Structured Format for Product Monographs

From Health Canada

Current status: Open

Opened on May 15, 2019 and will close to new input on June 29, 2019.

Health Canada is seeking feedback on a new structured format for product monographs. The new Structured Product Monograph is based on Extensible Markup Language (XML), Health Level 7's (HL7) Structured Product Label (SPL) standard and controlled vocabularies.

The goal is to improve access to drug labeling information in order to help Canadians make informed decisions about their medications; and encourage the adoption of digital health technology to increase efficiency.

The draft guidance documents Preparation of Product Monographs in the Extensible Markup Language Format; and Validation Rules for Product Monographs in the Extensible Markup Language Format outline how to implement this new format.

Join in: how to participate

  1. Read the draft guidance documents: Preparation of Product Monographs in the Extensible Markup Language Format and Validation Rules for Product Monographs in the Extensible Markup Language Format
  2. To make yourself heard, send an email to Business Informatics Division at hc.dhpr-rmps.sc@canada.ca with your ideas or comments.

Who is the focus of this consultation?

We will engage with:

  • the pharmaceutical industry and industry associations
  • software developers
  • the provinces and territories
  • health care professionals

Goals of the consultation

The goal of this consultation is to receive feedback on the guidance documents Preparation of Product Monographs in the Extensible Markup Language Format and Validation Rules for Product Monographs in the Extensible Markup Language Format. These guidance documents provide business and technical conformance rules needed to prepare a product monograph using the XML format and the HL7SPL standard.

Related information

Notice of Intent: Transitioning Product Monographs to a Structured Format

Contact us

Business Informatics Division
Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Email: hc.dhpr-rmps.sc@canada.ca

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