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Contract manufacturing of medicines / by Magdalena Krekora.
2008
F 630 KRE.C
Available at WIPO Library
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详细记录
题名
Contract manufacturing of medicines / by Magdalena Krekora.
版本
Third edition.
描述
xiv, 445 pages ; 24 cm.
国际图书编号
9789041126429
9041126422
9041126422
替代索书号
F 630 KRE.C
摘要
Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of s.
书目等附注
Includes bibliographical references (pages 433-442) and index.
格式化内容附注
1. Outsourcing of manufacturing in the pharmaceutical industry; 2. Basic definitions; 3. Manufacturing and importation of medicines - legal aspects; 4. The good manufacturing practice; 5. Contract manufacturing - basic requirements; 6. Regulatory affairs; 7. Quality assurance - basic requirements; 8. The role of the authorized/qualified person; 9. Liability for defective products; 10. Confidentiality; 11. Intellectual property; 12. Deliveries - terms and conditions; 13. Disputes between the parties; 14. Taxes, duties and additional costs; 15. Manufacturing of API; 16. Conclusions.
丛编
Kluwer law international.
出版信息
Alphen aan den Rijn, Netherlands : Kluwer Law International, c2008.
语言
eng
记录出处