A new notification program for veterinary health products (VHPs) came into effect on November 13, 2017.1
What You Need To Know
- The new program formalizes the Interim Notification Pilot Program (INPP) for companion animal VHPs,2 extends its application to food animals, and creates a mandatory rather than voluntary notification framework.
- It comes as part of Health Canada's effort to mitigate the health risks associated with antimicrobial resistance—VHP uses could potentially reduce the need to use antimicrobials.3
- VHPs are low risk drugs in dosage form, used in managing animal health.
- The logistics around the process of notification has now been finalized.
- Law. This VHP program is a law, not a guidance. The mandatory reporting as part of the VHP program became law on November 13, 2017.
- Transition period for labelling. Different transition periods apply for products that have received INPP approval to those products that do not have INPP approval.
- Products with INPP notification number have an 18 month transition period and must comply with the new labelling requirements by May 13, 2019.
- Products without INPP notification number have a 6 month transition period and must comply with the new labelling requirements by May 13, 2018.
- Pre-notification before selling/importing. Companies are required to notify Health Canada at least 30 days before selling/importing a VHP or making a change to a marketed VHP. Upon accepting a notification application, Health Canada will issue a notification number for the VHP.
- Renewal. Although there is no annual renewal requirement for VHP notification, companies must re-notify Health Canada if there are changes to the original notification.
- Permitted substances. Compliant VHPs must only contain Health Canada approved medicinal and non-medicinal substances.
- The list of permitted active, homeopathic, and traditional medicine substances are described on List C: Veterinary Health Products,4 provided for in the amended Food and Drug Regulations. The list also specifies limitations on each substance, such as the species and routes of administration permitted.
- Health Canada also maintains a List of Permitted Substances,5 which includes non-medicinal ingredients, as well as the active, homeopathic, and traditional medicine substances described on List C.
- Claims. VHPs are used for the maintenance and promotion of health and wellbeing in food and companion animals. A VHP cannot claim use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms. Therefore, a product making general health claims supported by sufficient evidence would be acceptable.
- Good manufacturing practices (GMPs). Manufacturers are required to meet the GMP requirements in the Natural Health Products Regulations6 (NHPR).
- Labelling. In addition to complying with the Food and Drug Regulations labelling requirements, VHP labels must also include the statement "Veterinary Health Product" and any additional mandatory statements specified on List C.
- Serious adverse reactions. Companies must report to Health Canada any serious adverse drug reactions within 15 calendar days of receiving the information about the event.
- Fees. There are currently no fees associated with the new notification program, but Health Canada will be consulting on proposed fees for health products in the coming months.
Companies that sell/import or intend to sell/import VHPs should sign up7 for an account on the new VHP notification program website. All notifications, requests, or reports are submitted online. Foreign manufacturers/distributors of VHPs will need a Canadian representative responsible for the product in Canada. Companies already marketing VHPs need to provide notification of the products to Health Canada and, depending on whether or not the product has an existing INPP notification number, take note of the labelling requirement compliance deadlines of May 13, 2018 or 2019, as applicable.
3 We reported on the 2017 amendments to the Food and Drug Regulations that address antimicrobial resistance from the veterinary use aspect, see "Rules Change for Veterinary use of Antimicrobials."
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
For permission to republish this or any other publication, contact Janelle Weed.
© 2020 by Torys LLP.
All rights reserved.