Contract Manufacturing of Medicines

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.