# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 150: Amendment of regulation 190 (signal detection: holder obligation)

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

For regulation 190(1) substitute—
“(1) The holder must inform—
(a) the licensing authority, and
(b) in respect of a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the EMA,
without delay if it detects any relevant changes in relation to the product.”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/150 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-150
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.