Regulatory enrolment process (REP)
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The regulatory enrolment process (REP) facilitates the filing and processing of regulatory information related to:
- company
- dossier and product
- regulatory activity
- regulatory transaction
REP consists of web-based templates that capture information in a structured format. The REP templates replace existing Health Canada application and fee forms.
This process enables a move towards a common submission intake across product lines and allows Health Canada to automate the receipt and import of regulatory transactions into its repositories.
| Product line | Version of the regulatory transaction template | Production (voluntary use) | Mandatory |
|---|---|---|---|
| Human use drugs (pharmaceutical, biologic and radiopharmaceutical) and disinfectants | Current - v5.1.0 | Closed | Current (implemented Oct. 2020) |
| Medical devices | Current - v4.0.1 | Closed | Current (implemented Apr. 2026) |
| Clinical trials | N/A | Date to be determined | Date to be determined |
| Veterinary drugs | Current - v5.1.0 | Closed | Current (implemented Oct. 2022) |
Human drugs, veterinary drugs and disinfectants
Templates, stylesheets and forms
Guidance documents and notices
- Guidance document: Regulatory enrolment process (REP): Drugs for human/veterinary use, disinfectants and biocides (available upon request no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'REP Guidance document drugs and biocides' is in the subject line of the email. [2025-03-17]
Medical devices
Templates, stylesheets and forms
Guidance document and notices
Related information
- Filing submission electronically information page
- Electronic submissions gateway information page
- Fees for human drugs
- Fees for medical devices
- Fees for veterinary drugs
Contact us
If you have any questions regarding the regulatory enrolment process, please contact us by email at: ereview@hc-sc.gc.ca