http://ema.europa.eu/fhir/CodeSystem/200000018799
type: CodeSystem
node role: treeRoot
id:
  v: 200000018799
meta:
  version id:
    v: 5.0.0
  last updated:
    v: 2023-08-03T11:35:00.198Z
text:
  status:
    v: generated
  div: Generated Narrative: CodeSystem 200000018799 version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000 This case-sensitive code system http://spor.ema.europa.eu/v1/lists/200000018799 defines the following codes: Code Display 200000018808 Safety - Medicine is harmful (Art. 116, 117(1a) of Directive No 2001/83/EC) 200000018809 Efficacy – Lack of efficacy (Art. 116, 117(1b) of Directive No 2001/83/EC) 200000018810 Risk/benefit - Not favourable (Art. 116, 117(1c) of Directive No 2001/83/EC) 200000018811 Quality - Composition not as declared (Art. 116, 117(1d) of Directive No 2001/83/EC) 200000018812 Quality - Controls have not been carried out or MA obligations not fulfilled (Art. 117(1e) of Directive No 2001/83/EC) 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) 200000018814 Any conditions as per Art. 21, 22 not fulfilled (e.g. PAES, PASS) (Art. 116 of Directive No 2001/83/EC) 200000018815 Commercial reasons (excl. Art. 116, 117 of Directive No 2001/83/EC)
url:
  v: http://spor.ema.europa.eu/v1/lists/200000018799
version:
  v: 1.2.0
name:
  v: ReasonforMarketingUnavailabilityCs
title:
  v: Reason for Marketing Unavailability
status:
  v: active
experimental:
  v: false
date:
  v: 2025-10-21T12:20:05+01:00
publisher:
  v: EMA
contact:
  name:
    v: EMA
  telecom:
    system:
      v: url
    value:
      v: https://support.ema.europa.eu/esc
description:
  v: Reason for Marketing Unavailability
case sensitive:
  v: true
content:
  v: complete
count:
  v: 8
concept:
  code:
    v: 200000018808
  display:
    v: Safety - Medicine is harmful (Art. 116, 117(1a) of Directive No 2001/83/EC)
concept:
  code:
    v: 200000018809
  display:
    v: Efficacy – Lack of efficacy (Art. 116, 117(1b) of Directive No 2001/83/EC)
concept:
  code:
    v: 200000018810
  display:
    v: Risk/benefit - Not favourable (Art. 116, 117(1c) of Directive No 2001/83/EC)
concept:
  code:
    v: 200000018811
  display:
    v: Quality - Composition not as declared (Art. 116, 117(1d) of Directive No 2001/83/EC)
concept:
  code:
    v: 200000018812
  display:
    v: Quality - Controls have not been carried out or MA obligations not fulfilled (Art. 117(1e) of Directive No 2001/83/EC)
concept:
  code:
    v: 200000018813
  display:
    v: Particulars of Art. 8-11 incorrect/not amended as Art. 23 (obligation to keep dossier updated) (Art. 116 of Directive No 2001/83/EC)
concept:
  code:
    v: 200000018814
  display:
    v: Any conditions as per Art. 21, 22 not fulfilled (e.g. PAES, PASS) (Art. 116 of Directive No 2001/83/EC)
concept:
  code:
    v: 200000018815
  display:
    v: Commercial reasons (excl. Art. 116, 117 of Directive No 2001/83/EC)