正文
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 Commission
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（
