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- How to complete a submission for in-feed route of administration classification on the List of Permitted Substances
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How to complete a submission for in-feed route of administration classification on the List of Permitted Substances
Following the success of two in-feed Veterinary Health Product (VHP) pilot projects, Health Canada (HC) is now accepting submissions for substances with an in-feed route of administration for all active and excipient (non-medicinal) ingredients.
Apart from the 12 VHPs notified for in-feed use during the pilot project in 2021, in-feed administration of VHPs continues to be prohibited until the updated Feeds Regulations are published (anticipated in fall 2023). However, by submitting applications and having substances added to the List of Permitted Substances for in-feed use pre-emptively, companies will be able to notify their desired in-feed VHPs immediately upon publication of the updated Regulations.
To learn how to complete your in-feed substance submission and discover our submission key points, follow the instructions below.
1. Submit the Short Substance Application on Health Canada’s website
Visit Health Canada’s Veterinary Health Products – Notification Program webpage
Head to Health Canada’s Veterinary Health Products – Notification Program webpage, and login or sign up to create your profile. Once you are logged in to your profile, a drop down option will appear on the ‘Permitted Substances’ tab. Click on the drop down arrow and select ‘Start a New Substance Application‘.
Select the application type
For all in-feed administration submissions, whether your substance is currently on the List of Permitted Substances (LPS) or not, select ‘Start a new Short Substance Application‘. Some submissions for substances not yet listed on the LPS may also require a Long Substance Application, but Health Canada will follow up with the applicant to request that additional documentation if it is needed.
Complete the Short Substance Application
Complete the various pages of the Short Substance Application with the required information and submit when finished.
Short Substance Application key points
- On the ‘Type’ page, select ‘Modification of an ingredient already listed on the List of Permitted Substances’ if your substance is an active or excipient ingredient already listed on the LPS. If your substance is not currently listed on the LPS, select either ‘New Active Ingredient’ or ‘New Non-medicinal (excipient) ingredient’ as applicable.
- When entering the substance’s proper name, indicate ‘In-Feed’ or ‘IF’ to enable Health Canada to easily recognize your submission. For example, if you were completing an in-feed submission for Benzoic acid, you would enter ‘Benzoic acid In-Feed’ or ‘Benzoic acid IF’ as the proper name.
- Select any livestock species within the list of ‘Intended Species’. Non-livestock species are currently excluded from this phase of the in-feed VHP rollout.
- Note that the ‘Route of Administration’ list does not currently include ‘in-feed’ as an option. Instead, be sure to indicate ‘In-Feed’ or ‘IF’ in the substance proper name field, as mentioned above.
2. Complete the Potential Drug Incompatibility Assessment
An important part of the in-feed submission process is an assessment of drug incompatibility using the Potential Drug Incompatibility Assessment document. This document must be completed and submitted by email to email@example.com.
Potential Drug Incompatibility Assessment key points
- Within every summary of findings field, provide a written overview of the relevant scientific findings your search generated. If there were no findings, indicate that by noting ‘nothing found’ in the summary of findings field. This ensures it is clear that all sources were checked as part of your assessment.
- When submitting your Potential Drug Incompatibility Assessment by email, be sure to note your Short Substance Application number and ‘In-Feed’ as part of your email. This will help Health Canada to quickly identify your submission.
More information on the VHP notification program is available on Health Canada’s website.