SCHEDULES

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

PART 3Amendment of Part 4 (amendment of Part 4 (requirement for authorisation))

I133

In regulation 45 (amendment of regulation 46 (requirement for authorisation))—

a

for paragraph (2)(b) and (c) substitute—

b

after sub-paragraph (a) insert—

aa

an EU marketing authorisation;

b

for paragraphs (4)(a) to (c) substitute—

a

after “in force for the product” insert “ in the country in which the product is intended to be sold or supplied, or offered for sale or supply ”;

b

in sub-paragraph (a), before “marketing authorisation”, insert “ UK ”; and

c

after sub-paragraph (a) insert—

aa

an EU marketing authorisation;

c

omit paragraph (5).