DECENTRALISED PROCEDURE MEMBER STATES’ …
Introduction This document was produced by the CMD(h) in order to facilitate and harmonise the practical application of Article 28(3) of Directive 2001/83/EC as amended.
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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
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Packaging ‘blue-box’ requirements for products …
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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
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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
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CMD(h) BEST PRACTICE GUIDE ON THE …
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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
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CMDv/BPG/003 Best Practice Guide For The Repeat …
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FLOW CHART FOR THE MUTUAL RECOGNITION …
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