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)
Safety - Medicine is harmful (Art. 116, 117(1a) of Directive No 2001/83/EC)
Efficacy – Lack of efficacy (Art. 116, 117(1b) of Directive No 2001/83/EC)
Risk/benefit - Not favourable (Art. 116, 117(1c) of Directive No 2001/83/EC)
Quality - Composition not as declared (Art. 116, 117(1d) of Directive No 2001/83/EC)
Quality - Controls have not been carried out or MA obligations not fulfilled (Art. 117(1e) of Directive No 2001/83/EC)
Particulars of Art. 8-11 incorrect/not amended as Art. 23 (obligation to keep dossier updated) (Art. 116 of Directive No 2001/83/EC)
Any conditions as per Art. 21, 22 not fulfilled (e.g. PAES, PASS) (Art. 116 of Directive No 2001/83/EC)
Commercial reasons (excl. Art. 116, 117 of Directive No 2001/83/EC)