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) ”.