Confidentiality
Article 5
1. EU reference laboratories shall have a confidentiality policy that includes the following: (a) the type of information that shall be considered confidential; (b) rules for the appropriate secure handling, storage and processing of confidential information and measures to prevent undue disclosure; (c) rules for sharing of confidential and non-confidential information with staff, and the public; (d) rules for granting access to confidential information to a competent authority of a Member State upon its request in the context of market surveillance or vigilance activities by the competent authority; (e) rules for sharing confidential information, on the initiative of the EU reference laboratory, with a competent authority of a Member State and with the Commission where the EU reference laboratory has reason to believe that such sharing is in the interest of protection of public health. 2. EU reference laboratories shall put in place and document measures to ensure that the staff complies with the confidentiality policy referred to in paragraph 1.