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.

• Vol. 2: Notice to applicants: medicinal products for human use.

• Vol. 3: Guidelines: medicinal products for human use.

• Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use.

• Vol. 5: Pharmaceutical legislation: veterinary medicinal products.

• Vol. 6: Notice to applicants: veterinary medical products.

• Vol. 7. Guidelines: Veterinary medicinal products.

• 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)