Long Carol, Crane Mark
Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey, UK.
Toxicol Lett. 2003 May 15;142(3):219-25. doi: 10.1016/s0378-4274(03)00070-5.
This paper is in response to a previous article in a Special Issue of Toxicology Letters. That article criticised the current regulatory framework in the European Union for the environmental risk assessment of veterinary medicinal products (VMPs) and feed additives (FAs), in particular the ongoing process of international harmonisation of guidance. This response addresses the concerns raised in relation to veterinary medicinal products and demonstrates that the VICH process has been brought within the scope of current EU regulatory processes for veterinary medicines and therefore is not separate to them. Consultation with stakeholders takes place throughout the VICH process, with an additional period of open public consultation before guidance is adopted and implemented.
本文是对《毒理学快报》特刊中一篇先前文章的回应。该文章批评了欧盟当前关于兽药产品(VMPs)和饲料添加剂(FAs)环境风险评估的监管框架,特别是正在进行的国际指南协调进程。本回应解决了与兽药产品相关的问题,并表明兽药国际协调会议(VICH)进程已纳入欧盟当前兽药监管程序的范围内,因此并非与之分离。在整个兽药国际协调会议进程中都与利益相关者进行了磋商,在指南通过和实施之前还额外进行了一段公开征求公众意见的时期。