SCHEDULES

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

PART 4Amendment of Part 5 (amendment of Part 5 (marketing authorisations))

I165

For regulation 88 (omission of regulation 79 (failure to provide information on marketing authorisations to EMA)) substitute—

Amendment of regulation 79 (failure to provide information on marketing authorisations to EMA)88

In regulation 79 (failure to provide information on marketing authorisations to EMA)—

a

in paragraph (1), for the first reference to “a marketing authorisation” substitute “ a UKMA(NI) or UKMA(UK) ”;

b

in paragraph (2), for the first reference to “a marketing authorisation” substitute “ UKMA(NI) or UKMA(UK) ”.