# The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, Regulation 15: Amendment of regulation 34 (clinical trials conducted in third countries)

Extent: E+W+S+N.I.

(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.”.

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Source: https://www.legislation.gov.uk/uksi/2019/744/regulation/15 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019/regulation-15
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.