Licensing approach to produce and distribute alcohol-based hand sanitizers: guidance document

Approach updated: 2020-07-13

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This guide outlines the licensing approach for companies that wish to manufacture, package, label or import alcohol-based hand sanitizers for the COVID-19 pandemic. It also outlines the application and review process for both site and product licences.

Licensing requirements

Alcohol-based hand sanitizers are natural health products (NHPs) in Canada and are regulated under the Natural Health Products Regulations (NHPR). They contain these medicinal ingredients:

ethanol, also known as anhydrous alcohol, ethyl alcohol or grain alcohol
isopropanol, also known as isopropyl alcohol or 2-propanol

All approved alcohol-based hand sanitizers must meet the necessary requirements under the NHPR.

A site licence (SL) is required to manufacture, package, label or import an NHP hand sanitizer in Canada. An SL is required to produce finished NHPs, but not to produce raw materials.

A product licence (PL) is represented by a Natural Product Number (NPN). This number is required to legally distribute (for instance, donate or sell) the product.

You can use this process to get an SL and PL if your hand sanitizer meets the requirements and acceptable uses of the antiseptic skin cleansers (personal domestic use) monograph. The monograph supports the safety and efficacy of alcohol-based hand sanitizers with a final concentration of 60% to 80% ethanol or 60% to 75% isopropanol (isopropyl alcohol).

Due to shortages of hand sanitizers caused by the COVID-19 pandemic, Health Canada has guidance on the use of both ethanol and isopropanol in hand sanitizers. Please see the:

Applications that go beyond the parameters of the monograph (such as making additional claims) are not eligible for the licensing process described in this guide. In these cases, an applicant must provide supporting evidence on safety, efficacy and quality in order to receive a PL. For more information on these types of applications, please refer to the NHP management of applications policy.

When you need an SL or PL

You need:

both an SL and a PL if you intend to manufacture, package, label or import alcohol-based hand sanitizers
an SL if you intend to only manufacture, package, label or import alcohol-based hand sanitizers for another company
a PL if you intend to only distribute alcohol-based hand sanitizers branded under your company name but made by another company in Canada
a PL if you already have an SL to manufacture, package, label or import NHPs and you are adding an alcohol-based hand sanitizer to your product line, which you intend to distribute

Include a cover letter with your application. Indicate in the letter that your application is for an alcohol-based hand sanitizer. This will help us prioritize your application.

Applying only for a site licence (SL)

Before you apply for a SL, Health Canada:

must assign a company code (a number) for your company
- if you do not already have a company code, email us at nnhpd.consultation-dpsnso@hc-sc.gc.ca and put in the subject line COVID-19 - Request for a company code
- in the body of your email, include the company information that you will be using to complete your site licence application form, including company name and address, contact information and senior official (for example, chief executive officer or director)
initiate an ePost conversation with the applicant through ePost Connect once we email you the company code
- if you do not have an ePost Connect account, register with Canada Post to open an account by following the instructions in the conversation notification email
- ePost is the encrypted digital platform currently used for the exchange of confidential messages relating to applications

To complete the site licence application form, please follow the instructions below.

Site Licence Application Form

Part 1: Applicant and contact information

Block A, applicant or licensee information: Provide the full legal name of the applicant or company applying for an SL
- Do not abbreviate the applicant or company name
Block B, senior official: Provide the name of the senior official who represents the company at the address given
Block C, contact for this application: Provide the name of the main person we can contact with questions about the application
- This may be an employee of the company or a consultant
Block D, quality assurance person: Provide the name of the person who is responsible for assuring the quality of the alcohol-based hand sanitizer before it is distributed
- This person should be qualified (through education, training and experience) to perform quality assurance activities

Part 2: Submission information

Select the "New Site Licence Application" box.

Part 3: Canadian site information

Provide the requested details on the building(s) where each of the authorized activities will be performed.

Part 4: Foreign site information

This section applies only to importers, not to manufacturers in Canada.

Part 5: Attestation

Both the quality assurance person identified in block D and the senior official named in block B must sign the attestation. If the senior official is currently in quarantine or teleworking, an electronic signature is acceptable.

The quality assurance person is responsible for ensuring that:

good manufacturing practices (GMPs) are followed
the necessary and relevant tests are carried out
all product specifications are met
products are not released for sale until their quality has been determined to be satisfactory

Good manufacturing practices (GMPs)

SL applications must meet good manufacturing practices (GMP) outlined in part 3 of the NHPR. To demonstrate that your company meets the GMP standard, your application must include:

a report from a quality assurance person, along with supporting documents, which is completed using the quality assurance report form or
other acceptable form of GMP evidence, as outlined in the the site licensing guidance document

You must establish a shelf life for your product, based on scientific evidence. However, you will only be required to submit results of stability tests when you renew your SL for the first time (assuming you receive an SL).

Submit the completed SL application form, along with supporting GMP evidence, using the ePost conversation created for this purpose within the ePost Connect site.

If your application meets all regulatory requirements, Health Canada will issue an SL as follows:

within 35 business days for applications with pre-cleared information for every site or
65 business days for applications supported by GMP evidence, up to 9 sites

Applications that do not meet the regulatory requirements are refused.

Once issued, an SL is valid for 1 year, at which time you will need to apply to renew it.

Applying only for a product licence (PL)

When you apply for a product licence (PL), Health Canada:

must assign a company code to your company
- if you do not have a company code email us at nnhpd.consultation-dpsnso@hc-sc.gc.ca, with the subject line COVID-19 - Request for a company code
- in the body of the email, include the company information to be included in your product licence application form, including the company name and address, contact information and senior official
will email the company code and initiate an ePost conversation with you through ePost Connect
- if you do not have an ePost Connect account, register with Canada Post to open an account by following the instructions in the conversation notification email
- ePost is the encrypted digital platform currently used for the exchange of confidential messages relating to applications

For different packaging sizes, only 1 application is required if the product formula and dosage form are the same.

To complete the web-based product licence application form, please follow the instructions below.

Natural Health Product Licence Application Form (web-based)

Choose the PLA version 4 with class I monograph validation on the form. Select the "table of contents" button at the top of the page, which will open the other sections to be completed. Complete and validate the form in its entirety before submitting (you can start to fill out the form while waiting to receive your company code).

For additional guidance on completing the form, please see the user guide:

under Application Type, select compendial and then antiseptic skin cleansers from the drop-down list of monographs
for "Is this formulation hypothetical" indicate no
- no reference submission or master file is required
- select Continue to move to next section
for the "primary brand name" indicate a generic descriptor of the product and alcohol content (for example, company name-ethanol hand sanitizer 80%)
- do not include any references to viruses, including COVID-19, SARS-CoV-2 or coronavirus, diseases or infectious conditions as these are outside the scope of the antiseptic skin cleansers monograph
- brand names indicating a false or misleading statement are prohibited
under "dosage form" select the appropriate dosage form for your product, such as gel, solution, liquid or aerosol (spray)
- given the possibility of shortages in gelling agents, please see Health Canada’s list of alternative rheology modifiers for use in the production of hand sanitizers
under was animal tissue used in the processing of this product, select no
- Select Continue to move to next section
on the "add medicinal ingredient" page, select the applicable type of alcohol to be incorporated in your product, by adding either ethanol or isopropyl alcohol under the action column:
- under “standard dosage unit information” select the dose type as unmeasured dose and click save
- a medicinal ingredients table will be populated: select modify under the Actions column
- select the common name and standard or grade of the ingredient
- under Quantity, for ethanol, indicate a concentration between 60% and 80% in the "quantity per dosage unit" field
  - click continue or
- if you chose isopropanol or isopropyl alcohol, indicate a concentration between 60% and 75% in the "quantity per dosage unit" field
  - click continue
- indicate if animal tissue is used for the ingredient
once all information is populated in the medicinal ingredients table, select next: non-medicinal ingredients
add any acceptable non-medicinal ingredients (for example, hydrogen peroxide) to the list by searching in the non-medicinal ingredient search bar, as applicable:
- the Natural Health Products Ingredient Database (NHPID) lists ingredients that are acceptable and can be used in the product formulation
- the purposes associated with the non-medicinal ingredients must be appropriate for the intended use of this product (for instance, topical use)
- some restrictions apply, as described in the ingredient page in the NHPID
- for additions or modifications to the NHPID, please complete an NHPID issue form and email to hc.ingredient.support.sc@canada.ca
  - this includes some denaturants, which reduce the risk of accidental or deliberate ingestion
  - the use of denaturants, including denatonium benzoate, sucrose octaacetate and t-butyl alcohol, is recommended but not required
  - note that certain ingredients such as methanol, ethyl acetate and formaldehyde are not acceptable as denaturants for use in hand sanitizers as they pose an additional safety risk in these products
- if you are following the World Health Organization-recommended handrub formulations and use a final concentration of 0.125% (v/v) hydrogen peroxide and 1.45% (v/v) glycerol, and water, please indicate so in the "non-medicinal ingredients" section
a non-medicinal ingredients table will be populated: select modify under the Actions column to add information on the non-medicinal ingredient that was chosen
select the common name and purpose from the list by selecting the applicable options
- they must match exactly the wording of the monograph
- click continue
once all information is populated in the non-medicinal ingredients table, select next: recommended use or purpose
select the desired recommended use or purpose statements from the list by checking the applicable boxes and click continue
add any desired subpopulation(s)
- complete the required minimum Age field and click on the add button
- once added, a recommended dosage table will be populated: select modify under the Actions column to add information and select the dosage is described in the directions for use section
- select the check box for the following directions for use statements:
  - for all products:
    - "supervise children when they use this product"
    - "for occasional and personal domestic use"
  - for products intended as handrubs or wipes, also add:
    - "rub thoroughly into hands for at least 30 seconds”
    - “allow to dry"
  - for products intended as handwashes, also add:
    - "lather in hands with water for at least 30 seconds”
    - “rinse well"
- click continue
once all information is populated in the recommended dosage table for all sub-populations, select next: duration of use
leave the duration statements blank and select continue or next: risk information
- no "duration of use" statement (for example, "for use beyond X days, see a health care practitioner") is required
all "cautions and warnings" statements listed in the monograph are required and will be automatically selected in the form
once completed, select next: animal tissue forms
there are no animal tissue forms required for these applications
- select next: proposed regulatory label text
once the form is completed, a label text will be generated for the product:
- provide the "net quantity" in the packaged final product (numerical value and units such as mL and L)
- "security features" (for example, plastic bottle seal cap) will need be described or checked as self-evident
- click continue

Before completing the form, carefully review the "summary" and then select the “complete” button. If you need to edit previous sections, choose the “table of contents” button at the bottom of the page to go back to the appropriate sections.

Click “complete.” If your application has been completed satisfactorily, you will not see a warning message. Choose “validate compendial application” to validate the information that you have entered in the form. Correct any validation errors before finalizing and submitting the form. Review the "attestation" at the bottom of the page. To sign the "attestation" select the "I agree" checkbox. This will generate an attestation code confirming that you accept the terms of the attestation. After agreeing with the attestation, the "finalize" button will appear. Click on "finalize" to lock the form, generate a unique tracking number and go to the "finalized view."

The "finalized view" includes the tracking number, a summary of the application and a signed attestation. “Save” a copy, save the .html version of the form on your system in the .html format and keep the same naming convention of the file. Once completed, submit the application form (in .html format) through the ePost conversation channel within the ePost Connect site. The application form is not sent automatically to Health Canada.

If the application meets all regulatory requirements, you will receive a PL. The service standard for issuing a licensing decision for this type of application is 60 calendar days. Our dedicated team is processing new alcohol-based hand sanitizer applications to ensure decisions are issued in a timely manner. Note that only applications using the new web-based form (version 4) will receive priority.

Using domestic hand sanitizers in other settings

Products licensed through a monograph are for personal (domestic) use only. However, we recognize that health care institutions, such as hospitals or clinics, or other commercial settings may be experiencing shortages and may wish to access these products.

During the COVID-19 pandemic, alcohol-based hand sanitizers may be distributed for use in hospitals, clinics, commercial settings and other acceptable facilities. Health Canada must be notified of this intent.

To notify us, companies must send an email to nnhpd.consultation-dpsnso@hc-sc.gc.ca. In the email include:

the subject line COVID-19 product notification
in the body of the email, information on the product (for instance, provide the product name and NPN) and its intended distribution (for example, hospitals)

Companies must submit the email notification before distributing but do not need a response from us.

These products have not met the evidence requirements for higher-risk uses in a general health care setting or as pre-surgical scrubs. For this reason, they must be labelled for personal use only, as outlined below. (See section on labelling requirements.)

If your company wants to obtain approval to label your product for use by health professionals, for uses such as pre-surgical scrubs, or make explicit claims related to COVID-19, you must submit additional evidence to support safety and efficacy. For more information on these types of applications, refer to the NHP management of applications policy.

Applying for both a product and a site licence

If your company is seeking both a PL and a SL, you must complete applications for both a PL and SL. Follow the steps in the previous 2 sections above. Submit the applications separately using the ePost conversation channel within the ePost Connect site. Indicate the application type in your ePost message.

Labelling requirements for products

Under the Food and Drugs Act, it is illegal to label, sell or advertise a product, including hand sanitizers, in a false, misleading or deceptive manner. Labelling must be compliant with the PL. This means that the claims made must be consistent (verbatim) with what is provided in the antiseptic skin cleansers monograph and on the application form. Authorization under this monograph does not permit references to COVID-19, SARS-CoV-2 or coronavirus.

PL holders must ensure that the label complies with the labelling requirements set out in part 5 of the NHPR, specifically sections 94, 95 and 97, if applicable. As outlined in sections 86(1) and 87(1), companies may not sell a natural health product unless it is packaged and labelled in accordance with the Regulations. All label information must be presented in both official languages (French and English).

Labelling checklist

Elements that must appear on the main display panel:

primary brand name
product number (NPN, issued upon approval of your product)
dosage form
net amount in the container in terms of weight or measure

Elements that must appear on any panel:

name and address of the PL holder
name of each medicinal ingredient
quantity of the medicinal ingredient per dosage unit (for instance, %)
recommended use(s) or purpose(s)
recommended route of administration - topical (if not self-evident)
recommended dose (including subpopulation amount, frequency and directions of use, if any)
risk information
list of all non-medicinal ingredients
recommended storage conditions (if any)
lot number
expiry date
storage conditions (if outside normal conditions)

Other elements:

cautionary statements (for example, flammability, poison warning)
information displayed clearly and predominantly for the consumer

Companies that want to use technical-grade ethanol in their product should review the:

interim guide on the production of ethanol for use in alcohol-based hand sanitizers additional labelling and authorization requirements for companies

Reporting adverse reactions

As with any health product, an adverse reaction may occur with the use of alcohol-based hand sanitizers. PL holders must report serious adverse reactions that occur in Canada and internationally. You must report any adverse reactions to Health Canada within 15 days of receiving the information or risk compliance and enforcement actions.

Mandatory reporting is done through the Canada Vigilance Program. Select the Natural Health Products box.

For more information on reporting adverse reactions, see the guidance document on reporting adverse reactions to marketed health products.

End of temporary licence measures

Companies that successfully apply for a PL or SL, or both, will be issued a regular licence.

PLs issued under the previous expedited licensing approach were not temporary and remain valid. However, manufacturers, packagers, labellers and importers will require a valid SL once the regular supply of hand sanitizers stabilizes.

Companies with an interim COVID-19 SL (denoted by the prefix COV0000) under the previous expedited attestation process will be notified when the interim period ends (when demand of alcohol-based hand sanitizers stabilizes).

When notified, you will have 60 days to:

stop manufacturing, importing, packaging, labelling or distributing alcohol-based hand sanitizers
apply for a valid SL to continue producing hand sanitizer until you receive a decision on your application

Contact us

If you have questions, you can contact the Natural and Non-prescription Health Products Directorate at nnhpd.consultation-dpsnso@hc-sc.gc.ca.

Please do not contact us for a status update on your application. We will contact you using the ePost channel if we have questions about your application. Please monitor your ePost account closely, including the junk folder.

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Date modified:: 2022-07-21

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