Guidance for industry on safety monitoring and reporting requirements for marketed biocides: Information retention requirements

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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:

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:

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:

You must preserve the integrity of the data. Based on how documents are preserved, you should consider having processes to:

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:

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