Article 15 Confidentiality

The applicant may indicate which information submitted under Article 7 should be treated as confidential because disclosure may significantly harm his or her competitive position. Verifiable justification must be given in such cases.

Without prejudice to paragraph 3, the F1Authority shall determine, after consultation with the applicant, which information should be kept confidential and shall inform the applicant F2... of its decision.

Without prejudice to Article 39(3) of Regulation (EC) No 178/2002, information relating to the following shall not be considered confidential:

Notwithstanding paragraph 2, the Authority shall on request supply the F3appropriate authority with all information in its possession.

The F4appropriate authority and the Authority shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation except for information which must be made public if circumstances so require in order to protect human health.

If an applicant withdraws or has withdrawn an application, the Authority, F5and the appropriate authority shall respect the confidentiality of the commercial and industrial information provided, including research and development information as well as information on which the F6Authority and the applicant disagree as to its confidentiality.