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'EudraLex' is the collection of rules and regulations governing medicinal products in the European Union.
EudraLex consists of 10 volumes:

★ Concerning Medicinal Products for Human use:

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★ Volume 1 - Pharmaceutical Legislation.

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★ Volume 2 - Notice to Applicants.

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★ Volume 2A deals with procedures for marketing authorisation.

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★ Volume 2B deals with the presentation and content of the application dossier.

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★ Volume 2C deals with Guidelines.

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★ Volume 3 - Guidelines.

★ Concerning Medicinal Products for human use in clinical trials (investigational medicinal products).

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★ Volume 10 - Clinical trials

★ Concerning Veterinary Medicinal Products:

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★ Volume 5 - Pharmaceutical Legislation.

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★ Volume 6 - Notice to Applicants.

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★ Volume 7 - Guidelines.

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★ Volume 8 - Maximum residue limits.


★ Concerning Medicinal Products for Human and Veterinary use:

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★ Volume 4 - Good Manufacturing Practices

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★ Volume 9 - Pharmacovigilance

★ Miscellaneous:

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★ Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

Contents

Directives

See also

External links

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

See 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

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)