Regulation 51 Amendment to regulation 61I1

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

in paragraph (6), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”;

in paragraph (6A), after “UKMA(GB)” insert “or UKMA(UK)(Category 1)”;

for paragraph (7), substitute—

“(7)

The obligation under paragraph (5) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive while taking account of the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.”;

omit paragraph (7A);

in paragraph (13), for “or UKMA(UK)” substitute “or UKMA(UK)(Category 2)”.