The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024
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Change 1
10 Amendments to regulation 21
(1) Regulation 21 (sales report) is amended as follows. (2) In paragraph (1)— (a) after sub-paragraph (b), insert— (ba) the total of the net sales income received for the total supply of presentations which are newer presentations and older presentations in respect of which that manufacturer or supplier is required to make a payment in accordance with regulation 3 and any direction given under regulation 4; ; (b) after sub-paragraph (c), insert— (ca) the total payments for newer presentations and older presentations required to be paid by the manufacturer or supplier in accordance with regulation 3 and any direction given under regulation 4; ; and (c) after sub-paragraph (g), insert— (ga) each item of new active substance presentation supplied and the total of the net sales income received in respect of the total supply of all of those presentations; (gb) each item which is a line extension to which regulation 3(4)(f) applies that is supplied and the total of the net sales income received in respect of the total supply of all those presentations; (gc) each item of exceptional central procurement presentation supplied and the total of the net sales income received in respect of the total supply of all of those presentations; (gd) each item of centrally procured vaccine presentation supplied and the total of the net sales income received in respect of the total supply of all of those presentations; (ge) each item of presentation of plasma derived medicinal products supplied and the total of the net sales income received in respect of the total supply of all of those presentations; (gf) each item of presentation to which regulation 3(4A)(b) applies that is supplied and the total of the net sales income received in respect of the total supply of all of those presentations; . (3) After paragraph (1), insert— (1A) Each manufacturer or supplier must provide information in a manner that supports a best estimate calculation of any payments due under regulation 3(1AA) for the period a sales report covers and an explanation to the satisfaction of the Secretary of State of the method of calculating that best estimate with the relevant sales report. .
10 Amendments to regulation 21
(1) Regulation 21 (sales report) is amended as follows. (2) In paragraph (1)— (a) after sub-paragraph (b), insert— (ba) the total of the net sales income received for the total supply of presentations which are newer presentations and older presentations in respect of which that manufacturer or supplier is required to make a payment in accordance with regulation 3 and any direction given under regulation 4; ; (b) after sub-paragraph (c), insert— (ca) the total payments for newer presentations and older presentations required to be paid by the manufacturer or supplier in accordance with regulation 3 and any direction given under regulation 4; ; and (c) after sub-paragraph (g), insert— (ga) each item of new active substance presentation supplied and the total of the net sales income received in respect of the total supply of all of those presentations; (gb) each item which is a line extension to which regulation 3(4)(f) applies that is supplied and the total of the net sales income received in respect of the total supply of all those presentations; (gc) each item of exceptional central procurement presentation supplied and the total of the net sales income received in respect of the total supply of all of those presentations; (gd) each item of centrally procured vaccine presentation supplied and the total of the net sales income received in respect of the total supply of all of those presentations; (ge) each item of presentation of plasma derived medicinal products supplied and the total of the net sales income received in respect of the total supply of all of those presentations; (gf) each item of presentation to which regulation 3(4A)(b) applies that is supplied and the total of the net sales income received in respect of the total supply of all of those presentations; . (3) After paragraph (1), insert— (1A) Each manufacturer or supplier must provide information in a manner that supports a best estimate calculation of any payments due under regulation 3(1AA) for the period a sales report covers and an explanation to the satisfaction of the Secretary of State of the method of calculating that best estimate with the relevant sales report. .
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