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Paragraph 121

Original text. Later amendments are not shown.

In regulation 154 (omission of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive))—

(a)

in the heading, for “omission” substitute “amendment”; and

(b)

for “Omit regulation 194.” substitute “In regulation 194(1) after “medicinal product” insert “authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation”.”.