CHAPTER III

ACCESS TO THE FILE, REPRESENTATION, CONFIDENTIALITY AND TEMPORAL PROVISIONS

Access to the file
Article 21
Following notification under Article 7, the marketing authorisation holder shall have the right, on request, to access the documents and other materials compiled by the Agency and the Commission which serve as evidence of an alleged infringement.
Documents obtained through access to the file shall be used only for the purposes of judicial or administrative proceedings for the application of this Regulation.

Legal representation
Article 22
The marketing authorisation holder shall have the right to legal representation during the infringement procedure.

Confidentiality and professional secrecy
Article 23
1
Without prejudice to the exchange and to the use of information foreseen in Article 3, an infringement procedure shall be carried out subject to the principles of confidentiality and of professional secrecy. The Agency and the Commission, their officials, servants and other persons working under their supervision shall not disclose information acquired or exchanged by them pursuant to this Regulation and of the kind covered by the obligation of professional secrecy and confidentiality.
2
Without prejudice to the right to access the case-file, the marketing authorisation holder shall not have access to business secrets, confidential information or internal documents held by the Agency, the Commission or a Member State.
3
Any person who submits information or observations pursuant to Articles 8, 9, 12 or 14 shall clearly identify any material considered to be confidential, giving reasons, and provide a separate non-confidential version by the date set by the Agency or the Commission.
4
Without prejudice to paragraph 3, the Agency and the Commission may require persons who submit information or observations pursuant to this Regulation to identify the documents or parts of documents which they consider to contain business secrets or other confidential information belonging to them.
The Agency and the Commission may also require marketing authorisation holders and other persons to identify any part of a report by the Agency, of a statement of objections or of a decision adopted by the Commission which in their view contains business secrets.
The Agency and Commission may set a time-limit within which the marketing authorisation holder and other persons are to:
a
substantiate their claim for confidentiality with regard to each individual document or part of document;
b
provide the Commission with a non-confidential version of the documents, in which the confidential passages are deleted;
c
provide a concise description of each piece of deleted information.
The time-limit referred to in the third subparagraph shall be at least two weeks.
5
If the marketing authorisation holder or other persons fail to comply with paragraphs 3 and 4, the Commission may assume that the information or observations concerned do not contain confidential information.

Application of time-limits
Article 24
1
The time-limits laid down in this Regulation shall run from the day following receipt of a communication or delivery thereof by hand.
In the case of a communication from the marketing authorisation holder, it shall be sufficient for the purposes of the relevant time-limits for the communication to have been dispatched by registered post before the relevant time-limit has expired.
2
Where the time-limit falls to expire on a Saturday, Sunday or public holiday, it shall be extended up to the end of the following working day.
3
In setting the time-limits provided for in Articles 6, 8(1), 12(1) and 14(1), the Agency and the Commission, as the case may be, shall have regard both to the time required for preparation of the submission and to the urgency of the case.
4
Where appropriate and upon reasoned request made before the expiry of the original time-limit, time-limits may be extended.

Limitation periods for the imposition of financial penalties
Article 25
1
The right of the Commission to adopt a decision imposing a financial penalty pursuant to Article 16 shall expire after five years.
In the case of the financial penalties provided for in Article 19, the right of the Commission to adopt a decision imposing such a penalty shall expire after three years.
Time shall begin to run on the day on which the infringement is committed. However, in the case of continuing or repeated infringements, time shall begin to run on the day on which the infringement ceases.
2
Any action taken by the Agency or the Commission for the purpose of the investigation or infringement procedure shall interrupt the limitation periods laid down in paragraph 1. The limitation period shall be interrupted with effect from the date on which the action is notified to the marketing authorisation holder.
3
Each interruption shall start time running afresh. However, the limitation period shall expire at the latest on the day on which a period equal to twice the limitation period has elapsed without the Commission having imposed a financial penalty. The period shall be extended by the time during which limitation is suspended pursuant to paragraph 4.
4
The limitation period for the imposition of financial penalties shall be suspended for as long as the decision of the Commission is the subject of proceedings pending before the Court of Justice of the European Communities.

Limitation periods for the collection of financial penalties
Article 26
1
The right to start a recovery procedure shall expire one year after the decision pursuant to Article 16 or Article 19 has become final.
2
The limitation period for the recovery of financial penalties shall be interrupted by any action of the Commission or of a Member State, acting at the request of the Commission, designed to enforce payment of the penalty.
3
Each interruption shall start time running afresh.
4
The limitation period for the recovery of financial penalties shall be suspended for so long as:
a
time to pay is allowed;
b
enforcement of payment is suspended pursuant to a decision of the Court of Justice of the European Communities.