_{Cannabis adverse reaction reporting for licence holders: General information}

On this page

• Who this is for
• Scope
• Type of adverse reactions
• Requirements for adverse reaction reporting
• Contact us
• Foreword and disclaimer

Who this is for

This information is intended for the following cannabis licence holders:

• micro-processing and standard processing
• sale for medical purposes
• research

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

• selling directly to patients for medical purposes
• selling to consumers through provincial or territorial-authorised retailers
• distributing or selling a finished cannabis product from one licence holder to another

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

• patients
• consumers
• authorized retailers
• health care professionals
• hospitals and health care institutions

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:

• drugs containing cannabis or cannabinoids (for example Cesamet^® and Sativex^®) that are regulated under the Food and Drugs Act
• cannabis as an active pharmaceutical ingredient or drug in a clinical trial as defined in C.05.001 of the Food and Drug Regulations

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:

• food
• alcohol
• tobacco
• cosmetics
• natural health products
• drugs (prescription or non-prescription drugs, biologic drugs)
• other substances

Serious and medically important adverse reactions

The Regulations classify an adverse reaction as serious if it:

• requires in-patient hospitalization
• prolongs existing hospitalization
• causes congenital malformation
• results in persistent or significant disability or incapacity
• is life-threatening or results in death

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:

• endanger the patient
• require intervention to prevent one of the other serious outcomes listed above

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

Examples of medically important adverse reactions:

• an allergic reaction that caused breathing difficulties and that required treatment in an emergency room or consultation with a health care practitioner
• a seizure (convulsion) that did not result in hospitalization but involved a medical intervention

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:

• submit to Health Canada a detailed report on all serious adverse reactions within 15 days of becoming aware of them
• prepare an annual summary report for all adverse reactions to their cannabis products during the previous 12 months

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:

• cases of overdose (accidental or intentional), dosing errors and other cases of direct exposure
• adverse reactions due to recalled products, discontinued products or previously available products

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.

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:

• mandatory reporting of serious adverse reactions to Health Canada
• preparing and maintaining annual summary reports of all adverse reactions
• authorizing the collection of information by the other party for the licence holder
• ensuring that the reports submitted would meet the reporting requirements, such as the timelines and required content

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:

• a corporation who reports adverse reactions for a subsidiary who is a licence holder
• a third party who conducts adverse reaction reporting activities for a licence holder

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:

• monitoring
• assessing
• analysing
• reporting

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.