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I. Introduction |
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II. The Legislation and Implementation Dates |
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III. European Medicines Evaluation Agency Structure and Tasks |
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IV. Procedures |
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A. Centralized Procedure |
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B. Decentralized or Mutual Recognition Procedure |
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C. National Procedure |
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V. Fees |
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VI. Computer Assisted Product Licence Applications (Caplas) |
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VII. Impact of New Procedures on Regulatory Strategies |
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VIII. Conclusion |
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References |
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