate (VDD, drugs) or the Canadian Food Inspection Agency (CFIA, feed and certain feed supplements). These agencies took more of a pharmaceuticalapproach, with complex, expensive and lengthy assessment timelines. Today, Canada has a simpler and more transparent registration system in place for registering pet supplements.
In 2012, Health Canada partnered with a third party Program Administrator, North American Compendiums (NAC), and created the Low-Risk Veterinary Health Products (LRVHP) Interim Notification Program (INP).
This notification programallows LRVHP to obtain market access for pet supplements in Canada by issuing Notification Numbers (NN, valid for one year and renewed annually) provided certain conditions and requirements are met. The program applies to products generally recognized as veterinary natural health products or supplements used orally or topically and intended for dogs, cats and horses that are not intended for food. Products intended for other species, or routes of administration, are still required to undergo the normal pre-market approval regulatory process (i.e., achieve DIN registrations).
Products meeting the definedcriteria are limited to products that contain active medicinal ingredients that are identified as low risk; and which have general health claims; which attest to GMP requirements for LRVHP; with evidence to support their safety and efficacy; and with the appropriate labeling including any applicable risk information statements. The INP program maintains the list of substances considered to be low risk. Because the list is not within the regulations, it can be updated and ingredients are regularly added. Our firm has been successful in adding ingredients to this list.
From its inception, the program was voluntary but this became a source of confusion for industry as some companies understood the voluntary nature of the program to mean that no registration or approval was needed for these product types. In truth, the voluntary nature of the program means that should a company not wish to undergo assessment of their product via the INP, the normal approval process would still need to be followed through either the VDD or the CFIA. In other words, not achieving an NN for a pet supplement would mean a company would have to achieve a DIN instead, which is considerably more costly and time-consuming. This new system provides a framework that is more proportional to the safe nature of these products.
It is also important to make the distinction that the INP program is not exactly a pre-market approval process. In other words, a Notification Number does not hold the same market authorization as say a DIN or NPN. But achieving an NN keeps enforcement/compliance away from your doorstep, which is important for anyone launching health products in Canada.
It is worth noting that the INP is a temporary program. Health Canada continues to work on a framework for veterinary NHPs similar to the system overseen by the Non-Prescription and Natural Health Products Directorate (NNHPD); however, we are not aware of when this new program will be available although we hope Health Canada will unveil its plans this year. It is commonly thought (and discussed) that achieving an NN under this temporary program will grandfather the product into the new licensing system coming in the years ahead.
To find out how NHP Consulting can help you achieve a Notification Number under this program, Contact Us and speak with one of our sales consultants. Thanks for reading!