EudraLex
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EudraLex is the collection of rules and regulations governing medicinal products in
the European Union.
Contents
1Volumes
2Directives
3See also
4References
5External links
Volumes[edit]
EudraLex consists of 10 volumes:
Concerning Medicinal Products for Human use:
o Volume 1 - Pharmaceutical Legislation.
o 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.
o Volume 3 - Guidelines.
Concerning Medicinal Products for human use in clinical trials (investigational
medicinal products).
o Volume 10 - Clinical trials.
Concerning Veterinary Medicinal Products:
o Volume 5 - Pharmaceutical Legislation.
o Volume 6 - Notice to Applicants.
o Volume 7 - Guidelines.
o Volume 8 - Maximum residue limits.
Concerning Medicinal Products for Human and Veterinary use:
o Volume 4 - Good Manufacturing Practices.
o Volume 9 - Pharmacovigilance.
Miscellaneous:
o Guidelines on Good Distribution Practice of Medicinal Products for Human
Use (94/C 63/03)
Directives[edit]
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[edit]
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[edit]
Eudralex,The Rules Governing Medicinal Products in the European Union,
European Communities Commission. Directorate-General for Industry,
Pharmaceuticals and Cosmetics.
o Vol. 1: Pharmaceutical legislation: medicinal products for human
use. ISBN 92-828-2032-7
o Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-
975780-X
o Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-
5
o Vol. 4: Good manufacturing practices: medicinal products for human and
veterinary use. ISBN 92-828-2029-7
o Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 92-
828-2037-8
o Vol. 6: Notice to applicants: veterinary medical products. ISBN 0-11-
985351-5
o 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[edit]
News on Pharmaceuticals, (European Union)
EudraLex
EUR-Lex
Review of pharmaceutical legislation (EU DG Enterprise and Industry)
Directorate General Enterprise and Industry (European Commission)
