Regulatory enrolment process (REP)
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 | Functional Pilot | Production (voluntary use) | Mandatory |
|---|---|---|---|---|
| Human Use Drugs (Pharmaceutical, Biologic and Radiopharmaceutical) and Disinfectants | Current - v4.4.3 | Closed | Closed | Current (Implemented Oct. 2020) |
| Medical Devices | Current - v3.0.0 | Closed | Current (Implemented July 2024) | 18 months from the production date |
| Clinical Trials | N/A | Date to be determined | Date to be determined | Date to be determined |
| Veterinary Drugs | Current - v4.4.3 | Closed | Closed | Current (Implemented Oct. 2022) |
Human Drugs, Veterinary Drugs and Disinfectants
Templates, Stylesheets and Forms
Guidance documents and Notices
- Guidance Document The Regulatory Enrolment Process (REP): Drugs for Human/ Veterinary Use and Disinfectants [2022-11-04] (available upon request: Click here to submit an email request to no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'Request for REP Guidance Document Drugs' is in the subject line of the email.
Medical Devices
Templates, Stylesheets and Forms
Guidance document and Notices
- Guidance Document: The Regulatory Enrolment Process (REP): Medical Devices [2024-03-15] (available upon request no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'Request for REP Guidance Document Medical Devices' is in the subject line of the email.
Related information
- Filing Submission Electronically information page
- Common 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 via email at: ereview@hc-sc.gc.ca
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