Navigating Regulatory Complexity: From New Ingredient Approval to Successful VHP Notification

At GNHP Consulting, we specialize in helping companies successfully navigate Canada’s evolving Veterinary Health Product (VHP) regulatory landscape. Our recent collaboration with Ultra Oil for Pets demonstrates how expert regulatory guidance can help overcome challenges and bring innovative pet health products to the Canadian market efficiently.

The Challenge

Ultra Oil for Pets approached GNHP Consulting with a Veterinary Health Product formulation containing an ingredient that was not yet included on Health Canada’s Veterinary Health Product List of Permitted Substances. Before a Notification Number (NN) application could be submitted, the ingredient first needed to be reviewed and accepted for inclusion on the permitted substances list.

In addition to this regulatory hurdle, a detailed formulation assessment identified that one ingredient, when evaluated against the recommended dosage instructions, exceeded acceptable daily intake levels for pets. Without proper resolution, this issue could have resulted in delays, requests for additional information, reformulation requirements, or notification refusal.

Our Approach

GNHP Consulting worked closely with the Ultra Oil for Pets team to develop a strategic regulatory pathway.

Our regulatory experts:

• Prepared and submitted the scientific and regulatory documentation required to support the addition of the new ingredient to Health Canada’s VHP List of Permitted Substances.
• Conducted a comprehensive formulation and dosage review to identify potential compliance concerns.
• Applied extensive Veterinary Health Product regulatory knowledge and formulation expertise to address the dosage issue while maintaining product integrity and intended use.
• Developed a compliant submission strategy that aligned with Health Canada’s Veterinary Health Product Notification Program requirements.