Notice: Preparation of Veterinary Drug Regulatory Activities in the -Non-eCTD Electronic-Only- Format

December 14, 2016
Our file number: 16-113214-695

Health Canada is pleased to announce the acceptance of Veterinary Drug regulatory activities in “non-eCTD electronic-only” format. This Notice serves as a revision to the Guidance for industry: Preparation of electronic submissions for the Veterinary Drugs Directorate, published on October 7th, 2014.

Electronic documents will be uploaded onto the Health Canada viewing tool, where they will be immediately accessible to Health Canada staff involved in the review of the regulatory activities. This will contribute to effective record management and ensure authenticity, integrity, availability, traceability, and non-repudiation of the data.

Effective immediately the following regulatory activities will be accepted in “non-eCTD electronic-only” format:

  • Application for Drug Identification Number (DIN)
  • New Drug Submission (NDS)
  • Abbreviated New Drug Submission (ANDS)
  • Supplement to a New Drug Submission (SNDS)
  • Supplement to an Abbreviated New Drug Submission (SANDS)
  • Notifiable Change (NC)
  • Request for Priority Review Status for NDS or SNDS
  • Periodic Safety Update Report (PSUR)
  • Pre-Submission Meeting Information (e.g.: MPNDS, MPSNDS, MPDIN, or MPANDS)
  • Change to DIN Submission
  • Experimental Studies Certificate (ESCs) and their amendments
  • Investigational New Drug (IND)
  • Investigational New Drug (IND) amendments
  • Protocol Review
  • Veterinary Drugs Master Files (MF)

Any transactions related to the above regulatory activity types will also be accepted in “non-eCTD electronic-only” format. These transactions include, however are not limited to, the following:

  • Response to a Clarification Request (also known as Response to Minor Information Request for Veterinary Drugs)
  • Responses to Notice of Non-compliance (NON) and Notice of Deficiency (NOD)
  • Response to Screening Deficiency Notice (SDN)
  • Drug Notification Form (DNF)
  • Notification of Discontinued Sale (DIN Cancellation)
  • PSUR requested during the pre-market review process VDD
  • CEP and Attestations
  • CEP Revisions and Attestations
  • MF Updates (updates or amendments)
  • MF Response to Deficiency Letter or Incomplete Letter
  • MF Administrative Information
  • MF Authorization to Access
  • MF Statement of Commitment
  • MF BSE/TSE Certificate

As of April 1st, 2017, Health Canada will no longer accept paper copies of the above indicated regulatory activities or their related transactions.

Refer to the Guidance Document: Preparation of Drug Regulatory Activities in “Non-eCTD Electronic-Only” Format for detailed guidance on filing the above regulatory activities or transactions in the ‘non-eCTD electronic-only” format.

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