The Commission may, insofar as specifically provided for in the delegated acts referred to in point (b) of paragraph 10, impose the financial penalties referred to in paragraph 1 also on a legal entity or legal entities other than the marketing authorisation holder provided that such entities form part of the same economic entity as the marketing authorisation holder and that such other legal entities:
exerted a decisive influence over the marketing authorisation holder; or
were involved in, or could have addressed, such failure to comply with the obligation by the marketing authorisation holder.
For the purposes of paragraph 1, the Commission shall also take into account:
any infringement procedure initiated by a Member State against the same marketing authorisation holder on the basis of the same legal grounds and the same facts; and
any sanctions, including penalties, already imposed on the same marketing authorisation holder on the basis of the same legal grounds and the same facts.
Where the marketing authorisation holder continues to fail to comply with its obligations referred to in paragraph 1, the Commission may adopt a decision imposing periodic penalty payments per day not exceeding 2,5 % of the marketing authorisation holder’s average daily Union turnover in the business year preceding the date of that decision.
Periodic penalty payments may be imposed for a period running from the date of notification of the relevant Commission's decision until the failure to comply with the obligation by the marketing authorisation holder, as referred to in paragraph 1, has been brought to an end.
The Commission is empowered to adopt delegated acts in accordance with Article 87b in order to supplement this Regulation by laying down:
procedures to be applied by the Commission when imposing fines or periodic penalty payments, including rules on the initiation of the procedure, measures of inquiry, rights of the defence, access to file, legal representation and confidentiality;
further detailed rules on the imposition by the Commission of financial penalties on legal entities other than the marketing authorisation holder;
rules on duration of procedure and limitation periods;
elements to be taken into account by the Commission when setting the level of and imposing fines and periodic penalty payments, as well as the conditions and methods for their collection.