Guide to EU Pharmaceutical Regulatory Law - Image 1

Price loading...

Wolters Kluwer Guide to EU Pharmaceutical Regulatory Law

Name: Guide to EU Pharmaceutical Regulatory Law
Brand: Wolters Kluwer

International

Price History & Forecast

No Price Data Available

Price history will appear here once data is collected from Amazon.

Price Distribution

No price data available for histogram

Description

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.

Product Specifications

Brand: Wolters Kluwer
Format: paperback
ASIN: 9041169520
Category: Books > Subjects > Business, Finance & Law > Law > International
Domain: Amazon UK
Release Date: 17 February 2017
Listed Since: 19 March 2017

Barcode

No barcode data available

Wolters Kluwer Guide to EU Pharmaceutical Regulatory Law

Price History & Forecast

No Price Data Available

Price Distribution

Description

Product Specifications

Barcode

Similar Products You Might Like

Guide to EU and UK Pharmaceutical Regulatory Law

EU Law of Competition and Trade in the Pharmaceutical Sector (Elgar Competition Law and Practice series)

European Union Health Law

European Trademark Law: Community Trademark Law and Harmonized National Trademark Law

Navigating European Pharmaceutical Law: An Expert's Guide

Contract Manufacturing of Medicines

The Law of Off-label Uses of Medicines: Regulation and Litigation in the EU, UK and USA

European SPCs Unravelled: A Practitioner’s Guide to Supplementary Protection Certificates in Europe

Eu Competition Law: Between Public and Private Enforcement ( International Competition Law Series 55)

Competition and Patent Law in the Pharmaceutical Sector: An International Perspective (International Competition Law, 65)

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

EU Competition Law and Pharmaceuticals (New Horizons in Competition Law and Economics series)

EU Competition Law and Intellectual Property Rights (Elgar Competition Law and Practice series)

Evergreening Patent Exclusivity in Pharmaceutical Products: Supplementary Protection Certificates, Orphan Drugs, Paediatric Extensions and ATMPs

European Regulation of Medical Devices and Pharmaceuticals: Regulatee Expectations of Legal Certainty

Regulatory Protection in the Pharmaceutical and Life Science Industries: Challenges, Opportunities and Ongoing Reform (Elgar Monographs in Intellectual Property Law)

Telecommunication Laws in Europe: Law and Regulation of Electronic Communications in Europe

Competition Law of the European Union

Research Handbook on EU Health Law and Policy (Research Handbooks in European Law series)

EU Law and Healthcare Services: Normative Approaches to Public Health Systems (European Monograph)

Special Protection of Trade Marks with a Reputation under European Union Law

A Practical Guide to National Competition Rules Across Europe: 13 (International Competition Law)

Competition Law and Intellectual Property: A European Perspective ( INternational Competition Law Series 50)

Digital Competition Law in Europe: A Concise Guide