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The Human Tissue (Quality and Safety for Human Application) Regulations 2007

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This is the original version (as it was originally made).

PART 6AMENDMENTS TO THE 2004 ACT

Remit of the Authority

30.—(1) Section 14 (remit) of the 2004 Act is amended as follows.

(2) At the end of subsection (1) insert—

“(h)the procurement, processing, preservation, testing, storage, distribution, import or export of tissue or cells, in so far as those activities are activities to which regulation 7(1) or (2) of the 2007 Regulations applies and are not within the remit of the Authority by virtue of paragraphs (a) to (g).”.

(3) After subsection (2) insert—

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

Exclusion from licensing requirement of section 16

31.—(1) Section 16 of the 2004 Act is amended as follows.

(2) After subsection (2), insert—

“(2A) This section does not apply to the procurement, testing, processing, preservation, storage, distribution, import or export of tissue and cells intended for human application in so far as those activities are activities to which regulation 7(1) 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) or (2) of those Regulations applies is to be read subject to regulation 2(3) of those Regulations.”.

Interpretation of Part 2 of the 2004 Act

32.  In section 41 (interpretation of Part 2) of the 2004 Act, before the definition of “anatomical specimen” insert—

““the 2007 Regulations” means the Human Tissue (Quality and Safety for Human Application) Regulations 2007;”.

Applications under Schedule 3 to the 2004 Act

33.  In paragraph 13(1) of Schedule 3 to the 2004 Act, after “Schedule”, insert “and Schedule 1 to the 2007 Regulations”.

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