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

SCHEDULES

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

PART 4 U.K. 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— U.K.

“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 ”.”.

Commencement Information

I1 Sch. 2 para. 49 in force at 31.12.2020 immediately before IP completion day, see reg. 1