{
  "resourceType" : "CodeSystem",
  "id" : "apix-business-status",
  "language" : "en",
  "text" : {
    "status" : "generated",
    "div" : "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"><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><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p></div><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>"
  },
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "brr"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 1,
    "_valueInteger" : {
      "extension" : [{
        "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
        "valueCanonical" : "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"
      }]
    }
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "trial-use",
    "_valueCode" : {
      "extension" : [{
        "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
        "valueCanonical" : "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"
      }]
    }
  }],
  "url" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status",
  "version" : "0.1.0",
  "name" : "APIXBusinessStatusCS",
  "title" : "APIX Regulatory Business Status",
  "status" : "draft",
  "experimental" : false,
  "date" : "2026-04-14T02:37:56+00:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [{
    "name" : "HL7 International / Biomedical Research and Regulation",
    "telecom" : [{
      "system" : "url",
      "value" : "http://www.hl7.org/Special/committees/rcrim"
    }]
  }],
  "description" : "Code system for regulatory business status in APIX submissions",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "code" : "001",
      "display" : "World"
    }]
  }],
  "caseSensitive" : true,
  "content" : "complete",
  "count" : 14,
  "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."
  }]
}