Paragraph 113

For regulation 145 (amendment of regulation 186 (reporting obligations on the licensing authority)) substitute—

“145.

In regulation 186—

(a)

in paragraph (1), for sub-paragraphs (d) and (e) substitute—

“(d)

submit reports of serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i)

a UKMA(NI),

(ii)

a UKMA(UK),

(iii)

a THR(NI),

(iv)

a THR(UK), or

(v)

an Article 126a authorisation,

to the EMA before the end of the period of 15 days beginning on the day following the day on which the report was received; and

(e)

submit reports of non-serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—

(i)

a UKMA(NI),

(ii)

a UKMA(UK),

(iii)

a THR(NI),

(iv)

a THR(UK), or

(v)

an Article 126a authorisation,

to the EMA before the end of the period of 90 days beginning on the day following the day on which the report was received.”;

(b)

omit paragraph (4).”.