Download or read book Parallel Trade in Europe written by Christopher Stothers and published by Bloomsbury Publishing. This book was released on 2007-04-02 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: Shortlisted for the 2008 Young Authors Inner Temple Book Prize Are parallel importers the key to free trade, breaking down long-established national barriers for the benefit of all? Or do they instead just operate in a dubious 'grey market' for their own profit, free-loading on the investment of innovators and brand owners to the ultimate detriment of everyone? Parallel trade is in turn lionised and demonised, both in legal commentary and in the mainstream press. As one might expect, the truth lies somewhere between these extremes. Once goods have been manufactured they are put onto the market in one country by the manufacturer. Parallel trade occurs when the goods are subsequently transferred to a second country by another party (the parallel trader, who may be the end consumer). The distinguishing feature of parallel trade is that the manufacturer did not intend those particular goods to end up in the second country. The goods are normally described in that country as 'parallel imports' or 'grey market goods'. The latter term is generally used to suggest that the trade, while not exactly 'black market', is not entirely lawful either. Understanding how European Community law operates to permit or restrict parallel trade involves exploring a complex matrix of rules from the fields of free movement, intellectual property, competition and regulatory law, including both private and public enforcement regimes. Where goods are parallel imported from outside the Community these rules change and new considerations come into play, such as obligations arising from the European Economic Area, the World Trade Organization and bilateral free trade agreements. The experience of Europe, which has grappled with the issues on a regional basis for more than four decades, provides a fertile source for examination of parallel trade in other jurisdictions. Christopher Stothers' comprehensive treatment successfully analyses this difficult topic, considering both Community and national decisions.
Download or read book Guide to EU Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2017-02-17 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Counterfeit Medicines written by Jonathan Harper and published by Council of Europe. This book was released on 2006-01-01 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report has been commissioned by the Council of Europe as part of its ongoing activities to minimise the public health risks posed by the production of counterfeit medicines. It is based on surveys undertaken in 2003-04 within Council of Europe member states, as well as amongst pharmaceutical manufacturers and wholesalers in Europe. Issues considered include: the current and estimated market and trade matters, national and international co-operation between regulatory authorities, the adequacy of legal, judicial and administrative systems, and professional training aspects.
Download or read book Distribution Marketing of Drugs written by Eric Stupp and published by Sweet & Maxwell. This book was released on 2013 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive text on Professional Liability. It provides comprehensive coverage of the law and is an essential reference point for every practitioner. The 7th edition is bought fully up to date with the latest supplement.
Download or read book Parliamentary Debates Hansard written by Great Britain. Parliament. House of Commons and published by . This book was released on 2002 with total page 846 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Statutory Instruments written by Great Britain and published by . This book was released on 1998 with total page 748 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Download or read book British National Bibliography for Report Literature written by and published by . This book was released on 1999 with total page 750 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book German Homoeopathic Pharmacopoeia written by and published by CRC Press. This book was released on 2003-11-03 with total page 838 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the increased popularity of alternative medicine, quality assurance and testing methods for alternative medicinal products has moved to the forefront of the field. And although regulation of these products varies from country to country, universally they are required satisfy the same quality requirements as the medicines used in allopathy. Filling the need for an authoritative resource, German Homoeopathic Pharmacopoeia contains monographs covering homoeopathic products and their related analytical and manufacturing techniques. Each monograph is uniformly structured supplying, where applicable: Origin Description Characteristics Identification Purity Tests Assays Basic dosage forms Manufacture Storage Completely revised and updated, the volumes put the latest information within easy reach. An extensive collection of manufacturing and testing techniques, German Homoeopathic Pharmacopoeia establishes standards to ensure the pharmaceutical quality and safety of homoeopathic medicinal products.
Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Download or read book Importing Into the United States written by U. S. Customs and Border Protection and published by . This book was released on 2015-10-12 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explains process of importing goods into the U.S., including informed compliance, invoices, duty assessments, classification and value, marking requirements, etc.
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Download or read book Pharmaceutical Medicine Biotechnology and European Law written by Richard Goldberg and published by Cambridge University Press. This book was released on 2000 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lawyers and academics reassess the impact of European law on health care and pharmaceutical law.
Download or read book Reports of Cases Before the Court of Justice and the Court of First Instance written by Court of Justice of the European Communities and published by . This book was released on 2008 with total page 882 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Dale and Appelbe s Pharmacy Law and Ethics written by Joseph R. Dale and published by Rittenhouse Book Distributors. This book was released on 1993 with total page 668 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fifth edition of a work on pharmacy law and ethics. It contains changes to the National Health Service and dangerous subtances data, and includes a new chapter on the European Community's impact on the law in Britain. The Code of Ethics and the Standards of Professional Practice are included.
Download or read book Reports of Cases Before the Court of Justice and the Court of First Instance written by and published by . This book was released on 2008 with total page 876 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Laws of Scotland written by and published by Butterworths. This book was released on 1987 with total page 2538 pages. Available in PDF, EPUB and Kindle. Book excerpt: The title of the Encyclopaedia acknowledges the debt owed by modern Scots lawyers to Viscount Stair, whose Institutions of the Law of Scotland, published in 1681, was the first authoritative and comprehensive statement of Scots Law, and helped to ensure the survival of an independent and distinct system of jurisprudence in Scotland. The Stair Memorial Encyclopedia is the first comprehensive statement of Scots Law for more than 50 years.
