CEP证书的暂停或撤销、关闭 2012.10 英文.pdfVIP

Certification of Substances Division HB/CB PUBLIC DOCUMENT (Level 1) English only/Anglais seulement PA/PH/CEP (08) 17, R3 Strasbourg, October 2012 Certification of suitability to Monographs of the European Pharmacopoeia SUSPENSION OR WITHDRAWAL OF A CERTIFICATE OF SUITABILITY, CLOSURE OF AN APPLICATION For implementation December 2012 Address: 7 allée Kastner CS 30026 - F 67081 Strasbourg Telephone: 33 (0) 3 88 41 30 30 - E-mail:cep@edqm.eu - Fax: 33 (0) 3 88 41 27 71 Internet : http://www.edqm.eu DCEP PA/PH/CEP (08) 17, R3 Certification of Substances Division This document describes the policy of the EDQM for suspension or withdrawal of a certificate of suitability (CEP) and for closure of a CEP application in accordance with the provisions of Resolution AP-CSP (07) 1 of the Council of Europe. 1. DEFINITIONS • CEP: Certificate of suitability to the monographs of the European Pharmacopoeia, granted by the EDQM. • Suspension: Temporary cancellation of a granted CEP made either upon request by the holder of the CEP or by a decision of the EDQM. Under certain conditions, the CEP may be restored. • Withdrawal : Definitive cancellation of a granted CEP made either upon request by the holder of the CEP or by a decision of the EDQM. • Closure: Cancellation of an on-going CEP application made either upon request of the holder of the CEP or by a decision of the EDQM. • Hearing A hearing provides an opportunity for the applicant or the holder of a CEP to submit a writt