# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 117


For regulation 150 (amendment of regulation 190 (signal detection: holder obligation)) substitute—
“150. 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.”.”.

---
Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/117 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-117
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.