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Report From The Comission To The European Parliament And The Council On Implementation Of The Regulation Ec
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Book Synopsis Good Manufacturing Practice (GMP) Guidelines by : Mindy J. Allport-Settle
Download or read book Good Manufacturing Practice (GMP) Guidelines written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2009-12 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
Book Synopsis Regulation (EU) NO 608/2013 Concerning Customs Enforcement Of Intellectual Property Rights by : Olivier Vrins
Download or read book Regulation (EU) NO 608/2013 Concerning Customs Enforcement Of Intellectual Property Rights written by Olivier Vrins and published by Kluwer Law International B.V.. This book was released on 2024-04-17 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Derived from the renowned multi-volume International Encyclopaedia of Laws, this monograph provides a survey and analysis of the rules concerning Regulation (EU) No 608/2013 Concerning Customs Enforcement of Intellectual Property Rights. It covers every type of intellectual property right in depth – copyright and neighbouring rights, patents, utility models, trademarks, trade names, industrial designs, plant variety protection, chip protection, trade secrets, and confidential information. Particular attention is paid throughout to recent developments and trends. The analysis approaches each right in terms of its sources in law and in legislation, and proceeds to such legal issues as subject matter of protection, conditions of protection, ownership, transfer of rights, licences, scope of exclusive rights, limitations, exemptions, duration of protection, infringement, available remedies, and overlapping with other intellectual property rights. The book provides a clear overview of intellectual property legislation and policy, and at the same time offers practical guidance on which sound preliminary decisions may be based. Lawyers representing parties with interests in Regulation (EU) No 608/2013 Concerning Customs Enforcement of Intellectual Property Rights will welcome this very useful guide, and academics and researchers will appreciate its value in the study of comparative intellectual property law.
Book Synopsis Better Regulation Practices across the European Union by : OECD
Download or read book Better Regulation Practices across the European Union written by OECD and published by OECD Publishing. This book was released on 2019-03-19 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations affect the daily lives of businesses and citizens. High-quality laws promote national welfare and growth, while badly designed laws hinder growth, harm the environment and put the health of citizens at risk. This report analyses practices to improve the quality of laws ...
Book Synopsis Pesticide Policy and Politics in the European Union by : Emanuela Bozzini
Download or read book Pesticide Policy and Politics in the European Union written by Emanuela Bozzini and published by Springer. This book was released on 2017-03-23 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the regulation of pesticides in the European Union in order to reveal the complex, controversial, and contested nature of an assessment system proudly declared by the EU to be ‘the strictest in the world’. The current regulatory framework is based on Regulation 1107/2009, which substantially reformed the previous system. The analysis describes the new criteria and procedures for the authorization of active substances to be used in the production of pesticides, traces the lengthy policy formulation process, and identifies factors that made policy change possible. Further, the book illustrates the current controversies that characterise the implementation of Regulation 1107/2009: the ban of pesticides harmful to pollinators, the renewal of the authorization of glyphosate, and the definition of criteria for the assessment of endocrine disruption. The author provides information on policy outcomes and highlights persisting shortcomings in the enforcement of EU regulation. This book will appeal to students and scholars from a variety of disciplines, including political science, political sociology, and public policy.
Book Synopsis Specialized Administrative Law of the European Union by : Herwig C. H. Hofmann
Download or read book Specialized Administrative Law of the European Union written by Herwig C. H. Hofmann and published by Oxford University Press. This book was released on 2018-11-30 with total page 785 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume deals with the law governing the administrative implementation of European Union public policy. Much of this law is specific to individual policy sectors. The volume provides a study of such specialized admininstrative law for more than twenty sectors. This cross-sectoral approach allows for detailed comparisons of EU administration in diverse policy fields. It identifies situations where legal structures and approaches may be unnecessarily duplicated, thus indicating where a comprehensive, general system could be advantageous for both Union law and policy achievement. The comparative nature of the study also draws attention to policy fields which have proven to be testing grounds for approaches adopted subsequently in other areas. In addition, the work highlights the distinctive, highly networked, and strongly cooperative character of EU administration, as a reflection of, and a foundation for, the operative nature of the European Union as a whole.
Download or read book EU Customs Law written by Timothy Lyons and published by Oxford University Press. This book was released on 2018-06-27 with total page 869 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third edition of EU Customs Law provides a fully updated treatment of legislation, new treaties and cases in the two courts of the EU especially but also in Member States. This volume also includes commentary on the Union Customs Code and secondary legislation, and increased coverage of areas such as the wider role of customs authorities apart from the collection of customs duty, such as security of goods and post 9/11 developments generally, the history of customs unions and their implications for governments, non-EU customs unions to which EU law is relevant, and the inter-relation between customs duty and direct tax.
Book Synopsis Research Handbook on the Enforcement of EU Law by : Miroslava Scholten
Download or read book Research Handbook on the Enforcement of EU Law written by Miroslava Scholten and published by Edward Elgar Publishing. This book was released on 2023-09-06 with total page 581 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive Research Handbook investigates the success of EU law enforcement processes. Going beyond traditional analyses of administrations and courts in isolation, it focuses on the increased cooperation seen between national and EU authorities, and on the widening variety of means used to enhance compliance with EU norms.
Book Synopsis Governing Mobility Beyond the State by : A. Müller
Download or read book Governing Mobility Beyond the State written by A. Müller and published by Springer. This book was released on 2014-07-29 with total page 362 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the structural tensions and conflicts that arise with the abolition of border controls between the EU's member states and how this conflict ridden relationship affects and is affected by the institutional shape of the EU's external borders.
Book Synopsis The Alternative Investment Fund Managers Directive by : Dirk A. Zetzsche
Download or read book The Alternative Investment Fund Managers Directive written by Dirk A. Zetzsche and published by Kluwer Law International B.V.. This book was released on 2015-09-14 with total page 907 pages. Available in PDF, EPUB and Kindle. Book excerpt: Apart from MiFID, the Alternative Investment Fund Managers Directive (AIFMD) may be the most important European asset management regulation of the early twenty-first century. In this in-depth analytical and critical discussion of the content and system of the directive, thirty-eight contributing authors – academics, lawyers, consultants, fund supervisors, and fund industry experts – examine the AIFMD from every angle. They cover structure, regulatory history, scope, appointment and authorization of the manager, the requirements for depositaries and prime brokers, rules on delegation, reporting requirements, transitional provisions, and the objectives stipulated in the recitals and other official documents. The challenging implications and contexts they examine include the following: – connection with systemic risk and the financial crisis; - nexus with insurance for negligent conduct; - connection with corporate governance doctrine; - risk management; - transparency; - the cross-border dimension; - liability for lost assets; - impact on alternative investment strategies, and - the nexus with the European Regulation on Long-Term Investment Funds (ELTIFR). Nine country reports, representing most of Europe’s financial centres and fund markets add a national perspective to the discussion of the European regulation. These chapters deal with the potential interactions among the AIFMD and the relevant laws and regulations of Austria, France, Germany, Italy, Luxembourg, Liechtenstein, The Netherlands, Malta and the United Kingdom. The second edition of the book continues to deliver not only the much-needed discussion of the inconsistencies and difficulties when applying the directive, but also provides guidance and potential solutions to the problems it raises. The second edition considers all new developments in the field of alternative investment funds, their managers, depositaries, and prime brokers, including, but not limited to, statements by the European Securities and Markets Authority (ESMA) and national competent authorities on the interpretation of the AIFMD, as well as new European regulation, in particular the PRIIPS Regulation, the ELTIF Regulation, the Regulation on European Venture Capital Funds (EuVeCaR), the Regulation on European Social Entrepreneurship Funds (EUSEFR), MiFID II, and UCITS V. The book will be warmly welcomed by investors and their counsel, fund managers, depositaries, asset managers, administrators, as well as regulators and academics in the field.
Book Synopsis Innovation in Healthy and Functional Foods by : Dilip Ghosh
Download or read book Innovation in Healthy and Functional Foods written by Dilip Ghosh and published by CRC Press. This book was released on 2016-04-19 with total page 616 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of food science and technology has shifted from previous goals of improving food safety and enhancing food taste toward providing healthy and functional foods. Today's consumers desire foods that go beyond basic nutrition-foods capable of promoting better health, or even playing a disease-prevention role. To meet this need for innovation,
Book Synopsis Routledge Handbook of Water Law and Policy by : Alistair Rieu-Clarke
Download or read book Routledge Handbook of Water Law and Policy written by Alistair Rieu-Clarke and published by Taylor & Francis. This book was released on 2017-02-24 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: Water plays a key role in addressing the most pressing global challenges of our time, including climate change adaptation, food and energy security, environmental sustainability and the promotion of peace and stability. This comprehensive handbook explores the pivotal place of law and policy in efforts to ensure that water enables positive responses to these challenges and provides a basis for sound governance. The book reveals that significant progress has been made in recent decades to strengthen the governance of water resource management at different scales, including helping to address international and sub-national conflicts over transboundary water resources. It demonstrates that ‘effective’ laws and policies are fundamental drivers for the safe, equitable and sustainable utilization of water. However, it is also shown that what might constitute an effective law or policy related to water resources management is still hotly debated. As such, the handbook provides an important and definitive reference text for all studying water governance and management.
Book Synopsis The Legislative Choice Between Delegated and Implementing Acts in EU Law by : Eljalill Tauschinsky
Download or read book The Legislative Choice Between Delegated and Implementing Acts in EU Law written by Eljalill Tauschinsky and published by Edward Elgar Publishing. This book was released on 2018-11-30 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the face of the current confusion about the use of arts 290 and 291 TFEU, there is need of further development of the theory of legislative delegation to the EU Commission. This timely book approaches this question from a practical perspective with a detailed examination of how the legislator uses delegated and implementing mandates in different fields of EU law. Offering an analysis of legislative practice and providing concrete evidence of how articles 290 and 291 TFEU are actually handled, it offers new insight into potential developments in EU administrative law.
Book Synopsis Essential Texts on International and European Criminal Law by : Gert Vermeulen
Download or read book Essential Texts on International and European Criminal Law written by Gert Vermeulen and published by Gompel&Svacina. This book was released on 2021-01-19 with total page 992 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book comprises the principal multilateral legal instruments on international and European criminal law, with a special institutional focus on Europol, Eurojust and the European Public Prosecutor’s Office, a substantive focus on international, organised and serious crime, including terrorism, and a focus on procedural rights approximation. Given the relevance thereof for international information exchange in criminal matters, relevant data protection instruments have also been included in the selection. The texts have been ordered according to the corresponding multilateral co-operation level: either Prüm, the European Union (comprising Schengen-related texts), the Council of Europe or the United Nations. This edition provides students as well as practitioners (judicial and law enforcement authorities, lawyers, researchers, …) throughout Europe with an accurate and up-to-date edition of essential texts on international and European criminal law. All texts have been updated until 13 January 2021.
Book Synopsis Regulating Financial Derivatives by : Alexandra G. Balmer
Download or read book Regulating Financial Derivatives written by Alexandra G. Balmer and published by Edward Elgar Publishing. This book was released on 2018-06-29 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book puts forward a holistic approach to post-crisis derivatives regulation, providing insight into how new regulation has dealt with the risk that OTC derivatives pose to financial stability. It discusses the implications that post crisis regulation has had on central counterparties and the risk associated with clearing of OTC derivatives. The author offers a novel solution to tackle the potential negative externalities from the failure of a central counterparty and identifies potential new risks arising from post crisis reforms.
Book Synopsis Human Rights and Emerging Technologies by : Daniele Ruggiu
Download or read book Human Rights and Emerging Technologies written by Daniele Ruggiu and published by CRC Press. This book was released on 2018-06-26 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: What is the state of current European governance on new and emerging technologies, and where is it going? What is, and what can be, the role of human rights in governance arrangements? These are the main questions that this book answers for both European and non-European scholars. It provides a wide picture of current European governance, notably in biotechnology, nanotechnology and synthetic biology, and discusses the model of Responsible Research and Innovation, which is gaining popularity within the European Union, under a human rights perspective. It shows how human rights can contribute to governance frameworks without posing obstacles to research and innovation. The theory presented in the book is followed by practical guidelines drawn from human rights law. Starting from the Strasbourg Court jurisprudence, it provides a complete review of the wide range of rights that the European Convention on Human Rights protects in light of the challenges of techno-scientific advances. This analysis will come in handy for private actors, policymakers, regulators, as well as judges in solving hard cases raised by techno-scientific progress in the future.
Book Synopsis Infrastructure for Asian Connectivity by : Biswa N. Bhattacharyay
Download or read book Infrastructure for Asian Connectivity written by Biswa N. Bhattacharyay and published by Edward Elgar Publishing. This book was released on 2012-01-01 with total page 521 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses the prospects and challenges concerning both soft and hard infrastructure development in Asia and provides a framework for achieving Asian connectivity through regional infrastructure cooperation towards a seamless Asia. Key topics included are: ' demand estimates of national and regional infrastructure in transport, electricity, information and communication technology, and water and sanitation; ' empirical results on the costs and benefits of regional infrastructure for economies and households; ' the impact of infrastructure development on the environment and climate; ' sources and instruments of infrastructure financing; ' best practices and lessons learned from the experiences of the Asian region and other regions; and ' experiences of public_private partnership projects. This insightful book will serve as a definitive knowledge product for policymakers, academics, private sector experts and infrastructure practitioners interested in the regional and national infrastructure demand, investment and benefits in the region. Concerned officials from private and public sectors, and other experts involved in environmental and natural resources studies will also find this compendium invaluable.
Book Synopsis Deficits in EU and US Mandatory Environmental Information Disclosure by : Dirk Bünger
Download or read book Deficits in EU and US Mandatory Environmental Information Disclosure written by Dirk Bünger and published by Springer Science & Business Media. This book was released on 2011-10-20 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is the publicity about the Pollutant Release Inventory’s data which creates an incentive for firms to achieve emission reductions. Accordingly, public access to environmental information constitutes a core characteristic of the aforementioned inventory. Here, in essence, two facets arise. First, with regard to the collection, it is disputed whether such information, which may comprise confidential commercial and industrial information in the EU as well as trade secrets in the US, can be protected under fundamental and constitutional property rights respectively. Second, in the context of dissemination and utilisation, it is arguable whether the information indeed impacts polluters and produces an outcome that secures a certain level of environmental protection. The author responds to the first issue by taking the EU and US jurisdictions into account and strives to analyse how this novel form of Internet disclosure liberates market mechanisms in the quest for effective and efficient emission reductions.
