The North American Compendium (NAC) has upgraded the software running the Interim Notification Pilot (INP) Program for Low Risk Veterinary Health Products (LRVHP), affecting certain aspects of the notification process. The role of the Canadian Representative has also been clarified to greater detail.

In May 2014, the Low Risk Veterinary Health Product Interim Notification Process webpage underwent a massive “facelift” transforming from a bland unconnected option-limited site to a more colorful intuitive webpage which has become easier for first-time users to navigate and understand the requirements for products to be considered a Low Risk Veterinary Health Product. The NAC that runs the program and its website has made it more streamlined and has improved the flow process from each step to the next of the entire notification application process.

The changes to the website extend beyond the cosmetic and into the realm of the functional. Now in the dosage form section of the Notification Application, a “dosage unit” field has been added, which is required to be filled before the application is completed.

Another massive change is that all individuals listed on the form require a user account on the Low Risk Veterinary Health Product website. Previously, none of the individuals listed on the notification application have to have a user account. Now, even before an individual can be entered into a notification application, they have to be registered with an account on the Low Risk Veterinary Health Product website. After this, the individual appear selectable on the website, but even before they can be added, a confirmation by the selected party is required via an e-mail request from the Low Risk Veterinary Health Product website on behalf of the notifier completing the notification application.

A key individual on the Low Risk Veterinary Health Product notification application is the Canadian Representative. The role of the Canadian Representative was quite vague in terms of role and responsibilities in the past. However, as of the end of March 2014, the role of Canadian Representative was clarified to be the person located in Canada who is responsible for the sale of the product in Canada and ensuring it meets the requirements of the Low Risk Veterinary Health Product. Their responsibilities are now outlined in greater detail and must:

1. have systems in place to be able to effect a recall or take corrective actions in a timely manner for all products in Canada. This includes taking corrective action should Health Canada consider that the product does not meet the requirements of the INP and the relevant regulatory provisions or that it is unsafe or likely to cause the public to be deceived.
2. satisfactorily implement the collection of distribution and sales data and channels for each product in the case of a product recall
3. attest to the safety of the product
4. attest to the use of Good Manufacturing Practices (GMP) of the manufacturing, packaging, labelling, distribution and sale of the product.
5. collect all adverse event reactions data and report serious adverse event reactions

dicentra provides regulatory and scientific guidance on Low Risk Veterinary Health Products and would be happy to assist you with Notification Number registration by conducting ingredient/claim verification, application and safety/efficacy dossier preparation, formulation reviews, label and advertising material reviews, and other Low Risk Veterinary Health Product consulting tasks that can help manage your product and have its notification number granted as swiftly as possible.

dicentra specializes in the areas of veterinary products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or info@dicentra.com