These Regulations may be cited as the National Health Service (General Medical Services Contracts) Regulations 2015.

They come into force on 7th December 2015.

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 2010 M2;

• F2...

• “adjudicator” means the Secretary of State or one or more people appointed by the Secretary of State under section 9(8) of the Act M3 (NHS contracts) or under regulation 83(5)(b);

• F1“advanced electronic signature” means an electronic signature which meets the following requirements—

  1. a

     it is uniquely linked to the signatory;

  2. b

     it is capable of identifying the signatory;

  3. c

     it is created using electronic signature creation data that the signatory can, with a high level of confidence, use under the signatory’s sole control; and

  4. d

     it is linked to the data signed in such a way that any subsequent change in the 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 Act M4 (arrangements for pharmaceutical services);

• F5“appropriate person”—

  1. a

     in relation to a person who has not attained the age of 16 years, means a person mentioned in paragraph 18(4)(a)(i), (ii) or (iii) of Schedule 3;

  2. b

     in relation to a person who lacks capacity—

     1. i

        to make an application or provide information to, to accept an offer from, or otherwise communicate with, the contractor, or

     2. ii

        to authorise the making of an application or provision of information to, the acceptance of an offer from, or other communication with, the contractor on their behalf,

     means a person mentioned in paragraph 18(4)(b)(i), (ii), (iii) or (iv) of Schedule 3;

• “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 2006 M5;

• “assessment panel” means the panel appointed by F62NHS England for the purpose of making determinations under paragraph 41(7) of Schedule 3;

• F38“authorised person”, in relation to a patient, is a person who is entitled to make an application for pharmaceutical services on behalf of the patient by virtue of regulation 116(a) to (c) of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (authorised persons to apply for services);

• “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 1971 M6 (bank holidays);

• “batch issue” means a form, in the format required by F62NHS England 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);

• F60...

• “Care Quality Commission” means the body established under section 1 of the Health and Social Care Act 2008 M7 (The Care Quality Commission);

• F9...

• “CCT” means a certificate of completion of training awarded under section 34L(1) of the Medical Act 1983 F54(award and withdrawal of a Certificate of Completion of Training) F56...;

• F33“cervical screening services” has the meaning given in paragraph (2);

• “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 1968 M8 (general provisions); or

  2. b

     a supplier of appliances,

  who is included in the list held by F62NHS England under section 129 of the Act M9 (regulations as to pharmaceutical services), or a local pharmaceutical services scheme made under Schedule 12 to the Act (LPS Schemes);

• “child” F3, other than in Part 2A of Schedule 3, means a person who has not attained the age of 16 years;

• F8“child health surveillance services” has the meaning given in paragraph (3);

• F16...

• “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 F15Health Professions Order 2001 (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;

• F35“contraceptive services” means the following services—

  1. a

     the giving of advice about the full range of contraceptive methods;

  2. b

     where appropriate, the medical examination of patients seeking such advice;

  3. c

     the treatment of such patients for contraceptive purposes and the prescribing of contraceptive substances and appliances (excluding the fitting and implanting of intrauterine devices and implants);

  4. d

     the giving of advice about emergency contraception and, where appropriate, the supplying or prescribing of emergency hormonal contraception;

  5. e

     the giving of advice and referral in cases of unplanned pregnancy including advice about the availability of free pregnancy testing in the contractor’s practice area;

  6. f

     the giving of initial advice about sexual health promotion and sexually transmitted infections; and

  7. g

     the referral as necessary to specialist sexual health services, including tests for sexually transmitted infections;

• “contract”, except in regulation 96 F47and in the definitions of “contract of engagement” and “third party contract” in regulation 27AA, means a general medical services contract made under section 84(2) of the Act M10 (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);

• F13“contractor’s EPS phase 4 date” means the date, encoded within the Electronic Prescription Service software, which is the date that a contractor has agreed is to be the date on and after which the contractor’s prescribers are to use the Electronic Prescription Service for all eligible prescriptions;

• “contractor's list of patients” means the list prepared and maintained by F62NHS England under paragraph 17 of Schedule 3;

• “core hours” means F52, subject to regulation 3A(1), 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;

• F63“digital practice area map” means a map of the practice area produced on digital tools provided by NHS England;

• F10“directly bookable appointment” means an appointment of a type which, in line with the guidance entitled “Directly bookable appointments – guidance for practices” issued by NHS England, is available for booking by a registered patient or an appropriate person on their behalf;

• “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 Act M11;

• “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 Act M12 (arrangements for additional pharmaceutical services);

• “electronic communication” has the meaning given in section 15 of the Electronic Communications Act 2000 M13 (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 F39NHS England;

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

• F4“electronic signature” means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign;

• “electronic signature creation data” means unique data which is used by the signatory to create an electronic signature;

• F58“English health service medicine” means a medicinal product used to any extent for the purposes of the health service continued under section 1(1) of the Act;

• “enhanced services” are—

  1. a

     services other than essential services, F51minor surgery or out of hours services; or

  2. b

     essential services, F51minor surgery 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;

• F31“EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—

  1. a

     is issued by a prescriber at the same time as an electronic prescription is created; and

  2. b

     has a barcode that enables the prescription to be dispensed by a provider of pharmaceutical services that is able to use the Electronic Prescription Service for the purposes of dispensing prescriptions, in circumstances where the provider is not dispensing the prescription as a nominated dispenser;

• “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 1983 M14 (registration of medical practitioners);

• F29“GPIT Operating Model” means the document entitled “Securing Excellence in Primary Care (GP) Digital Services: The Primary Care (GP) Digital Services Operating Model 2021-23 V5” issued by NHS England;

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

• “GMS Statement of Financial Entitlements” M15 means the directions given by the Secretary of State under section 87 of the Act M16 (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 1983 M17 (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 1972 M18 (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 1991 M19 (ancillary services);

• “Health Board” means a Health Board established under section 2 of the National Health Service (Scotland) Act 1978 M20 (Health Boards);

• “health care professional” has the meaning given in section 108 of the Act M21 (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 Act M22 (NHS contracts);

• “home oxygen order form” means a form provided by F62NHS England 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 1989 M23; 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;

• F22“integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the Act;

• “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 1907 M24 (registration of limited partnerships required);

• F23...

• F23...

• F28“listed prescription items” means the prescription items mentioned in regulation 13(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 2015 (exemption from charges: risks to public health);

• F28“listed prescription items voucher” means a form which—

  1. a

     is provided or approved by F62NHS England for the purposes of ordering a prescription item mentioned in regulation 13(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 2015; and

  2. b

     may be an electronic form sent or to be sent via a secure service approved for this purpose by F62NHS England;

• “Local Health Board” means a body established under section 11 of the National Health Service (Wales) Act 2006 M25 (Local Health Boards);

• “Local Medical Committee” means a committee recognised by F62NHS England under section 97 of the Act M26 (local medical committees);

• F48“maternity medical services” has the meaning given in paragraph (4);

• F59...

• “medical performers list” means the list of medical practitioners maintained and published by F62NHS England in accordance with section 91 of the Act M27 (persons performing primary medical services);

• “Medical Register” means the registers kept under section 2 of the Medical Act 1983 M28 (registration of medical practitioners);

• F32“minor surgery” has the meaning given in paragraph (6A);

• “national disqualification” means—

  1. a

     a decision made by the First Tier Tribunal under section 159 of the Act M29 (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 Act M30; or

  1. b

     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 Act M31 (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;

• F61“NHS England” means the body corporate established under section 1H of the Act;

• “NHS foundation trust” has the meaning given in section 30 of the Act M32 (NHS foundation trusts);

• “NHS trust” means a body established under section 25 of the Act M33 (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 F39NHS England;

• “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 F62NHS England, 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 2001 M34 (establishment and maintenance of register);

• F25“online consultation tool” has the meaning given in regulation 71ZD(2);

• F26“online practice profile” has the meaning given in regulation 73(7);

• “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 1989 M35 (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 F20subject to regulation 3A(2)—

  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 F19minor surgery funded under the global sum;

• F18“paramedic independent 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 register maintained by the Health and Care Professions Council under article 5 of the F37Health Professions Order 2001 (establishment and maintenance of 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 paramedic independent prescriber;

• “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 2010 M36 (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 1976 M37; 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 F14Health Professions Order 2001 (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 1983 M38 (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;

• F44“practice website” means F27a website through which the contractor advertises the primary medical services it provides;

• F46“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 paramedic independent prescriber;

  6. f

     a pharmacist independent prescriber;

  7. g

     a physiotherapist independent prescriber;

  8. h

     a supplementary prescriber; and

  9. i

     a therapeutic radiographer independent prescriber;

• “prescription form” means—

  1. a

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

     1. i

        is provided by F62NHS England , a local authority or the Secretary of State and is in the format required by the NHS Business Services Authority M39,

     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 F41nominated dispenser or via an information hub 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 2012 M40 (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 Act M41;

  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 2012 M42 (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;

• F6“private services” means the provision of any treatment which would amount to primary medical services if it were provided under or by virtue of a contract or agreement to which the provisions of Part 4 of the Act apply;

• “registered patient” means—

  1. a

     a person who is recorded by F62NHS England 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 F62NHS England, and who has not been notified by F62NHS England 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 2010 M43 (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 1976 M44;

  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 1989 M45 (register of opticians); and

  4. d

     the part of the register maintained by the Health and Care Professions Council under article 5 of the F36Health Professions Order 2001 (establishment and maintenance of register) relating to—

     1. i

        F40 chiropodists and podiatrists,

     2. ii

        paramedics,

     3. iii

        physiotherapists, or

     4. iv

        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;

• F29“remote consultation” means a consultation under the contract in which a patient, or their representative, participates by any means permitted under the contract, other than in person;

• F29“remote service” means a service under the contract which is—

  1. a

     an online consultation under regulation 71ZD;

  2. b

     a secure electronic communication under regulation 71ZE;

  3. c

     a video consultation under regulation 71ZF;

  4. d

     a telephone consultation;

  5. e

     an electronic prescription;

  6. f

     any other service which can be provided through a digital or telecommunications method, including administrative tasks in support of the contract;

• “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;

• F49“repeatable prescription” means—

  1. a

     a form provided by F62NHS England, a local authority or Secretary of State for the purpose of ordering a drug, medicine or appliance which is in the format required by the NHS Business Services Authority 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

  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 dispenser or via an information hub 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 Act M46 (arrangements for the provision of primary medical services);

• “service provider” has the meaning given in regulation 2 of the Care Quality Commission (Registration) Regulations 2009 M47 (interpretation);

• F21“signatory” means a natural person who creates an electronic signature;

• “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 2010 M48 (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 1976 M49,

     4. iv

        F50the register maintained by the Health and Care Professions Council under article 5 of the F24Health Professions Order 2001 (establishment and maintenance of register) relating to—

        1. aa

           chiropodists and podiatrists,

        2. bb

           dieticians,

        3. cc

           paramedics,

        4. dd

           physiotherapists, or

        5. ee

           radiographers, or

     5. v

        the register of optometrists maintained by the General Optical Council under section 7(a) of the Opticians Act 1989 M50 (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;

• F34“temporary resident” means a person—

  1. a

     accepted by the contractor as a temporary resident under paragraph 20, 32E or 32G of Schedule 3, and

  2. b

     for whom the contractor’s responsibility has not terminated under paragraph 20, 32E or 32G (as the case may be) of Schedule 3.

• F12“therapeutic radiographer independent prescriber” means a radiographer—

  1. a

     who is registered in Part 11 of the register maintained under article 5 of the F11Health Professions Order 2001; and

  2. b

     against whose name in that register is recorded—

     1. i

        an entitlement to use the title “therapeutic radiographer”, and

     2. ii

        an annotation signifying that the radiographer is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;

• F42“vaccine and immunisation services” has the meaning given in paragraph (7);

• “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.

For the purposes of paragraph (4)(c) “child” includes a still-born child within the meaning of the Births and Deaths Registration Act 1953 F57 (see section 41(1) of that Act).

For the purposes of paragraph (4)—

• “antenatal period” means the period beginning with the start of the pregnancy and ending with the onset of labour;

• “maternal postnatal consultation” means a consultation with a general medical practitioner, at which the physical and mental health and well-being of the mother is reviewed;

• “postnatal consultation period” means the period which—

  1. a

     begins six weeks after the conclusion of the delivery of the baby, and

  2. b

     ends—

     1. i

        eight weeks after the conclusion of the delivery, or

     2. ii

        if the mother has not been discharged from secondary care services before the end of that period, eight weeks after the mother’s discharge from secondary care services;

• “postnatal period” means the period which—

  1. a

     begins with the later of—

     1. i

        the conclusion of the delivery of the baby, and

     2. ii

        the mother’s discharge from secondary care services, and

  2. b

     ends eight weeks after the conclusion of the delivery;

• “relevant services”—

  1. a

     in relation to a patient (other than a baby), means all primary medical services relating to pregnancy, excluding intra partum care;

  2. b

     in relation to a baby, means any primary medical services necessary in their first eight weeks of life.

For the purposes of paragraph (7)—

• “immunisation information” means—

  1. a

     either—

     1. i

        the patient’s consent to immunisation, or

     2. ii

        where another person consents to immunisation on behalf of the patient, the name of the person who gave that consent and their relationship to the patient;

  2. b

     the batch number, expiry date and title of the vaccine;

  3. c

     the date of administration of the vaccine;

  4. d

     where two vaccines are administered by injections, in close succession, the route of administration and the injection site of each vaccine;

  5. e

     any contraindications to the vaccine; and

  6. f

     any adverse reactions to the vaccine.

For the purposes of paragraphs (2) to (7) “a patient’s record” means the record which is kept in relation to a patient in accordance with regulation 67.