Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024

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Consequential amendments to Regulations of 2006

36. (1) The Regulations of 2006 are amended—

(a) in Regulation 2—

(i) by the insertion of the following definitions:

“ ‘Act of 2024’ means the Human Tissue (Transplantation, Post-Mortem, Anatomical Examination and Public Display) Act 2024;

‘relevant provisions of Part 2 of the Act of 2024’ means those provisions concerning transplantation activities relating to tissues and cells in respect of which the Authority is required to monitor compliance pursuant to section 35 of the Act of 2024;”,

and

(ii) in the definition of “inspection”, by the substitution of “these Regulations, the Regulations of 2007 and the relevant provisions of Part 2 of the Act of 2024” for “these Regulations and the Regulations of 2007”,

(b) in paragraphs (1) and (2) of Regulation 4, by the substitution of “the Directives, these Regulations and the relevant provisions of Part 2 of the Act of 2024” for “the Directives and these Regulations” in both places where it occurs,

(c) in Regulation 6—

(i) in paragraph (1)(a)(ii), by the substitution of “Regulations, the relevant provisions of Part 2 of the Act of 2024” for “Regulations, or”,

(ii) in paragraph (1)(b)(iii), by the substitution of “the Directives, these Regulations and the relevant provisions of Part 2 of the Act of 2024” for “the Directives and these Regulations”,

(iii) in paragraph (6)(a), by the insertion of “and the relevant provisions of Part 2 of the Act of 2024” after “these Regulations”,

(iv) in paragraph (6)(b), by the insertion of “and the relevant provisions of Part 2 of the Act of 2024” after “these Regulations”,

(v) in paragraph (11)(a), by the substitution of “the Directives, these Regulations and the relevant provisions of Part 2 of the Act of 2024” for “the Directives and these Regulations”,

(vi) in paragraph (11)(b), by the substitution of “this Regulation and the relevant provisions of Part 2 of the Act of 2024” for “this Regulation”,

(vii) in paragraph (11A)(iv), by the substitution of “the Directives, these Regulations and the relevant provisions of Part 2 of the Act of 2024” for “the Directives and these Regulations”,

(viii) in paragraph (11A)(v), by the substitution of “this Regulation and the relevant provisions of Part 2 of the Act of 2024”, for “this Regulation”, and

(ix) in paragraph (14), by the substitution of “the Directives, these Regulations and the relevant provisions of Part 2 of the Act of 2024” for “the Directives and these Regulations”,

(d) in Regulation 7—

(i) by the substitution, in paragraph (1)(a), of “the Directives, these Regulations and the relevant provisions of Part 2 of the Act of 2024” for “the Directives and these Regulations”, and

(ii) by the substitution, in paragraph (1)(b), of “the Directives, these Regulations and the relevant provisions of Part 2 of the Act of 2024” for “the Directives and these Regulations”,

(e) in Regulation 8, by the substitution, in paragraph (1)(a), of “these Regulations and the relevant provisions of Part 2 of the Act of 2024” for “these Regulations”,

(f) in Regulation 9—

(i) by the substitution, in paragraph (2), of “Schedule 4 and the relevant provisions of Part 2 of the Act of 2024” for “Schedule 4”, and

(ii) by the substitution, in paragraph (4)(d)(ii), of “or compliance with the relevant provisions of Part 2 of the Act of 2024, as appropriate” for “or authorisation”,

(g) in Regulation 11—

(i) by the substitution, in paragraph (3), of “Reproductive cells” for “Tissues and cells”,

(ii) by the deletion, in paragraph (3), of “(in the case of a living adult) or the next of kin (in the case of a deceased person or a person who is unable to give consent)”,

(iii) by the substitution, in paragraph (4), of “reproductive cells” for “tissues and/or cells in relation to living donors”,

(iv) by the deletion, in paragraph (4)(a), of “, or the donor, next of kin, (in the case of a person who is unable to give consent)”,

(v) by the substitution, in paragraph (4)(e), of “reproductive cells” for “tissue and/or cell”, and

(vi) by the deletion of paragraph (5),

(h) in Regulation 13—

(i) by the substitution, in paragraph (1), of “reproductive cells” for “human tissues and cells”,

(ii) by the substitution, in paragraph (2), of “reproductive cells” for “tissues and cells”,

(iii) by the substitution, in paragraph (3)(a), of “reproductive cells” for “human tissues and cells”, and

(iv) by the substitution, in paragraph (3)(b), of “reproductive cells” for “tissues and cells”,

(i) in Regulation 19, by the substitution, of “these Regulations, the Regulations of 2007 and the relevant provisions of Part 2 of the Act of 2024” for “these Regulations and the Regulations of 2007” in each place where it occurs,

(j) in Regulation 22—

(i) in paragraph (1)—

(I) by the substitution of “Chief Executive of the Health Products Regulatory Authority,” for “IMB” in each place where it occurs, and

(II) by the substitution of “her or him” for “it”,

and

(ii) by the substitution of “these Regulations or the relevant provisions of Part 2 of the Act of 2024” for “these Regulations” in each place where it occurs,

(k) in Regulation 24, by the substitution of “these Regulations or the relevant provisions of Part 2 of the Act of 2024” for “these Regulations”,

(l) in Regulation 26, by the substitution of “these Regulations, and the relevant provisions of P Part 2 of the Act of 2024” for “these Regulations”,

(m) in Regulation 32(1), by the substitution of “these Regulations and the relevant provisions of Part 2 of the Act of 2024” for “these Regulations”,

(n) in Schedule 4—

(i) by the substitution, in paragraph 1.1.1(a), of “Regulation 11 in relation to reproductive cells and in accordance with the relevant provisions of Part 2 of the Act of 2024 for all other tissues and cells” for “Regulation 11”,

(ii) by the substitution, in paragraph 1.1.2, of “In the case of living donors of reproductive cells” for “In the case of living donors”, and

(iii) by the substitution, in paragraph 2.4(a), of—

(I) “reproductive cells” for “tissues and cells”, and

(II) “reproductive cells” for “tissue or cells”,

and

(o) in Schedule 5, by the substitution of “Regulations 2006 and the relevant provisions of Part 2 of the Act of 2024” for “Regulations 2006”.