SCHEDULES

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

PART 10Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))

I1119

In regulation 152 (amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements))—

a

in paragraph (3), for “for “EMA” to the end substitute “after “EMA” insert “ and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only, ”;

b

for paragraph (4) substitute—

4

In paragraph (9), after “paragraph (3)(a)” insert “ from the holder of a UKMA(UK), UKMA(NI), THR(UK), THR(NI) or Article 126a authorisation ”.