EMA新闻20150226：法规信息：EMA申报费用自2015年4月1日起调整

EMA新闻20150226：法规信息：EMA申报费用自2015年4月1日起调整  

2015-02-27 20:06:36|  分类： EMA

26/02/2015

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/02/news_detail_002278.jsp&mid=WC0b01ac058004d5c1

Regulatory information - Adjusted fees for applications to European Medicines Agency from 1 April 2015

法规信息：EMA申报费用自2015年4月1日起调整

Fees expected to decrease by 0.1%

费用预期降低0.1%

The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees will be coming into effect on Wednesday 1 April 2015.

EMA提醒申报人和上市许可持有人，调整后的费用将于2015年4月1日生效。

Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. The European Commission is currently in the process of adopting a regulation adjusting the fees payable to the Agency in line with the 2014 inflation rate. Although the final adjustment is not yet known, the Agency expects its fees to decrease by around 0.1%.

每年，EMA都会在4月1日对其费用进行调整，以保持与欧盟通胀一致。欧盟委员会现在正在针对2014年欧盟的通胀率来调整费用。尽管最终调整结果还不知道，但EMA预期费用将会降低约0.1%。

The Agency will publish full details of the revised fees at the end of March, once the European Commission has adopted the regulation and published it in the Official Journal of the European Unionand the Agency's Management Board has reached a decision on its implementation.

一旦欧盟委员会采纳了调整结果，在欧盟官方杂质上公布，EMA管理董事会达成实施决议，EMA将在3月公布修改后的费用清单，

All applications received by 31 March will be charged at the current fee and reduction rates. Applications received after that date will be charged the adjusted fees and be subject to the revised reduction rates, where applicable. For scientific advice and protocol assistance, the cut-off date will be the date of validation of the request for advice.

所有在3月31日收到的申报资料将根据现行费率和减免费率收费。此后收到的申报资料将按调整后的费率和修订后的减免费率收费。对于科学咨询和方案协助，结算日期将是咨询申请被核实的日期。

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015127104237879/

好资料，好好学习

FDA在涨，欧盟竟然在降