Guidance for industry on safety monitoring and reporting requirements for marketed biocides: Serious incident reporting

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• What is a reportable incident
• Reporting serious incidents

What is a reportable incident

Serious incident reporting is required under section 39 of the Biocides Regulations (regulations). You must report to us the following incidents within 15 calendar days of becoming aware of the incident:

• any serious (expected or unexpected) incident related to your biocide that occurs in Canada
• any serious unexpected incident related to your biocide that occurs outside of Canada

An incident is reportable when the:

• threshold established in the definition of serious incident for incidents that occurred in Canada is met or
• threshold established in the definition of serious unexpected incident for incidents that occurred outside of Canada is met and
• minimum information for reporting is available

Serious incidents include those where user error and misuse, accidental exposure or occupational exposure have occurred and have led to a response that is either life-threatening or results in serious injury harm or death.

You should also consider important medical events as serious incidents. These are events that may not be immediately life-threatening or result in death or hospitalization, but that may:

• jeopardize the patient, in the clinician's judgment, or
• require intervention to prevent any of the outcomes noted in the serious incident definition

You should consider incidents that occur outside of Canada and that involve a fatal outcome as unexpected and reportable under serious incident reporting. The fatal outcome can only be considered expected if your Canadian label specifically states that using the product may be associated with a fatal outcome.

Failure in effectiveness

The definition of a serious incident includes a failure in effectiveness of the biocide that results in a serious injury to human health, a life-threatening event or death. For a serious incident related to a failure in effectiveness to be reportable, the following must occur:

• a substantial failure of the expected performance of the biocide product, contrary to the claims made by the product in its conditions of use
• a person has been exposed to and contracted an illness or disease from a microorganism that the biocide failed to destroy, inactivate, reduce or control
• the illness or disease that the biocide failed to prevent caused the patient to be hospitalized, prolonged hospitalization, led to chronic or significant disability or incapacity, caused congenital malformation, was life-threatening or resulted in death

You are responsible for validating the failure in effectiveness information before you report to us under serious incident reporting. You should investigate first to determine if there has been a substantial failure and if there is a plausible link between the failure and the illness or disease contracted.

Source of information

During the course of compiling information as part of your safety monitoring activities, if you become aware of an incident that meets the threshold of a serious incident, you must report the incident through serious incident reporting.

You may become aware of serious incidents through a variety of sources, for example:

• consumer complaints
• poison control centres
• Canada Vigilance Database

If you identify a serious incident when searching the Canada Vigilance Database and you have a report from another source on the same incident, you should submit the report from the new source to the Canada Vigilance program. Only reports from the additional source should be submitted to the Canada Vigilance program. Do not resubmit a report that you retrieved from the Canada Vigilance database.

Notable incident not reportable

Notable incidents do not meet the threshold established in the definitions for serious incident or serious unexpected incident required for reporting. As such, notable incidents are not reportable under the serious incident reporting provisions of the regulations. However, they are to be compiled and considered as part of your safety monitoring activities.

Examples of reportable incidents

The following are examples of serious incidents, which must be reported to us under serious incident reporting:

• While using a product in accordance with the directions of use indicated on the label, a user accidentally drops the open container and the biocide splashes onto the user's face. The user had a reaction to the biocide and required hospitalization.
• A young patient is hospitalized with rotavirus that was linked back to a daycare centre outbreak. The daycare centre had strict cleaning and disinfection procedures and used your biocide, which had an approved disinfection claim against the virus, on all touch surfaces according to the label directions. You investigated the situation and determined that your biocide failed to perform as indicated against the virus.
• A user in Canada failed to read the directions of use and warnings on the label of your biocide and mixed your biocide with a cleaning product. Toxic fumes were produced as a result of the mixture and were inhaled by the user. The user had a pre-existing lung condition and died from inhaling the toxic fumes.
• A user intentionally drank your biocide as part of a challenge and died as a result.

The following are examples of incidents that are not reportable under serious incident reporting:

• A user accidentally poured your biocide on their skin and received a minor burn. The user went to an urgent care clinic and was treated by the attending physician and released without needing further treatment. You should only consider the incident as part of your safety monitoring activities.
• A user outside of Canada failed to read the directions of use on the label of your biocide and mixed your biocide with a cleaning product. The Canadian label of your biocide contained a warning that mixing the product with certain other products may result in a fatal outcome. The user inhaled the toxic fumes that were produced as a result of the mixture. The user had a pre-existing lung condition and died from inhaling the toxic fumes. You should consider the incident as part of your safety monitoring activities, as this was a serious expected incident that occurred outside of Canada.

Reporting serious incidents

You must submit a report to us of a serious (expected and unexpected) domestic incident or a serious unexpected foreign incident within 15 calendar days after becoming aware of the incident. The time clock starts on the day that you first have all the minimum information for an incident report.

You must report all serious domestic incidents and serious unexpected foreign incidents that you become aware of. This applies even if the biocide product in question is not currently being sold or has not been sold in Canada for some time. To facilitate the processing of incident reports, the reporter should indicate if the report is domestic or foreign by clearly indicating the country where the reaction occurred.

If you become aware of a serious incident or a serious unexpected incident after your market authorization has been permanently discontinued and revoked, you should still continue to report such incidents.

What information to include

The minimum information required to submit a serious incident report are:

• an incident
• a biocide product
• an identifiable reporter and
• an identifiable person who experienced the harm

You should include all information that is available and relevant in your incident report. Often, you will need to submit an initial report to us with at least the minimum information in order to meet the reporting timelines. You should actively seek follow-up information and provide significant new information to us as it becomes available by submitting a follow-up report.

Significant new information related to the initial report includes, for example:

• a new suspected incident or response
• an additional or changed suspected biocide product
• a change in the assessment for causality
• any new or updated information on the incident that may impact the narrative of what has occurred
• additional key data elements
  • for the person who experienced the harm, such as age, sex, pre-existing medical conditions
  • for the suspected biocide, such as lot number
  • for the incident, such as additional description of the response or reported signs and symptoms

You should clearly identify follow-up reports to ensure that we can link the follow-up report to the initial report.

An incident

You should document and report all relevant and available information on the incident. The information about the incident should have sufficient detail to provide a narrative of what has occurred.

You should document and report a full description of the serious incident, including:

• the harm that has occurred, including body site and severity
• the reported signs and symptoms
• the criterion (or criteria) for regarding the incident as serious if reported as such
• specific diagnosis for the harm or reaction, if applicable
• the date on which the person was exposed to the biocide
• the date that the harm or reaction first occurred
• the date that the person's health was restored to its original state before the incident
• any relevant diagnostic test results and laboratory data
• the setting where the incident occurred
  • for example, home, hospital, commercial setting, place of employment
• the outcome
  • recovery and any subsequent health effects
• stated cause of death and relevant autopsy or post-mortem findings for a fatal outcome
• other factors that may have contributed to the serious incident
• how the biocide relates to the harm, reaction or event

A biocide product

You should document and report all available information on the biocide product known or suspected of being linked to the incident to make it easier to identify the product. Such information would include the:

• lot number
• brand name
• physical form
• identification number
• method of application
• settings in which the product is intended to be used

An identifiable reporter

To avoid duplicate reports and to facilitate follow-up, an identifiable reporter is required for an incident report. An identifiable reporter is the source of the information. You should document and report the source of the information, including the:

• date on which you first received the incident information
• reporter qualification, if applicable, for example:
  • a user or another person on behalf of the user
  • a health professional and their specialty

If the source of the information is not an identifiable person (for example, a literature search, regulatory authority), you should clearly identify the source and the date you documented the report.

Include in the report your name and contact information (such as an email address or phone number) as the sender of the information.

An identifiable person

To avoid duplicate reports, an identifiable person is also required for an incident report. The identifiable person is the one who experienced harm from the serious incident or serious unexpected incident. This could be, for example, a user of the product or a bystander close to where the product was used.

You should document and report key details of the person, including:

• the person's height and weight
• the person's sex and/or gender
• the person's age or age category
• whether the person had any pre-existing medical conditions
• whether there were contributing factors associated with the person's use of the biocide
  • for example, occupational exposure
• whether the person is considered part of a vulnerable population
  • for example, pregnant or lactating, psychiatric, pediatric, geriatric

How to submit

You should submit serious (expected or unexpected) incident reports and serious unexpected incident reports to us using the form available online and submitted by fax or by mail.

Canada Vigilance Program
Health Products Surveillance and Epidemiology Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1908C
Ottawa ON K1A 0K9
Telephone: 613-957-0337
Facsimile: 613-957-0335

For information about serious incident reporting, email us with your request: canada.vigilance@hc-sc.gc.ca. Do not send reports by email.