XML Product Monograph/validation

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DRAFT Validation rules for product monographs in the XML format

These validation rules (see table below) are being posted to provide further information to stakeholders to assist them in the preparation of product monographs in the XML format. The rules also build on the information provided in the Guidance Document: Validation Rules for Product Monographs in the Extensible Markup Language Format and the HL7 Version 3 Standard: Structured Product Labeling, Release 7 (SPL R7) specification.

Health Canada provides Validation Reports only for XML product monographs that failed validation. Sponsors are expected to validate their XML product monograph and correct any warning(s) and error(s) before sending them to Health Canada.