EudraLex

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.
• *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

  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