CHAPTER IIU.K.INFRINGEMENT PROCEDURE

SECTION 3U.K.Non-cooperation

Article 19U.K.Financial penalties

1.The Commission may by decision impose on marketing authorisation holders fines not exceeding 0,5 % of their Community turnover in the preceding business year where, intentionally or negligently:

(a)they do not comply with a measure of inquiry adopted pursuant to Article 8(1);

(b)they supply incorrect or misleading information in response to a measure of inquiry adopted pursuant to Article 8(1);

(c)they do not comply with a request for information pursuant to Article 14;

(d)they supply incorrect or misleading information in response to a request for information pursuant to Article 14.

2.Where the non-cooperation of the marketing authorisation holder continues, the Commission may, in the decision referred to in paragraph 1, impose periodic penalty payments per day not exceeding 0,5 % 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 non-cooperation has ceased.

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.

Article 20U.K.Procedure

When the Commission intends to adopt a decision as referred to in Article 19(1), it shall first notify in writing the marketing authorisation holder, setting a time-limit within which the marketing authorisation holder may submit to the Commission his written observations. That time-limit shall be at least four weeks.

The Commission shall not be obliged to take into account written observations received after the expiry of that time-limit.