Pharmaceutical Product Licensing

Requirements for Europe

Brian R. Matthews, Anthony C. Cartwright (Herausgeber)

Buch | Hardcover

328 Seiten

1991
Taylor & Francis Ltd (Verlag)
978-0-13-662883-5 (ISBN)

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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.

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

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

Erscheint lt. Verlag	31.5.1991
Verlagsort	London
Sprache	englisch
Maße	174 x 246 mm
Gewicht	453 g
Themenwelt	Recht / Steuern ► EU / Internationales Recht
	Recht / Steuern ► Wirtschaftsrecht
	Technik
ISBN-10	0-13-662883-4 / 0136628834
ISBN-13	978-0-13-662883-5 / 9780136628835
Zustand	Neuware