EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations, which apply to the United Kingdom, require the provision of information in relation to the prices of branded medicines which are supplied for the purposes of the health services in England, Wales, Scotland and Northern Ireland (see the definition of “health service” in section 266(6) of the National Health Service Act 2006).
These Regulations apply only to medicines in respect of which marketing authorisations have been granted that are supplied by companies which are members of the Pharmaceutical Price Regulation Scheme (PPRS). The 2005 PPRS is the present voluntary price regulation scheme. It was agreed in November 2004 between the Department of Health and the Association of the British Pharmaceutical Industry and came into effect on 1st January 2005. The PPRS is available on the Department of Health’s website at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4093228&chk=qW14At.
Regulation 3 requires information on the sales of branded health service medicines to be supplied to the Secretary of State.
Provision is made for the recovery of penalties where there is a failure to provide information under regulation 3 and for appeals (regulations 4 and 5).
Transitional provision is made for the period before the coming into force of these Regulations which would otherwise fall within the scope of these Regulations (regulation 6).
Regulation 7 revokes various Regulations which no longer reflect the current policy on statutory price controls of medicines supplied for NHS purposes.
A Regulatory Impact Assessment has been prepared and copies may be obtained from the Department of Health, Zone 456D, Skipton House, 80 London Road, London, SE1 6LH.