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

CodeSystem: 04 Labelling Code System

Official URL: http://ema.europa.eu/fhir/CodeSystem/300000000003 Version: 1.0.0
Active as of 2025-02-14 Computable Name: EUepilabellingcodesystem

List of section codes allowed in Labelling documents, defined in EMA's Referentials Management Service.

This Code system is referenced in the content logical definition of the following value sets:

Generated Narrative: CodeSystem 300000000003

version: 5.0.0; Last updated: 2024-11-03 11:35:00+0000

This case-sensitive code system http://ema.europa.eu/fhir/CodeSystem/300000000003 defines the following codes:

CodeDisplay
000000000000 Code for custom sub-sections (reserved)
200000029861 LABELLING
200000029862 PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {NATURE/TYPE}
200000029863 1. NAME OF THE MEDICINAL PRODUCT
200000029864 2. STATEMENT OF ACTIVE SUBSTANCE(S)
200000029865 3. LIST OF EXCIPIENTS
200000029866 4. PHARMACEUTICAL FORM AND CONTENTS
200000029867 5. METHOD AND ROUTE(S) OF ADMINISTRATION
200000029868 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
200000029869 7. OTHER SPECIAL WARNING(S), IF NECESSARY
200000029870 8. EXPIRY DATE
200000029871 9. SPECIAL STORAGE CONDITIONS
200000029872 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
200000029873 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
200000029874 12. MARKETING AUTHORISATION NUMBER(S)
200000029875 13. BATCH NUMBER<, DONATION AND PRODUCT CODES>
200000029876 14. GENERAL CLASSIFICATION FOR SUPPLY
200000029877 15. INSTRUCTIONS ON USE
200000029878 16. INFORMATION IN BRAILLE
200000029879 17. UNIQUE IDENTIFIER - 2D BARCODE
200000029880 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
200000029881 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}
200000029882 1. NAME OF THE MEDICINAL PRODUCT
200000029883 2. NAME OF THE MARKETING AUTHORISATION HOLDER
200000029884 3. EXPIRY DATE
200000029885 4. BATCH NUMBER<, DONATION AND PRODUCT CODES>
200000029886 5. OTHER
200000029887 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}
200000029888 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
200000029889 2. METHOD OF ADMINISTRATION
200000029890 3. EXPIRY DATE
200000029891 4. BATCH NUMBER<, DONATION AND PRODUCT CODES>
200000029892 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
200000029893 6. OTHER