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 forms such as the HC-SC3011 drug submission application form and the human drug submission application fee form.
This process enables a move towards a common submission intake across product lines and allows Health Canada to:
- receive a broader range of regulatory information via the Common Electronic Submission Gateway (CESG)
- automate the import of regulatory transactions into its repositories
| Product Line | REP Status | |||
|---|---|---|---|---|
| Non-Functional Pilot | Functional Pilot | Production (voluntary use) | Mandatory | |
| Human Use Drugs (Pharmaceutical, Biologic and Radiopharmaceutical) and Disinfectants | Closed | Closed | Closed | Current (Implemented Oct. 2020) |
| Medical Devices | N/A | Current (Expanded Mar. 2019) | Date to be determined | Date to be determined |
| Clinical Trials | Closed | Date to be determined | Date to be determined | Date to be determined |
| Veterinary Drugs | N/A | Closed | Closed | Current (Implemented Oct. 2022) |
| N/A - not applicable | ||||
REP Production - Human Drugs, Veterinary Drugs and Disinfectants
The REP is available for regulatory transactions prepared in either electronic common technical document (eCTD) and Non-eCTD formats. Use of the REP is mandatory for human drugs, veterinary drugs and disinfectants.
Templates, Stylesheets, Forms and Tutorials
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.
REP Pilots
The draft pilot guidance documents and links to REP pilot templates are sent to participants via email upon participation.
Medical devices (functional pilot)
- Notice: Expansion of the medical device Regulatory Enrolment Process (REP) pilot and the scope for transactions sent via the Common Electronic Submissions Gateway (CESG) [2020-05-26]
- Dossier ID Request Form for Medical Devices
This form is for REP pilot use ONLY
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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