# The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, Regulation 16: Amendment of regulation 35 (annual list of suspected serious adverse reactions and safety report)

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

(1) Regulation 35 is amended as follows.
(2) In paragraph (2)(b), for “EEA State” substitute “ any country ”.
(3) In paragraph (3)—
(a) for “an EEA State” substitute “ a country ”; and
(b) for sub-paragraphs (a) and (b), substitute—
“(a) the date on which the trial was authorised by a regulatory body responsible for authorising clinical trials in that country; or
(b) where the clinical trial was conducted in a country without a formal authorisation process, a date designated by the sponsor that is linked to the commencement of the first clinical trial.”.

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Source: https://www.legislation.gov.uk/uksi/2019/744/regulation/16 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019/regulation-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.