Regulation 140 Amendment to Schedule 12AI1

United Kingdom

In Schedule 12A (further provision as to the performance of pharmacovigilance activities)^f1—

(a)

in paragraph 1(3), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;

(b)

in paragraph 12(5), after “UKMA(GB)” insert “or the UKMA(UK)(Category 1), as the case may be,”;

(c)

in paragraph 16(3), after “UKMA(GB)” insert “or the UKMA(UK)(Category 1), as the case may be,”;

(d)

in paragraph 22(1)(d), after “UKMA(GB)” insert “or the UKMA(UK)(Category 1)”;

(e)

in paragraph 30(g), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”.

Annotations

f1: Schedule 12A was inserted by S.I. 2019/775 as amended by S.I. 2020/1488.