OpenLegislation

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

Original text. Later amendments are not shown.

(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—

    1. (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

    2. (b)

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