SOCIAL QUESTIONS|health|pharmaceutical industry
- staidéar iar-údarúcháin ar mheasúnú riosca comhshaoil Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- post-authorisation environmental risk assessment study
- en
- Sainmhíniú evaluation of risks posed to human health and the environment, whether direct or indirect, if there are concerns about the risks to the environment or public health, including antimicrobial resistance, due to an authorised medicinal product in the European Union, or related active substance Tagairt "COM-Terminology Coordination, based on: Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 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"