# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 113


For regulation 145 (amendment of regulation 186 (reporting obligations on the licensing authority)) substitute—
“145. 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/ukdsi/2020/9780348213980/schedule/2/paragraph/113 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-113
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.