Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing

Starting date:
March 18, 2020
Posting date:
March 31, 2020
Type of communication:
Advisory
Subcategory:
Medical Device, Natural health products
Source of recall:
Health Canada
Issue:
Supply
Audience:
General Public
Identification number:
RA-72623

Last updated:

Update: March 31, 2020

An updated list of products is available: Disinfectants and hand sanitizers accepted under COVID-19 interim measure.

Original Text: March 18, 2020

Summary

Products: Hand sanitizers, disinfectants, personal protective equipment (such as masks and gowns) and swabs.
Issue: Health Canada is expediting access to supplies of these products to help limit the spread of COVID-19.
What to do: Check this web page regularly for updated information on new supplies being made available in Canada.

Issue

In light of the unprecedented demand and urgent need for products that can help limit the spread of COVID-19—including hand sanitizers, disinfectants and personal protective equipment (such as masks and gowns)—as well as swabs, Health Canada is facilitating access to products that may not fully meet current regulatory requirements, as an interim measure.

In Canada, disinfectants are classified as non-prescription drugs. Hand sanitizers are classified as natural health products (NHPs) or non-prescription drugs, depending on the ingredients. Class I personal protective equipment (such as masks and gowns) and swabs are regulated as medical devices in Canada.

While these products are typically subject to regulatory requirements, such as licensing and bilingual labelling, Health Canada will allow certain products to be sold in Canada under this interim measure, including:

  • products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g., English-only labelling, different packaging from what was authorized); and
  • products that are not authorized for sale in Canada, but are authorized or registered in other jurisdictions with similar regulatory frameworks and quality assurances.

In addition, Health Canada is expediting approvals of product, as well as establishment and site licences related to these types of products.

The Department will continue to update Canadians on any further efforts to increase supplies of health products that may be used to help combat the COVID-19 pandemic.

Information for manufacturers and importers

  • Importers who currently have a Drug Establishment Licence (DEL) or Site Licence (SL) to conduct activities related to hand sanitizers and disinfectants that are covered by this measure are required to notify Health Canada in advance that they will be importing products and maintain records that will facilitate product recalls, if needed.
  • Domestic companies that do not currently have a DEL or SL to conduct activities related to hand sanitizers and disinfectants covered by this measure may submit an application for expedited review to Health Canada. Authorization will be granted based on an attestation to the requirements.
  • Domestic companies that do not currently have a DIN or NPN for a disinfectant or hand sanitizer may submit an application for expedited review to Health Canada.
  • Medical Device Establishment Licence (MDEL) applications for Class I medical devices related to COVID-19 can be submitted for expedited review using the MDEL Application Form (FRM-0292) available on Health Canada’s website. The completed MDEL application form should be sent to hc.mdel.application.leim.sc@canada.ca. Authorization will be granted based on an attestation to the requirements.
  • Requests to import or manufacture medical devices that may not fully meet current regulatory requirements can be submitted to: hc.mdel.application.leim.sc@canada.ca.

Information for consumers

  • Check the table below for information on disinfectant and hand sanitizer products being supplied in Canada as a result of this interim measure.
  • Products already authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN) or Natural Product Number (NPN) on the product label. These products are listed on Health Canada's Drug Product Database or Licensed Natural Health Products Database.
  • If you see a disinfectant or hand sanitizer for sale that does not have a DIN or NPN on the product label and is not on the list below, please report it to Health Canada.
  • Report any health product adverse events to Health Canada.
  • Follow the Public Health Agency of Canada’s advice on preventing coronavirus.

Products

The following products permitted to be sold in Canada under this interim measure that may not fully meet labelling, licensing or packaging requirements (e.g., some products may be labelled in English only or may be labelled only with a foreign identifier number instead of a DIN or NPN):

Product Name Foreign Identifier Canadian Reference Product Name Canadian Reference Product Identifier Date added
Clorox Disinfecting Wipes 5813-79 Clorox Disinfecting Wipes DIN 02466031 March 18, 2020
Clorox Kitchen Cleaner and Disinfectant 5813-105 Clorox Kitchen Cleaner and Disinfectant DIN 02419696 March 18, 2020
Clorox Regular Bleach₂ with CLOROMAX® 5813-120 Clorox Disinfecting Concentrated Bleach DIN 02488590 March 18, 2020
PURELL® Advanced Hand Sanitizer Gel NDC 21749-700 PURELL® Advanced Hand Rub Gel NPN 80047004 March 18, 2020
PURELL® Advanced Hand Sanitizer Gel Refreshing Gel NDC 21749-704 PURELL® Advanced Hand Sanitizer Refreshing Aloe NPN 80047004 March 18, 2020
PURELL® Advanced Hand Sanitizer Naturals NDC 21749-625 PURELL® Advanced Hand Sanitizer Gel NPN 80072316 March 18, 2020
PURELL® Advanced Instant Hand Sanitizer Fragrance Free NDC 21749-530 PURELL® Advanced Hand Rub Gel NPN 80047004 March 18, 2020
PURELL® Advanced Hand Sanitizer Green Certified Gel NDC 21749-702 PURELL® Advanced Hand Rub Gel NPN 80047004
NPN 80027804
March 18, 2020
PURELL® Professional Advanced Hand Sanitizer Fragrance Free Gel NDC 21749-717 PURELL® Advanced Hand Rub Gel NPN 80047004
NPN 80027804
March 18, 2020
PURELL® Advanced Hand Sanitizer Soothing Gel NDC 21749-713 PURELL® Advanced Hand Sanitizer Refreshing Aloe NPN 80047004
NPN 80037256
March 18, 2020
PURELL® Hand Sanitizing Wipes NDC 21749-368 PURELL® Sanitizing Wipes DIN 02403471 March 18, 2020
PURELL® Advanced Hand Sanitizer Skin Nourishing Foam NDC 21749-801 PURELL® Advanced Moisturizing Foam Hand Rub NPN 80027784 March 18, 2020
PURELL® Advanced Hand Sanitizer Green Certified Foam NDC 21749-806 PURELL® Advanced Foam Hand Rub NPN 80027784 March 18, 2020
PURELL® Professional Advanced Hand Sanitizer Fragrance Free Foam NDC 21749-821 PURELL® Advanced Foam Hand Rub NPN 80027784 March 18, 2020

Related links

Public Health Agency of Canada COVID-19

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991
1-866 225-0709
hcinfo.infosc@canada.ca