Regulation 137 Amendment to Schedule 8I1

United Kingdom

In Schedule 8 (material to accompany an application for a UK marketing authorisation)^f1—

(a)

in paragraph 18—

(i)

omit sub-paragraph (a);

(ii)

in sub-paragraph (b), omit “in the case of a medicinal product for sale or supply in Great Britain,”;

(b)

in paragraph 23—

(i)

in sub-paragraph (a), for “medicinal product for sale or supply in Northern Ireland” substitute “UKMA(NI) or a UKMA(UK)(Category 2)”;

(ii)

in sub-paragraph (b), for “medicinal product for sale or supply in Great Britain” substitute “UKMA(GB) or a UKMA(UK)(Category 1)”;

(c)

in paragraph 25A, omit “for sale or supply in Great Britain”.

Annotations

f1: Paragraphs 18 and 23 were substituted by, and paragraph 25A was inserted by, S.I. 2019/755 as amended by S.I. 2020/1488.