Article 10 Content and time-limits

The Agency shall provide the Commission, the Member States and the marketing authorisation holder with a report summarising its findings in the light of the inquiry carried out in accordance with this Section.

Where the Agency considers that the marketing authorisation holder has committed an infringement as referred to in Article 1, the report shall also include an assessment of the circumstances of the specific case in accordance with the criteria set out in Article 18(2) and a request to the Commission for application of financial penalties.

The Agency shall adopt its report no later than 18 months after notification of initiation of the procedure in accordance with Article 7 or one year after notification by the Commission of the return of the file in accordance with Article 15.