Paragraph 134

In regulation 167 (insertion of regulation 205A (further obligations in respect of pharmacovigilance activities)), in the inserted regulation 205A—

(a)

in paragraph (1), after “Schedule 12A” insert “applies in relation to medicinal products for sale or supply under a UKMA(GB) or THR(GB) and”;

(b)

in paragraph (2)—

(i)

for “The Ministers” substitute “The Secretary of State”;

(ii)

after “by regulations” insert “in respect of Great Britain”.