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Canada: TPD Published Validation Rules for Transactions for “non-eCTD” Format

Friday, July 28, 2017: The Health Canada is publishing a set of validation rules for regulatory activities in the "non-eCTD electronic-only" format. These rules build on the information provided in the Guidance Document: Preparation of Regulatory Activities in "Non-eCTD Electronic-Only" format and will assist sponsors in preparing their regulatory transactions for filing to Health Canada.

It is important for sponsors to ensure that the validation rules are followed accurately in order to avoid encountering validation errors. Although they may be updated in the future, Health Canada is currently validating regulatory transactions in “non-eCTD electronic-only” format using the rules listed in the table below. 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.

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