1st Edition
Pharmaceutical Product Licensing Requirements for Europe
328 Pages
by
CRC Press
328 Pages
by
CRC Press
Also available as eBook on:
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.
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
Biography
Cartwright, A. C.; Cartwright, A. C.
