Cannabis adverse reaction reporting: Annual summary report

On this page

• Requirements for annual summary report
• Overview of the report
• Content and format
• When to submit
• How to submit
• Contact us

Requirements for annual summary report

Paragraph 248.1 (1) (b) of the Cannabis Regulations (the Regulations) requires licence holders that sell or distribute cannabis products to prepare an annual adverse reaction summary report. This summary report needs to contain all known adverse reaction information for their cannabis products for the previous 12 months. Licence holders must keep the reports for at least 25 years after they were prepared. The reports must be kept on site or be easily accessible for Health Canada to assess a potential risk or to audit during an inspection.

Health Canada has developed this guide to:

• clarify the format and content of the annual summary report
• outline what licence holders need to consider in their preparation of this report
• outline when and how licence holders must submit this report

The requirement to prepare annual summary reports begins when the licence holder first sells or distributes a cannabis product in Canada. Licence holders should prepare their annual summary reports on an annual basis within 70 calendar days of the end of the calendar year.

Non-therapeutic research on cannabis (NTRC) studies

Licence holders conducting non-therapeutic research on cannabis (NTRC) studies are not required to prepare an annual summary report. However, there may be a term and condition on the licence which requires the submission of a summary report of all adverse reactions observed during their study under certain situations. An interim study summary report of all adverse reactions may also be required where a study is ongoing for a period greater than 12 months. These licence holders need to submit their report within 70 days of study completion.

Overview of the report

The goal of the annual summary report is to provide a comprehensive, concise, and critical analysis of all known adverse reaction reports involving a licence holder's cannabis products. All adverse reactions to cannabis, whether expected^{Footnote 1} or not, must be in the annual summary report. The depth of analysis of the annual summary report depends on the nature and amount of the information collected.

Annual summary reports:

• summarize and integrate new cumulative risk information gained from exposure to cannabis product produced and/or distributed by the licence holder
• should focus primarily on domestic cases, but should include any foreign reports in their own section of the report
• should only include issues related to quality or good production practices if they resulted in or contributed to an adverse reaction

Content and format

There's no mandatory format for the annual summary report; however, this is harmonized guidance on preparing and submitting the report with national and international guidelines, where applicable.

The information included in the annual summary report will vary depending on the adverse reaction data known to the licence holder and the products they distribute or sell.

Adverse reaction data from other licence holders may need to be included if:

• it comes from one of their formal partners such as contractual partners or subsidiaries. For example, it involves a cannabis product produced by the licence holder but was distributed to another licence holder for retail sale. The processing licence holder should also include these cases in their own report
• it comes from other licence holders on an ad hoc basis. For example, if multiple cannabis products are suspected the licence holder that receives the adverse reaction may flag the adverse reaction to the licence holder of the other suspect product

In general, an annual summary report should include:

• Canadian data
• spontaneous reports (serious and non-serious)
• any new potential or identified risks
• special topics, if applicable (for example, vulnerable sub-populations, cannabis-drug interactions, medication errors or overdose, and accessory issues)

Licence holders should also include the following when it's available:

• foreign data
• reports from non-interventional studies or from non-therapeutic interventional studies (for example, non-therapeutic research on cannabis)

The annual summary report should stratify adverse reaction data in separate sections based on the characteristics of the suspected products. This may include cannabinoid profiles and any clinical observations by cannabinoid dominance or concentration, especially if effects are expected to vary (for example, when used alone or with other suspect products).

Regardless of format, licence holders should include the same core data period (that is, calendar year) to highlight any significant changes to the products' risk profile over a set period. Regardless of the reporting format selected by the licence holder it is expected that they include, in an appendix to the annual summary report, a line listing of all cases received during the reporting period. Refer to Appendix 1: Line listings for more information.

Reporting period

Licence holders must prepare an annual summary report reflective of the previous 12-month period. Licence holders should prepare the report on a calendar-year basis (January 1^st to December 31^st), unless Health Canada specifies otherwise. Even if a product does not yet have a full year of marketing experience, the licence holder should include all adverse reaction data for that calendar year.

No adverse reaction reports

If licence holders receive consumer complaints that also involve or report a side effect (symptomatic complaints), they should consider them as adverse reactions and include them in their annual summary report.

If the licence holder doesn't receive any adverse reaction reports within a reporting period, they should still prepare and maintain an annual summary report. It should include all relevant sections and the licence holder must indicate that they didn't receive any reports.

Canada Vigilance adverse reaction database

Licence holders should verify that their adverse reaction records are complete by comparing them to the Canada Vigilance adverse reaction online database. The database is updated monthly, which is why licence holders have 70 days to complete the annual summary report. However, the data in the Canada Vigilance adverse reaction online database lag by 3 months. For example, the database may be updated on June 4, 2024, to include data up to March 4, 2024. Any changes to a report (for example, any follow-up information that may change key case details) will only appear online in the next database update. Licence holders should pay close attention to the data inclusion dates listed in the database. For more information, refer to Instructions for the Canada Vigilance adverse reaction online database.

Requesting up-to-date line listings and case information

If a licence holder needs an up-to-date line listing of cases in the Canada Vigilance adverse reaction online database to verify their records, they should email a request to cannabis_oss-cannabis_bss@hc-sc.gc.ca. Use the subject line: [Licence holder name] _[Year] ASR Canada Vigilance line listing request" and including the required start and end dates.

Requesting full adverse reaction case reports from Health Canada

If a licence holder wants to get full adverse reaction case reports from Health Canada, they must submit an Access to Information and Privacy (ATIP) request.

Preferred format

Even though there isn't a mandatory format for the annual summary report, Health Canada prefers the format described in this section. It has been adapted from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other Health Canada guidance to meet the needs of annual summary reports involving cannabis products.

Licence holders should include all sections listed below. If a licence holder can't complete a section, the licence holder should add an explanation in that section describing why the section cannot be completed.

Main (title) page

Contains the licence holder's name, the year and the phrase "Annual adverse reaction summary report".

Executive summary

Highlights any notable changes in general to the risk profile of the products during the reporting period.

Introduction

Introduces the licence holder and the type of cannabis products in the report (such as, product class, cannabinoid concentration). The licence holder may also choose to include any contextual information they deem relevant.

Summary of known changes about product risk profile

Summarizes any changes observed in risk profile of the products, such as:

• adverse reaction severity
• outcome of the adverse reaction
• population impacted or affected
• changes in how people use the product (for example, not being used as intended)
• product types involved
• product formulation or ingredients

If applicable, the licence holder should indicate if they observed no changes.

Information on regulatory actions

Describes any regulatory actions that happened during the reporting period inside or outside of Canada, such as:

• voluntary or mandatory recalls of their products
• requests for more information (during post-marketing period)
• any significant changes to a cannabis product (formulation of cannabis or accessory)

Marketing sales data in Canada

Summarizes any available Canadian marketing sales data relevant to the products included in the report, including cannabis for medical and non-medical purposes. Market data can provide context around an exposure and can contribute to the licence holder's assessment of risk for their products and their potential for causing harm. Presentation of marketing sales data by product class is preferable, if applicable.

Geography of adverse reactions

Includes the total number of adverse reactions by region (for example, domestic, foreign) and further disaggregated by seriousness and reason for seriousness, for example:

• fatal
• life threatening
• hospitalization or prolongation of hospitalization
• disability
• congenital malformation
• other medically important condition

The licence holder may also consider highlighting any foreign cases involving cannabis products that are also sold in Canada.

Submission of cases under other regulatory programs

Describes any cases reported as incidents under other regulatory programs (for example, the Canada Consumer Product Safety Act) and the outcome of such reporting, if applicable.

Critical analysis of adverse reaction cases

Includes an analysis of all domestic adverse reaction cases to assess if there have been any new or potential risks identified. The following subsections are preferred.

• Adverse reactions by demographic variables: Analysis by any available demographic information, including age, sex, location
• Adverse reactions by source: Analysis by initial report source (for example, consumer, health care professional). Refer to Sources of adverse reaction reports for a detailed description of this subsection
• Adverse reactions by seriousness: Analysis by seriousness (for example, serious versus non-serious cases). If possible, the licence holder should include a breakdown by reason for seriousness (for example, fatal, life threatening, hospitalization, disability, congenital malformation, other medically important condition)
• Adverse reactions by reason for use: Analysis by reason for use (for example, medical or non-medical purposes)
• Adverse reactions by product information: Analysis of data by product variables, including:
  • product class (format) and sub-class
  • route of administration (for example, oral, inhalation, sublingual, topical)
  • cannabinoid dominance
  • by seriousness and reason for use, if necessary

Adverse reaction reports by observed clinical event

Includes an analysis of adverse reaction reports by MedDRA system organ class and frequency of clinical events reported (that is, MedDRA preferred term). Licence holders may also use a broader grouping of clinical events, if desired.

New or emerging adverse reactions

Include any new or emerging adverse reactions identified during the reporting period. The licence holder may include new or emerging adverse reactions even if information is missing.

Licence holders should focus on special topics, particularly those associated with:

• vulnerable populations (for example, pediatrics, elderly, pregnant individuals, breastfeeding individuals)
• cannabis-drug interactions (for example, prescription, non-prescription, over-the-counter medications, herbal remedies, natural health products, homeopathic medicines, vitamins)
• any overconsumption or misuse, whether accidental or deliberate
• any consumption errors that may be due to packaging or labelling (for example, product label confusion), or the accessory (for example, device malfunction resulting in overexposure)
• any latent or persistent (that is, long-term) effects
• any commentary on causality, whether cannabis contributed to the reported adverse reactions or not
• any commentary on non-cannabis ingredients (for example, carrier oils) and their potential role (if any)

Conclusion

Includes a conclusion as to whether there's:

• any new or emerging adverse reactions or safety signals
• a significant change in the overall risk profile of their licence holder's cannabis products

Appendix 1: Line listings

Includes a line listing of all cases received during the reporting period. Licence holders can include this appendix within the main report document or as a separate table or Excel spreadsheet.

Licence holder may wish to use similar columns or headers as those used in the Canada Vigilance adverse reaction online database (extract).

A line listing summarizes individual case details on individual lines as records and includes all available case information, including verbatim. Line listing should include each case report only once regardless of how many adverse reactions (that is, side effects) are reported in the case. If there is more than 1 adverse reaction reported, licence holders should list them all in the same line. All adverse reactions described by a reporter must be included.

It's possible that the same consumer may experience more than 1 adverse reaction (either with the same or different cannabis products) on different occasions. Licence holders should treat such experiences as separate cases. In these cases, a consumer may appear in more than one line listing. Licence holders should cross-reference, when possible, cases of multiple reports by 1 consumer and linked reports (for example, where a shared product results in adverse events in multiple consumers). Duplicates should be within the same line (for example, where multiple reporters report the same consumer and adverse event). If this isn't possible, there should be a way to identify and filter these duplicate cases.

Suggested headings for line listings:

• date report received
• date of reaction (if known)
• source of report (for example, consumer, health professional, Canada Vigilance adverse reaction online database)
• nature or type of report (for example, spontaneous, solicited, study)
• serious or non-serious adverse reaction
• reason for seriousness (for example, death, life-threatening, hospitalization or prolonged hospitalization, disability, congenital malformation, other medically important)
• age and sex of the consumer
• any other relevant consumer details, medical history (for example, allergies, existing medical conditions, use of other medications)
• suspect cannabis products
• cannabis product class (for example, dried cannabis, edible cannabis, cannabis extracts, cannabis topicals)
• THC and CBD concentrations or amounts
• other cannabinoids and concentrations or amounts
• other ingredients
• dose of the product and duration of use
• description of the adverse reaction (verbatim, and corresponding MedDRA terms)
• medical intervention received (for serious and medically important cases), if known
• dechallenge (reaction stops when cannabis was stopped) or rechallenge (reaction returned when the cannabis was restarted) information
• outcome
• any interpretation or comments by the licence holder (for example, opinion of causality from the initial reporter, causality assessment by the licence holder)

Other acceptable formats

If a licence holder uses a format other than Health Canada's preferred format, they should describe and rationalize this choice in the introduction section of their annual summary report.

Health Canada would also accept other summary report formats as long as they fulfill paragraph 248.1 (1) (b) of the Regulations. For example, standardized periodic summary report formats like the Periodic Safety Update Report (PSUR) and the Periodic benefit-risk evaluation report (PBRER) would be acceptable.

Licence holders can omit the following sections from standardized periodic summary reports when drafting their annual summary report:

• worldwide marketing approval or authorization status
• cumulative subject exposure in clinical trials
• cumulative and interval patient exposure from marketing experience
• cumulative summary tabulations of serious adverse events from clinical trials
• summaries of significant findings from clinical trials during the reporting period
• integrated benefit-risk analysis for approved indications
• information from other clinical trials
• lack of efficacy in controlled clinical trials

Refer to the ICH E2C(R1) and ICH E2C(R2) guidance documents for further information on the PSUR and PBRER formats and content.

If a standardized periodic summary report format is used by the licence holder, Health Canada may request additional sections of information, as necessary, such as line listings.

Sources of adverse reaction reports

Includes sources of adverse reaction reports with cannabis products. These are similar to the sources of the original reports, refer to Adverse reaction reports by source for more information.

• Spontaneous sources
  • Domestic reports
  • Foreign reports
• Study sources
  • Observational studies
  • Non-therapeutic research on cannabis (NTRC) studies
  • Clinical trials
• Published sources
  • Scientific or medical literature
  • Any publications relevant to adverse reactions observed during the reporting year (not mandatory)
• Canada Vigilance adverse reaction online database and other regulatory sources

  Note: To prevent duplicate cases, licence holders don't need to include cases they've submitted to Health Canada when they summarize the results of their search. For more information, refer to Instructions for the database.

  • Reports in Canada Vigilance adverse reaction online database and not previously known to the licence holder (from another source)
  • Reports from foreign regulatory sources
• Media or other sources
  • Publicly available information such as social media or media reports

When to submit

Unless Health Canada has requested it, licence holders aren't required to submit their annual summary reports. Health Canada may request the report to assess potential risk or during an inspection. Licence holders can also decide to submit their annual summary report voluntarily.

Requested to assess potential risk

To verify or assess the risk of a cannabis product, Health Canada may request any of the following, as applicable:

• their most recent annual summary report
• every annual summary report
• an interim summary for an incomplete year (from January to the date of the request)

Licence holders should submit their annual summary report within 30 calendar days of the request unless otherwise specified.

Requested during an inspection

To verify record keeping, inspectors may request to review annual summary reports on file to ensure that licence holders have appropriately prepared and maintained their records. They may also request the reports to examine the risk profile of a cannabis product.

Voluntary submission by the licence holder

Licence holders are encouraged to submit their annual summary reports on a voluntary basis. Health Canada may review the voluntarily submitted annual summary report and provide feedback as necessary. For example, a licence holder may wish to submit an annual summary report:

• to provide an update about all the adverse reaction data they've received, even if there is no significant change observed in the risk profile of the cannabis product
• if their report concludes that there has been a significant change in the observed risk profile of a cannabis product

How to submit

Licence holders should provide their annual summary reports in electronic-only format.

Use the following naming convention: [Licence holder name]_[Year] ASR. For any appendices, use: [Licence holder name]_Appendix 1 Line Listing_[Year] ASR.

• When requested by Health Canada to assess a potential risk: follow the instructions provided by Health Canada
• When requested during an inspection: follow the instructions provided by the inspector
• To voluntarily submit: email the report to cannabis_oss-cannabis_bss@hc-sc.gc.ca. Use the subject line: "[Licence holder name]_[Year] ASR submission"

Record keeping

Licence holders must maintain their annual summary reports for at least 25 years after the day on which they prepared them. In addition, they must keep all reports easily accessible and, when requested, submit them to Health Canada.

Refer to Record keeping requirements for information about general record keeping procedures for adverse reaction reports.

Contact us

For questions about the information or requirements, email cannabis_oss-cannabis_bss@hc-sc.gc.ca. Use the subject line: "Preparing and maintaining annual summary reports for cannabis products guidance".