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The Branded Health Service Medicines (Costs) Regulations 2018

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3.—(1) Subject to paragraph (4), the manufacturer or supplier that is responsible for the first relevant supply of an item of presentation must pay 7.80% of the net sales income received in respect of that supply to the Secretary of State in accordance with Schedule 1.

(2) Subject to paragraph (3), for these purposes the first relevant supply is the first occasion on which that item of presentation is supplied by any manufacturer or supplier having a place of business in the United Kingdom (MS1) to another person having a place of business in the United Kingdom (MS2) that is not in the same group as MS1.

(3) If MS2 is—

(a)the marketing authorisation holder (MAH) in respect of that item of presentation; or

(b)a manufacturer or supplier in the same group as MAH,

the first relevant supply is the next supply of that item of presentation to a person having a place of business in the United Kingdom that is not in the same group as MS2.

(4) Subject to paragraph (5), paragraph (1) does not apply to the net sales income received in respect of the supply of—

(a)any item of presentation which was in respect of that supply, supplied under—

(i)a contract with a contracting authority based on a framework agreement where that framework agreement was entered into on or before the date of the coming into force of these Regulations or was entered into following a tender which closed on or before the date of the coming into force of these Regulations,

(ii)a public contract entered into on or before the date of the coming into force of these Regulations or was entered into following a tender which closed on or before the date of the coming into force of these Regulations;

(b)any item of low cost presentation;

(c)any item of parallel distributed presentation;

(d)any item of voluntary scheme presentation.

(5) Paragraph (4)(a) does not apply to any item of presentation added to a framework agreement or public contract after the coming into force of these Regulations.

(6) This regulation does not apply to a small manufacturer or supplier.

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