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.
Edited by:
Brian R. Matthews, Anthony C. Cartwright Imprint: Taylor & Francis Ltd Country of Publication: United Kingdom Dimensions:
Height: 246mm,
Width: 174mm,
Spine: 21mm
Weight: 453g ISBN:9780136628835 ISBN 10: 0136628834 Pages: 328 Publication Date:31 May 1991 Audience:
Professional and scholarly
,
General/trade
,
Undergraduate
Format:Hardback Publisher's Status: Active
