European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - final
| Official URL: http://ema.europa.eu/fhir/ValueSet/EUepilabellingcodesVs | Version: 1.0.0 | |||
| Active as of 2026-08-26 | Computable Name: EUepilabellingcodesVs | |||
List of section codes allowed in Labelling documents, defined in EMA's Referentials Management Service.
References
http://ema.europa.eu/fhir/CodeSystem/200000029659 version 📦1.0.0| Code | Display |
| 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 |
Expansion performed internally based on codesystem Sections v1.0.0 (CodeSystem)
This value set contains 34 concepts
| System | Code | Display (en) | JSON | XML |
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 000000000000 | Code for custom sub-sections (reserved) | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029861 | LABELLING | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029862 | PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE} | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029863 | 1. NAME OF THE MEDICINAL PRODUCT | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029864 | 2. STATEMENT OF ACTIVE SUBSTANCE(S) | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029865 | 3. LIST OF EXCIPIENTS | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029866 | 4. PHARMACEUTICAL FORM AND CONTENTS | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029867 | 5. METHOD AND ROUTE(S) OF ADMINISTRATION | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029868 | 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029869 | 7. OTHER SPECIAL WARNING(S), IF NECESSARY | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029870 | 8. EXPIRY DATE | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029871 | 9. SPECIAL STORAGE CONDITIONS | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029872 | 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029873 | 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029874 | 12. MARKETING AUTHORISATION NUMBER(S) | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029875 | 13. BATCH NUMBER[, DONATION AND PRODUCT CODES] | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029876 | 14. GENERAL CLASSIFICATION FOR SUPPLY | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029877 | 15. INSTRUCTIONS ON USE | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029878 | 16. INFORMATION IN BRAILLE | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029879 | 17. UNIQUE IDENTIFIER - 2D BARCODE | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029880 | 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029881 | MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE} | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029882 | 1. NAME OF THE MEDICINAL PRODUCT | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029883 | 2. NAME OF THE MARKETING AUTHORISATION HOLDER | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029884 | 3. EXPIRY DATE | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029885 | 4. BATCH NUMBER[, DONATION AND PRODUCT CODES] | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029886 | 5. OTHER | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029887 | MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE} | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029888 | 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029889 | 2. METHOD OF ADMINISTRATION | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029890 | 3. EXPIRY DATE | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029891 | 4. BATCH NUMBER[, DONATION AND PRODUCT CODES] | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029892 | 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT | ||
http://ema.europa.eu/fhir/CodeSystem/200000029659 | 200000029893 | 6. OTHER |
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |