CHAPTER II

INFRINGEMENT PROCEDURE
SECTION 1

Inquiry
Subsection 1

Initiation of procedure

Notification
Article 7
The Agency shall send written notification of the initiation of an infringement procedure to the marketing authorisation holder concerned, to the Member States and to the Commission.
The notification shall set out the allegations against the marketing authorisation holder, specifying the provision allegedly infringed, and the evidence on which those allegations are founded.
It shall give notice to the marketing authorisation holder that fines or periodic penalty payments may be imposed.