Eudralex

EudraLex is the European Union's collection of medicines legislation, guidance, and information for human and veterinary use. Maintained by the European Commission with input from the European Medicines Agency, it is publicly available to ensure harmonized regulation across EU member states. The catalogue includes binding regulations and directives as well as non-binding guidelines, organized into volumes and modules that cover core areas such as good manufacturing practice (GMP), good distribution practice (GDP), good laboratory practice (GLP), pharmacovigilance, clinical trials, marketing authorization, and post-approval requirements.

The purpose of EudraLex is to standardize manufacturing, distribution, and post-authorization supervision to safeguard the quality, safety, and efficacy of medicines and to enable the smooth functioning of the EU internal market. It serves as the reference framework for national authorities, pharmaceutical companies, contract manufacturers, and healthcare professionals.

Access to EudraLex is provided through the EU’s EudraLex portal, where documents can be searched and downloaded. Updates occur as EU legislation evolves and as the agencies issue new or revised guidelines. The material is used by regulators and industry to ensure compliance and consistent interpretation across member states.

EudraLex reflects the EU’s ongoing approach to medicines regulation, balancing binding legal requirements with supportive guidelines. It is a living framework that incorporates changes in EU law, agency recommendations, and best practices to maintain high standards for medicinal products across the union.