EMA Write PMS API Implementation Guide - Enrichments
1.2.1 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: http://ema.europa.eu/fhir/vs/reasonforMarketingUnavailability | Version: 1.2.1 | |||
| Active as of 2026-06-26 | Computable Name: ReasonforMarketingUnavailabilityVs | |||
Marketing Status Reason
References
Expansion performed internally based on codesystem Reason for Marketing Unavailability v1.2.1 (CodeSystem)
This value set contains 8 concepts
| System | Code | Display (en) | JSON | XML |
http://spor.ema.europa.eu/v1/lists/200000018799 | 200000018808 | Safety - Medicine is harmful (Art. 116, 117(1a) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/200000018799 | 200000018809 | Efficacy – Lack of efficacy (Art. 116, 117(1b) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/200000018799 | 200000018810 | Risk/benefit - Not favourable (Art. 116, 117(1c) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/200000018799 | 200000018811 | Quality - Composition not as declared (Art. 116, 117(1d) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/200000018799 | 200000018812 | Quality - Controls have not been carried out or MA obligations not fulfilled (Art. 117(1e) of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/200000018799 | 200000018813 | Particulars of Art. 8-11 incorrect/not amended as Art. 23 (obligation to keep dossier updated) (Art. 116 of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/200000018799 | 200000018814 | Any conditions as per Art. 21, 22 not fulfilled (e.g. PAES, PASS) (Art. 116 of Directive No 2001/83/EC) | ||
http://spor.ema.europa.eu/v1/lists/200000018799 | 200000018815 | Commercial reasons (excl. Art. 116, 117 of Directive No 2001/83/EC) |
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 |