Paragraph 137

In regulation 175 (amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation))—

(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,”.”.