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Pharmaceutical Product Licensing - Requirements for Europe (Hardcover)
Loot Price: R3,112
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Pharmaceutical Product Licensing - Requirements for Europe (Hardcover)
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All medicinal products have to be licensed before marketing in any
of the EEC, Nordic and EFTA countries. This book provides a
systematic account of the major technical, administrative and legal
requirements for registering a product in any of the national
markets within the EEC, using the existing procedures, with
guidance as to how these procedures are likely to change with the
creation of a single European market in pharmaceuticals after 1992.
The book should be of value to the pharmaceutical industry and
their suppliers (the bulk excipient and active substance
manufacturers); to government regulatory agencies; and to members
of many technical, professional, scientific, medical and regulatory
societies and organizations concerned directly and indirectly with
medicinal products - particularly to members of the pharmaceutical
and medical professions. There is an enormous interest in this
subject in the EEC, the USA and Japan due to the likelihood of the
creation in 1992 of a single market with some 350,000 patients.
General
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