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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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.
Pharmaceutical product licensing.
0136628834
Drugs-- Law and legislation-- European Economic Community countries.