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

CodeSystem: APIX Task Code System

Official URL: http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code Version: 0.1.0
Standards status: Trial-use Draft as of 2026-03-18 Maturity Level: 1 Computable Name: APIXTaskCodeCS

Code system for regulatory task types in APIX submissions

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

Language: en

This case-sensitive code system http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code defines the following codes in a Is-A hierarchy:

CodeDisplayDefinition
initial-submission Initial Submission First submission of a new application or major variation
supplement Supplement / Variation Post-authorization change (Type IA, IB, II, extension, etc.)
variation-type-ib Type IB Variation Minor, post-approval change to a medicinal product's marketing authorization that has minimal impact on quality, safety, or efficacy
response-to-questions Response to Information Request Applicant response to regulator questions
information-request List of Questions / Information Request Regulator raises questions or requests additional data
validation-report Validation Report Technical or business validation outcome
approval Approval Letter / Positive Decision Final positive regulatory decision
rejection Rejection / Negative Decision Final negative regulatory decision
withdrawal Withdrawal by Applicant Applicant withdraws the procedure
annual-report Periodic Safety Update Report / Annual Report PSUR, DSUR, or other periodic report
request-payment Request Payment Requested payment of regulatory fees

Description of the above table(s).