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 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="300000000003"/>
<meta>
<versionId value="5.0.0"/>
<lastUpdated value="2024-11-03T11:35:00.198Z"/>
</meta>
<text>
<status value="generated"/>
<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>
</text>
<url value="http://ema.europa.eu/fhir/CodeSystem/300000000003"/>
<version value="1.0.0"/>
<name value="EUepilabellingcodesystem"/>
<title value="04 Labelling Code System"/>
<status value="active"/>
<experimental value="false"/>
<date value="2025-02-14T17:19:16+00:00"/>
<publisher value="European Medicines Agency"/>
<contact>
<name value="European Medicines Agency"/>
<telecom>
<system value="url"/>
<value value="https://ema.europa.eu/fhir"/>
</telecom>
</contact>
<contact>
<name value="FHIR at EMA"/>
<telecom>
<system value="url"/>
<value value="http://ema.europa.eu/fhir"/>
</telecom>
</contact>
<description
value="List of section codes allowed in Labelling documents, defined in EMA's Referentials Management Service."/>
<caseSensitive value="true"/>
<content value="complete"/>
<count value="34"/>
<concept>
<code value="000000000000"/>
<display value="Code for custom sub-sections (reserved)"/>
</concept>
<concept>
<code value="200000029861"/>
<display value="LABELLING"/>
</concept>
<concept>
<code value="200000029862"/>
<display
value="PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {NATURE/TYPE}"/>
</concept>
<concept>
<code value="200000029863"/>
<display value="1. NAME OF THE MEDICINAL PRODUCT"/>
</concept>
<concept>
<code value="200000029864"/>
<display value="2. STATEMENT OF ACTIVE SUBSTANCE(S)"/>
</concept>
<concept>
<code value="200000029865"/>
<display value="3. LIST OF EXCIPIENTS"/>
</concept>
<concept>
<code value="200000029866"/>
<display value="4. PHARMACEUTICAL FORM AND CONTENTS"/>
</concept>
<concept>
<code value="200000029867"/>
<display value="5. METHOD AND ROUTE(S) OF ADMINISTRATION"/>
</concept>
<concept>
<code value="200000029868"/>
<display
value="6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN"/>
</concept>
<concept>
<code value="200000029869"/>
<display value="7. OTHER SPECIAL WARNING(S), IF NECESSARY"/>
</concept>
<concept>
<code value="200000029870"/>
<display value="8. EXPIRY DATE"/>
</concept>
<concept>
<code value="200000029871"/>
<display value="9. SPECIAL STORAGE CONDITIONS"/>
</concept>
<concept>
<code value="200000029872"/>
<display
value="10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE"/>
</concept>
<concept>
<code value="200000029873"/>
<display
value="11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER"/>
</concept>
<concept>
<code value="200000029874"/>
<display value="12. MARKETING AUTHORISATION NUMBER(S)"/>
</concept>
<concept>
<code value="200000029875"/>
<display value="13. BATCH NUMBER<, DONATION AND PRODUCT CODES>"/>
</concept>
<concept>
<code value="200000029876"/>
<display value="14. GENERAL CLASSIFICATION FOR SUPPLY"/>
</concept>
<concept>
<code value="200000029877"/>
<display value="15. INSTRUCTIONS ON USE"/>
</concept>
<concept>
<code value="200000029878"/>
<display value="16. INFORMATION IN BRAILLE"/>
</concept>
<concept>
<code value="200000029879"/>
<display value="17. UNIQUE IDENTIFIER - 2D BARCODE"/>
</concept>
<concept>
<code value="200000029880"/>
<display value="18. UNIQUE IDENTIFIER - HUMAN READABLE DATA"/>
</concept>
<concept>
<code value="200000029881"/>
<display
value="MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}"/>
</concept>
<concept>
<code value="200000029882"/>
<display value="1. NAME OF THE MEDICINAL PRODUCT"/>
</concept>
<concept>
<code value="200000029883"/>
<display value="2. NAME OF THE MARKETING AUTHORISATION HOLDER"/>
</concept>
<concept>
<code value="200000029884"/>
<display value="3. EXPIRY DATE"/>
</concept>
<concept>
<code value="200000029885"/>
<display value="4. BATCH NUMBER<, DONATION AND PRODUCT CODES>"/>
</concept>
<concept>
<code value="200000029886"/>
<display value="5. OTHER"/>
</concept>
<concept>
<code value="200000029887"/>
<display
value="MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}"/>
</concept>
<concept>
<code value="200000029888"/>
<display
value="1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION"/>
</concept>
<concept>
<code value="200000029889"/>
<display value="2. METHOD OF ADMINISTRATION"/>
</concept>
<concept>
<code value="200000029890"/>
<display value="3. EXPIRY DATE"/>
</concept>
<concept>
<code value="200000029891"/>
<display value="4. BATCH NUMBER<, DONATION AND PRODUCT CODES>"/>
</concept>
<concept>
<code value="200000029892"/>
<display value="5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT"/>
</concept>
<concept>
<code value="200000029893"/>
<display value="6. OTHER"/>
</concept>
</CodeSystem>