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Contract Manufacturing of Medicines
By:Magdalena Krekora
Published on 2008-01-01 by Kluwer Law International B.V.

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\u0095 definition of and\u0091medicineand\u0092 in different jurisdictions; and\u0095 categories of medicines; and\u0095 manufacturing and importation regulation in numerous jurisdictions worldwide; and\u0095 inspection regimes; and\u0095 good manufacturing practice (GMP); and\u0095 marketing authorization; and\u0095 manufacturing documentation; and\u0095 complaints and product recall; and\u0095 liability insurance; and\u0095 protection of trade secrets; and\u0095 data exclusivity and data protection; and\u0095 deficiencies and delays; and and\u0095 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.

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Book ID of Contract Manufacturing of Medicines's Books is xOA7ifLDbVcC, Book which was written byMagdalena Krekorahave ETAG "Hgz+HvPoRus"

Book which was published by Kluwer Law International B.V. since 2008-01-01 have ISBNs, ISBN 13 Code is 9789041126429 and ISBN 10 Code is 9041126422

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