Download or read book Navigating European Pharmaceutical Law written by Maria Isabel Manley and published by Oxford University Press, USA. This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patents / Dominic Adair, Greg Bacon, and Vanessa Rieu -- Clinical trials / Helen Middleton -- Procedures for obtaining a marketing authorisation and legal bases for application / Maria Isbel Manley and Libby Amos -- Pricing, reimbursement, and health technology appraisals (market access) / Maria Isabel Manley and Maria Georgiou -- Paediatrics / Georgia Gavriilidou -- Orphan drugs / Maria Isabel Manley and Chris Boyle -- Biological medicinal products and biosimilars / Dev Kumar and Lauren Wilks -- Regulatory data protection / Maria Isabel Manley and Grant Strachan -- Supplementary protection certificates / Maria Isabel Manley and Marina Vickers -- Maximisation of regulatory IP rights / Maria Isabel Manley and Marina Vickers -- The interaction between intellectual property law and competition law / Pat Treacy -- Access to information / Vincenzo Salvatore -- Litigating decisions of regulatory authorities / Kelyn Bacon, QC and Hugo Leith -- Pharmacovigilance / Maria Isabel Manley abd Edward Bray -- Data protection / Hazel Grant -- The promotion of medicinal products in the EU / Maria Isabel Manley and Libby Amos -- Borderline products / Maria Isabel Manley and Joanna Hook -- Product liability : the UK perspective / Mark Brown -- Pharmaceutical licensing and collaboration agreements : key consideration from the licensee's perspective / Jerry Temko -- Trade mark protection and enforcement in the pharmaceutical field / Sally Dunstan

Download or read book Navigating European Pharmaceutical Law written by Maria Isabel Manley and published by . This book was released on 2015 with total page 737 pages. Available in PDF, EPUB and Kindle. Book excerpt: An authoritative and comprehensive analysis of EU pharmaceutical law and the most controversial legal issues within the innovative industry, supported by case studies and practical guidance.

Download or read book The Challenges of the New EU Pharmaceutical Legislation written by José Luis Valverde and published by IOS Press. This book was released on 2005 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the domain of public policy on pharmaceuticals, protecting public health requires a dual strategy: robust regulation on the one hand and stimulation of competitiveness and innovation on the other. Regulation must be robust to ensure that only medicines meeting exact standards of safety, quality and efficacy are authorised for human and animal use. At the same time competitiveness and innovation must be stimulated. Without innovation in pharmaceuticals, the incurable diseases of today will remain incurable. Competitiveness drives innovation and innovation saves lives. Increased competitiveness of the pharmaceutical sector will not only better protect public health, but will also create high quality jobs and create growth. In this context the implementation of the G10 recommendations, particularly regarding the pricing and reimbursement of medicines by Member States, remains a considerable challenge.

Download or read book An Introduction to EU Pharmaceutical Law written by John Lisman and published by . This book was released on 2005 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Guide to Eu Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International. This book was released on 2017-03-21 with total page 639 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guide to EU Pharmaceutical Regulatory Law, which is updated annually to reflect the speed at which the rules and regulations change, provides a comprehensive and practical guide to, and analysis of, the current European Union (EU) Pharmaceutical Regulatory Regime. In the EU and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure that such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. What's in this book: Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe - from its underlying rationales to the relevant committees and agencies - each of the fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: obtaining a marketing authorisation; stages and standards for creating a product dossier; clinical trials; how and when an abridged procedure can be used; criteria for conditional marketing authorisations; generic products and 'essential similarity'; paediatric use and the requisite additional trials; biologicals and 'biosimilars'; homeopathic and herbal medicines; reporting procedures; pharmacovigilance; parallel trade; relevant competition law and IP rights; and advertising. In addition, national variation charts in many of the chapters illustrate how the regime operates in the eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are also included. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. How this will help you: Starting with an overview, this book primarily deals with how pharmaceutical products are brought to market from the conduct of clinical trials through amendments to marketing authorisations and abridged (generic) applications - the routes to obtaining a marketing authorisation covering special regimes such as the paediatric system and conditional marketing authorisations. Thus, this book serves as a guide for pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations. In addition, this book also provides guidance on how ancillary subjects such as IP law, competition law, parallel imports and the regulation of homeopathic products influence pharmaceutical regime.

Download or read book New Developments of Pharmaceutical Law in the EU written by J. L. Valverde and published by Ios PressInc. This book was released on 2010-01-01 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book EudraBook written by and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 2015 marks the 50th anniversary of pharmaceutical legislation in the EU, which began with Directive 65/65 in 1965 in the wake of the Thalidomide disaster. The EU legal framework for medicinal products for human use guarantees high standards of quality and safety of medicinal products and intends to promote the functioning of the internal market, with measures which encourage innovation and competiveness in Europe. It is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities. A large body of legislation has developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisations since the 1960s, implemented across the whole European Economic Area. Nowadays, medicinal products may be either authorised centrally by the European Commission or nationally by Member States' competent authorities.^The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities guaranteeing a constant exchange and flow of information regarding the scientific assessment of medicinal products in the EU. The EU legal framework is definitely not an area in which the law stands still. Quite the contrary, its history is marked by a constant ambition to improve its functioning or tackling shortcomings in order to guarantee the right balance between early access of patients to new medicines and high standards of quality and safety. Moreover, over the past 50 years science has developed. New technologies and further knowledge about diseases led to the introduction of new concepts or re-shaping of existing medical therapies that were subsequently mirrored in legislation.^The pharmaceutical sector is characterised by an abundance of guidelines intended to help and support the key players in the application of the EU legal framework. Still, the guidance documents would be nothing without the basic legislation on which they build. To understand the EU legal framework for medicinal products it is important to know the applicable provisions of the legislation itself. This E-Book is intended to support readers in this regard by putting together the most recent versions of the key legal instruments on medicinal products for human use. It provides a useful overview for stakeholders, especially the pharmaceutical industry, regulatory authorities, legal practitioners, but also interested citizens, patients and healthcare professionals.

Download or read book Eu Pharmaceutical Law written by Peter Bogaert and published by . This book was released on 2003 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book European Regulation of Medical Devices and Pharmaceuticals written by Nupur Chowdhury and published by Springer Science & Business. This book was released on 2014-04-29 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.

Download or read book The Interplay of Global Standards and EU Pharmaceutical Regulation written by Sabrina Röttger-Wirtz and published by Bloomsbury Publishing. This book was released on 2021-08-26 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

Download or read book EU Competition Law and Pharmaceuticals written by Wolf Sauter and published by Edward Elgar Publishing. This book was released on 2022-11-15 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. It carefully considers the balance between competition and innovation, as well as between competition and regulation, and concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.

Download or read book EU Competition Law and Intellectual Property Rights written by Pat Treacy and published by Edward Elgar Publishing. This book was released on 2024-07-05 with total page 555 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative book from one of the top experts in the field sets out a detailed and practical analysis of the complex and often fraught relationship between EU competition rules and intellectual property rights. It is an essential resource for competition lawyers litigating Tech and Pharma cases and advising companies in those sectors, for in-house counsel within those industries, and for IP lawyers needing to understand the competition aspects of licensing agreements. It is also an indispensable reference for courts, enforcement agencies and national competition authorities, as well as for scholars researching in the field.

Download or read book Evergreening Patent Exclusivity in Pharmaceutical Products written by Frantzeska Papadopoulou and published by Bloomsbury Publishing. This book was released on 2021-09-23 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.

Download or read book Supplementary Protection Certificates for Medicinal Products written by Georgia A. Roussou and published by Edward Elgar Publishing. This book was released on 2023-01-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores whether the judicial developments related to the Supplementary Protection Certificate (SPC) regulation correspond to the objectives of the European legislator. Examining the role of SPCs for medicinal products in the European patent system, it highlights both the jurisprudence of the Court of Justice of the European Union and the respective judgements of the member states’ national courts.

Download or read book Contemporary Issues in Pharmaceutical Patent Law written by Bryan Mercurio and published by Taylor & Francis. This book was released on 2017-02-17 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges

Download or read book Bringing Your Pharmaceutical Drug to Market written by Neil P. DiSpirito and published by . This book was released on 2016-10-13 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: