SCHEDULES

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

PART 7 Amendment 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”.”.