Good Manufacturing Practice (GMP) Guidelines


Book Description

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.




EU Immigration and Asylum Law (Text and Commentary): Second Revised Edition


Book Description

Since 1999, the EU has adopted legislation harmonizing many areas of immigration law, in particular rules on borders, visas, legal migration, and irregular migration. The much-enlarged and fully updated second edition of this book contains the text of and detailed commentary upon every significant measure in this field proposed or adopted up until 1 September 2011. It includes commentary on the EU visa code, the Schengen Borders Code, the Frontex Regulation, the Returns Directive, the Directives on family reunion, long-term residents and single permits for migrant workers, and many more besides. This is the essential guide for any lawyers, academics, civil servants, NGOs and students interested in this area of law.




International Climate Change Law


Book Description

This textbook, by three experts in the field, provides a comprehensive overview of international climate change law. Climate change is one of the fundamental challenges facing the world today, and is the cause of significant international concern. In response, states have created an international climate regime. The treaties that comprise the regime - the 1992 United Nations Framework Convention on Climate Change, the 1997 Kyoto Protocol and the 2015 Paris Agreement establish a system of governance to address climate change and its impacts. This book provides a clear analytical guide to the climate regime, as well as other relevant international legal rules. The book begins by locating international climate change law within the broader context of international law and international environmental law. It considers the evolution of the international climate change regime, and the process of law-making that has led to it. It examines the key provisions of the Framework Convention, the Kyoto Protocol and the Paris Agreement. It analyses the principles and obligations that underpin the climate regime, as well as the elaborate institutional and governance architecture that has been created at successive international conferences to develop commitments and promote transparency and compliance. The final two chapters address the polycentric nature of international climate change law, as well as the intersections of international climate change law with other areas of international regulation. This book is an essential introduction to international climate change law for students, scholars and negotiators.




International Civil Aviation Organization (ICAO)


Book Description

Derived from the renowned multi-volume International Encyclopaedia of Laws, this practical analysis of the structure, competence, and management of International Civil Aviation Organization (ICAO) provides substantial and readily accessible information for lawyers, academics, and policymakers likely to have dealings with its activities and data. No other book gives such a clear, uncomplicated description of the organization’s role, its rules and how they are applied, its place in the framework of international law, or its relations with other organizations. The monograph proceeds logically from the organization’s genesis and historical development to the structure of its membership, its various organs and their mandates, its role in intergovernmental cooperation, and its interaction with decisions taken at the national level. Its competence, its financial management, and the nature and applicability of its data and publications are fully described. Systematic in presentation, this valuable time-saving resource offers the quickest, easiest way to acquire a sound understanding of the workings of International Civil Aviation Organization (ICAO) for all interested parties. Students and teachers of international law will find it especially valuable as an essential component of the rapidly growing and changing global legal milieu.




Introduction to Air Law


Book Description

The world of aviation has moved on rapidly since the appearance of the ninth edition of this pre-eminent resource five years ago. Those developments pertain to market access and market behaviour by air carriers, including competition, new perceptions of safety and security, among others, in relation to transparency of accident investigation and cybersecurity, case law in the area of airline liability, with new cases from the United States, product liability and insurance, the United Kingdom, and elsewhere, the growing importance of environmental concerns, the rights and obligations of passengers, also in the context of ‘unruly’ passengers, and innovative methods for financing aircraft. Special attention has been paid in this edition to regional integration movements, especially in Europe, affecting the mentioned subjects. The book’s extensive references to other sources in the field have been expanded and updated by the author and experts in specialised areas. The present edition addresses the following topics: the regulatory framework governing the operation of air services, including the principle of sovereignty in national airspace; the distinction between State and civil aircraft; dispute settlement in international civil aviation; economic regulation of international air transport services, including the establishment of air services agreements; inter-airline cooperation in the context of competition law regimes; liability of the various service providers, in particular airlines, and related insurance coverage; the promotion of safety standards; criminal acts affecting the safety of aviation; the role of international and regional organisations with particular reference to that of the European Union; liability of the aircraft manufacturer for equipment; and financial and security interests in mobile equipment. The many practitioners, officials, business people, and academics with a professional interest in aviation law will appreciate this new edition as one of the fundamental works in the field, and newcomers will discover an incomparable resource. This eleventh edition is ready to be of unmatched service to any practising member of the air law community anywhere in the world.




European Tax Law, Volume 1


Book Description

Ben Terra (1946–2019) was professor of tax law at the universities of Amsterdam (UvA), the Netherlands, and Lund, Sweden. Peter Wattel is Advocate General in the Supreme Court of the Netherlands, State Councillor extraordinary in the Netherlands, Council of State and professor of EU tax law at the Amsterdam Centre for Tax Law (ACTL), University of Amsterdam. Sjoerd Douma is professor at the ACTL, Director of the Adv LLM programme in International Tax Law at Amsterdam Law School, and partner at Lubbers, Boer & Douma in The Hague. Otto Marres is professor at the ACTL, and tax lawyer at Meijburg & Co., Amsterdam. Hein Vermeulen is Director of PwC’s EU Direct Tax Group, Amsterdam. Dennis Weber is professor of European Corporate Taxation at the ACTL and of counsel at Loyens & Loeff. The eighth edition of this leading textbook brings its comprehensive and systematic survey of European Tax Law up to March 2022. With its critical discussion of the EU tax rules and of the European Court’s case law in tax matters, it surpasses every other textbook on EU Tax Law in its clarification and analysis of the implications of the EU Treaties and secondary EU law for national and bilateral tax law. The in-depth coverage of Volume I includes the following: 1. The far-reaching consequences of the EU free movement rights, the EU State aid prohibition, the EU Charter of Fundamental Rights, and the general principles of EU law for national tax law, tax treaties, national (tax) procedure, State liability, and relations with third States. 2. Secondary EU law in force and proposed on direct taxes (Parent-Subsidiary Directive, Tax Merger Directive, Interest and Royalties Directive, cross-border tax dispute settlement instruments, the Anti-Tax Avoidance Directive and pending company tax proposals). 3. (Automatic) exchange of information and other administrative assistance in the assessment and recovery of taxes between the EU Member States. 4. Soft Law on Harmful Tax Competition. Procedural matters and the extent of judicial protection are emphasized throughout this volume. This new edition will continue to be of immense value to law school and university programmes in (international) tax law and in European Union law and for practice. Volume II (2021) of this book covers harmonization of indirect taxation, energy taxation and capital duty, as well as administrative cooperation in the field of indirect taxation.




Treatise on International Criminal Law


Book Description

Since the adoption of the Rome Statute of the International Criminal Court in 1998, international criminal law has rapidly grown in importance. This three-volume treatise on international criminal law presents a foundational, systematic, consistent, and comprehensive analysis of the field. Taking into account the scholarly literature, not only sources written in English but also in French, German, Italian, Portuguese, and Spanish, the book draws on the author's extensive academic and practical work in international criminal law. This third volume offers a comprehensive analysis of the procedures and implementation of international law by international criminal tribunals and the International Criminal Court. Through analysis of the framework of international criminal procedure, the author considers each stage in the process of proceedings before the ICC, including the role of legal participants, the scope of jurisdiction, and the enforcement of sentences. The full three-volume treatise addresses the entirety of international criminal law, re-stating and re-examining the fundamental principles upon which it rests, the manner it is enacted, and the key issues that are shaping its future. It is essential reading for practitioners, scholars, and students of international criminal law alike.




The Greenhouse Gas Protocol


Book Description

The GHG Protocol Corporate Accounting and Reporting Standard helps companies and other organizations to identify, calculate, and report GHG emissions. It is designed to set the standard for accurate, complete, consistent, relevant and transparent accounting and reporting of GHG emissions.




EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP


Book Description

Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is




Yearbook Commercial Arbitration Volume XXXV - 2011


Book Description

The Yearbook Commercial Arbitration continues its longstanding commitment to serving as a primary resource for the international arbitration community with reporting on arbitral awards and court decisions applying the leading arbitration conventions, as well as on arbitration legislation and rules.