SCHEDULES

SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 7Amendment of Part 8 (omission of Part 8 (Article 126a authorisations))

99

For regulation 132 (omission of Part 8), substitute—

Amendment of regulation 156 (article 126a authorisations)132

In regulation 156—

a

in paragraph (1)—

i

after “126a authorisation for” insert “sale or supply of”;

ii

after “medicinal product” insert “in Northern Ireland only,”;

b

in paragraph (2), after “is in force” insert “in Northern Ireland”;

c

in paragraph (3), after “traditional herbal registration” insert “to be in force in Northern Ireland”;

d

in paragraph (4) for “the United Kingdom” substitute “Northern Ireland”; and

e

in paragraph (5) for “another member State” substitute “an EU member State”.

Amendment of regulation 157 (requests from other member States)132A

In regulation 157(1)—

a

in the heading for “other member States” substitute “EU member States”; and

b

in paragraph (1)—

i

after “where the licensing authority” insert “, in relation to a UKMA(NI),”; and

ii

for “another member State” substitute “a member State”.