Hard-surface disinfectants and hand sanitizers (COVID-19): Information for manufacturers
On this page
- Expediting access
- How to obtain authorization to produce and sell hand sanitizers
- Distribution to hospitals and clinics
- Disinfectant claims for COVID-19
- Alternate sources of active ingredients for disinfectants and non-alcohol-based hand sanitizers
- Compounding information for pharmacists
- Hand sanitizer manufacturing exchange
- Hand sanitizer packaging and reusing containers
- End of interim measures
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:
- publishing an interim step-by-step guide to obtaining a licence to manufacture and sell an alcohol-based hand sanitizer and an interim guide on the production of ethanol for this purpose
- providing administrative flexibilities to companies on site licensing and site licence renewal applications, including:
- site licence holders can submit applications for renewal less than 30 days before the site licence expiry date
- site licences with an expiry date between March 10, 2020, and June 1, 2020, are being extended to July 1, 2020, effective immediately
- prioritize the review of applications for hand sanitizers
- prioritize the review of applications for disinfectants that can demonstrate efficacy against the COVID-19 virus
- facilitating access to products that may not fully meet current regulatory requirements
- allowing licensed pharmacists to compound and sell hand sanitizers
For more information on interim measures, please contact us:
- site and product licence applications: firstname.lastname@example.org
- drug establishment licence applications: email@example.com
- questions on the interim approach for importing hand sanitizers: firstname.lastname@example.org
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:
- submit a product licence application to support the safety, efficacy and quality of their alcohol-based hand sanitizer and
- provide a cover letter with attestation that the site being used to manufacture, package, and/or import their product meets acceptable good manufacturing practices
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 email@example.com.
The expedited access measure allows importers to supply sanitizers or disinfectants that:
- do not fully meet Health Canada requirements or
- are authorized or registered in other jurisdictions where the regulatory frameworks and quality assurances are similar
Under this measure, importers must:
- notify Health Canada prior to importing
- keep records in the event of a product recall
Contact Health Canada by email at firstname.lastname@example.org 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.
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 email@example.com and include:
- COVID-19 product notification in the subject line
- Information on the product in the body of the email (i.e., NPN) and its intended distribution.
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: firstname.lastname@example.org
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:
- labelled as a broad-spectrum virucide
- carry a specific claim against non-enveloped viruses of the picornaviridae, caliciviridae, astroviridae, reoviridae, or papillomaviridae families or
- carry a specific claim against a specific coronavirus, such as
- human coronavirus strain 229E
Alternate sources of active ingredients for disinfectants and non-alcohol-based hand sanitizers
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: email@example.com.
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:
- are a supplier of ingredients and/or materials entering into the production of hand sanitizer or
- have the capability to manufacture hand sanitizers
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
- Any food or pharmaceutical grade packaging can be used to package hand sanitizers (i.e., bottles, bags, pouches, etc.), provided that it is chemically resistant to the hand sanitizer.
- Although typically hand sanitizers are packed in clear (see-through) containers, appropriately graded packaging that are opaque (white, coloured, etc.) can also be used.
- Health Canada does not regulate the size of hand sanitizer packaging. As long as the formulation is identical to what has been authorized by Health Canada, any size packaging that ensures appropriate shelf-life will suffice. The same Natural Product Number (NPN) can be used for different container sizes.
- The size of the opening on the container must be minimized to prevent evaporation (i.e. no wide-mouth containers). Large openings increase the surface area where alcohol and other ingredients can evaporate, lessening the effectiveness of the product.
- Large format containers used for bulk packaging should be labelled as refill containers.
- In order to prevent contamination and evaporation, only lids designed for use with the container should be used.
- Packaging which is not re-sealable may be subject to contamination and evaporation once opened. As such, these should only be used for single-use applications.
- Product manufacturers are encouraged to make refill formats compatible with existing pump or lid components.
- 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 sanitizer, it is possible to clean or disinfect hand sanitizer containers. To do so:
- Clean containers thoroughly with detergent and tap water to eliminate any residual product.
- Disinfect containers by boiling in water if heat-resistant. This is the preferred method for disinfecting containers.
- Chemical disinfection is acceptable for containers that are not heat-resistant. This includes soaking the bottles in a solution containing 1000 ppm of chlorine (e.g., add 35 mL of 3% sodium hypochlorite solution (bleach) to 965 mL of water, to obtain a 1 L solution) for a minimum of 15 minutes and then rinsing with cooled boiled water in a covered container to prevent re-contamination.
- After disinfection, leave containers to dry completely upside-down in a bottle rack.
- Store dry containers with a lid and store, protected from dust, until use.
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.
- Manufacturers of hand sanitizers using technical-grade ethanol
- Notify on the use of technical-grade ethanol in hand sanitizers
- Labelling of hand sanitizers, disinfectants, soaps and cleaning products in the context of the COVID-19 response
- Guidance document - Disinfectant drugs
- Guide on Health Canada interim expedited licensing approach for the production and distribution of alcohol-based hand sanitizers
- Interim guide on the production of ethanol for use in alcohol-based hand sanitizers
- Guidance document - Management of disinfectant drug applications
- Call to action: Canadian manufacturers needed to help combat COVID-19
- Hand-Sanitizers Manufacturing Exchange
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