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The Branded Health Service Medicines (Costs) Regulations 2018

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4.  A manufacturer or supplier referred to in paragraph 2 that considers that it is likely to receive in respect of the total supply of all presentations, a total net sales income below the thresholds set out in column (2) of table 1 where it satisfies the corresponding description of the manufacturer’s or supplier’s current accounting reference period specified in column (1) of table 1, must provide in writing to the Secretary of State information setting out—

(a)an estimate of the total net sales income it is likely to receive in respect of the total supply of all presentations for its current financial year within 30 days of the date on which the requirement to make payments under regulation 3 or under a direction given under regulation 4(2)(b) would begin to apply were it not for the fact that regulation 3(6) or 4(5) applied;

(b)the total net sales income in respect of the total supply of all presentations for its previous financial year within 30 days of the completion of the first financial year during which the requirement to make payments under regulation 3 or under a direction given under regulation 4(2)(b) would have first applied were it not for the fact that regulation 3(6) or 4(5) applied.

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