SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 4Amendment of Part 5 (amendment of Part 5 (marketing authorisations))
I155
In regulation 74 (amendment of regulation 66 (application for renewal of authorisation)) for “66(2)” to the end substitute—
66, for paragraph (2) substitute—
2
The applicant, where it is applying for renewal of—
a
a UKMA(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 UKMA(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 UKMA(UK), must be established in the United Kingdom.