CEP/PA/PH/CEP(04)2,4R执行日期:2010年3月1日欧洲药典适用性证书持有人必须向EDQM报告所有与申报文件有关的变更,申报时应填写申请表格和所有必要的资料,证明变更符合以下指南的规定。根据变更可能对最终产品产生的影响程度,变更分为三类(通知/微小/重大)。分类原则是根据EC法规1234/2008(IA-IAIN/IB/II):EC成员...
Administrative information: (application form) III. Module 2: Quality Overall Summary IV. Module 3: Technical documentation for Herbal Drug V. Module 3: Technical documentation for Herbal Drug Preparation VI. References Page 2 of 16 EDQM PA/PH/CEP (02) 6 1R Certification of Substances Division ...
A revision of the CEP procedure was already made in December 2012. The EDQM has published revised guidelines for the suspension or withdrawal of a CEP or the closure of a CEP procedure. The document entitled "Suspension or Withdrawal of a Certificate of Suitability, Closure of an Application" ...