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.
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.
Subsection 2

Decision and financial penalties

Forms of financial penalty and maximum amounts
Article 16
1
Where, following the procedure provided for in Subsection 1, the Commission finds that the marketing authorisation holder has committed, intentionally or negligently, an infringement as referred to in Article 1, it may adopt a decision imposing a fine not exceeding 5 % of the holder’s Community turnover in the preceding business year.
2
Where the marketing authorisation holder has not terminated the infringement, the Commission may, in the decision referred to in paragraph 1, impose periodic penalty payments per day not exceeding 2,5 % of the holder’s average daily Community turnover in the preceding business year.
Periodic penalty payments may be imposed for a period running from the date of notification of that decision until the infringement has been brought to an end.
3
For the purposes of paragraphs 1 and 2, the preceding business year refers to the business year preceding the date of the decision referred to in paragraph 1.

Decision
Article 17
1
The decision provided for in Article 16 shall be based exclusively on grounds on which the marketing authorisation holder has been able to comment.
2
The Commission shall inform the marketing authorisation holder of the judicial remedies available.
3
The Commission shall communicate the adoption of the decision to the Agency and to the Member States.
4
When publishing details of its decision in accordance with the second subparagraph of Article 84(3) of Regulation (EC) No 726/2004, the Commission shall have regard to the legitimate interest of marketing authorisation holders and other persons in the protection of their business secrets.

Principles governing the application and quantification of financial penalties
Article 18
1
In determining whether to impose a financial penalty and in determining the appropriate financial penalty, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness.
2
In each case, the Commission shall take into consideration, where relevant, the following circumstances:
a
the seriousness and the effects of the infringement, and, in particular, the following:
1. the way in which the infringement adversely affects the rights, safety or well-being of patients;
2. its effects on animal health and welfare and the impact on animal owners;
3. whether it poses or could pose a risk to public health, animal health or the environment;
4. the gravity of the infringement in relation to public health, animal health and the environment;
b
on the one hand, the good faith of the marketing authorisation holder in the interpretation and fulfilment of the obligations connected with marketing authorisations granted in accordance with Regulation (EC) No 726/2004 or, on the other hand, any evidence of wilful deceit on the part of the marketing authorisation holder;
c
on the one hand, the degree of diligence and cooperation shown by the marketing authorisation holder in the detection of the infringement and the application of corrective action, or during the course of the infringement procedure or, on the other hand, any obstruction by the marketing authorisation holder of the detection of an infringement and the conduct of an infringement procedure, or any non-compliance by the marketing authorisation holder with requests made by the Agency, the Commission or a national competent authority in application of this Regulation;
d
the turnover of the medicinal product concerned;
e
the need to adopt provisional measures by the Commission or urgent action by a Member State in accordance with Articles 20 or 45 of Regulation (EC) No 726/2004 as a result of an infringement;
f
the repetition, frequency or duration of the infringement by that marketing authorisation holder;
g
prior sanctions, including penalties, imposed on the same marketing authorisation holder.
3
In determining the amount of the financial penalty, the Commission shall take into account any penalties already imposed on the marketing authorisation holder at national level on the basis of the same legal grounds and the same facts.
SECTION 3

Non-cooperation

Financial penalties
Article 19
1
The Commission may by decision impose on marketing authorisation holders fines not exceeding 0,5 % of their Community turnover in the preceding business year where, intentionally or negligently:
a
they do not comply with a measure of inquiry adopted pursuant to Article 8(1);
b
they supply incorrect or misleading information in response to a measure of inquiry adopted pursuant to Article 8(1);
c
they do not comply with a request for information pursuant to Article 14;
d
they supply incorrect or misleading information in response to a request for information pursuant to Article 14.
2
Where the non-cooperation of the marketing authorisation holder continues, the Commission may, in the decision referred to in paragraph 1, impose periodic penalty payments per day not exceeding 0,5 % of the holder’s average daily Community turnover in the preceding business year.
Periodic penalty payments may be imposed for a period running from the date of notification of that decision until the non-cooperation has ceased.
3
For the purposes of paragraphs 1 and 2, the preceding business year refers to the business year preceding the date of the decision referred to in paragraph 1.

Procedure
Article 20
When the Commission intends to adopt a decision as referred to in Article 19(1), it shall first notify in writing the marketing authorisation holder, setting a time-limit within which the marketing authorisation holder may submit to the Commission his written observations. 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.