PART 14Amendment of Part 13 (packaging and leaflets)
Amendment of regulation 268 (offence relating to packaging and package leaflets)I1207
1
Regulation 268 M1 is amended as follows.
F11A
In the heading to the regulation, after “packaging and package leaflets” insert “in Great Britain”.
F22
In paragraph (1)—
a
for “marketing authorisation, Article 126a authorisation” substitute “UKMA(UK), UKMA(GB)”;
b
after “the purpose of sale or supply” insert “, in Northern Ireland”.
3
In paragraph (2)(a)—
a
for “Article 28 or 32 of the Paediatric Regulation” substitute “
regulation 50C(4), 50D(8) or 58A(2)(b)
”
; and
b
omit “, Article 9 of Commission Regulation 2016/161”.