Upcoming changes or updates to the IG

List of updates planned for v1.1.0 of this IG:

Administrative Updates

• Narrative text updates to increase clarity and understanding of ePI
• Style updates (e.g., tables borders and text spacing)
• Update best practice section on XHTML constraints (e.g., table errors)
• Update best practice section to explain how to handle images (i.e., contained with extension)
• update the Steps to Create diagrams to properly show how to handle images.
• Clarify that this IG is the minimal requirements and a framework for all ePIs in the world (EMA, US, Brazil, Malaysia, Jordan). And how to handle region specific requirements or extensions
• Clarify how to assign and use ids vs identifiers
• Profile updates
• Add best practices for working with Arabic
• Add capability statement for the server side components reflecting what can actually be expected from a client side perspective
• Add standard URL for extensions; e.g., hl7.org/fhir/uv/emedicinal-product-info/extension/dummyValidationLink
• update to clarify that the extension is no longer needed for images. New format for images is as follows:

<Composition>
…
                <contained>
                    <Binary>
                        <id value="step0" />
                        <contentType value="image/jpg" />
                        <data value=”” />
                    </Binary>
                </contained>
…
                    <section id="f3505a60-0d4e-ee11-be6e-000d3aaa06fe">
                        <title value="7. Instructions for Use of XELJANZ oral solution" />
                        <code>
              <coding>
                <system value="[https://spor.ema.europa.eu/v1/lists/200000029659/terms/](https://urldefense.com/v3/__https:/spor.ema.europa.eu/v1/lists/200000029659/terms/__;!!H9nueQsQ!4RNOaMODanhB7_dn3XJeERpaeNg_MkFCtrHbBip2OIxlqQniFfKCoHrC8L3SZ1nNgfqBZwju7qsDgNe4oIAc8dvWrCFP-AtMQg$)" />
                <code value="200000029916" />
                <display value="7. Instructions for Use of XELJANZ oral solution" />
              </coding>
            </code>
                        <text>
                            <status value="generated" />
                            <div xmlns="[http://www.w3.org/1999/xhtml](https://urldefense.com/v3/__http:/www.w3.org/1999/xhtml__;!!H9nueQsQ!4RNOaMODanhB7_dn3XJeERpaeNg_MkFCtrHbBip2OIxlqQniFfKCoHrC8L3SZ1nNgfqBZwju7qsDgNe4oIAc8dvWrCG5pBTGzg$)">
                                <p><img src="#step0" alt="Contents of the carton" /></p>

Profile Updates

• Maintain alignment with EMA and IDMP where needed
• Alignment with JFDA
• Move Language from Bundle to Composition
• Add support for product images to the manufactured item
• Composition parent section changes from 0..* to 1..1 since Bundles should only contain one document with a single parent section and many subsections.
• Composition child section changes from 0..* to 1..* since there must be at least one child section in any ePI document

Sample Data

• Add at least one example for each element of the QRD templates (SmPC, Label and Package Leaflet)
• More detailed product information (e.g., pack layers, reconstituted product, kit or combo product). Reuse UNICOM examples.

List of updates under consideration for a future version of this IG

• Medical Devices
• Veterinary Drugs
• Terminology examples and regional requirements