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 no-reply.ereview.non-reponse@hc-sc.gc.ca, 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 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.
  • This document contains a table detailing the organization and placement of documents within the Canadian module 1.
  • A list of descriptions, by regulatory activity type, that details the reason for filing a transaction. Note: This document is updated frequently.

  eCTD format only

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

  • Dossier ID Request Form for Master File Dossiers
    The Dossier ID Request Form is the only method used to request eCTD dossiers for Master Files. A request for a dossier ID should be sent a maximum of eight weeks prior to filing a regulatory transaction.
  • Dossier ID request Form for Clinical Trial Applications
    The dossier ID Request Form is the only method used to request eCTD dossiers for Clinical Trials.
    • Dossier ID Request Form for Biologic Clinical Trial Dossiers
    • Dossier ID Request Form for Pharmaceutical Clinical Trial Dossiers

    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 no-reply.ereview.non-reponse@hc-sc.gc.ca). 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.

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

      Veterinary drugs (Division 1 and 8)

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