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)