In these Regulations—

• “the 1978 Act” means the National Health Service (Scotland) Act 19782;

• “the 2006 Act” means the National Health Service Act 2006;

• “the 2006 Wales Act” means the National Health Service (Wales) Act 20063;

• “the 1972 Order” means the Health and Personal Social Services (Northern Ireland) Order 19724;

• “Annual Financial Return” means the Annual Financial Return that must be submitted by a scheme member under the PPRS;

• “branded health service medicine” means a health service medicine which—

  1. a

     is identifiable by and traded under a specific name given to it by the manufacturer, supplier or holder of a marketing authorisation relating to it;

  2. b

     is a medicinal product in respect of which a marketing authorisation has been granted; and

  3. c

     is not—

     1. i

        in relation to England, listed in Schedule 1 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 20045;

     2. ii

        in relation to Scotland, specified in any directions given by the Scottish Ministers under section 17N(6) (other mandatory contract terms)6 of the 1978 Act as being drugs, medicines or other substances which may not be ordered by a GMS contractor for patients in the provision of primary medical services under a general medical services contract made under section 17J (health boards power to enter into general medical services contracts)7 of the 1978 Act in relation to Scotland; or

     3. iii

        in relation to Northern Ireland, listed in Schedule 1 to the Health and Personal Social Services (General Medical Services Contracts) (Prescription of Drugs Etc.) Regulations (Northern Ireland) 20048;

• “dispensing doctor” means a registered medical practitioner who provides pharmaceutical services;

• “GMS contractor” means a person providing primary medical services under a general medical services contract made under—

  1. a

     section 84 (general medical services contracts: introductory) of the 2006 Act in relation to England;

  2. b

     section 42 (general medical services contracts: introductory) of the 2006 Wales Act in relation to Wales;

  3. c

     section 17J (health boards power to enter into general medical services contracts) of the 1978 Act in relation to Scotland; or

  4. d

     article 57 of the 1972 Order in relation to Northern Ireland;

• “health service hospital” means a hospital owned or managed by a health service body;

• “health service body” means—

  1. a

     a Strategic Health Authority, Special Health Authority, Primary Care Trust, National Health Service Trust or NHS foundation trust established or continued under the 2006 Act;

  2. b

     a Local Health Board established or continued under the 2006 Wales Act;

  3. c

     a Health Board or Special Health Board constituted under section 2 (Health Boards and Special Health Boards)9 of the 1978 Act;

  4. d

     a Health and Social Services Board established under the 1972 Order;

  5. e

     a special health and social services agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 199010;

  6. f

     the Common Services Agency for the Scottish Health Service constituted under section 10 (Common Services Agency)11 of the 1978 Act;

  7. g

     the Northern Ireland Central Services Agency for the Health and Social Services established under the 1972 Order; or

  8. h

     a Health and Social Services trust established under the Health and Personal Social Services (Northern Ireland) Order 199112;

• “marketing authorisation” means a marketing authorisation for a medicinal product for human use granted—

  1. a

     by the competent authority of the United Kingdom in accordance with Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use13; or

  2. b

     by the European Commission in accordance with Regulation (EC) No. 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency14;

• “pharmaceutical services” means pharmaceutical services within the meaning of—

  1. a

     section 126 (arrangements for pharmaceutical services) of the 2006 Act in England;

  2. b

     section 80 (arrangements for pharmaceutical services) of the 2006 Wales Act in Wales;

  3. c

     section 27 (arrangements for provision of pharmaceutical services)15 of the 1978 Act in Scotland; or

  4. d

     article 63 (arrangements for pharmaceutical services) of the 1972 Order in Northern Ireland;

• “PMS contractor” means a person providing primary medical services under—

  1. a

     a personal medical services agreement made under section 92 (arrangements by Strategic Health Authorities for the provision of primary medical services) in relation to England;

  2. b

     an agreement made under section 50 (arrangements by Local Health Boards for the provision of primary medical services) of the 2006 Wales Act in relation to Wales;

  3. c

     an agreement made under section 17C (personal medical or dental services)16 of the 1978 Act in relation to Scotland; or

  4. d

     a personal medical services agreement made under article 15B (provision of primary medical services or personal dental services) of the 1972 Order in relation to Northern Ireland;

• “PPRS” means the Pharmaceutical Price Regulation Scheme17;

• “quarter” means the period—

  1. a

     1st January to 31st March;

  2. b

     1st April to 30th June;

  3. c

     1st July to 30th September; or

  4. d

     1st October to 31st December;

• “relevant scheme member” means a scheme member who falls within regulation 3(1) but who does not fall within regulation 3(2) (unless regulation 3(3) applies);

• “retail pharmacist” means a person lawfully conducting a retail pharmacy business in accordance with section 69 (general provisions) of the Medicines Act 196818 who provides pharmaceutical services;

• “sales income” means income from sales after deduction of all trade and other discounts (howsoever named) including settlement discounts, rebates and sales taxes;

• “supply” means supply by way of sale; and

• “wholesaler” means a person who—

  1. a

     is a holder of a wholesale dealer’s licence within the meaning of subsection (3) and (3A) of section 8 (provisions as to manufacture and wholesale dealing)19 of the Medicines Act 1968; and

  2. b

     is not a retail pharmacist, dispensing doctor, GMS contractor or PMS contractor nor is a health service hospital.

A health service medicine is supplied on the date on which a contract for its sale for health service use is concluded.