My bookmarksSign up free

Regulation (EU) 2025/2455 CHAPTER IX — ENFORCEMENT AND PENALTIES

Article 30–Article 31 · 2 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Cooperation on compliance

Article 30

The Agencies shall cooperate with Member States’ enforcement authorities and exchange information on the compliance by business operators and laboratories with the obligation to notify studies in accordance with Article 26.

Penalties for non-compliance

Article 31

1.   Member States shall introduce penalties for non-compliance by business operators and laboratories with the obligations laid down in Article 26, and shall take all necessary measures to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. 2.   Member States shall notify the Commission of those rules and of those measures by 2 November 2027, and shall notify the Commission without delay of any subsequent amendment thereto.

Back to Regulation (EU) 2025/2455 — full text

Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next