Contract Manufacturing of Medicines - Image 1

Price loading...

Kluwer Law International Contract Manufacturing of Medicines

Name: Contract Manufacturing of Medicines
Brand: Kluwer Law International

Law

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

Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: and#8226; definition of and#8216;medicineand#8217; in different jurisdictions; and#8226; categories of medicines; and#8226; manufacturing and importation regulation in numerous jurisdictions worldwide; and#8226; inspection regimes; and#8226; good manufacturing practice (GMP); and#8226; marketing authorization; and#8226; manufacturing documentation; and#8226; complaints and product recall; and#8226; liability insurance; and#8226; protection of trade secrets; and#8226; data exclusivity and data protection; and#8226; deficiencies and delays; and and#8226; recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.

Product Specifications

Brand: Kluwer Law International
Format: hardcover
ASIN: 9041126422
Category: Books > Subjects > Business, Finance & Law > Law
Domain: Amazon UK
Release Date: 08 January 2008
Listed Since: 08 January 2008

Barcode

No barcode data available

Kluwer Law International Contract Manufacturing of Medicines

Price History & Forecast

No Price Data Available

Price Distribution

Description

Product Specifications

Barcode

Similar Products You Might Like

International Contracting: Law and Practice: Law and Practice

Springer - Contract Research and Development Organizations Book

The Law and Ethics of the Pharmaceutical Industry

International Licensing Agreements: IP, Technology Transfer and Competition Law

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

Guide to EU Pharmaceutical Regulatory Law

Guide to EU and UK Pharmaceutical Regulatory Law

Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow’s World

Basics of Pharmaceutical Manufacturing and Quality Operations: A Comprehensive Guide

The Global Pharmaceutical Industry: The Demise and the Path to Recovery (Routledge Advances in Management and Business Studies)

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

Wiley - Continuous Manufacturing of Pharmaceuticals Book

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

Contract Research and Development Organizations-Their History, Selection, and Utilization

Edward Elgar - Intellectual Property, Pharmaceuticals and Public Health

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Intellectual Property Law and Access to Medicines: TRIPS Agreement, Health, and Pharmaceuticals (Law, Development and Globalization)

Liability for Products in a Global Economy: 26 (Comparative Law Yearbook Series Set)

Globalization and Animal Law: Comparative Law, International Law and International Trade (Global Trade Law, 32)

Pharmaceuticals, Corporate Crime and Public Health

Trade Sanctions and International Sales: An Inquiry into International Arbitration and Commercial Litigation

Contract Law in India

Pharmaceutical Supply Chain: Drug Quality and Security Act