TheEDQM‘s Position onCEPApplications for Biological Substances REVISON AND RENEWALS GUIDELINES REVISION APPLICATION FORMRENEWALS APPLICATION FORM Guidance for Submission of Electronic Documentation for Applications for Certificates of Suitability (CEPs): Revised Procedures PA/PH/CEP (09) 108, 1RProcedures ...
A certificate of suitability to the monographs of the European Pharmacopoeia (CEP) issued by the EDQM is considered to replace the relevant sections in the application for marketing authorization demonstrating the quality of substances for pharmaceutical use. The inclusion of a CEP in an MAA ...
EDQM 使用CEP描述起始物料来申请另一个CEP 2016.9 英文.pdf,Certification of Substances Division FML/CB PUBLIC DOCUMENT (LEVEL 1) (LEVEL 1) English only/Anglais seulement PA/PH/CEP (14) 06, 1 R Strasbourg, September 2016 Certification of suitability to Monog
edqm所接受的物质质量标准中所包括的内容要少。 - subtitle(e.g. particle size, polymorphic form, sterile) 子标题(例如,颗粒度、多晶型、无菌) the cep applicant can request that a subtitle isincluded on the cep, provided that the conditions laid down ...
In exceptional cases where the holder of the certificate will not be the manufacturer, please provide the following declarations: A declaration from the manufacturer to commit to inform the holder of any change made so that the dossier submitted to the EDQM can be updated without any delay by ...
如何准备CEP修订的申请 英文.pdf,How to prepare an application How to prepare an application for revision of CEP for revision of CEP P.Poukens-Renwart Certification of Substances Division EDQM P.Poukens-Renwart, 31-03-10 ©2010 EDQM, Council of Europe, A
includedinthecertificationdossierbysendinganapplicationformandallnecessarydocuments demonstratingthattheconditionslaiddowninthepresentguidelinearemet. 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。
WITHDRAWAL 18 7. LIST OF ABBREVIATIONS 19 Page 2 of 19 EDQM PA/PH/CEP (15) 31 Certification of Substances Department 1. Introduction This document has been created with the intention of clarifying the information to be concluded 下载文档...