SCHEDULES

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

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

I1133

In regulation 166 (amendment of regulation 205 (obligations on holders in relation to public announcements))—

a

in paragraph (2) for “for “bodies listed” to the end substitute “after “bodies listed in paragraph (3)” insert “ where the product is subject to a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation, or the licensing authority where the product is subject to a UKMA(GB) or THR(GB), ””;

b

omit paragraph (3).