What it is
EudraLex is the European Commission’s collection of rules for medicinal products. Its volumes mix binding law and nonbinding guidance, which is the single most important thing to get right when you feed it to AI.
| Volume | Covers | Type | Status |
|---|---|---|---|
| 1 | Pharmaceutical legislation, human | Legislation | Current |
| 2 | Notice to applicants, human | Guidelines | Current |
| 3 | Scientific guidelines, human | Guidelines | Current |
| 4 | GMP, human and veterinary | Guidelines | Veterinary use only until 15 July 2026 |
| 5 | Pharmaceutical legislation, veterinary | Legislation | Current |
| 6 | Notice to applicants, veterinary | Guidelines | Current |
| 7 | Scientific guidelines, veterinary | Guidelines | No longer applies |
| 8 | Maximum residue limits | Guidelines | No longer applies |
| 9 | Pharmacovigilance | Guidelines | No longer applies |
| 10 | Clinical trials | Guidelines | Current |
Recent change. For veterinary medicines, Volume 4 applied only until 15 July 2026. Veterinary GMP now follows Regulation (EU) 2019/6 and Implementing Regulations (EU) 2025/2091 and 2025/2154, both applicable from 16 July 2026. The old EudraBook (May 2015) is no longer current.
Specific rules also apply to paediatric, orphan, herbal, and advanced therapy medicines.
Where to find it
The European Commission’s EudraLex page links to every volume. Much scientific guidance in Volume 3 is hosted by EMA (see the EMA guidelines article).
Reuse terms
Commission content is generally licensed under CC BY 4.0 unless otherwise indicated. Reuse, including commercial use, is allowed with credit and an indication of changes. Logos, third-party material, and content covered by industrial property rights are excluded. Legislation in Volumes 1 and 5 is also on EUR-Lex, where only the Official Journal is authentic.
Using EudraLex in AI and RAG
- Tag every document as “legislation” or “guideline” following the volume table above.
- Mark Volumes 7, 8, and 9 as no longer applicable, or exclude them.
- Split Volume 4 by scope: human GMP current; veterinary GMP superseded from 16 July 2026.
- Pull legislation from EUR-Lex with CELEX and dates, and use EudraLex as the navigation layer.
- Keep CC BY attribution in outputs.
- Refresh quarterly, since the Commission lists updates on each volume page.
Common mistakes
- Treating a guideline volume as binding law.
- Answering veterinary GMP questions from Volume 4 after 15 July 2026.
- Indexing Volume 9 pharmacovigilance text as current.
- Relying on the 2015 EudraBook.
Checklist
- Legislation and guideline tags applied
- Obsolete volumes excluded or labeled
- Veterinary GMP scope updated
- Legislation linked to EUR-Lex originals
- Attribution in outputs
- Refresh schedule set
How AskDona helps
AskDona keeps EudraLex volumes labeled by type and status, so when you check an SOP or dossier section, each finding says whether it rests on legislation or guidance and which version.
Run a sample EudraLex dossier check
AskDona shows the evidence; your regulatory team decides.
Editor’s note. This article is general information, not legal advice. The “CC BY 4.0, conditional use” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
Is EudraLex legally binding? Volumes 1 and 5 contain legislation. The other volumes are guidelines.
Does Volume 4 still cover veterinary products? Only until 15 July 2026. Veterinary GMP now follows Regulation 2019/6 and its 2025 implementing regulations.
Can I use EudraLex in a commercial AI tool? Generally yes under CC BY 4.0, with credit and a note of changes.
Which volumes are obsolete? Volumes 7, 8, and 9 no longer apply.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| European Commission: EudraLex | Volume list, types, obsolete volumes, veterinary Volume 4 end date |
| European Commission: EudraLex Volume 4 | Veterinary implementing regulations applicable from 16 July 2026 |
| European Commission legal notice | CC BY 4.0 reuse and exclusions |
| EUR-Lex legal notice | OJ authenticity |