The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024

Amendment to regulation 48

25.—(1) Regulation 48 (application of Part) is amended as follows.

(2) In paragraph (2)—

(a) omit the definition of “EU reference medicinal product”(1);

(b) in the definition of “excluded reference product”(2), in paragraph (c), for “53A(1)” substitute “53B(1)”;

(c) in the definition of “generic medicinal product”(3)—

(i) in paragraph (a), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;

(ii) in paragraph (b), in the opening words, for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”;

(d) in the definition of “reference medicinal product”(4)—

(i) omit paragraph (b);

(ii) in paragraph (c)—

(aa) at the end of sub-paragraph (i), for “; or” substitute a comma;

(bb) omit sub-paragraph (ii).

(3) In paragraph (7)(5), for “51A(1) and (6)” substitute “51B(1) and (6)”.

(4) Omit paragraphs (8) and (9).

(1)

The definition was inserted by S.I. 2019/775 as amended by S.I. 2020/1488.

(2)

The definition was inserted by S.I. 2019/775 as amended by S.I. 2020/1488.

(3)

The definition was substituted by S.I. 2019/775 as amended by S.I. 2020/1488.

(4)

The definition was substituted by S.I. 2019/775 as amended by S.I. 2020/1488.

(5)

Paragraphs (7), (8) and (9) were inserted by S.I. 2019/775 as amended by S.I. 2020/1488.