PART 11Amendment of Part 11 (Pharmacovigilance)

Amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements)I1152

1

Regulation 192 is amended as follows.

2

In paragraph (1)(a), insert “ UK ” before “marketing authorisation”.

3

In paragraph (3), F1after “EMA” insert “and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only,

F24

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”.