Exceptional importation and sale of biocides in relation to COVID-19:  For industry

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About the new regulations and exceptional importation

The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) comes into force on March 1. Under these Regulations, the exceptional importation of biocides would no longer be permitted.

However, Health Canada is delaying the end date by which importers of products on the List of biocides for exceptional importation and sale (the List) must stop importing. We are basing this decision on the current state of the COVID-19 pandemic in Canada and its effect on the supply chain.

For designated biocides that were accepted previously to the List under the IO, Health Canada is permitting the:

How to import and sell designated biocides

Step 1: Approval to import and sell designated biocides

Importers will be permitted to import and sell designated biocides once the biocide is on the

Although importers may sell designated biocides once these are included on the list of designated biocides, they must still notify Health Canada when importing designated biocides.

Step 2: Pre-importation notification requirements

Importers must notify Health Canada at least 5 calendar days before the day they import a designated biocide. They must do so by sending an email to biocidesibr-ipr@hc-sc.gc.ca. The email must contain the following information:

Step 3: Information to support safe use requirements

Importers must ensure information is available in a manner that supports safe use of the biocide. This includes providing the information in both official languages.

Regulatory requirements for selling designated biocides

At this time, importers may bring designated biocides into the country without meeting all the requirements of the Food and Drug Regulations. However, Health Canada wishes to highlight the following:

The following provisions of the Regulations do not apply to a designated biocide that is imported:

Accessibility of information to support safe use

Importers must take steps to ensure that information is accessible to Canadians and supports the safe use of the biocide. Thus, labelling information must include a detailed description of the designated biocide’s conditions of use and be accessible in both official languages (English and French).

Release process

For more information on the fabrication, control and distribution of disinfectants, importers can refer to the following voluntary guidance document:

Release documentation should clearly indicate that the biocide was released for exceptional importation and sale.

Contact us

To import designated biocides, email notifications to biocidesibr-ipr@hc-sc.gc.ca.

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