Paragraph 66

for paragraph (3) substitute—

“(3)

For paragraph (a) substitute—

“(a)

fails—

(i)

in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or

(ii)

in respect of a UKMA(NI), UKMA(UK) or EU marketing authorisation, to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,

that the holder has taken urgent safety restrictions on the holder’s own initiative;”.”;

for paragraph (4) substitute—

“(4)

For paragraph (b) substitute—

“(b)

fails—

(i)

in respect of a UKMA(GB), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or

(ii)

in respect of a UKMA(NI) or UKMA(UK), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or”.”;

after paragraph (4) insert—

“(4A)

In paragraph (c) after “fails” insert “in respect of a UKMA(NI)”.”;

in paragraph (5)—