Paragraph 127 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 is a UKMA(NI) or UKMA(UK);

(b)

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

before the study is commenced.”.”;

for paragraph (3) substitute—

“(3)

In paragraph (4)—

(a)

after “protocol is submitted” insert “ only ”;

(b)

after “paragraphs (2) and (3)(a)” insert “ (and is not submitted to the Pharmacovigilance Risk Assessment Committee) ”.”;

omit paragraphs (4) to (6).