EDQM TSE风险物质的文档内容 2018.1 英文.pdfVIP

Certification of Substances Department CSA/CB PUBLIC DOCUMENT (LEVEL 1) (LEVEL 1) English only/Anglais seulement PA/PH/CEP (06) 2, 1R Strasbourg, January 2018 Certification of suitability to the Monographs of the European Pharmacopoeia CONTENT OF THE DOSSIER FOR A SUBSTANCE FOR TSE RISK ASSESSMENT Addresses Role Date TSE TAB Adopted by correspondence September 2017 Steering Committee Adopted by correspondence December 2017 Address: 7 Allée Kastner, CS 30026 F-67081 Strasbourg (France) Tel: +33 (0) 3 88 41 30 30 – Fax: +33 (0) 3 88 41 27 71 - e-mail: cep@edqm.eu Internet: http://www.edqm.eu EDQM PA/PH/CEP (06) 2, 1R Certification of Substances Department This document is intended for applicants as a guide for compiling a dossier that is meant to be evaluated to get a Certificate of Suitability (CEP) for a material likely to present a TSE risk. The scope is to demonstrate compliance of the material to the Ph.Eur. General Monograph 1483 on Products with risk of transmitting animal spongiform encephalopathy agents and the Ph.Eur. General Chapter 5.2.8 Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products. The procedure is also applicable to raw materials intended to be used in medical devices. A new CEP application should contain three modules (modules 1, 2 and 3). Module 1 should c