EudraLex

EudraLex是歐盟一系列關於藥物規則和規章。

分冊
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

*有關人類用藥物的臨床試驗
**第10冊 - 臨床試驗

*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

*有關人畜共用的藥物：
**第4冊 - 良好生產規範
**第9冊 -

*其他：
**Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

指令
參見
*歐盟法律
*歐盟指令
*歐洲理事會
*
*良好藥品臨床試驗規範
*歐洲藥物管理局
*
*
*（美國）

參考資料

• 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

• [https://web.archive.org/web/20100413104348/http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm News on Pharmaceuticals], (European Union)
• [http://ec.europa.eu/health/documents/eudralex/index_en.htm EudraLex]
• [http://eur-lex.europa.eu/en/index.htm EUR-Lex]
• [https://web.archive.org/web/20061021073704/http://ec.europa.eu/enterprise/pharmaceuticals/review/index.htm Review of pharmaceutical legislation] (EU DG Enterprise and Industry)
• [https://web.archive.org/web/20130421021032/http://ec.europa.eu/enterprise/index_en.htm Directorate General Enterprise and Industry] (European Commission)