The Genetically Modified Food and Feed (Authorisations and Modifications of Authorisations) (England) Regulations 2023 PDF Download
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Author: Maria Lee Publisher: Edward Elgar Publishing ISBN: 184844396X Category : Science Languages : en Pages : 297
Book Description
Lee s book is a valuable addition to the literature for those wishing to broaden their understanding of the range of legal disciplines involved in GMO regulation. Tracey Epps, European Review of Agricultural Economics Maria Lee s work is a successful attempt to illustrate the big legal issues behind the regulation of genetically modified organisms (GMOs). This study, which is thorough and well documented, is particularly welcomed in view of the need for a dialogue between different legal specialisms for which GMOs are a relevant area of research. . . [The] book provides a very interesting and insightful examination of the legal problems raised by GMOs. I would warmly recommend its reading to academics and practitioners who are interested in European risk regulation law, environmental law, biotechnology and trade law. Sara Poli, European Law Review Genetically modified organisms (GMOs) are an extraordinary innovation. They raise great expectations of economic prosperity and improved capacity to address pressing problems of poverty and environmental degradation, whilst simultaneously raising great concerns about the type of social and physical world they promise. Finding space in regulation to consider the full range of issues provoked by GMOs is a huge challenge. This book explores the EU s elaborate regulatory framework for GMOs, which extends far beyond the process of their authorisation (or not) for the EU market, embracing disparate legal disciplines including intellectual property, consumer protection and civil liability. The regulation of GMOs also highlights questions of EU legitimacy in a context of multi-level governance, both internally towards national and local government, and externally in a world where technologies and their regulation have global impacts. This book will be of interest to academics and students in both law and social sciences, as well as practising lawyers and policy makers. It addresses questions that are significant for those involved in environmental or food issues, as well as specialists in GMOs.
Author: Publisher: ISBN: 9789291998661 Category : Languages : en Pages : 8
Book Description
According to Articles 11(6) and 23(6) of Regulation (EC) No 1829/2003 on genetically modified food and feed, the European Food Safety Authority should publish detailed guidance to assist applicants in the preparation and presentation of their applications for the renewal of authorisations of that genetically modified food and feed. This guidance document describes the data requirements for renewal applications, which should contain a copy of the authorisation, post-market monitoring and post-market environmental monitoring reports, systematic search and evaluation of literature, updated bioinformatics and any additional documents or studies performed by or on behalf of the applicant during the authorisation period. The applicant is requested to assess the collected information and conclude whether the previous risk assessment remains valid. The applicant can also propose amending or complementing the original conditions of the authorisation, including the monitoring plan(s).
Author: Great Britain Publisher: ISBN: 9780348392982 Category : Languages : en Pages : 32
Book Description
Enabling power: Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, arts 7 (3), 9 (2), 11, 19 (3), 21 (2), 23, 35. Issued: 27.04.2022. Sifted: -. Made: 25.04.2022. Laid before Senedd Cymru: 27.04.2022. Coming into force: 20.05.2022. Effect: None. Territorial extent & classification: W. General. EC note: Commission Decision (EC) 2009/813; Commission Decision (EC) 2009/814; Commission Decision (EC) 2009/866; Commission Decision (EU) 2010/419; Commission Implementing Decision (EU)2018/1111 revoked [in relation to Wales]
Author: Scotland Publisher: ISBN: 9780111054451 Category : Languages : en Pages : 24
Book Description
Enabling power: Regulation (EC) No 1829/2003 of the European Parliament and of the Council, arts 7 (3), 9 (2), 11, 19 (3), 21 (2), 23, 35Issued: 21.04.2022. Made: 19.04.2022. Laid before the Scottish Parliament: 21.04.2022. Coming into force: 31.05.2022. Effect: None. Territorial extent & classification: S. General. EC note: Commission Decision (EC) 2009/813, (EC) 2009/814, (EC) 2009/866, (EU) 2010/419 & Commission Implementing Decision (EU) 2018/1111 revoked
Author: Maria Cristina Galli Publisher: Springer ISBN: 3319186183 Category : Medical Languages : en Pages : 235
Book Description
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Author: James R. May Publisher: Cambridge University Press ISBN: 1107022258 Category : Business & Economics Languages : en Pages : 427
Book Description
Reflecting a global trend, scores of countries have affirmed that their citizens are entitled to healthy air, water, and land and that their constitution should guarantee certain environmental rights. This book examines the increasing recognition that the environment is a proper subject for protection in constitutional texts and for vindication by constitutional courts. This phenomenon, which the authors call environmental constitutionalism, represents the confluence of constitutional law, international law, human rights, and environmental law. National apex and constitutional courts are exhibiting a growing interest in environmental rights, and as courts become more aware of what their peers are doing, this momentum is likely to increase. This book explains why such provisions came into being, how they are expressed, and the extent to which they have been, and might be, enforced judicially. It is a singular resource for evaluating the content of and hope for constitutional environmental rights.
Author: Great Britain
Author: Great Britain
Author: Great Britain
Author: Scotland
Author: Maria Lee
Author: 
Author: Great Britain
Author: Great Britain
Author: Scotland
Author: Maria Cristina Galli
Author: James R. May