European Regulation of Medical Devices and Pharmaceuticals

Regulatee Expectations of Legal Certainty

Nonfiction, Reference & Language, Law, Reference, International
Cover of the book European Regulation of Medical Devices and Pharmaceuticals by Nupur Chowdhury, Springer International Publishing
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Nupur Chowdhury ISBN: 9783319045948
Publisher: Springer International Publishing Publication: April 29, 2014
Imprint: Springer Language: English
Author: Nupur Chowdhury
ISBN: 9783319045948
Publisher: Springer International Publishing
Publication: April 29, 2014
Imprint: Springer
Language: English

One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation.

In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Taken together, these characteristics of law are referred to as legal certainty. In traditional approaches to legal certainty, law is regarded as a hierarchical system of rules characterized by stability, clarity, uniformity, calculable enforcement, publicity and predictability. However, the current reality is that national legal systems no longer operate in isolation, but within a multilevel legal order, wherein norms created at both the international and regional level are directly applicable to national legal systems. Also, norm creation is no longer the exclusive prerogative of public officials of the state: private actors have an increasing influence on norm creation as well. Social scientists have referred to this phenomenon of interacting and overlapping competences as multilevel governance. Only recently have legal scholars focused attention on the increasing interconnectedness (and therefore the concomitant loss of primacy of national legal orders) between the global, European and national regulatory spheres through the concept of multilevel regulation.

In this project the author uses multilevel regulation as a term to characterize a regulatory space in which the process of rule making, rule enforcement and rule adjudication (the regulatory lifecycle) is dispersed across more than one administrative or territorial level and amongst several different actors, both public and private. The author draws on the concept of a regulatory space, using it as a framing device to differentiate between specific aspects of policy fields. The relationship between actors in such a space is non-hierarchical and they may be independent of each other. The lack of central ordering of the regulatory lifecycle within this regulatory space is the most important feature of such a space. The implications of multilevel regulation for the notion of legal certainty have attracted limited attention from scholars and the demand for legal certainty in regulatory practice is still a puzzle. The book explores the idea of legal certainty in terms of the perceptions and expectations of regulatees in the context of medical products – specifically, pharmaceuticals and medical devices, which can be differentiated as two regulatory spaces and therefore form two case studies. As an exploratory project, the book necessarily explores new territory in terms of investigating legal certainty first in terms of regulatee perceptions and expectations and second, because it studies it in the context of multilevel regulation.

More books from Springer International Publishing

Cover of the book Characteristics of Temporary Migration in European-Asian Transnational Social Spaces by Nupur Chowdhury
Cover of the book Challenging the Paradoxes of Integration Policies by Nupur Chowdhury
Cover of the book R for Marketing Research and Analytics by Nupur Chowdhury
Cover of the book Thermal Stresses—Advanced Theory and Applications by Nupur Chowdhury
Cover of the book Progress in Pattern Recognition, Image Analysis, Computer Vision, and Applications by Nupur Chowdhury
Cover of the book Catalysis with Supported Size-selected Pt Clusters by Nupur Chowdhury
Cover of the book Brain Informatics by Nupur Chowdhury
Cover of the book Concentrating Photovoltaics (CPV): The Path Ahead by Nupur Chowdhury
Cover of the book On the Shores of Titan's Farthest Sea by Nupur Chowdhury
Cover of the book Contemporary Masculinities by Nupur Chowdhury
Cover of the book Large-Scale Quantum-Mechanical Enzymology by Nupur Chowdhury
Cover of the book Dictionary of Corporate Social Responsibility by Nupur Chowdhury
Cover of the book Development, Governance, and Real Property Tax in China by Nupur Chowdhury
Cover of the book Adaptive Control of Solar Energy Collector Systems by Nupur Chowdhury
Cover of the book Perspectives in Environmental Toxicology by Nupur Chowdhury
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy