Amendment of regulation 34 (clinical trials conducted in third countries)I115

1

In the heading of regulation 34, for “third countries” substitute “ countries other than the United Kingdom ”.

2

In regulation 34—

a

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

b

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.