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In month of June 2020, USFDA updated header of Structured Product Labeling (SPL) XML:

  • Updated xml-stylesheet reference
  • Updated the schemaLocation of the urn:hl7-org:v3 namespace

    Error during the Pragmatic SPL Data Validation with old header:

  1. There must be an xml-stylesheet reference to “https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl“.
  2. The schemaLocation of the urn:hl7-org:v3 namespace must be provided as “https://www.accessdata.fda.gov/spl/schema/spl.xsd“.

Old VS Current SPL Header Comparison

Old Header New Header

<?xml version=”1.0″ encoding=”UTF-8″?>

<?xml-stylesheet href=”http://www.accessdata.fda.gov/spl/stylesheet/spl.xsl” type=”text/xsl”?>

<document xmlns=”urn:hl7-org:v3″ xmlns:xsi=”http://www.w3.org/2001/XMLSchema-instance” xsi:schemaLocation=”urn:hl7-org:v3 http://www.accessdata.fda.gov/spl/schema/spl.xsd”>

<?xml version=”1.0″ encoding=”UTF-8″?>

<?xml-stylesheet href=”https://www.accessdata.fda.gov/spl/stylesheet/spl.xsl” type=”text/xsl”?>

<document xmlns=”urn:hl7-org:v3″ xmlns:xsi=”http://www.w3.org/2001/XMLSchema-instance” xsi:schemaLocation=”urn:hl7-org:v3 https://www.accessdata.fda.gov/spl/schema/spl.xsd”>

Differences:

  1. Yellow highlights are updated as per new header.
  2. http updated to https in at xml-stylesheet reference and schemaLocation of the urn:hl7-org:v3 namespace.

 

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