# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 145: Amendment of regulation 186 (reporting obligations on the licensing authority)

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

In regulation 186—
(a) in paragraph (1), for sub-paragraphs (d) and (e) substitute—
“(d) submit reports of serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—
(i) a UKMA(NI),
(ii) a UKMA(UK),
(iii) a THR(NI),
(iv) a THR(UK), or
(v) an Article 126a authorisation,
to the EMA before the end of the period of 15 days beginning on the day following the day on which the report was received; and
(e) submit reports of non-serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—
(i) a UKMA(NI),
(ii) a UKMA(UK),
(iii) a THR(NI),
(iv) a THR(UK), or
(v) an Article 126a authorisation,
to the EMA before the end of the period of 90 days beginning on the day following the day on which the report was received.”;
(b) omit paragraph (4).

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/145 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-145
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.