CEP新申报涨价了

julia朱玉姣

Change of the fee for CEP applications

CEP申报费用变更 EDQM 2016-2-1

A review of the pricing policy for the activitiesassociated with the procedure for Certificates of suitability to the monographsof the European Pharmacopoeia was performed in 2015. As a result of this review,the fees for most activities rest unchanged but the fee for a new chemicalapplication will be increased to 5000 Euros.

2015年对CEP的价格进行了审核，审核后决定对大部分价格保持不变，但新化学申报的价格会增加到5000欧元。

A similar increase is also applied to the fee for anapplication for a new double certificate (chemical purity + TSE) which willincrease to 8000 Euros, for an application for a new CEP for chemical purityand sterility which will increase to 8000 Euros, whilst for an application fora new CEP covering the chemical purity and sterility and TSE, the fee willremain 9000 Euros.

相似的增长也针对新的双证（化学纯度+TSE），增加长为8000欧元；新的化学纯度和无菌CEP申报，增加后为8000欧元，而新的化学纯度和无菌+TSE的CEP申报，则保持9000欧元。

It is worth noting that whilst there was a revision ofthe fee structure relating to inspections in 2014 and revision activities in2013, the last revision of fees for new applications was more than 15 yearsago.

上次新申报价格调整是在15年之前了，检查费用调查是在2014年，修订费用调整是在2013年。

EDQM believes that a CEP remains an attractive choicefor applicants despite this increase in fees.

EDQM相信尽管价格略有增长，对于申报者来说，CEP仍是一个具有吸引力的选择。

The full details of fees for Certification relatedactivities can be found here.

全部的认证相关活动费用参见上述网址。

The fee increase is implemented from 1st March 2016and at this time there will be a new application form associated with the newfee structure.

费用的增加从2016年3月1日开始，那时新提交的申报就会按新的费用来划分和收取。

Link to current form(to be used until 29/02/2016)  

Link to revised form(to be used from 01/03/2016)

  - See more at: https://www.edqm.eu/en/news/change-fee-cep-applications#sthash.1cuSQ3F9.dpuf

新费用清单

CEP 028 Simple chemical certificate

化学单证5000

CEP 027 Simple TSE or herbal certificate

TSE或者草药单证3000

CEP 026 Double certificate (chemical + TSE)*

化学+TSE双证8000

CEP 025Certificate for chemical purity and sterility

化学纯度和无菌8000

CEP 024Certificate for chemical purity andsterility  + TSE**

化学纯度和无菌+TSE双证9000

唐灬僧

楼主你研发的还是干注册的。

julia朱玉姣

唐灬僧 发表于 2016-2-16 11:03
楼主你研发的还是干注册的。

我啥也不干 就是偶尔吃吃唐僧肉    嘻嘻

萧向天

涨价，是这几年的主题

fudan13

julia朱玉姣 发表于 2016-2-16 11:06
我啥也不干 就是偶尔吃吃唐僧肉    嘻嘻

原来是大王啊

制药企业小菜鸟

fudan13 发表于 2016-2-16 11:13
原来是大王啊

大王让你去巡山呢

北重楼

又涨价了

kc1711422001

Thanks for sharing