(2003; 148 pages)
2.13 Confidentiality Undertaking
The evaluators and inspectors will treat all information to which they will gain access during the evaluations and inspections, or otherwise in connection with the discharge of their responsibilities in regard to the above-mentioned project, as confidential and proprietary to WHO or parties collaborating with WHO in accordance with the terms set forth below and those contained in the attached Provisions for evaluators of product dossiers and inspectors (team members participating in site visits) within the scope of the quality assessment procedure of pharmaceutical products.
Evaluators and inspectors will take all reasonable measures to ensure
(a) that confidential information is not used for any other purpose than the evaluation/inspection activities described in this document, and
(b) that it is not disclosed or provided to any person who is not bound by similar obligations of confidentiality and non-use as contained herein.
Evaluators and inspectors will not, however, be bound by any obligations of confidentiality and non-use to the extent they are clearly able to demonstrate that any part of the confidential information:
- was known to them prior to any disclosure by or on behalf of WHO (including by manufacturers); or
- was in the public domain at the time of disclosure by or on behalf of WHO (including by manufacturers); or
- has become part of the public domain through no fault of theirs; or
- has become available to them from a third party not in breach of any legal obligations of confidentiality.