Regulation 190 Signal detection: holder obligation
F1(1)
The holder must inform—
(a)
the licensing authority, and
(b)
in respect of F2a 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).
Annotations
Textual amendments
- F1
Reg. 190(1) substituted (31.12.2020) by S.I. 2019/775, reg. 150 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 117)
- F2
Words in reg. 190(1)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 81