European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - ci-build

European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

: 04 Labelling Code System - TTL Representation

Active as of 2025-02-14

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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:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "300000000003"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "5.0.0" ] ;
fhir:lastUpdated [ fhir:v "2024-11-03T11:35:00.198Z"^^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 300000000003</b></p><a name=\"300000000003\"> </a><a name=\"hc300000000003\"> </a><a name=\"300000000003-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: 2024-11-03 11:35:00+0000</p></div><p>This case-sensitive code system <code>http://ema.europa.eu/fhir/CodeSystem/300000000003</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\">000000000000<a name=\"300000000003-000000000000\"> </a></td><td>Code for custom sub-sections (reserved)</td></tr><tr><td style=\"white-space:nowrap\">200000029861<a name=\"300000000003-200000029861\"> </a></td><td>LABELLING</td></tr><tr><td style=\"white-space:nowrap\">200000029862<a name=\"300000000003-200000029862\"> </a></td><td>PARTICULARS TO APPEAR ON &lt;THE OUTER PACKAGING&gt; &lt;AND&gt; &lt;THE IMMEDIATE PACKAGING&gt; {NATURE/TYPE}</td></tr><tr><td style=\"white-space:nowrap\">200000029863<a name=\"300000000003-200000029863\"> </a></td><td>1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td style=\"white-space:nowrap\">200000029864<a name=\"300000000003-200000029864\"> </a></td><td>2. STATEMENT OF ACTIVE SUBSTANCE(S)</td></tr><tr><td style=\"white-space:nowrap\">200000029865<a name=\"300000000003-200000029865\"> </a></td><td>3. LIST OF EXCIPIENTS</td></tr><tr><td style=\"white-space:nowrap\">200000029866<a name=\"300000000003-200000029866\"> </a></td><td>4. PHARMACEUTICAL FORM AND CONTENTS</td></tr><tr><td style=\"white-space:nowrap\">200000029867<a name=\"300000000003-200000029867\"> </a></td><td>5. METHOD AND ROUTE(S) OF ADMINISTRATION</td></tr><tr><td style=\"white-space:nowrap\">200000029868<a name=\"300000000003-200000029868\"> </a></td><td>6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN</td></tr><tr><td style=\"white-space:nowrap\">200000029869<a name=\"300000000003-200000029869\"> </a></td><td>7. OTHER SPECIAL WARNING(S), IF NECESSARY</td></tr><tr><td style=\"white-space:nowrap\">200000029870<a name=\"300000000003-200000029870\"> </a></td><td>8. EXPIRY DATE</td></tr><tr><td style=\"white-space:nowrap\">200000029871<a name=\"300000000003-200000029871\"> </a></td><td>9. SPECIAL STORAGE CONDITIONS</td></tr><tr><td style=\"white-space:nowrap\">200000029872<a name=\"300000000003-200000029872\"> </a></td><td>10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE</td></tr><tr><td style=\"white-space:nowrap\">200000029873<a name=\"300000000003-200000029873\"> </a></td><td>11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER</td></tr><tr><td style=\"white-space:nowrap\">200000029874<a name=\"300000000003-200000029874\"> </a></td><td>12. MARKETING AUTHORISATION NUMBER(S)</td></tr><tr><td style=\"white-space:nowrap\">200000029875<a name=\"300000000003-200000029875\"> </a></td><td>13. BATCH NUMBER&lt;, DONATION AND PRODUCT CODES&gt;</td></tr><tr><td style=\"white-space:nowrap\">200000029876<a name=\"300000000003-200000029876\"> </a></td><td>14. GENERAL CLASSIFICATION FOR SUPPLY</td></tr><tr><td style=\"white-space:nowrap\">200000029877<a name=\"300000000003-200000029877\"> </a></td><td>15. INSTRUCTIONS ON USE</td></tr><tr><td style=\"white-space:nowrap\">200000029878<a name=\"300000000003-200000029878\"> </a></td><td>16. INFORMATION IN BRAILLE</td></tr><tr><td style=\"white-space:nowrap\">200000029879<a name=\"300000000003-200000029879\"> </a></td><td>17. UNIQUE IDENTIFIER - 2D BARCODE</td></tr><tr><td style=\"white-space:nowrap\">200000029880<a name=\"300000000003-200000029880\"> </a></td><td>18. UNIQUE IDENTIFIER - HUMAN READABLE DATA</td></tr><tr><td style=\"white-space:nowrap\">200000029881<a name=\"300000000003-200000029881\"> </a></td><td>MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}</td></tr><tr><td style=\"white-space:nowrap\">200000029882<a name=\"300000000003-200000029882\"> </a></td><td>1. NAME OF THE MEDICINAL PRODUCT</td></tr><tr><td style=\"white-space:nowrap\">200000029883<a name=\"300000000003-200000029883\"> </a></td><td>2. NAME OF THE MARKETING AUTHORISATION HOLDER</td></tr><tr><td style=\"white-space:nowrap\">200000029884<a name=\"300000000003-200000029884\"> </a></td><td>3. EXPIRY DATE</td></tr><tr><td style=\"white-space:nowrap\">200000029885<a name=\"300000000003-200000029885\"> </a></td><td>4. BATCH NUMBER&lt;, DONATION AND PRODUCT CODES&gt;</td></tr><tr><td style=\"white-space:nowrap\">200000029886<a name=\"300000000003-200000029886\"> </a></td><td>5. OTHER</td></tr><tr><td style=\"white-space:nowrap\">200000029887<a name=\"300000000003-200000029887\"> </a></td><td>MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}</td></tr><tr><td style=\"white-space:nowrap\">200000029888<a name=\"300000000003-200000029888\"> </a></td><td>1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION</td></tr><tr><td style=\"white-space:nowrap\">200000029889<a name=\"300000000003-200000029889\"> </a></td><td>2. METHOD OF ADMINISTRATION</td></tr><tr><td style=\"white-space:nowrap\">200000029890<a name=\"300000000003-200000029890\"> </a></td><td>3. EXPIRY DATE</td></tr><tr><td style=\"white-space:nowrap\">200000029891<a name=\"300000000003-200000029891\"> </a></td><td>4. BATCH NUMBER&lt;, DONATION AND PRODUCT CODES&gt;</td></tr><tr><td style=\"white-space:nowrap\">200000029892<a name=\"300000000003-200000029892\"> </a></td><td>5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT</td></tr><tr><td style=\"white-space:nowrap\">200000029893<a name=\"300000000003-200000029893\"> </a></td><td>6. OTHER</td></tr></table></div>"
  ] ; # 
  fhir:url [ fhir:v "http://ema.europa.eu/fhir/CodeSystem/300000000003"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "1.0.0"] ; # 
  fhir:name [ fhir:v "EUepilabellingcodesystem"] ; # 
  fhir:title [ fhir:v "04 Labelling Code System"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 
  fhir:date [ fhir:v "2025-02-14T17:19:16+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "European Medicines Agency"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "European Medicines Agency" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://ema.europa.eu/fhir" ]     ] )
  ] [
fhir:name [ fhir:v "FHIR at EMA" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://ema.europa.eu/fhir" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "List of section codes allowed in Labelling documents, defined in EMA's Referentials Management Service."] ; # 
  fhir:caseSensitive [ fhir:v "true"^^xsd:boolean] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:count [ fhir:v "34"^^xsd:nonNegativeInteger] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "000000000000" ] ;
fhir:display [ fhir:v "Code for custom sub-sections (reserved)" ]
  ] [
fhir:code [ fhir:v "200000029861" ] ;
fhir:display [ fhir:v "LABELLING" ]
  ] [
fhir:code [ fhir:v "200000029862" ] ;
fhir:display [ fhir:v "PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {NATURE/TYPE}" ]
  ] [
fhir:code [ fhir:v "200000029863" ] ;
fhir:display [ fhir:v "1. NAME OF THE MEDICINAL PRODUCT" ]
  ] [
fhir:code [ fhir:v "200000029864" ] ;
fhir:display [ fhir:v "2. STATEMENT OF ACTIVE SUBSTANCE(S)" ]
  ] [
fhir:code [ fhir:v "200000029865" ] ;
fhir:display [ fhir:v "3. LIST OF EXCIPIENTS" ]
  ] [
fhir:code [ fhir:v "200000029866" ] ;
fhir:display [ fhir:v "4. PHARMACEUTICAL FORM AND CONTENTS" ]
  ] [
fhir:code [ fhir:v "200000029867" ] ;
fhir:display [ fhir:v "5. METHOD AND ROUTE(S) OF ADMINISTRATION" ]
  ] [
fhir:code [ fhir:v "200000029868" ] ;
fhir:display [ fhir:v "6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN" ]
  ] [
fhir:code [ fhir:v "200000029869" ] ;
fhir:display [ fhir:v "7. OTHER SPECIAL WARNING(S), IF NECESSARY" ]
  ] [
fhir:code [ fhir:v "200000029870" ] ;
fhir:display [ fhir:v "8. EXPIRY DATE" ]
  ] [
fhir:code [ fhir:v "200000029871" ] ;
fhir:display [ fhir:v "9. SPECIAL STORAGE CONDITIONS" ]
  ] [
fhir:code [ fhir:v "200000029872" ] ;
fhir:display [ fhir:v "10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE" ]
  ] [
fhir:code [ fhir:v "200000029873" ] ;
fhir:display [ fhir:v "11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER" ]
  ] [
fhir:code [ fhir:v "200000029874" ] ;
fhir:display [ fhir:v "12. MARKETING AUTHORISATION NUMBER(S)" ]
  ] [
fhir:code [ fhir:v "200000029875" ] ;
fhir:display [ fhir:v "13. BATCH NUMBER<, DONATION AND PRODUCT CODES>" ]
  ] [
fhir:code [ fhir:v "200000029876" ] ;
fhir:display [ fhir:v "14. GENERAL CLASSIFICATION FOR SUPPLY" ]
  ] [
fhir:code [ fhir:v "200000029877" ] ;
fhir:display [ fhir:v "15. INSTRUCTIONS ON USE" ]
  ] [
fhir:code [ fhir:v "200000029878" ] ;
fhir:display [ fhir:v "16. INFORMATION IN BRAILLE" ]
  ] [
fhir:code [ fhir:v "200000029879" ] ;
fhir:display [ fhir:v "17. UNIQUE IDENTIFIER - 2D BARCODE" ]
  ] [
fhir:code [ fhir:v "200000029880" ] ;
fhir:display [ fhir:v "18. UNIQUE IDENTIFIER - HUMAN READABLE DATA" ]
  ] [
fhir:code [ fhir:v "200000029881" ] ;
fhir:display [ fhir:v "MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}" ]
  ] [
fhir:code [ fhir:v "200000029882" ] ;
fhir:display [ fhir:v "1. NAME OF THE MEDICINAL PRODUCT" ]
  ] [
fhir:code [ fhir:v "200000029883" ] ;
fhir:display [ fhir:v "2. NAME OF THE MARKETING AUTHORISATION HOLDER" ]
  ] [
fhir:code [ fhir:v "200000029884" ] ;
fhir:display [ fhir:v "3. EXPIRY DATE" ]
  ] [
fhir:code [ fhir:v "200000029885" ] ;
fhir:display [ fhir:v "4. BATCH NUMBER<, DONATION AND PRODUCT CODES>" ]
  ] [
fhir:code [ fhir:v "200000029886" ] ;
fhir:display [ fhir:v "5. OTHER" ]
  ] [
fhir:code [ fhir:v "200000029887" ] ;
fhir:display [ fhir:v "MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}" ]
  ] [
fhir:code [ fhir:v "200000029888" ] ;
fhir:display [ fhir:v "1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION" ]
  ] [
fhir:code [ fhir:v "200000029889" ] ;
fhir:display [ fhir:v "2. METHOD OF ADMINISTRATION" ]
  ] [
fhir:code [ fhir:v "200000029890" ] ;
fhir:display [ fhir:v "3. EXPIRY DATE" ]
  ] [
fhir:code [ fhir:v "200000029891" ] ;
fhir:display [ fhir:v "4. BATCH NUMBER<, DONATION AND PRODUCT CODES>" ]
  ] [
fhir:code [ fhir:v "200000029892" ] ;
fhir:display [ fhir:v "5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT" ]
  ] [
fhir:code [ fhir:v "200000029893" ] ;
fhir:display [ fhir:v "6. OTHER" ]
  ] ) . #