Paragraph 129 I1

for paragraph (2) substitute—

“(2)

In paragraph (2) for “to the body specified in paragraph (3)” to the end substitute—

“to—

(a)

the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or UKMA(UK);

(b)

the licensing authority, where the authorisation for the product is a UKMA(GB),

a final study report and an abstract of the study results.”.”;

omit paragraph (3);

in paragraph (4) for “omit from” to the end substitute “omit “for reports falling under paragraph (3)(a)” and “for reports falling under paragraph (3)(b)”.