In these Regulations—

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

• “2004 Regulations” means the National Health Service (General Medical Services Contracts) Regulations 2004;

• “2010 Order” means the Postgraduate Medical Education and Training Order of Council 20103;

• “additional services” means one or more of the following—

  1. a

     cervical screening services;

  2. b

     contraceptive services;

  3. c

     childhood vaccines and immunisations;

  4. d

     vaccines and immunisations;

  5. e

     child health surveillance services;

  6. f

     maternity medical services; and

  7. g

     minor surgery;

• “adjudicator” means the Secretary of State or one or more people appointed by the Secretary of State under section 9(8) of the Act4 (NHS contracts) or under regulation 83(5)(b);

• “advanced electronic signature” means an electronic signature which is—

  1. a

     uniquely linked to the signatory;

  2. b

     capable of identifying the signatory;

  3. c

     created using means that the signatory can maintain under the signatory’s sole control; and

  4. d

     linked to the data to which it relates in such a manner that any subsequent change of data is detectable;

• “appliance” means an appliance which is included in a list for the time being approved by the Secretary of State for the purposes of section 126 of the Act5 (arrangements for pharmaceutical services);

• “armed forces of the Crown” means the forces that are “regular forces” or “reserve forces” within the meaning given in section 374 of the Armed Forces Act 20066;

• “assessment panel” means the panel appointed by the Board for the purpose of making determinations under paragraph 41(7) of Schedule 3;

• “bank holiday” means any day that is specified or proclaimed as a bank holiday in England and Wales under section 1 of the Banking and Financial Dealings Act 19717 (bank holidays);

• “batch issue” means a form, in the format required by the Board and approved by the Secretary of State, which—

  1. a

     is issued by a repeatable prescriber at the same time as a non-electronic repeatable prescription to enable a chemist or person who provides dispensing services to receive payment for the provision of repeat dispensing services;

  2. b

     relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;

  3. c

     is generated by a computer and not signed by a repeatable prescriber;

  4. d

     is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs, medicines or appliances ordered on the non-electronic repeatable prescription may be provided; and

  5. e

     has included on it a number denoting its place in the sequence referred to in paragraph (d);

• “the Board” means the National Health Service Commissioning Board8;

• “Care Quality Commission” means the body established under section 1 of the Health and Social Care Act 20089 (The Care Quality Commission);

• “CCG” means a clinical commissioning group10;

• “CCT” means a certificate of completion of training awarded under section 34L(1) of the Medical Act 198311 (award and withdrawal of a Certificate of Completion of Training) including any such certificate awarded in pursuance of the competent authority functions of the General Medical Council specified in section 49B of, and Schedule 4A to, that Act12 (The Directive: designation of competent authority etc.);

• “cervical screening services” means the services described in paragraph 2(2) of Schedule 1;

• “charity trustee” means one of the persons having the general control, management and administration of a charity;

• “chemist” means—

  1. a

     a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 196813 (general provisions); or

  2. b

     a supplier of appliances,

  who is included in the list held by the Board under section 129 of the Act14 (regulations as to pharmaceutical services), or a local pharmaceutical services scheme made under Schedule 12 to the Act (LPS Schemes);

• “child” means a person who has not attained the age of 16 years;

• “child health surveillance services” means the services described in paragraph 6(2) of Schedule 1;

• “childhood vaccines and immunisations” means the services described in paragraph 5(2) of Schedule 1;

• “chiropodist or podiatrist independent prescriber” means a person—

  1. a

     who is engaged or employed by the contractor or is a party to the contract; and

  2. b

     who is registered in Part 2 of the register maintained under article 5 of the Health and Social Work Professions Order 200115 (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that the chiropodist or podiatrist is qualified to order drugs, medicines and appliances as a chiropodist or podiatrist independent prescriber;

• “clinical services” means medical services under the contract which relate to the actual observation and treatment of patients;

• “closed”, in relation to a contractor’s list of patients, means closed to applications for inclusion in the list of patients other than from immediate family members of registered patients;

• “contraceptive services” means the services described in paragraph 3(2) of Schedule 1;

• “contract”, except in regulation 96, means a general medical services contract made under section 84(2) of the Act16 (general medical services contracts: introductory);

• “contractor”, except in regulation 6, has the meaning given in section 84(5) of the Act (general medical services contracts: introductory);

• “contractor’s list of patients” means the list prepared and maintained by the Board under paragraph 17 of Schedule 3;

• “core hours” means the period beginning at 8.00am and ending at 6.30pm on any day from Monday to Friday except Good Friday, Christmas Day or bank holidays;

• “dispenser” means a chemist, medical practitioner or contractor whom a patient wishes to dispense the patient’s electronic prescriptions;

• “dispensing services” means the provision of drugs, medicines or appliances that may be provided as pharmaceutical services by a medical practitioner in accordance with arrangements under section 126 (arrangements for pharmaceutical services) and section 132 (persons authorised to provide pharmaceutical services) of the Act17;

• “Drug Tariff” means the publication known as the Drug Tariff which is published by the Secretary of State and which is referred to in section 127(4) of the Act18 (arrangements for additional pharmaceutical services);

• “electronic communication” has the meaning given in section 15 of the Electronic Communications Act 200019 (general interpretation);

• “electronic prescription” means an electronic prescription form or an electronic repeatable prescription;

• “electronic prescription form” means a prescription form which falls within paragraph (b) of the definition of “prescription form”;

• “Electronic Prescription Service” means the service of that name which is managed by the Health and Social Care Information Centre20;

• “electronic repeatable prescription” means a prescription which falls within paragraph (b) of the definition of “repeatable prescription”;

• “enhanced services” are—

  1. a

     services other than essential services, additional services or out of hours services; or

  2. b

     essential services, additional services or out of hours services, or an element of such a service, that a contractor agrees under the contract to provide in accordance with specifications set out in a plan, which requires of the contractor an enhanced level of service provision compared to that which it needs generally to provide in relation to that service or element of that service;

• “essential services” means the services required to be provided in accordance with regulation 17;

• “financial year” has the meaning given in section 275(1) of the Act (interpretation);

• “general medical practitioner” means a medical practitioner whose name is included in the General Practitioner Register kept by the General Medical Council under section 2 of the Medical Act 198321 (registration of medical practitioners);

• “global sum” has the meaning given in the GMS Statement of Financial Entitlements;

• “GMS Statement of Financial Entitlements”22 means the directions given by the Secretary of State under section 87 of the Act23 (GMS contracts: payments);

• “GP Specialty Registrar” means a general medical practitioner who is being trained in general practice by a general medical practitioner who is approved under section 34I(1)(c) of the Medical Act 198324 (postgraduate education and training: approvals) for the purpose of providing training in accordance with that section, whether as part of training leading to a CCT or otherwise;

• “Health and Social Services Board” means a Health and Social Services Board established under article 16 of the Health and Social Services (Northern Ireland) Order 197225 (establishment of Health and Social Services Boards);

• “Health and Social Services Trust” means a Health and Social Services Trust established under article 10 of the Health and Personal Services (Northern Ireland) Order 199126 (ancillary services);

• “Health Board” means a Health Board established under section 2 of the National Health Service (Scotland) Act 197827 (Health Boards);

• “health care professional” has the meaning given in section 108 of the Act28 (participants in section 107 arrangements) and “health care profession” is to be construed accordingly;

• “health service body” has the meaning given in section 9(4) of the Act29 (NHS contracts);

• “home oxygen order form” means a form provided by the Board and issued by a health care professional to authorise a person to supply home oxygen services to a patient requiring oxygen therapy at home;

• “home oxygen services” means any of the following forms of oxygen therapy or supply—

  1. a

     ambulatory oxygen supply;

  2. b

     urgent supply;

  3. c

     hospital discharge supply;

  4. d

     long term oxygen therapy; and

  5. e

     short burst oxygen therapy;

• “immediate family member” means—

  1. a

     a spouse or civil partner;

  2. b

     a person whose relationship with the registered patient has the characteristics of the relationship between spouses;

  3. c

     a parent or step-parent;

  4. d

     a son or daughter;

  5. e

     a child of whom the registered patient is—

     1. i

        the guardian, or

     2. ii

        the carer duly authorised by the local authority to whose care the child has been committed under the Children Act 198930; or

  6. f

     a grandparent;

• “independent nurse prescriber” means a person—

  1. a

     who is either engaged or employed by the contractor or who is a party to the contract;

  2. b

     who is registered in the Nursing and Midwifery Register; and

  3. c

     against whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines or appliances as a community practitioner nurse prescriber, a nurse independent prescriber or as a nurse independent/supplementary prescriber;

• “licensing body” means a body that licenses or regulates a profession;

• “limited partnership” means a partnership registered in accordance with section 5 of the Limited Partnerships Act 190731 (registration of limited partnerships required);

• “listed medicines” means the drugs mentioned in regulation 13(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 201532;

• “listed medicines voucher” means a form provided by the Board for use for the purpose of ordering a listed medicine;

• “Local Health Board” means a body established under section 11 of the National Health Service (Wales) Act 200633 (Local Health Boards);

• “Local Medical Committee” means a committee recognised by the Board under section 97 of the Act34 (local medical committees);

• “maternity medical services” means the services described in paragraph 7(1) of Schedule 1;

• “medical card” means a card issued by the Board or a Local Health Board, Health Authority, Health Board or Health and Social Services Board to a person for the purpose of enabling that person to obtain, or to establish entitlement to receive, primary medical services;

• “medical performers list” means the list of medical practitioners maintained and published by the Board in accordance with section 91 of the Act35 (persons performing primary medical services);

• “Medical Register” means the registers kept under section 2 of the Medical Act 198336 (registration of medical practitioners);

• “minor surgery” means the services described in paragraph 8(2) of Schedule 1;

• “national disqualification” means—

  1. a

     a decision made by the First Tier Tribunal under section 159 of the Act37 (national disqualification) or under regulations corresponding to that section made under—

     1. i

        section 91(3) of the Act (persons performing primary medical services),

     2. ii

        section 106(3) of the Act (persons performing primary dental services),

     3. iii

        section 123(3) of the Act (persons performing primary ophthalmic services), and

     4. iv

        sections 145, 146, 147A or 149 (performers of pharmaceutical services and assistants),

  of the Act38; or

  1. a

     a decision under provisions in force in Wales, Scotland or Northern Ireland corresponding to section 159 of the Act (national disqualification);

• “NHS contract” has the meaning given in section 9 of the Act39 (NHS contracts);

• “NHS dispute resolution procedure” means the procedure for the resolution of disputes specified—

  1. a

     in Part 12; or

  2. b

     in a case to which paragraph 42 of Schedule 3 applies, in that paragraph;

• “NHS foundation trust” has the meaning given in section 30 of the Act40 (NHS foundation trusts);

• “NHS trust” means a body established under section 25 of the Act41 (NHS trusts);

• “nominated dispenser” means a chemist, medical practitioner or contractor who has been nominated in respect of a patient where the details of that nomination are held in respect of that patient in the Patient Demographics Service which is managed by the Health and Social Care Information Centre42;

• “non-electronic prescription form” means a prescription form which falls within paragraph (a) of the definition of “prescription form”;

• “non-electronic repeatable prescription” means a prescription form for the purpose of ordering a drug, medicine or appliance which—

  1. a

     is provided by the Board, a local authority or the Secretary of State;

  2. b

     is issued, or is to be issued, by the prescriber;

  3. c

     indicates that the drug, medicine or appliance ordered may be provided more than once; and

  4. d

     specifies, or is to specify, the number of occasions on which the drag, medicine or appliance may be provided;

• “normal hours” means those days and hours on which and the times at which services under the contract are normally made available and normal hours may be different for different services;

• “Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 200143 (establishment and maintenance of register);

• “open”, in relation to a contractor’s list of patients, means open to applications from patients in accordance with paragraph 18 of Schedule 3;

• “optometrist independent prescriber” means a person—

  1. a

     who is registered in the register of optometrists maintained under section 7(a) of the Opticians Act 198944 (register of opticians); and

  2. b

     against whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;

• “out of hours period” means—

  1. a

     the period beginning at 6.30pm on any day from Monday to Thursday and ending at 8.00am on the following day;

  2. b

     the period beginning at 6.30pm on Friday and ending at 8.00am on the following Monday; and

  3. c

     Good Friday, Christmas Day and bank holidays,

  and “part” of an out of hours period means any part of any one or more of the periods described in paragraphs (a) to (c);

• “out of hours services” means the services required to be provided in all or part of the out of hours period which—

  1. a

     would be essential services if provided by a contractor to its registered patients in core hours; or

  2. b

     are included in the contract as additional services funded under the global sum;

• “parent” includes, in relation to any child, any adult who, in the opinion of the contractor, is for the time being discharging in respect of that child the obligations normally attaching to a parent in respect of their child;

• “patient” means—

  1. a

     a registered patient;

  2. b

     a temporary resident;

  3. c

     persons to whom the contractor is required to provide immediately necessary treatment under regulation 17(7) or (9) respectively;

  4. d

     any other person to whom the contractor has agreed to provide services under the contract; and

  5. e

     any person in respect of whom the contractor is responsible for the provision of out of hours services;

• “performer” means a performer of medical services under the contract to whom the provisions of Part 7 of these Regulations apply;

• “pharmacist independent prescriber” means a person—

  1. a

     who is either engaged or employed by the contractor or is a party to the contract;

  2. b

     who is registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 201045 (establishment, maintenance of and access to the register) or the register maintained under article 6 (the Register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 197646; and

  3. c

     against whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;

• “physiotherapist independent prescriber” means a person who is—

  1. a

     engaged or employed by the contractor or is a party to the contract; and

  2. b

     registered in Part 9 of the register maintained under article 5 of the Health and Social Work Professions Order 200147 (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that that physiotherapist is qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;

• “post registration programme” means a programme that is for the time being recognised by the General Medical Council under regulation 10A of the Medical Act 198348 (programmes for provisionally registered doctors) as providing provisionally registered doctors with an acceptable foundation for future practise as a fully registered medical practitioner;

• “practice” means the business operated by the contractor for the purpose of delivering services under the contract;

• “practice area” means the area referred to in regulation 20(1)(d);

• “practice leaflet” means a leaflet drawn up in accordance with regulation 78;

• “practice premises” means an address specified in the contract as one at which services are to be provided under the contract;

• “prescriber” means—

  1. a

     a chiropodist or podiatrist independent prescriber;

  2. b

     an independent nurse prescriber;

  3. c

     a medical practitioner;

  4. d

     an optometrist independent prescriber;

  5. e

     a pharmacist independent prescriber;

  6. f

     a physiotherapist independent prescriber; and

  7. g

     a supplementary prescriber,

  who is either engaged or employed by the contractor or is a party to the contract;

• “prescription form” means—

  1. a

     a form for the purpose of ordering a drug, medicine or appliance which—

     1. i

        is provided by the Board, a local authority or the Secretary of State and is in the format required by the NHS Business Services Authority49,

     2. ii

        is issued, or is to be issued, by the prescriber, and

     3. iii

        does not indicate that the drug, medicine or appliance ordered may be provided more than once; or

  2. b

     in the case of an electronic prescription to which regulation 57 applies, data created in an electronic form for the purpose of ordering a drug, medicine or appliance, which—

     1. i

        is signed, or is to be signed, with a prescriber’s advanced electronic signature,

     2. ii

        is transmitted, or is to be transmitted, as an electronic communication to a nominated dispensing contractor by the Electronic Prescription Service, and

     3. iii

        does not indicate that the drug, medicine or appliance ordered may be provided more than once;

• “prescription only medicine” means a medicine referred to in regulation 5(3) of the Human Medicines Regulations 201250 (classification of medicinal products);

• “primary care list” means—

  1. a

     a list of persons performing primary medical services, primary dental services, primary ophthalmic services or pharmaceutical services prepared in accordance with regulations made under—

     1. i

        section 91 of the Act (persons performing primary medical services),

     2. ii

        section 106 of the Act (persons performing primary dental services),

     3. iii

        section 123 of the Act (persons performing primary ophthalmic services), or

     4. iv

        sections 145, 146, 147A or 149 (performers of pharmaceutical services and assistants),

     of the Act51;

  2. b

     a list of persons undertaking to provide, or assist in the provision of—

     1. i

        primary medical services in accordance with regulations made under Part 4 of the Act (primary medical services),

     2. ii

        primary dental services in accordance with regulations made under Part 5 of the Act (primary dental services),

     3. iii

        primary ophthalmic services in accordance with regulations made under Part 6 of the Act (primary ophthalmic services), and

     4. iv

        pharmaceutical services in accordance with regulations made under Part 7 of the Act (pharmaceutical services and local pharmaceutical services); or

  3. c

     a list corresponding to any of the above in Wales, Scotland or Northern Ireland;

• “Primary Care Trust” means the Primary Care Trust which was a party to the contract immediately before the coming into force of section 34 of the Health and Social Care Act 201252 (abolition of primary care trusts);

• “primary carer” means, in relation to an adult, the adult or organisation primarily caring for that adult;

• “primary medical services” means medical services provided under or by virtue of a contract or agreement to which the provisions of Part 4 of the Act applies;

• “registered patient” means—

  1. a

     a person who is recorded by the Board as being on the contractor’s list of patients; or

  2. b

     a person whom the contractor has accepted for inclusion in its list of patients, whether or not notification of that acceptance has been received by the Board, and who has not been notified by the Board as having ceased to be on that list;

• “relevant register” means—

  1. a

     in relation to a nurse, the Nursing and Midwifery Register;

  2. b

     in relation to a pharmacist, Part 1 of the register maintained under article 19 of the Pharmacy Order 201053 (establishment, maintenance of and access to the register) or the register maintained under article 6 (the Register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 197654;

  3. c

     in relation to an optometrist, the register maintained by the General Optical Council in pursuance of section 7(a) of the Opticians Act 198955 (register of opticians); and

  4. d

     the part of the register maintained by the Health and Care Professions Council under article 5 of the Health and Social Work Professions Order 200156 (establishment and maintenance of register) relating to—

     1. i

        chiropodists and podiatrists,

     2. ii

        physiotherapists, or

     3. iii

        radiographers;

• “repeat dispensing services” means pharmaceutical services or local pharmaceutical services which involve the provision of drugs, medicines or appliances by a chemist in accordance with a repeatable prescription;

• “repeatable prescriber” means a prescriber who is—

  1. a

     engaged or employed by a contractor which provides repeatable prescribing services under the terms of its contract which give effect to regulation 59; or

  2. b

     a party to a contract under which such services are provided;

• “repeatable prescribing services” means services which involve the prescribing of drugs, medicines or appliances on a repeatable prescription;

• “repeatable prescription” means—

  1. a

     a form provided by the Board, a local authority or the Secretary of State for the purpose of ordering a drug, medicine or appliance which is in the format required by the NHS

  2. b

     Business Services Authority57 and which—

     1. i

        is issued, or is to be issued, by a repeatable prescriber to enable a chemist or person providing dispensing services to receive payment for the provision of repeat dispensing services,

     2. ii

        indicates, or is to indicate, that the drug, medicine or appliance ordered may be provided more than once, and

     3. iii

        specifies, or is to specify, the number of occasions on which the drug, medicine or appliance may be provided; or

  3. c

     in the case of an electronic prescription to which regulation 57 applies, data created in an electronic form for the purpose of ordering a drug, medicine or appliance, which—

     1. i

        is signed, or is to be signed, with a prescriber’s advanced electronic signature,

     2. ii

        is transmitted, or is to be transmitted, as an electronic communication to a nominated dispensing contractor by the Electronic Prescription Service, and

     3. iii

        indicates, or is to indicate, that the drug, medicine or appliance ordered may be provided more than once and specifies, or is to specify, the number of occasions on which the drug, medicine or appliance may be provided;

• “restricted availability appliance” means an appliance which is approved for particular categories of persons or for particular purposes only;

• “Scheduled drug” means—

  1. a

     a drug, medicine or other substance specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs etc.) as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract; or

  2. b

     except where the conditions in regulation 61(3) are satisfied, a drug, medicine or other substance which is specified in any directions given by the Secretary of State under section 88 of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes;

• “section 92 provider” means a person who is providing services in accordance with arrangements under section 92 of the Act58 (arrangements for the provision of primary medical services);

• “service provider” has the meaning given in regulation 2 of the Care Quality Commission (Registration) Regulations 200959 (interpretation);

• “supplementary prescriber” means a person—

  1. a

     who is either engaged or employed by the contractor or is a party to the contract;

  2. b

     whose name is registered in—

     1. i

        the Nursing and Midwifery Register,

     2. ii

        Part 1 of the register maintained under article 19 of the Pharmacy Order 201060 (establishment, maintenance of and access to the register),

     3. iii

        the register maintained under article 6 (the Register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 197661,

     4. iv

        the part of the register maintained by the Health Professions Council under of article 5 of the Health Professions Order 200162 (establishment and maintenance of register) relating to—

        1. aa

           chiropodists and podiatrists,

        2. bb

           physiotherapists, or

        3. cc

           radiographers, or

     5. v

        the register of optometrists maintained by the General Optical Council under section 7(a) of the Opticians Act 198963 (register of opticians); and

  3. c

     against whose name is recorded in the relevant register an annotation or entry signifying that that person is qualified to order drugs, medicines and appliances as a supplementary prescriber or, in the case of the Nursing and Midwifery Register, a nurse independent/supplementary prescriber;

• “temporary resident” means a person accepted by the contractor as a temporary resident under paragraph 20 of Schedule 3 and for whom the contractor’s responsibility has not been terminated in accordance with that paragraph;

• “working day” means any day except Saturday, Sunday, Christmas Day, Good Friday or a bank holiday; and

• “writing”, except in paragraph 57 of Schedule 3, includes electronic mail and “written” is to be construed accordingly.