SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 10Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))
I1112
In regulation 143 (amendment of regulation 184 (obligation on holder to audit pharmacovigilance system)), in the inserted paragraph (3) after “The holder” insert “
of a UKMA(GB) or THR(GB)
”
.