On 22 July 2025, the European Commission adopted Regulation (EU) 2025/1466, which updates Commission Implementing Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities (pursuant to Regulation (EC) No 726/2004 and Directive 2001/83/EC).
Entry into force: 20 days after publication, i.e. on 12 August 2025.
Date of application: from 12 February 2026, except for the provisions of Article 1 points 7 and 9, which apply from the date of entry into force.
Full text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32025R1466&qid=1736153699001
The amendments concern the following articles:
Article 2 — description of the organisational structure of MAH
Article 4 (paragraph 3) — documentation of significant deviations
Article 6 (paragraphs 3–4) — subcontractor contract requirements
Article 11 (paragraph 1(d)) — modification of requirements
Article 13 — risk-based audits of third parties
Article 17 (paragraph 1) — common audit standards
Article 18 (paragraphs 2–3) — obligations when to monitoring the Eudravigilance database
Article 19 (paragraph 1, third subparagraph) — signals related to ADR are taken into account
Article 21 (paragraphs 3–4; paragraph 2 repealed) — reorganisation of signal validation
Article 23 (second subparagraph) — EMA support for Eudravigilance users
Article 25 (paragraphs 1–2) — harmonised terminology
Article 26 (paragraph 1a, paragraph 2) — new formats and standards
Article 28 (paragraph 1, second subparagraph; paragraph 3, points b, i) — requirements for submitting ADR reports
Article 34 (paragraph 3) — requirements for PSUR content
Article 36 (new paragraph 5) — registration of PASS study within 1 month after completion
Annex II – Part III, point 16.5 — risk minimisation measures
Annex III – Section 3, point 5(f) — study milestones
The changes will be reflected in NaviReg content on the date they become applicable.