S.L. 483.8 Art. 8Writtenagreements with third country suppliers.

(1) The importing tissue establishment shall enter into written agreement with the third country supplier where any of the activities of donation, procurement, testing, processing, preservation, storage or export to Malta of tissues and cells to be imported into Malta are carried out outside of the Union: Provided that, where the importing tissue establishment decides not to enter into a written agreement with the third country supplier in the case of one-off imports, the said importing tissue establishment shall ensure that suitable national measures are in place to regulate such imports and that such national measures ensure:

(a) traceability from donor to recipient and vice versa; and

(b) imported tissues and cells are not applied to anyone other than their intended recipients.

(2) The written agreement referred to in sub-article (1) shall specify:

(a) the quality and safety requirements to be met to ensure the quality and safety standards of the tissues and cells to be imported;

(b) the contents listed in Schedule IV; and

(c) the right of the Authority to inspect the activities including the facilities of any third country supplier during the duration of the written agreement and for a period of two years following its termination.

(3) The importing tissue establishment shall provide copies of such written agreement to the Authority, together with the application for accreditation, designation, authorisation or licence provided for under regulation 5.