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

On this page

• Purpose and policy objective
• Compliance and enforcement
• Note about guidance documents in general

Purpose and policy objective

This guidance document will help regulated parties understand and comply with the Biocides Regulations (regulations) as it relates to information requirements for your marketed biocide. This includes your post-market safety monitoring and reporting obligations. These obligations under the regulations include:

• safety monitoring under section 40
• serious incident reporting under section 39
• issue-related reports under section 41
• information retention under section 40

These requirements include responsibilities for you, the holder of a biocide market authorization, to continue to review new information on the benefits, risks and uncertainties of your own product after it's authorized for sale in Canada.

You must also notify us of any significant safety issues related to the risks or benefits associated with your biocide.

Compliance and enforcement

All regulated activities conducted with biocides are subject to compliance and enforcement tools and actions as outlined in our Compliance and enforcement policy for health products (POL-0001). If we identify non-compliance, we will apply the provisions of the Food and Drugs Act and the Biocides Regulations using a risk-based approach.

For example, under the regulations, the Minister may suspend the market authorization or take other compliance and enforcement actions, as appropriate, if you:

• fail to comply with your safety monitoring and reporting obligations or
• do not respond to a request for information or analysis

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As appropriate, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the regulations and other applicable guidance documents.

Market authorization holders (MAHs) should refer to the most up-to-date versions of the guidance documents. The links to these other guidance documents are a starting point to help applicants/MAHs. They are not an exhaustive list.