CHAPTER II

INFRINGEMENT PROCEDURE
SECTION 2

Decision-making stage
Subsection 1

Procedure

Statement of objections
Article 11
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.

Right to reply
Article 12
1
When notifying the statement of objections, the Commission shall set a time-limit within which the marketing authorisation holder may submit to the Commission his written observations on the statement of objections.
That time-limit shall be at least four weeks.
The Commission shall not be obliged to take into account written observations received after the expiry of that time-limit.
2
The marketing authorisation holder may annex to his written observations, statements from other persons who may corroborate any aspect of those written observations.

Oral hearing
Article 13
1
Where the marketing authorisation holder so requests in his written observations, the Commission shall give him an opportunity to develop his arguments at an oral hearing.
The date for the oral hearing shall be set by the Commission.
2
Where necessary, the Commission may invite the national competent authorities or any other persons to take part in the oral hearing.
3
The oral hearing shall not be public. Each person may be heard separately or in the presence of other persons invited to attend, having regard to the legitimate interest of marketing authorisation holders and other persons in the protection of their business secrets and other confidential information.

Requests for information
Article 14
1
After receipt of a request from the Agency pursuant to Article 10(2) and before adoption of the decision referred to in Article 16, the Commission may at any time request the marketing authorisation holder to provide written or oral explanations, or particulars or documents, relating to the alleged infringement.
Requests shall be addressed in writing to the marketing authorisation holder. The Commission 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)(c) and (d) for failing to comply with the request or supplying incorrect or misleading information.
2
The Commission may request the Agency, the national competent authorities or any other 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. Where the request is addressed to the Agency or a national competent authority, the time-limit by which the information is to be provided shall be determined by the Commission after consultation of the Agency or the national competent authority to which the request is addressed, having regard to the specific circumstances of the case. Where the request is addressed to other natural or legal persons, it shall fix a time-limit by which the information is to be provided, which shall be at least four weeks.

New period of inquiry
Article 15
1
Where, having regard to the report of the Agency, the observations of the marketing authorisation holder and, as the case may be, other information submitted to it, the Commission considers that additional information is needed in order to continue the procedure, it may return the case-file to the Agency for a new period of inquiry.
The Commission shall clearly indicate to the Agency the points of fact which it should further examine and, if appropriate, suggest possible measures of inquiry to that effect.
2
Subsections 2 and 3 of Section 1 shall apply to the conduct of the new period of inquiry.