Annex 7 to the Good manufacturing practices guide - Selected non-prescription drugs (GUI-0066): Overview

Document change log

Date issued: September 29, 2023

Date implemented: September 29, 2023

Replaces: Annex 7 to the Good Manufacturing Practices guide for drug products – Selected non-prescription drugs (August 25, 2020)

Disclaimer: This document does not constitute part of the Food and Drugs Act (the Act) or its regulation. In the event of any inconsistency or conflict between the Act or regulations and this document, the Act or regulations takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies.

On this page

• Purpose
• Scope
• Introduction
• Note about guidance documents in general

Purpose

This guide is for people who work with selected non-prescription drugs as:

• fabricators
• packagers
• labellers
• testers
• distributors
• importers

This document is an annex to the Good manufacturing practices guide for drug products (GUI-0001). You must read the 2 documents together to understand all relevant guidelines. These guides will help you understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations), which is about good manufacturing practices (GMP).

Note: The title of this document was changed in 2020 to refer to “selected non-prescription drugs”, as it applies to an expanded list of drugs. Earlier versions of this document focused solely on Category IV monograph products.

Scope

This annex applies to non-sterile drugs that meet the following criteria:

• are subject to Part C, Division 2 of the Regulations
• have a drug identification number (DIN) and
• are on the List of non-prescription drugs for which the testing requirements set out in subsections C.02.019(1) and (2) of the Food and Drug Regulations do not apply

Selected non-prescription drugs include:

• toothpastes
• mouthwashes
• antiperspirants
• throat lozenges
• sunscreen products
• diaper rash products
• antidandruff products
• athlete's foot treatment
• antiseptic skin cleansers
• medicated skin care products
• acne therapies (topical) products

Note: Many of the products listed above are Category IV monographs. Each monograph specifies the following:

• ingredients
• strength indications
• directions for use
• warnings

For imported products, the exemptions granted under a mutual recognition agreement (MRA) are limited to products that are considered drugs/medicinal products in their country of origin. If you are an importer, you are responsible for determining the classification of the product in the country of origin.

Introduction

The Food and Drug Regulations and Good manufacturing practices guide for drug products (GUI-0001) apply to all drugs. However, some interpretations in GUI-0001 may not apply in all situations, such as with some personal care products.

Note: Although antiseptic skin cleansers intended for personal use in a commercial or institutional setting (e.g. workplaces, washrooms in public buildings), or for professional use in food-handling premises or in healthcare settings (e.g. hospitals, nursing homes, clinics, dental offices) are excluded from the monograph, these products will still be subject to interpretations of this guide and any associated regulations.

This annex to the current edition of GUI-0001 clarifies those aspects of GMP that are relevant to fabricating, packaging/labelling, testing, importing and distributing selected non-prescription drugs.

To avoid repetition, we have included in this annex only those interpretations that are different from the ones in GUI-0001. The numbering of each interpretation used in this annex corresponds to the numbering of the interpretation being modified from GUI-0001.

Note about guidance documents in general

Guidance documents like this one help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, ensuring that the rules enforced are fair, consistent and effective across Canada.

Health Canada inspects establishments to assess their compliance with the Food and Drugs Act (the Act) and associated regulations. When we conduct an inspection, we use this document as a guide to assess your compliance with GMP requirements.

These guidelines are not the only way that GMP regulations can be interpreted and do not cover every possible case. With proper scientific justification, we will consider other ways to comply with GMP regulations. Also, as new technologies emerge, different approaches may be called for.

Guidance documents are administrative and do not have the force of law. Because of this, they allow for flexibility in approach. Use this document to help you develop specific approaches that meet your unique needs.