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2015-03-11 22:58:43| 分类： EDQM CEP
来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015211105020436/
EDQM
Certification of Substances Division PA/PH/CEP(15)10
Certification of suitability to the Monographs of the European Pharmacopoeia
Strasbourg, March 2015
CERTIFICATION MONTHLY REPORT
FEBRUARY 2015
2015年2月月报
New granted CEPs新颁发的CEP
| CEPs granted (total 2015) |
TSE | 3 |
Herbal | 0 |
Revised CEPs granted 修订后颁发的CEP
| CEPs granted (total 2015) |
TSE | 4 |
Herbal | 0 |
Time for treatment (rate of dossiers treated in time for chemical applications)
处理时间（化学CEP申报的文件处理速度）
Inspections 现场检查
| Month (current) 当前月 | Cumulated /year 本年累计 |
Nr of inspections审计次数 | 3 | 6 |
Asia 亚洲 | 1 | 4 |
EEA | 0 | 0 |
Other places 其它地区 | 2 | 2 |
Sites covered without inspection (eg. By exchange of information) 无现场检查即通过的工厂（例如通过信息互换） | 3 | 4 |
Suspended /withdrawn CEPs 证书搁置和撤销
| Month (current) 当前月 |
Nr of CEPs supended 搁置CEP证书数量 | 1 |
Nr of CEPs expired 过效期CEP证书数量 | 1 |
Nr of CEPs withdrawn by EDQM 由EDQM撤销的证书数量 | 0 |
Nr of CEP withdrawn by holder 由持有人撤销的证书数量 | 1 |
Nr of closed applications 关闭的申报数量 | 7 |
Information published on the EDQM Website (www.edqm.eu)
? Restoration of suspended CEP 已搁置CEP的恢复（以下CEP由S.I.M.S. S.R.L. IT 50066 Reggello 持有）
n 09/02/15 Bupivacaine hydrochloride CEP 2001-013
n 09/02/15 Lidocaine hydrochloride CEP 2001-014
n 09/02/15 Ketoprofen CEP 2002-097
n 09/02/15 Ticlopidine hydrochlorid CEP 2002-106
n 09/02/15 Metoprolol tartrate CEP 2004-087
n 09/02/15 Lidocaine CEP 2004-156
n 09/02/15 Dipyridamole CEP 2004-204
n 09/02/15 Articaine hydrochloride CEP 2009-137
n 09/02/15 Mepivacaine hydrochloride CEP 2010-129
? CEP Suspensions: Upon request from the holder, due to a temporary inability to produce the product under the approved conditions
n 13/02/15 Oxytocin CEP 2011-003
? CEP搁置：持有人因暂时无法按批准的条件生产因此申请搁置
n 2015年2月13日，后叶催产素，CEP2011-003（该CEP由上海苏豪逸明制药有限公司 200 333 Shanghai持有）
? 13/02/2015: New provisions for the invoicing of inspection expenses (PA/PH/CEP (12) 28, 1R)
? 2015年2月13日：检查费用发票新条款（PA/PH/CEP(12)28, 1R）
? 25/02/2015: New Indian state of Telangana – impact on CEPs
? 2015年2月25日：新印度邦对CEP的影响
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