HEALTH CANADA VITAMIN & MINERAL SUPPLEMENTS MONOGRAPH

Overview

This Canadian monograph guides the preparation of Product Licence Applications and labels for Natural Health Products. It serves as a reference and includes 12 sections covering proper names, administration routes, dosage forms, uses, durations, risk information, storage, and product claims. It supports both single and multi-ingredient products and offers formulation guidance. Appendices are also included.

Appendix I- Source ingredients with two active components

Appendix II- Guidelines for use or purpose statements

Appendix III- Definitions and dosage value derivations

Appendix IV- Recommended dietary allowances

Appendix V- Extra information on products containing beta carotene

Appendix VI- Conversion factors for a range of vitamins

Appendix VII- Zinc and copper interactions

Appendix VII- Guidance on labelling specific mineral supplements

Link to Document

MULTI-VITAMIN/MINERAL SUPPLEMENTS MONOGRAPH