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))

49.  For regulation 66 (amendment of regulation 60 (conditions of UK marketing authorisation: exceptional circumstances)) substitute—

“66.   In regulation 60—

(a) after “UK marketing authorisation” in each place it occurs (including the heading to the regulation) insert “or parallel import licence”;

(b) after “the authorisation” in each place it occurs insert “or licence”;

(c) in paragraph (3), after “an authorisation” insert “or licence”;

(d) for paragraph (9) substitute—

“(9) The licensing authority must notify the EMA of any UKMA(NI) or UKMA(UK) that it has granted subject to a condition included in accordance with this regulation.”;

(e) in paragraph (10), after “a marketing authorisation” insert “or licence”.”.