SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 4Amendment of Part 5 (amendment of Part 5 (marketing authorisations))
I166
In regulation 89 (amendment of regulation 80 (urgent safety restrictions))—
a
for paragraph (3) substitute—
3
For paragraph (a) substitute—
a
fails—
i
in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or
ii
in respect of a UKMA(NI), UKMA(UK) or EU marketing authorisation, to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,
that the holder has taken urgent safety restrictions on the holder's own initiative;
b
for paragraph (4) substitute—
4
For paragraph (b) substitute—
b
fails—
i
in respect of a UKMA(GB), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or
ii
in respect of a UKMA(NI) or UKMA(UK), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or
c
after paragraph (4) insert—
4A
In paragraph (c) after “fails” insert
“ in respect of a UKMA(NI) ”.
d
in paragraph (5)—
i
for “For sub-paragraph (c) substitute” substitute “
After paragraph (c) insert
”
;
ii
renumber the paragraph inserted as sub-paragraph (d);
iii
in the paragraph inserted, after “fails” insert “
in respect of a UKMA(GB)
”
.