# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 160: Amendment of regulation 200 (amendment to study protocols for required studies)

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

(1) Regulation 200 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),
before their implementation.”.
(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/160 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-160
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.