欧洲药典适用性证书变更更新管理程序 中英对照 2013.07.13.pdfVIP

Procedures for management of revisions/renewals of certificates of suitability to the European Pharmacopoeia monographs Certification of suitability to Monographs of the European Pharmacopoeia 欧洲药典适用性证书 PROCEDURES FOR MANAGEMENT OF REVISIONS/RENEWALS OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS 欧洲药典适用性证书的变更/更新的管理程序 Introduction: 介绍 This document should be read in conjunction with the EDQM “Guideline on Requirements on Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 2, as amended), which describes the conditions to be fulfilled as well as the documentation to be submitted for each request for revision. 此文件应该与EDQM 的“欧洲药典适用性证书修订与更新规定指南” (PA/PH/CEP (04) 2)联 合起来阅读，后者描述了每个变更所要求满足的条件，以及要提供的文件资料。 The procedures for the management of revisions of certificates of suitability (CEPs) are described below and have been revised according to the revis ed European Regulation for Variations to Marketing Authorisation Applications. 对于CEP 证书变更管理的程序，在下面进行了描述，并且按照新修订的欧洲市场授权申请 的有关法规进行了修订。 The revised system includes: 修订的制度包括： - Introduction of a “Do and Tell” procedure where some notifications may be submitted within 12 months of implementation 引进了一种“Do and Tell”的程序，规定一些通知性变更可以在实施后 12 个月以内进行提交。 - Introduction of “Minor revision by default”, for the changes which are not described in the EDQM guideline for revisions 引进了一种“微小变更不完全列出”的管理方式，目的是将那些在EDQM 指南中未描述到的 变更包括进来。 - Introduction of “grouped procedures” for changes affecting more than one CEP application 引进了一种“组合程序”来处理那些可能不止影响一个CEP 申请的变更。 - The possibility to submit several changes in the same request for revision was already in place and is maintained. Consequential changes are considered as part of the original variation. 以相同的变更要求相同时可以同时提交几个变更。由于变更而引起的间接变更可以作