SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 10Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))
I1130
For regulation 162 (omission of regulation 202 (follow up of final study reports)) substitute—
Amendment of regulation 202 (follow up of final study reports)162
In regulation 202(1), after “This regulation applies” insert
“ in respect of a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation ”.