Regulatory Enrolment Process (REP) for Human and Veterinary Drugs and Disinfectants

REP Templates & Form Links

Outside the Regulatory Transaction Process

Company (CO) Template (updated 2021-11-22)
  • Required to obtain a company ID and/or update company information to Health Canada.
  • Sent via email.
    • Attach draft CO XML file to email prior to sending.
  • Refer to section “2.3 Enrolment/Amendment Process” of the REP guidance document.
Dossier ID Request Form for Human drugs and disinfectants
  • Required to obtain a Dossier ID, prior to filing a regulatory transaction for a new dossier, when converting a dossier from non-eCTD to eCTD format, or when filing a regulatory transaction for a dossier for which you do not know the Dossier ID.
  • Refer to section “2.4 Dossier ID Request Process” of the REP guidance document.
Dossier ID Request Form for Veterinary drugs
  • Required to obtain a Dossier ID, prior to filing a regulatory transaction for a new dossier or a dossier for which you do not know the Dossier ID.
  • Refer to section “2.4 Dossier ID Request Process” of the REP guidance document.

Within the Regulatory Transaction Process

Regulatory Transaction (RT) Template (updated on 2022-10-07)
  • Required with each regulatory transaction filed to Health Canada.
  • Sent via the CESG in folder 1.2.1 for human drugs and disinfectants or part I folder 1.5 for veterinary drugs of the regulatory transaction (submission).
  • Refer to section “2.5 Regulatory Transaction Filing Process” and “3.2 Folder Structure” of the REP guidance document, and REP Video Tutorial #4, for detailed descriptions of the requirements for the RT and PI templates.
Product Information (PI) Template (updated on 2022-10-07)
  • Required for only a subset of transactions. Refer to section “2.5.2 Product information (PI) Template and Process” of the REP Guidance Document for list of subset transaction.
  • Sent via the CESG in folder 1.2.1 for human drugs and disinfectants or part I folder 1.5 for veterinary drugs of the regulatory transaction (when provided).
  • Refer to sections “2.5 Regulatory Transaction Filing Process” and “3.2 Folder Structure” of the REP guidance document, and REP Video Tutorial #4, for detailed descriptions of the requirements for the RT and PI templates.

Stylesheet Download Links

Training Material Download Links

Date modified: 2022-10-07