Response to Regulatory Questions (RTQ), published by HL7 International. 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/rtq-ig/ and changes regularly. See the Directory of published versions
Questionnaire: Question Set ID001
| Official URL: https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/questionnaire-ID001 | Version: 0.1.0 | |||
| Active as of 2025-11-11 | Computable Name: BRRRegulatoryQAQuestionnaire | |||
| Other Identifiers: Regulator-issued Identifier: ID001, Regulator-issued Identifier: EMEA/H/C/005432/II/0023 | ||||
version: 1; Last updated: 2025-11-11 22:30:00+0000
Profile: Questionnaire
| LinkID | Text | Cardinality | Type | Description & Constraints |
|---|---|---|---|---|
  BRRRegulatoryQAQuestionnaire | Questionnaire | https://build.fhir.org/ig/HL7/rtq-ig/Questionnaire/questionnaire-ID001#0.1.0 | ||
  admin-1 | Is the fee for the Type II variation fully paid and documented? | 0..1 | question | |
 admin-2 | Are all required metadata fields in the application form complete? | 0..1 | group | |
| product-1 | Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance? | 0..1 | question | |
| product-2 | Is the patient leaflet revised to clarify the extended shelf life? | 0..1 | question | |
| product-3 | Is the updated ePI text sufficiently clear for all EU languages? | 0..1 | question | |
| quality-1 | Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies? | 0..1 | question | |
| quality-2 | Does the data support all intended climatic zones? | 0..1 | question | |
| quality-3 | Are the test methods used the same as in the previously submitted stability information? | 0..1 | question | |
| quality-4 | Are there any new degradation products identified within the newly submitted data? | 0..1 | question | |
 quality-5 | Any changes in the packaging configuration and/or storage of the samples during stability? | 0..1 | question | |
| Documentation for this format | ||||