Exceptional importation and sale of biocides in relation to COVID-19: For industry
On this page
- About the new regulations and exceptional importation
- How to import and sell designated biocides
- Regulatory requirements for selling designated biocides
- Contact us
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:
- exceptional importation of designated biocides until September 30, 2022
- distribution of these products to retail facilities until December 31, 2022
- retail sale and use at the institutional level until the product in stock has been exhausted or has expired
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 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
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 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 must comply only with the requirements set out in the sections on 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).
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
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).
- 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 for exceptional importation and sale.
To import designated biocides, email notifications to firstname.lastname@example.org.
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