SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 21Amendment of Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities))
I1192
In Schedule 6 (insertion of new Schedule 12A (further provision as to the performance of pharmacovigilance activities)), in the inserted Schedule 12A—
a
in paragraphs 1(3), 12(5), 16(3), 22(1)(d) and 30(g), for “UK marketing authorisation” substitute “
UKMA(GB)
”
;
b
in paragraph 2(a)—
i
at the end of paragraph (iii) omit “and”;
ii
in paragraph (iv), for “pharmacovigilance;” substitute “
pharmacovigilance, and
”
;
iii
after paragraph (iv) insert—
v
responsibilities and contact details of the nominated person (where a person is nominated under regulation 182(2A));
c
in paragraph 2(d), for “handing” substitute “
handling
”
;
d
omit paragraph 4(4);
e
in paragraph 7—
i
omit sub-paragraph (1);
ii
in sub-paragraph (2)—
aa
after “qualified person” insert “
and nominated person (where a person is nominated under regulation 182(2A))
”
;
bb
for “has” substitute “
have
”
.