137. In regulation 175 (amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation))—U.K.
(a)in paragraph (2)—
(i)for “for” substitute “ after ”;
(ii)for “substitute “Schedule 12A”” substitute “ insert “and Schedule 12A” ”;
(b)in paragraph (3) for sub-paragraphs (a) and (b) substitute—
“(a)in sub-paragraph (a), at the beginning insert “ in relation to a UKMA(NI), UKMA(UK), THR(NI) THR(UK) or Article 126a authorisation, ”;
(b)after sub-paragraph (a) insert—
“(aa)in relation to a UKMA(GB) or THR(GB), fails to comply with any requirement or obligation contained in a provision of Schedule 12A listed in paragraph (2A); or”.”;
(c)in paragraph (4)—
(i)for “For paragraph (2) substitute” substitute “ After paragraph (2) insert ”;
(ii)the inserted paragraph (2) becomes inserted paragraph (2A);
(iii)omit the inserted paragraphs (3) and (4);
(d)after paragraph (4) insert—
“(5) In paragraph (4), after “Implementing Regulation” insert “ , or of paragraph 26(8) or 29(1) of Schedule 12A, ”.”.
Commencement Information
I1Sch. 2 para. 137 in force at 31.12.2020 immediately before IP completion day, see reg. 1
