Paragraph 65 I1

For regulation 88 (omission of regulation 79 (failure to provide information on marketing authorisations to EMA)) substitute—

“Amendment of regulation 79 (failure to provide information on marketing authorisations to EMA)

88

In regulation 79 (failure to provide information on marketing authorisations to EMA)—

(a)

in paragraph (1), for the first reference to “a marketing authorisation” substitute “ a UKMA(NI) or UKMA(UK) ”;

(b)

in paragraph (2), for the first reference to “a marketing authorisation” substitute “ UKMA(NI) or UKMA(UK) ”.”.