- accounting reference date
has the meaning given to it under section 391 of the Companies Act 2006;
- accounting reference period
has the meaning given to it under section 391 of the Companies Act 2006;
- active substance
has the meaning given in regulation 8(1) of the 2012 Regulations;
- an arrangement
includes any scheme, arrangement or understanding, whether or not legally enforceable;
- applicable auditing standards
means any relevant International Standard on Auditing and related Statements or Standards produced by the Financial Reporting Council Limited;... • “applicable related services standard” means any relevant International Standard on Related Services recognised by, or equivalent standard produced by, the Financial Reporting Council Limited;
- applicable presentation
means the presentation for which a reference price is to be applied or an alternate presentation to be relied on as a comparator, as the case may be;
- applicable related services standard
means any relevant International Standard on Related Services recognised by, or equivalent standard produced by, the Financial Reporting Council Limited;
- audited sales report
means a sales report audited in accordance with regulation 23(1);
- average presentation selling price
means, in relation to the supply of an item of presentation by a manufacturer or supplier during a relevant period, the quotient of the total net sales income during the relevant period divided by total quantity supplied during the relevant period (the calculation is to be based on information in the relevant presentation report, provided that the Secretary of State considers that information is accurate);
- Bank of England base rate
means—
- biological medicinal product
has the meaning given to it by regulation 8(1) of the 2012 Regulations;
- branded medicine
means a medicinal product to which a brand name has been applied that enables the medicine to be identified without reference to the common name;
- calendar quarter
means a period of three months beginning on— (a) 1st January;
- calendar year
means a period of 12 months beginning on 1st January;
- centrally procured vaccine presentation
means a presentation which—
- commercial relationship
means a contractual or other business relationship, whether or not legally enforceable, regarding the manufacturing or supplying of an item of presentation including, but not limited to, licensing;
- exceptional centrally procured presentation
means a presentation which—
- final quarter
means the last quarter in a financial year;
- financial year
has the meaning given to it under section 390 of the Companies Act 2006;
- framework agreement
means— (a) a framework as defined in section 45(2) of the Procurement Act 2023, where the framework was awarded under that Act;
- gross sales income
means income from sales, excluding value added taxes, and before deduction of all trade and other discounts (howsoever named) including settlement discounts, rebates or deduction of any payments, including penalties, made under these Regulations;
- group
has the meaning given to it under section 474(1) of the Companies Act 2006;
- health service use
means used to any extent for the purposes of— (a) the health service continued under section 1(1) of the 2006 Act;
- incomplete
includes circumstances where no information has been provided, notwithstanding the obligation to provide it), he may write to the manufacturer or supplier, and where appropriate by giving an information notice, to request complete information from the manufacturer or supplier be provided within a period of 30 days.
- individual accounts
means accounts of the manufacturer or supplier prepared in accordance with section 394 of the Companies Act 2006;
- licensing authority
has the meaning given to it in regulation 3(5H);
- line extension
means a new presentation with the same active substance as another presentation which is marketed under the same brand name and by the same manufacturer or supplier but is distinguishable by reference to its strength, an excipient, its pack size, its method of administration or its formulation.
- low cost presentation
means a presentation which has a maximum price, as determined by regulation 8, for each item of presentation of less than £2.00;
- marketing authorisation
has the meaning given by regulation 8(1) of the 2012 Regulations;
- marketing authorisation holder
means a manufacturer or supplier that holds a marketing authorisation;
- medicines information standard
means the inter-operability standard for the transfer of medicines information that is published by NHS BSA in the document known as the dictionary of medicines and devices;
- net sales income
means income from sales, excluding value added taxes, and after deduction of all trade and other discounts (howsoever named) including settlement discounts and rebates but before deduction of any payments, including penalties, made under these Regulations;
- new active substance presentation
means a presentation containing a new active substance with a marketing authorisation incorporating the first therapeutic indication for that active substance, but not other presentations marketed under a different brand name which nevertheless contain that new active substance (whether alone or in combination with other active substances);
- new manufacturer or supplier
means a manufacturer or supplier that is within its first accounting reference period;
- new presentation
means a presentation which at the time the notification under paragraph (3) must be made, is not subject to a maximum price under regulation 8(2) or under a direction made under regulation 8(3), 10(1), 11(2), 12(2), or 13(1).
- Non United Kingdom medicinal products
means a medicinal product— (a) which is a branded medicine;
- non-proprietary name
means a name which is, or which is a permitted variation of— (a) an International Non-proprietary Name (INN);
- originator
means, in relation to an active ingredient, or in the case of a combination medicine the combination of active ingredients, of a relevant medicine for a presentation— (a) the person who— (a) received the first marketing authorisation for the virtual therapeutic moiety of that active ingredient or combination of active ingredients, or (b) is not the same as the person specified in paragraph (i) but who holds a valid supplementary protection certificate for the active ingredient or combination of active ingredients;
- originator licensee
means a person, other than an originator, who is marketing a presentation and, during the period the presentation was a newer presentation, was— (a) doing so under a licence from the originator permitting marketing of the relevant medicine;
- parallel distributed presentation
means a presentation in respect of which a parallel distribution notice with the United Kingdom as the Member State of destination has been given;
- patent protection period
means the total period of the term of patent and if a supplementary protection certificate has been granted, the duration of the supplementary protection certificate;
- plasma derived medicinal product
means a presentation that includes an active ingredient from any of the following virtual therapeutic moieties— (a) albumin human;
- presentation
means a particular form of a relevant medicine which may be distinguished from other forms of the medicine by reference to its active ingredients, strength and excipients, pack size, method of administration or formulation;
- previous accounting reference period
means the one immediately preceding its current accounting reference period.
- primary medical services provider
means any person who provides primary medical services (who may be a provider of pharmaceutical services as well as primary medical services) under— (a) Part 4 of the 2006 Act;
- public contract
means— (a) a contract of a kind specified in section 3(2) of the Procurement Act 2023, where the contract was awarded under that Act;
- qualified independent auditor
means the auditor of the manufacturer's or supplier's statutory audited accounts, or with the agreement of the Secretary of State, another suitably qualified auditor.
- quarter
means, in relation to a financial year which is of at least three months duration, the three month period beginning on the first day of the financial year, and every subsequent three month period in that year even if there are more than four such periods in that financial year;
- reference anchor date
means in relation to— (a) an older presentation supplied by a manufacturer or supplier who is an originator, originator licensee, vaccine originator or vaccine originator licensee of that presentation, is the 1st January of the year before that presentation finally ceased to be a newer presentation in accordance with regulation 3B;
- reference price
has the meaning given to it in regulation 3C(9).
- relevant medicine
means a health service medicine— (a) which is a branded medicine or a biological medicinal product (whether or not it is a branded medicine);
- relevant NHS BSA online gateway
means the service provided for on the NHS BSA website for receiving information for the purpose in question;
- relevant period
has the meaning given to it in regulation 3A(5);
- relevant UK hospital
means— (a) a UK health service hospital;
- relevant virtual therapeutic moiety
has the meaning given to it in regulation 3B(9).
- remaining period
means— (a) in relation to a financial year which is of less than three months' duration, the entire financial year;
- review of any information provided to the Secretary of State
includes review of estimated or audited information.
- review period
means the period of one year beginning on the date of the coming into force of these Regulations.
- statutory audited accounts
means— (a) in relation to individual accounts of the manufacturer or supplier required to be audited in accordance with Part 16 of the Companies Act 2006, the individual accounts audited in accordance with Part 16 of that Act;
- supplementary protection certificate
has the meaning given by section 128B(2) of the Patents Act 1977;
- supplier
means any person who supplied any item of presentation and is not limited to circumstances where that supply is by way of sale.
- supply
means supply by way of sale unless the context otherwise requires;
- the 1978 Act
means the National Health Service (Scotland) Act 1978;
- the 2006 Act
means the National Health Service Act 2006;
- the 2006 Wales Act
means the National Health Service (Wales) Act 2006;
- the 2008 Regulations
means the Health Service Branded Medicines (Control of Prices and Supply of Information)(No.2) Regulations 2008;
- the 2012 Regulations
means the Human Medicines Regulations 2012;
- UKHSA
means the executive agency of the Department of Health and Social Care known as the United Kingdom Health Security Agency;
- unbranded generic health service medicine
means a health service medicine the labelling of which includes the common name of the medicinal product but does not include an invented name;
- vaccine
has the meaning given in regulation 8(1) of the 2012 Regulations.
- vaccine originator
means, in relation to an active ingredient or a combination of active ingredients of a relevant medicine for a presentation that is a vaccine— (a) the person who— (a) received the first marketing authorisation of any presentation for the applicable virtual therapeutic moiety, (b) is not the same person specified in paragraph (i) but who holds a valid supplementary protection certificate for the active ingredient or combination of active ingredients, or (c) if different from the persons specified in paragraph (i) or (ii), was the first person to place the relevant medicine on the market for health service use and, at the time, the licensing authority designated the presentation to include a new active substance;
- vaccine originator licensee
means a person, other than a vaccine originator, who is marketing a vaccine and was, during the period the presentation is a newer presentation— (a) doing so under a licence from the vaccine originator permitting the marketing of the relevant medicine;
- virtual medicinal product pack
means an abstract representation of a relevant medicine as formulated in the medicines information standard which has any one or more of the characteristics of active ingredients, strength, excipients, pack size, method of administration or formulation in common with similar presentations which have been placed on the market for health service use by any manufacturer or supplier.
- virtual therapeutic moiety
means the abstract representation of an active ingredient or active ingredients of a relevant medicine formulated in the medicines information standard as— (a) a medicinal product;
- voluntary scheme
means a scheme referred to in section 261(1) of the 2006 Act;
- voluntary scheme presentation
means a presentation covered by a voluntary scheme at the time of supply of that presentation;
- wholesaler
means a person who— (a) is a holder of a wholesale dealer's licence;