API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build International flag

API for the Exchange of Medicinal Product Information (APIX), published by HL7 International / Biomedical Research and Regulation. 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

ValueSet: APIX Regulatory Business Status

Official URL: http://hl7.org/fhir/uv/apix/ValueSet/apix-business-status-vs Version: 0.1.0
Standards status: Trial-use Draft as of 2026-03-18 Maturity Level: 1 Computable Name: APIXBusinessStatusVS

Value set for regulatory business status in APIX submissions

References

Logical Definition (CLD)

Language: en

 

Expansion

Expansion performed internally based on codesystem APIX Regulatory Business Status v0.1.0 (CodeSystem)

This value set contains 14 concepts

SystemCodeDisplay (en)DefinitionJSONXML
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  submittedSubmittedThe application has been submitted by the applicant.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  receivedReceivedThe application or submission has been received by the regulator.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  validation-successfulValidation SuccessfulThe technical and administrative validation has been completed successfully.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  validation-failedValidation FailedThe submission failed validation and cannot proceed.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  under-assessmentUnder AssessmentThe submission is currently undergoing scientific review.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  clock-stopClock StopThe review timeline is paused, typically waiting for applicant response to questions.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  clock-restartClock RestartThe review timeline has resumed following receipt of a response.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  consolidated-reviewConsolidated ReviewComments from multiple assessors are being consolidated.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  decision-pendingDecision PendingThe assessment is complete and the final decision is being prepared.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  approvedApprovedThe application has been approved.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  rejectedRejectedThe application has been rejected.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  withdrawnWithdrawnThe application has been withdrawn by the applicant.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  payment-requestedPayment RequestedA fee payment has been requested by the regulator.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  payment-receivedPayment ReceivedThe fee payment has been received and confirmed.

Description of the above table(s).