Drug, natural health product and biocide recall guide (GUI-0039): Overview
Date issued: December 13, 2024
Date implemented: December 13, 2024
Replaces: GUI-0039 (October 24, 2019)
Disclaimer: This document does not constitute part of the Food and Drugs Act or its regulations. If there is any inconsistency or conflict between the act or regulations and this document, the act or the regulations take precedence. This document is an administrative document intended to facilitate compliance by the regulated party with the act, regulations and applicable administrative policies.
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About this guide
This guide has been updated to include changes published in the Canada Gazette, Part II on July 3, 2024, and June 19, 2024, to respectively:
- amend the Food and Drug Regulations for drug recalls (to come into force December 14, 2024) and
- introduce the Biocides Regulations (to come into force May 31, 2025)
On June 22, 2023, the definition of "therapeutic product" was revised in the Food and Drugs Act to include natural health products. The section “Natural Health Products Regulations requirements for recalls” contains the updated Natural Health Product Regulations. The glossary has been updated to reflect current Health Canada definitions.
Purpose
This guide is for anyone working with drugs, natural health products or biocides. It will help you understand and comply with sections of the following legal instruments that relate to recalls:
- Food and Drugs Act (act)
- Food and Drug Regulations (FDR)
- Natural Health Products Regulations (NHPR) and
- Biocides Regulations (BR)
Health Canada conducts compliance verification activities, including inspections, to assess compliance with the act and associated regulations. We will use this document as a guide when assessing compliance of recall activities.
Recall: A responsible party’s removal from further sale or use, or correction, of a distributed product that presents a risk to the health of consumers or violates the act or regulations.
Recalls are public information. Visit our Health pages to find information about each drug, natural health product and biocide recall, as well as:
- public advisories
- information updates
- notices to stakeholders
- communications to health care professionals
For information about a particular recall, search the Recalls and safety alerts database.
Therapeutic product means a drug or device or any combination of drugs and devices. Biocides and natural health products are considered drugs under the act and are therefore included in the definition of a therapeutic product.
Learn more about our approach to regulatory compliance and enforcement, including measures we may take to enforce the act and regulations:
- Compliance and enforcement policy for health products (POL-0001)
Specifically, this guide will tell you how to:
- notify Health Canada about a recall
- develop and execute a recall strategy
- submit a final recall report to Health Canada
Note: If we believe you are selling a drug, natural health product or biocide that poses a serious or imminent risk to health, we may order a recall. As stated in paragraph 21.3(1)(a) of the act:
If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a person who sells the product to
- recall the product
Scope
This guide covers the requirements for drug, natural health product and biocide recalls.
The requirements apply to establishments that work with drugs, natural health products or biocides:
- fabricators
- importers
- distributors
- packagers and labellers
- wholesalers (for drugs only)
This guide does not apply to product withdrawals or stock recovery. Use these actions when there is no health and safety risk and no contravention of the applicable legislation, or the product has not been distributed.
For more information on how to conduct recalls for medical devices, consult:
Introduction
Drug, natural health product and biocide companies are required to follow regulations related to product recalls. This guide provides information on how to comply with them.
Guides like this one are meant to help you, the industry and health care professionals understand how to comply with regulatory requirements. They also provide guidance to Health Canada staff, so that the regulations are enforced fairly, consistently and effectively across Canada.
Guides are administrative and do not have force of law. They allow for flexibility. Health Canada is open to considering other ways of conducting a recall, provided that your method satisfies all applicable regulations. If you wish to use a different approach, we encourage you to contact us first to ensure you meet the requirements.
Guides are not intended to cover every conceivable case and will be subject to periodic reviews and updates. If there’s a discrepancy between this guide and the regulations, the regulations always take precedence.
Read this guide along with the relevant sections of the act, the FDR, NHPR and BR, as well as our relevant guides and policies, including:
- Recall policy for health products (POL-0016)
- Compliance and enforcement policy for health products (POL-0001)
- Good manufacturing practices guide for drug products (GUI-0001)
- Guide to reporting drug shortages and discontinuations (GUI-0120)
- Good manufacturing practices guidance document for natural health products
Note: To help ensure a health product is safe, effective and of high quality, we may:
- request relevant information or materials from your establishment
- define conditions under which a product may be recalled that are not specifically described in this guide
If you read this guide and still have questions about your responsibilities, refer to the Contact us section of this guidance.
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