Guidance for industry on safety monitoring and reporting requirements for marketed biocides: Information retention requirements
On this page
- What information is required to be kept
- The form and manner of information retention
- Who is required to keep the information
This section only applies to the information retention requirements in section 40 of the Biocides Regulations (regulations). The regulations also contain other record-keeping requirements for recalls and quality assurance.
What information is required to be kept
You must keep all information compiled in accordance with subsection 40(1) of the regulations.
Subject to further discussions (which follow), you must keep information for at least 10 years after becoming aware of it. You cannot destroy or dispose of this information (including any documentation) before the end of the 10-year retention period.
Incidents and foreign actions
You must keep all information that you become aware of relating to notable incidents, serious incidents and serious unexpected incidents regarding your biocide.
Examples of information that you must keep, if available, include:
- details of the biocide, such as the brand name, identification number, lot number, physical form, method of application, settings
- details of the person who experienced the harm, such as age or age category, sex or gender, height and weight, pre-existing conditions
- details of the incident, such as a description of the reaction and event, outcome, if there was user error or accidental exposure, date and time of incident, setting where the incident occurred
- details of the reporter, including the source of the report and date it was reported
- any assessments you've made about the incident
- evidence that the incident was reported to the Canada Vigilance Program, if applicable
You must also keep all information that you become aware of relating to measures that have been taken outside of Canada to address a significant safety issue.
If, in the course of your safety monitoring activities, you discover that a quality issue is related to the failure in effectiveness of your biocide, the quality control records retention period under section 52(3) no longer applies. Rather, the information retention provisions under section 40 of the regulations would apply to all the relevant quality control records related to the failure of effectiveness.
Safety monitoring documentation
You are expected to keep documentation of your safety monitoring activities. Section 40(1) of the regulations requires you to compile and review information "in a manner that ensures the effective and timely detection of issues." The information that you keep should be sufficient for auditing purposes and to verify compliance.
Examples of information that supports the documentation of safety monitoring activities include:
- a description of your safety monitoring activities, such as written procedures, contractual agreements, training standards and records
- the rationale for the timing, frequency and nature of the safety review and scanning of sources to detect issues
- how and from where you collected the compiled information
- your findings for any detected significant safety issue
- your conclusions following safety monitoring activities, including if no new significant safety information was identified
The form and manner of information retention
The form and manner in which you keep the information is at your discretion. However, you must ensure that the information:
- is readily accessible
- includes all relevant and required information
- could be submitted to us within the requested timeframe
You must preserve the integrity of the data. Based on how documents are preserved, you should consider having processes to:
- restrict file access to relevant personnel
- validate computerized systems and audit trails
- make periodic backups for electronic documents
- ensure documents are preserved in disaster situations
We also recommend that the information be easily searchable to ensure that a request can be addressed in a timely manner.
Information must be kept "at the ready." This means it must either be kept on-site or be easily accessible and, when requested, be submitted to us within the specified timelines.
Who is required to keep the information
You are responsible for keeping the information for the applicable retention period. If you decide to store documents outside of your facility (for example, at a third-party facility), you are still responsible for ensuring the documents are preserved and accessible.
If your market authorization is revoked or suspended, you continue to be responsible for keeping the information for the remainder of the retention period. The requirement to keep information does not stop when a market authorization is revoked or suspended.
If a new MAH substitutes you, you must transfer all information to the new holder. You are responsible for keeping the information until its transfer. Once you have transferred the information, the new MAH is then responsible for keeping the information for the remainder of the retention period.
Examples of a new MAH stepping in as a substitute include a:
- transfer of the market authorization
- takeover by a new corporation or legal entity
- sale of the product and its market authorization
Page details
- Date modified: