Permitted material2

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)4;

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 20125.