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 Version of the Regulatory Transaction Template Functional Pilot Production (voluntary use) Mandatory
Human Use Drugs (Pharmaceutical, Biologic and Radiopharmaceutical) and Disinfectants Current - v4.4.1
As of May 1, 2024 - v4.4.2
Closed Closed Current (Implemented Oct. 2020)
Medical Devices Current - v2.0.0
As of July 2024 - v3.0.0
Current (Expanded Mar. 2019) Jul. 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 - v4.4.1
As of May 1, 2024 - v4.4.2
Closed Closed Current (Implemented Oct. 2022)

Human Drugs, Veterinary Drugs and Disinfectants

Templates, Stylesheets and Forms

Guidance documents and Notices

Medical Devices

Related information

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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