SCHEDULES

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

PART 16Amendment of Part 17 (amendment of Part 16 (enforcement))

I1180

In regulation 221 (amendment of regulation 327 (powers of inspection, sampling and seizure))—

a

in paragraph (2), for sub-paragraphs (b) and (c) substitute—

b

after paragraph (v), insert—

va

an EU marketing authorisation;

b

for paragraph (3) substitute—

3

In paragraph (2)(g), after paragraph (iv) insert—

iva

the requirements of Schedule 12A (further provision as to the performance of pharmacovigilance activities);

c

omit paragraphs (4) and (5).