EU Pharmaceutical & Public Health Legislation (Consolidated)

European Union · aktualizacje: weekly · eu-pharmaceutical-law

Consolidated EU pharmaceutical and public-health legislation — every consolidated version of every regulation, directive and decision in force that EUR-Lex itself files under directory code 13.30.15 Proprietary medicinal products or 15.30 Health protection, in English, taken from the Publications Office’s keyless CELLAR repository in the publisher’s own Formex XML. Measured on 24 August 2026: 212 consolidated versions of 68 acts — Directive 2001/83/EC and Regulation (EC) No 726/2004, the Clinical Trials Regulation and Directive, the Orphan, Paediatric and Advanced Therapy Regulations, the falsified-medicines safety features, the veterinary medicinal products Regulation, the blood, tissues and substances-of-human-origin standards, cross-border healthcare, the ECDC and the EMA’s reinforced role among them, together with what the publisher files under health protection beside them, such as the organic-product import rules. The Medical Devices and In Vitro Diagnostic Regulations are filed under consumer health and safety, a code that also carries food law, GMO authorisations and product-safety acts, and are not here. One record is one article or one annex, so a provision can be cited and retrieved on its own. Identity carries the date: a record’s key is the consolidated CELEX number, which names the act and the date its text was in force from, so the same article across successive consolidations is a series of records a buyer can diff. Each record states the act and its title, the consolidation date and layer, the ELI, whether a later consolidated version of the same act exists in the release, the Part/Title/Chapter it sits under, every amending act folded into the consolidation, and — read off the publisher’s own consolidation marks — which amending act changed that particular provision. Formulae published as images are omitted and counted. The directory codes that define the dataset ride on every record, so an act the publisher files under two of these datasets says so in both. Reuse rests on Commission Decision 2011/833/EU, and the source acknowledgement, the statement of what was changed and the notice that consolidated texts have no legal effect ride on every record. Every record carries its source URL, fetch timestamp, HTTP status and the SHA-256 of both the raw response and the extracted record. Every release ships a manifest with every file’s SHA-256 and a Merkle root over every chunk hash, which the buyer can recompute from the downloaded files. record_id and chunk_id are stable across releases. Personal data is screened out inside the pipeline before any hash is computed.