European practice library : EC pharmaceutical law
著者
書誌事項
European practice library : EC pharmaceutical law
Chancery Law Publishing, 1992
1st ed.
内容説明・目次
内容説明
The development, manufacture and marketing of pharmaceuticals is a global business - companies in this sector function on a truly international basis and therefore their in-house lawyers and professional advisers must be familiar with the changes and developments that are now taking place in EC law. The pharmaceutical industry is a sector increasingly governed by strict legal restrictions and controls affecting day to day operations. Within Europe, this is taking the form of complex and detailed legislation coming from Brussels as part of the implementation of the Single Market programme. It is at present an area of especially fast moving change in both law and policy. Pharmaceutical companies in Europe are themselves undergoing a major change - in many cases restructuring their production bases, adopting a pan-European approach rather than a purely national one - thus making it all the more important that they understand and have access to the law coming from Brussels. "EC Pharmaceutical Law" is a manual which is designed to provide better use and understanding of this litigation.
It presents the legislation in the first half of the book and then gives detailed commentary in the second half, providing cross references to the legislative texts and the analysis in the first part. "EC Pharmaceutical Law" aims to help the industry protect itself as well as learn about this area of law.
目次
- General principles of EC legislation
- definition of medical product
- authorization and supervision
- research and development - manufacturing
- intellectual property
- pricing
- labelling and package leaflets
- distribution and supply
- marketing
- export/import
- consumer protection
- medical devices
- EC legislation - basic legislation, authorization and supervision, research and development: manufacturing, intellectual property, pricing, labelling and package leaflets, distribution and supply, marketing, parallel imports, medical devices.
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