Regulatory Workflows and Interactions - pharma
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Regulatory Workflows and Interactions - pharma, 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: Value Set 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 Maturity Level: 1 Computable Name: APIXBusinessStatusVS

Value set for regulatory business status in APIX submissions

References

Logical Definition (CLD)

 

Expansion

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

This value set contains 22 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.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  icsr-acceptedReport Accepted (CA)The individual report was accepted. ICH E2B(R3) report acknowledgment code CA (ACK.B.r.6).
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  request-for-information-issuedRequest for Information IssuedThe regulator has sent a request for information to the sponsor.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  authorisedAuthorisedThe trial or modification has been authorised.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  labelling-comments-issuedLabelling Comments IssuedThe regulator has returned comments or a revised version to the applicant.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  counter-proposal-receivedCounter-Proposal ReceivedThe applicant has returned a counter-proposal on the product information.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  response-receivedResponse ReceivedThe applicant’s response has been received.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  awaiting-applicant-responseAwaiting Applicant ResponseThe regulator is waiting for the applicant to respond.
http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status  labelling-agreedLabelling AgreedApplicant and regulator have agreed the product information text.

Description of the above table(s).