Amendment of regulation 190 (signal detection: holder obligation)U.K.
This section has no associated Explanatory Memorandum
[F1150. 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.”.]
Textual Amendments
F1Reg. 150 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 117
Commencement Information
I1Reg. 150 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1