Health Canada has updated the Regulatory Enrolment Process (REP) templates to reflect process changes and improvements. Refer to the Guidance Document: Regulatory Enrolment Process (REP) – Drugs for Human and Veterinary Use and Disinfectants for more information on the templates.
Should you have any questions regarding the content of this document, please contact ereview@hc-sc.gc.ca.
In order to access the most up-to-date version of the template, please be reminded to delete your cache frequently and “refresh” the template links on your web browser prior to each use.
May 1, 2024 Release
| Template |
Change |
Regulatory Transaction (RT) Template
Version 4.4.2 |
- Updated the definition for Regulatory Activity Type Undefined Regulatory Activity (UDRA)
- Updated the picklist options for Regulatory Transaction Description when UDRA is selected as the Regulatory Activity Type
- Added definitions for all picklist options for Regulatory Transaction Description when UDRA is selected as the Regulatory Activity Type
- Updated Regulatory Transaction Description for Discontinuation of Sale Notification and Notification for Interruption of Sale
- Added definitions for Discontinuation of Sale Notification and Notification for Interruption of Sale
- Updated the Regulatory Activity Type that appear with the Regulatory Transaction Description for Discontinuation of Sale Notification and Notification for Interruption of Sale
|
February 12, 2024 Release
| Template |
Change |
| Product Information (PI) Template |
- Added the Pediatric Pilot Survey
|
February 28, 2023 Release
| Template |
Change |
| Regulatory Transaction (RT) Template
|
- Updated email address in the Privacy Notice Statement
- Updated veterinary drugs email address in instructions
- Increased character limit allowed for Product Name
|
| Product Information (PI) Template
|
- Updated email address in the Privacy Notice Statement
- Updated veterinary drugs email address in instructions
- Increased character limit allowed for Product Name
|
| Stylesheet Package
|
- New RT and PI version 4.4.1 stylesheets to match changes to REP RT and PI templates
|
January 4, 2023 Release
| Template |
Change |
| Company (CO) Template
|
- Added text regarding fax number
- Updated email address in the Privacy Notice Statement
|
October 1, 2022 Release
| Template |
Change |
| Regulatory Transaction (RT) Template
|
- Updated the Pharmaceutical Drugs Directorate name
- Removal of the fee amounts
- Updated the instructions regarding the fees
- Removal of Regulatory Activity Type “DSUR (Developmental Safety Update Report)”
- Removal of Regulatory Transaction Description “Second Language PM & Final Package Insert” and “Second Language Product Monograph”
- Added new Regulatory Transaction Description “Product Labelling-Post approval”
|
| Product Information (PI) Template
|
- Updated instructions for Cross-licensed Product
- Removal of the rule requiring at least one medical ingredient in a formulation
- Updated instructions for dilutes, adjuvants and placebos
- Added disaggregated data questions
|
| Stylesheet Package
|
- New RT and PI version 4.4 stylesheets to match changes to REP RT and PI templates.
|
March 1, 2022 Release
| Template |
Change |
| Regulatory Transaction (RT) Template [in effect April 1, 2022]
|
- Updated fees as per section 4.1 of the Fees in Respect of Drugs and Medical Devices Order.
- Added Submission Class – “Labelling only - with administrative component”
- Added new Regulatory Activity “Protocol Review” and associated transaction descriptions for dossier type “veterinary”
- Updated instructions for various fields and added further descriptions for fields.
|
| Product Information (PI) Template
|
- Added “Administrative component” question and reason for administrative component picklist.
|
| Stylesheet Package
|
- New RT and PI version 4.3 stylesheets to match changes to REP RT and PI templates.
|
November 22, 2021 Release
| Template |
Change |
| Company (CO) Template
|
- Added the “Submit to Health Canada” button to generate email template. Refer to section 2.3 of the REP guidance document for more information.
- Removed Primary REP contact role.
|
May 3, 2021 Release
| Template |
Change |
| Company (CO) Template
|
- Added “Reason for Filing” field. Refer to instruction on CO template for more information.
- Removed importer company role and importer contact role Refer to section 3 of the REP guidance document for more information.
- Updated instructions for various fields.
- Revised “Country” picklist.
|
| Regulatory Transaction (RT) Template
|
- Updated picklist option for “Dossier Type”, “Regulatory Activity Lead”, “Regulatory Activity Types” and “Associated Transaction Descriptions” to incorporate veterinary drugs.
- Updated instructions for various fields to include veterinary drugs.
- Updated instructions for various fields and added further descriptions for fields.
|
| Product Information (PI) Template
|
- Resolved bugs
- Added option for proprietary information under the formulation section and revised associated requirements for non-medicinal ingredient. Refer to section 5 of the REP guidance document for more information.
- Revised “Calculated as Base” picklist to include the option “ingredient is not a salt”.
- Updated instructions for various fields.
- Removed HC6-024 prefix from “Dossier Identifier” field.
- Removed Importer Company Identifier” field.
- Updated instructions for various fields specific to veterinary drugs.
- Revised “Country” picklist.
|
| Stylesheet Package
|
- New CO and PI version 4.2 stylesheets to match changes to REP CO and PI templates.
|