Commission Regulation (EC) No 658/2007Show full title

Article 23 U.K. Confidentiality and professional secrecy

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.