Regulation 41 Amendment of regulation 45F (provision of information)I1

In regulation 45F(1) M1 for sub-paragraph (b) substitute—

“F1(b)

in the case of a broker in—

(i)

Great Britain, either—

(aa)

the UK marketing authorisation holder, or

(bb)

where applicable, the holder of the licence or authorisation granted by an appropriate authority responsible for the licensing of medicinal products in an approved country for import, or

(ii)

Northern Ireland, either—

(aa)

the UK marketing authorisation holder, or

(bb)

where applicable, the EU marketing authorisation holder, ”.