# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 161: Amendment of regulation 201 (submission and evaluation of final study reports for required studies)

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

(1) Regulation 201 is amended as follows.
(2) In paragraph (2) for “to the body specified in paragraph (3)” to the end substitute—
“to—
(a) the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or UKMA(UK);
(b) the licensing authority, where the authorisation for the product is a UKMA(GB),
a final study report and an abstract of the study results.”.
(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) In paragraph (4), omit “for reports falling under paragraph (3)(a)” and “for reports falling under paragraph (3)(b)

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/161 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-161
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.