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Are you ready for Health Canada's mandatory XML PMs?

Writer's picture: Tharshini VeerasingamTharshini Veerasingam
Nov 18, 20242 min read
computer code on a screen

As per the notice released by Health Canada on November 18, 2024, the XML PM will be a mandatory filing requirement effective July 18, 2025 for:

  • New drug submissions (NDS)

  • Extraordinary use new drug submission (EUNDS)


At the time of filing, you are required to:

  • Include the first language XML PM for:

    • in-scope product lines and submission types

    • products with a previously authorized XML PM

  • Complete the XML PM section of the following:

    • Labels and Packages Certification Form for Prescription (revised version, once available)

    • Labels and Packages Certification Form for Non-Prescription Products (revised version, once available)

 

A clarification request or a negative decision will be issued during the screening of the submission If you do not submit an XML PM when required.

 

Post-authorization, you are required to:

  • File the XML PM in both English and French after you receive the notice of compliance (NOC) or no objection letter (NOL)

  • Submit both XML PMs in the same regulatory transaction as the second-language product monograph in PDF format

    • Use the regulatory transaction description "Product Labelling - Post-Approval"

 

Health Canada aims to have the following in place prior to the mandatory implementation of the XML PM:

  • Publish the final XML PM guidance document

  • Publish updated XML samples in both English and French

  • Make sure the XML PM guidance document and samples are aligned with the final version of the Product Monograph Master Template

  • Begin publishing final XML PMs on the Drug and Health Product Portal (https://dhpp.hpfb-dgpsa.ca/)

    • Will include both the human-readable HTML version and the .xml file

 

Regxia has participated with the XML PM pilot and has successfully prepared, validated and submitted several XML PMs to Health Canada. 

Our team makes the process simple, transforming your existing Word documents into a validated XML PM submission. Regxia is able to create your XML PM without you requiring extra training or resources to understand XML coding. Once validated, all documents needed for the XML submission will be provided to you by Regxia. This includes access to a viewer friendly HTML version of the XML PM so you see the end result posted by Health Canada.

 

Minimize disruption and let Regxia prepare and execute your conversion plan today. Contact us to get started.

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