SOCIAL QUESTIONS|health|pharmaceutical industry
- comhairle eolaíoch chomhthreomhar Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Context 'Maidir leis an tacaíocht feabhsaithe rialála, bunóidh an Ghníomhaireacht sásra comhordúcháin laistigh de 6 mhí ó glacadh í chun comhairle eolaíoch chomhthreomhar a chumasú le measúnú ar theicneolaíocht sláinte agus le comhlachtaí rialála maidir le feistí leighis.' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
- parallel scientific advice
- en
- Definition scientific advice, requested by undertakings or, as relevant, not-for-profit entities established in the European Union, that takes place in parallel to the joint scientific consultation carried out by the Member State Coordination Group on Health Technology Assessment, in line with Article 16(5) of Regulation (EU) 2021/2282 and/or, in the case of medicinal products involving a medical device, in parallel with the consultation of the expert panels referred to in Article 61(2) of Regulation (EU) 2017/745 Reference "COM-Terminology Coordination, based on: Article 59 of Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006, COM(2023) 193"