Applying for a Drug Identification Number (DIN) to distribute or sell hand sanitizer: Application process

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Overview

File your application for a monographed hand sanitizer product in accordance with the Guidance Document: Management of Drug Submissions and Applications, as summarized below. All information will be reviewed to ensure it is complete and of suitable quality.

Applying

You must use the  Regulatory Enrolment Process (REP) to apply for a DIN attesting to the monograph for the following reasons:

Use of the REP is mandatory as of October 1, 2020.

The REP regulatory transaction (RT) file, and product information (PI) file if applicable, must be included in the application.

Follow the instructions when completing the form. This table summarizes common errors that could delay the processing of your application.

Table 1: Avoid common errors when completing REP template
REP Template Instructions
Field 8. Drug Use field on Product Information (PI) template Select "HUMAN".
Field: Regulatory Activity Type on Regulatory Transaction (RT) template Select "DINF (Application for a Drug Identification Number - Category IV Monograph Product)".
Field 5. Proper, Common or Non-Proprietary Name field on PI template Provide the proper, common or non-proprietary name of the drug. Consult the Guidance Document: Labelling of Pharmaceutical Drugs for Human Use for the interpretation of proper or common name of a drug product. Proper names are indicated in specific sections of the Food and Drugs Act or Food and Drug Regulations for some ingredients. Common or non-proprietary names refer to the standard (non-chemical) names that the ingredients are commonly called.
Field 11B. Dosage Form field on PI template "liquid" is no longer an acceptable answer. Use "solution" or "wipe" as applicable.
Field 11E. Container Types, Package Size and Shelf Life section on PI template Ensure that the package size fields are up-to-date.
Field 3. Dossier Type on PI template Select "Pharmaceutical" and not "Disinfectants".

When indicating the concentrations for the active and inactive ingredients in your product, provide the full units as applicable, such as:

Identify the purpose (preservatives, colouring agent, capsule shell and so on) when listing the product’s inactive ingredients. Omit any instructions or annexes that do not apply to your application.

Table 2: Notes for completing the fee section of the REP template
REP Template Instructions
Fees section of Regulatory Transaction (RT) template Place a check mark in column 4 of section 12 ("Drug identification number application – labelling standards").
Fees section of RT template, Mitigation Measures section

If you have applied for small business status with Health Canada and have been approved (and continue to meet the definition), check the box.

  • A small business is any business that has fewer than 100 employees or between $30,000 and $5,000,000 (CAD) in annual gross revenues.
  • To receive a small business reduction on your fee, check off the "Small Business" box on the Fee Form of your drug application. You must already have small business status through the Drug and Medical Device Small Business Application before you fill out your DIN application. Failure to do so will result in the full fees being charged.
  • For more information on applying for Small Business Status with Health Canada, visit Small business mitigation for drugs and medical devices: How to apply for small business status.
  • As of April 1, 2020, Health Canada has adopted measures for small business fee reductions for human and veterinary drugs and medical devices. To receive a 25% reduction on your fee, check off the “Small Business” box on the Fee Form of your drug application.  

Do not include advance payment when filing the submission.

Fees increase each year to align with inflation.

Complete:

Bilingual label mock-ups, or label texts for the product

For the specific text to include on the product label, see Health Canada’s Antiseptic Skin Cleansers (Personal Domestic Use) monograph (March 20, 2020), including the Drug Facts Table section.

The following minimum formatting requirements must be met:

For other labelling requirements, see the Guidance Document: Labelling Requirements for Non-prescription Drugs. Also view the recent Health Canada notice on labelling of hand sanitizers, disinfectants, soaps and cleaning products in the context of the COVID-19 response.

Provide a cover letter with Drug Hand sanitizer Monograph submission in the subject line. Also clearly state what you are providing and the reason for filing.

Interim measures during the COVID-19 pandemic

Health Canada has lifted flexibilities for drug establishment licences (DELs) and labels under the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. DELs and full label mock-ups are now required for hand sanitizers.

The following sponsors of hand sanitizers may be affected and may need to follow transitional requirements:

For more information, please refer to our information for industry page.

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