# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 127


In regulation 159 (amendment of regulation 199 (submission of draft study protocols for required studies))—
(a) for paragraph (2) substitute—
“(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.”.”;
(b) for paragraph (3) substitute—
“(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)”.”;
(c) omit paragraphs (4) to (6).

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/127 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-127
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.