Exceptional importation and sale of biocides in relation to COVID-19: For industry
On this page
- How to propose an addition to the list of designated biocides
- How to import and sell designated biocides
- Regulatory requirements for selling designated biocides
- Contact us
How to propose an addition to the list of designated biocides
The following actions must be taken to propose an addition to the list of designated biocides.
Step 1: Submit proposal
To add a biocide to the List of Biocides for Exceptional Importation and Sale, email us at hc.biocidesIBR-IPR.email@example.com for a biocide IBR list proposal form. You will receive, as needed, detailed instructions on eligibility criteria and other applicable supporting documents. Email the completed biocide IBR list proposal form to hc.biocidesIBR-IPR.firstname.lastname@example.org.
Health Canada will assess the proposal and may contact you to clarify information or to ask for product-specific information.
Importers are required to make the labelling information, including a detailed description of the designated biocide’s conditions of use, available in both official languages.
Note: We may also add a product to the list without receiving a proposal form.
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 list of biocides for exceptional importation and sale.
Although the importer is permitted to sell designated biocides once included on the list of designated biocides, they must still notify Health Canada when designated biocides are imported.
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 hc.biocidesIBR-IPR.email@example.com.. The email must contain the following information:
- importer’s name and contact information
- name, address and contact information of each fabricator, packager/labeller and tester involved with the biocide
- brand name of the biocide to be imported
- medicinal ingredient(s)
- dosage form
- types of premises for which its use is recommended
- identifying code or number, if any, assigned in the country in which it is authorized for sale
- detailed description of the conditions of use of the biocide
- intended port of entry into Canada
- estimated date of arrival into Canada
- customs identification number for the shipment
- total quantity of biocide to be imported
Step 3: Information to support safe use requirements
Under section 13 of the interim order, importers are required to ensure information is available in a manner that supports safe use of the biocide, which includes providing the information in both official languages.
Regulatory requirements for selling designated biocides
During the application of the interim order, 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 prohibition set out in section C.01.016 of the Regulations applies to the sale of a designated biocide that is imported. However despite this prohibition, the manufacturer of the designated biocide is required to comply only with the requirements set out in the sections related to Serious Adverse Drug Reaction Reporting (C.01.017) and Issue-Related Summary Reports (C.01.019).
- Hospitals and medical professionals must continue to report serious adverse drug reactions (C.01.020.1).
- Importers must report all recalls (C.01.051).
As indicated in the interim order, the following provisions of the Regulations do not apply to a designated biocide that is imported:
- sections A.01.044, A.01.051 and A.01.060
- provisions of Part C other than sections C.01.020.1 and C.01.051
For more information on the fabrication, control and distribution of disinfectants, importers can refer to the voluntary Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices (GUI-0049).
Release documentation should clearly indicate that the biocide was released under the Interim Order No.2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19.
To add a biocide to the List of Designated Biocides, request a proposal form and email proposals to hc.biocidesIBR-IPR.firstname.lastname@example.org.
To import designated biocides, email notifications to hc.biocidesIBR-IPR.email@example.com.
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