SOCIAL QUESTIONS|health|pharmaceutical industry · SOCIAL QUESTIONS|health|health policy|organisation of health care|medical device · SOCIAL QUESTIONS|health|health policy|organisation of health care|pharmaceutical legislation
- substaint choimhdeach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Comhthéacs 'I gcás ina bhfaigheann an t-údarás um tháirgí íocshláinte a ndeachthas i gcomhairle leis faisnéis maidir leis an tsubstaint choimhdeach, a bhféadfadh tionchar a bheith aici ar an riosca nó ar an tairbhe a bunaíodh roimhe seo a bhaineann leis an tsubstaint a ionchorprú san fheiste, cuirfidh sé comhairle ar an gcomhlacht dá dtugtar fógra faoi cibé acu atá tionchar ag an bhfaisnéis sin ar an riosca nó ar an tairbhe a bunaíodh roimhe seo a bhaineann leis an tsubstaint a ionchorprú san fheiste.' Tagairt "Rialachán (AE) 2017/745 maidir le feistí leighis, lena leasaítear Treoir 2001/83/CE, Rialachán (CE) Uimh. 178/2002 agus Rialachán (CE) Uimh. 1223/2009 agus lena n-aisghairtear Treoir 90/385/CEE ón gComhairle agus Treoir 93/42/CEE ón gComhairle,CELEX:32017R0745/GA"
- ancillary substance
- en
- Sainmhíniú substance incorporated as an integral part in a device, which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device Tagairt "COM-Terminology Coordination, based on: Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Directives 90/385/EEC and 93/42/EEC"