FHIR IG analytics| Package | hl7.fhir.uv.apix |
| Resource Type | ImplementationGuide |
| Id | ImplementationGuide-hl7.fhir.uv.apix.json |
| FHIR Version | R5 |
| Source | https://build.fhir.org/ig/HL7/APIX---API-Exchange-for-Medicinal-Products/index.html |
| URL | http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix |
| Version | 0.1.0 |
| Status | active |
| Date | 2026-02-05T04:12:11+00:00 |
| Name | ApixIG |
| Title | API for the Exchange of Medicinal Product Information (APIX) |
| Realm | uv |
| Authority | hl7 |
| Description | A global standard for real-time, API-based exchange of biopharmaceutical regulatory information (e.g., drug labeling and drug quality). |
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Note: links and images are rebased to the (stated) source
Generated Narrative: ImplementationGuide hl7.fhir.uv.apix
The official URL for this implementation guide is:
http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix
A global standard for real-time, API-based exchange of biopharmaceutical regulatory information (e.g., drug labeling and drug quality).
FHIR
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"date": "2026-02-05T04:12:11+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
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"license": "CC0-1.0",
"fhirVersion": [
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},
"name": "APIX CTD/eCTD Section Code System",
"description": "Value set for CTD section codes used in APIX regulatory submissions",
"isExample": false
},
{
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],
"reference": {
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},
"name": "APIX CTD/eCTD Section Code System",
"description": "Code system defining all relevant CTD/eCTD section codes used in APIX regulatory submissions to EMA, FDA, PMDA and other agencies. Based on ICH M4 guidelines.",
"isExample": false
},
{
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],
"reference": {
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},
"name": "APIX Endpoint for FHIR Subscription Notifications",
"description": "Endpoint requiring identifier, name, and connectionType of hl7-fhir-subscription-notify.",
"isExample": false
},
{
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"valueString": "StructureDefinition:resource"
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],
"reference": {
"reference": "StructureDefinition/apix-organization"
},
"name": "APIX Organization",
"description": "Organization profile for APIX regulatory workflows, derived from and compatible with ePI requirements.",
"isExample": false
},
{
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"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/apix-business-status-vs"
},
"name": "APIX Regulatory Business Status",
"description": "Value set for regulatory business status in APIX submissions",
"isExample": false
},
{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
}
],
"reference": {
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},
"name": "APIX Regulatory Business Status",
"description": "Code system for regulatory business status in APIX submissions",
"isExample": false
},
{
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"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/apix-documentreference"
},
"name": "APIX Regulatory DocumentReference",
"description": "DocumentReference profile used in APIX regulatory submissions. Supports both embedded base64 data and referenced binaries via URL (Index Pattern). Includes support for versioning, lifecycle status, and CTD section categorization.",
"isExample": false
},
{
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"valueString": "StructureDefinition:resource"
}
],
"reference": {
"reference": "StructureDefinition/apix-task"
},
"name": "APIX Regulatory Task",
"description": "Task profile for APIX regulatory submission workflows",
"isExample": false
},
{
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{
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"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/apix-submission-type-vs"
},
"name": "APIX Submission Types",
"description": "Value set for submission types in APIX regulatory procedures",
"isExample": false
},
{
"extension": [
{
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}
],
"reference": {
"reference": "StructureDefinition/task-creation-with-organization-assigned-filter"
},
"name": "APIX Task Assignment and Creation With Organization Filter",
"description": "SubscriptionTopic notifying an organization when a Task is created and assigned to them.",
"isExample": false
},
{
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"valueString": "CodeSystem"
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],
"reference": {
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},
"name": "APIX Task Code System",
"description": "Code system for regulatory task types in APIX submissions",
"isExample": false
},
{
"extension": [
{
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"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/apix-task-code-vs"
},
"name": "APIX Task Codes ValueSet",
"description": "Value set for task codes in APIX regulatory submissions",
"isExample": false
},
{
"extension": [
{
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"valueString": "ValueSet"
}
],
"reference": {
"reference": "ValueSet/apix-task-input-type-vs"
},
"name": "APIX Task Input Types",
"description": "Value set for task input types in APIX regulatory submissions",
"isExample": false
},
{
"extension": [
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"valueString": "CodeSystem"
}
],
"reference": {
"reference": "CodeSystem/apix-task-input-type"
},
"name": "APIX Task Input Types Code System",
"description": "Code system for task input types in APIX regulatory submissions",
"isExample": false
},
{
"extension": [
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],
"reference": {
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},
"name": "APIX Task Output Types Code System",
"description": "Code system for task output types in APIX regulatory submissions",
"isExample": false
},
{
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],
"reference": {
"reference": "StructureDefinition/task-status-change-with-identifier-filter"
},
"name": "APIX Task Status Change With Identifier Filter",
"description": "Triggers when a Task.status value changes and allows filtering by Task.identifier.",
"isExample": false
},
{
"extension": [
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"valueString": "Endpoint"
}
],
"reference": {
"reference": "Endpoint/1005"
},
"name": "Example APIX interaction Endpoint with header",
"description": "Example APIX interaction Endpoint with header information; payload is very loosely defined, sufficient where payload considerations are handled internally and not exposed. Note identifier. n",
"isExample": true,
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},
{
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"valueString": "Endpoint"
}
],
"reference": {
"reference": "Endpoint/1003"
},
"name": "Example basic APIX interaction Endpoint",
"description": "Example basic APIX interaction Endpoint, payload is very loosely defined; payload considerations are handled internally and not exposed. Note identifier.",
"isExample": true,
"profile": [
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]
},
{
"extension": [
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"valueString": "DocumentReference"
}
],
"reference": {
"reference": "DocumentReference/docref-invoice"
},
"name": "Invoice #INV-2025-001",
"description": "Financial invoice for regulatory submission review",
"isExample": true
},
{
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"valueString": "Organization"
}
],
"reference": {
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},
"name": "Organization example with Endpoint",
"description": "Organization example with Endpoint.",
"isExample": true,
"profile": [
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]
},
{
"extension": [
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"valueString": "Task"
}
],
"reference": {
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},
"name": "scenario1-01-initial-submission",
"isExample": true,
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},
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"reference": {
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"name": "scenario1-01b-stability-update-1",
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"name": "scenario1-03-finance-invoice",
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"name": "scenario1-04-finance-payment",
"isExample": true,
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"isExample": true,
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"reference": {
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"name": "scenario1-07-final-decision",
"isExample": true,
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},
{
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"valueString": "Subscription"
}
],
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"isExample": true
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{
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],
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],
"reference": {
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},
"name": "Task Status Change With Identifier Filter",
"description": "Triggers when a Task.status value changes. Allows subscriptions to filter by Task.identifier.",
"isExample": true,
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},
{
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"valueString": "Task"
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"reference": {
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},
"name": "task-nda-submission-index-2025",
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{
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],
"reference": {
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},
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},
{
"extension": [
{
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"valueString": "MedicinalProductDefinition"
}
],
"reference": {
"reference": "MedicinalProductDefinition/example-ma"
},
"name": "WonderDrug",
"isExample": true
}
],
"page": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "toc.html",
"name": "toc.html",
"title": "Table of Contents",
"generation": "html",
"page": [
{
"extension": [
{
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],
"sourceUrl": "index.html",
"name": "index.html",
"title": "IG Home",
"generation": "markdown"
},
{
"extension": [
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"valueCode": "informative"
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],
"sourceUrl": "usecases.html",
"name": "usecases.html",
"title": "Use Cases",
"generation": "markdown"
},
{
"extension": [
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"valueCode": "informative"
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],
"sourceUrl": "apixinteractionpattern.html",
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"title": "APIX Interaction Example",
"generation": "markdown"
},
{
"extension": [
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],
"sourceUrl": "apixtask.html",
"name": "apixtask.html",
"title": "APIX Task Structure",
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},
{
"extension": [
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"valueCode": "informative"
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],
"sourceUrl": "apixsubscription.html",
"name": "apixsubscription.html",
"title": "Subscription",
"generation": "markdown"
},
{
"extension": [
{
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"valueCode": "informative"
}
],
"sourceUrl": "apixsubscriptionTopic.html",
"name": "apixsubscriptionTopic.html",
"title": "SubscriptionTopic",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "apixsubscriptionNotificationAndStatus.html",
"name": "apixsubscriptionNotificationAndStatus.html",
"title": "SubscriptionNotification Bundle/SubscriptionStatus",
"generation": "markdown"
},
{
"extension": [
{
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"valueCode": "informative"
}
],
"sourceUrl": "apixorganizationEndpoint.html",
"name": "apixorganizationEndpoint.html",
"title": "Endpoint/Organization",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "apixdocumentReference.html",
"name": "apixdocumentReference.html",
"title": "DocumentReference",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "workflow.html",
"name": "workflow.html",
"title": "Workflow Example",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "subscriptions.html",
"name": "subscriptions.html",
"title": "Real-Time Subscriptions",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "architecture.html",
"name": "architecture.html",
"title": "Architecture",
"generation": "markdown"
}
]
},
"parameter": [
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "copyrightyear"
},
"value": "2025+"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "releaselabel"
},
"value": "ci-build"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-contact"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-jurisdiction"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-publisher"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-version"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "apply-wg"
},
"value": "true"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "path-history"
},
"value": "http://hl7.org/fhir/uv/apix/history.html"
},
{
"code": {
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "autoload-resources"
},
"value": "true"
},
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