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
Shelf Life Extension
This page outlines a scenario demonstrating the use of the API Exchange IG and Structured Regulatory Correspondence IG for a Type II variation submission to extend the shelf life of a biologic product.
Scenario Overview
This scenario is for a Type II variation to extend the shelf life of a biologic product from 24 to 36 months. The variation requires updates to labeling (ePI) and pharmaceutical quality (PQI) content. The submission, or Transaction Bundle, includes a Task, a DocumentReference with base64-encoded attachments (application form as a Collection Bundle, ePI Document Bundle, PQI Collection Bundle), and a Provenance. The EMA processes the Transaction Bundle, sends a Transaction Bundle back which includes a LoQ with 10 questions (2 administrative, 3 labeling, 5 CMC) as a Questionnaire. PharmaInc responds with a Transaction Bundle that includes a QuestionnaireResponse (including an SVG image and multi-paragraph text for specific answers). Finally, the EMA issues a Decision Letter Document Bundle within a final 'Transaction Bundle'. All exchanges use RESTful FHIR APIs per the API Exchange IG.
Figure 1: Flow diagram showing the 5 Step exchange between PharmaInc and the EMA, conducted via FHIR Transaction Bundles over RESTful APIs.
Step 1: PharmaInc Submits Type II Variation
PharmaInc submits a Type II variation to extend the shelf life from 24 to 36 months via a Transaction Bundle to the EMA’s FHIR server (https://ema.example.org/fhir). The Bundle includes:
- Task: Requests the variation, with PharmaInc as requester and EMA as owner.
- DocumentReference: References the application form (Collection Bundle), ePI Document Bundle (updated storage conditions), and PQI Collection Bundle (stability data) as base64-encoded attachments.
- Provenance: Records the submission’s origin.
{
"resourceType": "Bundle",
"type": "transaction",
"entry": [
{
"fullUrl": "urn:uuid:task-001",
"resource": {
"resourceType": "Task",
"id": "task-001",
"status": "requested",
"intent": "proposal",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/task-code",
"code": "submit-variation",
"display": "Submit Type II Variation"
}
]
},
"description": "Type II variation for shelf life extension from 24 to 36 months",
"for": {
"reference": "MedicinalProductDefinition/mpd-001"
},
"authoredOn": "2025-06-29",
"requester": {
"reference": "Organization/pharma-inc"
},
"owner": {
"reference": "Organization/ema"
}
},
"request": {
"method": "POST",
"url": "Task"
}
},
{
"fullUrl": "urn:uuid:doc-ref-001",
"resource": {
"resourceType": "DocumentReference",
"id": "doc-ref-001",
"status": "current",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "51851-4",
"display": "Administrative report"
}
]
},
"content": [
{
"attachment": {
"contentType": "application/json",
"data": "base64 data placeholder",
"hash": "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=",
"size": 1234,
"title": "Type II Variation Application Form Collection Bundle"
}
},
{
"attachment": {
"contentType": "application/json",
"data": "base64 data placeholder",
"hash": "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=",
"size": 1234,
"title": "ePI Storage Update Document Bundle"
}
},
{
"attachment": {
"contentType": "application/json",
"data": "base64 data placeholder",
"hash": "qZk+NkcGgWq6PiVxeFDCbJzQ2J0=/nE+3Y2c=",
"size": 1234,
"title": "PQI Stability Data Collection Bundle"
}
}
]
},
"request": {
"method": "POST",
"url": "DocumentReference"
}
},
{
"fullUrl": "urn:uuid:provenance-001",
"resource": {
"resourceType": "Provenance",
"id": "provenance-001",
"target": [
{
"reference": "DocumentReference/doc-ref-001"
}
],
"recorded": "2025-06-29T17:25:00-04:00",
"agent": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/provenance-participant-type",
"code": "author"
}
]
},
"who": {
"reference": "Organization/pharma-inc"
}
}
],
"signature": [
{
"type": [
{
"system": "urn:iso-astm:E1762-95:2013",
"code": "1.2.840.10065.1.12.1.1"
}
],
"when": "2025-06-29T17:25:00-04:00",
"who": {
"reference": "Organization/pharma-inc"
}
}
]
},
"request": {
"method": "POST",
"url": "Provenance"
}
},
{
"fullUrl": "urn:uuid:application-form-001",
"resource": {
"resourceType": "Bundle",
"id": "application-form-001",
"type": "collection",
"entry": [
{
"fullUrl": "urn:uuid:activity-definition-001",
"resource": {
"resourceType": "ActivityDefinition",
"id": "activity-definition-001",
"status": "draft",
"description": "Type II variation application for shelf life extension from 24 to 36 months"
}
}
]
},
"request": {
"method": "POST",
"url": "Bundle"
}
},
{
"fullUrl": "urn:uuid:epi-bundle-001",
"resource": {
"resourceType": "Bundle",
"id": "epi-bundle-001",
"type": "document",
"entry": [
{
"fullUrl": "urn:uuid:epi-composition-001",
"resource": {
"resourceType": "Composition",
"id": "epi-composition-001",
"status": "preliminary",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "34391-3",
"display": "Product Labeling"
}
]
},
"title": "Updated ePI for Monoclonal Antibody",
"section": [
{
"title": "Storage",
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">Store at 2-8°C for up to 36 months.</div>"
}
}
]
}
}
]
},
"request": {
"method": "POST",
"url": "Bundle"
}
},
{
"fullUrl": "urn:uuid:pqi-bundle-001",
"resource": {
"resourceType": "Bundle",
"id": "pqi-bundle-001",
"type": "collection",
"entry": [
{
"fullUrl": "urn:uuid:observation-001",
"resource": {
"resourceType": "Observation",
"id": "observation-001",
"status": "final",
"code": {
"coding": [
{
"system": "http://loinc.org",
"code": "76662-2",
"display": "Stability study"
}
]
},
"valueString": "Stability data supports shelf life extension to 36 months"
}
}
]
},
"request": {
"method": "POST",
"url": "Bundle"
}
}
]
}
Step 2: EMA Receives and Processes the Submission
The EMA’s FHIR server receives the Transaction Bundle at https://ema.example.org/fhir, validates it per the API Exchange IG, and processes the resources:
- Task: Logged as a variation request for
MedicinalProductDefinition/mpd-001. - DocumentReference: Base64-encoded attachments are decoded to access the application form (Collection Bundle), ePI Document Bundle, and PQI Collection Bundle.
- Provenance: Verified for integrity and origin from PharmaInc.
The EMA prepares to send a List of Questions (LoQ). No new FHIR resources are created in this step.
Step 3: EMA Sends List of Questions
The EMA compiles a LoQ with 10 questions (2 administrative, 3 labeling, 5 CMC) in a Questionnaire resource within a Collection Bundle. The Transaction Bundle includes a Task (requesting responses), the Questionnaire, and a Provenance, sent to PharmaInc’s FHIR server (https://pharma-inc.example.org/fhir).
Questions:
- Administrative:
- Is the fee for the Type II variation fully paid and documented?
- Are all required metadata fields in the application form complete?
- Labeling:
- Storage Instructions: Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance?
- Patient Information: Is the patient leaflet revised to clarify the extended shelf life?
- Label Clarity: Is the updated ePI text sufficiently clear for all EU languages?
- CMC:
- Stability Data: Do stability studies cover all required environmental conditions for 36 months?
- Analytical Methods: Are analytical methods validated for detecting degradation over 36 months?
- Impurities: Are new impurities identified in extended stability studies?
- Container Closure System: Is the container closure system validated for 36 months?
- Degradation Products: Are degradation products fully characterized for 36 months?
{
"resourceType": "Bundle",
"type": "transaction",
"entry": [
{
"fullUrl": "urn:uuid:task-002",
"resource": {
"resourceType": "Task",
"id": "task-002",
"status": "requested",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/task-code",
"code": "respond-to-questions",
"display": "Respond to List of Questions"
}
]
},
"description": "Provide responses to the List of Questions for Type II variation (shelf life extension)",
"for": {
"reference": "MedicinalProductDefinition/mpd-001"
},
"authoredOn": "2025-06-29T17:56:00-04:00",
"requester": {
"reference": "Organization/ema"
},
"owner": {
"reference": "Organization/pharma-inc"
}
},
"request": {
"method": "POST",
"url": "Task"
}
},
{
"fullUrl": "urn:uuid:loq-bundle-001",
"resource": {
"resourceType": "Bundle",
"id": "loq-bundle-001",
"type": "collection",
"entry": [
{
"fullUrl": "urn:uuid:questionnaire-001",
"resource": {
"resourceType": "Questionnaire",
"id": "questionnaire-001",
"status": "active",
"title": "List of Questions for Type II Variation (Shelf Life Extension)",
"item": [
{
"linkId": "admin-1",
"text": "Is the fee for the Type II variation fully paid and documented?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "administrative"
}
}
]
},
{
"linkId": "admin-2",
"text": "Are all required metadata fields in the application form complete?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "administrative"
}
}
]
},
{
"linkId": "labeling-1",
"text": "Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "labeling-storage"
}
}
]
},
{
"linkId": "labeling-2",
"text": "Is the patient leaflet revised to clarify the extended shelf life?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "labeling-patient-info"
}
}
]
},
{
"linkId": "labeling-3",
"text": "Is the updated ePI text sufficiently clear for all EU languages?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "labeling-clarity"
}
}
]
},
{
"linkId": "cmc-1",
"text": "Do stability studies cover all required environmental conditions for 36 months?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "cmc-stability"
}
}
]
},
{
"linkId": "cmc-2",
"text": "Are analytical methods validated for detecting degradation over 36 months?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "cmc-analytical"
}
}
]
},
{
"linkId": "cmc-3",
"text": "Are new impurities identified in extended stability studies?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "cmc-impurities"
}
}
]
},
{
"linkId": "cmc-4",
"text": "Is the container closure system validated for 36 months?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "cmc-container"
}
}
]
},
{
"linkId": "cmc-5",
"text": "Are degradation products fully characterized for 36 months?",
"type": "string",
"extension": [
{
"url": "http://example.org/fhir/StructureDefinition/question-category",
"valueCoding": {
"system": "http://example.org/codes",
"code": "cmc-degradation"
}
}
]
}
]
}
}
]
},
"request": {
"method": "POST",
"url": "Bundle"
}
},
{
"fullUrl": "urn:uuid:provenance-002",
"resource": {
"resourceType": "Provenance",
"id": "provenance-002",
"target": [
{
"reference": "Bundle/loq-bundle-001"
}
],
"recorded": "2025-06-29T17:56:00-04:00",
"agent": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/provenance-participant-type",
"code": "author"
}
]
},
"who": {
"reference": "Organization/ema"
}
}
],
"signature": [
{
"type": [
{
"system": "urn:iso-astm:E1762-95:2013",
"code": "1.2.840.10065.1.12.1.1"
}
],
"when": "2025-06-29T17:56:00-04:00",
"who": {
"reference": "Organization/ema"
}
}
]
},
"request": {
"method": "POST",
"url": "Provenance"
}
}
]
}
Step 4: PharmaInc Responds to List of Questions
PharmaInc’s FHIR server processes the LoQ, prepares a QuestionnaireResponse with answers to all 10 questions, and sends a Transaction Bundle to the EMA’s FHIR server (https://ema.example.org/fhir). For cmc-4 (container closure system), the response includes a base64-encoded SVG image. For cmc-5 (degradation products), the response includes two paragraphs. The Bundle includes a Task (indicating completion), the QuestionnaireResponse, and a Provenance.
Responses:
- Administrative:
- Fee paid on June 25, 2025, with documentation.
- All metadata fields are complete per EMA guidelines.
- Labeling:
- No additional patient guidance needed for storage conditions.
- Patient leaflet updated for 36-month shelf life.
- ePI text translated and clear in all EU languages.
- CMC:
- Stability studies cover all environmental conditions per ICH guidelines.
- Analytical methods validated, with results in PQI.
- No new impurities identified.
- Container closure system validated, with SVG diagram.
- Degradation products characterized, with no significant changes (two paragraphs).
{
"resourceType": "Bundle",
"type": "transaction",
"entry": [
{
"fullUrl": "urn:uuid:task-003",
"resource": {
"resourceType": "Task",
"id": "task-003",
"status": "completed",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/task-code",
"code": "submit-response",
"display": "Submit Response to List of Questions"
}
]
},
"description": "Submission of responses to the List of Questions for Type II variation (shelf life extension)",
"for": {
"reference": "MedicinalProductDefinition/mpd-001"
},
"authoredOn": "2025-06-29T18:15:00-04:00",
"requester": {
"reference": "Organization/pharma-inc"
},
"owner": {
"reference": "Organization/ema"
}
},
"request": {
"method": "POST",
"url": "Task"
}
},
{
"fullUrl": "urn:uuid:response-bundle-001",
"resource": {
"resourceType": "Bundle",
"id": "response-bundle-001",
"type": "collection",
"entry": [
{
"fullUrl": "urn:uuid:questionnaire-response-001",
"resource": {
"resourceType": "QuestionnaireResponse",
"id": "questionnaire-response-001",
"questionnaire": "Questionnaire/questionnaire-001",
"status": "completed",
"authored": "2025-06-29T18:15:00-04:00",
"item": [
{
"linkId": "admin-1",
"text": "Is the fee for the Type II variation fully paid and documented?",
"answer": [
{
"valueString": "Yes, the fee was paid on June 25, 2025, with documentation included in the application form."
}
]
},
{
"linkId": "admin-2",
"text": "Are all required metadata fields in the application form complete?",
"answer": [
{
"valueString": "All metadata fields are complete, as verified against EMA guidelines."
}
]
},
{
"linkId": "labeling-1",
"text": "Do the updated storage conditions (2-8°C for 36 months) require additional patient guidance?",
"answer": [
{
"valueString": "No additional guidance is needed; the ePI clearly states storage at 2-8°C for 36 months."
}
]
},
{
"linkId": "labeling-2",
"text": "Is the patient leaflet revised to clarify the extended shelf life?",
"answer": [
{
"valueString": "Yes, the patient leaflet has been updated to reflect the 36-month shelf life."
}
]
},
{
"linkId": "labeling-3",
"text": "Is the updated ePI text sufficiently clear for all EU languages?",
"answer": [
{
"valueString": "The ePI text has been translated and reviewed for clarity in all EU languages."
}
]
},
{
"linkId": "cmc-1",
"text": "Do stability studies cover all required environmental conditions for 36 months?",
"answer": [
{
"valueString": "Yes, stability studies include temperature, humidity, and light conditions for 36 months, per ICH guidelines."
}
]
},
{
"linkId": "cmc-2",
"text": "Are analytical methods validated for detecting degradation over 36 months?",
"answer": [
{
"valueString": "Analytical methods are fully validated, with results included in the PQI submission."
}
]
},
{
"linkId": "cmc-3",
"text": "Are new impurities identified in extended stability studies?",
"answer": [
{
"valueString": "No new impurities were identified; all impurities are within acceptable limits."
}
]
},
{
"linkId": "cmc-4",
"text": "Is the container closure system validated for 36 months?",
"answer": [
{
"valueString": "The container closure system is validated for 36 months, with supporting data in the PQI Bundle."
},
{
"valueAttachment": {
"contentType": "image/svg+xml",
"data": "PHN2ZyB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciIHdpZHRoPSIxMDAiIGhlaWdodD0iMTAwIj48cmVjdCB3aWR0aD0iMTAwIiBoZWlnaHQ9IjEwMCIgZmlsbD0iI2ZmZiIvPjx0ZXh0IHg9IjUwIiB5PSI1MCIgZm9udC1zaXplPSIxNSIgZmlsbD0iIzAwMCIgdGV4dC1hbmNob3I9Im1pZGRsZSI+U1ZHIFBsYWNlaG9sZGVyPC90ZXh0Pjwvc3ZnPg==",
"title": "Container Closure System Diagram"
}
}
]
},
{
"linkId": "cmc-5",
"text": "Are degradation products fully characterized for 36 months?",
"answer": [
{
"valueString": "Degradation products are fully characterized. No significant changes were observed in the 36-month stability studies.\nAll identified degradation products remain within acceptable limits, as detailed in the PQI submission."
}
]
}
]
}
}
]
},
"request": {
"method": "POST",
"url": "Bundle"
}
},
{
"fullUrl": "urn:uuid:provenance-003",
"resource": {
"resourceType": "Provenance",
"id": "provenance-003",
"target": [
{
"reference": "Bundle/response-bundle-001"
}
],
"recorded": "2025-06-29T18:15:00-04:00",
"agent": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/provenance-participant-type",
"code": "author"
}
]
},
"who": {
"reference": "Organization/pharma-inc"
}
}
],
"signature": [
{
"type": [
{
"system": "urn:iso-astm:E1762-95:2013",
"code": "1.2.840.10065.1.12.1.1"
}
],
"when": "2025-06-29T18:15:00-04:00",
"who": {
"reference": "Organization/pharma-inc"
}
}
]
},
"request": {
"method": "POST",
"url": "Provenance"
}
}
]
}
Step 5: EMA Issues Decision Letter
The EMA reviews PharmaInc’s LoQ responses and approves the variation. The Decision Letter is a Document Bundle with a Composition, encoded as base64 data in a DocumentReference. The Transaction Bundle includes a Task, the DocumentReference, and a Provenance, sent to PharmaInc’s FHIR server (https://pharma-inc.example.org/fhir).
{
"resourceType": "Bundle",
"type": "transaction",
"entry": [
{
"fullUrl": "urn:uuid:task-004",
"resource": {
"resourceType": "Task",
"id": "task-004",
"status": "completed",
"intent": "order",
"code": {
"coding": [
{
"system": "http://hl7.org/fhir/task-code",
"code": "issue-decision",
"display": "Issue Decision Letter"
}
]
},
"description": "Issuance of Decision Letter approving Type II variation for shelf life extension",
"for": {
"reference": "MedicinalProductDefinition/mpd-001"
},
"authoredOn": "2025-06-29T18:30:00-04:00",
"requester": {
"reference": "Organization/ema"
},
"owner": {
"reference": "Organization/pharma-inc"
}
},
"request": {
"method": "POST",
"url": "Task"
}
},
{
"fullUrl": "urn:uuid:doc-ref-002",
"resource": {
"resourceType": "DocumentReference",
"id": "doc-ref-002",
"status": "current",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "51851-4",
"display": "Administrative report"
}
]
},
"content": [
{
"attachment": {
"contentType": "application/fhir+json",
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