Paragraph 122

In regulation 155 (amendment of regulation 195 (obligation on licensing authority to assess PSURs)—

(a)

after paragraph (2) insert—

“(2A)
Before paragraph (1) insert—

“(A1)
This regulation applies in the circumstances specified in paragraphs (1) and (1A).”.

(2B)
In paragraph (1)—

(a)
after “relating to a medicinal product” insert “authorised for sale or supply authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation”; and

(b)
in sub-paragraph (a)(i) omit “other than the United Kingdom”.”;

(b)

in paragraph (3)—

(i)

for “For” substitute “After”;

(ii)

for “substitute” substitute “insert”;

(iii)

the inserted paragraph (1) becomes inserted paragraph (1A);

(iv)

in the inserted paragraph (1A), after “to a medicinal product” insert “authorised for sale or supply under a UKMA(GB) or THR(GB)”;

(c)

omit paragraph (5).