Amendment of regulation 184 (obligation on holder to audit pharmacovigilance system)U.K.
This section has no associated Explanatory Memorandum
143. In regulation 184, after paragraph (2) insert—
“(3) The holder [F1of a UKMA(GB) or THR(GB)] must also comply with the requirements of paragraph 13 of Schedule 12A in relation to auditing the pharmacovigilance system.”.
Textual Amendments
F1Words in reg. 143 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 112
Commencement Information
I1Reg. 143 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1