Package | hl7.fhir.uv.rfi-ig |
Resource Type | ImplementationGuide |
Id | hl7.fhir.uv.rfi-ig |
FHIR Version | R5 |
Source | http://hl7.org/fhir/uv/rfi-ig/https://build.fhir.org/ig/cander2/rfi-ig/index.html |
URL | http://hl7.org/fhir/uv/rfi-ig/ImplementationGuide/hl7.fhir.uv.rfi-ig |
Version | 0.1.0 |
Status | draft |
Date | 2025-06-19T00:08:28+00:00 |
Name | RFI |
Title | Regulatory Correspondence |
Realm | uv |
Authority | hl7 |
Description | Standard for structuring regulatory correspondence from a health authority to a Market Authorization Holder. This includes List of Questions (LOQ), List of Issues (LOI), Request for Information, and decision letters. |
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Note: links and images are rebased to the (stated) source
Generated Narrative: ImplementationGuide hl7.fhir.uv.rfi-ig
The official URL for this implementation guide is:
http://hl7.org/fhir/uv/rfi-ig/ImplementationGuide/hl7.fhir.uv.rfi-ig
Standard for structuring regulatory correspondence from a health authority to a Market Authorization Holder. This includes List of Questions (LOQ), List of Issues (LOI), Request for Information, and decision letters.
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