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Packagehl7.fhir.uv.apix
Resource TypeCodeSystem
IdCodeSystem-apix-business-status.json
FHIR VersionR5
Sourcehttps://build.fhir.org/ig/HL7/APIX---API-Exchange-for-Medicinal-Products/CodeSystem-apix-business-status.html
URLhttp://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status
Version0.1.0
Statusactive
Date2026-02-05T04:12:11+00:00
NameAPIXBusinessStatusCS
TitleAPIX Regulatory Business Status
Realmuv
Authorityhl7
DescriptionCode system for regulatory business status in APIX submissions
Contentcomplete

Resources that use this resource

ValueSet
apix-business-status-vsAPIX Regulatory Business Status

Resources that this resource uses

No resources found


Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: CodeSystem apix-business-status

This case-sensitive code system http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status defines the following codes:

CodeDisplayDefinition
submitted SubmittedThe application has been submitted by the applicant.
received ReceivedThe application or submission has been received by the regulator.
validation-successful Validation SuccessfulThe technical and administrative validation has been completed successfully.
validation-failed Validation FailedThe submission failed validation and cannot proceed.
under-assessment Under AssessmentThe submission is currently undergoing scientific review.
clock-stop Clock StopThe review timeline is paused, typically waiting for applicant response to questions.
clock-restart Clock RestartThe review timeline has resumed following receipt of a response.
consolidated-review Consolidated ReviewComments from multiple assessors are being consolidated.
decision-pending Decision PendingThe assessment is complete and the final decision is being prepared.
approved ApprovedThe application has been approved.
rejected RejectedThe application has been rejected.
withdrawn WithdrawnThe application has been withdrawn by the applicant.
payment-requested Payment RequestedA fee payment has been requested by the regulator.
payment-received Payment ReceivedThe fee payment has been received and confirmed.

Source1

{
  "resourceType": "CodeSystem",
  "id": "apix-business-status",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "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": "active",
  "experimental": false,
  "date": "2026-02-05T04:12:11+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."
    }
  ]
}