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Canada Guidance: Regulatory Enrolment Process (REP)

Yesterday (29-September 2022) Health Canada updated their guidance on Regulatory Enrolment Process (REP).

Health Canada's Regulatory Enrolment Process (REP) assists regulators in filing and processing regulatory information about:

  • Company

  • Dossier and product

  • Regulatory activity

  • Regulatory transaction

REP consists of web-based templates that capture information in a structured format. Health Canada forms such as the HC-SC3011 drug submission application form and the human drug submission application fee form will be replaced by the REP templates.

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

Click this LINK to know more about Regulatory Enrolment Process (REP)


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