What Commission Implementing Regulation (EU) 2025/1467 laying down technical specifications for the EU SoHO Platform to exchange information concerning substances of human origin requires
This Commission Implementing Regulation (EU) 2025/1467 of 18 July 2025 lays down rules for the application of Regulation (EU) 2024/1938 as regards the technical specifications for the EU SoHO Platform. The EU SoHO Platform is a digital platform to facilitate efficient and effective exchange of information concerning substances of human origin (SoHO) activities in the Union. The Regulation defines actors, authorised actors, and local administrators; sets requirements for platform maintenance, accessibility via a dedicated website, and minimum modules and functionalities as listed in Annex I. Access is controlled via authentication and authorisation tools, with local administrators managing access rights. Personal data, including data concerning health, pseudonymised when necessary, is processed for obligations under Article 76(1)-(5) of Regulation 2024/1938. Categories of personal data and retention periods are specified in Annex II: up to 5 years after an authorised actor loses capacity, up to 30 years after donation or human application for safety/quality data, and up to 15 years for SoHO Coordination Board members. The general public can view publicly available information without registration. Member States, SoHO competent authorities, the SoHO Coordination Board, the Commission, and SoHO entities must use English for information exchanged when appropriate. The Regulation applies from 7 August 2027.
Pillar: Legal & IP Sovereignty · Authority: European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R1467
SHA-256 integrity: b955f7a491970187c3b8871e44350b18c28f0c4e56e5c9488cade364923e3c61
Primary Citations — 7 traced to source
- Commission Implementing Regulation (EU) 2025/1467 of 18 July 2025, Article 1(1) - definition of actor
- Commission Implementing Regulation (EU) 2025/1467 of 18 July 2025, Article 2(1) - Commission shall maintain and optimise the EU SoHO Platform
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