Guidance for industry on safety monitoring and reporting requirements for marketed biocides: Issue-related reports

What is an issue-related report

A request for an issue-related report will come from Health Canada. This report contains:

a concise critical analysis of the issue specified in the request
the information on which the analysis is based and
any additional information specified and that is accessible to you

We may request, in writing, that you submit an issue-related report when we become aware of an issue that could have significant implications for benefits or risks associated with a biocide.

For example, we may request an issue-related report in response to:

a notification from you of a significant safety issue under subsection 40(2) of the Biocides Regulations (regulations)
a safety signal identified by us through the Canada Vigilance Program
new information from a foreign jurisdiction on a similar or equivalent biocide product
emerging trends or safety information on the benefits or risks of an active ingredient of your biocide

Information to include in an issue-related report

An issue-related report should contain relevant information, such as:

a description of the health issues relating to the subject of the report
a description of the strategy used to collect the relevant information
a summary analysis of the cases relevant to the issue, such as:
- a tabulation of notable incidents and serious incidents
- your comments on the incidents
- analysis of the relationship between exposure to the biocide and the incidents
- summary analysis of possible risk factors and confounding circumstances
data about Canadian and international exposure
- for example, how much product used
reference information that reflects Canadian market entry requirements
- for example, marketed labels and approved labelling information
your conclusion on the safety of the product as it relates to the events in question and, if applicable, any risk mitigating actions you plan to take
- for example, making changes to the product or the labelling

In certain instances, we may ask for specific information that is relevant to the analysis. We will specify this in our request letter.

It may be necessary for you to conduct an additional targeted search of available information in order to address our questions. You should include all the information we request that is accessible to you in your issue-related report.

Information is accessible to you if it can be obtained by you. For example:

public information available through web access
information that can be gathered by contacting poison control centres or other public bodies

Submitting an issue-related report

You must submit an issue-related report when requested, within the timeline outlined in our request letter.

How to submit

You should provide the issue-related report to us in electronic-only format, in either English or French, using the non e-CTD format. You should include a cover letter, with your identification number, and the reason for your submission (for example, response to issue-related report request letter dated YYYY-MM-DD).

If you have questions about issue-related reports, you may contact the Regulatory Project Management Office at the Marketed Health Products Directorate.

Regulatory Project Management Office
Bureau of Strategic Engagement and Integrated Management Services
Marketed Health Products Directorate
Health Canada
Address Locator 0702L
200 Tunney's Pasture Driveway
Ottawa ON K1A 0K9
Email: bbrs.rpm-gpr.bbra@hc-sc.gc.ca

Timelines

When we request an issue-related report, we will specify a reasonable timeframe for submitting the report. This timeframe is typically a 30-day period. However, we may specify different timeframes:

longer as needed or
shorter than 30 days if the information is needed quickly and we believe your biocide may pose a serious and imminent risk of injury to human health

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Date modified:: 2024-06-18

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