Regulatory Enrolment Process

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. This format uses pick lists and business rules, which help to increase the accuracy of information captured in the 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

Templates and stylesheets

Pharmaceutical/biologics (human drugs)

Guidance documents and notices

Pharmaceutical/biologics (human drugs)

Clinical trials

Medical devices

Veterinary drugs

Related information

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