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

Resource Profile: APIX Regulatory Task - Examples

Page standards status: Trial-use Maturity Level: 1

Examples for the apix-task Profile.

scenario1 01 initial submission
scenario1 02 validation
scenario1 03 finance invoice original Task
scenario1 04 finance payment reflected by invoice Task update
scenario1 05 technical question
scenario1 06 technical response
scenario1-07-final-decision
scenario2 01 initial ICSR submitted
scenario2 02 initial ICSR acknowledged
scenario2 03 follow-up ICSR submitted
scenario2 04 follow-up ICSR acknowledged
scenario3 01 clinical trial application submitted
scenario3 02 clinical trial application validated
scenario3 03 request for information issued
scenario3 04 request for information answered
scenario3 05 clinical trial authorised
scenario4 01 Type II variation submitted
scenario4 02 Type II variation validated
scenario4 03 Type II variation under assessment
scenario4 04 labelling comments round 1 issued
scenario4 05 labelling comments round 1 answered with a counter-proposal
scenario4 06 labelling comments round 2 issued
scenario4 07 labelling comments round 2 accepted
scenario4 08 labelling agreement requested
scenario4 09 labelling agreed
scenario4 10 Type II variation approved