Regulatory Workflows and Interactions - pharma
0.1.0 - ci-build International flag

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

CodeSystem: APIX Regulatory Business Status

Official URL: http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status Version: 0.1.0
Standards status: Trial-use Maturity Level: 1 Computable Name: APIXBusinessStatusCS

Code system for regulatory business status in APIX submissions

This Code system is referenced in the definition of the following value sets:

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

CodeDisplayDefinition
submitted Submitted The application has been submitted by the applicant.
received Received The application or submission has been received by the regulator.
validation-successful Validation Successful The technical and administrative validation has been completed successfully.
validation-failed Validation Failed The submission failed validation and cannot proceed.
under-assessment Under Assessment The submission is currently undergoing scientific review.
clock-stop Clock Stop The review timeline is paused, typically waiting for applicant response to questions.
clock-restart Clock Restart The review timeline has resumed following receipt of a response.
consolidated-review Consolidated Review Comments from multiple assessors are being consolidated.
decision-pending Decision Pending The assessment is complete and the final decision is being prepared.
approved Approved The application has been approved.
rejected Rejected The application has been rejected.
withdrawn Withdrawn The application has been withdrawn by the applicant.
payment-requested Payment Requested A fee payment has been requested by the regulator.
payment-received Payment Received The fee payment has been received and confirmed.
icsr-accepted Report Accepted (CA) The individual report was accepted. ICH E2B(R3) report acknowledgment code CA (ACK.B.r.6).
request-for-information-issued Request for Information Issued The regulator has sent a request for information to the sponsor.
authorised Authorised The trial or modification has been authorised.
labelling-comments-issued Labelling Comments Issued The regulator has returned comments or a revised version to the applicant.
counter-proposal-received Counter-Proposal Received The applicant has returned a counter-proposal on the product information.
response-received Response Received The applicant’s response has been received.
awaiting-applicant-response Awaiting Applicant Response The regulator is waiting for the applicant to respond.
labelling-agreed Labelling Agreed Applicant and regulator have agreed the product information text.

Description of the above table(s).