# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 149: Amendment of regulation 189 (signal detection: licensing authority obligations)

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

(1) Regulation 189 is amended as follows.
(2) In paragraph (1)—
(a) in sub-paragraph (a), for “in the Eudravigilance database” substitute “ that it collects by virtue of operating its pharmacovigilance system under this Part ”; and
(b) in sub-paragraph (d), for “regulations 59 to 61” substitute “ regulations 59, 60 and 61 ”.
(3) In paragraphs (2) and (3), for “The licensing” insert “In relation to medicinal products subject to a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/149 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-149
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.