Selling a Low-Risk Veterinary Health Products (LRVHPs) required a Drug Identification Number (DIN) prior to March 19, 2012. 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.
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.
Our services in Low-Risk Veterinary Health Products (LRVHPs) Consulting include:
- Verification that ingredients are on the permitted list
- Verification that claims meet the “low risk” definition
- Preparation of applications for submission to NAC
- Product Formulations (medicinal composition)
- Preparation of Safety/Efficacy dossiers to support product claims
- Assessment of manufacturers and importers for compliance with Low Risk Veterinary GMPs
- Review of retail labels and advertising materials for compliance
dicentra can assist you in navigating this process and in ensuring that applications are managed in a simple, straightforward manner.