# 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, Article 11: Statement of objections

Extent: E+W+S+N.I.

1. Where, following a request from the Agency pursuant to Article 10(2), the Commission decides to continue with the infringement procedure, it shall notify in writing to the marketing authorisation holder a statement of objections containing the following:
(a) the allegations against the marketing authorisation holder, including a precise indication of which provision has allegedly been infringed, and the evidence on which those allegations are founded;
(b) notice that fines or periodic penalty payments may be imposed.
2. Where, within 18 months of receiving the request from the Agency, the Commission has not notified a statement of objections, it shall provide the marketing authorisation holder with an explanatory statement.

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Source: https://www.legislation.gov.uk/eur/2007/658/article/11 (the official version)
Page: https://openlegislation.uk/eu-regulation-2007-658/article-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.