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EXTENSION APPLICATIONS IN MUTUAL …
CMD(h) Recommendations Extension applications in MRP/DCP July 2006 Page 3/8-A complete application according to Art. 8.3(i) of Dir. 2001/83/EC: 1) When the extension is a change to a product which was granted a marketing authorisation,
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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 and additional ...
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.
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
CMD(h) BEST PRACTICE GUIDE ON THE …
www.hma.euBPG 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
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 ”
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
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
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