Pharmaceutical Product Licensing: Requirements for Europe

ISBN-13: 9780136628835 / Angielski / Twarda / 1991 / 328 str.

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

Opis

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.

Spis treści

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

O autorze

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