API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
API for the Exchange of Medicinal Product Information (APIX), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
In APIX, the DocumentReference resource provides the metadata wrapper for regulatory documents submitted as part of a procedure. It links descriptive information (title, category, CTD section, author) with the actual payload stored separately on the FHIR server. E.g. A binary file is uploaded first as a raw Binary resource, and the DocumentReference then “claims” that binary by referencing it through DocumentReference.content.attachment.url.
The DocumentReference.author element identifies the creator of both the metadata and the associated binary content, ensuring clear provenance for regulatory submissions. DocumentReferences are then attached to Tasks via Task.input or Task.output, allowing the regulator to discover and retrieve documents only when needed.
Note: To keep the server healthy, buisness rules should be determined at what frequency unattached binaries and unused DocumentReferences be expunged.
| Element | Cardinality (APIX) | Value / Example | Purpose / Notes |
|---|---|---|---|
DocumentReference.content.attachment.url |
1..1 | Binary/123 |
Main link to the raw binary mentioned in the [Architecture](architecture.html#binary-upload-guide-post-then-link) page; the most important element for retrieval of the binary |
DocumentReference.category |
0..* | e.g. Module 3, Quality, Clinical | Used for indexing, grouping, and regulatory classification |
DocumentReference.type |
0..1 | e.g. Stability Report, Study Protocol | Describes the document’s regulatory purpose |
DocumentReference.author |
0..* | Reference to Organization or Practitioner |
Identifies the creator of both the DocumentReference metadata and the associated binary content |
DocumentReference.date |
0..1 | Date/time of creation | Useful for audit trails and version tracking |
DocumentReference.status |
1..1 | current |
Indicates that the document is active and available for use |
DocumentReference.description |
0..1 | Human‑readable title or summary | Improves usability and searchability |
DocumentReference.subject |
0..1 | Indicates what is the subject of the document | Used to link to specific products, such as a `MedicinalProductDefinition` |
DocumentReference.securityLabel |
0..1 | Field for tagging confidentiality | Used to restrict access |