Paragraph 117 I1

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.”.”.