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Health Canada Adopts SPL

The Structured Product Monograph(SPM) is Health Canada's implementation of the HL7 Structured Product Labeling (SPL) standard and marks their entry into structured content.

The SPM is being introduced as the new submission format for the Pristine Product Monograph(on Rx products). The intention is to improve ease of navigation and access to timely, useful and relevant health and safety information to the health care professionals, patients and consumers.

i4i is committed to supporting the SPM as part of our flagship A4L solutions. On June 7th, 2017 i4i participated in the Health Canada(HC) kick-off meeting for the Technical Testing Pilot for the Structured Product Monograph (SPM). We are actively engaged in the pilot, partnering with sponsors, assisting with sample submissions and helping prepare for a quick and seamless adoption.

Current implementations of our Global Labeling Solution offer the Canadian Product Monograph and we expect the evolution of this structured content template to the new HC SPM guidelines to be a smooth transition.

Our comprehensive A4L solution has been successfully deployed at over 100 pharmaceutical customers. It provides a full structured document authoring and collaboration cycle, in the familiar Microsoft Word, to produce XML documents that conform to the SPL/SPM specification.

The Solution

Extending the value proposition of your existing IT infrastructure to deliver a complete SPL solution. A4L is delivered in the following configurations:

  • A4L PROFESSIONAL (single-user desktop version) more...

  • ALiCE for Labeling - US SPL Edition (multi-user server version with full collaboration capabilities) more...

  • SPL DIRECT assists in any part of the SPL creation and submission process, ranging from full outsourcing to in-house ad-hoc conversions.
    i4i has assisted in the SPL creation and submission process for a wide range of clients around the globe, resulting in 1000's of valid SPL submissions, to date. more...


What is SPL (in brief)

SPL - Structured Product Labeling is an HL7 document mark-up standard that specifies the structure and semantics of the content of authorized published drug product and facility information. The use of consistent structure and controlled vocabularies and terminologies facilitates the organisation, indexing and processing of the content.

Since 2005, SPL has been a mandated submission format for the FDA. Starting with prescription drug products, this initiative was expanded in 2009 and continues to grow across divisions. And now Canada is working to adopt the standard.