LEADER 06184nam 22008295 450 001 9910484411203321 005 20200919154629.0 010 $a3-319-04594-6 024 7 $a10.1007/978-3-319-04594-8 035 $a(CKB)3710000000106735 035 $a(EBL)1730991 035 $a(OCoLC)884584821 035 $a(SSID)ssj0001204895 035 $a(PQKBManifestationID)11658763 035 $a(PQKBTitleCode)TC0001204895 035 $a(PQKBWorkID)11180470 035 $a(PQKB)11530035 035 $a(MiAaPQ)EBC1730991 035 $a(DE-He213)978-3-319-04594-8 035 $a(PPN)178317241 035 $a(EXLCZ)993710000000106735 100 $a20140429d2014 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aEuropean Regulation of Medical Devices and Pharmaceuticals $eRegulatee Expectations of Legal Certainty /$fby Nupur Chowdhury 205 $a1st ed. 2014. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2014. 215 $a1 online resource (190 p.) 300 $aDescription based upon print version of record. 311 $a3-319-04593-8 327 $a1. Introduction -- 2. Conceptualizing Multilevel Regulation -- 3. Reconceptualizing Legal Certainty: From a Principle of Positive Law to Regulatee Expectations -- 4. Explanation of Methodological Choices -- 5. Pilot Study of Regulatory Uncertainty in Marketing Authorization of Medical Products in Europe -- 6. Case Study on Medical Devices Regulation in Europe -- 7. Case Study on Pharmaceutical Regulation in Europe -- 8. Case Study on Borderline Medical Products in Europe -- 9. Conclusion. 330 $aOne 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. 606 $aLaw?Europe 606 $aLaw?Philosophy 606 $aLaw 606 $aEuropean Economic Community literature 606 $aInternational law 606 $aTrade 606 $aMedical laws and legislation 606 $aPharmacy 606 $aEuropean Law$3https://scigraph.springernature.com/ontologies/product-market-codes/R20000 606 $aTheories of Law, Philosophy of Law, Legal History$3https://scigraph.springernature.com/ontologies/product-market-codes/R11011 606 $aEuropean Integration$3https://scigraph.springernature.com/ontologies/product-market-codes/W33010 606 $aInternational Economic Law, Trade Law$3https://scigraph.springernature.com/ontologies/product-market-codes/R19050 606 $aMedical Law$3https://scigraph.springernature.com/ontologies/product-market-codes/R16005 606 $aPharmacy$3https://scigraph.springernature.com/ontologies/product-market-codes/F00008 615 0$aLaw?Europe. 615 0$aLaw?Philosophy. 615 0$aLaw. 615 0$aEuropean Economic Community literature. 615 0$aInternational law. 615 0$aTrade. 615 0$aMedical laws and legislation. 615 0$aPharmacy. 615 14$aEuropean Law. 615 24$aTheories of Law, Philosophy of Law, Legal History. 615 24$aEuropean Integration. 615 24$aInternational Economic Law, Trade Law. 615 24$aMedical Law. 615 24$aPharmacy. 676 $a337142 676 $a340 676 $a340.1 676 $a341.2422 700 $aChowdhury$b Nupur$4aut$4http://id.loc.gov/vocabulary/relators/aut$01227336 906 $aBOOK 912 $a9910484411203321 996 $aEuropean Regulation of Medical Devices and Pharmaceuticals$92849857 997 $aUNINA