SOCIAL QUESTIONS|health|pharmaceutical industry
- máistirchomhad plasma Reference "Togra le haghaidh Rialachán maidir le caighdeáin cháilíochta agus sábháilteachta le haghaidh substaintí de bhunús daonna a bheartaítear lena n-úsáid sa duine agus lena n-aisghairtear Treoracha 2002/98/CE agus 2004/23/CE, CELEX:52022PC0338/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
- ga
- Plasma Master File | PMF
- en
- Definition stand-alone documentation, which is separate from the dossier for marketing authorisation which provides all relevant detailed information on the characteristics of the entire human plasma used as a starting material and/or a raw material for the manufacture of sub/intermediate fractions, constituents of the excipient and active substance(s), which are part of medicinal products or medical devices referred to in Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EC as regards medical devices incorporating stable derivatives of human blood or human plasma Reference "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use"