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Pharmaceutical product licensing : requirements for Europe

Author: A C Cartwright; Brian Matthews
Publisher: New York : Ellis Horwood, ©1991.
Series: Ellis Horwood series in pharmaceutical technology.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:

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,  Read more...

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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: A C Cartwright; Brian Matthews
ISBN: 9780136628835 0136628834
OCLC Number: 23732380
Description: 328 pages : illustrations.
Contents: 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
Series Title: Ellis Horwood series in pharmaceutical technology.
Responsibility: editors, A.C. Cartwright and Brian R. Matthews.

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