Regulation 143 Amendment of regulation 184 (obligation on holder to audit pharmacovigilance system)I1
United Kingdom
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.”.
Annotations
Textual amendments
- F1
Words 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
- I1
Reg. 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