Guide To Eu Pharmaceutical Regulatory Law

Author : Sally Shorthose
Publisher : Unknown
Page : 672 pages
File Size : 52,9 Mb
Release : 2010
Category : Law
ISBN : 904112845X

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Guide to EU Pharmaceutical Regulatory Law by Sally Shorthose Pdf

This online version of this title will be shortly available atwww.kluwerlawonline.com.legislation, cases and customs which apply to the introduction, marketing andsale of a medicinal product (or a medical device) in Europe and to providesome clarity around the aforementioned complicated systems. It iswritten by and for lawyers, both in-house and in private practice, who findthemselves having to advise a client or clients on this ever-changing area oflaw, perhaps on the steps needed to bring a product to market including anysupplementary obligations (such as the need to conduct a clinical trial of theproduct for paediatric use), or perhaps when advising on clinical trialagreements, what “normal” rights and obligations of parties shouldbe included in the agreement. We hope the book will also be of interest andassistance to regulatory advisers. Each chapter presents a particularprocess or subject from a Europe-wide perspective. The chapters take thereader through the life of a medicinal product or medical device, fromdevelopment to clinical trials to product launch and afterwards, and weprovide guidance in matters where regulatory law is used as an instrument oflife-cycle management. With the exception of the advertising chapter,this book deals primarily with the European level of legislation. Where thereare significant national deviations or differences in interpretation, we havebeen able to take advantage of the breadth of Bird & Bird experience in anumber of major jurisdictions: ;UK, ;France, ;Germany, ;Spain, ;Belgium, ;TheNetherlands, ;Italy and ;Sweden tocreate national variations charts that appear at the end of certainchapters. These charts provide information on how the subject matter of thechapter is implemented in those eight major Member States, and they also serveto illustrate how implementation of the EU regulations varies between MemberStates. We have only included relevant or significant information so thelength of these appendices varies, and for some subjects, such as paediatrics,the legislation is so new and pan-European that we decided that no localvariation needed to be included. In addition, at the end of eachchapter we have included a list of guidelines/publications which will directthe readers to sources of additional information. European legislation ispeppered with acronyms. For help keeping them all straight, we included a listof the most commonly used ones in the pharmaceutical area, in addition tothose that appear in each chapter. This online version of this title will be shortly available atwww.kluwerlawonline.com.

Author : Sally Shorthose
Publisher : Kluwer Law International B.V.
Page : 840 pages
File Size : 42,5 Mb
Release : 2023-01-10
Category : Law
ISBN : 9789403530239

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Guide to EU and UK Pharmaceutical Regulatory Law by Sally Shorthose Pdf

In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure 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 clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as 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 following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.

Author : Sabrina Röttger-Wirtz
Publisher : Bloomsbury Publishing
Page : 288 pages
File Size : 49,5 Mb
Release : 2021-08-26
Category : Law
ISBN : 9781509943012

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The Interplay of Global Standards and EU Pharmaceutical Regulation by Sabrina Röttger-Wirtz Pdf

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.

Author : Maria Isabel Manley
Publisher : Unknown
Page : 737 pages
File Size : 43,5 Mb
Release : 2015
Category : Electronic
ISBN : 019102788X

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Navigating European Pharmaceutical Law by Maria Isabel Manley Pdf

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.

Author : José Luis Valverde,Paul Weissenberg
Publisher : IOS Press
Page : 154 pages
File Size : 51,9 Mb
Release : 2005
Category : Business & Economics
ISBN : 1586035215

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The Challenges of the New EU Pharmaceutical Legislation by José Luis Valverde,Paul Weissenberg Pdf

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.

Author : John J. Tobin,Gary Walsh
Publisher : John Wiley & Sons
Page : 341 pages
File Size : 44,9 Mb
Release : 2023-08-29
Category : Science
ISBN : 9783527688982

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Medical Product Regulatory Affairs by John J. Tobin,Gary Walsh Pdf

Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

Author : Sally Shorthose
Publisher : Kluwer Law International B.V.
Page : 589 pages
File Size : 42,5 Mb
Release : 2017-02-17
Category : Law
ISBN : 9789041170026

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Guide to EU Pharmaceutical Regulatory Law by Sally Shorthose Pdf

In the European Union (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 such essential products are not only efficacious but 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 clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. 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 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 intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.

Author : Maria Isabel Manley,Marina Vickers
Publisher : Oxford University Press, USA
Page : 0 pages
File Size : 40,9 Mb
Release : 2015
Category : Law
ISBN : 0198717997

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Navigating European Pharmaceutical Law by Maria Isabel Manley,Marina Vickers Pdf

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

Author : J. R. Sharp
Publisher : Interpharm CRC
Page : 292 pages
File Size : 55,8 Mb
Release : 1994
Category : Drugs
ISBN : UOM:39015038422583

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European Pharmaceutical Technical and Regulatory Compendium by J. R. Sharp Pdf

Author : Pablo Figueroa,Alejandro Guerrero
Publisher : Edward Elgar Publishing
Page : 758 pages
File Size : 55,9 Mb
Release : 2019
Category : Business & Economics
ISBN : 9781785362613

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EU Law of Competition and Trade in the Pharmaceutical Sector by Pablo Figueroa,Alejandro Guerrero Pdf

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.

Author : Medicines and Healthcare Products Regulatory Agency
Publisher : Unknown
Page : 1140 pages
File Size : 52,9 Mb
Release : 2022-03-07
Category : Electronic
ISBN : 0857114395

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Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022 by Medicines and Healthcare Products Regulatory Agency Pdf

Author : Jon Merrills,Jonathan Fisher
Publisher : Academic Press
Page : 570 pages
File Size : 50,8 Mb
Release : 2013-04-19
Category : Medical
ISBN : 9780123946188

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Pharmacy Law and Practice by Jon Merrills,Jonathan Fisher Pdf

The fifth edition of Pharmacy Law and Practice provides a straightforward and useable guide for students, practitioners, academics and others interested in pharmacy law and practice in the United Kingdom. This multi-dimensional book includes discussions of socio-political influences on legal developments to provide greater insight to the reader. It clearly sets out the background to regulatory issues together with simple and practical statements of what a pharmacist has to do to obey the law. As in previous editions, this book discusses topics thematically rather than by statute. It is a unique and reader-friendly guide that boils down the complex or difficult language of the law, describes the reasons behind it, and illustrates the application to pharmacy practice. Thoroughly updated to reflect regulatory and legal developments in areas including employment law, online transactions and internet pharmacies, non-medical prescribing and more Takes an intuitive, problem-solving approach and discusses topics thematically rather than by statute to show how all of the larger pieces fit together The electronic version of this book contains valuable links to provide readers with the most current information in a rapidly changing subject area

Author : Frantzeska Papadopoulou
Publisher : Bloomsbury Publishing
Page : 368 pages
File Size : 52,6 Mb
Release : 2021-09-23
Category : Law
ISBN : 9781509950300

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Evergreening Patent Exclusivity in Pharmaceutical Products by Frantzeska Papadopoulou Pdf

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.

Author : Andrea Parziale
Publisher : Taylor & Francis
Page : 183 pages
File Size : 54,6 Mb
Release : 2022-08-12
Category : Law
ISBN : 9781000634389

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The Law of Off-label Uses of Medicines by Andrea Parziale Pdf

This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit’s impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.

Author : Rafal Sikorski,Żaneta Zemła-Pacud
Publisher : Kluwer Law International B.V.
Page : 474 pages
File Size : 52,9 Mb
Release : 2021-02-16
Category : Law
ISBN : 9789403524146

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Patents as an Incentive for Innovation by Rafal Sikorski,Żaneta Zemła-Pacud Pdf

Patents as an Incentive for Innovation Edited by Rafal Sikorski & Zaneta Zemla-Pacud Patents are a reward for human inventiveness. A well-functioning patent system must provide incentives for innovation, safeguard dynamic competition and protect the public interest – a balancing act fraught with difficulty in the ‘connected’ global world. This ground-breaking book is the first to deeply analyse how patent law today performs its function of stimulating innovation in the crucial sectors of healthcare, agriculture, artificial intelligence and communications technology. Patent specialists, practitioners and scholars from various jurisdictions thoroughly describe how patent rights can be deployed to incentivize investments in researching and developing socially critical innovations without sacrificing the public’s interest in sharing the benefits that are produced. Among the emerging issues of patent rights investigated are the following: protectability and morality of according private rights over material derived from the human body; licensing on fair, reasonable and non-discriminatory (FRAND) terms; the supplementary protection certificate (SPC) manufacturing waiver; patent eligibility of artificial intelligence-related inventions; excessive enforcement of patents by patent assertion entities; enforcement of second medical use innovations; the so-called farmer’s privilege, the farm-save seed exemption, and breeders’ rights; international trade regulations and their influence on patent systems; human enhancement technologies and the consequences of patenting them; specifics of patent protection for biologic medicines; challenges posed by artificial intelligence for the disclosure requirement in patent law; and standard essential patent licensing, particularly in the context of the 5G standard. Perspectives taken into consideration by the authors include protectability criteria, length and scope of the granted protection, mechanisms for dealing with the friction between generalized application and specialized concerns, and rights enforcement. These aspects are analysed on the domestic, international and global levels. The COVID-19 pandemic has highlighted the urgent need to strike the right balance between innovation and access in healthcare and other technologies, a need rooted in patent law. Because the problems discussed – and solutions offered – in this collection of expert essays are of tremendous practical and cultural significance, the book will be of immeasurable value to practitioners, policymakers and researchers in patent law and other fields of intellectual property law.