]> 2026-10-07T13:00:58+02:00 Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) 3002 en Article 2 (m) EN 5 (m)‘adverse event’: any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessa… HM TAG-00045-Adv-hte ++ TAG-00244-Def-ini ++ TAG-00066-Cau-enh ++ TAG-00001-Med-rzn 5.1.1 2026-07-16T11:50:13Z 2461237.993206 GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m)