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

52.  For regulation 69 (amendment of regulation 64 (duties of licensing authority in connection with determination)) substitute—

“69.   For regulation 64(4)(d) substitute—

“(d) any conditions—

(i) in the case of a UKMA(NI) or UKMA(UK), established in accordance with Articles 21a, 22 and 22a of the 2001 Directive;

(ii) in the case of UKMA(GB), imposed under regulations 59 to 61; and”.”.