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EMEA Annual Report 2007 EMEA/MB/17464/2008 2.4, CURRENT Page 2/138 6

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EMEA Annual Report 2007 EMEA/MB/17464/2008 2.4, CURRENT Page 2/138 6 European Medicines Agency London, 13 May 2008 Doc. ref.: EMEA/MB/17464/2008 Annual report of the European Medicines Agency 2007 Adopted by the Management Board on 6 March 2008 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: [email protected] http://www.emea.europa.eu © European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged. CONTENTS CONTENTS..................................................................................................................................................................2 MISSION STATEMENT.............................................................................................................................................4 FOREWORD BY THE CHAIR OF THE MANAGEMENT BOARD....................................................................5 INTRODUCTION BY THE EXECUTIVE DIRECTOR .........................................................................................6 1. EMEA IN THE EUROPEAN SYSTEM.................................................................................................................8 1.1 Management Board ______________________________________________________________ 8 1.2 European medicines network _______________________________________________________ 8 1.3 Transparency and communication ___________________________________________________ 9 1.4 Support for innovation and access to medicines ________________________________________ 9 1.5 European public-health activities ___________________________________________________ 10 1.6 Preparations for future enlargement _________________________________________________ 11 1.7 International cooperation _________________________________________________________ 12 1.8 Integrated management at the Agency _______________________________________________ 12 2. MEDICINES FOR HUMAN USE ........................................................................................................................13 2.1 Orphan medicinal products _______________________________________________________ 13 2.2 Scientific advice and protocol assistance _____________________________________________ 15 2.3 Initial evaluation________________________________________________________________ 18 2.4 Post-authorisation activities _______________________________________________________ 23 2.5 Parallel distribution _____________________________________________________________ 26 2.6 Pharmacovigilance and maintenance activities ________________________________________ 28 2.7 Arbitration and Community referrals ________________________________________________ 30 2.8 Medicines for children ___________________________________________________________ 34 2.9 Herbal medicinal products ________________________________________________________ 36 2.10 Emerging therapies and new technologies ____________________________________________ 37 2.11 Provision of information to patients and healthcare professionals__________________________ 38 2.12 Scientific committees, working parties and scientific advisory groups ______________________ 40 2.13 Coordination Group for Mutual-Recognition and Decentralised Procedures–Human___________ 42 2.14 Regulatory activities_____________________________________________________________ 44 3. MEDICINES FOR VETERINARY USE .............................................................................................................45 3.1 Scientific advice________________________________________________________________ 45 3.2 Initial evaluation________________________________________________________________ 46 3.3 Establishment of maximum residue limits ____________________________________________ 49 3.4 Post-authorisation activities _______________________________________________________ 51 3.5 Pharmacovigilance and maintenance activities ________________________________________ 53 3.6 Arbitration and Community referrals ________________________________________________ 55 3.7 Committee for Medicinal Products for Veterinary Use __________________________________ 56 3.8 Coordination group _____________________________________________________________ 58 4. INSPECTIONS.......................................................................................................................................................59 4.1 Inspections ____________________________________________________________________ 59 4.2 Mutual-recognition agreements ____________________________________________________ 61 4.3 Certificates of medicinal products __________________________________________________ 62 4.4 Sampling and testing ____________________________________________________________ 63 4.5 Implementation of the Clinical Trials Directives _______________________________________ 64 4.6 GMP harmonisation _____________________________________________________________ 64 5. EU TELEMATICS STRATEGY..........................................................................................................................65 EMEA annual report 2007 EMEA/MB/17464/2008 2.4, CURRENT Page 2/138 6. SUPPORT ACTIVITIES.......................................................................................................................................67 6.1 Administration _________________________________________________________________ 67 6.2 Information technology __________________________________________________________ 70 6.3 Meetings and conferences at the EMEA _____________________________________________ 72 6.4 EMEA document management and publishing ________________________________________ 73 ANNEXES...................................................................................................................................................................76 Annex 1 Members of the Management Board ________________________________________________ 77 Annex 2 Members of the Committee for Medicinal Products for Human Use________________________ 79 Annex 3 Members of the Committee for Medicinal Products for Veterinary Use _____________________ 83 Annex 4 Members of the Committee for Orphan Medicinal Products ______________________________ 86 Annex 5 Members of the Committee on Herbal Medicinal Products _______________________________ 88 Annex 6 Members of the Paediatric Committee_______________________________________________ 91 Annex 7 National competent authority partners _______________________________________________ 92 Annex 8 EMEA budget summaries 2006–2008 ______________________________________________ 101 Annex 9 EMEA establishment plan _______________________________________________________ 102 Annex 10 IT projects and operational activities _______________________________________________ 103 Annex 11 CHMP opinions in 2007 on medicinal products for human use___________________________ 104 Annex 12 CVMP Opinions in 2007 on Medicinal Products for Veterinary Use ______________________ 113 Annex 13 COMP opinions in 2007 on designation of orphan medicinal products_____________________ 115 Annex 14 HMPC Community herbal monographs_____________________________________________ 123 Annex 15 Entries to the ‘List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’_______________________________________________________ 125 Annex 16 PDCO opinions and EMEA decisions on paediatric investigation plans and waivers in 2007 ___ 126 Annex 17 Guidelines and working documents in 2007 _________________________________________ 127 Annex 18 Arbitration and Community referrals overview 2007 __________________________________ 134 Annex 19 EMEA contact points ___________________________________________________________ 137 EMEA annual report 2007 EMEA/MB/17464/2008 2.4, CURRENT Page 3/138 MISSION STATEMENT The mission of the European Medicines Agency is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health. Legal role The European Medicines Agency is the European Union body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products. The Agency provides the Member States and the institutions of the EU the best-possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use referred to it in accordance with the provisions of EU legislation relating to medicinal products. Principal activities Working with the Member States and the European Commission as partners in a European medicines network, the European Medicines Agency: provides independent, science-based recommendations on the quality, safety and efficacy of medicines, and on more general issues relevant to public and animal health that involve medicines; applies efficient and transparent evaluation procedures to help bring new medicines to the market by means of a single, EU-wide marketing authorisation granted by the European Commission; implements measures for continuously supervising the quality, safety and efficacy of authorised medicines to ensure that their benefits outweigh their risks; provides scientific advice and incentives to stimulate the development and improve the availability of innovative new medicines; recommends safe limits for residues of veterinary medicines used in food-producing animals, for the establishment of maximum residue limits by the European Commission; involves
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