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 ...
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 ...
ManagementofapplicationsfornewCertificatesofSuitability,RequestsforRevisionorRenewalofCertificates ofSuitabilityandapplicationsusingthe‘sisterfiles’procedure(PA/PH/CEP(13)110,3R,November2021) EDQMTimelinefortheassessment oftheinitialapplication •Notification 23WorkingDays •MinorRevision •MajorRevision 46Workin...
For any revision the documentation should consist of: - a cover letter - the application form, duly filled and listing all the changes applied for - a description of each change together with a justification - data showing, when applicable, that the conditions have been met ...
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...
Foranyrevisionthedocumentationshouldconsistof: -acoverletter -theapplicationform,dulyfilledandlistingallthechangesappliedfor -adescriptionofeachchangetogetherwithajustification -datashowing,whenapplicable,thattheconditionshavebeenmet -updateoftherelevantsection(s)ofthedossier(presentedinEU-CTDformat). ...
Division Certification of Substances CP/CB PUBLIC DOCUMENT (Level 1) English only/Anglais seulement PA/PH/ CEP (04) 1 4R February 2007 Certification of suitability of Monographs of the European Pharmacopoeia Content of the dossier for chemical purity and microbiological quality (Revision of Annex I...
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 ...
Figure 2– Example of an eCTD module for Drug Substance CEP usage The aspects most frequently mentioned related to the use of the CEP were: To notify the status of applications in the online “certification database” (e.g. requests for revision approved, changelog with a general description ...
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 ...