The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

SCHEDULES

SCHEDULE 2 U.K. Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 10 U.K. Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))

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

(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 ”.”.

Commencement Information

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