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EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels F2/ 2008 Revision 9 NOTICE TO APPLICANTS Medicinal Products for Human Use VOLUME 2B Module 1 Administrative information Application form May 2008 This application form will be included in The Rules governing Medicinal Products in the European Community The Notice to Applicants - Volume 2B - Common Technical Document-Module 1-Administrative info...

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yyyy 2001 2008 EEA GMP Telefax E-Mail Paediatric EMEA centralised CHMP EudraGMP MRA Eur decentralised holder4 ATC bioequivalence PMF bioavailability excipient OJ VAMF SME incl TSE CZ harmonise UK EudraCT

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