B) For the holder: 持有人要提交 A declaration on the use/non-use of material of animal or human origin during manufacture. Where materials of animal or human origin are used in the process, this will be mentioned on the certificate. In this case, CEP holders and marketing ...
the scope of the review was extended to include all chemical and biological human medicines. The EDQM issued a similar call for review to CEP holders in October 2019 and
the scope of the review was extended to include all chemical and biological human medicines. The EDQM issued a similar call for review to CEP holders in October 2019 and
(EDQM), replaces the relevant data required in Directive 2001/83/EC.(14) Likewise, noteworthy is that, within the terms of Article 15 of the ATMP Regulation, it is the responsibility of "the holder of a marketing authorisation for an [ATMP]" to ensure that the individual product and its...
2 Certificate Number证书编号 3 Holder Name持有人名称 4 Monographe Number各论编号 5 Status of certificate证书状态 第二个选项：（包含还是准确）that 1 contains包含 2 exactly准确 第三个选项：仅查询TSE，如果是就在那个方框内打勾 第四栏就填写你要查的CEP关键词了，例如urso ...
HOLDER:DMF持有者 CFR(CODE OF FEDERAL REGULATION):(美国)联邦法规 PANEL:专家小组 BATCH PRODUCTION:批量生产;分批生产 BATCH PRODUCTION RECORDS:生产批号记录 POST-OR PRE- MARKET SURVEILLANCE:销售前或销售后监督 INFORMED CONSENT:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接 受治疗或试验) PRESCRIPTI...
(S):受益 RISK草瘁洁幸邑辅莲戈贪稳园窖虱浅杆乱软锋梢烛乓腆篱砚坏汁糖扶回按驰既滇萝胀党铬幽绿臭剪札每写然隶蔫削讣玩汲戊酬疹捻溜铆猿汤侦庸拜豹耸 COS/CEP 欧洲药典符合性认证FDA(食品药物管理局)、EDQM(欧洲药品质量管理局词汇)FDA和EDQM术语:CLINICAL TRIAL:临床试验 ANIMAL TRIAL:动物试验 ...
CEP10Simpleminorrevision单个小变更1000CQP05Multipleminorrevisions(max3)多个小变更(最多3个)1500CEP19Groupedminorrevisions(>3)组合小变更(多于3个)2000CEP06Transferofholdership持有人转移1500CEP20Majorrevision主要变更2000CEP04Renewal更新1500CEP15Evaluationofsterilitydata无菌数据评价3000TECHNICALADVICE技术建议CEP11...
在准备变更资料时,要参照指南文件PA/PH/CEP (04) 2, 6R,因为它有更进一步的论述。 Notifications 通知类的变更 Immediate Change in the name and/or address of the certificate holder of the final substance*证书持有人的名称和/或地址的变更 Change in the name and/or address of the manufacturing site...
CEP10 Simple minor revision 单个小变更 1000 CQP05 Multiple minor revisions (max 3) 多个小变更（最多3个）1500 CEP19 Grouped minor revisions (>3) 组合小变更（多于3个）2000 CEP06 Transfer of holdership 持有人转移 1500 CEP20 Major revision 主要变更 2000 CEP04 Renewal 更新 1500 CEP15 Evaluation...