The Rules Governing Medicinal Products in the European Union

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”. The basic legislation is supported by a series of guidelines that are also published in the “The rules governing medicinal products in the European Union”.

Basic Legislation:

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

Supporting guidelines:

• 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.