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.