The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018

Amendments to the Act relating to the import of tissues or cells

9.—(1) The Act is amended as follows.

(2) In section 14 (remit of Human Tissue Authority)—

(a) in subsection (1)(h)—

(i) omit the word “preservation,”; and

(ii) after the words “regulations 7(1)” insert “, (1A)”; and

(b) in subsection (2A) after the words “regulation 7(1)” insert “, (1A)”.

(3) In section 16 (licence requirement)—

(a) in subsection (2A)(1)—

(i) omit the words “, preservation” and “intended for human application”; and

(ii) after the words “regulation 7(1)” insert “, (1A)”; and

(b) in subsection (2B)(2) after the words “regulation 7(1)” insert “, (1A)”.

(4) In paragraph 7(2) of Schedule 3 (revocation of licence otherwise than on application)—

(a) omit “or” at the end of paragraph (f); and

(b) after paragraph (g) insert—

“or

(h)

it is not satisfied that any third country premises are suitable for carrying out activities in a manner which secures that tissues or cells imported from a third country by an importing licence holder meet standards of quality and safety equivalent to those laid down in the 2007 Regulations.”.

(5) After paragraph 7(2) of Schedule 3 insert—

“(3) For the purposes of sub-paragraph (2)(h), “importing licence holder”, “third country” and “third country premises” have the same meaning as in the 2007 Regulations.”.

(1)

Inserted by the Human Tissue (Quality and Safety for Human Application) Regulations 2007/1523, Part 6, regulation 31(2).

(2)

Inserted by the Human Tissue (Quality and Safety for Human Application) Regulations 2007/1523, Part 6, regulation 31(2).