# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 159: Amendment of regulation 199 (submission of draft study protocols for required studies)

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

(1) Regulation 199 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 is a UKMA(NI) or UKMA(UK);
(b) the licensing authority, where the authorisation is a UKMA(GB),
before the study is commenced.”.
(3) In paragraph (4)—
(a) after “protocol is submitted” insert “only”;
(b) after “paragraphs (2) and (3)(a)” insert “(and is not submitted to the Pharmacovigilance Risk Assessment Committee)”.
(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/159 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-159
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.