Mandatory reporting by hospitals of serious adverse drug reactions related to biocides: Notice

Learn how the new Biocides Regulations will change mandatory reporting obligations for hospitals.

On this page

New regulations for biocides

Health Canada has introduced a new set of regulations under the Food and Drugs Act (FDA) to regulate substances or mixtures of substances that sanitize or disinfect non-living and non-liquid surfaces more effectively.

The new Biocides Regulations will bring 3 lines of products under a single legal framework:

When the new regulations come into force, hospitals will be required to report serious adverse drug reactions (ADRs) related to biocides. This requirement stems from section 21.8 of the FDA.

We will be updating the guidance on mandatory reporting by hospitals later to include information on mandatory reporting under the new regulations.

Guidance on mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals

About mandatory reporting and biocides

This section highlights what hospitals need to know about the new requirements for mandatory reporting of serious ADRs related to biocides.


A biocide is a drug that's manufactured, sold or represented for use in destroying or inactivating micro-organisms, or in reducing or controlling their number, on a non-living and non-liquid surface.

In other words, biocides are surface disinfectants and surface sanitizers.

Biocides do not include products for use as follows:

Like drugs under the FDR, biocides authorized under the new regulations will be issued a drug identification number (DIN).

Serious ADRs and biocides

We modified the definition of "serious adverse drug reaction" for the Biocides Regulations to update the regulatory language and to better reflect biocide products. However, the qualifying level of seriousness of the adverse reaction is the same as the level outlined in the FDR for other drug products.

A serious ADR from a biocide is one that:

Note: Serious ADRs related to biocides include important medical events in the same manner as serious ADRs related to drugs.

How to determine reportability

To determine if a scenario involving a biocide is reportable, hospitals should consider the following:

Information to be provided in hospital reports

We adapted language from the FDR to describe the information that hospitals must provide in their reports for biocide products. This information is comparable to existing requirements in the FDR.

For serious ADRs related to biocides, hospitals must provide the following information:

When providing information on the description of the reaction, include the effect of the serious ADR on the patient's health. Examples:

Note: If the only information available is that the patient was discharged from the hospital, without any indication on their status, the outcome should be considered unspecified and reported as unknown.

Other reporting requirements for biocides

The reporting timeline for a serious ADR is 30 days, the same as the timeline outlined in the FDR.

For more information on mandatory reporting requirements for hospitals and how to report a serious ADR, consult the following guidance document:

We will be updating the hospital serious ADR reporting form to include biocides before the new regulations come into force.

Coming into force

The Biocides Regulations will come into force 1 year after their registration. Mandatory reporting by hospitals of serious ADRs related to biocides will come into effect at that time.

Manufacturers of surface disinfectants (under the FDR) and registrants of surface sanitizers (under the PCPA) have a 4-year transition period after the Biocides Regulations come into force. Manufacturers of surface sanitizers for use in food premises have a 6-year transition period.

These transition periods will give them time to transfer their products to these new regulations. Until the end of the transition periods, products will continue to be authorized under the FDR and the PCPA as well as the Biocides Regulations.

During this transition period, hospitals may not know whether the serious adverse drug reaction is subject to mandatory reporting. All products with an 8-digit DIN will be subject to mandatory reporting. When in doubt, hospitals are strongly encouraged to report it, regardless of whether the product is a sanitizer or a disinfectant.

Contact us

If you have questions about mandatory reporting, you may contact the Canada Vigilance Program by:

Page details

Date modified: