Paragraph 121 I1

United Kingdom

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 ”.”.

Annotations

Commencement

I1: Sch. 2 para. 121 in force at 31.12.2020 immediately before IP completion day, see reg. 1