Commission, the medicines regulatory authorities in EU Member States and Economic Area (EEA), and the European Medicines Agency (EMA) — works to
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[PDF] The European regulatory system for medicines
Commission, the medicines regulatory authorities in EU Member States and Economic Area (EEA), and the European Medicines Agency (EMA) — works to
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of the European Medicines Agency (EMA) European Regulation of Medicinal Products • Procedural Aspects Regulatory Agencies—Comment Period
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polity', European Law Journal 8 ( 2002 ), 319–39 14 G Majone, 'The agency model: the growth of regulation and regulatory institutions in the European Union'
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The European Commission argues that agencies 'will improve the way rules are applied and enforced across the Union' (COM(2001) 428: 24) The 'European
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Much of the principal-agent literature is based on experiences outside Western Europe, particularly of delegation by Congress to regulatory agencies 4 Hence its
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regulaory networks Keywords: European Union, regulatory networks, administrative integration, national agencies, organizational perspective
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regulatory agencies (IRAs) since the 1990s This logic made of IRAs the “natural” intermediaries between European agencies and state-level institutions
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Audits for notified bodies: Notified Bodies will be audited for compliance with the new regulations jointly by two Competent Authorities (i e , the regulatory body for
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