Hard-surface disinfectants and hand sanitizers (COVID-19): Information for manufacturers

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Licensing approach

The COVID-19 pandemic has created an unprecedented demand and urgent need for disinfectants and hand sanitizers. But the manufacture and sale of disinfectants and hand sanitizers require authorization from Health Canada before they can start.

To increase access to these products in Canada, we have taken the following interim measures:

For more information on our interim measures, please contact us:

How to obtain authorization to produce and sell hand sanitizers

Manufacturers of alcoholic beverages and other alcohol producers may apply for authorization to manufacture and sell alcohol-based hand sanitizers through the step-by-step guide.

To obtain authorization, manufacturers must submit a:

Interested companies should follow the instructions outlined in the guide on the licensing approach for the production and distribution of alcohol-based hand sanitizers. Please also see the interim guide on the production of ethanol for use in alcohol-based hand sanitizers.

Once hand sanitizers are authorized through this process, they are added to the list of approved hand sanitizers. We are updating the list regularly.

Companies are required to maintain records to facilitate product recalls if needed.
If you have any questions on the application process, please contact us at hc.nnhpd-dpnso.sc@canada.ca.

Expedited access for importers

The expedited access measure allows importers to supply sanitizers or disinfectants that:

Under this measure, importers must:

Contact us by email at hc.covid19healthproducts-produitsdesante.sc@canada.ca for an attestation form.

This attestation form helps us work with the Canada Border Services Agency to facilitate importation. The information provided helps authorities take necessary action if the product is considered to pose a health risk.

Distribution to hospitals and clinics

We are facilitating access to products that may not fully meet current regulatory requirements to address the urgent need for products by hospitals and clinics.

As part of this interim measure, an alcohol-based hand sanitizer product authorized for personal use can also be distributed to hospitals and clinics once we are notified.

You must notify us by email at hc.nnhpd-dpsnso.sc@canada.ca. Your email should include:

Please note: The existing label referencing personal use should continue to be used. Any changes to the label will need to be reviewed by us.

You do not need to wait for a reply or confirmation from us that we have received the notification email before distributing the product to hospitals and clinics.

For more information, please contact us by email: hc.nnhpd-dpsnso.sc@canada.ca

Disinfectant claims for COVID-19

Manufacturers and distributors of hard-surface disinfectants can make indirect efficacy claims for SARS-CoV-2, the virus that causes COVID-19, if these authorized products are already:

Alternate sources of active ingredients for disinfectants and non-alcohol-based hand sanitizers

Alternate sources of active ingredients for disinfectants and hand sanitizers may be accessed.

Hard-surface disinfectants

When there are active ingredient shortages for hard-surface disinfectants, manufacturers may change suppliers for their active ingredients if the Chemical Abstracts Service (CAS) numbers and concentrations are identical.

Non-alcohol-based hand sanitizers

When there are shortages of active ingredients manufactured under Good Manufacturing Practice (GMP) compliant conditions, manufacturers may use non-GMP active ingredients. These ingredients are listed in the antiseptic skin cleansers monograph. The non-GMP active ingredients must meet a quality standard.

Where there is a pharmacopoeial standard (schedule B, Food and Drugs Act) for the active ingredient, the ingredient should be manufactured and tested against that standard. However, other quality standards such as ISO (International Organization for Standardization) and HACCP (Hazard Analysis and Critical Control Point Approach) are also acceptable.

Manufacturers of hard-surface disinfectants and non-alcohol-based hand sanitizers are responsible for conducting a risk assessment to ensure that a change in ingredient source will not affect the product's safety, efficacy and quality. For example, you should conduct stability testing using representative batches of the new sources of active ingredients to ensure that the product's shelf life remains the same. The dosage form fabricator and the DIN holder continue to be responsible for ensuring all applicable requirements of division 2 (GMP) of the Food and Drug Regulations are met.

When the interim measures expire once the regular supply stabilizes, production using the original active ingredient source must resume. However, the existing product stock can be used up.

Compounding information for pharmacists

During the COVID-19 pandemic, we are allowing licensed pharmacists to compound and sell hand sanitizers in their province or territory of practice. We recommend pharmacists follow a reputable formula, such as the one published by the World Health Organization.

Should a pharmacist wish to distribute their product for resale by a third party, they would be required to obtain a valid site and product licence through the process listed above.

For more information, please contact us by email: hc.nnhpd-dpsnso.sc@canada.ca.

Hand-Sanitizers Manufacturing Exchange

To help expand production, we have facilitated a dialogue between the hand sanitizer industry and other industries that are able to provide ingredients and materials.  As a result, Cosmetics Alliance Canada (CAC), Spirits Canada/Association of Canadian Distillers (ACS) and the Canadian Consumer Specialty Products Association (CCSPA) have created the Hand-Sanitizers Manufacturing Exchange. Through this exchange, manufacturing capacity will be matched with suppliers of raw materials.

You are strongly encouraged to join this exchange and help contribute to the fight against COVID-19 if you:

Due to shortages in rheology modifiers being experienced by hand sanitizer manufacturers, Health Canada and the National Research Council have collaborated with experts and stakeholders to develop a list of alternatives.

Hand sanitizer packaging and reusing containers

We are providing additional flexibilities to industry on acceptable packaging materials and sizes. We are also allowing hand sanitizer packaging that has been disinfected to be reused. Both strategies will ensure the continued availability of these products during the COVID-19 pandemic.

Product packaging is an important factor in ensuring the proper use of the product. If a hand sanitizer container, its format or its appearance looks similar to that of other products intended to be handled differently, errors may occur and harm may result.

Packaging of hand sanitizers

The flexibilities for packaging are outlined below.

Also:

Suppliers are encouraged to facilitate or advise users to continue to recycle used containers in accordance with the recommended practices and waste management systems available locally

Reusing hand sanitizer containers

In commercial and institutional settings where there is a shortage of packaging for hand sanitizers, it is possible to clean or disinfect hand sanitizer containers. To do so:

Hospitals may have their own procedures for contamination control. Re-introducing refillable containers into these settings may defeat the purpose of their contamination controls.

Refill bags intended to replace box-in-bag dispenser units should be compatible with the specific dispenser units. These refill bags are single-use and cannot be reused.

End of interim measures

Health Canada will lift the interim measures when the regular supply stabilizes.

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