Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions
: Specification Status Terminology - TTL Representation
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:ValueSet ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "pqcmc-specification-status-terminology"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>Include these codes as defined in <a href=\"CodeSystem-cmc-ncit-dummy.html\"><code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C25425\">C25425</a></td><td>Approved</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C48660\">C48660</a></td><td>Not Applicable</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C134011\">C134011</a></td><td>Not Approved</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C134012\">C134012</a></td><td>Reported in a CBE or AR</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C134010\">C134010</a></td><td>Tentatively Approved</td></tr></table></li></ul></div>"
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [ fhir:v "brr" ]
] ) ; #
fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology"^^xsd:anyURI] ; #
fhir:version [ fhir:v "0.1.20"] ; #
fhir:name [ fhir:v "PqcmcSpecificationStatusTerminology"] ; #
fhir:title [ fhir:v "Specification Status Terminology"] ; #
fhir:status [ fhir:v "draft"] ; #
fhir:experimental [ fhir:v "true"^^xsd:boolean] ; #
fhir:date [ fhir:v "2024-03-04T02:24:01+00:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; #
fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "brr@lists.HL7.org" ] ] )
] ) ; #
fhir:description [ fhir:v "Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."] ; #
fhir:jurisdiction ( [
( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "US" ] ;
fhir:display [ fhir:v "United States of America" ] ] )
] ) ; #
fhir:compose [
( fhir:include [
fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ;
( fhir:concept [
fhir:code [ fhir:v "C25425" ] ;
fhir:display [ fhir:v "Approved" ] ] [
fhir:code [ fhir:v "C48660" ] ;
fhir:display [ fhir:v "Not Applicable" ] ] [
fhir:code [ fhir:v "C134011" ] ;
fhir:display [ fhir:v "Not Approved" ] ] [
fhir:code [ fhir:v "C134012" ] ;
fhir:display [ fhir:v "Reported in a CBE or AR" ] ] [
fhir:code [ fhir:v "C134010" ] ;
fhir:display [ fhir:v "Tentatively Approved" ] ] ) ] )
] . #