Paragraph 130 I1

For regulation 162 (omission of regulation 202 (follow up of final study reports)) substitute—

“Amendment of regulation 202 (follow up of final study reports)

162

In regulation 202(1), after “This regulation applies” insert “ in respect of a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation ”.”.