Draft for consultation: Quality of natural health products guide: About this guide

On this page

• Purpose
• Scope
• Note about guidance documents in general

Purpose

This guide describes the quality requirements of the Natural Health Products Regulations (the regulations), with the goal of helping regulated parties and other stakeholders better understand and comply with those requirements.

Specifically, Health Canada (we) developed this guide for people (you) who work with natural health products (NHPs) and are involved in activities related to product specifications, including:

• creating and amending finished product specifications (FPS) for product licensing and post-licensing change purposes (for example, by product licence (PL) holders and NHP consultants)
• characterizing raw materials for use in NHPs (for example, by formulation developers)
• maintaining and revising specifications for use during the production and release of bulk or finished products (for example, by manufacturers, packagers or labellers)
• confirming imported products meet their specifications in accordance with Health Canada's regulatory requirements (for example, by importers)
• reviewing and approving specifications used for product release (for example, by a quality assurance person (QAP))
  • for more information on the responsibilities of a QAP, refer to the Good manufacturing practices (GMP) guide for natural health products (GUI-0158) (NHP GMP guide)
• applying stability specifications in product stability studies (for example, by manufacturers or importers)
• performing testing of NHPs (for example, by in-house or contract laboratories)
• monitoring quality and updating related documentation

This document provides guidance to assist you in making sure your NHP is of high quality. This includes providing you with the information necessary to develop and maintain the specifications of your product.

Refer to the glossary and acronyms used in this guide, as well as the references.

Scope

This guide applies to all types of NHPs, including:

• non-sterile NHPs (such as probiotics, botanical remedies, vitamins and minerals, amino acids, essential fatty acids, and other products like hand sanitizers, oral health products, skin and hair health products and diaper rash products)
• sterile NHPs (such as sterile water for irrigation and ophthalmic products)
• homeopathic medicines
• traditional medicines (such as traditional Chinese medicines and Ayurvedic medicines)

Unless stated otherwise, the quality standards and related information in this guide apply to all NHPs.

This guide applies to the FPS in the context of PL applications, related amendment applications, and other post-licensing changes. It also applies to situations where specifications are necessary, including:

• conducting raw material, in-process, finished product and stability testing
• supporting product development, contract manufacturing, product release and site licence (SL) applications
• handling post-market activities

You may also use this guide for products intended for clinical trials. If you are seeking authorization for a clinical trial, refer to the guide Clinical trials for natural health products.

For additional guidance on related topics, refer to:

• Site licensing guidance document on the requirements to obtain an SL
• Natural health products management of applications policy (NHP MAP) on the requirements to obtain a PL

Note about guidance documents in general

Guidance documents (guides) provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a health product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the regulations and other applicable guidance documents.