Low-Risk Veterinary Health Products (LRVHPs)

As of February 6, 2012 Health Canada’s Interim Notification Pilot Program for Low-Risk Veterinary Health Products began accepting applications and started issuing Notification Numbers as of March 19, 2012! Previous to March 19, 2012 a Drug Identification Number (DIN) was required to sell Low-Risk Veterinary Health Products (LRVHPs).

Applications are to be submitted to North American Compendium (NAC), a third party administrator enlisted by Health Canada to manage the Interim Notification Program (INP), which will issue a Notification Number to Health Canada allowing for the sale of the Low-Risk Veterinary Health Products without a DIN.

To obtain a Notification Number the Pilot Program only requires that applicants 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.

MEDERA can assist in this application process by providing the following services:

  • Review of retail labels and advertising materials for compliance
  • Product Formulations (medicinal composition) and ingredients review
  • Preparation of applications for submission to North American Compendiums
  • Preparation of Safety/Efficacy dossiers to support product claims
  • Assessment of manufacturers and importers for compliance with Low Risk Veterinary GMPs

Contact us to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here.