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(1) These Regulations may be cited as the Human Tissue (Permitted Material) Regulations (Northern Ireland) 2023.
(2) These Regulations come into operation on 1st June 2023.
(3) These Regulations apply in relation to activities done in Northern Ireland for the purpose of transplantation.
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(1) All relevant material (within the meaning given by section 53 of the Human Tissue Act 2004) is specified as permitted material for the purposes of section 3(6AA) of that Act; but this is subject to paragraphs (2) and (5).
(2) Except as provided by paragraphs (3) and (4), the whole or any part of the following is not permitted material—
(a) arm;
(b) brain;
(c) face;
(d) finger;
(e) foot;
(f) forearm;
(g) hand;
(h) leg;
(i) lower leg;
(j) mouth;
(k) nose;
(l) spinal cord;
(m) thigh;
(n) toe;
(o) trachea;
(p) upper arm;
(q) cervix;
(r) clitoris;
(s) embryo (inside the body);
(t) fallopian tube;
(u) foetus;
(v) labia;
(w) ovary;
(x) penis;
(y) perineum;
(z) placenta;
(aa) prostate;
(bb) testicle;
(cc) umbilical cord;
(dd) uterus;
(ee) vagina;
(ff) vulva.
(3) The following tissue does not fall within paragraph (2) in so far as it is disaggregated from any of the relevant material specified in sub-paragraphs (a) to (p) of that paragraph (and, accordingly, such tissue is permitted material)—
(a) artery;
(b) bone;
(c) muscle;
(d) nervous tissue;
(e) skin;
(f) tendon.
(4) The whole or part of the trachea does not fall within paragraph (2) in so far as it is attached to a lung (and, accordingly, such tissue is permitted material).
(5) The following types of cells are not permitted material in so far as all or part of the cells is for use in, or as, an advanced therapy medicinal product—
(a) limbal stem cells;
(b) liver cells;
(c) lung epithelial cells;
(d) pancreatic cells;
(e) renal epithelial cells.
(6) In this regulation, “advanced therapy medicinal product” has the same meaning as in the Human Medicines Regulations 2012.
Sealed with the Official Seal of the Department of Health on 1st March 2023
(L.S.)Ryan Wilson
A senior officer of the Department of Health
