Response to Regulatory Questions (RTQ)
0.1.0 - ci-build
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
Procedure: EMEA/H/C/005432/II/0023
Product: ExampleDrug 10 mg Tablets
Submitted by: SynthPharma AG
Submitted to: European Medicines Agency (EMA)
Date: November 15, 2025
This response addresses all administrative, labeling, and CMC stability questions for the Type II Variation.