Updated Regulatory Enrolment Process (REP) For Human And Veterinary Drugs And Disinfectants

Posted Date: 31-March-2025

Updated Regulatory Enrolment Process (REP) For Human And Veterinary Drugs And Disinfectants

 

This guidance document has been updated and is in effect as of May 31, 2025, to reflect:

  • Revision in section 1.3 Scope and application
  • Addition of Biocides into scope for company enrolment and dossier request
  • Addition of Figure 2: Overview of the dossier request process
  • Addition of YBPR to the list when product information (PI) file is required (2.5.2)
  • Revisions in section 5 important considerations
  • Removal of the Appendix D: Third party authorization letter
  • Removal of the Appendix C: Stylesheet instructions
  • Addition of Appendix C: Undefined regulatory activity (UDRA)
  • General revisions for clarity