SOCIAL QUESTIONS|health|pharmaceutical industry
- táirge íocshláinte dílleachtach a théann i ngleic le riachtanas ard leighis Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- orphan medicinal product addressing a high unmet medical need
- en
- Definition "orphan medicinal product that fulfils the following requirements: (a) there is no medicinal product authorised in the European Union for such condition or where, despite medicinal products being authorised for such condition in the European Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancement; (b) the use of the orphan medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population" Reference "COM-Terminology Coordination, based on: 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, COM(2023) 193"