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| Author | : Brian R. Matthews |
| Publisher | : CRC Press |
| Total Pages | : 383 |
| Release | : 1991-05-31 |
| Genre | : Medical |
| ISBN | : 113499494X |
Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.
| Author | : Sandeep Narayan Patil, PMP |
| Publisher | : Notion Press |
| Total Pages | : 206 |
| Release | : 2021-05-25 |
| Genre | : Medical |
| ISBN | : 1638736723 |
This is the second book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book mainly discusses launch of drug products in EU market which are manufactured in countries like India or china by supplier manufacturer. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.
| Author | : Michael Kaeding |
| Publisher | : Springer |
| Total Pages | : 136 |
| Release | : 2017-02-20 |
| Genre | : Political Science |
| ISBN | : 3658172762 |
This book is open access under a CC BY 4.0 license. The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level.
| Author | : John J. Tobin |
| Publisher | : John Wiley & Sons |
| Total Pages | : 341 |
| Release | : 2023-08-29 |
| Genre | : Science |
| ISBN | : 3527688986 |
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 | : Thomas Brendler |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2009 |
| Genre | : Materia medica, Vegetable |
| ISBN | : 9780853697848 |
This publication seeks to Answer all questions most frequently asked by manufacturers and provides full guidance on license applications. The procedure for licensing herbal products in the UK and European Union is changing. The Traditional Herbal Medicinal Product Directive (THMPD) was implemented in the UK in 2005 and allows herbal products to be registered under medicines law. By 2011, every pharmaceutical company manufacturing herbal medicines that are sold in the UK and European Union must have obtained a market authorization. As a manufacturer of such products, you need to ask the following: what type of herbal products are you manufacturing?; would your product comply with the regulations?; are you required to register your herbal products?; what type of registration or license do you need?; what evidence and manufacturing data do you need to provide?; what are the packaging and leaflet requirements for your product?; and, most importantly: how do you apply for a license? It also provides full guidance on product registration, including step-by-step guidance on completing the application forms, information on to whom the forms should be submitted and what costs are involved. All the official legal guidelines and forms are included within the guide. This text is easy and practical to use, guiding you and your company through the initial decision-making process to registering your herbal products.
| Author | : Sally Shorthose |
| Publisher | : Kluwer Law International B.V. |
| Total Pages | : 589 |
| Release | : 2017-02-17 |
| Genre | : Law |
| ISBN | : 9041170022 |
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 | : A. C. Cartwright |
| Publisher | : CRC Press |
| Total Pages | : |
| Release | : 1991-05-31 |
| Genre | : Medical |
| ISBN | : 9781134994953 |
Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.
| Author | : C. Lumley |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 182 |
| Release | : 2012-12-06 |
| Genre | : Medical |
| ISBN | : 9400917880 |
Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 318 |
| Release | : 2011-10-25 |
| Genre | : Medical |
| ISBN | : 0309212456 |
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
| Author | : Christine Godt |
| Publisher | : Nomos Verlagsgesellschaft |
| Total Pages | : 0 |
| Release | : 2010 |
| Genre | : Compulsory licensing of patents |
| ISBN | : 9783832942809 |
This book discusses the policies of price differentiation for life saving drugs in Europe. It documents two different things: a legal expert opinion and the contributions to a conference held in Bremen in October 2008. The point of departure is the question of whether or not compulsory licenses can legally be utilized for improving access to essential medicines in countries with a small GDP, particularly affected by specific diseases, exemplified in Bulgaria, Romania, and Estonia. Central to the legal opinion are the market effects of a Member State's compulsory license for the internal market. A central finding is that the effects will depend on the type of the compulsory license. In line with the Pharmon-doctrine of the European Court of Justice, the exhaustion of patent rights is, in principle, limited to the territory of the issuing State. However, the expertise identifies several constellations under which the marketing will result into Community wide exhaustion. The contributions to the conference discuss these findings and position the very question into the broader European debate on pricing policies for pharmaceuticals and the international debate about access to essential medicines.
