SCHEDULES

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

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

125.  In regulation 157 (omission of regulation 197 (EU urgent action procedure))—

(a) in the heading for “Omission” substitute “Amendment”;

(b) for “Omit” substitute “In;

(c) after “regulation 197” insert “, in paragraph (1), after “class of medicinal products” insert “authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation””.