SCHEDULES

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

PART 13Amendment of Part 14 (amendment of Part 13 (packaging and leaflets))

I1157

In regulation 203 (amendment of regulation 260 (package leaflets))—

a

in paragraph (2), in the inserted paragraph (1A), after the first reference to “advanced therapy medicinal product” insert “ for sale or supply in Great Britain only ”;

b

in paragraph (3), in the inserted text, after “advanced therapy medicinal product,” insert “ for sale or supply in Great Britain only ”;

c

in paragraph (4)—

i

omit “, Article 126a authorisation”;

ii

after “UK marketing authorisation” insert “ , EU marketing authorisation, ”.