Low Risk Veterinary Pilot Program Now a Reality!

March 12, 2012 By

By William Morkel, BSc
Director of Quality & Compliance
March 12, 2012

On January 30, 2012, dicentra posted an article on our website entitled Health Canada’s Interim Notification Program for Low-Risk Veterinary Health Products – Consultation (by Clara Di Tella), which discussed Health Canada’s intentions to launch a new pilot program for certain veterinary products. This program is now a reality. As of March 19, 2012, North American Compendiums1 will start issuing “Notification Numbers” to applicants that qualify under the program.

Why is this good news for industry? Until now, the only way one could go to market with a veterinary health product was to obtain a Drug Identification Number (DIN) and sell the product as a drug. This is because the current Natural Health Product Regulations apply only to products intended for human use. Consequently, a sponsor of a health product intended for animals would have to first file a New Drug Submission and obtain an Establishment Licence, all of which could run into the tens of thousands of dollars in government fees alone. The result was the rather absurd situation where the requirements to market a product for use by animals far exceeded the requirements to market the same product for use by humans.

Now, under the new program, one simply has to attest in a formal application that they are meeting certain ingredient requirements, that they have adequate safety and efficacy data to support their product, and that they are manufacturing the product in accordance with GMPs. Once North American Compendiums has approved the application and has issued a Notification Number, Health Canada will permit the applicant to sell the product. Companies can now go potentially to market with veterinary products in a matter of weeks, as opposed to months or years under the drug regulatory framework.

There are, however, some very important limitations to the program. Among these are the following:

  • It applies only to dogs, cats, and horses. All other animals are excluded.
  • It applies only to products formulated with ingredients on the List of Admissible Substances. This list covers both medicinal and non-medicinal ingredients and includes certain vitamins, herbs, extracts, and homeopathic remedies
  • It permits only general health benefit claims to be made. Therapeutic or treatment claims are not permitted on labels or in advertising.
  • It excludes certain routes of administration, such as ophthalmic, otic, inhalation, and injectable

Bear in mind that this Program is only an interim measure until such time as a complete and more comprehensive regulatory framework can be developed and implemented. In principle, one still needs a DIN to legally sell a veterinary health product, but the Inspectorate has agreed not to take enforcement action against products that are in compliance with the pilot program. This is a significant first step and good news for industry and pet owners alike.

1North American Compendium is a third party administrator enlisted by Health Canada to manage the Interim Notification Program.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com