Contract Manufacturing of Medicines
by Magdalen Krekora

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Book Summary Information

Summary of Contract Manufacturing of Medicines

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:
Definition of medicine in different jurisdictions;
Categories of medicines;
Manufacturing and importation regulation in numerous jurisdictions worldwide;
Inspection regimes;
Good manufacturing practice (GMP);
Marketing authorization;
Manufacturing documentation;
Complaints and product recall;
Liability insurance;
Protection of trade secrets;
Data exclusivity and data protection;
Deficiencies and delays;
And 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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• Law
• Intellectual Property > General
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• Family & Health Law > Medical Law & Legislation
• Professional & Technical > Law > Family & Health Law > Medical Law & Legislation
• Intellectual Property > General