Download or read book The Human Medicines and Medical Devices Amendment Etc EU Exit Regulations 2019 written by Great Britain and published by . This book was released on 2019-07-30 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, s. 8 (1), sch. 7, para. 21. Issued: 30.07.2019. Sifted: -. Made: -. Laid: -. Coming into force: In accord. with reg. 1. Effect: S.I. 2019/775 (in turn amending S.I. 2012/1916), 791 (in turn amending S.I. 2002/618) amended. Territorial extent & classification: E/W/S/NI. This draft Statutory Instrument has been printed to correct errors in S.I. 2019/775 (ISBN 9780111185858) and S.I. 2019/791 (ISBN 9780111185810). It is being issued free of charge to all known recipients of those Statutory Instruments For approval by resolution of each House of Parliament

Download or read book The Human Medicines Amendment Etc EU Exit Regulations 2019 written by Great Britain and published by . This book was released on 2019-01-29 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, s. 8 (1), sch. 4, paras 1 (1), 7 (2), sch. 7, para. 21. Issued: 28.01.2019. Sifted: -. Made: -. Laid: -. Coming into force: In accord. with reg. 1. Effect: 2006 c. 41; 2016 c. 9; S.I. 1977/670; 1997/1830; 2001/1841; 2002/3170; 2003/1680; 2005/50; 2007/2785; 2008/548; 2012/1916; 2013/349; 2014/1663; 2015/895; 2016/190; 2018/677, 345; S.R. 2015/339 amended. Territorial extent & classification: E/W/S/NI. For approval by resolution of each House of Parliament. EC note: These Regulations are made in exercise of the powers in order to address failures of retained EU law to operate effectively and other deficiencies. These Regulations make amendments to legislation in the field of the regulation of medicinal products for human use. Consequential amendments are made in Schedule 8 and revocations of retained EU law are made in Schedule 9.

Download or read book The Medical Devices Amendment Etc EU Exit Regulations 2019 written by Great Britain and published by . This book was released on 2019-02-04 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, s. 8 (1), sch. 4, para. 7 (2), sch. 7, para. 21. Issued: 04.02.2019. Sifted: -. Made: -. Laid: -. Coming into force: In accord. with reg. 1. Effect: S.I. 2002/618 amended. Territorial extent & classification: E/W/S/NI. For approval by resolution of each House of Parliament. EC note: Part 1 of these regs amends the existing Medical Devices Regulations 2002 ('the 2002 Regulations') which implemented three European Union Directives which aimed to ensure the safety and quality of general medical devices, active implantable medical devices and in vitro diagnostic medical devices ('the three Directives'). Part I also makes certain transitional and savings provisions and amends EU tertiary legislation which relates to the regime implemented by the 2002 Regulations and revokes certain tertiary legislation along with the two EU Regulations insofar as they are retained EU law. Parts 2 and 3 restate (by inserting restated new provisions into the 2002 Regulations) the provisions of two EU Regulations: Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the two EU Regulations). Rights, powers, liabilities, obligations restrictions, remedies and procedures contained in the two Regulations were retained by virtue Section 4 of the Withdrawal Act and limited provisions were retained by virtue of section 3 of that Act

Download or read book The Human Medicines Amendment Etc EU Exit Regulations 2020 written by Great Britain and published by . This book was released on 2020-12-10 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, ss. 8 (1), 8C, sch. 4, paras 1 (1), 7 (2), sch. 7, para. 21. Issued: 11.12.2020. Sifted: -. Made: 08.12.2020. Laid: -. Coming into force: In accord. with reg. 1. Effect: SI. 1999/3106; 2019/744, 775, 1385 amended. Territorial extent & classification: E/W/S/NI. General. Supersedes draft SI. (ISBN 9780348213980), issued 21.10.2020

Download or read book The Medical Devices Amendment Etc EU Exit Regulations 2020 written by GREAT BRITAIN. and published by . This book was released on 2020-10-16 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, ss. 8 (1), 8C, sch. 4, para. 1 (1) (ab), 7 (2), sch. 7, para. 21 & European Union (Withdrawal Agreement) Act 2020, s. 41 (1). Issued: 16.10.2020. Sifted: -. Made: -. Laid: -. Coming into force: In accord. with reg. 1 (2) (3). Effect: S.I. 2002/618; 2019/791, 1385 amended. Territorial extent & classification: E/W/S/NI. EC note: Directive 90/385; 93/42; 98/79 modified. For approval by resolution of each House of Parliament

Download or read book The Medicines for Human Use Clinical Trials Amendment EU Exit Regulations 2019 written by Great Britain and published by . This book was released on 2019-01-28 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, s. 8 (1), sch. 7, para. 21. Issued: 28.01.2019. Sifted: -. Made: -. Laid: -. Coming into force: In accord. with reg. 1. Effect: S.I. 2004/1031 amended. Territorial extent & classification: E/W/S/NI. For approval by resolution of each House of Parliament

Download or read book The Human Medicines Amendment Regulations 2019 written by GREAT BRITAIN. and published by . This book was released on 2019-01-24 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Communities Act 1972, ss. 2 (2) (5). Issued: 24.01.2019. Sifted: -. Made: 14.01.2019. Laid: 18.01.2019. Coming into force: 09.02.2019. Effect: S.I. 2012/1916 amended. Territorial extent & classification: E/W/S/NI. General. EC note: These Regulations amend the Human Medicines Regulations 2012 in order to implement: points 8, 9, 11 and 12 of Article 1 of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Directive 2011/62/EU); Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (the Delegated Regulation).

Download or read book The Human Medicines Amendment Etc EU Exit No 2 Regulations 2021 written by GREAT BRITAIN. and published by . This book was released on 2021-11-25 with total page 8 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, s. 8C, sch. 4, para. 1 (1) (ab), 7 (2), sch. 7, para. 21. Issued: 25.11.2021. Sifted: -. Made: -. Laid: -. Coming into force: -. Effect: S.I. 2004/1031; 2012/1916; 2016/190 amended. Territorial extent & classification: E/W/S/NI. For approval by resolution of each House of Parliament

Download or read book The Food and Drink Veterinary Medicines and Residues Amendment Etc EU Exit Regulations 2019 written by Great Britain and published by . This book was released on 2019-04-18 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, s. 8, sch. 4, para. 1, sch. 7, para. 21. Issued: 18.04.2019. Sifted: -. Made: 11.04.2019. Laid: -. Coming into force: In accord. with reg. 1. Effect: S.I. 2008/3206; 2009/1976; 2011/2936; 2018/1275; 2013/2033 amended. Territorial extent & classification: E/W/S/NI. General. Supersedes draft (ISBN 9780111181249) issued 10.02.19. This Statutory Instrument has been published in substitution of the S.I. 2019/788 which did not reflect the version approved by Parliament and has been removed from legislation.gov.uk. These Regulations are being issued free of charge to all known recipients of that Statutory Instrument. EC note: Commission Regulation (EC) No 2870/2000; Regulation (EU) No 1151/2012; Commission Implementing Regulation (EU) No 716/2013; Regulation (EU) No 251/2014; Commission Delegated Regulation (EU) No 664/2014; Commission Delegated Regulation (EU) No 665/2014; Commission Implementing Regulation (EU) No 668/2014; Commission Delegated Regulation (EU) 2018/273; Commission Implementing Regulation (EU) 2018/274; Annex 2 to the EEA Agreement; Regulation (EC) No 470/2009 amended & 42 Decisions & Regulations revoked in accord. with sch. 7

Download or read book The REACH Etc Amendment Etc EU Exit Regulations 2019 written by GREAT BRITAIN. and published by . This book was released on 2019-02-11 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, s. 8 (1), sch. 4, para. 1, sch. 7 para. 21. Issued: 11.02.2019. Sifted: -. Made: -. Laid: -. Coming into force: In accord. with reg. 1 (1). Effect: S.I. 2000/1043; 2008/2852; 2009/1976 amended & S.I. 2007/1742 revoked. Territorial extent & classification: E/W/S/NI. EC note: Regulation (EC) no. 1907/2006; Commission Regulation (EC) no. 440/2008; Implementing Regulation (EU) 2016/9; Commission Regulation (EC) no. 340/2008; Decision C (2017) 3439; EEA Agreement Annex 2 amended & Commission Regulation (EC) no. 506/2007; Commission Regulation (EC) no. 1238/2007; Commission Regulation (EC) no. 465/2008; Commission Regulation (EC) no. 466/2008; Commission Regulation (EC) no 771/2008; Commission Decision 2010/226/EU revoked. For approval by resolution of each House of Parliament. This draft Statutory Instrument supersedes the draft of the same title which was laid before Parliament on 9th January 2019 and published on 9th January 2019 (ISBN 9780111178034). It is being issued free of charge to all known recipients of that draft Statutory Instrument

Download or read book The Product Safety and Metrology Etc Amendment Etc EU Exit Regulations 2019 written by Great Britain and published by . This book was released on 2018-12-12 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, s. 8 (1), sch. 7, para. 21. Issued: 14.12.2018. Sifted: -. Made: -. Laid: -. Coming into force: In accord. with reg. 1. Effect: 1973 c. 43; 1985 c. 72; 1987 c. 43; S.I. 1977/932; 1988/186, 2039; 1998/2307; 2001/1701; 2005/1803, 3117; 2006/659; 2008/1597; 2009/2824, 3155; 2011/1881; 2014/1638; 2015/356, 398, 1553; 2016/1091, 1092, 1093, 1101, 1105, 1107, 1152, 1153; 2017/737, 1206; S.R. 2013/48; 2016/366; 2017/90 amended. Territorial extent & classification: E/W/S/NI. For approval by resolution of each House of Parliament. EC note: These Regulations are made in order to address failures of retained EU law. These Regulations make amendments to legislation in the field of product safety and metrology. Part 2 amends primary legislation, Part 3 amends subordinate legislation, Part 4 amends subordinate legislation applying to Northern Ireland, Part 5 amends retained direct EU legislation and Part 6 makes revocations

Download or read book A User s Guide to Intellectual Property in Life Sciences written by Paul England and published by Bloomsbury Publishing. This book was released on 2021-03-26 with total page 922 pages. Available in PDF, EPUB and Kindle. Book excerpt: Life Sciences is one of the most innovative and complex areas of law. It is currently undergoing a period of intense transformation, with companies facing an ever-increasing level of regulation as well as strict cost management in order to remain competitive and profitable. The latest in "A User's Guide to..." series it covers life sciences in relation to: - patents - copyright - trade marks; and - data protection The book covers UK law with references to significant EPO cases. A key part of the book is the coverage of case law. Case studies and detailed analysis of the key cases, eg the Kymab mouse case, the human genome sciences case, and the pregabalin case feature heavily helping to put this often complex area of law into context. Where appropriate and for comparison purposes, approaches of key foreign jurisdictions are summarised and for ease of use there are clearly signposted. A key text for practitioners specialising in life sciences and intellectual property in general and patents officers dealing with life sciences applications.

Download or read book Clinical Negligence written by Dr Michael Powers KC and published by Bloomsbury Publishing. This book was released on 2023-07-31 with total page 1609 pages. Available in PDF, EPUB and Kindle. Book excerpt: "I would highly recommend this book...It is high quality, clear and comprehensive and will no doubt prove an invaluable source of reference. Five stars on all counts." Tim Kevan, co-editor, PIBULJ.COM This book remains the only text of its kind to cover both the medical and legal aspects of medical negligence. Written by a team of more than 60 experts, it continues to provide the most comprehensive and authoritative guidance on all aspects of clinical negligence claims, from bringing an action for damages to presenting expert evidence in court. It also includes detailed consideration of funding and cost implications. Those needing clear guidance to make the best possible preparations for an action will find all they need here. The new 6th edition has been fully revised and restructured, including new chapters on the future of clinical negligence litigation, cardiology, gynaecology, obstetrics, haematology , and also includes coverage and analysis of recent key cases such as: - Williams v Bermuda Hospitals [2016] UKPC 4 (causation) - R (on the application of Maughan) v HM Senior Coroner for Oxfordshire [2020] UKSC 46 (suicide in inquests) - Darnley v Croydon Health Authority [2018] UKSC 50 (duty of care owed by receptionist) - ABC v St George's Hosp [2020] EWHC 455 (Huntington's chorea confidentiality) - Swift v Carpenter [2020] EWCA Civ 1295 (future accommodation costs) - Whittington Hospital NHS Trust v XX [2020] UKSC 14 (damages for surrogacy) - Khan v Meadows [2021] UKSC 21 (scope of duty of care) - Nguyen v HM Assistant Coroner for Inner West London [2021] EWHC 3354 (sufficiency of inquiry) Easy-to-access structure The new edition maintains its easy-to-access, two-part structure. The first part, set out in 16 chapters, deals with legal aspects of medical malpractice, including complaints procedures, poor performance and medical professional governance, preparation of medical evidence, settlements and trial. There are also chapters on product liability, and coronial law. The final 27 chapters in the second part cover the risks associated with particular areas of specialist medical practice. This title is included in Bloomsbury Professional's Clinical Negligence online service.

Download or read book Guide to EU and UK Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2023-01-10 with total page 840 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Medicine patients and the law written by Emma Cave and published by Manchester University Press. This book was released on 2023-06-06 with total page 729 pages. Available in PDF, EPUB and Kindle. Book excerpt: Embryo research, cloning, assisted conception, neonatal care, pandemic vaccine development, saviour siblings, organ transplants, drug trials – modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up. In this highly acclaimed and very accessible book Margaret Brazier, Emma Cave and Rob Heywood provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The seventh edition of this book has been fully revised and updated to cover the latest cases, Brexit-related regulatory reform and COVID-19 pandemic measures. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law.

Download or read book Product Liability written by Duncan Fairgrieve and published by Oxford University Press. This book was released on 2020-05-20 with total page 1112 pages. Available in PDF, EPUB and Kindle. Book excerpt: Product Liability is a recognised authority in the field and covers the product liability laws through which manufacturers, retailers, and others may be held liable to compensate persons who are injured, or who incur financial loss, when the products which they manufacture or sell are defective or not fit for their purpose. Product defects may originate in the production process, be one of design, or be grounded in a failure to issue an adequate warning or directions for safe use and practitioners advising business clients or claimants will find this book provides all the necessary information for practitioners to manage a product liability claim. This new edition has been fully updated to take account of 10 years of development in case law and regulation, and the increasing impact of cross-border and transnational sale of goods. The Court of Justice of the European Union handed down major rulings concerning the Product Liability Directive which affect the application of the Directive and national arrangements and Fairgrieve and Goldberg examines this in detail. For any legal practitioner operating in areas which require knowledge of European product liability law, an understanding of the impact of recent developments is essential and this work is an essential resource for practitioners working on product liability, sale of goods, personal injury and negligence. The work provides comprehensive coverage of the law of negligence as it applies to product liability, of the strict liability provisions of the Consumer Protection Act 1987, and of the EU's Product Liability Directive on which the Act is based. Although the majority of cases involve pharmaceuticals and medical devices, in recent English cases the allegedly defective products have been as diverse as a child's buggy, an All Terrain Vehicle, and even a coffee cup. Many cases are brought as group actions, and the book examines the rights of those who are injured by defective products. As well as considering the perspective of the law as it has developed in the UK, this edition contains detailed discussion of case law from other jurisdictions including the USA, Australia, New Zealand, Canada, France and Germany. The coverage in the work is complemented by a full analysis of issues which arise in transnational litigation involving problems of jurisdiction and the choice of laws.

Download or read book Law and Legacy in Medical Jurisprudence written by Edward S. Dove and published by Cambridge University Press. This book was released on 2022-03-10 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Graeme Laurie stepped down from the Chair in Medical Jurisprudence at the University of Edinburgh in 2019. This edited collection pays tribute to his extraordinary contributions to the field. Graeme often spoke about the importance of 'legacy' in academic work and forged a remarkable intellectual legacy of his own, notably through his work on genetic privacy, human tissue and information governance, and the regulatory salience of the concept of liminality. The essays in this volume animate the concept of legacy to analyse the study and practice of medical jurisprudence. In this light, legacy reveals characteristics of both benefit and burden, as both an encumbrance to and facilitator of the development of law, policy and regulation. The contributions reconcile the ideas of legacy and responsiveness and show that both dimensions are critical to achieve and sustain the health of medical jurisprudence itself as a dynamic, interdisciplinary and policy-engaged field of thinking.