CMD(h) BEST PRACTICE GUIDE ON THE …
BPG on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures Rev.5, November 2008 Page 2/11 The principle applies that the marketing authorisation holder may apply for a renewal earlier than
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Guidance on the homeopathic medicinal products …
www.hma.euSPECIFIC GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER Introduction With the implementation of Directive 2001/83/EC as amended all Member States of the
Packaging ‘blue-box’ requirements for products …
www.hma.euCMDv GUI-027 _ addition CP EMA/CMDv/391895/2012 Page 1 of 42 . CMDv-GUI-27 EMA/CMDv/391895/2012 . Version 072904/101/2014 . Packaging ‘blue-box’ requirements for products authorised via
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www.hma.euLegal Status For medicinal products restricted to special prescription (narcotics), a number code assigned by the Minister of Health and a double red line are mandatory.
BEST PRACTICE GUIDE for Veterinary Decentralised …
www.hma.euBEST PRACTICE GUIDE . for . Veterinary Decentralised Procedure (DCP) Edition number: 05 . Edition date: 7 November 2013 . Implementation date: 6 February 2006
CONSULTATION WITH TARGET PATIENT GROUPS …
www.hma.euconsultation with target patient groups - meeting the requirements of article 59(3) without the need for a full test - recommendations for bridging
DECENTRALISED PROCEDURE MEMBER STATES’ …
www.hma.euDECENTRALISED PROCEDURE MEMBER STATES’ STANDARD OPERATING PROCEDURE October 2005 Final Revision 1 November 2007 TABLE OF CONTENTS Abbreviations.....1
FLOW CHART OF THE DECENTRALISED …
www.hma.euFlow Chart of the Decentralised Procedure 25 July 2005 Page 1/3 FLOW CHART OF THE DECENTRALISED PROCEDURE 1. Issue The Heads of Medicines Agencies (HMA) together with MRFG and VMRFG have
CMDv/BPG/003 Best Practice Guide For The Repeat …
www.hma.euIn case of electronic submissions the “Guideline on the specifications for provision of an electronic submission (esubmission) for a veterinary medicinal product- should be ”
FLOW CHART FOR THE MUTUAL RECOGNITION …
www.hma.euFLOW CHART FOR THE MUTUAL RECOGNITION PROCEDURE May 2007 Approx. 90 days before submission to CMS Applicant requests RMS to update Assessment Report (AR) and allocate
BEST PRACTICE GUIDE for Grouping of Variations
www.hma.euBEST PRACTICE GUIDE for grouping of variations CMDv/BPG/016 Ed.: 01 Page 2 of 8 . Index . 1. Introduction . 2. Aim and Scope . 3. …
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