Lorenz Blog

In January 2020 Health Canada notified industry of their plans and timelines to start transitioning product monograph templates into a structure format based on XML, HL7 Structured Product Label (SPL) standard and controlled vocabularies. Phase I was initiated by Health Canada in June 2020 for production testing in which sponsors could submit requests to participate. This phase helped ensure that both Health Canada and industry systems were functioning as expected.

As of June 14, 2021 Phase II for full production on a voluntary basis will begin. What will change:

• Sponsors will no longer need 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
• New Controlled Vocabulary List website available (Click here to visit it)
• Revised validation rules for XML PM (Click here to visit it)

Since Phase I LORENZ offers a free pilot profile that is compatible with our eValidator Basic for those companies who participated in the initial trial phases and we are happy to announce that this offer is now also available for all companies wishing to submit XML product monographs to Health Canada during Phase II. The pilot profile has been updated to be compliant with the revised validation rules and new controlled vocabularies posted by Health Canada.

Other commercial offerings will become available as the health authority announces its timelines and strategic plans to make the XML Product Monograph format mandatory in future Phases.

To obtain more information and gain access to the free Phase II eValidator XML Product Monograph validation profile please email us at cad_xml_pm_pilot@lorenz.cc.

This entry was posted in LORENZ Solutions and Services.