Paragraph 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”.”.