EHDS, Article 99, NO

Member States shall lay down the rules on penalties applicable to infringements of this Regulation, in particular for infringements which are not subject to administrative fines pursuant to Articles 63 and 64, and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 26 March 2027, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Member States shall take into account the following non-exhaustive and indicative criteria for the imposition of penalties for infringements of this Regulation, where appropriate:

(a)

the nature, gravity, scale and duration of the infringement;

(b)

any action taken by the infringer to mitigate or remedy the damage caused by the infringement;

(c)

any previous infringements by the infringer;

(d)

the financial benefits gained or losses avoided by the infringer due to the infringement, insofar as such benefits or losses can be reliably established;

(e)

any other aggravating or mitigating factors applicable to the circumstances of the case;

(f)

the infringer’s annual turnover in the Union in the preceding financial year.

Official source

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Source: NovaCopilot