Guidance Documents – Site licensing – Natural health products

This guidance document is meant to help manufacturers, packagers and labellers of natural health products (NHPs) in Canada and elsewhere, including Canadian importers and distributors of these products, meet the good manufacturing practice (GMP) requirements of the Natural Health Products Regulations. In addition, the guidance document is a tool for the Quality Assurance Person (QAP) to implement and maintain GMP and to fulfill their role in assuring the quality of a NHP before it is made available for sale.

This document outlines what a site licence is, when it is required, who must hold one, how to apply for one and how to change and renew one. It also describes the process applications go through when they reach the Natural and Non-prescription Health Products Directorate, and includes samples of all the necessary forms. It can be used as an aid to complete an effective site licence application, to provide clarity on how to maintain a valid site licence and to gain a better overall understanding of the site licensing process and regulations.

This guidance document explains the provisions of Part 6 of the Natural Health Products Regulations, specifically sections 108 to 115, the provisions that govern the transition periods associated with the Regulations.