Change in filing requirements for the extensible markup language product monograph (XML PM): Notice

• November 18, 2024
• Our file number: 24-110596-493

On this page

• Mandatory use of the XML PM
• Voluntary transition continues
• Contact us

Mandatory use of the XML PM

Health Canada is announcing the first phase of the mandatory use of the extensible markup language product monograph (XML PM). In this first phase, a subset of submission types will be required to include the XML PM at the time of filing. We will inform you when we expand the scope to other submission types.

This first phase takes effect on July 18, 2025.

As of July 18, 2025, the XML PM will be a mandatory filing requirement for:

• new drug submissions (NDS)
• extraordinary use new drug submission (EUNDS)

The mandatory filing requirement will not apply to the following new drug submission types:

• administrative new drug submissions (Admin NDS)
• new drug submissions for priority review
• new drug submissions - COVID (NDS-CV)
• new drug submissions where advanced consideration notice of compliance with conditions (NOC/c) was granted
• abbreviated new drug submissions (ANDS)

The following product lines will be affected:

• pharmaceutical drugs
  • prescription drugs and drugs administered by or obtained from a health care provider
  • non-prescription drugs regulated under Division 8 of the Food and Drug Regulations
• biologic drugs (Schedule D)
• radiopharmaceutical drugs (Schedule C)

Voluntary transition continues

The voluntary transition to the XML PM continues for all other submission types. However, please take note of the below information.

For generic products:

• Do not submit an XML PM until the Canadian Reference Product (CRP) has an authorized XML PM. The authorized XML PM will be posted on the Drug and Health Products Portal. Once that is done, all associated generic products must include an XML PM in their next submission.
• Generic products with an existing authorized XML PM should continue to use it. Any updates to the controlled vocabulary must be consistent with the CRP, even if it causes an XML PM validation error.

For cross-licensed products:

• Do not submit an XML PM until the licensor's product has an authorized XML PM. The authorized XML PM will be posted on the Drug and Health Products Portal. Once that is done, all associated cross-licensed products must include an XML PM in their next submission.

For biosimilar products:

• Begin to use the XML PM if you wish. The Canadian Reference Biologic Drug does not have to have an authorized XML PM posted to the Drug and Health Products Portal first.

Once an XML PM has been authorized, it becomes a filing requirement for subsequent submissions that include changes to the product monograph.

During this transition period, changes needed to align the controlled vocabulary to the authorized PM should have little impact. However, if you need to update or adjust terminology to fit the following controlled vocabulary, you can only make those changes during a submission that includes a quality review stream:

• Ingredient identifier
• Dosage form
• Route of administration
• Package type
  • only for packaging that comes in contact with the product or provides a functional purpose

Aligning all terminology to the controlled vocabulary may require multiple submissions. During this transition period, you may use the terminology from the currently authorized product monograph instead of the controlled vocabulary lists specified above. While this may lead to validation errors, these will be accepted as part of the transition process.

During the transition period, there may be situations where the terminology used in the PM cannot be aligned with the controlled vocabulary requirements of the XML PM within the timeframe of a single submission. If this happens, Health Canada's review teams will make the final decision regarding terminology.

Include the package label mock-ups in your submission if aligning to the controlled vocabulary results in a level 1 change to the package labelling materials.

Expectations

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)

If you do not submit an XML PM when required, we will ask for it in a clarification request or a negative decision during the screening of the submission.

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"

What we're doing before phase 1 of mandatory use of the XML PM begins

Before the first phase begins, we will:

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

You should read the following along with this notice :

• Guidance document: Preparation of the extensible markup language product monograph (XML PM)
• XML PM sample
• Controlled Vocabulary List
• Validation rules for product monographs in the extensible markup language (XML) format
• Product monograph: Guidance document
• Product monograph master template
• Guidance document: The management of drug submissions and applications
• Questions and answers: Plain language labelling regulations for prescription drugs
• Guidance document: Questions and answers: Plain language labelling regulations for non-prescription drugs
• Guidance document: Post-notice of compliance (NOC) changes: Safety and efficacy document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)

Contact us

If you have questions about this notice, send an email to the XML PM team at xmlpm-pmxml@hc-sc.gc.ca.