Forms of financial penalty and maximum amounts
1. Where, following the procedure provided for in Subsection 1, the Commission finds that the marketing authorisation holder has committed, intentionally or negligently, an infringement as referred to in Article 1, it may adopt a decision imposing a fine not exceeding 5 % of the holder’s Community turnover in the preceding business year.
2. Where the marketing authorisation holder has not terminated the infringement, the Commission may, in the decision referred to in paragraph 1, impose periodic penalty payments per day not exceeding 2,5 % of the holder’s average daily Community turnover in the preceding business year.
Periodic penalty payments may be imposed for a period running from the date of notification of that decision until the infringement has been brought to an end.
3. For the purposes of paragraphs 1 and 2, the preceding business year refers to the business year preceding the date of the decision referred to in paragraph 1.
Decision
1. The decision provided for in Article 16 shall be based exclusively on grounds on which the marketing authorisation holder has been able to comment.
2. The Commission shall inform the marketing authorisation holder of the judicial remedies available.
3. The Commission shall communicate the adoption of the decision to the Agency and to the Member States.
4. When publishing details of its decision in accordance with the second subparagraph of Article 84(3) of Regulation (EC) No 726/2004, the Commission shall have regard to the legitimate interest of marketing authorisation holders and other persons in the protection of their business secrets.
Principles governing the application and quantification of financial penalties
1. In determining whether to impose a financial penalty and in determining the appropriate financial penalty, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness.
2. In each case, the Commission shall take into consideration, where relevant, the following circumstances:
(a)
the seriousness and the effects of the infringement, and, in particular, the following:
(i)
the way in which the infringement adversely affects the rights, safety or well-being of patients;
(ii)
its effects on animal health and welfare and the impact on animal owners;
(iii)
whether it poses or could pose a risk to public health, animal health or the environment;
(iv)
the gravity of the infringement in relation to public health, animal health and the environment;
(b)
on the one hand, the good faith of the marketing authorisation holder in the interpretation and fulfilment of the obligations connected with marketing authorisations granted in accordance with Regulation (EC) No 726/2004 or, on the other hand, any evidence of wilful deceit on the part of the marketing authorisation holder;
(c)
on the one hand, the degree of diligence and cooperation shown by the marketing authorisation holder in the detection of the infringement and the application of corrective action, or during the course of the infringement procedure or, on the other hand, any obstruction by the marketing authorisation holder of the detection of an infringement and the conduct of an infringement procedure, or any non-compliance by the marketing authorisation holder with requests made by the Agency, the Commission or a national competent authority in application of this Regulation;
(d)
the turnover of the medicinal product concerned;
(e)
the need to adopt provisional measures by the Commission or urgent action by a Member State in accordance with Articles 20 or 45 of Regulation (EC) No 726/2004 as a result of an infringement;
(f)
the repetition, frequency or duration of the infringement by that marketing authorisation holder;
(g)
prior sanctions, including penalties, imposed on the same marketing authorisation holder.
3. In determining the amount of the financial penalty, the Commission shall take into account any penalties already imposed on the marketing authorisation holder at national level on the basis of the same legal grounds and the same facts.
