欧洲药典适用性证书申请要求.pdf

European Directorate for the Quality of Medicines Healthcare Certification of Substances Division ADE/CB PUBLIC DOCUMENT (Level 1) English/Chinese PA/PH/Exp. CEP/T(08) 37 Strasbourg, June 2008 Certification of suitability to Monographs of the European Pharmacopoeia Note for applicants: Procedure for validation of new applications CEP 200806 Address: 7 allée Kastner CS 30026 - F 67081 Strasbourg Telephone: 33 (0) 3 88 4 1 30 30 - E-mail:cep@edqm .eu - Fax : 33 (0) 3 88 4 1 27 7 1 Internet : http ://www.edqm.eu EDQM EDQM PA/PH/Exp . CEP /T (08) 37 Certification of Substances Division This document presents the measures taken for the validation of new applications for a CEP that were put in place in 2007, and also the results obtained. 2007CEP2007 1. Procedure for validation of new applications: All applications are screened at reception to check whether they are acceptable and can be validated. The main criteria that are checked for completeness are: - administrative information: the application form and all the declarations filled in, the signed quality overall summary and the technical dossier in CTD format are present. CTD - the dossier contains all the relevant sections of the CTD as described in the relevant document “Content of the dossier” (PA/PH/CEP 04 1 4R, or PA/PH/CEP (06) 2). CTD“”(PA/PH/CEP 04 1 4R, PA/PH/CEP (06) 2) The evaluation clock can start only once the application has been validated. Otherwise, it is blocked and a deficiency letter is sent to the applicant