EMA和EC共同发布问答20170531

julia朱玉姣

31/05/2017

Regulatory guidance for industry to prepare for theUK’s withdrawal from the EU EMA and the European Commission publish first in aseries of Q&As for companies

行业法规指南：为英国撤出EU EMA做准备，EC首发一份对公司的问答系列

The European Medicines Agency (EMA) and the European Commissionfile:///C:\Users\Jzhu\AppData\Local\Temp\msohtmlclip1\01\clip_image001.gif have published guidance to help pharmaceuticalcompanies to prepare for the United Kingdom's withdrawal from the EuropeanUnion. The guidance relates to both human and veterinary medicines.

EMA和EC已经发布了指南帮助药企为英国脱欧做准备。本指南与人药和兽药相关。

The questions-and–answersdocument concernsinformation related to the location of establishment of a company in thecontext of centralised procedures and certain activities, including thelocation of orphan designation holders, qualified persons for pharmacovigilance(QPPVs) and companies’ manufacturing and batch release sites.

问答文件主要是关于集中审评程序下公司工厂所在位置与特定活动相关的信息，包括孤儿药持有人、药物警戒授权人（QPPV）和公司的生产及批放行所在地问题。

EMA is preparing a series of further guidancedocuments which will be published on its website in due course. Companies areadvised to regularly check EMA’s dedicated webpage on the consequencesof Brexit.

EMA正在准备一系列进一步指南文件，这些文件将在其官网发布。建议公司定期查看EMA关于英国脱欧后续问题专题网页。

This first questions-and-answers document follows thepublication of the EuropeanCommission/EMA notice to marketing authorisation holders of centrally authorised medicines for human andveterinary use on 2 May 2017.

此次首份问答文件是在2017年5月2日EC/EMA发布对集中审评人药和兽药上市许可持有人通知之后发布的。

附件为问答原文及中英文对照，可直接下载。

syhorchid

了解一下

新华123

谢谢分享，非常感谢

学习之名

谢谢分享，学一下

玻璃杯

感谢分享，
英格兰脱欧，不但影响政治，还影响制药政策和法规

情之殇

感谢分享，英国脱欧，一石激起千层浪啊

洁白的羽毛

谢谢分享

cmcpu

了解一下~这也是个大方向啊

JL052

学习一下                    

wongscm

Thanks for sharing

114363808

多了一些审批和门槛

kc1711422001

Thanks for sharing

小刀

谢谢分享…………

小金库

谢谢分享。