Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Tracked Changes

Page standards status: Informative

Technical Details · Annotation Model

Auditable Document Evolution

A structured approach for embedding tracked changes and reviewer comments directly inside FHIR Composition narratives — enabling transparent regulatory collaboration.

How It Works
1
Mark the Range

Anchor tags (<a>) mark the start and end of each insertion, deletion, or comment within the Composition narrative.

2
Store the Details

A separate Annotations section in the Composition holds the author, date, and text for every change and comment marker.

3
Render Visually

CSS classes (InsertStart, DeleteStart) let viewers render insertions in green and deletions in red automatically.

Annotation Types
✅ Insertion
Proposed New Content

Marks content being added. Rendered with a green highlight and no strikethrough. Uses InsertStart / InsertEnd anchor classes.

❌ Deletion
Proposed Removal

Marks content proposed for removal. Rendered in red with a strikethrough. Uses DeleteStart / DeleteEnd anchor classes.

💬 Comment
Reviewer Discussion

Wraps content associated with a reviewer note or thread. Uses CommentStart / CommentEnd anchor classes.

Common Annotation Markers
Marker Class Tag Type Purpose
InsertStart / InsertEnd <a id> / <a href> Marks the beginning and end of newly proposed content.
DeleteStart / DeleteEnd <a id> / <a href> Marks content proposed for removal.
CommentStart / CommentEnd <a id> / <a href> Wraps content associated with a specific reviewer comment or discussion thread.
XML Code Examples
XML — Annotations Section
<!-- Delete annotation -->
<div class="Delete" title="del01">
  <span class="Author"
       title="FDA Reviewer"/>
  <span class="Date"
       title="2024-11-25T10:00:00Z"/>
</div>

<!-- Insert annotation -->
<div class="Insert" title="ins01">
  <span class="Author"
       title="Company 1"/>
  <span class="Date"
       title="2025-01-28T10:00:00Z"/>
</div>
XML — Change Markers in Content
<!-- Start/End of an insertion -->
<a id="ins01"
   class="InsertStart"/>
... new proposed text ...
<a href="ins01"
   class="InsertEnd"/>

<!-- Start/End of a deletion -->
<a id="del01"
   class="DeleteStart"/>
... text being removed ...
<a href="del01"
   class="DeleteEnd"/>
Visual Rendering (CSS)
CSS — Track Change Styles
/* Proposed insertions — green highlight */
.InsertStart + * {
    background-color: #e6ffed;
    border-bottom: 2px solid #22863a;
}
/* Proposed deletions — red strikethrough */
.DeleteStart + * {
    background-color: #ffeef0;
    color: #cb2431;
    text-decoration: line-through;
}
/* Hide markers in final rendered view */
.InsertStart, .InsertEnd,
.DeleteStart, .DeleteEnd,
.CommentStart, .CommentEnd {
    display: none;
}