EudraLex

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v t e

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
• 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

• News on Pharmaceuticals, (European Union)
• EudraLex
• EUR-Lex
• Review of pharmaceutical legislation (EU DG Enterprise and Industry)
• Directorate General Enterprise and Industry (European Commission)