S.L. 483.4 Art. 11Single European Code. Re-numbered by: L.N. 304 of 2013.

(1) Without prejudice to sub-regulation (2), a Single

European Code shall be applied to all tissues and cells distributed for human application. For the other situations where tissues and cells are released for circulation, as a minimum the donation identification sequence shall be applied at least in the accompanying documentation.

(2) The provisions of sub-regulation (1) shall not apply to:

(a) reproductive cells from partner donation;

(b) tissues and cells distributed directly for immediate transplantation to the recipient, as provided for under the Tissues and Cells (Quality and Safety)

Regulations;

(c) tissues and cells imported into the Union in case of emergency authorised directly by the competent authority or authorities, as referred to in the Human Blood and Transplants Act;

(d) tissues and cells other than reproductive cells for partner donation, when these tissues and cells remain within the same centre; and

(e) tissues and cells that are imported into the Union, when these tissues and cells remain within the same centre from importation to application, provided that the centre comprises a tissue establishment authorised, designated, accredited, or licensed to carry out importing activities.