Applying for a Drug Identification Number (DIN) to distribute or sell hand sanitizer: Application process
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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.
You must use the Regulatory Enrolment Process (REP) to apply for a DIN attesting to the monograph for the following reasons:
- REP’s web-based templates capture information in a structured format
- REP uses pick lists and business rules, which increase the accuracy of the information
- REP allows transactions to be sent using the Common Electronic Submissions Gateway (CESG)
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.
|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:
- percent weight/weight (w/w)
- weight/volume (w/v) or
- volume/volume (v/v)
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.
|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.
Do not include advance payment when filing the submission.
- Following the review, we will send an invoice for the fee ($1,616 as of April 1, 2020, minus any eligible deductions)
- Refer to the how to pay fees document for information about payment of invoices
Fees increase each year to align with inflation.
- A full listing of current fees is in fees for examination of a submission: drugs for human use
- Note: The drug right-to-sell fee is an annual fee for the right to maintain a drug on the Canadian market
- non-prescription drug monograph attestation form
- labels and packages certification form for non-prescription drugs
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:
- text: 6 point sans serif font, 6.5 point leading minimum
- headings and subheadings left justified and in bold font style
- 'Warnings' must be kept together
- for optimal contrast, all text must be printed with a 100% black on white background
- where this is not available, the colour must be displayed in the strongest contrasting colour being used (100% screen black, dark blue, dark brown, dark green and dark purple are acceptable)
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.
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:
- those who applied for a Drug Identification Number (DIN) on or after March 30, 2020
- those who have disinfectants and hand sanitizers accepted under COVID-19 interim measures
For more information, please refer to our information for industry page.
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