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How should we conceive of regulation in the European context? This paper attempts to answer this by developing multilevel regulation as a theoretical concept. The basic aim of the paper is to explore the difference and convergence between regulation and governance and develop multilevel governance and multilevel regulation as two individual heuristic concepts. We suggest that it is useful to frame multilevel governance in the context of regulatory spaces. As an example, we undertake an exploratory investigation of multilevelness of the regulatory space of marketing authorisation of medical devices. This allows us to help focus on certain aspects of the regulatory process by acknowledging that it is no longer located in the hand of a single (governmental) actor and highlighting the necessity of considering interventions beyond the state in addressing regulatory effectiveness problems that may crop up in this context. Ultimately, we assess whether multilevel regulation is a legal translation of the concept of multilevel governance.  相似文献   

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This article represents the first of a projected series of annotated translations of the Mahārthama?jarīparimala of Maheśvarānanda, a Śaiva Śākta author active in Cidambaram around the turn of the fourteenth century of the Common Era. The present translation includes excerpts from the text’s presentation of two of the levels of reality (tattvas), puruṣa and prakṛti. These two tattvas, the apex of the older Sāṃkhya scheme incorporated centuries earlier by the Śaivas, provide for Maheśvarānanda the centerpiece and climax of his understanding of the structure of the Śaiva cosmos. Fundamental to the rhetoric of Maheśvarānanda’s idiosyncratic presentation is his reliance upon a simultaneous strategy of integration and distinction of his argument within the wider world of Śaiva doctrinal common sense. He seeks to integrate the characteristic meditative structure of his Krama or Mahārtha system within a theological framework shared by all Śaiva theists. It can be seen that Maheśvarānanda’s interpretation of the junction between these two reality levels delineates a picture of what it is to be a human being, equipped with an inner life and a personality. The article also reviews the quality of the published editions of the Mahārthama?jarī, discusses its textual history, and offers a number of suggested emendations to the passages translated.  相似文献   

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