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
I1Sch. 2 para. 49 in force at 31.12.2020 immediately before IP completion day, see reg. 1