Article 19 Financial penalties
United Kingdom
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:
they do not comply with a measure of inquiry adopted pursuant to Article 8(1);
they supply incorrect or misleading information in response to a measure of inquiry adopted pursuant to Article 8(1);
they do not comply with a request for information pursuant to Article 14;
they supply incorrect or misleading information in response to a request for information pursuant to Article 14.
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.
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.
Notes on the whole EU Regulation
Textual amendments
- F1
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(n) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)