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