SCHEDULES

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

PART 6 Amendment of Part 7 (amendment of Part 7 (Traditional Herbal Registrations))

89.  In regulation 118 (amendment of regulation 133 (application for renewal of registration)) for “for “European Union”” to the end substitute—

“for “must be established in the European Union” substitute—

“, where it is applying for renewal of—

(a) a THR(NI)—

(i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;

(ii) on any other basis, must be established in the United Kingdom;

(b) a THR(GB)—

(i) under the unfettered access route, must be established in Northern Ireland;

(ii) other than under the unfettered access route, must be established in the United Kingdom;

(c) a THR(UK), must be established in the United Kingdom.”.”.