Notice - Re: Preparation of Drug Master File (DMF) in "Non-eCTD Electronic-Only" Format
October 5, 2015
Our file number: 15-110442-152
Health Canada is pleased to announce the acceptance of Drug Master Files in "non-eCTD electronic-only" format.
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 should be provided in "non-eCTD electronic-only" format:
- New DMFs;
- Transactions related to existing DMFs (for example, letters of access, administrative information);
- DMF updates (the first update must include a complete DMF conversion in "non-eCTD electronic-only" format for the existing DMF in paper format).
As of January 1, 2016, Health Canada will no longer accept paper copies of DMF transactions. Any paper received after this date will be shredded or returned at the owner's expense.
By March 31, 2016, all existing DMFs in paper format must be replaced by a complete DMF conversion in "non-eCTD electronic-only" format. Failure to provide the complete electronic copy of the DMF will result in the DMF being suspended (no further access for review will be granted and no update will be accepted for the DMF).
Refer to the Guidance Document: Preparation of Drug Regulatory Activities in "Non-eCTD Electronic-Only" Formatfor detailed guidance on filing DMFs in the 'non-eCTD electronic-only" format.
Alternatively, DMFs can be filed in eCTD format even in the absence of a formal guidance document, as long as the below requirements are met:
- Prior to filing a DMF in eCTD format a sample according to the eCTD guidelines must be provided to Health Canada, regardless of a company's experience with using eCTD format.
- A Pre-technical meeting is recommended for company's using eCTD for the first time and is mandatory for DMF Type II and III.
- A Dossier Identifier (e123456) should be requested via email to firstname.lastname@example.org, for all DMFs filed in eCTD format. The request should include a fully completed DMF application form.
- DMFs provided in eCTD format must be sent via the Common Electronic Submission Gateway (CESG).
- Instructions provided in the Guidance Document: Preparation of Drug Regulatory Activities in the eCTD formatand theGuidance Document: Preparation of Drug Regulatory Activities in "Non-eCTD Electronic-Only" Formatshould be followed.
- Questions related to eCTD format should be directed via email to email@example.com.
Questions related to this notice may be directed via email to firstname.lastname@example.org.
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