InterpretationE+W
This section has no associated Explanatory Memorandum
3. In these Regulations—
“the Act” means the National Health Service Act 2006;
“2004 Regulations” means the National Health Service (Personal Medical Services Agreements) Regulations 2004;
“adjudicator” means the Secretary of State or a person or persons appointed by the Secretary of State under section 9(8) of the Act (NHS contracts) or under regulation 76(5)(b);
[“advanced electronic signature” means an electronic signature which meets the following requirements—
(a)
it is uniquely linked to the signatory;
(b)
it is capable of identifying the signatory;
(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
(d)
it is linked to the data signed in such a way that any subsequent change in the data is detectable;]
“agreement”, except in regulation 88 [or in the definitions of “contract of engagement” and “third party contract” in regulation 21AA], means an agreement for primary medical services made under section 92 of the Act (arrangements by [NHS England] for the provision of primary medical services);
“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 (arrangements for pharmaceutical services);
[“appropriate person”—
(a)
in relation to a person who has not attained the age of 16 years, means a person mentioned in paragraph 17(4)(a)(i), (ii) or (iii) of Schedule 2;
(b)
in relation to a person who lacks capacity—
(i)
to make an application or provide information to, to accept an offer from, or otherwise communicate with, the contractor, or
(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 17(4)(b)(i), (ii), (iii) or (iv) of Schedule 2;]
“armed forces GP” means a medical practitioner, who is employed on a contract of service by the Ministry of Defence, whether or not as a member of the armed forces of the Crown;
“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 ;
“assessment panel” means the panel appointed by [NHS England] for the purposes of making determinations under paragraph 40(3) of Schedule 2;
[“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 (bank holidays);
“batch issue” means a form, in the format required by [NHS England] and approved by the Secretary of State, which—
(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;
(b)
relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;
(c)
is generated by a computer and not signed by a repeatable prescriber;
(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
(e)
has included on it a number denoting its place in the sequence referred to in paragraph (d);
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“CCT” means a certificate of completion of training awarded under section 34L(1) of the Medical Act 1983 (award and withdrawal of a Certificate of Completion of Training) ...;
“charity trustee” means one of the persons having the general control, management and administration of a charity;
“chemist” means—
(a)
a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 (general provisions); or
(b)
a supplier of appliances,
who is included in the list held by [NHS England] under section 129 of the Act (regulations as to pharmaceutical services), or a local pharmaceutical services scheme made under Schedule 12 to the Act (LPS Schemes);
“child” [, other than in Part 2A of Schedule 2,] means a person who has not attained the age of 16 years;
“chiropodist or podiatrist independent prescriber” means a person who—
(a)
is engaged or employed by a party to the agreement; and
(b)
is registered in Part 2 of the register maintained under article 5 of the [Health 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 agreement 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;
“contractor”, except in regulation 5, means a person or persons other than [NHS England] who is a party, or who are parties, to the agreement;
[“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 [NHS England] under paragraph 13 of Schedule 2;
“core hours” means [, 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;
[“digital practice area map” means a map of the practice area produced on digital tools provided by NHS England;]
[“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 would like 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 ;
“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 (arrangements for additional pharmaceutical services);
“electronic communication” has the meaning given in section 15 of the Electronic Communications Act 2000 (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 [NHS England];
“electronic repeatable prescription” means a prescription which falls within paragraph (b) of the definition “repeatable prescription”;
[“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;]
[“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;]
[“EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—
(a)
is issued by a prescriber at the same time as an electronic prescription is created; and
(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 of the General Medical Services Contracts Regulations;
“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 (registration of medical practitioners);
“General Medical Services Contracts Regulations” means the National Health Service (General Medical Services Contracts) Regulations 2015 ;
[“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;]
“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 (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 the Health and Social Services (Northern Ireland) Order 1972 (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 (ancillary services);
“Health Board” means a Health Board established under section 2 of the National Health Service (Scotland) Act 1978 (Health Boards);
“health care professional” has the meaning given in section 108 of the Act (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 (NHS contracts);
“home oxygen order form” means a form provided by [NHS 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—
(a)
ambulatory oxygen supply;
(c)
hospital discharge supply;
(d)
long term oxygen therapy; and
(e)
short burst oxygen therapy;
“immediate family member” means—
(a)
a spouse or civil partner;
(b)
a person whose relationship with the registered patient has the characteristics of the relationship between spouses;
(c)
a parent or step-parent;
(e)
a child of whom the registered patient is—
(ii)
the carer duly authorised by the local authority to whose care the child has been committed under the Children Act 1989 ; or
“independent nurse prescriber” means a person—
(a)
who is either engaged or employed by the contractor or who is a party to the agreement;
(b)
who is registered in the Nursing and Midwifery Register; and
(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 community practitioner nurse prescriber, a nurse independent prescriber or as a nurse independent/supplementary prescriber;
[“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;
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[“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);]
[“listed prescription items voucher” means a form which—
(a)
is provided or approved by [NHS 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
(b)
may be an electronic form sent or to be sent via a secure service approved for this purpose by [NHS England];]
“Local Health Board” means a body established under section 11 of the National Health Service (Wales) Act 2006 (Local Health Boards);
“Local Medical Committee” means a committee recognised by [NHS England] under section 97 of the Act (local medical committees);
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“medical performers list” means the list of medical practitioners maintained and published by [NHS England] in accordance with section 91 of the Act (persons performing medical services);
“Medical Register” means the registers kept under section 2 of the Medical Act 1983 (registration of medical practitioners);
“national disqualification” means—
(a)
a decision made by the First-tier Tribunal under section 159 of the Act (national disqualification) or under regulations corresponding to that section made under—
(i)
section 91(3) of the Act (persons performing primary medical services),
(ii)
section 106(3) of the Act (persons performing primary dental services),
(iii)
section 123(3) of the Act (persons performing primary ophthalmic services), and
(iv)
section 145, 146 or 147A (performers of pharmaceutical services and assistants),
of the Act ; or
(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 (NHS contracts);
“NHS dispute resolution procedure” means the procedure for the resolution of disputes specified—
(b)
in a case to which paragraph 41 of Schedule 2 applies, in that paragraph;
[“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 (NHS foundation trusts);
“NHS trust” means a body established under section 25 of the Act (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 operated by [NHS 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—
(a)
is provided by [NHS England], a local authority or the Secretary of State;
(b)
is issued, or is to be issued, by the prescriber;
(c)
indicates that the drug, medicine or appliance ordered may be provided more than once; and
(d)
specifies, or is to specify, the number of occasions on which the drug, medicine or appliance may be provided;
“normal hours” means those days and hours on which and the times at which services under the agreement are normally made available and 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 (establishment and maintenance of register);
[“online consultation tool” has the meaning given in regulation 64ZD;]
[“online practice profile” has the meaning given in regulation 66(7);]
“open”, in relation to a contractor's list of patients, means open to applications from patients in accordance with paragraph 17 of Schedule 2;
“optometrist independent prescriber” means a person—
(a)
who is registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989 (register of opticians); and
(b)
against whose name 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 [subject to regulation 3A(2)]—
(a)
the period beginning at 6.30pm on any day from Monday to Thursday and ending at 8.00am on the following day;
(b)
the period beginning at 6.30pm on Friday and ending at 8.00am on the following Monday; and
(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 would be essential services if provided by a contractor to its registered patients in core hours;
[“paramedic independent prescriber” means a person—
(a)
who is either engaged or employed by the contractor or who is a party to the agreement;
(b)
who is registered in the register maintained by the Health and Care Professions Council under article 5 of the [Health Professions Order 2001] (establishment and maintenance of register); and
(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, an 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—
(c)
persons to whom the contractor is required to provide immediately necessary treatment as part of its obligation to provide essential services; and
(d)
any other person to whom the contractor has agreed to provide services under the agreement; and
(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 agreement to whom the provisions of Part 8 of these Regulations applies;
“pharmacist independent prescriber” means a person who—
(a)
is either engaged or employed by the contractor or is a party to the agreement;
(b)
is registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (establishment, maintenance and access to the Register), or the register maintained under article 6 (the registers) and 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976 ; and
(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—
(a)
engaged or employed by the contractor or is a party to the agreement; and
(b)
registered in Part 9 of the register maintained under article 5 of the [Health Professions Order 2001] (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that that person 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 (programmes for provisionally registered doctors) as providing 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 agreement;
“practice area” means the area specified in the agreement as the area in which essential services are to be provided;
“practice leaflet” means a leaflet drawn up in accordance with regulation 71;
“practice premises” means an address specified in the agreement as one at which services are to be provided under the agreement;
[“practice website” means [a] website through which the contractor advertises the primary medical services it provides;]
[“prescriber” means—
(a)
a chiropodist or podiatrist independent prescriber;
(b)
an independent nurse prescriber;
(c)
a medical practitioner;
(d)
an optometrist independent prescriber;
(e)
a paramedic independent prescriber;
(f)
a pharmacist independent prescriber;
(g)
a physiotherapist independent prescriber;
(h)
a supplementary prescriber; and
(i)
a therapeutic radiographer independent prescriber;]
“prescription form” means—
(a)
a form for the purpose of ordering a drug, medicine or appliance which is—
(i)
provided by [NHS England], a local authority or the Secretary of State which is in the form required by the NHS Business Services Authority ,
(ii)
issued, or is to be issued, by the prescriber, and
(iii)
does not indicate that the drug, medicine or appliance ordered may be provided more than once; or
(b)
in the case of an electronic prescription to which regulation 50 applies, data created in an electronic form for the purpose of ordering a drug, medicine or appliance, which—
(i)
is signed, or is to be signed, with a prescriber's electronic signature,
(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
(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 (classification of medicinal products);
“primary care list” means—
(a)
a list of persons performing primary medical services, primary dental services or primary ophthalmic services or pharmaceutical services prepared in accordance with regulations made under—
(i)
section 91 of the Act (persons performing primary medical services),
(ii)
section 106 of the Act (persons performing primary dental services),
(iii)
section 123 of the Act (persons performing primary ophthalmic services), and
(iv)
sections 145, 146, 147A or 149 (performers of pharmaceutical services and assistants),
of the Act ;
(b)
a list of persons undertaking to provide, or assist in the provision of—
(i)
primary medical services, prepared in accordance with regulations made under Part 4 of the Act (primary medical services),
(ii)
primary dental services, prepared in accordance with regulations made under Part 5 of the Act (primary dental services),
(iii)
primary ophthalmic services prepared in accordance with regulations made under Part 6 of the Act (persons performing primary ophthalmic services),
(iv)
pharmaceutical services, prepared in accordance with regulations made under Part 7 of the Act (pharmaceutical services and local pharmaceutical services); or
(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 agreement immediately before the coming into force of section 34 of the Health and Social Care Act 2012 (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 Part 4 of the Act applies;
[“private services” means the provision of any treatment which would amount to primary medical services if it was provided under or by virtue of a contract or agreement to which the provisions of Part 4 of the Act apply;]
“registered patient” means a person—
(a)
who is recorded by [NHS England] as being included in the contractor's list of patients; or
(b)
whom the contractor has accepted for inclusion in its list of patients, whether or not notification of that acceptance has been received by [NHS England] and who has not been notified by [NHS England] as having ceased to be on that list;
“relevant register” means—
(a)
in relation to a nurse, the Nursing and Midwifery Register;
(b)
in relation to a pharmacist, Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (establishment, maintenance 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 ;
(c)
in relation to an optometrist, the register maintained by the General Optical Council under section 7(a) of the Opticians Act 1989 (register of opticians); and
(d)
the part of the register maintained by the Health and Care Professions Council under article 5 of the [Health Professions Order 2001] (establishment and maintenance of register) relating to—
(i)
[chiropodists and podiatrists,
(iii)
physiotherapists, or
[“remote service” means—
(a)
an online consultation under regulation 64ZD;
(b)
a secure electronic communication under regulation 64ZE;
(c)
a video consultation under regulation 64ZF;
(d)
a telephone consultation;
(e)
an electronic prescription;
(f)
any other service which can be provided through a digital or telecommunications method, including administrative tasks in support of the agreement;]
“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—
(a)
engaged or employed by a contractor which provides repeatable prescribing services under the terms of its agreement which give effect to regulation 52; or
(b)
a party to an agreement 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—
(a)
a form provided by [NHS England], 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 Business Services Authority , and which—
(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,
(ii)
indicates, or is to indicate, that the drug, medicine or appliance ordered may be provided more than once, and
(iii)
specifies, or is to specify, the number of occasions on which the drug, medicine or appliance may be provided; or
(b)
in the case of an electronic prescription to which regulation 50 applies, data created in an electronic form for the purpose of ordering a drug, medicine or appliance, which—
(i)
is signed, or is to be signed, with a prescriber's advanced electronic signature,
(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
(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 particular purposes only;
“Scheduled drug” means—
(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 agreement; or
(b)
except where the conditions set out in regulation 54(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 (GMS contracts: prescription of drugs etc) as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes;
[“signatory” means a natural person who creates an electronic signature;]
“supplementary prescriber” means a person—
(a)
who is either engaged or employed by the contractor or is a party to the agreement;
(b)
whose name is registered in—
(i)
the Nursing and Midwifery Register,
(ii)
Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (establishment, maintenance of and access to the register),
(iii)
the register maintained under articles 6 (the Register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976 ,
(iv)
[the register maintained by the Health and Care Professions Council under article 5 of the [Health Professions Order 2001] (establishment and maintenance of register) relating to—
(aa)
chiropodists and podiatrists,
(v)
the register of optometrists maintained by the General Optical Council under section 7(a) of the Opticians Act 1989 (register of opticians); and
(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—
(a)
accepted by the contractor as a temporary resident under paragraph 19, 31E or 31G of Schedule 2, and
(b)
for whom the contractor’s responsibility has not terminated under paragraph 19, 31E or 31G (as the case may be) of Schedule 3.]
[“therapeutic radiographer independent prescriber” means a radiographer—
(a)
who is registered in Part 11 of the register maintained under article 5 of the [Health Professions Order 2001]; and
(b)
against whose name in that register is recorded—
(i)
an entitlement to use the title “therapeutic radiographer”, and
(ii)
an annotation signifying that the radiographer is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;]
“working day” means any day except Saturday, Sunday, Christmas Day, Good Friday or a bank holiday; and
“writing”, except in paragraph 52(1) of Schedule 2, includes electronic mail and “written” is to be construed accordingly.
Textual Amendments
Marginal Citations