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 ”.