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
| Active as of 2025-04-02 |
{
"resourceType" : "CodeSystem",
"id" : "100000155531",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem 100000155531</b></p><a name=\"100000155531\"> </a><a name=\"hc100000155531\"> </a><a name=\"100000155531-en-US\"> </a><p>This case-insensitive code system <code>http://ema.europa.eu/fhir/CodeSystem/100000155531</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\">100000155532<a name=\"100000155531-100000155532\"> </a></td><td>Summary of Product Characteristics</td></tr><tr><td style=\"white-space:nowrap\">100000155533<a name=\"100000155531-100000155533\"> </a></td><td>Annex II</td></tr><tr><td style=\"white-space:nowrap\">100000155534<a name=\"100000155531-100000155534\"> </a></td><td>Outer Packaging</td></tr><tr><td style=\"white-space:nowrap\">100000155535<a name=\"100000155531-100000155535\"> </a></td><td>Labelling</td></tr><tr><td style=\"white-space:nowrap\">100000155537<a name=\"100000155531-100000155537\"> </a></td><td>Other Product Information</td></tr><tr><td style=\"white-space:nowrap\">100000155538<a name=\"100000155531-100000155538\"> </a></td><td>Package Leaflet</td></tr><tr><td style=\"white-space:nowrap\">100000155539<a name=\"100000155531-100000155539\"> </a></td><td>Combined File of all Documents</td></tr><tr><td style=\"white-space:nowrap\">100000155540<a name=\"100000155531-100000155540\"> </a></td><td>Mock ups</td></tr><tr><td style=\"white-space:nowrap\">100000155541<a name=\"100000155531-100000155541\"> </a></td><td>Appendix V</td></tr></table><p><b>Additional Language Displays</b></p><table class=\"codes\"><tr><td><b>Code</b></td><td><b>Bulgarian (bg)</b></td><td><b>Czech (cs)</b></td><td><b>Dansk (Danish, da)</b></td><td><b>Deutsch (German, de)</b></td><td><b>Greek (el)</b></td><td><b>English (English, en)</b></td><td><b>Spanish (es)</b></td><td><b>Estonian (et)</b></td><td><b>Finnish (fi)</b></td><td><b>French (fr)</b></td><td><b>ga</b></td><td><b>Croatian (hr)</b></td><td><b>hu</b></td><td><b>Icelandic (is)</b></td><td><b>Italian (it)</b></td><td><b>Lithuanian (lt)</b></td><td><b>Latvian (lv)</b></td><td><b>mt</b></td><td><b>Nederlands (Dutch, nl)</b></td><td><b>Norwegian (no)</b></td><td><b>Polskie (Polish, pl)</b></td><td><b>Portuguese (pt)</b></td><td><b>Romanian (ro)</b></td><td><b>Slovakian (sk)</b></td><td><b>Slovenian (sl)</b></td><td><b>Swedish (sv)</b></td></tr><tr><td>100000155532</td><td>КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА</td><td>SOUHRN ÚDAJŮ O PŘÍPRAVKU</td><td>PRODUKTRESUMÉ</td><td>ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS</td><td>ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ</td><td>SUMMARY OF PRODUCT CHARACTERISTICS</td><td>FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO</td><td>RAVIMI OMADUSTE KOKKUVÕTE</td><td>VALMISTEYHTEENVETO</td><td>RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT</td><td>ACHOIMRE AR SHAINTRÉITHE AN TÁIRGE</td><td>SAŽETAK OPISA SVOJSTAVA LIJEKA</td><td>ALKALMAZÁSI ELŐÍRÁS</td><td>SAMANTEKT Á EIGINLEIKUM LYFS</td><td>RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO</td><td>PREPARATO CHARAKTERISTIKŲ SANTRAUKA</td><td>ZĀĻU APRAKSTS</td><td>SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT</td><td>SAMENVATTING VAN DE PRODUCTKENMERKEN</td><td>PREPARATOMTALE</td><td>CHARAKTERYSTYKA PRODUKTU LECZNICZEGO</td><td>RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO</td><td>REZUMATUL CARACTERISTICILOR PRODUSULUI</td><td>SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU</td><td>POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA</td><td>PRODUKTRESUMÉ</td></tr><tr><td>100000155533</td><td>ПРИЛОЖЕНИЕ II</td><td>PŘÍLOHA II</td><td>BILAG II</td><td>ANHANG II</td><td>ΠΑΡΑΡΤΗΜΑ ΙΙ</td><td>ANNEX II</td><td>ANEXO II</td><td>II LISA</td><td>LIITE II</td><td>ANNEXE II</td><td>IARSCRÍBHINN II</td><td>PRILOG II.</td><td>II. MELLÉKLET</td><td>VIÐAUKI II</td><td>ALLEGATO II</td><td>II PRIEDAS</td><td>II PIELIKUMS</td><td>ANNESS II</td><td>BIJLAGE II</td><td>VEDLEGG II</td><td>ANEKS II</td><td>ANEXO II</td><td>ANEXA II</td><td>PRÍLOHA II</td><td>PRILOGA II</td><td>BILAGA II</td></tr><tr><td>100000155534</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>100000155535</td><td>ДАННИ ВЪРХУ ОПАКОВКАТА</td><td>OZNAČENÍ NA OBALU</td><td>ETIKETTERING</td><td>ETIKETTIERUNG</td><td>ΕΠΙΣΗΜΑΝΣΗ</td><td>LABELLING</td><td>ETIQUETADO</td><td>PAKENDI MÄRGISTUS</td><td>MYYNTIPÄÄLLYSMERKINNÄT</td><td>ÉTIQUETAGE</td><td>LIPÉADÚ</td><td>OZNAČIVANJE</td><td>CÍMKESZÖVEG</td><td>ÁLETRANIR</td><td>ETICHETTATURA</td><td>ŽENKLINIMAS</td><td>MARĶĒJUMA TEKSTS</td><td>TIKKETTAR</td><td>ETIKETTERING</td><td>MERKING</td><td>OZNAKOWANIE OPAKOWAŃ</td><td>ROTULAGEM</td><td>ETICHETAREA</td><td>OZNAČENIE OBALU</td><td>OZNAČEVANJE</td><td>MÄRKNING</td></tr><tr><td>100000155537</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>100000155538</td><td>ЛИСТОВКА</td><td>PŘÍBALOVÁ INFORMACE</td><td>INDLÆGSSEDDEL</td><td>PACKUNGSBEILAGE</td><td>ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ</td><td>PACKAGE LEAFLET</td><td>PROSPECTO</td><td>PAKENDI INFOLEHT</td><td>PAKKAUSSELOSTE</td><td>NOTICE</td><td>BILEOG PHACÁISTE</td><td>UPUTA O LIJEKU</td><td>BETEGTÁJÉKOZTATÓ</td><td>FYLGISEÐILL</td><td>FOGLIO ILLUSTRATIVO</td><td>PAKUOTĖS LAPELIS</td><td>LIETOŠANAS INSTRUKCIJA</td><td>FULJETT TA TAGĦRIF</td><td>BIJSLUITER</td><td>PAKNINGSVEDLEGG</td><td>ULOTKA DLA PACJENTA</td><td>FOLHETO INFORMATIVO</td><td>PROSPECTUL</td><td>PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA</td><td>NAVODILO ZA UPORABO</td><td>BIPACKSEDEL</td></tr><tr><td>100000155539</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>100000155540</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>100000155541</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table></div>"
},
"url" : "http://ema.europa.eu/fhir/CodeSystem/100000155531",
"version" : "1.0.0",
"name" : "EUepirmsdocumenttype",
"title" : "01 Document Type Code System",
"status" : "active",
"experimental" : false,
"date" : "2025-04-02T11:27:42+01:00",
"publisher" : "European Medicines Agency",
"contact" : [
{
"name" : "European Medicines Agency",
"telecom" : [
{
"system" : "url",
"value" : "https://ema.europa.eu/fhir"
}
]
},
{
"name" : "FHIR at EMA",
"telecom" : [
{
"system" : "url",
"value" : "http://ema.europa.eu/fhir"
}
]
}
],
"description" : "EU EPI document type code system, defined in EMA's Referentials Management Service.",
"caseSensitive" : false,
"content" : "complete",
"count" : 9,
"concept" : [
{
"code" : "100000155532",
"display" : "Summary of Product Characteristics",
"designation" : [
{
"language" : "en",
"value" : "SUMMARY OF PRODUCT CHARACTERISTICS"
},
{
"language" : "bg",
"value" : "КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА"
},
{
"language" : "hr",
"value" : "SAŽETAK OPISA SVOJSTAVA LIJEKA"
},
{
"language" : "cs",
"value" : "SOUHRN ÚDAJŮ O PŘÍPRAVKU"
},
{
"language" : "da",
"value" : "PRODUKTRESUMÉ"
},
{
"language" : "nl",
"value" : "SAMENVATTING VAN DE PRODUCTKENMERKEN"
},
{
"language" : "et",
"value" : "RAVIMI OMADUSTE KOKKUVÕTE"
},
{
"language" : "fi",
"value" : "VALMISTEYHTEENVETO"
},
{
"language" : "fr",
"value" : "RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT"
},
{
"language" : "de",
"value" : "ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS"
},
{
"language" : "el",
"value" : "ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ"
},
{
"language" : "hu",
"value" : "ALKALMAZÁSI ELŐÍRÁS"
},
{
"language" : "is",
"value" : "SAMANTEKT Á EIGINLEIKUM LYFS"
},
{
"language" : "ga",
"value" : "ACHOIMRE AR SHAINTRÉITHE AN TÁIRGE"
},
{
"language" : "it",
"value" : "RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO"
},
{
"language" : "lv",
"value" : "ZĀĻU APRAKSTS"
},
{
"language" : "lt",
"value" : "PREPARATO CHARAKTERISTIKŲ SANTRAUKA"
},
{
"language" : "mt",
"value" : "SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT"
},
{
"language" : "no",
"value" : "PREPARATOMTALE"
},
{
"language" : "pl",
"value" : "CHARAKTERYSTYKA PRODUKTU LECZNICZEGO"
},
{
"language" : "pt",
"value" : "RESUMO DAS CARACTERÍSTICAS DO MEDICAMENTO"
},
{
"language" : "ro",
"value" : "REZUMATUL CARACTERISTICILOR PRODUSULUI"
},
{
"language" : "sk",
"value" : "SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU"
},
{
"language" : "sl",
"value" : "POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA"
},
{
"language" : "es",
"value" : "FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO"
},
{
"language" : "sv",
"value" : "PRODUKTRESUMÉ"
}
]
},
{
"code" : "100000155533",
"display" : "Annex II",
"designation" : [
{
"language" : "en",
"value" : "ANNEX II"
},
{
"language" : "bg",
"value" : "ПРИЛОЖЕНИЕ II"
},
{
"language" : "hr",
"value" : "PRILOG II."
},
{
"language" : "cs",
"value" : "PŘÍLOHA II"
},
{
"language" : "da",
"value" : "BILAG II"
},
{
"language" : "nl",
"value" : "BIJLAGE II"
},
{
"language" : "et",
"value" : "II LISA"
},
{
"language" : "fi",
"value" : "LIITE II"
},
{
"language" : "fr",
"value" : "ANNEXE II"
},
{
"language" : "de",
"value" : "ANHANG II"
},
{
"language" : "el",
"value" : "ΠΑΡΑΡΤΗΜΑ ΙΙ"
},
{
"language" : "hu",
"value" : "II. MELLÉKLET"
},
{
"language" : "is",
"value" : "VIÐAUKI II"
},
{
"language" : "ga",
"value" : "IARSCRÍBHINN II"
},
{
"language" : "it",
"value" : "ALLEGATO II"
},
{
"language" : "lv",
"value" : "II PIELIKUMS"
},
{
"language" : "lt",
"value" : "II PRIEDAS"
},
{
"language" : "mt",
"value" : "ANNESS II"
},
{
"language" : "no",
"value" : "VEDLEGG II"
},
{
"language" : "pl",
"value" : "ANEKS II"
},
{
"language" : "pt",
"value" : "ANEXO II"
},
{
"language" : "ro",
"value" : "ANEXA II"
},
{
"language" : "sk",
"value" : "PRÍLOHA II"
},
{
"language" : "sl",
"value" : "PRILOGA II"
},
{
"language" : "es",
"value" : "ANEXO II"
},
{
"language" : "sv",
"value" : "BILAGA II"
}
]
},
{
"code" : "100000155534",
"display" : "Outer Packaging"
},
{
"code" : "100000155535",
"display" : "Labelling",
"designation" : [
{
"language" : "en",
"value" : "LABELLING"
},
{
"language" : "bg",
"value" : "ДАННИ ВЪРХУ ОПАКОВКАТА"
},
{
"language" : "hr",
"value" : "OZNAČIVANJE"
},
{
"language" : "cs",
"value" : "OZNAČENÍ NA OBALU"
},
{
"language" : "da",
"value" : "ETIKETTERING"
},
{
"language" : "nl",
"value" : "ETIKETTERING"
},
{
"language" : "et",
"value" : "PAKENDI MÄRGISTUS"
},
{
"language" : "fi",
"value" : "MYYNTIPÄÄLLYSMERKINNÄT"
},
{
"language" : "fr",
"value" : "ÉTIQUETAGE"
},
{
"language" : "de",
"value" : "ETIKETTIERUNG"
},
{
"language" : "el",
"value" : "ΕΠΙΣΗΜΑΝΣΗ"
},
{
"language" : "hu",
"value" : "CÍMKESZÖVEG"
},
{
"language" : "is",
"value" : "ÁLETRANIR"
},
{
"language" : "ga",
"value" : "LIPÉADÚ"
},
{
"language" : "it",
"value" : "ETICHETTATURA"
},
{
"language" : "lv",
"value" : "MARĶĒJUMA TEKSTS"
},
{
"language" : "lt",
"value" : "ŽENKLINIMAS"
},
{
"language" : "mt",
"value" : "TIKKETTAR"
},
{
"language" : "no",
"value" : "MERKING"
},
{
"language" : "pl",
"value" : "OZNAKOWANIE OPAKOWAŃ"
},
{
"language" : "pt",
"value" : "ROTULAGEM"
},
{
"language" : "ro",
"value" : "ETICHETAREA"
},
{
"language" : "sk",
"value" : "OZNAČENIE OBALU"
},
{
"language" : "sl",
"value" : "OZNAČEVANJE"
},
{
"language" : "es",
"value" : "ETIQUETADO"
},
{
"language" : "sv",
"value" : "MÄRKNING"
}
]
},
{
"code" : "100000155537",
"display" : "Other Product Information"
},
{
"code" : "100000155538",
"display" : "Package Leaflet",
"designation" : [
{
"language" : "en",
"value" : "PACKAGE LEAFLET"
},
{
"language" : "bg",
"value" : "ЛИСТОВКА"
},
{
"language" : "hr",
"value" : "UPUTA O LIJEKU"
},
{
"language" : "cs",
"value" : "PŘÍBALOVÁ INFORMACE"
},
{
"language" : "da",
"value" : "INDLÆGSSEDDEL"
},
{
"language" : "nl",
"value" : "BIJSLUITER"
},
{
"language" : "et",
"value" : "PAKENDI INFOLEHT"
},
{
"language" : "fi",
"value" : "PAKKAUSSELOSTE"
},
{
"language" : "fr",
"value" : "NOTICE"
},
{
"language" : "de",
"value" : "PACKUNGSBEILAGE"
},
{
"language" : "el",
"value" : "ΦΥΛΛΟ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ"
},
{
"language" : "hu",
"value" : "BETEGTÁJÉKOZTATÓ"
},
{
"language" : "is",
"value" : "FYLGISEÐILL"
},
{
"language" : "ga",
"value" : "BILEOG PHACÁISTE"
},
{
"language" : "it",
"value" : "FOGLIO ILLUSTRATIVO"
},
{
"language" : "lv",
"value" : "LIETOŠANAS INSTRUKCIJA"
},
{
"language" : "lt",
"value" : "PAKUOTĖS LAPELIS"
},
{
"language" : "mt",
"value" : "FULJETT TA TAGĦRIF"
},
{
"language" : "no",
"value" : "PAKNINGSVEDLEGG"
},
{
"language" : "pl",
"value" : "ULOTKA DLA PACJENTA"
},
{
"language" : "pt",
"value" : "FOLHETO INFORMATIVO"
},
{
"language" : "ro",
"value" : "PROSPECTUL"
},
{
"language" : "sk",
"value" : "PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA"
},
{
"language" : "sl",
"value" : "NAVODILO ZA UPORABO"
},
{
"language" : "es",
"value" : "PROSPECTO"
},
{
"language" : "sv",
"value" : "BIPACKSEDEL"
}
]
},
{
"code" : "100000155539",
"display" : "Combined File of all Documents"
},
{
"code" : "100000155540",
"display" : "Mock ups"
},
{
"code" : "100000155541",
"display" : "Appendix V"
}
]
}