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cmdh 173 2010 rev 15 june 2016
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Chapter 1: CMDh Best Practice Guide for the allocation of the Mutual Recognition Variation. Number for Type I Notifications, Type II variations, Grouping and Worksharing. Chapter 2: Procedure for Automatic Validation of Mutual Recognition Procedures for Variations. Chapter 3: CMDh Best Practice Guide for the Processing
CMDh/004/2005/Rev.13. November 2015. 1. INTRODUCTION. This Best Practice Guide is intended to facilitate the processing of renewals in the mutual recognition and decentralised procedures, with an aim of giving procedural advice to assist Member States and applicants, in order to ensure a consistent and beneficial
CMDh Best Practice Guide on the use of eCTD in the MRP / DCP (July 2017) [Track version] Any change requests for the document should be handled in accordance with the change request instructions given on the EMA eSubmissions website. Q&A on Mandatory eCTD in MRP and how to manage changes to eCTD
Renewal Procedure. In order to view some of the documents on this website you need Acrobat Reader (click here to download) · CMDh Best Practice Guide on the processing of renewals in the MRP / DCP (October 2017) [Track version]. Common grounds seen for delaying Day 0 Renewals (July 2017) [Track version].
Best Practice Guide for the exchange of regulatory and administrative information regarding orphan medicinal products between EMA and National Competent Authorities (October 2016) [Track version]. CMDh position paper on sunset clause and its application to marketing authorisations granted in more than one MS
3 Nov 2011 CMDh BPG on the use of the eCTD in the MRP/DCP. November 2011. Page 1/22. CMDh BEST PRACTICE GUIDE. ON THE USE OF THE ELECTRONIC COMMON TECHNICAL. DOCUMENT (eCTD). IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES. Doc. Ref.:CMDh/084/2008/
CMDh BEST PRACTICE GUIDE. ON THE USE OF THE ELECTRONIC COMMON TECHNICAL. DOCUMENT (eCTD). IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES. Doc. Ref.:CMDh/084/2008/Rev2. June 2010. CMDh BPG on the use of the eCTD in the MRP/DCP. June 2010. Page 1/28
This document provides information on the processing of renewals in the mutual recognition and decentralised procedures.
CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (April 2016) [Track version] · CMS Validation Checklist for human medicinal products in DCP (December 2017). RMS Validation Checklist for human medicinal products in DCP
Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure (Please note: for purely national Marketing Authorisations these Best Practise Guides will apply from 4 August 2013). Chapter 1: CMDh BPG for the allocation of the mutual recognition variation number for
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