Guidance documents: Infant formula and human milk fortifiers

The following guidance documents aim to assist health and industry stakeholders in the interpretation of policies and regulations, and to assist infant formula and human milk fortifier manufacturers in preparing premarket submissions when seeking approval from Health Canada for human milk substitutes (infant formulas) and human milk fortifiers.

To request an electronic copy of any of the guidance documents listed below, please contact Health Canada Food Directorate’s Submission Management and Information Unit at hc.smiu-ugdi.sc@canada.ca with the title of guidance document in the subject line, i.e., “Request for [TITLE OF GUIDANCE DOCUMENT]”.

This document provides guidance on conditions relating to the sale of human milk fortifiers, such as who can sell human milk fortifiers, how to obtain human milk fortifiers, and who can write orders for human milk fortifiers.

The purpose of this document is to assist food manufacturers in the preparation of infant formula or human milk fortifier premarket submissions.

This document elaborates on the submission process and includes sections on the regulatory context, the information requirements and nutritional, clinical, manufacturing, packaging and labelling components that must be addressed as well as administrative considerations.

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