57. In regulation 77 (amendment of regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence))—U.K.
(a)in paragraph (3), for sub-paragraph (b) substitute—
“(b)for “established in the European Union” substitute—
“established in—
(a)the United Kingdom; or
(b)in relation to a UKMA(NI), either the United Kingdom or the European Union,
in accordance with the requirements of these Regulations.”.”;
(b)for paragraph (5) substitute—
“(5) In paragraph (9)(a) omit “other than the United Kingdom”.”;
(c)in paragraph (8)—
(i)in the inserted paragraph (11E), for “exit day” in both places it occurs substitute “ IP completion day ”;
(ii)after the inserted paragraph (11F), insert—
“(11G) Condition P is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.”.
Commencement Information
I1Sch. 2 para. 57 in force at 31.12.2020 immediately before IP completion day, see reg. 1