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))

135.  In regulation 170 (amendment of regulation 206 (infringement notices)) for paragraphs (2) and (3) substitute—

“(2) In paragraph (3), after “paragraph (1)” insert “in relation to a product authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI) or THR(UK)”.

(3) In paragraph (4) after sub-paragraph (a) insert—

“(aa) Schedule 12A;”.”.