These Validation rules build on the information provided in Preparation of Regulatory Activities in “Non-eCTD Electronic-Only” format guideline.
The revised rules assist stakeholders in the preparation of regulatory transactions in Non-eCTD format.
It is important for sponsors to ensure that the validation rules are followed accurately in order to avoid encountering validation errors.
Stakeholders are encouraged to use a commercially available tool to validate their regulatory transactions in “non-eCTD electronic-only” format, prior to filing them to Health Canada.
Although the Agency updated validation criteria without further notice, as of March 30, 2019, Health Canada will be validating regulatory transactions in non-eCTD format using version 4.4 of the “non-eCTD electronic-only” validation rules.
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