EudraLex
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| 歐盟政府与政治 系列条目 |
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歐洲聯盟主题 |
分冊
[编辑]EudraLex共分10冊：
- 有關人類用的藥物分冊：
- 第1冊 - 製藥法例
- 第2冊 - Notice to Applicants.
- 第2A冊 deals with procedures for marketing authorisation.
- 第2B冊 deals with the presentation and content of the application dossier.
- 第2C冊 deals with Guidelines.
- 第3冊 - 指引
- 有關動物用的藥物：
- 第5冊 - 製藥法例
- 第6冊 - Notice to Applicants.
- 第7冊 - 指引
- 第8冊 - 最大殘留限制
- 其他：
- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
指令
[编辑]參見
[编辑]參考資料
[编辑]- Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics.
- Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7
- Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X
- Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5
- Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828-2029-7
- Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 92-828-2037-8
- Vol. 6: Notice to applicants: veterinary medical products. ISBN 0-11-985351-5
- Vol. 7. Guidelines: Veterinary medicinal products. ISBN 0-11-985366-3
- Markus Hartmann and Florence Hartmann-Vareilles, The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research?, PLoS Clin Trials. 2006 June; 1(2): e13
外部链接
[编辑]- News on Pharmaceuticals, (European Union)
- EudraLex（页面存档备份，存于互联网档案馆）
- EUR-Lex（页面存档备份，存于互联网档案馆）
- Review of pharmaceutical legislation (EU DG Enterprise and Industry)
- Directorate General Enterprise and Industry (European Commission)
