Updates to guide and form for reporting recalls of drugs, natural health products and biocides

Drug Establishment Licensing Bulletin #183, December 13, 2024

On this page

• About the guide and form
• Overview of key changes
• Contact us

About the guide and form

Health Canada has updated the guide for reporting recalls of drugs, natural health products and biocides. The updated version takes effect immediately and replaces the previous version that was published on October 24, 2019. An updated version of the recall reporting form (FRM-0356) will be available soon.

Regulated parties who work with drugs, natural health products or biocides should:

• consult the Drug, natural health product and biocide recall guide (GUI-0039) to understand and comply with the regulations related to recalls:
  • set out in the Food and Drugs Act, Food and Drug Regulations, Natural Health Products Regulations, and the Biocides Regulations
• use the current version of the Drug and natural health product recall reporting form (FRM-0356) to notify us of any recalls.

Overview of key changes

The guide reflects changes to the Food and Drug Regulations and the new Biocides Regulations.

The Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) were published in the Canada Gazette, Part II on July 3, 2024. They come into force on December 14, 2024.

The amended regulations introduce key regulatory changes for overseeing therapeutic products once they come onto the Canadian market. They also represent a major milestone in our ongoing efforts to improve the regulation of drug establishment licensing in Canada.

The Biocides Regulations were published in the Canada Gazette, Part II on June 19, 2024, and will come into force on May 31, 2025. They introduce a new regulatory framework for biocides.

We made the following updates:

• GUI-0039: to clarify regulatory requirements when conducting recalls of drugs, natural health products and biocides, including the requirements for reporting recalls

We consulted stakeholders on the updated guide and form in March 2024.

Contact us

If you have questions, contact the Health Product Compliance and Risk Management Division of the Regulatory Operations and Enforcement Branch by email: hpce-cpsal@hc-sc.gc.ca.