Paragraph 119 I1

United Kingdom

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 ”.”.

Annotations

Commencement

I1: Sch. 2 para. 119 in force at 31.12.2020 immediately before IP completion day, see reg. 1