Notice: Phase II of the XML PM Project (Product Monograph in the Extensible Markup Language Format)

May 28, 2021

Phase II: Full Production (Voluntary)

In April 2019, Health Canada announced its intent to transition product monograph templates to a structured format based on XML format, Health Level 7 (HL7)'s Structured Product Label (SPL) standard and controlled vocabularies.

In June 2020, Health Canada initiated Phase I: Production Testing of the XML PM project, which required sponsors to submit a request to participate. This approach was put in place to control the volume of XML PMs submitted to ensure both Health Canada and industry systems are functioning as expected.

Beginning June 14, 2021, Health Canada will initiate Phase II: Full Production on a voluntary basis. Sponsors will no longer be required to submit a request to participate and may file their XML PM for review for all product monographs for human pharmaceutical, radiopharmaceutical and biologic drugs.

The new Controlled Vocabulary List website will be available on June 14, 2021. This website is accessible, fully bilingual and provides the ability to search online or by downloading in either XML or CSV format. Each list and term will include the source, status and date it was last updated.

Health Canada will validate all XML PMs against a defined set of rules to confirm that the XML file is valid and in an expected structure and required data has been provided. In preparation for Phase II, Health Canada has revised the validation rules for the XML PM. These revisions include a small number of new rules, several minor changes and the rewording of all the rules to provide clarity. The revised rules will come into effect on June 14, 2021.

Health Canada is working on a strategic approach to support the transition of all product monographs into the XML format, which will become a mandatory requirement for product monographs. More information will be provided in subsequent communications.