Archived - Applying for a Drug Identification Number (DIN) for a disinfectant drug during the COVID-19 pandemic: Submit your application
On this page
- Application format and transmission
- Tracking your application
- Review timelines
- Drug Product Database (DPD)
- Marketing status
Application format and transmission
We accept disinfectant applications (regulatory transactions) in Electronic Common Technical Document (eCTD) format or non-eCTD format, depending on the regulatory activity type. We do not accept paper applications or submissions sent by ePost Connect or email.
For all transactions, you must use the Regulatory Enrolment Process (REP) which:
- replaces the HC-SC3011 drug application form and fee application form
- uses web-based templates to capture information in a structured format
- uses pick lists and business rules, which increase the accuracy of the information
- allows transactions to be sent using the Common Electronic Submission Gateway (CESG)
Use of the REP is mandatory as of October 1, 2020.
Please refer to the Guidance Document: Management of Drug Submissions and Applications. It outlines the submission process along with the Guidance Document: Management of Disinfectant Drug Applications (2020).
The format and method of transmission for transactions should be 1 of the following:
- eCTD format
- Please refer to the Guidance Document: Preparation of Drug Regulatory Activities in the Electronic Common Technical Document Format for detailed information.
- Transmit these transactions through the CESG and refer to the REP information page for details.
- Non-eCTD format (using REP)
- Please refer to the Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format.
- Transmit these transactions through the CESG. Please 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 through the CESG for a limited time. In this case, the company will need to set up a CESG account.
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 regarding filing of a transaction and help setting up a new CESG account to the Office of Submissions and Intellectual Property (OSIP) at hc.ereview.sc@canada.ca.
Send all questions regarding the contents to be included in your data package (such as safety and efficacy data, test methods) to the Natural and Non-prescription Health Products Directorate (NNHPD) at nnhpd.consultation-dpsnso@hc-sc.gc.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 Database (DSTS).
Use the DSTS-IA to check the status of your submissions/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
We outline our service delivery standards to reach a first decision in the Service Standards for Drug Submission Evaluations.
Service standards begin once we process the application and deem it administratively complete.
As of March 2020, the Bureau of Product Review and Assessment (BPRA) within the Natural and Non-prescription Health Products Directorate (NNHPD) began expediting submissions related to certain disinfectant drugs, in comparison to normal performance standards. These disinfectant drugs require efficacy data to support pathogen specific (COVID-19 direct and indirect) claims. You can find examples of direct and indirect COVID-19 claims in the section Adding an indirect or direct claim against coronavirus. During this period, depending on the quality and complexity of a disinfectant drug submission, as well as the volume of submissions in queue, a regulatory decision for expedited submissions is likely to be made earlier than the normal performance standards.
Starting on October 1, 2021, the Natural and Non-prescription Health Products Directorate (NNHPD) will be returning to normal performance standards for disinfectant drugs, given there is now sufficient quantity of products on the market to meet the needs of Canadians. Normal performance standards will apply to new submissions received on or after October 1, 2021.
| Submission Type | Normal Performance Standard | Expedited COVID Review Targets |
|---|---|---|
| DIN-D Full Review with Data (new DIN) | 255 | 150 |
| DIN-D Full Review with Data (amendment) | 255 | 90 |
| DIN-D Labelling Only | 135 | 90 |
| DIN-D Labelling Standard (Monograph) | 60 | 45 |
| DIN-D Administrative | 45 | 40 |
| Post-Authorization Division 1 Change (PDC) | 30 | 30 |
| New Drug Submission (NDS-D) | 345 | Varies depending on complexity of review |
Drug Product Database (DPD)
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
Authorized surface disinfectants may appear in the Drug Product Database 6 months after authorization.
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 and timelines for reporting.