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 ”; andc
after sub-paragraph (a) insert—
aa
an EU marketing authorisation;
c
omit paragraph (5).