EudraLex


EudraLex

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
*Directive 75/318/EEC
*Directive 75/319/EEC
*Directive 93/41/EEC
*Directive 2001/20/EC
*Directive 2001/83/EC
*Directive 2005/28/EC

ee also

*European Union law
*European Union directive
*European Commission
*Directorate-General
*EUR-Lex
*Regulatory requirement
*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 9282820327
** Vol. 2: Notice to applicants: medicinal products for human use. ISBN 011975780X
** Vol. 3: Guidelines: medicinal products for human use. ISBN 9282824365
** Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 9282820297
** Vol. 5: Pharmaceutical legislation: veterinary medicinal products. ISBN 9282820378
** Vol. 6: Notice to applicants: veterinary medical products. ISBN 0119853515
** Vol. 7. Guidelines: Veterinary medicinal products. ISBN 0119853663
* 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

* [http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm News on Pharmaceuticals] , (European Union)
* [http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/ EudraLex]
* [http://eur-lex.europa.eu/en/index.htm EUR-Lex]
* [http://ec.europa.eu/enterprise/pharmaceuticals/review/index.htm Review of pharmaceutical legislation] (EU DG Enterprise and Industry)
* [http://ec.europa.eu/enterprise/index_en.htm Directorate General Enterprise and Industry] (European Commission)


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