Guidance On Applications For Technical Equivalence

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Guidance On The Biocidal Products Regulation

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Author :
language : en
Publisher:
Release Date : 2018

Guidance On The Biocidal Products Regulation written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with categories.

The BPR provides a centralised provision for the assessment of technical equivalence between active substances. The legal basis is Article 54, which sets out the procedure for the assessment of technical equivalence applications, under the responsibility of the Agency. This guidance document is intended to inform potential applicants about their obligations when they need to apply for an assessment of technical equivalence for an active substance and the procedural steps in making such an application. The guidance also informs potential applicants about the assessment conducted by the Agency and the approach used for assessing the technical equivalence of the alternative source of an active substance versus its reference source.

Guidance On Applications For Technical Equivalence

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Author :
language : en
Publisher:
Release Date : 2013

Guidance On Applications For Technical Equivalence written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with categories.

This document contains guidance on Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Biocidal Products Regulation, BPR). This document describes the BPR obligations and how to fulfil them. However, users are reminded that the text of the BPR is the only authentic legal reference and that the information in this document does not constitute legal advice. The European Chemicals Agency does not accept any liability with regard to the contents of this document.

Series On Pesticides And Biocides Guidance Document On Semiochemical Active Substances And Plant Protection Products

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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2018-01-10

Series On Pesticides And Biocides Guidance Document On Semiochemical Active Substances And Plant Protection Products written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-10 with categories.

This document provides guidance to both industry and regulatory authorities on how procedures and data requirements can be applied to facilitate the submission of a complete data package/dossier for semiochemical active substances in plant protection products, and the subsequent evaluation of this data package/dossier by the regulatory authorities.

Eu Environmental Law

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Author : Geert Van Calster
language : en
Publisher: Edward Elgar Publishing
Release Date : 2017-02-24

Eu Environmental Law written by Geert Van Calster and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-24 with Law categories.

EU Environmental Law discusses the reality for legal practice throughout the EU, as environmental law of the Member States is becoming ever less 'national'. Consequentially European environmental regulation is becoming more complex and interrelated, making it an emerging field of study for European law graduates, and an area of increasing exposure to the legal profession. This book gives readers a thorough overview of core European environmental law, with a section on the basic framework and principles, as well as on substantive law issues giving insight into the legislation in the different sectors and the most topical developments.

Fao Who Guidance To Governments On The Application Of Haccp In Small And Or Less Developed Food Businesses

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Author : Food and Agriculture Organization of the United Nations
language : en
Publisher: Food & Agriculture Org.
Release Date : 2006-01-01

Fao Who Guidance To Governments On The Application Of Haccp In Small And Or Less Developed Food Businesses written by Food and Agriculture Organization of the United Nations and has been published by Food & Agriculture Org. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-01-01 with Technology & Engineering categories.

This document has been developed by FAO and WHO following a request from the Thirty-fifth Session of the Codex Committee on Food Hygiene (CCFH) for guidance on HACCP (Hazard Analysis and Critical Control Point) in small and less-developed businesses (SLDBs), to address obstacles, identified by member countries, facing the small food business sector. It provides a historical background and a summary of the work of the Codex Alimentarius Commission on HACCP. It identifies the challenges facing small food businesses in the application of HACCP, outlines the steps for the development of a HACCP strategy and describes a number of strategic activities based on the collective experience of experts. Wherever possible, examples of national approaches are provided.--Publisher's description.

Agriculture Rural Development Food And Drug Administration And Related Agencies Appropriations For 2003

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Author : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
language : en
Publisher:
Release Date : 2002

Agriculture Rural Development Food And Drug Administration And Related Agencies Appropriations For 2003 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002 with United States categories.

Bioequivalence Requirements In Various Global Jurisdictions

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Author : Isadore Kanfer
language : en
Publisher: Springer Nature
Release Date : 2025-04-29

Bioequivalence Requirements In Various Global Jurisdictions written by Isadore Kanfer and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-04-29 with Science categories.

An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory requirements for the market approval of multi-source (generic) drug products in various global jurisdictions. In view of the dynamic nature of regulatory requirements which are usually regularly updated, updating these requirements to remain current is an important necessity to provide such information to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products. The revised volume includes updated information based on recent guidances and guidelines from the respective regulatory agencies as well as important trends and descriptions relating to innovative approaches for bioequivalence assessment.

Research Handbook On Environment Health And The Wto

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Author : Geert van Calster
language : en
Publisher: Edward Elgar Publishing
Release Date : 2013

Research Handbook On Environment Health And The Wto written by Geert van Calster and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Political Science categories.

ÔThis edited collection brings together an impressive array of authors from the world of international trade, the environment and public health. Each of them is eminently well-placed to bring their own particular expertise to bear on the issue at hand, and to do so in a knowledgeable and stimulating manner. This Research Handbook is a must for anyone interested in these overlapping fields of law and policy whether as a basis for learning or as a resource for further research.Õ Ð Mary Footer, University of Nottingham School of Law, UK ÔThis fantastic collection of essays explores the multiple intersections between trade and environment in the WTO. The contributions by leading scholars are theoretically engaged whilst practical in their focus. It is a Òmust readÓ for those concerned to ensure that trade liberalisation does not stand in the way of sustainable development, including urgently needed action to mitigate the risks and consequences of climate change.Õ Ð Joanne Scott, University College London, UK ÔGeert Van Calster and Denise PrŽvost have managed to induce virtually all the great experts on health, environment and WTO law to contribute to their Research Handbook on these subjects. The result is undoubtedly an excellent volume that should adorn the bookcase of any and all interested in the important problem of the relation between international rule-making and regulatory autonomy of states in this area of international economic law.Õ Ð Pieter Jan Kuijper, University of Amsterdam, The Netherlands This Handbook provides state-of-the-art analysis by leading authors on the links between the international trade regime and health and environment concerns Ð concerns that make up an increasing proportion of WTO dispute settlement. Research Handbook on Environment, Health and the WTO surveys fields as diverse as climate change mitigation, non-communicable diseases, nanotechnology and public health care. The volume brings to the fore the debates and complexities surrounding these issues and their implications for the international trading system. The Handbook begins in Part I with a survey of general issues that sets a context for the more specific sectorial studies. Part II considers the most pressing issues within health regulation and trade law, whilst Part III is devoted to environmental regulation and its interface with trade law. Part IV looks specifically at aspects of the dispute settlement process and in particular standard of review, and the book concludes in Part V with a consideration of the impact of trade measures on the health and environment regimes of emerging economies. This comprehensive yet concise Handbook will appeal to academics and researchers in international trade law and environmental law, as well as trade law practitioners.

The Age Of Esma

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Author : Niamh Moloney
language : en
Publisher: Bloomsbury Publishing
Release Date : 2018-11-29

The Age Of Esma written by Niamh Moloney and has been published by Bloomsbury Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-29 with Law categories.

Since its establishment in 2011, the European Securities and Markets Authority (ESMA) has become a pivotal actor in EU financial market regulation and supervision. Its burgeoning influence extends from the rule-making process to supervisory convergence/coordination to direct supervision. Reflecting the now critical importance of ESMA to how the EU regulates and supervises financial markets, and with ESMA at an inflection point in its evolution, particularly in light of the Commission's 2017 proposals to reform ESMA and the UK's withdrawal from the EU, The Age of ESMA maps, contextualises, and examines ESMA's role and the implications for EU financial market governance.

Planning Writing And Reviewing Medical Device Clinical And Performance Evaluation Reports Cers Pers

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Author : Joy Frestedt
language : en
Publisher: Elsevier
Release Date : 2024-09-19

Planning Writing And Reviewing Medical Device Clinical And Performance Evaluation Reports Cers Pers written by Joy Frestedt and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-09-19 with Medical categories.

A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. - Identifies and explains data analysis for clinical evaluation of medical devices - Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations - Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing