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 Gravitate Health Project. 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
{
"resourceType" : "Task",
"id" : "scenario1-01-initial-submission",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-15T09:00:00+01:00",
"profile" : [
🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Task: Initial Submission of Type IB Variation (Shelf-Life)</div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "org-synthpharma-ag",
"name" : "SynthPharma AG",
"contact" : [
{
"name" : [
{
"text" : "Dr. John Doe, Head of Regulatory Affairs"
}
],
"telecom" : [
{
"system" : "email",
"value" : "john.doe@synthpharma.example",
"use" : "work"
}
]
}
]
},
{
"resourceType" : "Organization",
"id" : "org-ema-srm-hmed",
"name" : "European Medicines Agency – Human Medicines Evaluation Division",
"contact" : [
{
"name" : [
{
"text" : "Scientific and Regulatory Management"
}
],
"telecom" : [
{
"system" : "email",
"value" : "srm@ema.example.eu",
"use" : "work"
}
]
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "doc1",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "cover-letter",
"display" : "Cover Letter"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m1",
"display" : "Module 1"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/pdf",
"url" : "https://api.synthpharma.example/binaries/submission-123/m1/cover-letter.pdf",
"size" : "1250000",
"title" : "Cover Letter.pdf",
"creation" : "2025-11-15T08:30:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "doc2",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "application-form",
"display" : "Application Form"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m1",
"display" : "Module 1"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/pdf",
"url" : "https://api.synthpharma.example/binaries/submission-123/m1/app-form.pdf",
"size" : "3400000",
"title" : "Application Form.pdf",
"creation" : "2025-11-15T08:35:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "doc3",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "annotated-label",
"display" : "Annotated Label"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m1",
"display" : "Module 1"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/fhir+json",
"url" : "https://api.synthpharma.example/bundles/submission-123/m1/annotated-label.json",
"size" : "45000",
"title" : "Annotated Label (Bundle)",
"creation" : "2025-11-14T16:00:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "doc4",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "clean-label",
"display" : "Clean Label"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m1",
"display" : "Module 1"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/fhir+json",
"url" : "https://api.synthpharma.example/bundles/submission-123/m1/clean-label.json",
"size" : "42000",
"title" : "Clean Label (Bundle)",
"creation" : "2025-11-14T16:05:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "doc5",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "pack-mockup",
"display" : "Pack Mockup"
}
]
},
"content" : [
{
"attachment" : {
"contentType" : "text/html",
"url" : "https://api.synthpharma.example/binaries/submission-123/m1/mockup.html",
"size" : "890000",
"title" : "Pack Mockup.html",
"creation" : "2025-11-14T10:00:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "doc6",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "cmc-stability-summary",
"display" : "Stability Summary"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m3",
"display" : "Module 3"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/fhir+json",
"url" : "https://api.synthpharma.example/bundles/submission-123/m3/stability-summary.json",
"size" : "156000",
"title" : "CMC Doc 1 - Summary (Transaction Bundle)",
"creation" : "2025-11-12T14:30:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "doc7",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "cmc-stability-data",
"display" : "Stability Data"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m3",
"display" : "Module 3"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/fhir+json",
"url" : "https://api.synthpharma.example/bundles/submission-123/m3/stability-data.json",
"size" : "5600000",
"title" : "CMC Doc 2 - Data (Transaction Bundle)",
"creation" : "2025-11-12T14:35:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "doc8",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "cmc-stability-commitment",
"display" : "Stability Commitment"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m3",
"display" : "Module 3"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/fhir+json",
"url" : "https://api.synthpharma.example/bundles/submission-123/m3/stability-commitment.json",
"size" : "24000",
"title" : "CMC Doc 3 - Commitment (Transaction Bundle)",
"creation" : "2025-11-12T14:40:00+01:00"
}
}
]
}
],
"identifier" : [
{
"use" : "official",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type",
"code" : "task-instance-uuid",
"display" : "Task Instance UUID"
}
]
},
"system" : "urn:ietf:rfc:3986",
"value" : "urn:uuid:workflow-step1-instance"
}
],
"groupIdentifier" : {
"use" : "official",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type",
"code" : "submission-group-uuid",
"display" : "Submission Group UUID"
}
]
},
"system" : "urn:ietf:rfc:3986",
"value" : "urn:uuid:workflow-group-id-12345"
},
"status" : "requested",
"businessStatus" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status",
"code" : "submitted",
"display" : "Submitted"
}
]
},
"intent" : "order",
"priority" : "routine",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-type",
"code" : "variation-type-ib",
"display" : "Type IB Variation"
}
]
},
"authoredOn" : "2025-11-15T09:00:00+01:00",
"lastModified" : "2025-11-15T09:00:00+01:00",
"requester" : {
"reference" : "#org-synthpharma-ag",
"display" : "SynthPharma AG"
},
"requestedPerformer" : [
{
"reference" : {
"reference" : "#org-ema-srm-hmed",
"display" : "European Medicines Agency"
}
}
],
"input" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#doc1"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#doc2"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#doc3"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#doc4"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#doc5"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#doc6"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#doc7"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document",
"display" : "Regulatory Document"
}
]
},
"valueReference" : {
"reference" : "#doc8"
}
}
]
}