EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Active as of 2025-04-04 |
@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:CodeSystem ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "100000116045"] ; #
fhir:meta [
fhir:versionId [ fhir:v "5.0.0" ] ;
fhir:lastUpdated [ fhir:v "2023-08-03T11:35:00.198Z"^^xsd:dateTime ]
] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem 100000116045</b></p><a name=\"100000116045\"> </a><a name=\"hc100000116045\"> </a><a name=\"100000116045-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000</p></div><p>This case-sensitive code system <code>http://spor.ema.europa.eu/v1/lists/100000116045</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style=\"white-space:nowrap\">100000116046<a name=\"100000116045-100000116046\"> </a></td><td>Full application (Article 8(3) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116047<a name=\"100000116045-100000116047\"> </a></td><td>New active substance (Article 8(3) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116048<a name=\"100000116045-100000116048\"> </a></td><td>Known active substance (Article 8(3) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116049<a name=\"100000116045-100000116049\"> </a></td><td>Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116050<a name=\"100000116045-100000116050\"> </a></td><td>Generic application (Article 10(1) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116051<a name=\"100000116045-100000116051\"> </a></td><td>Hybrid application (Article 10(3) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116052<a name=\"100000116045-100000116052\"> </a></td><td>Similar biological application (Article 10(4) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116053<a name=\"100000116045-100000116053\"> </a></td><td>Well-established use application (Article 10a of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116054<a name=\"100000116045-100000116054\"> </a></td><td>Fixed combination application (Article 10b of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116055<a name=\"100000116045-100000116055\"> </a></td><td>Informed consent application (Article 10c of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116056<a name=\"100000116045-100000116056\"> </a></td><td>Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116057<a name=\"100000116045-100000116057\"> </a></td><td>Full application (Article 12(3) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116058<a name=\"100000116045-100000116058\"> </a></td><td>Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116059<a name=\"100000116045-100000116059\"> </a></td><td>Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116060<a name=\"100000116045-100000116060\"> </a></td><td>Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116061<a name=\"100000116045-100000116061\"> </a></td><td>Generic application (Article 13(1) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116062<a name=\"100000116045-100000116062\"> </a></td><td>Hybrid application (Article 13(3) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116063<a name=\"100000116045-100000116063\"> </a></td><td>Similar biological application (Article 13(4) of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116064<a name=\"100000116045-100000116064\"> </a></td><td>Well-established use application (Article 13a of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">100000116065<a name=\"100000116045-100000116065\"> </a></td><td>Fixed combination application (Article 13b of Directive No 2001/82/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000003511<a name=\"100000116045-200000003511\"> </a></td><td>Parallel Distributed/Imported medicinal product (Article 76(3) and (4) of Directive No 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000003512<a name=\"100000116045-200000003512\"> </a></td><td>Exceptional Circumstances Marketing Authorisation (Article 14(6) (8) of Regulation (EC) No 726/2004 or Article 22 of Directive 2001/83/EC)</td></tr><tr><td style=\"white-space:nowrap\">200000003513<a name=\"100000116045-200000003513\"> </a></td><td>Authorised homeopathic medicinal product</td></tr><tr><td style=\"white-space:nowrap\">200000003514<a name=\"100000116045-200000003514\"> </a></td><td>Authorised herbal medicinal product</td></tr><tr><td style=\"white-space:nowrap\">200000003515<a name=\"100000116045-200000003515\"> </a></td><td>Paediatric Use Marketing Authorisation (PUMA) (Article 30 of Regulation (EC) No 1901/2006)</td></tr><tr><td style=\"white-space:nowrap\">200000003516<a name=\"100000116045-200000003516\"> </a></td><td>Conditional Marketing Authorisation (Article 14 (7) of Regulation (EC) No 726/2004)</td></tr><tr><td style=\"white-space:nowrap\">200000003517<a name=\"100000116045-200000003517\"> </a></td><td>Other</td></tr></table></div>"^^rdf:XMLLiteral
] ; #
fhir:url [ fhir:v "http://spor.ema.europa.eu/v1/lists/100000116045"^^xsd:anyURI] ; #
fhir:version [ fhir:v "1.0.0"] ; #
fhir:name [ fhir:v "MarketingAuthorisationApplicationLegalBasisCs"] ; #
fhir:title [ fhir:v "Marketing Authorisation Application Legal Basis"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:experimental [ fhir:v false] ; #
fhir:date [ fhir:v "2025-04-04T16:15:09+01:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "EMA"] ; #
fhir:contact ( [
fhir:name [ fhir:v "EMA" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://support.ema.europa.eu/esc" ] ] )
] ) ; #
fhir:description [ fhir:v "Marketing Authorisation Application Legal Basis"] ; #
fhir:caseSensitive [ fhir:v true] ; #
fhir:content [ fhir:v "complete"] ; #
fhir:count [ fhir:v "27"^^xsd:nonNegativeInteger] ; #
fhir:concept ( [
fhir:code [ fhir:v "100000116046" ] ;
fhir:display [ fhir:v "Full application (Article 8(3) of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116047" ] ;
fhir:display [ fhir:v "New active substance (Article 8(3) of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116048" ] ;
fhir:display [ fhir:v "Known active substance (Article 8(3) of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116049" ] ;
fhir:display [ fhir:v "Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116050" ] ;
fhir:display [ fhir:v "Generic application (Article 10(1) of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116051" ] ;
fhir:display [ fhir:v "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116052" ] ;
fhir:display [ fhir:v "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116053" ] ;
fhir:display [ fhir:v "Well-established use application (Article 10a of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116054" ] ;
fhir:display [ fhir:v "Fixed combination application (Article 10b of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116055" ] ;
fhir:display [ fhir:v "Informed consent application (Article 10c of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116056" ] ;
fhir:display [ fhir:v "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "100000116057" ] ;
fhir:display [ fhir:v "Full application (Article 12(3) of Directive No 2001/82/EC)" ]
] [
fhir:code [ fhir:v "100000116058" ] ;
fhir:display [ fhir:v "Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)" ]
] [
fhir:code [ fhir:v "100000116059" ] ;
fhir:display [ fhir:v "Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)" ]
] [
fhir:code [ fhir:v "100000116060" ] ;
fhir:display [ fhir:v "Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC)" ]
] [
fhir:code [ fhir:v "100000116061" ] ;
fhir:display [ fhir:v "Generic application (Article 13(1) of Directive No 2001/82/EC)" ]
] [
fhir:code [ fhir:v "100000116062" ] ;
fhir:display [ fhir:v "Hybrid application (Article 13(3) of Directive No 2001/82/EC)" ]
] [
fhir:code [ fhir:v "100000116063" ] ;
fhir:display [ fhir:v "Similar biological application (Article 13(4) of Directive No 2001/82/EC)" ]
] [
fhir:code [ fhir:v "100000116064" ] ;
fhir:display [ fhir:v "Well-established use application (Article 13a of Directive No 2001/82/EC)" ]
] [
fhir:code [ fhir:v "100000116065" ] ;
fhir:display [ fhir:v "Fixed combination application (Article 13b of Directive No 2001/82/EC)" ]
] [
fhir:code [ fhir:v "200000003511" ] ;
fhir:display [ fhir:v "Parallel Distributed/Imported medicinal product (Article 76(3) and (4) of Directive No 2001/83/EC)" ]
] [
fhir:code [ fhir:v "200000003512" ] ;
fhir:display [ fhir:v "Exceptional Circumstances Marketing Authorisation (Article 14(6) (8) of Regulation (EC) No 726/2004 or Article 22 of Directive 2001/83/EC)" ]
] [
fhir:code [ fhir:v "200000003513" ] ;
fhir:display [ fhir:v "Authorised homeopathic medicinal product" ]
] [
fhir:code [ fhir:v "200000003514" ] ;
fhir:display [ fhir:v "Authorised herbal medicinal product" ]
] [
fhir:code [ fhir:v "200000003515" ] ;
fhir:display [ fhir:v "Paediatric Use Marketing Authorisation (PUMA) (Article 30 of Regulation (EC) No 1901/2006)" ]
] [
fhir:code [ fhir:v "200000003516" ] ;
fhir:display [ fhir:v "Conditional Marketing Authorisation (Article 14 (7) of Regulation (EC) No 726/2004)" ]
] [
fhir:code [ fhir:v "200000003517" ] ;
fhir:display [ fhir:v "Other" ]
] ) . #
IG © 2025 EMA. Package emavar#1.0.0 based on FHIR 5.0.0. Generated 2025-04-04
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