Regulation 61 Amendment to regulation 78BI1

United Kingdom

In regulation 78B (post authorisation requirements in relation to UKMA(GB) for advanced therapy medicinal products)^f1—

(a)

in the heading, for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”;

(b)

in paragraph (1)—

(i)

in the opening words, for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”;

(ii)

in sub-paragraph (c), for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”;

(iii)

in sub-paragraph (d), for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”;

(c)

in both places in paragraph (2), for “UKMA(GB)” substitute “UKMA(UK)(Category 1)”.

Annotations

f1: Regulation 78B was inserted by S.I. 2019/775 as amended by S.I. 2020/1488.