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)