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The Health Service Branded Medicines (Control of Prices and Supply of Information) (No. 2) Regulations 2008

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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations, which apply to the United Kingdom, control the price of presentations of medicines which are supplied for health service purposes. They also require the supply of information relating to those presentations to the Secretary of State.

Regulation 1 includes a definition of presentation.

Regulation 2 specifies the maximum price which may be charged for a presentation which is supplied in England for health service purposes on 1st December 2008, except where regulation 3 or 4 applies. That maximum price is calculated by deducting 3.9 % from the price for which that presentation was on sale for health service purposes in England on 1st December 2008.

Regulation 3 makes provision for presentations which are first supplied for health service purposes in England on or after 1st December 2008 (new presentations).

Regulation 4 exempts the maximum price of low cost presentations from the reduction made by regulation 2.

Regulation 5 enables the Secretary of State to exempt presentations where a maximum price may jeopardise supplies of those presentations for the purposes of the health service.

Regulation 6 makes provision for increases in the price of presentations.

Regulation 7 and the Schedule make provision for enforcement of the controls on the prices of presentations of medicines by imposing specified penalties.

Regulation 8 further amends the Health Service Medicines (Information Relating to Sales of Branded Medicines etc.) Regulations 2007, which require the provision of information to the Secretary of State.

Regulation 9 makes provision for appeals from decisions made under these Regulations by the Secretary of State.

Regulation 10 revokes the Health Service Branded Medicines (Control of Prices and Supply of Information) Regulations 2008.

An Impact Assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Department of Health, Zone 456D, Skipton House, 80 London Road, London SE1 6LH.

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