Filing submissions electronically 

Companies are required to file submissions electronically to Health Canada in either Electronic Common Technical Document (eCTD) format or non-eCTD format, depending on the regulatory activity type. The sections below include links to documents that provide detailed information on these formats and other information related to filing submissions electronically.

Some documents are only available and labeled as "available upon request". When you click the link to these documents, an email message should appear with information pre-filled; simply 'Send' this message. Alternatively, you can create an email to, and use the requested subject line as specified for each document below.

Guidance documents, notices and supporting documents

All electronic formats

  • Regulatory Enrolment Process (REP)
    • REP is a common submission intake method across product lines (i.e. prescription drugs for human and veterinary use, biologics and radiopharmaceuticals for human use, medical devices for human use and disinfectants) and filling formats (i.e. eCTD and non-eCTD format).
  • Dossier ID Request Form for Pharmaceutical/Biologic Dossiers
    • Dossier ID Process – the Dossier ID Request Form must be the only method used to request for a Dossier ID from Health Canada for REP and eCTD dossiers (Master Files, veterinary drugs and Clinical Trial eCTD excluded). A request for a dossier ID should be sent a maximum of eight weeks prior to filing a regulatory transaction.
  • Organisation and Document Placement for Canadian Module 1 [2024-04-02]
    • This document contains a table detailing the organization and placement of documents within the Canadian module 1.
  • Regulatory Transaction Descriptions (available upon request Please ensure the text 'Request for Regulatory Transaction Descriptions' is in the subject line of the email. [2022-10-21]
    • A list of descriptions, by regulatory activity type, that details the reason for filing a transaction. Note: This document is updated frequently.
  • Master File Application Form [2024-06-17] – current version 1.1.0
  • Common Electronic Submissions Gateway (CESG)

eCTD format only

Depending on the regulatory activity type of the drug, this may be either the mandatory or recommended format.

Non-eCTD format only

The alternative electronic format for regulatory activities not mandatory or accepted in eCTD format.

  • Guidance Document - Preparation of Regulatory Activities in Non-eCTD Format (available upon request Please ensure the text 'non eCTD Guidance Document' is in the subject line of the email. [2024-05-10]
  • Validation Rules for regulatory transactions filed in non-eCTD format [2024-01-30]
  • Folder structure
    • The table below contains the zip files of the folder structure for each product line as outlined in section 2.2 of the Guidance Document – Preparation of the Regulatory Activities in the non-eCTD format.
Product line zip file

Human Drugs, Disinfectants and Clinical Trials (Division 1 and 5)

zip file – Folder Structure

Veterinary drugs (Division 1 and 8)

zip file – Vet Drugs

Master File (Type I, II, III, IV)

zip file – MF Type I

zip file – MF Type II

zip file – MF Type III

zip file – MF Type IV

Consultations and upcoming activities

Supporting documents and pages from the International Council for Harmonisation (ICH)

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