The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 No. 832

Amendment to Schedule 12A

140.  In Schedule 12A (further provision as to the performance of pharmacovigilance activities)(1)—

(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)”.

(1)

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