Regulatory Enrolment Process (REP) for Human and Veterinary Drugs and Disinfectants
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REP Templates & Form Links
Outside the Regulatory Transaction Process
Company (CO) Template (2023-02-28)
- 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 Company Enrolment/Amendment Process” of the REP guidance document.
Dossier ID request form for human drugs
- 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.
Dossier ID request form for biocides
- 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 (2025-03-26)
- Required with each regulatory transaction filed to Health Canada.
- For detailed description of the requirements for the RT template, refer to section “2.5 Regulatory Transaction Filing Process” of the REP guidance document.
Product Information (PI) Template (2024-02-12)
- 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 transactions.
- For detailed description of the requirements for the PI template, refer to section “2.5 Regulatory Transaction Filing Process” of the REP guidance document.