Paragraph 57

In regulation 77 (amendment of regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence))—

(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.”.