Paragraph 116 I1

In regulation 149 (amendment of regulation 189 (signal detection: licensing authority obligations)) for paragraph (3) substitute—

“(3)

In paragraphs (2) and (3), for “The licensing” insert “ In relation to medicinal products subject to a UKMA(UK), a UKMA(NI), a THR(UK), a THR(NI) or an Article 126a authorisation, the licensing ”.”.