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

Amendment to regulation 8

7.  In regulation 8 (general interpretation)—

(a) in paragraph (1)—

(i) omit the definition of “advanced therapy medicinal product”;

(ii) in the definition of “Annex I to the 2001 Directive”(1), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”;

(iii) omit the definition of “Commission Regulation 2016/161”(2);

(iv) in the definition of “conditional marketing authorisation”(3), for “UKMA (GB)” substitute “UKMA(UK)(Category 1)”;

(v) omit the definition of “healthcare institution”(4);

(vi) in the definition of “marketing authorisation”, omit paragraph (b) and the “or” which precedes it;

(vii) in the definition of “name”, omit paragraph (b) (but not the “and” which follows it);

(viii) in the definition of “pharmacovigilance system”(5), omit “, EU marketing authorisation”;

(ix) in the definition of “pharmacovigilance system master file”(6), omit “, EU marketing authorisation”;

(x) in the definition of “post-authorisation safety study”, omit “, EU marketing authorisation”;

(xi) omit the definition of “Regulation (EC) No 1394/2007”;

(xii) in the definition of “UK marketing authorisation”(7), in paragraph (a), after “authorisation” insert “, within the definition of UKMA(UK)(Category 1) or UKMA(UK)(Category 2),”;

(xiii) after the definition of “UK marketing authorisation”, insert—

““UKMA(UK)(Category 1)” means a marketing authorisation of the description in regulation 49(1ZB);

“UKMA(UK)(Category 2)” means a marketing authorisation of the description in regulation 49(1ZC);”;

(xiv) in the definition of “under the unfettered access route”, in paragraph (a), for “UKMA(GB)” substitute “UKMA(UK)(Category 2)”;

(b) in paragraph (9)(8), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”.

(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. 2019/62 and S.R. 2019 No. 10.

(3)

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

(4)

The definition was inserted by S.I. 2019/62 and S.R. 2019 No. 10.

(5)

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

(6)

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

(7)

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

(8)

Paragraph (9) was inserted by S.I. 2019/775 as amended by S.I. 2020/1488