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

REP Templates & Form Links

Outside the Regulatory Transaction Process

• 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.

• 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.

• 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

• 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).
• For detailed descriptions of the requirements for the RT and PI templates, refer to section “2.5 Regulatory Transaction Filing Process” and “3.2 Folder Structure” of the REP guidance document.

• 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).
• For detailed descriptions of the requirements for the RT and PI templates, refer to sections “2.5 Regulatory Transaction Filing Process” and “3.2 Folder Structure” of the REP guidance document.

Stylesheet Download Links