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
REP Summary Table
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 Current (Implemented Nov. 2019) Date to be determined Date to be determined Date to be determined
Veterinary Drugs N/A Closed Current (Implemented May 2021) Date to be determined
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 and disinfectants, while it is voluntary for veterinary drugs.

Templates, Stylesheets, Forms and Tutorials

Guidance documents and Notices

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)

Clinical trials (non-functional pilot)

Related information

Contact us

If you have any questions regarding the Regulatory Enrolment Process, please contact us via email at: hc.ereview.sc@canada.ca

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: