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

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 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:

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
information-request List of Questions / Information Request Regulator raises questions or requests additional data
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
icsr-initial Initial ICSR First ICH E2B(R3) report of a case, identified by its worldwide unique case identification number (C.1.8.1).
icsr-follow-up Follow-up ICSR ICH E2B(R3) report with new information for a case already reported; same worldwide unique case identification number (C.1.8.1) and a later date of most recent information (C.1.5).
clinical-trial-application Clinical Trial Application Initial application to conduct a clinical trial (e.g., EU CTA under CTR, US IND, Health Canada CTA).
variation-type-ii Type II Variation Major change that may significantly affect quality, safety, or efficacy (EU).
labelling-comments Labelling Comments Regulator returns comments on, or a revised version of, the proposed product information for the applicant to accept or counter-propose.
labelling-agreement Labelling Agreement Regulator and applicant confirm the final agreed product information text.

Description of the above table(s).