# The Human Medicines Regulations 2012, Regulation 190: Signal detection: holder obligation


(1) The holder must inform—
(a) the licensing authority, and
(b) in respect of a UKMA(UK)(Category 2), 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.
(2) In this regulation, “relevant changes” has the meaning given in regulation 189(5).

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/190 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-190
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.