FOR HERBAL DRUGS AND HERBAL DRUG PREPARATIONS QUALITY EVALUATION SUMMARY I. Introduction II. Module 1: Administrative information: (application form) III. Module 2: Quality Overall Summary IV. Module 3: Technical documentation for Herbal Drug V. Module 3: Technical documentation for Herbal Drug ...
Introduction:The holder of a Certificate of suitability shall inform the EDQM of any change to the information in the certification dossier by sending an application form and all necessary documents demonstrating that the conditions laid down in the present guideline are met.Classification of changes ...
-持有人转让,新持有人与现行法人不同,这种转让不是公司合并、出售的结果,生产厂也没有以自己名义获取原有证书。欧洲药典修订或其它法规要求而产生的变更另论,通常由EDQM发起。DocumentationtobeprovidedForanyrevisionthedocumentationshouldconsistof:-acoverletter-theapplicationform,dulyfilledandlistingallthechangesappliedf...
Guidance on frequent changes to applications for Certificates of Suitability (CEPs)欧洲药典适用性证书常见CEP变更申请指南 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...
(04)2,4RStrasbourg,December2009CertificationofsuitabilitytoMonographsoftheEuropeanPharmacopoeiaGuidelineonRequirementsforRevision/RenewalofCertificatesofSuitabilitytotheEuropeanPharmacopoeiamonographsEDQMPA/PH/CEP(04)2,4RCertificationofSubstancesDivisionPage2of19GUIDELINEONREQUIREMENTSFORREVISION/RENEWALOFCERTIFICATESOF...
Therefore if the referenced CEP X is revised then a copy of the revised CEP X must be submitted as a revision to the CEP Y, as described in the current version of the EDQM Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (...
was revised in the paragraph 2.1.1 General to clarify the need for testing under accelerated or, where applicable, intermediate storage conditions. Revision in December 2003: The guideline CPMP/QWP/ 122/02, corr. was revised to be brought in line with the requirements of the Note for Guidance...
Introduction of a RMS without other changes CEP holders are given the possibility to introduce a RMS as part of a revision application (when there are no changes to the process or to the control strategy for the substance), by submitting a request for revision classified as “minor by ...
Introduction:The holder of a Certificate of suitability shall inform the EDQM of any change to the information in the certification dossier by sending an application form and all necessary documents demonstrating that the conditions laid down in the present guideline are met.Classification of changes ...
EDQM_COS_变更指南_中英对照 Date of implementation: 1 March 2010 Introduction:The holder of a Certificate of suitability shall inform the EDQM of any change to the information in the certification dossier by sending an application form and all necessary documents demonstrating that the conditions laid...