S.L. 483.8 Art. 4Inspections and other control measures of importing tissue establishments.

(1) The Authority shall every two years organise inspections and other control measures of importing tissue establishments and, where appropriate, their third country suppliers and ensure that the importing tissue establishment carries out appropriate controls to ensure quality and safety standards of the imported tissues and cells. Furthermore, the Authority may suspend or revoke the accreditation, designation, authorisation or licence, in whole or in part, of an importing tissue establishment if the inspections or other control measures demonstrate that such importing tissue establishment no longer meets the requirements set out in these regulations.

(2) All inspections and other control measures shall be carried out by an official, duly authorised in writing, who shall have the authority to:

(a) inspect the importing tissue establishment and, where necessary, the activity of any third country supplier;

(b) evaluate and verify the procedure and activities carried out by the importing tissue establishment and the facilities of the third country supplier that are relevant to ensure the quality and safety standards of the tissues and cells to be imported; and

(c) examine any documents or other records that are relevant for the evaluation and verification.

(3) The Authority shall, upon a justified request from another competent authority of another Member State, or from the Commission, provide information on the results of inspection and other control measures relating to importing tissue establishments and third country suppliers. The appropriate measures to be taken shall be decided by the Authority after consulting with the requesting competent authority.

(4) Where an on-site inspection takes place following a request, the Authority shall agree with the requesting competent authority on whether and how such authority shall participate in the inspection. The final decision shall be taken by the Authority upon a reasoned explanation to the requesting competent authority.