CHAPTER II

INFRINGEMENT PROCEDURE
SECTION 3

Non-cooperation

Financial penalties
Article 19
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.

Procedure
Article 20
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.