SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product
- táirge íocshláinte bitheolaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Context 'Ní bheidh an t-athrú infheidhme maidir le táirge íocshláinte bitheolaíoch ná táirge íocshláinte imdhíoneolaíoch.' Reference "Rialachán Cur Chun Feidhme (AE) 2023/997 lena leasaítear Rialachán Cur Chun Feidhme (AE) 2021/17 lena mbunaítear liosta modhnuithe nach n-éilíonn measúnú i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32023R0997/GA"
- bithchógas Reference "Comhairle-GA, bunaithe ar 'bithchógasaíocht' (téarma a chuireann síos ar an mbrainse eolaíochta seachas an táirge féin) in Dearbhú Versailles Faomhadh an téarma seo mar chuid de Thionscadal Lex"
- ga
- biologisches Arzneimittel | Biologikum | Biologika | Biopharmakon
- de
- Definition "Arzneimittel, dessen Wirkstoff ein biologischer Stoff ist" Reference "Richtlinie 2003/63/EG der Kommissionzur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel"
- biological medicinal product | biologic | biomedicine | biopharmaceutical
- en
- Definition "product, the active substance of which is a biological substance" Reference "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
- Comment medicinal product, the active substance of which is produced by or extracted from a biological source and which due to its complexity, its characterisation and the determination of its quality may require a combination of physico-chemical-biological testing, together with its control strategy
- médicament biologique | biomédicament
- fr
- Definition produit dont la substance active est une substance biologique Reference "Directive 2003/63/CE de la Commission, CELEX:32003L0063/fr"