PART 11Amendment of Part 11 (Pharmacovigilance)

Amendment of regulation 203 (obligations on licensing authority in relation to national medicines web-portal)164

1

Regulation 203 is amended as follows.

2

In paragraph (1), omit from “linked” to the end.

3

In paragraph (2)—

a

in sub-paragraph (e) for “Article 23 of Regulation (EC) No 726/2004” substitute “the list published by the licensing authority under, or which applies by virtue of, regulation 202A”; and

b

in sub-paragraph (f), omit “(including by way of the web-based forms referred to in Article 25 of Regulation (EC) No 725/2004”.