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
| Official URL: http://ema.europa.eu/fhir/ValueSet/EUepiannexqrdcodesVs | Version: 1.0.0 | |||
| Active as of 2025-04-02 | Computable Name: EUepiannexqrdcodesVs | |||
List of section codes allowed in Annex II documents, defined in EMA's Referentials Management Service.
References
Generated Narrative: ValueSet EUepiannexqrdcodesVs
http://ema.europa.eu/fhir/CodeSystem/200000029659| Code | Display |
| 000000000000 | Code for custom sub-sections (reserved) |
| 200000029850 | ANNEX II |
| 200000029851 | A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE |
| 200000029852 | B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE |
| 200000029853 | Official batch release |
| 200000029854 | C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION |
| 200000029855 | Periodic safety update reports (PSURs) |
| 200000029856 | D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT |
| 200000029857 | Risk management plan (RMP) |
| 200000029858 | Additional risk minimisation measures |
| 200000029859 | Obligation to conduct post-authorisation measures |
| 200000029860 | E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES |
Generated Narrative: ValueSet
Expansion done internally based on codesystem 02 Section Code System v1.0.0 (CodeSystem)
This value set contains 12 concepts
| Code | System | Display |
| 000000000000 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Code for custom sub-sections (reserved) |
| 200000029850 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | ANNEX II |
| 200000029851 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE |
| 200000029852 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE |
| 200000029853 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Official batch release |
| 200000029854 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION |
| 200000029855 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Periodic safety update reports (PSURs) |
| 200000029856 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT |
| 200000029857 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Risk management plan (RMP) |
| 200000029858 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Additional risk minimisation measures |
| 200000029859 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Obligation to conduct post-authorisation measures |
| 200000029860 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES |
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 |