ePI IG Roadmap: Planned updates for the next version of the ePI IG (v1.1.0) - Githubissues

HL7 / emedicinal-product-info

Gravitate Health Project

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ePI IG Roadmap: Planned updates for the next version of the ePI IG (v1.1.0) #100

Closed cander2 closed 9 months ago

cander2 commented 10 months ago

Version 1.1 Administrative

Narrative text updates
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
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

Alignment with EMA
Alignment with JFDA
Move Language from Bundle to Composition

Examples

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.

Updates under consideration for the version after 1.1

Medical Devices
Veterinary Drugs
Terminology examples and regional requirements
Best practices for working with Arabic

cander2 commented 9 months ago

Moved this to the wiki page