Regulation 82 Amendment to regulation 191I1

United Kingdom

In regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)^f1—

(a)

in paragraph (1)—

(i)

after “and the licensing authority” insert “in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)”;

(ii)

after “UKMA(GB”) insert “or a UKMA(UK)(Category 1)”;

(b)

in paragraph (4A), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;

(c)

in paragraph (7)—

(i)

after “and the licensing authority” insert “in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2)”;

(ii)

after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;

(d)

in paragraph (8A), after “UKMA(GB)” insert “or a UKMA(UK)(Category 1)”;

(e)

in paragraph (10)—

(i)

in sub-paragraph (b)(i), for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;

(ii)

in sub-paragraph (b)(ii)—

(aa)

after “a UKMA(GB)” insert “or a “UKMA(UK)(Category 1)”;

(bb)

for “Great Britain”, in both places, substitute “the United Kingdom”;

(iii)

in sub-paragraph (c)—

(aa)

in paragraph (i), in the opening words, for “UKMA(UK)” substitute “UKMA(UK)(Category 2)”;

(bb)

in paragraph (ii), for the opening words substitute—

“in relation to a product authorised under a UKMA(GB) or a UKMA(UK)(Category 1), the product has been placed on the market in the United Kingdom”.

Annotations

f1: Regulation 191 was amended by S.I. 2019/775 including as that instrument was amended by S.I. 2020/1488.