Open ProvincesNew or substantially changed infant formula: prepare the pre-market submission
New or substantially changed infant formula: prepare the pre-market submission
This pathway is for manufacturers. It provides no infant-formula recipe or advice on substituting infant feeds.
Confirm the right process
Determine whether this is a new formula, a major change or another product requiring a separate regulatory route.
Prepare the dossier
Gather formulation, manufacturing, controls, stability, labels and nutritional and safety evidence required by the current guidance.
Submit the application
Prepare the cover letter, checklists and online application; seek a pre-submission consultation for unresolved technical questions.
Follow up
Answer review comments and await the required decision before sale; maintain compliance, traceability and change control afterward.
Requirements and supporting information
Sources and limits
Official sources consulted August 30, 2026. Orientation guide: confirm current rules, documents, deadlines and conditions with the responsible authority.
General information based on federal and national rules; provincial rules may differ. Confirm with the official body before acting. Last reviewed : 2026-08-30.