By: Clara Di Tella, BSc, Pharm QA – Regulatory Affairs Specialist
January 30, 2012

Last spring, Health Canada consulted with stakeholders and the public on various options for policies for the regulation of Low-Risk Veterinary Health Products (LRVHPs). A proposed program was released for comments.

The Interim Notification Program, developed by Health Canada and the Canadian Animal Health Institute (CAHI) is intended to provide a temporary regulatory framework until the drug regulations are amended to cover low-risk veterinary health products. These include products such as homeopathic preparations, botanicals, vitamins and minerals, which only have general health claims. The program proposed a system in which the manufacturer or importer of the veterinary product would apply for a notification number and if all requirements were met, enforcement would not be prioritized for these products, unless a health risk was identified. The following criteria would need to be met in order to apply for the notification:

• The product is for use only on dogs, cats, or horses that are not intended for food.
• All medicinal ingredients are listed in and meet the conditions of the List of Admissible Substances established by Health Canada.
• All non-medicinal ingredients are listed in and meet the conditions of the list of non-medicinal ingredients established by Health Canada.
• The product is not to be used on pregnant or lactating animals.
• With respect to horses, the product is not to be mixed with feeds by a feed manufacturer in circumstances where the Feeds Regulations would apply.

The majority of stakeholders supported the proposed Interim Notification Program. There were some requests of further clarification on the List of Admissible Substances, and administrative/operational issues. Health Canada has indicated that the process for amending the list will be ready for the launch of the program, and that domestic and imported products will be subject to the same standards. Also the recommendations from Expert Advisory Committee for Veterinary Natural Health Products were considered during the development of the program, and members of the committee agreed that the proposal was in line with their comments.

Health Canada has not yet finalized the Interim Notification Program for Low-Risk Veterinary Health Products, but will communicate their next stage with stakeholders.

Link to “Proposed Interim Notification Program: Low-risk Veterinary Health Products”

http://www.hc-sc.gc.ca/dhp-mps/consultation/vet/com/not_prog_dec-eng.php#appa

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