Regulation 23 Amendment to regulation 45FI1

In regulation 45F (provision of information)^f1, in paragraph (1), for sub-paragraph (b) substitute—

“(b)

the UK marketing authorisation holder, or, where applicable—

(i)

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)

the EU marketing authorisation holder,”.