Regulation 11 Amendments to regulation 22

in paragraph (a), after “supplied” insert “and whether it is a newer presentation or an older presentation”;

in paragraphs (b) and (c), for “regulation 3(4)” substitute “regulation 3(4)(a), (b), (c), (d), (g) and (h)”; and

after paragraph (g), insert—

“(ga)

the quantity supplied and the total gross sales income and the total net sales income received for the supply of each item of new active substance presentation supplied;

(gb)

the quantity supplied and the total gross sales income and the total net sales income received for the supply of each item which is a line extension to which regulation 3(4)(f) applies that is supplied;

(gc)

the quantity supplied and the total gross sales income and the total net sales income received for the supply of each item of exceptional central procurement presentation supplied;

(gd)

the quantity supplied and the total gross sales income and the total net sales income received for the supply of each item of centrally procured vaccine presentation supplied;

(ge)

the quantity supplied and the total gross sales income and the total net sales income received for the supply of each item of presentation of plasma derived medicinal products;

(gf)

the quantity supplied and the total gross sales income and the total net sales income received for the supply of each item of presentation to which regulation 3(4A)(b) applies that is supplied;”.