S.L. 483.4 Art. 10Traceability. Re-numbered by: L.N. 304 of 2013.

(1) The Authority shall ensure that tissues and cells are traceable in particular through documentation and the use of the

Single European Code from procurement to human application or disposal and vice versa. Tissues and cells used for advanced therapy medicinal products shall be traceable under these regulations at least until transferred to the ATMP manufacturer.

(2) The Authority shall ensure that tissue establishments and organisations responsible for human application shall retain the data set out in Schedule VI for at least thirty years, using an appropriate and readable storage medium.

(3) Where tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, the Authority shall ensure an appropriate traceability system across the procurements..