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(This note is not part of the Regulations)
These Regulations, which apply to the United Kingdom, amend regulation 2 of the Health Service Branded Medicines (Control of Prices and Supply of Information) (No.2) Regulations 2008 (“the 2008 Regulations”).
Regulation 2 of the 2008 Regulations specifies the maximum price which may be charged for the presentation of a branded medicine which is supplied for health service purposes, unless the medicine falls within a voluntary scheme for limiting prices or profits or the price is determined under the other provisions of the Regulations. The amendment provides that the maximum price of a presentation is calculated by deducting 5.5 % (instead of 5.7 %) from the price for which that presentation was on sale for health service purposes in England on 1st December 2008. The amendment mirrors a change to the Pharmaceutical Price Regulation Scheme 2009 (available at www.dh.gov.uk), which also has effect on 1st January 2012.
An Impact Assessment has been prepared and is available at www.dh.gov.uk. Copies may also be obtained from the Department of Health, Zone 456D, Skipton House, 80 London Road, London SE1 6LH and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
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