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This chapter discusses issues and controversies concerning the prescription of advanced therapy medicinal products (ATMP). The source European Union (EU) regulation is focused, along with doubts related to its interpretation and implementation into national regulations. Special attention is paid to the Polish legislation and its incompatibility with the EU legislation, which, together with its improper application, allowed the development of the market of so-called unlicensed therapies. The chapter also discusses the future reform of EU law and its influence on national EU legal systems.

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Experimental Therapies with the Application of the EU Hospital Exemption Regulation for Advanced Therapy Medicinal Products: European and Polish Perspective

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  • 发表日期：

    2025年

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  • Marlena Pecyna

摘要

This chapter discusses issues and controversies concerning the prescription of advanced therapy medicinal products (ATMP). The source European Union (EU) regulation is focused, along with doubts related to its interpretation and implementation into national regulations. Special attention is paid to the Polish legislation and its incompatibility with the EU legislation, which, together with its improper application, allowed the development of the market of so-called unlicensed therapies. The chapter also discusses the future reform of EU law and its influence on national EU legal systems.