Guidance Documents – Site licensing – Natural health products

 

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

Thank you for your patience and understanding.

Good Manufacturing Practices
Date: December 2015 - version 3.0

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.

Site Licensing
Date: December 2015 - Version 3.0

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 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.

Transition
Date: November 2003

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.

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