CHAPTER II

INFRINGEMENT PROCEDURE
SECTION 1

Inquiry
Subsection 1

Initiation of procedure

Initiation of the infringement procedure
Article 5
1
The Agency may initiate the infringement procedure on its own initiative or following a request from the Commission or a Member State.
The Agency shall inform the Commission that it intends to initiate the infringement procedure.
2
The Agency shall initiate the infringement procedure only after informing the Member States.

Request for information
Article 6
Prior to initiating an infringement procedure, the Agency may request from the marketing authorisation holder concerned any information relating to the alleged infringement.
The Agency shall state the purpose of the request and the fact that it is made under this Regulation, and indicate a time-limit for the submission of the reply by the marketing authorisation holder, which shall be at least four weeks.
Where the request is in response to a request from a Member State under Article 5(1), that Member State shall be informed by the Agency.

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.
Subsection 2

Measures of inquiry

Requests by the Agency
Article 8
1
The Agency may request the marketing authorisation holder to provide written or oral explanations, or particulars or documents.
Requests shall be addressed in writing to the marketing authorisation holder. The Agency shall state the legal basis and the purpose of the request, fix a time-limit by which the information is to be provided, which shall be at least four weeks, and inform the marketing authorisation holder of the fines provided for in Article 19(1)(a) and (b) for failing to comply with the request or for supplying incorrect or misleading information.
2
The Agency may request national competent authorities to cooperate in the investigation in the following ways:
a
by performing any of the tasks entrusted to the supervisory authorities by Articles 19(1) and 44(1) of Regulation (EC) No 726/2004;
b
by performing inspections or other supervisory measures in accordance with Articles 111 to 115 of Directive 2001/83/EC and Articles 80, 81 and 82 of Directive 2001/82/EC.
Requests shall be addressed in writing and shall state the legal basis and the purpose of the request. The time-limit for the submission of the reply or the conduct of the measure of inquiry shall be determined by agreement between the Agency and the national competent authority to which the request is addressed, having regard to the specific circumstances of the case.
3
The Agency may ask any natural or legal persons to provide information relating to the alleged infringement.
Requests shall be addressed in writing and shall state the legal basis and the purpose of the request, and shall fix a time-limit by which the information should be provided, which shall be at least four weeks.

Right to be heard
Article 9
Before adoption of the report provided for in Article 10, the Agency shall invite the marketing authorisation holder to submit written observations.
It shall do so in writing, indicating a time-limit for the submission of those observations, which shall be at least four weeks.
Subsection 3

Report

Content and time-limits
Article 10
1
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.
2
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.
3
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.