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The Branded Health Service Medicines (Costs) Regulations 2018

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12.—(1) A manufacturer or supplier intending to make an application for a price decrease under paragraph (4) must record and keep for a period of six years the information required for such an application under this regulation.

(2) Subject to paragraph (3), the Secretary of State must within a period of 28 days, on receipt of all of the information required as part of an application made by a manufacturer or supplier in accordance with paragraph (4), confirm or decrease the maximum price of a presentation by direction to that manufacturer or supplier.

(3) Where the number of applications received by the Secretary of State under this regulation makes it impracticable for the Secretary of State to reply to all or any of the applications within the 28 day period, the Secretary of State may extend that period for a further 28 days and must notify the manufacturer or supplier if this is the case within the 28 day period.

(4) A request by a manufacturer or supplier to the Secretary of State for a reduction of the maximum price of an item of presentation must be made in writing and must—

(a)specify the presentation in respect of which the request is made;

(b)state the reasons for the request; and

(c)specify the proposed reduced maximum price.

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