EudraLex
You don't need to be Editor-In-Chief to add or edit content to WikiDoc. You can begin to add to or edit text on this WikiDoc page by clicking on the edit button at the top of this page. Next enter or edit the information that you would like to appear here. Once you are done editing, scroll down and click the Save page button at the bottom of the page.
Template:Legislation of the European Union EudraLex is the collection of rules and regulations governing medicinal products in the European Union.
EudraLex consists of 10 volumes:
- Concerning Medicinal Products for Human use:
- Volume 1 - Pharmaceutical Legislation.
- Volume 2 - Notice to Applicants.
- Volume 2A deals with procedures for marketing authorisation.
- Volume 2B deals with the presentation and content of the application dossier.
- Volume 2C deals with Guidelines.
- Volume 3 - Guidelines.
- Concerning Medicinal Products for human use in clinical trials (investigational medicinal products).
- Volume 10 - Clinical trials
- Concerning Veterinary Medicinal Products:
- Volume 5 - Pharmaceutical Legislation.
- Volume 6 - Notice to Applicants.
- Volume 7 - Guidelines.
- Volume 8 - Maximum residue limits.
- Concerning Medicinal Products for Human and Veterinary use:
- Volume 4 - Good Manufacturing Practices
- Volume 9 - Pharmacovigilance
- Miscellaneous:
- Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
Directives
- Directive 65/65/EEC1
- Directive 75/318/EEC
- Directive 75/319/EEC
- Directive 93/41/EEC
- Directive 2001/20/EC
- Directive 2001/83/EC
- Directive 2005/28/EC
See also
- European Union law
- European Union directive
- European Commission
- Directorate-General
- EUR-Lex
- Regulatory requirement
- Regulation of therapeutic goods
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Good Clinical Practice
- European Medicines Agency
- EUDRANET
- EudraVigilance
- Title 21 of the Code of Federal Regulations (USA)
- Drug development
External links
- News on Pharmaceuticals, (European Union)
- EudraLex
- EUR-Lex
- Review of pharmaceutical legislation (EU DG Enterprise and Industry)
- Directorate General Enterprise and Industry (European Commission)
 | This health-related article is a stub. You can help WikiDoc by expanding it. |
Acknowledgement and Attribution Regarding Sources of Content
Some of the initial content on this page may be incorporated in part from copyleft sources in the public domain including wikis such as Wikipedia and AskDrWiki. Drug information for patients came from the The National Library of Medicine. Infectious disease information may have come from the Centers for Disease Control (CDC). Differential Diagnoses are drawn from clinicians as well as an amalgamation of 3 sources: 1.The Disease Database; 2. Kahan, Scott, Smith, Ellen G. In A Page: Signs and Symptoms. Malden, Massachusetts: Blackwell Publishing, 2004:3; 3. Sailer, Christian, Wasner, Susanne. Differential Diagnosis Pocket. Hermosa Beach, CA: Borm Bruckmeir Publishing LLC, 2002:7 .
