EudraLex is the collection of rules and regulations governing medicinal products in the European Union.
Volumes
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, requires prior approval for marketing of proprietary medicinal products
- Directive 75/318/EEC, clarifies requirements of 65/65/EEC1 and requires member states to enforce them
- Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts
- Directive 93/41/EEC, establishes the European Agency for the Evaluation of Medicinal Products
- Directive 2001/20/EC, defines rules for the conduct of clinical trials
- Directive 2001/83/EC
- Directive 2005/28/EC, defines Good Clinical Practice for design and conduct of clinical trials
See also
- European Union law
- European Union directive
- European Commission
- Directorate-General
- EUR-Lex
- 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
References
- 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
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)