Part 2Regulation of activities involving human tissue

Licensing

I1I4I5F116Licence requirement

I2I31

No person shall do an activity to which this section applies otherwise than under the authority of a licence granted for the purposes of this section.

2

This section applies to the following activities—

a

the carrying-out of an anatomical examination;

b

the making of a post-mortem examination;

c

the removal from the body of a deceased person (otherwise than in the course of an activity mentioned in paragraph (a) or (b)) of relevant material of which the body consists or which it contains, for use for a scheduled purpose other than transplantation;

d

the storage of an anatomical specimen;

e

the storage (in any case not falling within paragraph (d)) of—

i

the body of a deceased person, or

I2I3ii

relevant material which has come from a human body,

for use for a scheduled purpose;

f

the use, for the purpose of public display, of—

i

the body of a deceased person, or

ii

relevant material which has come from the body of a deceased person.

F12A

This section does not apply to the procurement, testing, processing F4..., storage, distribution, import or export of tissue and cells F4... in so far as those activities are activities to which regulation 7(1) F2, (1A) or (2) of the 2007 Regulations applies.

2B

Expressions used in subsection (2A) and in the 2007 Regulations have the same meaning in that subsection as in those Regulations; and the reference to activities to which regulation 7(1) F3, (1A) or (2) of those Regulations applies is to be read subject to regulation 2(3) of those Regulations.

3

The Secretary of State may by regulations specify circumstances in which storage of relevant material by a person who intends to use it for a scheduled purpose is excepted from subsection (2)(e)(ii).

4

An activity is excluded from subsection (2) if—

a

it relates to the body of a person who died before the day on which this section comes into force or to material which has come from the body of such a person, and

b

at least one hundred years have elapsed since the date of the person’s death.

5

The Secretary of State may by regulations amend this section for the purpose of—

a

adding to the activities to which this section applies,

b

removing an activity from the activities to which this section applies, or

c

altering the description of an activity to which this section applies.

6

Schedule 3 (which makes provision about licences for the purposes of this section) has effect.

7

In subsection (2)—

a

references to storage do not include storage which is incidental to transportation, and

b

“relevant material”, in relation to use for the scheduled purpose of transplantation, does not include blood or anything derived from blood.