EU Legislation - Eudralex

The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing medicinal products in the European Union".

• Volume 1 - EU pharmaceutical legislation for medicinal products for human use
• Volume 5 - EU pharmaceutical legislation for medicinal products for veterinary use

The basic legislation is supported by a series of guidelines that are also published in the following volumes of "The rules governing medicinal products in the European Union":

• Volume 2 - Notice to applicants and regulatory guidelines for medicinal products for human use
• Volume 3 - Scientific guidelines for medicinal products for human use
• Volume 4 - Guidelines for good manufacturing practices for medicinal products for human and veterinary use
• Volume 6 - Notice to applicants and regulatory guidelines for medicinal products for veterinary use
• Volume 7 - Scientific guidelines for medicinal products for veterinary use
• Volume 8 - Maximum residue limits
• Volume 9 - Guidelines for pharmacovigilance for medicinal products for human and veterinary use
• Volume 10 - Guidelines for clinical trial

Medicinal products for paediatric use, orphan, herbal medicinal products and advanced therapies are governed by specific rules.

 

• Eudralex on CD