EudraLex
維基百科,自由的百科全書
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 - 藥物安全(英語:Pharmacovigilance)
- 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
- EUR-Lex(英語:EUR-Lex)
- 良好藥品臨床試驗規範
- 歐洲藥物管理局
- 歐盟藥物管理機構網絡(英語:EUDRANET)
- 歐盟藥物警戒系統(英語:EudraVigilance)
- 聯邦規章典集第21篇(英語:Title 21 of the Code of Federal Regulations)(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
外部連結
- News on Pharmaceuticals, (European Union)
- EudraLex(頁面存檔備份,存於網際網路檔案館)
- EUR-Lex(頁面存檔備份,存於網際網路檔案館)
- Review of pharmaceutical legislation (EU DG Enterprise and Industry)
- Directorate General Enterprise and Industry (European Commission)