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”.