OpenLegislation

Paragraph 119

Original text. Later amendments are not shown.

In regulation 152 (amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements))—

(a)

in paragraph (3), for “for “EMA” to the end substitute “after “EMA” insert “and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only,”;

(b)

for paragraph (4) substitute—

“(4)

In paragraph (9), after “paragraph (3)(a)” insert “from the holder of a UKMA(UK), UKMA(NI), THR(UK), THR(NI) or Article 126a authorisation”.”.