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/cander2/recon-ig/ and changes regularly. See the Directory of published versions
This page provides example FHIR Bundles to demonstrate regulatory workflows for two drug applications: a safety update and a shelf life update for the same drug (NDC: 12345-678-90). The examples align with the R2CS streaming architecture, using Apache Kafka to process JSON Bundles in real-time, and include:
type: transaction): Original submissions and approvals, containing Task, DocumentReference (inlining ePI, eAF, PQI Bundles in content.attachment.data), MedicinalProductDefinition, and Provenance.type: document): ePI, eAF, Requests for Information (RFIs), and company responses, containing Composition or DocumentReference, Task, and Provenance.type: collection): PQI content, inlined in submission Transaction Bundles.All Bundles are uniquely identified (Bundle.identifier), linked to parent applications (Task.basedOn), and tracked by NDC codes (MedicinalProductDefinition). They are streamed as NDJSON to r2cs-submissions or r2cs-notifications, with sanitization (schema validation, tag whitelisting, SHA-256 hashes) to ensure security and compliance (e.g., 21 CFR Part 11, EU GMP Annex 11).
The pharmaceutical company submits the safety update on May 1, 2025, inlining ePI and eAF Document Bundles.
{
"resourceType": "Bundle",
"type": "transaction",
"identifier": {
"system": "http://example.org/r2cs/submissions",
"value": "safety-submission-2025-05-01"
},
"timestamp": "2025-05-01T09:00:00Z",
"entry": [
{
"fullUrl": "urn:uuid:task-safety-001",
"resource": {
"resourceType": "Task",
"id": "task-safety-001",
"status": "requested",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/CodeSystem/task-code",
"code": "submit",
"display": "Submit"
}
]
},
"for": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"authoredOn": "2025-05-01T09:00:00Z",
"requester": {
"reference": "Organization/pharma-co"
},
"owner": {
"reference": "Organization/fda"
}
},
"request": {
"method": "POST",
"url": "Task"
}
},
{
"fullUrl": "urn:uuid:docref-epi-safety-001",
"resource": {
"resourceType": "DocumentReference",
"id": "docref-epi-safety-001",
"status": "current",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "34356-7",
"display": "Product Label"
}
]
},
"subject": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"content": [
{
"attachment": {
"contentType": "application/json",
"data": "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",
"hash": "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=",
"size": 1234,
"title": "ePI Safety Update Document Bundle"
}
}
]
},
"request": {
"method": "POST",
"url": "DocumentReference"
}
},
{
"fullUrl": "urn:uuid:docref-eaf-safety-001",
"resource": {
"resourceType": "DocumentReference",
"id": "docref-eaf-safety-001",
"status": "current",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "51851-4",
"display": "Administrative Form"
}
]
},
"subject": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"content": [
{
"attachment": {
"contentType": "application/json",
"data": "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",
"hash": "rL0Y20zC+Fzt72VPzMsf7oQhAewv3fG4=/pX+3Z2d=",
"size": 987,
"title": "eAF Safety Update Document Bundle"
}
}
]
},
"request": {
"method": "POST",
"url": "DocumentReference"
}
},
{
"fullUrl": "urn:uuid:mpd-123",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "mpd-123",
"identifier": [
{
"system": "http://hl7.org/fhir/sid/ndc",
"value": "12345-678-90"
}
],
"name": [
{
"productName": "[Medicinal Product]"
}
]
},
"request": {
"method": "POST",
"url": "MedicinalProductDefinition"
}
},
{
"fullUrl": "urn:uuid:prov-safety-001",
"resource": {
"resourceType": "Provenance",
"id": "prov-safety-001",
"target": [
{
"reference": "urn:uuid:task-safety-001"
},
{
"reference": "urn:uuid:docref-epi-safety-001"
},
{
"reference": "urn:uuid:docref-eaf-safety-001"
}
],
"recorded": "2025-05-01T09:00:00Z",
"agent": [
{
"who": {
"reference": "Organization/pharma-co"
},
"onBehalfOf": {
"reference": "Organization/fda"
}
}
],
"activity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
"code": "CREATE"
}
]
}
},
"request": {
"method": "POST",
"url": "Provenance"
}
}
]
}
Regulator requests additional data on May 3, 2025.
{
"resourceType": "Bundle",
"type": "transaction",
"identifier": {
"system": "http://example.org/r2cs/submissions",
"value": "safety-rfi-2025-05-03"
},
"timestamp": "2025-05-03T14:00:00Z",
"entry": [
{
"fullUrl": "urn:uuid:comp-safety-rfi-001",
"resource": {
"resourceType": "Composition",
"id": "comp-safety-rfi-001",
"status": "final",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "74468-0",
"display": "Question Response"
}
]
},
"subject": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"title": "RFI for Safety Update of [Medicinal Product]",
"section": [
{
"title": "Request Details",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Please provide clinical data supporting the dizziness warning update.</p></div>"
}
}
]
}
},
{
"fullUrl": "urn:uuid:task-safety-rfi-001",
"resource": {
"resourceType": "Task",
"id": "task-safety-rfi-001",
"status": "requested",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/CodeSystem/task-code",
"code": "review",
"display": "Review"
}
]
},
"focus": {
"reference": "urn:uuid:comp-safety-rfi-001"
},
"for": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"basedOn": [
{
"reference": "Task/task-safety-001"
}
],
"authoredOn": "2025-05-03T14:00:00Z",
"requester": {
"reference": "Organization/fda"
},
"owner": {
"reference": "Organization/pharma-co"
}
}
},
{
"fullUrl": "urn:uuid:mpd-123",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "mpd-123",
"identifier": [
{
"system": "http://hl7.org/fhir/sid/ndc",
"value": "12345-678-90"
}
],
"name": [
{
"productName": "[Medicinal Product]"
}
]
}
},
{
"fullUrl": "urn:uuid:prov-safety-rfi-001",
"resource": {
"resourceType": "Provenance",
"id": "prov-safety-rfi-001",
"target": [
{
"reference": "urn:uuid:comp-safety-rfi-001"
},
{
"reference": "urn:uuid:task-safety-rfi-001"
}
],
"recorded": "2025-05-03T14:00:00Z",
"agent": [
{
"who": {
"reference": "Organization/fda"
}
}
],
"activity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
"code": "UPDATE"
}
]
}
}
}
]
}
The company responds with clinical data on May 5, 2025.
{
"resourceType": "Bundle",
"type": "document",
"identifier": {
"system": "http://example.org/r2cs/submissions",
"value": "safety-response-2025-05-05"
},
"timestamp": "2025-05-05T10:00:00Z",
"entry": [
{
"fullUrl": "urn:uuid:docref-safety-response-001",
"resource": {
"resourceType": "DocumentReference",
"id": "docref-safety-response-001",
"status": "current",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "55107-7",
"display": "Supporting Documentation"
}
]
},
"subject": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"content": [
{
"attachment": {
"contentType": "application/pdf",
"url": "http://example.org/clinical-data.pdf",
"title": "Clinical Data for Dizziness Warning"
}
}
]
}
},
{
"fullUrl": "urn:uuid:task-safety-response-001",
"resource": {
"resourceType": "Task",
"id": "task-safety-response-001",
"status": "completed",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/CodeSystem/task-code",
"code": "fulfill",
"display": "Fulfill"
}
]
},
"focus": {
"reference": "urn:uuid:docref-safety-response-001"
},
"for": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"basedOn": [
{
"reference": "Task/task-safety-rfi-001"
}
],
"authoredOn": "2025-05-05T10:00:00Z",
"requester": {
"reference": "Organization/pharma-co"
},
"owner": {
"reference": "Organization/fda"
}
}
},
{
"fullUrl": "urn:uuid:mpd-123",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "mpd-123",
"identifier": [
{
"system": "http://hl7.org/fhir/sid/ndc",
"value": "12345-678-90"
}
],
"name": [
{
"productName": "[Medicinal Product]"
}
]
}
},
{
"fullUrl": "urn:uuid:prov-safety-response-001",
"resource": {
"resourceType": "Provenance",
"id": "prov-safety-response-001",
"target": [
{
"reference": "urn:uuid:docref-safety-response-001"
},
{
"reference": "urn:uuid:task-safety-response-001"
}
],
"recorded": "2025-05-05T10:00:00Z",
"agent": [
{
"who": {
"reference": "Organization/pharma-co"
}
}
],
"activity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
"code": "UPDATE"
}
]
}
}
}
]
}
Regulator approves the safety update on May 7, 2025.
{
"resourceType": "Bundle",
"type": "transaction",
"identifier": {
"system": "http://example.org/r2cs/submissions",
"value": "safety-approval-2025-05-07"
},
"timestamp": "2025-05-07T16:00:00Z",
"entry": [
{
"fullUrl": "urn:uuid:task-safety-approval-001",
"resource": {
"resourceType": "Task",
"id": "task-safety-approval-001",
"status": "completed",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/CodeSystem/task-code",
"code": "approve",
"display": "Approve"
}
]
},
"for": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"basedOn": [
{
"reference": "Task/task-safety-001"
}
],
"authoredOn": "2025-05-07T16:00:00Z",
"requester": {
"reference": "Organization/fda"
},
"owner": {
"reference": "Organization/pharma-co"
}
},
"request": {
"method": "POST",
"url": "Task"
}
},
{
"fullUrl": "urn:uuid:prov-safety-approval-001",
"resource": {
"resourceType": "Provenance",
"id": "prov-safety-approval-001",
"target": [
{
"reference": "urn:uuid:task-safety-approval-001"
}
],
"recorded": "2025-05-07T16:00:00Z",
"agent": [
{
"who": {
"reference": "Organization/fda"
}
}
],
"activity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
"code": "UPDATE"
}
]
}
},
"request": {
"method": "POST",
"url": "Provenance"
}
}
]
}
The company submits the shelf life update on May 8, 2025, inlining ePI, eAF, and PQI Bundles.
{
"resourceType": "Bundle",
"type": "transaction",
"identifier": {
"system": "http://example.org/r2cs/submissions",
"value": "shelf-life-submission-2025-05-08"
},
"timestamp": "2025-05-08T09:00:00Z",
"entry": [
{
"fullUrl": "urn:uuid:task-shelf-life-001",
"resource": {
"resourceType": "Task",
"id": "task-shelf-life-001",
"status": "requested",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/CodeSystem/task-code",
"code": "submit",
"display": "Submit"
}
]
},
"for": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"authoredOn": "2025-05-08T09:00:00Z",
"requester": {
"reference": "Organization/pharma-co"
},
"owner": {
"reference": "Organization/fda"
}
},
"request": {
"method": "POST",
"url": "Task"
}
},
{
"fullUrl": "urn:uuid:docref-epi-shelf-life-001",
"resource": {
"resourceType": "DocumentReference",
"id": "docref-epi-shelf-life-001",
"status": "current",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "34356-7",
"display": "Product Label"
}
]
},
"subject": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"content": [
{
"attachment": {
"contentType": "application/json",
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"size": 1456,
"title": "ePI Shelf Life Update Document Bundle"
}
}
]
},
"request": {
"method": "POST",
"url": "DocumentReference"
}
},
{
"fullUrl": "urn:uuid:docref-eaf-shelf-life-001",
"resource": {
"resourceType": "DocumentReference",
"id": "docref-eaf-shelf-life-001",
"status": "current",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "51851-4",
"display": "Administrative Form"
}
]
},
"subject": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"content": [
{
"attachment": {
"contentType": "application/json",
"data": "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",
"hash": "sK8+MjdFiWq8PjWyeHEDdLzS4K2=/nG+5Z4f=",
"size": 1098,
"title": "eAF Shelf Life Update Document Bundle"
}
}
]
},
"request": {
"method": "POST",
"url": "DocumentReference"
}
},
{
"fullUrl": "urn:uuid:docref-pqi-shelf-life-001",
"resource": {
"resourceType": "DocumentReference",
"id": "docref-pqi-shelf-life-001",
"status": "current",
"type": {
"coding": [
{
"system": "http://example.org/r2cs",
"code": "stability",
"display": "Stability Update"
}
]
},
"subject": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"content": [
{
"attachment": {
"contentType": "application/json",
"data": "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",
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"size": 876,
"title": "PQI Shelf Life Update Collection Bundle"
}
}
]
},
"request": {
"method": "POST",
"url": "DocumentReference"
}
},
{
"fullUrl": "urn:uuid:mpd-123",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "mpd-123",
"identifier": [
{
"system": "http://hl7.org/fhir/sid/ndc",
"value": "12345-678-90"
}
],
"name": [
{
"productName": "[Medicinal Product]"
}
]
},
"request": {
"method": "POST",
"url": "MedicinalProductDefinition"
}
},
{
"fullUrl": "urn:uuid:prov-shelf-life-001",
"resource": {
"resourceType": "Provenance",
"id": "prov-shelf-life-001",
"target": [
{
"reference": "urn:uuid:task-shelf-life-001"
},
{
"reference": "urn:uuid:docref-epi-shelf-life-001"
},
{
"reference": "urn:uuid:docref-eaf-shelf-life-001"
},
{
"reference": "urn:uuid:docref-pqi-shelf-life-001"
}
],
"recorded": "2025-05-08T09:00:00Z",
"agent": [
{
"who": {
"reference": "Organization/pharma-co"
},
"onBehalfOf": {
"reference": "Organization/fda"
}
}
],
"activity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
"code": "CREATE"
}
]
}
},
"request": {
"method": "POST",
"url": "Provenance"
}
}
]
}
Regulator requests additional stability data on May 10, 2025.
{
"resourceType": "Bundle",
"type": "transaction",
"identifier": {
"system": "http://example.org/r2cs/submissions",
"value": "shelf-life-rfi-2025-05-10"
},
"timestamp": "2025-05-10T14:00:00Z",
"entry": [
{
"fullUrl": "urn:uuid:comp-shelf-life-rfi-001",
"resource": {
"resourceType": "Composition",
"id": "comp-shelf-life-rfi-001",
"status": "final",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "74468-0",
"display": "Question Response"
}
]
},
"subject": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"title": "RFI for Shelf Life Update of [Medicinal Product]",
"section": [
{
"title": "Request Details",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Please provide additional stability test results for 36-month shelf life.</p></div>"
}
}
]
}
},
{
"fullUrl": "urn:uuid:task-shelf-life-rfi-001",
"resource": {
"resourceType": "Task",
"id": "task-shelf-life-rfi-001",
"status": "requested",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/CodeSystem/task-code",
"code": "review",
"display": "Review"
}
]
},
"focus": {
"reference": "urn:uuid:comp-shelf-life-rfi-001"
},
"for": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"basedOn": [
{
"reference": "Task/task-shelf-life-001"
}
],
"authoredOn": "2025-05-10T14:00:00Z",
"requester": {
"reference": "Organization/fda"
},
"owner": {
"reference": "Organization/pharma-co"
}
}
},
{
"fullUrl": "urn:uuid:mpd-123",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "mpd-123",
"identifier": [
{
"system": "http://hl7.org/fhir/sid/ndc",
"value": "12345-678-90"
}
],
"name": [
{
"productName": "[Medicinal Product]"
}
]
}
},
{
"fullUrl": "urn:uuid:prov-shelf-life-rfi-001",
"resource": {
"resourceType": "Provenance",
"id": "prov-shelf-life-rfi-001",
"target": [
{
"reference": "urn:uuid:comp-shelf-life-rfi-001"
},
{
"reference": "urn:uuid:task-shelf-life-rfi-001"
}
],
"recorded": "2025-05-10T14:00:00Z",
"agent": [
{
"who": {
"reference": "Organization/fda"
}
}
],
"activity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
"code": "UPDATE"
}
]
}
}
}
]
}
The company responds with stability data on May 12, 2025.
{
"resourceType": "Bundle",
"type": "transaction",
"identifier": {
"system": "http://example.org/r2cs/submissions",
"value": "shelf-life-response-2025-05-12"
},
"timestamp": "2025-05-12T10:00:00Z",
"entry": [
{
"fullUrl": "urn:uuid:docref-shelf-life-response-001",
"resource": {
"resourceType": "DocumentReference",
"id": "docref-shelf-life-response-001",
"status": "current",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "55107-7",
"display": "Supporting Documentation"
}
]
},
"subject": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"content": [
{
"attachment": {
"contentType": "application/pdf",
"url": "http://example.org/stability-data.pdf",
"title": "Additional Stability Test Results"
}
}
]
}
},
{
"fullUrl": "urn:uuid:task-shelf-life-response-001",
"resource": {
"resourceType": "Task",
"id": "task-shelf-life-response-001",
"status": "completed",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/CodeSystem/task-code",
"code": "fulfill",
"display": "Fulfill"
}
]
},
"focus": {
"reference": "urn:uuid:docref-shelf-life-response-001"
},
"for": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"basedOn": [
{
"reference": "Task/task-shelf-life-rfi-001"
}
],
"authoredOn": "2025-05-12T10:00:00Z",
"requester": {
"reference": "Organization/pharma-co"
},
"owner": {
"reference": "Organization/fda"
}
}
},
{
"fullUrl": "urn:uuid:mpd-123",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "mpd-123",
"identifier": [
{
"system": "http://hl7.org/fhir/sid/ndc",
"value": "12345-678-90"
}
],
"name": [
{
"productName": "[Medicinal Product]"
}
]
}
},
{
"fullUrl": "urn:uuid:prov-shelf-life-response-001",
"resource": {
"resourceType": "Provenance",
"id": "prov-shelf-life-response-001",
"target": [
{
"reference": "urn:uuid:docref-shelf-life-response-001"
},
{
"reference": "urn:uuid:task-shelf-life-response-001"
}
],
"recorded": "2025-05-12T10:00:00Z",
"agent": [
{
"who": {
"reference": "Organization/pharma-co"
}
}
],
"activity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
"code": "UPDATE"
}
]
}
}
}
]
}
Regulator approves the shelf life update on May 14, 2025.
{
"resourceType": "Bundle",
"type": "transaction",
"identifier": {
"system": "http://example.org/r2cs/submissions",
"value": "shelf-life-approval-2025-05-14"
},
"timestamp": "2025-05-14T16:00:00Z",
"entry": [
{
"fullUrl": "urn:uuid:task-shelf-life-approval-001",
"resource": {
"resourceType": "Task",
"id": "task-shelf-life-approval-001",
"status": "completed",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/CodeSystem/task-code",
"code": "approve",
"display": "Approve"
}
]
},
"for": {
"reference": "MedicinalProductDefinition/mpd-123"
},
"basedOn": [
{
"reference": "Task/task-shelf-life-001"
}
],
"authoredOn": "2025-05-14T16:00:00Z",
"requester": {
"reference": "Organization/fda"
},
"owner": {
"reference": "Organization/pharma-co"
}
},
"request": {
"method": "POST",
"url": "Task"
}
},
{
"fullUrl": "urn:uuid:prov-shelf-life-approval-001",
"resource": {
"resourceType": "Provenance",
"id": "prov-shelf-life-approval-001",
"target": [
{
"reference": "urn:uuid:task-shelf-life-approval-001"
}
],
"recorded": "2025-05-14T16:00:00Z",
"agent": [
{
"who": {
"reference": "Organization/fda"
}
}
],
"activity": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-DataOperation",
"code": "UPDATE"
}
]
}
},
"request": {
"method": "POST",
"url": "Provenance"
}
}
]
}