Information About

Eudralex

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:

--- 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 Trial s (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 Practice s

--- 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

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)