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
| Draft as of 2025-12-23 |
{
"resourceType" : "CodeSystem",
"id" : "apix-business-status",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem apix-business-status</b></p><a name=\"apix-business-status\"> </a><a name=\"hcapix-business-status\"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">submitted<a name=\"apix-business-status-submitted\"> </a></td><td>Submitted</td><td>The application has been submitted by the applicant.</td></tr><tr><td style=\"white-space:nowrap\">received<a name=\"apix-business-status-received\"> </a></td><td>Received</td><td>The application or submission has been received by the regulator.</td></tr><tr><td style=\"white-space:nowrap\">validation-successful<a name=\"apix-business-status-validation-successful\"> </a></td><td>Validation Successful</td><td>The technical and administrative validation has been completed successfully.</td></tr><tr><td style=\"white-space:nowrap\">validation-failed<a name=\"apix-business-status-validation-failed\"> </a></td><td>Validation Failed</td><td>The submission failed validation and cannot proceed.</td></tr><tr><td style=\"white-space:nowrap\">under-assessment<a name=\"apix-business-status-under-assessment\"> </a></td><td>Under Assessment</td><td>The submission is currently undergoing scientific review.</td></tr><tr><td style=\"white-space:nowrap\">clock-stop<a name=\"apix-business-status-clock-stop\"> </a></td><td>Clock Stop</td><td>The review timeline is paused, typically waiting for applicant response to questions.</td></tr><tr><td style=\"white-space:nowrap\">clock-restart<a name=\"apix-business-status-clock-restart\"> </a></td><td>Clock Restart</td><td>The review timeline has resumed following receipt of a response.</td></tr><tr><td style=\"white-space:nowrap\">consolidated-review<a name=\"apix-business-status-consolidated-review\"> </a></td><td>Consolidated Review</td><td>Comments from multiple assessors are being consolidated.</td></tr><tr><td style=\"white-space:nowrap\">decision-pending<a name=\"apix-business-status-decision-pending\"> </a></td><td>Decision Pending</td><td>The assessment is complete and the final decision is being prepared.</td></tr><tr><td style=\"white-space:nowrap\">approved<a name=\"apix-business-status-approved\"> </a></td><td>Approved</td><td>The application has been approved.</td></tr><tr><td style=\"white-space:nowrap\">rejected<a name=\"apix-business-status-rejected\"> </a></td><td>Rejected</td><td>The application has been rejected.</td></tr><tr><td style=\"white-space:nowrap\">withdrawn<a name=\"apix-business-status-withdrawn\"> </a></td><td>Withdrawn</td><td>The application has been withdrawn by the applicant.</td></tr><tr><td style=\"white-space:nowrap\">payment-requested<a name=\"apix-business-status-payment-requested\"> </a></td><td>Payment Requested</td><td>A fee payment has been requested by the regulator.</td></tr><tr><td style=\"white-space:nowrap\">payment-received<a name=\"apix-business-status-payment-received\"> </a></td><td>Payment Received</td><td>The fee payment has been received and confirmed.</td></tr></table></div>"
},
"url" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status",
"version" : "0.1.0",
"name" : "APIXBusinessStatusCS",
"title" : "APIX Regulatory Business Status",
"status" : "draft",
"date" : "2025-12-23T01:31:13+00:00",
"publisher" : "Gravitate Health Project",
"contact" : [
{
"name" : "Gravitate Health Project",
"telecom" : [
{
"system" : "url",
"value" : "https://www.gravitatehealth.eu/"
}
]
}
],
"caseSensitive" : true,
"content" : "complete",
"concept" : [
{
"code" : "submitted",
"display" : "Submitted",
"definition" : "The application has been submitted by the applicant."
},
{
"code" : "received",
"display" : "Received",
"definition" : "The application or submission has been received by the regulator."
},
{
"code" : "validation-successful",
"display" : "Validation Successful",
"definition" : "The technical and administrative validation has been completed successfully."
},
{
"code" : "validation-failed",
"display" : "Validation Failed",
"definition" : "The submission failed validation and cannot proceed."
},
{
"code" : "under-assessment",
"display" : "Under Assessment",
"definition" : "The submission is currently undergoing scientific review."
},
{
"code" : "clock-stop",
"display" : "Clock Stop",
"definition" : "The review timeline is paused, typically waiting for applicant response to questions."
},
{
"code" : "clock-restart",
"display" : "Clock Restart",
"definition" : "The review timeline has resumed following receipt of a response."
},
{
"code" : "consolidated-review",
"display" : "Consolidated Review",
"definition" : "Comments from multiple assessors are being consolidated."
},
{
"code" : "decision-pending",
"display" : "Decision Pending",
"definition" : "The assessment is complete and the final decision is being prepared."
},
{
"code" : "approved",
"display" : "Approved",
"definition" : "The application has been approved."
},
{
"code" : "rejected",
"display" : "Rejected",
"definition" : "The application has been rejected."
},
{
"code" : "withdrawn",
"display" : "Withdrawn",
"definition" : "The application has been withdrawn by the applicant."
},
{
"code" : "payment-requested",
"display" : "Payment Requested",
"definition" : "A fee payment has been requested by the regulator."
},
{
"code" : "payment-received",
"display" : "Payment Received",
"definition" : "The fee payment has been received and confirmed."
}
]
}