Regulatory Enrolment Process (REP) Template Revision History

This page outlines changes related to the Regulatory Enrolment Process (REP) templates. Should you have any questions regarding the content of this page, 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.

March 26, 2025 Release

Template Change
Regulatory Transaction (RT) Template
Version 5.0.0


Stylesheet package*
  • Added instructions regarding the “Load a regulatory transaction enrolment file” section
  • Reordered “Transaction details” section
  • Added info bubble for the control number
  • Removed the regulatory activity type: NDS CV
  • Added regulatory transaction description: Request for review report(s) to lead: Post-market vigilance (for Marketed Health Products Directorate (MHPD))
  • Removed the question “Are there new or revised fees associated with this transactions?”
  • Added submission class: Not applicable
  • Removed routing identifier


  • *New RT stylesheet to match changes on this template

October 28, 2024 Release

Template Change
Regulatory Transaction (RT) Template
Version 4.4.3
  • Updated instructions for Control Number
  • Removed Regulatory Activity Lead field for Veterinary dossier
  • Changed Regulatory Activity Lead from Post-Market Vigilance to Post-Market Vigilance (for Marketed Health Products Directorate)
  • Added definitions for various regulatory activity types and transactions descriptions
  • Updated the transaction description list for various regulatory activity types
  • Added new Regulatory Activity Type: Notification of Foreign Action (NFA-PV)
  • Removed the Regulatory Activity Type: New Drug Submission with flexibilities for Designated COVID-19 Drugs (NDS CV) and Regulatory Cooperation Council (RCC) from Veterinary Dossier
  • Added the Regulatory Transaction Descriptions: Final Risk Communication Document, Immediate Notification and Request Review Reports
  • Added requestor name field for transaction description: Comments on Summary Basis of Decision (SBD)
  • Updated info bubble for the third party authorization section

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
Stylesheet Package
  • New RT stylesheet to match changes to REP RT template

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 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
  • 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.