姐妹文件 申请指南 2013.8 英文.pdfVIP

Certification of Substances Division FS/CB PUBLIC DOCUMENT LEVEL 1) English only/Anglais seulement PA/PH/CEP (09) 141, 1R Strasbourg, August 2013 Certification of Suitability to Monographs of the European Pharmacopoeia Guidance on applications for « sister files » Implementation September 2013 Address: 7, allée Kastner, CS 30026 F - 67081 Strasbourg (France) Telephone: 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 (09) 141, 1R Certification of Substances Division I. Purpose This guideline provides information on the scope and applicability of the sister files procedure within the certification scheme. II. Scope The sister file procedure is intended to facilitate the submission of similar dossiers within the Certification procedure, and to allow applicants benefit from a fast-track procedure and harmonised assessments. An applicant who has been granted a certificate of suitability (CEP) may wish to apply for a second CEP for the same substance, either because the specifications of the final substance obtained with an alternative process cannot be covered by the existing CEP or because the applicant wishes to have separate CEPs for different conditions of preparation or qualities for example, to cover an alternative manufacturing site or an alternative grade). This new application can be submitted as a “sister file”, prov