EudraLex

EudraLex is the collection of rules and regulations governing medicinal products in the European Union. It is a comprehensive system that ensures the quality, safety, and efficacy of medicines intended for human and veterinary use within the EU.

Overview

EudraLex consists of 10 volumes, each covering a specific area of pharmaceutical law. The volumes are continuously updated to reflect changes in the regulatory environment. The rules and regulations are binding on all Member States of the European Union.

Volumes

The ten volumes of EudraLex are:

1. Volume 1: Pharmaceutical Legislation for Medicinal Products for Human Use
2. Volume 2: Notice to Applicants and Regulatory Guidelines for Medicinal Products for Human Use
3. Volume 3: Guidelines for Medicinal Products for Human Use
4. Volume 4: Good Manufacturing Practice (GMP) Guidelines
5. Volume 5: Pharmaceutical Legislation for Medicinal Products for Veterinary Use
6. Volume 6: Notice to Applicants and Regulatory Guidelines for Medicinal Products for Veterinary Use
7. Volume 7: Guidelines for Medicinal Products for Veterinary Use
8. Volume 8: Maximum Residue Limits
9. Volume 9: Pharmacovigilance
10. Volume 10: Clinical Trials Guidelines

Compliance

Compliance with EudraLex is mandatory for all pharmaceutical companies operating within the EU. Non-compliance can result in penalties, including fines and revocation of marketing authorisation.

See Also

• European Medicines Agency
• Good Manufacturing Practice
• Pharmacovigilance
• Clinical Trials