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 for health service purposes on or after 1st September 2008, except where regulation 3 applies. The maximum price is the “reference price” (as defined in paragraph (2)).
Regulation 3 makes provision for the specification of the maximum price for presentations which are first supplied for health service purposes on or after 1st March 2008 (new presentations).
Regulation 4 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 5 makes provision for increases in the price of presentations.
Regulation 6 and the Schedule make provision for enforcement of the controls on the prices of presentations of medicines by imposing specified penalties.
Regulation 7 amends the Health Service Medicines (Information Relating to Sales of Branded Medicines etc.) Regulations 2007, so as to impose requirements on manufacturers and suppliers to provide information to the Secretary of State.
Regulation 8 makes provision for appeals from decisions made under these Regulations by the Secretary of State.
Regulation 9 provides for the Regulations to cease to have effect on 1st September 2009.
An Impact Assessment for these Regulations has been prepared and copies may be obtained from the Department of Health, Zone 456D, Skipton House, 80 London Road, London SE1 6LH