SCHEDULES

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

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

I149

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 ”.