# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 139: Amendment of regulation 177 (application of Part and interpretation)

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

(1) Regulation 177 is amended as follows.
(2) After paragraph (1) insert—
“(1A) Schedule 12A applies in relation to medicinal products that are the subject of a UKMA(GB) ora THR(GB).”.
(3) In paragraph (2)—
(a) after “this Part” insert “ and Schedule 12A ”;
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) In paragraph (3)—
(a) for “Schedule 33” substitute “ Schedules 12A and 33 ”;
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(6) In paragraph (5)—
(a) for “Schedule 33” substitute “Schedules 33 and 33A”;
(b) in paragraph (c) of the definition of “relevant post-authorisation safety study”, omit “and”; and
(c) after that definition, insert—
““signal” means, in relation to a UKMA(GB) or THR(GB), information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action; and”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/139 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-139
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.