Paragraph 120

In regulation 153 (amendment of regulation 193 (harmonisation of PSUR frequency or date of submission))—

(a)

for paragraph (2) substitute—

“(2)
In paragraph (1) substitute—

“(1)
Where products that are subject to different authorisations or registrations contain the same active substance or the same combination of active substances, the frequency and dates of submission may be amended and harmonised in accordance with—

(a)
Article 107c(4) of the 2001 Directive, where—
(i)
any of the authorisations or registrations is a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation; and

(ii)
none of the authorisations or registrations is a UKMA(GB) or THR(GB); or

(b)
paragraphs (2A), (3) and (4A), where—
(i)
any of the authorisations or registrations is a UKMA(GB) or THR(GB); and

(ii)
none of the authorisations or registrations is a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation.”;”;

(b)

after paragraph (2) insert—

“(2A)
In paragraph (2), after “holder” insert “of a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation”.”;

(c)

in paragraph (3)—

(i)

for “For paragraph (2) substitute—” substitute “After paragraph (2) insert—”;

(ii)

the text to be inserted is renumbered as paragraph (2A);

(iii)

in the text to be inserted, after “the holder” insert “of a UKMA(GB) or THR(GB)”;

(d)

in paragraph (4)—

(i)

for “For paragraph (4) substitute—” substitute “After paragraph (4) insert—”;

(ii)

the text to be inserted is renumbered as paragraph (4A);

(iii)

in the text to be inserted, after “from a holder” insert “of a UKMA(GB) or THR(GB)”;

(e)

in paragraph (5)—

(i)

for sub-paragraph (a) substitute—

“(a)
after “of the 2001 Directive” insert “or paragraph (2A) (as the case may be)””; and

(ii)

for sub-paragraph (b) substitute—

“(b)
after “EMA” insert “or licensing authority (as the case may be)””;

(f)

in paragraph (6)—

(i)

for “For paragraph (6) substitute” substitute “After paragraph (6) insert”; and

(ii)

the substituted paragraphs (6) and (6A) become paragraphs (6A) and (6B) respectively; and

(iii)

in the substituted paragraph (6) for “(6A)” substitute “(6B)”; and

(g)

in paragraph (7) for “(6A)” substitute “(6B)”.