Regulation 15 Amendment of regulation 34 (clinical trials conducted in third countries)I1

for “a third country” substitute “ another country ”; and

for the words “entered into” to the end, substitute—

“reported as soon as possible to the licensing authority, and in any event—

(a)

in the case of a reaction that is fatal or life-threatening, within 7 days beginning with the day after the sponsor was first aware of the reaction; or

(b)

in any other case, within 15 days beginning with the day after the sponsor is first aware of the reaction.”.