S.L. 427.10 Art. 12Confidentiality.

(1) Without prejudice to the existing national provisions and practices on medical confidentiality, the Medicines Authority shall ensure that all the parties involved in the application of these regulations are bound to observe confidentiality with regard to all information obtained in carrying out their tasks: Provided that the provisions of this sub-regulation do not affect the obligation of the above authority with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.

(2) The following information shall not be treated as confidential:

(a) information on the registration of persons responsible for placing devices on the market in accordance with regulation 9(1) to (4);

(b) information to users sent out by the manufacture, authorised representative or distributor in relation to a measure in accordance with regulation 8(3) to (5);

(c) information contained in certificates issued, modified, supplemented, suspended or withdrawn.