Applying for a Drug Identification Number (DIN) to distribute or sell hand sanitizer: Submitting your application

On this page

• Application format and transmission
• Tracking your application
• Review timelines
• Drug Product Database
• Marketing status

Application format and transmission

We accept transactions in either Electronic Common Technical Document (eCTD) format or non-eCTD format, depending on the regulatory activity type. We do not accept or assess paper applications or submissions (regulatory transactions) sent by email.

Please refer to the Guidance Document: Management of Drug Submissions and Applications. It outlines the submission process for all therapeutic drugs including hand sanitizers. The format and method of transmission for regulatory transactions should be 1 of the following:

1. eCTD format
   • Refer to the Guidance Document: Preparation of Regulatory Activities in the eCTD format for detailed information (available upon request via email at: hc.publications-publications.sc@canada.ca).
   • Transmit these regulatory transactions in eCTD format via the Common Electronic Submissions Gateway (CESG).
2. Non-eCTD format (using REP)
   • Refer to the Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format.
   • Transmit these regulatory transactions via the CESG. Refer to the REP information page for details.
   • If you are unable to transmit a transaction on media due to the pandemic restrictions, we will accept transactions via the CESG for a limited time. In this case, you will need to set up a CESG account. Please refer to CESG information page for details.

For both eCTD and non-eCTD formats, prepare all regulatory transactions using the correct structure. Ensure they meet the requirements in the associated validation rules. Refer to the filing submissions electronically page for required documents.

Send all questions about filing a transaction and help setting up a new CESG account to the Office of Submissions and Intellectual Property at hc.ereview.sc@canada.ca.

Tracking your application

You can track your submission using the Drug Submission Tracking System – Industry Access (DSTS-IA) application. To access it, register for an account by emailing the Client Information Unit at hc.client.information.sc@canada.ca.

Once we validate your application, we will assign it a control number through the Drug Submission Tracking System – Industry Access.

Use the DSTS-IA to check the status of your submission/application. If you have questions about the status of your application, you may contact the Regulatory Project Manager at hc.nded-demvso.sc@canada.ca.  

Review timelines

Our service delivery standards to reach a first decision are outlined in the Service Standards for Drug Submission Evaluations.

Service standards begin once we process the application and deem it administratively complete. Once processed, the review timeline for a DINF application is 60 calendar days.

Drug Product Database

Once a product has received an authorization for sale, Health Canada will add it to the Drug Product Database. This database provides information such as:

• approval status of the drug in Canada
• product monograph for human drugs, if available

Marketing status

You must report to Health Canada when you:

• begin to market your product
• stop selling the product for 12 months or
• permanently stop selling the product

The Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) outlines notification requirements.