Paragraph 4 Amendment of regulation 47 (amendment of regulation 48 of the 2012 Regulations – application of Part 5)

In regulation 47(2)—

(a)

in sub-paragraph (a), in the inserted definition of “EU reference medicinal product”, after “paragraph (b)” insert “or (c)”; and

(b)

in sub-paragraph (d), in the substituted definition of “reference medicinal product”—

(i)

omit the “or” at the end of paragraph (a); and

(ii)

at the end of paragraph (b) insert—

“; or

(c)
in relation to which an EU marketing authorisation had ceased to be in force before exit day for reasons not relating to safety, quality or efficacy.”.