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Contract Manufacturing of Medicines by Magdalena Krekora

Contract Manufacturing of Medicines

By Magdalena Krekora


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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:

• 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.

Publish Date 01/28/2008
Product Line Kluwer Law International
ISBN 9789041126429
SKU 10057522-0001
Table of Contents

Preface, Chapter 1 Outsourcing of Manufacturing in the Pharmaceutical Industry Chapter 2 Basic Definitions Chapter 3 Manufacturing and Importation of Medicines – Legal Aspects Chapter 4 The Good Manufacturing Practice Chapter 5 Contract Manufacturing – Basic Requirements Chapter 6 Regulatory Affairs Chapter 7 Quality Assurance – Basic Requirements Chapter 8 The Role of the Authorized/Qualified Person Chapter 9 Liability for Defective Products Chapter 10 Confidentiality Chapter 11 Intellectual Property Chapter 12 Deliveries – Terms and Conditions Chapter 13 Disputes between the Parties Chapter 14 Taxes, Duties and Additional costs Chapter 15 Manufacturing of API Chapter 16 Conclusions Appendix, Bibliography, Index