Pharmaceutical Product Licensing

Requirements for Europe

Brian R. Matthews, Anthony C. Cartwright

$210

Hardback

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English

Taylor & Francis Ltd
31 May 1991

Licensing, gaming & club law; Pharmaceutical technology

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

Introduction and history of licensing requirements; new active substance products - quality requirements; new active substance products - pre- clinical requirements; new active substance products - clinical requirements; abridged applications; drug master files; biological products; radiopharmaceutical products; medicated devices; contact lens products; experts and expert reports; defects in applications - analysis; CPMP and its activities; CPMP multi-state procedure; high EFTA EEC

Cartwright, A. C.; Cartwright, A. C.