Cannabis adverse reaction reporting for licence holders: General information

On this page

Who this is for

This information is intended for the following cannabis licence holders:

Specifically, the reporting obligations apply to all licence holders who sell or distribute a cannabis product, whether inside or outside of Canada. This includes:

Important: This guidance also applies to licence holders who are conducting observational studies with cannabis products. Research licence holders conducting non-therapeutic research have different requirements. Refer to Report a side effect to cannabis: Licence holders - Canada.ca for more information.

This guidance may also be useful for those reporting adverse reactions to Health Canada on a voluntary basis, including:

Scope

This guide pertains to adverse reaction reporting requirements for licence holders under the Cannabis Act (the Act) and its regulations. Mandatory adverse reaction reporting requirements are outlined in section 248.1 of the Cannabis Regulations (the Regulations). They apply to licence holders that are authorized to sell or distribute cannabis products for medical or non-medical purposes. This guide does not apply to:

Types of adverse reactions

Adverse reactions, also known as side effects, are noxious (harmful, unpleasant) or unintended responses to cannabis products or accessories. They can be serious or non-serious.

Adverse reactions may be associated with 1 or more cannabis products alone, or combined with:

Serious and medically important adverse reactions

The Regulations classify an adverse reaction as serious if it:

Health Canada also considers medically important adverse reaction to be serious. Medically important adverse reactions may not be immediately life-threatening or result in death or hospitalization, but may:

A qualified health professional should exercise medical and scientific judgement in deciding whether an adverse reaction is serious or medically important.

Note: The European Medicines Agency has developed a list of important medical events using Medical Dictionary for Regulatory Activities (MedDRA) terminology. However, this list is only a guidance tool, and a qualified person should still use their medical and scientific judgement in determining whether an adverse reaction is medically important.

Examples of medically important adverse reactions:

A licence holder cannot downgrade an adverse reaction from serious to non-serious, even if they disagree with the seriousness assigned by the reporter. The adverse reaction report should record the opinions of both the reporter and the licence holder and identified as such.

Non-serious adverse reactions

A non-serious adverse reaction is one that does not meet any of the above criteria. A licence holder may voluntarily submit non-serious adverse reactions to Health Canada, particularly relevant if a new or unexpected issue is observed (for example, change in frequency of adverse reactions; cluster of related cases). Additionally, licence holders must collect and critically analyze all adverse reactions as part of the annual summary report. See Cannabis adverse reaction reporting: Annual summary report for more information.

Requirements for adverse reaction reporting

Subsection 248.1 (1) of the Regulations outlines the requirements for licence holders. They must:

Adverse reactions are usually reported based on the suspicions of a reporter (unsolicited). They may also be collected during a study or other organized data collection systems (solicited reports). All adverse reaction reports or complaints (such as reactions linked to quality issues) regardless of the source, are considered a reportable adverse reaction.

Licence holders must also report the following to Health Canada:

For pregnancy or breastfeeding exposure, licence holders should follow up on reports where in utero or neonatal exposure could have happened. This is to find out if any adverse outcomes happened in the foetus or newborn. Adverse reactions occurring in a parent and a foetus are considered 2 separate adverse reaction reports.

Important: Unlike for drugs, drugs containing cannabis (for example, cannabis with a drug identification number) and health products, the concept of "expected" adverse reactions does not apply to cannabis products. Therefore, all adverse reactions should be investigated by the licence holder and reported to Health Canada if they meet the definition of a serious adverse reaction, per the mandatory reporting obligations under the Act and Regulations.

Responsibilities when selling a cannabis product produced by another licence holder

If a licence holder sells a cannabis product produced by another licence holder, standard operating procedures need to be in place to meet adverse reaction reporting requirements. These procedures should include sending a report to the product's producer so they may also meet their adverse reaction reporting requirements. In such cases, the original report should indicate if it was also sent to the producer for record keeping purposes.

Responsibilities of other parties reporting for a licence holder

If a licence holder uses a corporation or third-party company to report adverse reactions, they should have a written agreement that includes:

If licence holders have such written arrangements, they can send them to Health Canada for transparency by emailing cannabis_oss-cannabis_bss@hc-sc.gc.ca.

Examples of such arrangements could include:

No matter the arrangement, it still is the responsibility of licence holders who sell or distribute cannabis products to meet the reporting requirements.

Contact us

For questions about this guide or the requirements listed, email cannabis_oss-cannabis_bss@hc-sc.gc.ca.

For all other questions, refer to Contact information for licence holders, applicants and industry for the correct email address.

Foreword and disclaimer

Foreword

This guidance is meant to help licence holders meet requirements for adverse reactions with cannabis products under section 248 of the Regulations. It also includes good case management practices that licence holders should follow to meet these requirements.

Adverse reaction reporting plays an important role in the post-market surveillance of cannabis products. It can help Health Canada and licence holders identify and respond to emerging health and safety issues. Licence holders should have procedures on reports of adverse reactions to minimize preventable harms, including:

Health Canada has harmonized as much as possible with the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use guidance documents.

Disclaimer

Licence holders need to read these pages along with the Act and the Regulations. If there are differences between these pages and the Act and the Regulations, the Act and the Regulations are correct.

Page details

Date modified: