The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

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))

132.  In regulation 165 (omission of regulation 204 (obligation on licensing authority in relation to public announcements))—

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

(b) for “Omit” substitute “In”;

(c) after “regulation 204” insert “, in paragraph (1), after “pharmacovigilance concerns” insert “which relate to products authorised under a UKMA(NI) or UKMA(UK)”.