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

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Expediting access

Due to the unprecedented demand and urgent need for disinfectants and hand sanitizers during the COVID-19 pandemic, Health Canada is implementing interim measures to increase supplies.

The manufacture and sale of disinfectants and hand sanitizers require authorization from Health Canada before they can start. To increase access for these products in Canada, we have taken the following interim measures:

For more information on interim measures, please contact us:

How to obtain authorization to produce and sell hand sanitizers

In Canada

Manufacturers of alcoholic beverages and other alcohol producers may apply for an authorization to manufacture and sell alcohol-based hand sanitizers through the Expedited Access process. We have developed a step-by-step guide to walk applicants through this process.

Under the Expedited Access process, manufacturers will be required to:

Interested companies should follow the instructions outlined in the Guide on Health Canada’s interim expedited licensing approach for the production and distribution of alcohol-based hand sanitizers.
For information on the use of ethanol as an ingredient in alcohol-based sanitizers, please see the interim guide on the production of ethanol for use in alcohol-based hand sanitizers .

Hand sanitizers authorized through this process are added to the list of approved hand sanitizers. The list is updated daily, Monday to Friday. 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

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

Under this measure, importers must:

Contact Health Canada by email at hc.covid19healthproducts-produitsdesante.sc@canada.ca to receive an attestation form to complete.

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

Distribution to hospitals and clinics

Due to the unprecedented demand and urgent need for products that can help limit the spread of COVID-19, Health Canada is facilitating access to products that may not fully meet current regulatory requirements.

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 Health Canada is notified.

You must notify Health Canada by email at hc.nnhpd-dpsnso.sc@canada.ca and include:

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

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

For more information, please contact us at: 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

Hard-surface disinfectants

For these products, in case of active ingredient shortages, manufacturers may change suppliers for their active ingredients if the Chemical Abstracts Service (CAS) numbers and concentrations are identical.

Non-alcohol-based hand sanitizers

For these products, in case of shortages of active ingredients manufactured under Good Manufacturing Practice (GMP) compliant conditions, manufacturers may use non-GMP active ingredients, as outlined in the Antiseptic Skin Cleansers Monograph, as long as the ingredients meet a quality standard. In cases where there is a pharmacopoeial standard (Schedule B to the 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 impact 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 to assure the acceptable quality and safety by meeting all applicable requirements of Division 2 (GMP) of the Food and Drug Regulations.

When the approach expires, production using the original active ingredient source must resume, although the existing product stock can be exhausted.

Compounding information for pharmacists

During the COVID-19 pandemic, Health Canada is permitting licensed pharmacists to compound and sell hand sanitizers in their province/territory of practice. Health Canada recommends 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 at: hc.nnhpd-dpsnso.sc@canada.ca.

Hand sanitizer manufacturing exchange

To help expand production, Health Canada facilitated a dialogue between the hand sanitizer industry and other industries that are able to provide ingredients and materials.

Cosmetics Alliance Canada (CAC), Spirits Canada/Association of Canadian Distillers (ACS) and the Canadian Consumer Specialty Products Association (CCSPA) have joined to create 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 National Research Council have collaborated with experts and stakeholders to develop the list of alternatives.

Hand sanitizer packaging and reusing containers

Health Canada is providing additional flexibilities to industry with regards to acceptable packaging materials and sizes. Furthermore, Health Canada is allowing disinfection of hand sanitizer packaging for reuse as strategies to ensure the continued availability of these products during the COVID-19 pandemic. Product packaging is an important factor to consider to ensure 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 sanitizer

Reusing hand sanitizer containers

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

Hospitals may have their own procedures in-place for contamination control. Re-introduction of refillable containers into these settings may defeat the purpose of certain 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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