ENVIRONMENT|deterioration of the environment|nuisance · SOCIAL QUESTIONS|health|health policy|organisation of health care|public health|health risk
- measúnú riosca don chomhshaol Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Context 'Déanfar measúnú ar shábháilteacht úsáideoirí, measúnú riosca don chomhshaol, staidéir ar ídiú iarmhar, agus staidéir chliniciúla maidir leis an táirge comhcheangailte seasta.' Reference "Rialachán Tarmligthe (AE) 2021/805 ón gCoimisiún an 8 Márta 2021 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
- measúnú riosca comhshaoil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- measúnú ar an mbaol don chomhshaol Reference an Ghníomhaireacht Eorpach Comhshaoil (GEC)
- ga
- environmental risk assessment | ERA
- en
- Definition evaluation of risks posed to human health and the environment - whether direct or indirect, immediate or delayed, due to the production/manufacturing of a substance, its use and its disposal - included in marketing authorisation applications for medicinal products in the European Union Reference "COM-Terminology Coordination, based on:1) Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220/EEC2) European Commisison. Health & Consumer Protection Directorate-General. 'Report on the ecological risk assessment of chemicals' (27.11.2023) discussed by the scientific steering committee at its meeting of 7-8 November 20023) Proposal for a Directive on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192"
- Comment For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product.
- évaluation des risques pour l’environnement
- fr
- Definition évaluation des risques, directs ou indirects, immédiats ou différés, que la dissémination volontaire ou la mise sur le marché d'OGM peut comporter pour la santé humaine et l'environnement Reference "COM-FR d'après Directive 2001/18/CE du Parlement européen et du Conseil du 12 mars 2001 relative à la dissémination volontaire d'organismes génétiquement modifiés dans l'environnement et abrogeant la directive 90/220/CEE du Conseil"