Purpose and context
This article and video aim to support users of the PLM Portal - ePI to validate FHIR xml files against the EU ePI Common Standard on their local machine, outside of the portal.
Validating ePI against the EU ePI Common Standard
Follow these steps to validate your ePI locally:
1) Download the jar to use the HL7 Validator on your local machine (under 2, Downloading the Validator):
https://confluence.hl7.org/spaces/FHIR/pages/35718580/Using+the+FHIR+Validator
2) Download the latest structure definitions from the EMRN ePI Implementation Guide (under 1.5, Structure Definitions) and unpack:
https://epi.ema.europa.eu/fhirig/index.html
The folder includes all relevant base profiles, code systems and value sets.
3) Open the FHIR xml you want to validate and add the url of the profiles you want to validate against in the respective meta element.
E.g. under the composition element of a bundle of type document for an SmPC for a CAP in English language, add the following profiles:
<Composition>
<meta>
<profile value="http://ema.europa.eu/fhir/StructureDefinition/EUEpiCompositionCAP" />
<profile value="http://ema.europa.eu/fhir/StructureDefinition/EUEpiCompositionSmPC" />
<profile value="http://ema.europa.eu/fhir/StructureDefinition/EUQRD-CAP-template-new-SmPC-en" />
</meta>
...
</Composition>
4) Open the Command Prompt on your computer and navigate to the folder where you stored the jar file.
5) Put the following command in the command line:
java -jar validator_cli.jar -ig [package|file|folder|url] [source]
6) You can output the validation report to HTML or JSON by adding the following command:
-output [file]
Example Command:
C:\Users>java -jar validator_cli.jar -ig C:\Users\epiprofiles C:\Users\DocumentFolder\DocumentName.xml -output C:\Users\DocumentFolder\ValidationReport.html
You can find a list with possible validation errors in the User Guide for Applicants.