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" : "task-shelf-life-extension-synthpharma-2025",
"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\">Type IB Variation (C.I.4) – Extension of shelf-life for the finished product SynthVac 50 mg film-coated tablets from 24 months to 36 months based on additional long-term stability data at 25°C/60% RH.</div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "org-synthpharma-ag",
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/v1/organisations",
"value" : "ORG-987654"
}
],
"name" : "SynthPharma AG",
"contact" : [
{
"name" : [
{
"text" : "Dr. John Doe, Head of Regulatory Affairs, Global Regulatory Strategy"
}
],
"telecom" : [
{
"system" : "email",
"value" : "john.doe@synthpharma.example",
"use" : "work"
}
]
}
]
},
{
"resourceType" : "Organization",
"id" : "org-ema-srm-hmed",
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/v1/organisations",
"value" : "ORG-EMA-000001"
}
],
"name" : "European Medicines Agency – Human Medicines Evaluation Division – Scientific and Regulatory Management",
"contact" : [
{
"name" : [
{
"text" : "Dr. Jane Doe, Scientific Officer"
}
],
"telecom" : [
{
"system" : "phone",
"value" : "+31-88-781-6000",
"use" : "work"
},
{
"system" : "email",
"value" : "jane.doe@example.eu",
"use" : "work"
}
]
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "docref-cover-letter",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-15T09:00:00+01:00",
"profile" : [
🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "1.0",
"display" : "Cover Letter"
}
]
},
"date" : "2025-11-15T09:00:00+01:00",
"content" : [
{
"attachment" : {
"contentType" : "application/fhir+json",
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"title" : "Cover_Letter_SynthVac_ShelfLife_Extension_2025.json",
"creation" : "2025-11-15T09:00:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "docref-labeling",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-15T09:00:00+01:00",
"profile" : [
🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "1.3.1",
"display" : "SPC, Labelling and Package Leaflet"
}
]
},
"date" : "2025-11-15T09:00:00+01:00",
"content" : [
{
"attachment" : {
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"title" : "SynthVac_Annotated_SmPC_PIL_36months.json",
"creation" : "2025-11-15T09:00:00+01:00"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "docref-quality",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-15T09:00:00+01:00",
"profile" : [
🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
"status" : "current",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "2.3",
"display" : "Quality Overall Summary"
}
]
},
"date" : "2025-11-15T09:00:00+01:00",
"content" : [
{
"attachment" : {
"contentType" : "application/fhir+json",
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"title" : "3.2.S.7_Stability_Summary_and_Conclusions.json",
"creation" : "2025-11-15T09:00:00+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:5f3e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3a"
},
{
"use" : "official",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type",
"code" : "regulator-procedure-number",
"display" : "Regulator Procedure Number"
}
]
},
"system" : "https://ema.europa.eu/fhir/identifier/procedure",
"value" : "EU/1/23/4567/001-IB/023"
}
],
"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:a1b2c3d4-e5f6-7890-g1h2-i3j4k5l6m7n8"
},
"status" : "requested",
"intent" : "proposal",
"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"
},
"requestedPerformer" : [
{
"reference" : {
"reference" : "Organization/org-mah-98765",
"display" : "PharmaCorp International Ltd"
}
}
],
"input" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document"
}
]
},
"valueReference" : {
"reference" : "#docref-cover-letter",
"display" : "Cover Letter"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document"
}
]
},
"valueReference" : {
"reference" : "#docref-labeling",
"display" : "Annotated Labeling"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document"
}
]
},
"valueReference" : {
"reference" : "#docref-quality",
"display" : "Quality Overall Summary"
}
}
]
}