- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council
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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.
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.
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