| Document Type
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BL
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| Record Number
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1036012
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| Doc. No
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b790382
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| Title & Author
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Pharmaceutical product licensing : : requirements for Europe /\ editors, A.C. Cartwright and Brian Matthews.
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| Publication Statement
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New York :: Ellis Horwood,, 1991.
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| Series Statement
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Ellis Horwood series in pharmaceutical technology
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| Page. NO
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1 online resource (328 pages) :: illustrations
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| ISBN
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0136628834
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: 0203984005
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: 9780136628835
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: 9780203984000
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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Book Cover; Half-Title; Title; Copyright; Table of Contents; 1 Introduction and history of pharmaceutical regulation; 2 The European Community: its structure, institutions, and regulation; 3 New chemical active substance products: quality requirements; 4 New chemical active substance products: preclinical requirements; 5 New chemical active substance products: clinical requirements; 6 Abridged applications; 7 Drug master files; 8 Radiopharmaceutical products; 9 Medicated devices; 10 Contact lens products and intrauterine contraceptive devices.
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| Abstract
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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 after 1992.
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| Subject
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Drugs-- Law and legislation-- European Economic Community countries.
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| Subject
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Drug Industry-- standards.
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| Subject
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Legislation, Drug-- standards.
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| Subject
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Drugs-- Law and legislation.
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| Subject
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LAW-- International.
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| Subject
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Europe.
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| Subject
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European Economic Community countries.
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| Dewey Classification
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341.7/54756151
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| LC Classification
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KJE6201.P48 1991eb
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| NLM classification
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QV 771P5363 1991
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| Added Entry
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Cartwright, A. C., (Anthony C.),1940-
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Matthews, Brian, (Brian R.)
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