Pharmaceutical product licensing : requirements for Europe
Author(s)
Bibliographic Information
Pharmaceutical product licensing : requirements for Europe
（Ellis Horwood series in pharmaceutical technology）
Ellis Horwood, 1991
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Note
Includes bibliographical references and index
Description and Table of Contents
Description
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.
Table of 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
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