Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations: Post-market requirements

On this page

• Introduction
• Flexible post-market powers
• Post-market surveillance
• Recall reporting and record keeping
• Annual notification process

Introduction

The Biocides Regulations (the regulations) include revised post-market requirements from the:

• Food and Drug Regulations (FDR)
• Pest Control Products Act (PCPA)
• Pest Control Products Regulations

The revised post-market requirements include changes to:

• flexible post-market powers (including terms and conditions)
• post-market surveillance
• record-keeping
• recall reporting
• annual notification process

In addition, as biocides fall within the definition of a "therapeutic product" under the Food and Drugs Act, the post-market authorities introduced through Vanessa's Law will also apply.

Vanessa’s Law

Flexible post-market powers

The FDR and PCPA both provide us with the ability to cancel authorizations and registrations. However, when these powers are used, it affects all products under the DIN and registration.

The regulations will introduce more flexibility in:

• how a market authorization can be suspended or revoked (for example, in whole or in part)
• requiring a stop sale for select persons

This will allow us to:

• minimize market disruptions, while protecting the health and safety of people in Canada
• strategically target and address select issues instead of impacting the entire authorization
• provide regulatory oversight based on risks and evolving evidence, and manage uncertainties

Terms and conditions

Terms and conditions are requirements that are additional to the requirements in the regulations. You must follow them if they are attached to your biocide's market authorization. They may be used to help us address significant uncertainties relating to your biocide's benefits and risks.

Guidance on biocide application pathways and general requirements

Post-market surveillance

New elements

Market authorization holders of biocides have specific post-market requirements under the regulations, which are tailored to biocides. As such, they differ from the requirements under the FDR and PCPA. These revised post-market surveillance requirements include:

• safety monitoring
• capturing certain failures in the effectiveness of a biocide
• using biocide specific terminology (for example, notable incident instead of adverse drug reaction)
• record retention period of 10 years instead of 25 years for safety-related incidents

Biocide market authorization holders will no longer need to prepare annual summary reports. Instead, you will have the flexibility to develop a method to monitor the safety of your marketed biocide (in both foreign and domestic markets) to detect safety issues as they emerge. Once you identify a significant safety issue, you will need to notify us without delay.

You will be responsible for ensuring that qualified personnel and adequate systems and procedures are in place for safety monitoring upon receiving a market authorization under the regulations.

Transferred elements

Certain post-market surveillance elements from the FDR are included in the regulations. These elements include:

• hospital reporting
• issue-related summary reports
• serious adverse reaction and serious unexpected adverse reaction reporting, with modifications to use the biocide terminology:
  • notable incident
  • serious incident
  • serious unexpected incident

Guidance for industry on safety monitoring and reporting requirements for marketed biocides

Recall reporting and record keeping

Recall reporting

The regulations adapt the recall reporting requirements in the FDR by formalizing requirements outlined in:

• Health Canada's Drug and Natural Health Products Recall Guide (GUI-0039)
• Recall Policy for Health Products (POL-0016)

These formalized requirements outline information that you must provide us when conducting a voluntary or a mandatory recall. Information that you must provide us includes:

• the biocide being recalled
• the volume of biocide affected
• recall strategy taken and measures to prevent recurrence
• results of the recall

Record keeping

In addition to keeping records to support a recall, the regulations include requirements for you to keep:

• master formula records
• information used to support the foreign market authorization, if applicable
• evidence that each lot or batch of the biocide has been manufactured, packaged, labelled and stored according to the master formula

The regulations include a record retention period based on the biocide's expiry date. Records must be retained for 1 year after the last day of the month of the biocide's expiry date. If the biocide does not have an expiry date on the label, you will need to maintain records for 6 years after the day on which you sold the biocide to which the record relates.

Annual notification process

The regulations set out requirements for the market authorization holder to provide sales-related information for biocides. The regulations include requirements for:

• notification of first sale
• notification of permanent discontinuation of sale
• annual market notification (to indicate continued sale or no sale in the previous 12 months)