欧洲药品管理局4月1日起调整申请费
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欧洲药品管理局4月1日起调整申请费
笔记 2016-03-11 收费预计增加0.2% 欧洲药品管理局（EMA）提醒申请人和上市许可持有人对除药物警戒程序之外的所有申请调整收费，将于2016年4月1日（周五）生效。 EMA每年于4月1日按照过去一年中的欧盟（EU）通货膨胀比率调整其收费。欧盟委员会目前正在通过一项法规，按照2015年通货膨胀率支付给EMA的费用调整0.2%。 一旦欧盟委员会通过法规并在欧盟官方公报上公布，且EMA管理委员会达成其实施决定后，EMA将在三月底公布调整后收费的全部细节。 3月31日收到的所有申请将按照现行收费和减免费率收取。3月31日之后收到的申请，如适用，将被收取调整后的费用并适用于修订后的减免费率。对于科学建议（Scientific advice）和孤儿药开发方案援助（Protocol assistance），截止日期将是请求建议的验证日期。对于年费，由周年日期确定申请费，因此任何周年日期在2016年4月1日或之后的申请将适用新收费。 按照法规（EU）658/2014的药物警戒程序收取的费用预计将于2016年7月1日更新。 Regulatory information - adjusted fees for applications to European Medicines Agency from 1 April 2016 The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on Friday 1 April 2016. 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 by 0.2% in line with the 2015 inflation rate. 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 Union and the Agency's Management Board has reached a decision on its implementation. 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. For annual fees the anniversary date defines the applicable fee and consequently any anniversary on or after 1 April 2016 will attract the new fee. Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be updated from 1 July 2016. |