The National Health Service (General Medical Services Contracts) Regulations 2015

• (1) Subject to paragraph (2), a variation of, or amendment to, the contract may only be made in the circumstances provided for in Part 8 of Schedule 3.

• (2) Paragraph (1) does not prevent a variation of, or amendment to, a contract in the circumstances provided for in—

• (a) regulation 30;

• (b) Part 6; and

• (c) paragraphs 44(8), 45(9), 57, 58 and 72 of Schedule 3.

Variation of contracts: registered patients from outside practice area

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• (1) A contractor may accept onto its list of patients a person who resides outside of the contractor's practice area in accordance with paragraph 18 of Schedule 3.

• (2) Subject to paragraphs (5) and (6), the terms of the contractor's contract specified in paragraph (3) must be varied so as to require the contractor to provide to the person any services which the contractor is required to provide to its registered patients under the contract as if the person resided within the contractor's practice area.

• (3) The terms of the contract specified in this paragraph are—

• (a) the terms under which the contractor is to provide essential services;

• (b) the terms under which the contractor is required to provide for arrangements to access services throughout core hours;

• (c) the terms under which the contractor is required to provide out of hours services; and

• (d) the terms which give effect to the following provisions of Schedule 3 (other contractual terms)—

• (i) paragraph 4(1) (attendance at practice premises),

• (ii) paragraph 5(2)(a) (attendance outside practice premises), and

• (iii) paragraph 21(2) (refusal of applications for inclusion in list of patients).

• (4) Where, under paragraph (1), a contractor accepts onto its list of patients a person who resides outside of the contractor's practice area and the contractor subsequently considers that it is not clinically appropriate or practical to continue to provide that patient with services in accordance with the terms specified in paragraph (3), or to comply with those terms, the contract must be varied so as to include a term which has the effect of modifying the application of paragraph 24 of Schedule 3 (which relates to the removal of a patient from the list at the contractor's request) in relation to that patient so that—

• (a) in sub-paragraph (1), the reference to the patient's disability or medical condition is removed; and

• (b) sub-paragraph (4) applies as if, after paragraph (a), there were inserted the following paragraph—

(aa) the reason for the removal is that the contractor considers that it is not clinically appropriate or practical to continue to provide services under the contract to the patient which do not include the provision of such services at the patient's home address.

• (5) Where the contractor is required to provide services to a patient in accordance with arrangements made under paragraph (1), the contract must also be varied so as to include terms which have the effect of releasing the contractor and NHS England from all obligations, rights and liabilities relating to the terms specified in paragraph (3) (including any right to enforce those terms) where, in the opinion of the contractor, it is not clinically appropriate or practical under those arrangements to—

• (a) provide the services in accordance with those terms; or

• (b) comply with those terms.

• (6) The contract must also include a term which has the effect of requiring the contractor to give notice in writing to a person, where the contractor is minded to accept that person on its list of registered patients in accordance with arrangements made under paragraph (1), that the contractor is under no obligation to provide—

• (a) essential services if, at the time treatment is required, it is not clinically appropriate or practical to provide primary medical services given the particular circumstances of the patient;

• (b) out of hours services if, at the time treatment is required, it is not clinically appropriate or practical to provide such services given the particular circumstances of the patient; or

• (c) minor surgery to the patient if it is not clinically appropriate or practical to provide that service given the particular circumstances of the patient.

Termination of a contract

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• (1) A contract may only be terminated in the circumstances provided for by Part 8 of Schedule 3.

• (2) A contract must make suitable provision for the arrangements which are to have effect on termination of the contract, including the consequences (whether financial or otherwise) of the contract ending.

Other contractual terms

32

• (1) Subject to paragraph (2), a contract must also contain provisions which are equivalent in their effect to the provisions set out in Parts 6 to 14 of, and Schedules 1 to 3 to, these Regulations, unless the contract is of a type or nature to which a particular provision does not apply.

• (2) The requirement in paragraph (1) does not apply to the provisions specified in—

• (a) regulation 83(5) to (15);

• (b) regulation 84; and

• (c) paragraphs 41(5) to (9) and 42(5) to (17) of Schedule 3,

which are to have effect in relation to the matters set out in those provisions.

PART 6 — Opt outs: additional and out of hours services

Opt outs: interpretation

33

In this Part—

• “opt out notice” means a notice given under regulation 35(1) to opt out permanently or temporarily of the provision of minor surgery;

• “out of hours opt out notice” means a notice given under regulation 38(1) to opt out permanently of the provision of out of hours services;

• “permanent opt out” in relation to the provision of minor surgery that is funded through the global sum, means the termination of the obligation under the contract for the contractor to provide that service, and “permanently opt out” is to be construed accordingly;

• “permanent opt out notice” means an opt out notice to permanently opt out;

• “preliminary opt out notice” means a notice given under regulation 35(1) that a contractor wants to temporarily opt out or permanently opt out of the provision of minor surgery;

• “temporary opt out” in relation to the provision of minor surgery that is funded through the global sum, means the suspension of the obligation under the contract for the contractor to provide that service for a period of more than six months and less than 12 months and includes an extension of a temporary opt out, and “temporarily opted out” is to be construed accordingly; and

• “temporary opt out notice” means an opt out notice to temporarily opt out.

Opt outs: general

34

Where a contract provides for the contractor to provide—

• (a) minor surgery, or

• (b) out of hours services,

to be funded through the global sum, the contract must contain terms relating to the procedure for opting out of the provision of any such service which have the same effect as those specified in the following provisions of this Part.

Opt outs: additional services

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• (1) Where a contractor wants to permanently or temporarily opt out of the provision of minor surgery, the contractor must give to NHS England in writing a preliminary opt out notice which must state the reasons for the contractor wanting to opt out.

• (2) NHS England must enter into discussions with the contractor concerning—

• (a) the support which NHS England is able to give to the contractor; or

• (b) other changes which NHS England or the contractor may make,

that would enable the contractor to continue to provide minor surgery.

• (3) NHS England and the contractor must use reasonable endeavours in order to achieve the aim specified in paragraph (2).

• (4) The discussions referred to in paragraph (2) must be—

• (a) entered into as soon as is reasonably practicable but before the end of the period of seven days beginning with the date on which the preliminary opt out notice was received by NHS England; and

• (b) completed before the end of the period of ten days beginning with the date on which the preliminary opt out notice was received by NHS England or as soon as reasonably practicable thereafter.

• (5) If, following the discussions referred to in paragraph (2), the contractor still wants to opt out of the provision of minor surgery, the contractor must send an opt out notice to NHS England.

• (6) An opt out notice must specify—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) whether ... the contractor wants to—

• (i) permanently opt out, or

• (ii) temporarily opt out;

• (c) the reasons for the contractor wanting to opt out;

• (d) the date from which the contractor would like the opt out to commence, which must—

• (i) in the case of a temporary opt out, be at least 14 days after the date of the service of the opt out notice, and

• (ii) in the case of a permanent opt out, be the day either three or six months after the date of service of the opt out notice; and

• (e) in the case of a temporary opt out, the desired duration of the opt out.

• (7) Where, before the end of the period of three years ending with the date on which the opt out notice was given to NHS England, a contractor has given two previous temporary opt out notices (whether or not they also concerned minor surgery), the latest opt out notice is to be treated as a permanent opt out notice (even if the opt out notice states that the contractor wishes to temporarily opt out).

Additional services: temporary opt outs and permanent opt outs following temporary opt outs

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• (1) Where NHS England has given a temporary opt out notice or a temporary opt out notice which, by virtue of regulation 35(7), is treated as a permanent opt out notice, NHS England must, as soon as is reasonably practicable and, in any event, before the end of the period of seven days beginning with the date on which NHS England receives a notice given under regulation 35(5)—

• (a) approve the opt out notice and specify, in accordance with paragraphs (4) and (5), the date on which the temporary opt out is to commence, and the date on which it is to come to an end (“the end date”); or

• (b) reject the opt out notice in accordance with paragraph (3).

• (2) NHS England must give notice to the contractor of its decision under paragraph (1) as soon as practicable, including the reasons for its decision.

• (3) NHS England may reject the opt out notice on the ground that the contractor—

• (a) is providing minor surgery to patients other than its own registered patients, or enhanced services; or

• (b) has no reasonable need to opt out temporarily having regard to its ability to deliver minor surgery.

• (4) The date specified by NHS England for the commencement of the temporary opt out must, where reasonably practicable, be the date requested by the contractor in the contractor's opt out notice.

• (5) Before determining the end date, NHS England must make reasonable efforts to reach agreement with the contractor.

• (6) Where NHS England approves an opt out notice, the contractor's obligation to provide minor surgery is to be suspended from the date specified by NHS England in its decision under paragraph (1) and is to remain suspended until the end date unless—

• (a) the contractor and NHS England agree in writing an earlier date, in which case the suspension comes to an end on the earlier date agreed;

• (b) NHS England specifies a later date under paragraph (7) in which case the suspension comes to an end on the later date specified;

• (c) paragraph (9) applies and the contractor refers the matter to the NHS dispute resolution procedure or the court, in which case the suspension comes to an end—

• (i) where the outcome of the dispute is to uphold the decision of NHS England, on the day after the date of the decision of the Secretary of State or the court,

• (ii) where the outcome is to overturn the decision of NHS England, 28 days after the date of the decision of the Secretary of State or the court, or

• (iii) where the contractor ceases to pursue the NHS dispute resolution procedure or court proceedings, on the day after the date on which the contractor withdraws its claim or the proceedings are otherwise terminated by the Secretary of State or the court;

• (d) paragraph (11) applies and—

• (i) NHS England refuses the contractor's request for a permanent opt out before the end of the period of 28 days ending with the end date, in which case the suspension comes to an end 28 days after the end date, or

• (ii) NHS England refuses the contractor's request for a permanent opt out after the end date, in which case the suspension comes to an end 28 days after the date of service of the notice.

• (7) Before the end date, NHS England may, in exceptional circumstances and with the agreement of the contractor, give notice in writing to the contractor of a later date on which the temporary opt out is to come to an end, being a date which is no more than six months later than the end date.

• (8) Where NHS England considers that—

• (a) the contractor will be unable to satisfactorily provide minor surgery at the end of the temporary opt out; and

• (b) it would not be appropriate to exercise its discretion under paragraph (7) to specify a later date on which the temporary opt out is to come to an end or the contractor does not agree to a later date,

NHS England may give notice in writing to the contractor at least 28 days before the end date that a permanent opt out is to follow a temporary opt out.

• (9) Where NHS England gives notice to the contractor under paragraph (8) that a permanent opt out is to follow a temporary opt out, the permanent opt out is to take effect immediately after the end of the temporary opt out.

• (10) A contractor who has temporarily opted out may, at least three months prior to the end date, give notice in writing to NHS England that it wants to permanently opt out of minor surgery.

• (11) Where the contractor has given notice to NHS England under paragraph (10) that it wants to permanently opt out, the temporary opt out is to be followed by a permanent opt out beginning on the day after the end date of the temporary opt out notice unless NHS England refuses the contractor's request to permanently opt out by giving notice in writing to the contractor to this effect.

• (12) A temporary opt out or a permanent opt out commences, and a temporary opt out ends, at 8.00am on the relevant day unless—

• (a) the day is Saturday, Sunday, Good Friday, Christmas Day or a bank holiday in which case the opt out is to take effect on the next working day at 8.00am; or

• (b) NHS England and the contractor agree a different day or time.

Additional services: permanent opt outs

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• (1) In this regulation—

• “A day” is the day specified by the contractor in the permanent opt out notice which the contractor gives to NHS England for the commencement of the permanent opt out;

• “B day” is the day six months after the date on which the permanent opt out notice was given to NHS England; and

• “C day” is the day nine months after the date on which the permanent opt out notice was given to NHS England.

• (2) NHS England must, as soon as is reasonably practicable and in any event before the end of the period of 28 days beginning with the date on which NHS England receives a permanent opt out notice under regulation 35(5) (or temporary opt out notice which is treated as a permanent opt out notice under regulation 35(7))—

• (a) approve the opt out notice; or

• (b) reject the opt out notice in accordance with paragraph (4).

• (3) NHS England must give notice to the contractor of its decision under paragraph (2) as soon as possible, including the reasons for its decision where that decision is to reject the opt out notice.

• (4) NHS England may reject the opt out notice on the ground that the contractor is providing minor surgery to patients other than its registered patients, or enhanced services.

• (5) A contractor may not withdraw an opt out notice once that notice has been approved by NHS England in accordance with paragraph (2)(a) without NHS England’s agreement.

• (6) If NHS England approves the opt out notice under paragraph (2)(a), NHS England must use reasonable endeavours to make arrangements for the contractor's patients to receive minor surgery from an alternative provider from A day.

• (7) The contractor's duty to provide minor surgery terminates on A day unless NHS England gives notice to the contractor under paragraph (8) (extending A day to B day or C day).

• (8) If NHS England is not successful in finding an alternative provider to take on the provision of minor surgery from A day, then NHS England must give notice in writing to the contractor of that fact no later than one month before A day, and in a case where A day is—

• (a) three months after the date on which the opt out notice was given, the contractor must continue to provide minor surgery until B day unless, at least one month before B day, the contractor is given notice in writing by NHS England under paragraph (9) to the effect that, despite using reasonable endeavours, NHS England has not been able to find an alternative provider to take on the provision of minor surgery from B day;

• (b) six months after the opt out notice was given, the contractor must continue to provide minor surgery until C day.

• (9) Where, in accordance with paragraph (8)(a), the permanent opt out is to commence on B day and NHS England , despite using reasonable endeavours, has not been able to find an alternative provider to take on the provision of minor surgery from that day, NHS England must give notice in writing to the contractor of that fact at least one month before B day, in which case the contractor must continue to provide minor surgery until C day.

• (10) As soon as is practicable and, in any event, within seven days of NHS England giving notice to the contractor under paragraph (9), NHS England must enter into discussions with the contractor concerning the support that NHS England is able to give to the contractor or other changes which NHS England or the contractor may make in relation to the provision of minor surgery until C day.

• (11) Nothing in the preceding paragraphs prevents the contractor and NHS England from agreeing a different date for the termination of the contractor's duty under the contract to provide minor surgery and, accordingly, varying the contract in accordance with regulation 29 and Part 8 of Schedule 3.

• (12) The permanent opt out takes effect at 8.00am on the relevant day unless—

• (a) the day is Saturday, Sunday, Good Friday, Christmas Day, or a bank holiday in which case the opt out is to take effect on the next working day at 8.00am; or

• (b) NHS England and the contractor agree a different day or time.

Out of hours services: opt outs

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• (1) Where a contractor wants to terminate its obligation under the contract to provide out of hours services, the contractor must give an out of hours opt out notice in writing to NHS England to that effect.

• (2) An out of hours opt out notice must specify the date on which the contractor would like the out of hours opt out to take effect, which must be either three or six months after the date on which that notice is given.

• (3) NHS England must approve the out of hours opt out notice and specify, in accordance with paragraph (6), the date on which the out of hours opt out is to commence (“OOH day”) as soon as is reasonably practicable and in any event before the end of the period of 28 days beginning with the date on which NHS England receives the out of hours opt out notice.

• (4) NHS England must give notice to the contractor of its decision as soon as possible.

• (5) The OOH day is the date that is specified in the out of hours opt out notice.

• (6) A contractor may not withdraw an out of hours opt out notice once it has been approved by NHS England under paragraph (3) without NHS England’s agreement.

• (7) Following receipt of the out of hours opt out notice, NHS England must use reasonable endeavours to make arrangements for the contractor's registered patients to receive out of hours services from an alternative provider from OOH day.

• (8) Paragraphs (7) to (10) of regulation 37 apply in respect of an out of hours opt out—

• (a) as they apply to a permanent opt out; and

• (b) as if the reference to “A day” was a reference to “OOH day”.

Informing patients of opt outs

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• (1) Before any opt out takes effect, NHS England and the contractor must discuss how to inform the contractor's patients of the proposed opt out.

• (2) The contractor must, if requested by NHS England, inform its registered patients of an opt out and of the arrangements made for those patients to receive minor surgery or out of hours services by—

• (a) placing a notice in the contractor's practice waiting rooms; or

• (b) including the information in the contractor's practice leaflet.

• (3) In this regulation, “opt out” means an out of hours opt out, a permanent opt out or a temporary opt out.

PART 7 — Persons who perform services

Qualifications of performers: medical practitioners

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A medical practitioner may only perform a clinical service under the contract where that medical practitioner is not—

• (a) prohibited from performing any such service by regulation 24 of the National Health Service (Performers Lists) (England) Regulations 2013;

• (b) suspended from the medical performers list or from the Medical Register; and

• (c) subject to interim suspension under section 41A of the Medical Act 1983.

Qualifications of performers: health care professionals

41

A health care professional (other than one to whom regulation 40 applies) may not perform clinical services under the contract unless—

• (a) that person is registered with the professional body relevant to that person's profession; and

• (b) that registration is not subject to a period of suspension.

Conditional registration or inclusion in primary care list

42

Where the registration of a health care professional or, in the case of a medical practitioner, the inclusion of that practitioner's name in a primary care list, is subject to conditions, the contractor must ensure compliance with those conditions in so far as they are relevant to the contract.

Clinical experience

43

A health care professional may not perform any clinical services under the contract unless that person has such clinical experience and training as are necessary to enable the person to properly perform such services.

Conditions for employment and engagement: medical practitioners

44

• (1) Subject to paragraph (2), a contractor may not employ or engage a medical practitioner unless the contractor has checked that the practitioner meets the requirements of—

• (a) regulation 40; and

• (b) regulation 43.

• (2) Where—

• (a) the employment or engagement of a medical practitioner is urgently needed; and

• (b) it is not possible for the contractor to check the matters referred to in regulation 43 in accordance with paragraph (1)(b) before employing or engaging the practitioner,

the contractor may employ or engage the practitioner on a temporary basis for a single period of up to seven days while such checks are undertaken.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Conditions for employment or engagement: health care professionals

45

• (1) Subject to paragraph (2), a contractor may not employ or engage a health care professional to perform clinical services under the contract unless—

• (a) the contractor has checked that the health care professional meets the requirements of regulation 41; and

• (b) the contractor has taken reasonable steps to satisfy itself that the health care professional meets the requirements of regulation 43.

• (2) Where—

• (a) the employment or engagement of a health care professional is urgently needed; and

• (b) it is not possible for the contractor to check that the health care professional meets the requirements referred to in regulation 41 before employing or engaging the health care professional,

the contractor may employ or engage the health care professional on a temporary basis for a single period of up to seven days while such checks are undertaken.

• (3) When considering a health care professional's experience and training for the purposes of paragraph (1)(b), the contractor must, in particular, have regard to—

• (a) any post-graduate or post-registration qualification held by the health care professional; and

• (b) any relevant training undertaken, and any relevant clinical experience gained, by the health care professional.

Clinical references

46

• (1) The contractor may not employ or engage a health care professional to perform clinical services under the contract (other than an exempt medical practitioner to whom regulation 40(3)(d) applies) unless—

• (a) that person has provided two clinical references, relating to two recent posts (which may include any current post) as a health care professional which lasted for three months without a significant break or, where this is not possible, a full explanation of why this is the case and details of alternative referees; and

• (b) the contractor has checked and is satisfied with the references.

• (2) Where—

• (a) the employment or engagement of a health care professional is urgently needed; and

• (b) it is not possible for the contractor to obtain and check the references in accordance with paragraph (1)(b) before employing or engaging that health care professional,

the contractor may employ or engage the health care professional on a temporary basis for a single period of up to 14 days while the references are checked and considered, and for an additional period of a further seven days if the contractor believes that the person supplying those references is ill, on holiday or otherwise temporarily unavailable.

• (3) Where the contractor employs or engages the same person on more than one occasion within a period of three months, the contractor may rely on the references provided on the first occasion, provided that those references are not more than 12 months old.

Verification of qualifications and competence

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• (1) The contractor must, before employing or engaging any person to assist it in the provision of services under the contract, take reasonable steps to satisfy itself that the person in question is both suitably qualified and competent to discharge the duties for which that person is to be employed or engaged.

• (2) The duty imposed on the contractor by paragraph (1) is in addition to the duties imposed by regulations 44 to 46.

• (3) When considering the competence and suitability of any person for the purposes of paragraph (1), the contractor must, in particular, have regard to that person's—

• (a) academic and vocational qualifications;

• (b) education and training; and

• (c) previous employment or work experience.

Training

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• (1) The contractor must ensure that for any health care professional who is—

• (a) performing clinical services under the contract, or

• (b) employed or engaged to assist in the performance of such services,

there are in place arrangements for the purpose of maintaining and updating the skills and knowledge of that health care professional in relation to the services which that health care professional is performing or assisting in the performance of.

• (2) The contractor must afford to each employee reasonable opportunities to undertake appropriate training with a view to maintaining that employee's competence.

Terms and conditions

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The contractor may only offer employment to a general medical practitioner on terms which are no less favourable than those contained in the document entitled “Model terms and conditions of service for a salaried general practitioner employed by a GMS practice” published by the British Medical Association and the NHS Confederation as item 1.2 of the supplementary documents to the GMS contract 2003 .

Arrangements for GP Specialty Registrars

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• (1) The contractor may only employ a GP Specialty Registrar subject to the conditions specified in paragraph (2).

• (2) The conditions specified in this paragraph are that the contractor must not, by reason only of having employed a GP Specialty Registrar, reduce the total number of hours for which other medical practitioners perform primary medical services under the contract or for which other staff assist those practitioners in the performance of those services.

• (3) Where a contractor employs a GP Specialty Registrar, the contractor must—

• (a) offer that GP Specialty Registrar terms of employment in accordance with such rates, and subject to such conditions, as are approved by the Secretary of State concerning the grants, fees, travelling and other allowances payable to GP Specialty Registrars; and

• (b) take into account the guidance contained in the document entitled “A Reference Guide For Postgraduate Specialty Training in the UK”.

Notice requirements in respect of relevant prescribers

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• (1) For the purposes of this regulation, “a relevant prescriber” is—

• (a) a chiropodist or podiatrist independent prescriber;

• (b) an independent nurse prescriber;

• (c) a pharmacist independent prescriber;

• (d) a physiotherapist independent prescriber; or

• (e) a supplementary prescriber.

• (2) The contractor must give notice to NHS England where—

• (a) a relevant prescriber is employed or engaged by a contractor to perform functions which include prescribing;

• (b) a relevant prescriber is a party to the contract whose functions include prescribing; or

• (c) the functions of a relevant prescriber whom the contractor already employs or has already engaged are extended to include prescribing.

• (3) The notice under paragraph (2) must be given in writing to NHS England before the expiry of the period of seven days beginning with the date on which—

• (a) the relevant prescriber was employed or engaged by the contractor or, as the case may be, became a party to the contract (unless immediately before becoming such a party, paragraph (2)(a) applied to that relevant prescriber); or

• (b) the functions of the relevant prescriber were extended to include prescribing.

• (4) The contractor must give notice to NHS England where—

• (a) the contractor ceases to employ or engage a relevant prescriber in the contractor's practice whose functions include prescribing in the contractor's practice;

• (b) a relevant prescriber ceases to be a party to the contract;

• (c) the functions of a relevant prescriber employed or engaged by the contractor in the contractor's practice are changed so that they no longer include prescribing in the contractor's practice; or

• (d) the contractor becomes aware that a relevant prescriber whom it employs or engages has been removed or suspended from the relevant register.

• (5) The notice under paragraph (4) must be given in writing to NHS England before the end of the second working day after the day on which an event described in sub-paragraphs (a) to (d) occurred in relation to the relevant prescriber.

• (6) The contractor must provide the following information when it gives notice to NHS England in accordance with paragraph (2)—

• (a) the person's full name;

• (b) the person's professional qualifications;

• (c) the person's identifying number which appears in the relevant register;

• (d) the date on which the person's entry in the relevant register was annotated to the effect that the person was qualified to order drugs, medicines and appliances for patients;

• (e) the date on which—

• (i) the person was employed or engaged (if applicable),

• (ii) the person became a party to the contract (if applicable), or

• (iii) the functions of the person were extended to include prescribing in the contractor's practice.

• (7) The contractor must provide the following information when it gives notice to NHS England in accordance with paragraph (4)—

• (a) the person's full name;

• (b) the person's professional qualifications;

• (c) the person's identifying number which appears in the relevant register;

• (d) the date on which—

• (i) the person ceased to be employed or engaged in the contractor's practice,

• (ii) the person ceased to be a party to the contract,

• (iii) the functions of the person were changed so as to no longer include prescribing in the contractor's practice, or

• (iv) the person was removed or suspended from the relevant register.

Signing of documents

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• (1) The contractor must ensure—

• (a) that the documents specified in paragraph (2) include—

• (i) the clinical profession of the health care professional who signed the document, and

• (ii) the name of the contractor on whose behalf the document is signed; and

• (b) that the documents specified in paragraph (3) include the clinical profession of the health care professional who signed the document.

• (2) The documents specified in this paragraph are—

• (a) certificates issued in accordance with regulation 22, unless regulations relating to particular certificates provide otherwise; and

• (b) any other clinical documents apart from—

• (i) home oxygen order forms, and

• (ii) the documents specified in paragraph (3).

• (3) The documents specified in this paragraph are batch issues, prescription forms and repeatable prescriptions.

• (4) This regulation is in addition to any other requirements relating to the documents specified in paragraphs (2) and (3) whether in these Regulations or elsewhere.

Level of skill

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The contractor must carry out its obligations under the contract with reasonable care and skill.

Appraisal and assessment

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• (1) The contractor must ensure that any medical practitioner performing services under the contract—

• (a) participates in the appraisal system provided by NHS England unless that medical practitioner participates in an appropriate appraisal system provided by another health service body or is an armed forces GP; and

• (b) co-operates with NHS England in relation to NHS England’s patient safety functions.

• (2) NHS England must provide an appraisal system for the purposes of paragraph (1)(a) after consultation with the Local Medical Committee (if any) for the area in which the practitioner provides services under the contract and such other persons as appear to it to be appropriate.

• (3) In paragraph (1), “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.

PART 8 — Prescribing and dispensing

Prescribing: general

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• (1) The contractor must ensure that—

• (a) any prescription form or repeatable prescription issued or created by a prescriber;

• (b) any home oxygen order form issued by a health care professional; and

• (c) any listed prescription items voucher issued by a prescriber or any other person acting under the contract,

complies as appropriate with the requirements in regulations 56, 57 and 59 to 63.

• (2) In regulations 56, 57 and 59 to 63, a reference to “drugs” includes contraceptive substances and a reference to “appliances” includes contraceptive appliances.

Orders for drugs, medicines or appliances

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• (1) Subject to paragraphs (1A), (2) and (3) and to the restrictions on prescribing in regulations 61 and 62, a prescriber must order any drugs, medicines or appliances which are needed for the treatment of any patient who is receiving treatment under the contract by—

• (a) issuing to the patient a non-electronic prescription form or a non-electronic repeatable prescription completed in accordance with paragraph (6); or

• (b) creating and transmitting an electronic prescription in circumstances to which regulation 57(1) applies,

and a non-electronic prescription form, non-electronic repeatable prescription or electronic prescription that is for health service use must not be used in any other circumstances.

• (1A) If, on a particular occasion when a drug, medicine or appliance is needed as mentioned in paragraph (1)—

• (a) the prescriber is able, without delay, to order the drug, medicine or appliance by means of an electronic prescription;

• (b) the Electronic Prescription Service software that the prescriber would use for that purpose provides for the creation and transmission of electronic prescriptions without the need for a nominated dispenser; and

• (c) none of the reasons for issuing a non-electronic prescription form or a non- electronic repeatable prescription given in paragraph (1B) apply,

the prescriber must create and transmit an electronic prescription for that drug, medicine or appliance.

• (1B) The reasons given in this paragraph are—

• (a) although the prescriber is able to use the Electronic Prescription Service, the prescriber is not satisfied that—

• (i) the access that the prescriber has to the Electronic Prescription Service is reliable, or

• (ii) the Electronic Prescription Service is functioning reliably;

• (b) the patient, or where appropriate the patient’s authorised person, informs the prescriber that the patient wants the option of having the prescription dispensed elsewhere than in England;

• (c) the patient, or where appropriate the patient’s authorised person, insists on the patient being issued with a non-electronic prescription form or a non-electronic repeatable prescription for a particular prescription and in the professional judgment of the prescriber the welfare of the patient is likely to be in jeopardy unless a non-electronic prescription form or a non-electronic repeatable prescription is issued;

• (d) the prescription is to be issued before the contractor’s EPS phase 4 date or the contractor has no such date.

• (2) A healthcare professional must order any home oxygen services which are needed for the treatment of a patient who is receiving treatment under the contract by issuing a home oxygen order form.

• (3) During an outbreak of an illness for which a listed prescription item may be used for a treatment or for prophylaxis, if—

• (a) the Secretary of State or NHS England has made arrangements for the distribution of a listed prescription item free of charge; and

• (b) that listed prescription item is needed for treatment or prophylaxis of any patient who is receiving treatment under the contract,

a prescriber may order that listed prescription item by using a listed prescription items voucher and must sign that listed prescription items voucher (with an electronic signature, if an electronic form is used) if one is used.

• (4) During an outbreak of an illness for which a listed prescription item may be used for a treatment or for prophylaxis, if—

• (a) the Secretary of State or NHS England has made arrangements for the distribution of a listed prescription item free of charge;

• (b) those arrangements contain criteria set out in a protocol which enable persons who are not prescribers to identify the symptoms of, and whether there is a need for treatment of that disease or for or prophylaxis;

• (c) a person acting on behalf of the contractor, who is not a prescriber but who is authorised by NHS England to order listed prescription items, has applied the criteria referred to in sub-paragraph (b) to a patient who is receiving treatment under the contract; and

• (d) having applied the criteria, that person has concluded that the listed prescription item is needed for the treatment or prophylaxis of the patient,

that person may order that listed prescription item by using a listed prescription items voucher and must sign that listed prescription items voucher (with an electronic signature, if an electronic form is used) if one is used.

• (5) A prescriber may only order drugs, medicines or appliances on a repeatable prescription where the drugs, medicines or appliances are to be provided more than once.

• (5A) A prescriber must only order one prescription item on a prescription form or repeatable prescription that is used by the prescriber for ordering a listed HRT prescription item.

• (5B) For the purposes of paragraph (5A), “listed HRT prescription item” is to be construed in accordance with regulation 17A(1)(a) of the National Health Service (Charges for Drugs and Appliances) Regulations 2015, read with regulation 17A(7) of those Regulations.

• (6) In issuing a non-electronic prescription form or a non-electronic repeatable prescription, the prescriber must—

• (a) sign the prescription form or repeatable prescription in ink in the prescriber's own handwriting, and not by means of a stamp, with the prescriber's initials, or forenames, and surname; and

• (b) only sign the prescription or repeatable prescription after particulars of the order have been inserted in the prescription form or repeatable prescription.

• (7) A prescription form or repeatable prescription must not refer to any previous prescription form or repeatable prescription form.

• (8) A separate prescription form or repeatable prescription must be used for each patient, except where a bulk prescription is issued for a school or institution under regulation 63.

• (9) A home oxygen order form must be signed by a health care professional.

• (10) Where a prescriber orders the drug buprenorphine or diazepam or a drug specified in Part 1 of Schedule 2 to the Misuse of Drugs Regulations 2001 (controlled drugs to which regulations 14 to 16, 18 to 21, 23, 26 and 27 of those Regulations apply) for supply by instalments for treating addiction to any drug specified in that Schedule, the prescriber must—

• (a) use only the prescription form provided specially for the purposes of supply by instalments;

• (b) specify the number of instalments to be dispensed and the interval between each instalment; and

• (c) order only such quantity of the drug as will provide treatment for a period not exceeding 14 days.

• (11) The prescription form provided specially for the purpose of supply by instalments must not be used for any purpose other than ordering drugs in accordance with paragraph (10).

• (12) In an urgent case, a prescriber may only request a chemist to dispense a drug or medicine before a prescription form or repeatable prescription is issued or created if—

• (a) the drug or medicine is not a Scheduled drug;

• (b) the drug is not a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Part 1 of Schedule 4 (controlled drugs subject to the requirements of regulations 22, 23, 26 and 27) or Schedule 5 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26) to the Misuse of Drugs Regulations 2001 ; and

• (c) the prescriber undertakes to—

• (i) provide the chemist within 72 hours from the time of the request with a non-electronic prescription form or a non-electronic repeatable prescription completed in accordance with paragraph (6), or

• (ii) transmit by the Electronic Prescription Service within 72 hours from the time of the request an electronic prescription.

• (13) In an urgent case, a prescriber may only request a chemist to dispense an appliance before a prescription form or repeatable prescription form is issued or created if—

• (a) the appliance does not contain a Scheduled drug, or a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26);

• (b) if the appliance is a restricted availability appliance, the patient is a person, or it is for a purpose, specified in the Drug Tariff; and

• (c) the prescriber undertakes to—

• (i) provide the chemist within 72 hours from the time of the request with a non-electronic prescription form or non-electronic repeatable prescription completed in accordance with paragraph (6), or

• (ii) transmit by the Electronic Prescription Service within 72 hours from the time of the request an electronic prescription.

Electronic prescriptions

57

• (1) A prescriber may only order drugs, medicines or appliances by means of an electronic prescription if—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) the prescription is not—

• (i) for a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), other than a drug which is for the time being specified in Schedules 2 to 5 to the Misuse of Drugs Regulations 2001, or

• (ii) a bulk prescription issued for a school or institution under regulation 63.

• (1A) If a prescriber orders a drug, medicine or appliance by means of an electronic prescription, the prescriber must issue the patient with—

• (a) subject to paragraph (1C), an EPS token; and

• (b) if the patient, or where appropriate an authorised person, so requests, a written record of the prescription that has been created.

• (1B) On and after the contractor’s EPS phase 4 date, if the order is eligible for Electronic Prescription Service use, the prescriber must ascertain if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser.

• (1C) The prescriber must not issue the patient with an EPS token if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser.

• (2) A health care professional may not order home oxygen services by means of an electronic prescription.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nomination of dispensers for the purposes of electronic prescriptions

58

• (1) A contractor authorised to use the Electronic Prescription Service for its patients must , if a patient, or where appropriate the patient’s authorised person, so requests, enter into the particulars relating to the patient which are held in the Patient Demographic Service managed by NHS England—

• (a) where the patient does not have a nominated dispenser, the dispenser chosen by the patient , or where appropriate the patient’s authorised person; and

• (b) where the patient does have a nominated dispenser—

• (i) a replacement dispenser, or

• (ii) a further dispenser,

chosen by the patient.

• (2) Paragraph (1)(b)(ii) does not apply if the number of the nominated dispensers would thereby exceed the maximum number permitted by the Electronic Prescription Service.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) A contractor must—

• (a) not seek to persuade a patient or a patient’s authorised person to nominate a dispenser recommended by the prescriber or the contractor; and

• (b) if asked by a patient or a patient’s authorised person to recommend a chemist whom the patient or the patient’s authorised person might nominate as the patient's dispenser, provide the patient or, as the case may be, the patient’s authorised person with the list given to the contractor by NHS England of all chemists in the area who provide an Electronic Prescription Service.

Repeatable prescribing services

59

• (1) The contractor may only provide repeatable prescribing services to a person on its list of patients if the contractor—

• (a) satisfies the conditions specified in paragraph (2); and

• (b) has given notice in writing to NHS England of its intention to provide repeatable prescribing services in accordance with paragraphs (3) and (4).

• (2) The conditions specified in this paragraph are that—

• (a) the contractor has access to computer systems and software which enable it to issue non-electronic repeatable prescriptions and batch issues; and

• (b) the practice premises at which the repeatable prescribing services are to be provided are located in a local authority area in which there is also located the premises of at least one chemist who has undertaken to provide, or has entered into arrangements to provide, repeat dispensing services.

• (3) The notice given under paragraph (1)(b) must confirm that the contractor—

• (a) wants to provide repeatable prescribing services;

• (b) intends to begin providing those services from a specified date; and

• (c) satisfies the conditions specified in paragraph (2).

• (4) The date specified by the contractor under paragraph (3)(b) must be at least ten days after the date on which the notice under paragraph (1)(b) was given.

• (5) Nothing in this regulation requires a contractor or a prescriber to provide repeatable prescribing services to any person.

• (6) A prescriber may only provide repeatable prescribing services to a person on a particular occasion if—

• (a) the person has agreed to receive such services on that occasion; and

• (b) the prescriber considers that it is clinically appropriate to provide such services to that person on that occasion.

• (7) The contractor may not provide repeatable prescribing services to any person on its list of patients to whom any person specified in paragraph (8) is authorised or required by NHS England to provide pharmaceutical services in accordance with arrangements under section 126 (arrangements for pharmaceutical services) and section 132 (persons authorised to provide pharmaceutical services) of the Act.

• (8) The persons specified in this paragraph are—

• (a) in the case of a contract with an individual medical practitioner, that medical practitioner;

• (b) in the case of a contract with two or more persons practising in a partnership, any medical practitioner who is a partner in the partnership;

• (c) in the case of a contract with a company limited by shares, any medical practitioner who is both a legal and beneficial shareholder in that company; or

• (d) any medical practitioner employed or engaged by the contractor.

Repeatable prescriptions

60

• (1) A prescriber who issues a non-electronic repeatable prescription must at the same time issue the appropriate number of batch issues.

• (2) Where a prescriber wants to make a change to the type, quantity, strength or dosage of drugs, medicines or appliances ordered on a person's repeatable prescription, the prescriber must—

• (a) in the case of a non-electronic repeatable prescription—

• (i) give notice to the person, and

• (ii) make reasonable efforts to give notice to the chemist providing repeat dispensing services to the person,

that the original repeatable prescription should no longer be used to obtain or provide repeat dispensing services and make arrangements for a replacement repeatable prescription to be issued to the person; or

• (b) in the case of an electronic repeatable prescription—

• (i) arrange with the Electronic Prescription Service for the cancellation of the original repeatable prescription, and

• (ii) create a replacement prescription relating to the person and give notice to the person that this has been done.

• (3) Where a prescriber has created an electronic repeatable prescription for a person, the prescriber must, as soon as practicable, arrange with the Electronic Prescription Service for its cancellation if, before the expiry of that prescription—

• (a) the prescriber considers that it is no longer safe or appropriate for the person to receive the drugs, medicines or appliances ordered on the person's electronic repeatable prescription or it is no longer safe or appropriate for the person to continue to receive repeatable prescribing services;

• (b) the prescriber has issued the person with a non-electronic repeatable prescription in place of the electronic repeatable prescription; or

• (c) it comes to the prescriber's notice that the person has been removed from the list of patients of the contractor on whose behalf the prescription was issued.

• (4) Where a prescriber has cancelled an electronic repeatable prescription relating to a person in accordance with paragraph (3), the prescriber must give notice of the cancellation to the person as soon as possible.

• (5) A prescriber who has issued a non-electronic repeatable prescription in relation to a person must, as soon as possible, make reasonable efforts to give notice to the chemist that that repeatable prescription should no longer be used to provide repeat dispensing services to that person, if, before the expiry of that repeatable prescription—

• (a) the prescriber considers that it is no longer safe or appropriate for the person to receive the drugs, medicines or appliances ordered on the person's repeatable prescription or that it is no longer safe or appropriate for the person to continue to receive repeatable prescribing services;

• (b) the prescriber issues or creates a further repeatable prescription in respect of the person to replace the original repeatable prescription other than in the circumstances referred to in paragraph (2)(a) (for example, because the person wants to obtain the drugs, medicines or appliances from a different chemist); or

• (c) it comes to the prescriber's notice that the person has been removed from the list of patients of the contractor on whose behalf the prescription was issued.

• (6) Where the circumstances in paragraph (5)(a) to (c) apply in respect of a person, the prescriber must as soon as possible give notice to that person that their repeatable prescription should no longer be used to obtain repeat dispensing services.

Restrictions on prescribing by medical practitioners

61

• (1) A medical practitioner, in the course of treating a patient to whom the practitioner is providing treatment under the contract, must comply with the following paragraphs.

• (2) The medical practitioner must not order on a listed prescription items voucher, prescription form or a repeatable prescription a drug, medicine or other substance specified in any directions given by the Secretary of State in regulations made under section 88 of the Act (GMS contracts: prescription of drugs etc) as being drugs, medicines or other substances which may not be ordered for patients in the provision of medical services under the contract.

• (3) The medical practitioner must not order on a listed prescription items voucher, a prescription form or repeatable prescription 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 can only be ordered for specified patients and for specified purposes unless—

• (a) the patient is a person of the specified description;

• (b) the drug, medicine or other substance is prescribed for that patient only for the specified purpose; and

• (c) if the order is on a prescription form, the practitioner includes on the form—

• (i) the reference “SLS”, or

• (ii) if the order is under arrangements made by the Secretary of State or NHS England for the distribution of a listed prescription item free of charge, the reference “ACP”.

• (4) The medical practitioner must not order on a prescription form or repeatable prescription a restricted availability appliance unless—

• (a) the patient is a person, or it is for a purpose, specified in the Drug Tariff; and

• (b) the practitioner includes on the prescription form the reference “SLS”.

• (5) The medical practitioner must not order on a repeatable prescription a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act) , other than a drug which is for the time being specified in Schedule 4 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26) or Schedule 5 (controlled drugs excepted from the prohibition on importation, exportation and possession and subject to the requirements of regulations 24 and 26) to the Misuse of Drugs Regulations 2001 .

• (6) Subject to regulation 24(2)(b) and to paragraph (7), nothing in the preceding paragraphs prevents a medical practitioner, in the course of treating a patient to whom this regulation refers, from prescribing a drug, medicine or other substance or, as the case may be, a restricted availability appliance or a controlled drug within the meaning of section 2 of the Misuse of Drugs Act 1971 (which relates to controlled drugs and their classification for the purposes of that Act), for the treatment of that patient under a private arrangement.

• (7) Where, under paragraph (6), a drug, medicine or other substance is prescribed under a private arrangement, if the order is to be transmitted as an electronic communication to a chemist for the drug, medicine or appliance to be dispensed—

• (a) if the order is not for a drug for the time being specified in Schedule 2 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 19, 20, 21, 23, 26 and 27) or 3 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 22, 23, 24, 26 and 27) to the Misuse of Drugs Regulations 2001 , it may be transmitted by the Electronic Prescription Service; but

• (b) if the order is for a drug for the time being specified in Schedule 2 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 19, 20, 21, 23, 26 and 27) or 3 (controlled drugs subject to the requirements of regulations 14, 15, 16, 18, 22, 23, 24, 26 and 27) to the Misuse of Drugs Regulations 2001, it must be transmitted by the Electronic Prescription Service.

Restrictions on prescribing by supplementary prescribers

62

• (1) The contractor must have arrangements in place to secure that a supplementary prescriber may only—

• (a) issue or create a prescription for a prescription only medicine;

• (b) administer a prescription only medicine for parenteral administration; or

• (c) give directions for the administration of a prescription only medicine for parenteral administration,

as a supplementary prescriber under the conditions set out in paragraph (2).

• (2) The conditions set out in this paragraph are that—

• (a) the person satisfies the conditions in regulation 215 of the Human Medicines Regulations 2012 (prescribing and administration by supplementary prescribers), unless those conditions do not apply by virtue of any of the exemptions set out in the subsequent provisions of those Regulations;

• (b) the medicine is not specified in any directions given by the Secretary of State in regulations 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;

• (c) the medicine is not 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 unless—

• (i) the patient is a person of the specified description,

• (ii) the medicine is prescribed for that patient only for the specified purposes, and

• (iii) if the supplementary prescriber is issuing or creating a prescription on a prescription form the prescriber includes on the form—

• (aa) the reference “SLS”, or

• (bb) in the case of a listed prescription item ordered under arrangements made by the Secretary of State or NHS England for the item’s distribution free of charge, the reference “ACP”.

• (3) Where the functions of a supplementary prescriber include prescribing, the contractor must have arrangements in place to secure that the person may only issue or create a prescription for—

• (a) an appliance; or

• (b) a medicine which is not a prescription only medicine,

as a supplementary prescriber under the conditions set out in paragraph (4).

• (4) The conditions set out in this paragraph are that—

• (a) the supplementary prescriber acts in accordance with a clinical management plan which is in effect at the time when that prescriber acts and which contains the following particulars—

• (i) the name of the patient to whom the plan relates,

• (ii) the illness or conditions which may be treated by the supplementary prescriber,

• (iii) the date on which the plan is to take effect, and when it is to be reviewed by the medical practitioner or dentist who is a party to the plan,

• (iv) reference to the class or description of medicines or types of appliances which may be prescribed or administered under the plan,

• (v) any restrictions or limitations as to the strength or dose of any medicine which may be prescribed or administered under the plan, and any period of administration or use of any medicine or appliance which may be prescribed or administered under the plan,

• (vi) relevant warnings about known sensitivities of the patient to, or known difficulties of the patient with, particular medicines or appliances,

• (vii) the arrangements for giving notice of—

• (aa) suspected or known adverse reactions to any medicine which may be prescribed or administered under the plan, and suspected or known adverse reactions to any other medicine taken at the same time as any medicine prescribed or administered under the plan, and

• (bb) incidents occurring with the appliance that might lead, might have led or have led to the death or serious deterioration of the state of health of the patient, and

• (viii) the circumstances in which the supplementary prescriber should refer to, or seek the advice of the medical practitioner or dentist who is a party to the plan;

• (b) the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by a medical practitioner or dentist who is a party to the plan;

• (c) if it is a prescription for a prescription only medicine, that prescription only medicine is not specified in any directions given by the Secretary of State in regulations made under section 88 of the Act (GMS contracts: prescription of drugs etc) as being a medicine which may not be ordered for patients in the provision of medical services under the contract;

• (d) if it is a prescription for a prescription only medicine which is not 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 medicine which can only be ordered for specified patients and specified purposes unless—

• (i) the patient is a person of the specified description,

• (ii) the medicine is prescribed for that patient only for the specified purposes, and

• (iii) when issuing or creating the prescription, the supplementary prescriber includes on the prescription form the reference “SLS”;

• (e) if it is prescription for an appliance, the appliance is listed in Part IX of the Drug Tariff; and

• (f) if it is a prescription for a restricted availability appliance—

• (i) the patient is a person of the description mentioned in the entry in Part IX of the Drug Tariff in respect of that appliance,

• (ii) the appliance is prescribed only for the purposes specified in respect of that person in that entry, and

• (iii) when issuing or creating the prescription, the supplementary prescriber includes on the prescription form the reference “SLS”.

• (5) In paragraph (4)(a), “clinical management plan” means a written plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

• (a) the patient to whom the plan relates;

• (b) the medical practitioner or dentist who is a party to the plan; and

• (c) any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan.

Bulk prescribing

63

• (1) A prescriber may use a single non-electronic prescription form where—

• (a) a contractor is responsible under the contract for the treatment of ten or more persons in a school or other institution in which at least 20 persons normally reside; and

• (b) the prescriber orders, for any two or more of those persons for whose treatment the contractor is responsible, drugs, medicines or appliances to which this regulation applies.

• (2) Where a prescriber uses a single non-electronic prescription form for the purpose mentioned in paragraph (1)(b), the prescriber must (instead of entering on the form the names of the persons for whom the drugs, medicines or appliances are ordered) enter on the form—

• (a) the name of the school or other institution in which those persons reside; and

• (b) the number of persons residing there for whose treatment the contractor is responsible.

• (3) This regulation applies to any drug, medicine or appliance which can be supplied as part of pharmaceutical services or local pharmaceutical services and which in the case of—

• (a) a drug or medicine, is not a prescription only medicine; or

• (b) an appliance, does not contain such a product.

Excessive prescribing

64

• (1) The contractor must not prescribe drugs, medicines or appliances the cost or quantity of which, in relation to a patient, is, by reason of the character of the drug, medicine or appliance in question, in excess of that which was reasonably necessary for the proper treatment of the patient.

• (2) In considering whether a contractor has breached its obligations under paragraph (1), NHS England must seek the views of the Local Medical Committee (if any) for the area in which the contractor provides services under the contract.

Provision of drugs, medicines and appliances for immediate treatment or personal administration

65

• (1) Subject to paragraphs (2) and (3), a contractor—

• (a) must provide to a patient a drug, medicine or appliance, which is not a Scheduled drug, where such provision is needed for the immediate treatment of the patient before provision can otherwise be obtained; and

• (b) may provide to a patient a drug, medicine or appliance, which is not a Scheduled drug, which the contractor personally administers or applies to the patient.

• (2) A contractor must only provide a restricted availability appliance under paragraph (1)(a) or (b) if it is for a person or a purpose specified in the Drug Tariff.

• (3) Nothing in paragraph (1) or (2) authorises a person to supply a prescription only medicine to a patient otherwise than in accordance with Part 12 of the Human Medicines Regulations 2012 (which relates to dealings with medicinal products).

PART 9 — Prescribing and dispensing: out of hours services

Supply of medicines etc. by contractors providing out of hours services

66

• (1) In this Part—

• “complete course” means the course of treatment appropriate to the patient's condition, being the same as the amount that would have been prescribed if the patient had been seen during core hours;

• “necessary drugs, medicines and appliances” means those drugs, medicines and appliances which the patient requires and for which, in the reasonable opinion of the contractor and having regard to the patient's medical condition, it would not be reasonable in all the circumstances for the patient to wait to obtain them;

• “out of hours performer” means a prescriber, a person acting in accordance with a Patient Group Direction or any other health care professional employed or engaged by the contractor who can lawfully supply a drug, medicine or appliance, who is performing out of hours services under the contract;

• “Patient Group Direction” has the meaning given in the regulation 213(1) of the Human Medicines Regulations 2012 (interpretation); and

• “supply form” means a form provided by NHS England and completed by or on behalf of the contractor for the purpose of recording the provision of drugs, medicines or appliances to a patient during the out of hours period.

• (2) Where a contractor whose contract includes the provision of out of hours services has agreed with NHS England that its contract should also include the supply of necessary drugs, medicines and appliances to patients at the time that it is providing them with out of hours services, the contractor must comply with the requirements of paragraphs (3) to (5).

• (3) The contractor must ensure that an out of hours performer—

• (a) only supplies necessary drugs, medicines and appliances;

• (b) supplies the complete course of the necessary medicine or drug to treat the patient; and

• (c) does not supply—

• (i) drugs, medicines or appliances which the contractor could not lawfully supply,

• (ii) appliances which are not listed in Part IX of the Drug Tariff,

• (iii) restricted availability appliances, except where the patient is a person, or it is for a purpose, specified in the Drug Tariff, or

• (iv) a drug, medicine or other substance listed in Schedule 1 to the National Health Service (General Medical Services Contract) (Prescription of Drugs etc) Regulations 2004 (drugs, medicines and other substances not to be ordered under a general medical services contract), or a drug listed in Schedule 2 to those Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), other than in the circumstances specified in that Schedule.

• (4) The out of hours performer—

• (a) must, except where paragraph (b) applies, record on a separate supply form for each patient any drugs, medicines or appliances supplied to the patient; and

• (b) may complete a single supply form in respect of the supply of any necessary drugs, medicines or appliances to two or more persons in a school or other institution in which at least 20 persons normally reside, in which case the out of hours performer may write on the supply form the name of the school or institution rather than the name of each individual patient.

• (5) The out of hours performer must ask any person to produce satisfactory evidence of entitlement where that person makes a declaration that a patient does not have to pay any of the charges specified in regulations made under section 172 of the Act (charges for drugs, medicines or appliances, or pharmaceutical services) or section 174 of the Act (pre-payment certificates) in respect of dispensing services to the patient by virtue of either—

• (a) entitlement to exemption under regulations made under section 172 or 174 of the Act; or

• (b) entitlement to full remission of charges under regulations made under section 182 (remission and repayment of charges) or 183 (payment of travelling expenses) of the Act.

• (6) Paragraph (5) does not apply if, at the time of the declaration, satisfactory evidence of entitlement is already available to the out of hours performer.

• (7) If, in accordance with paragraphs (5) and (6), no satisfactory evidence of entitlement is produced or no such evidence is otherwise already available to the out of hours performer, the out of hours performer must endorse the supply form to that effect.

• (8) Subject to paragraph (9), nothing in this regulation prevents an out of hours performer from supplying a Scheduled drug or a restricted availability appliance in the course of treating a patient under a private arrangement.

• (9) The provisions of regulation 24(2)(b) which relate to fees and charges apply in respect of the supply of any necessary drugs, medicines and appliances under this regulation as they apply in respect of prescriptions for any drugs, medicines and appliances.

PART 10 — Records and information

Patient records

67

• (1) The contractor must keep adequate records of its attendance on and treatment of its patients and must do so—

• (a) on forms supplied to it for the purpose by NHS England; or

• (b) with the written consent of NHS England , by way of computerised records,

or in a combination of those two ways.

• (2) The contractor must include in the records referred to in paragraph (1), clinical reports sent in accordance with paragraph 12 of Schedule 3 or from any other health care professional who has provided clinical services to a person on the contractor's list of patients.

• (3) The consent of NHS England required by paragraph (1)(b) may not be withheld or withdrawn provided NHS England is satisfied, and continues to be satisfied, that—

• (a) the computer system upon which the contractor proposes to keep the records meets the requirements set out in the GPIT Operating Model;

• (b) the security measures, audit and system management functions incorporated into the computer system and compliant with the GPIT Operating Model have been enabled; and

• (c) the contractor is aware of, and has signed an undertaking that it will have regard to, the guidelines contained in “Digital Primary Care: Good Practice Guidelines for GP electronic patient records – (GPGv5)”, published on 20th September 2023.

• (4) Where the patient's records are computerised records, the contractor must, as soon as possible following a request from NHS England, allow NHS England to access the information recorded on the computer system on which those records are held by means of the audit function referred to in paragraph (3)(b) to the extent necessary for NHS England to confirm that the audit function is enabled and functioning correctly.

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5A) Where a patient on a contractor’s list of patients has registered with another provider of primary medical services and the contractor receives a request from that provider for the complete records relating to that patient, the contractor must send to NHS England —

• (a) the complete records, or any part of the records, sent via the GP2GP facility in accordance with regulation 69 for which the contractor does not receive confirmation of safe and effective transfer via that facility; and

• (b) any part of the records held by the contractor only in paper form.

• (5B) Where a patient on a contractor’s list of patients—

• (a) is removed from that list at that patient’s request under paragraph 23 of Schedule 3, or by reason of the application of any of paragraphs 24 to 31 of that Schedule; and

• (b) the contractor has not received a request from another provider of medical services with which that patient has registered for the transfer of the complete records relating to that patient,

the contractor must send a copy of those records to NHS England.

• (5C) Where a contractor’s responsibility for a patient terminates in accordance with paragraph 32 of Schedule 3, the contractor must send any records relating to that patient that it holds to—

• (a) if known, the provider of primary medical services with which that patient is registered; or

• (b) in all other cases, NHS England .

• (5D) For the purposes of this regulation, “GP2GP facility” has the same meaning as in paragraph (2) of regulation 69.

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (8) A contractor whose patient records are computerised records must not disable, or attempt to disable, either the security measures or the audit system management functions referred to in paragraph (3).

• (9) In this regulation, “computerised records” means records created by way of entries on a computer.

Summary Care Record

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• (1) A contractor must, in any case where there is a change to the information included in a patient's medical record, enable the automated upload of summary information to the Summary Care Record, when the change occurs, using approved systems provided to it by NHS England .

• (2) In this regulation—

• “Summary Care Record” means the system approved by NHS England for the automated uploading, storing and displaying of patient data relating to medications, allergies, adverse reactions and, where agreed with the contractor and subject to the patient's consent, any other data (other than any information recorded in accordance with regulation 67A or any information about ethnicity provided under regulation 71ZC) taken from the patient's electronic record; and

• “summary information” means items of patient data that comprise the Summary Care Record.

Electronic transfer of patient records between GP practices

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• (1) A contractor must use the facility known as “GP2GP” for the safe and effective transfer of any patient records—

• (a) in a case where a new patient registers with the contractor's practice, to the contractor's practice from the practice of another provider of primary medical services (if any) with which the patient was previously registered; or

• (b) in a case where the contractor receives a request from another provider of primary medical services with which the patient has registered, in order to respond to that request.

• (2) In this regulation, “GP2GP facility” means the facility provided by NHS England to a contractor's practice which enables the electronic health records of a registered patient which are held on the computerised clinical systems of a contractor's practice to be transferred securely and directly to another provider of primary medical services with which the patient has registered.

• (3) The requirements of this regulation do not apply in the case of a temporary resident.

Clinical correspondence: requirement for NHS number

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• (1) A contractor must include the NHS number of a registered patient as the primary identifier in all clinical correspondence issued by the contractor which relates to that patient.

• (2) The requirement in paragraph (1) does not apply where, in exceptional circumstances outside of the contractor's control, it is not possible for the contractor to ascertain the patient's NHS number.

• (3) In this regulation—

• “clinical correspondence” means all correspondence in writing, whether in electronic form or otherwise, between the contractor and other health service providers concerning or arising out of the provision of a remote service or patient attendance and treatment at practice premises including referrals made by letter or by any other means; and

• “NHS number”, in relation to a registered patient, means the number, consisting of ten numeric digits, which serves as the national unique identifier used for the purpose of safely, accurately and efficiently sharing information relating to that patient across the whole of the health service in England.

Patient online services

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• (1) A contractor must promote and offer to its registered patients the facility for a patient to—

• (a) book, view, amend, cancel and print appointments online;

• (b) order repeat prescriptions for drugs, medicines or appliances online; and

• (c) view and print a list of any drugs, medicines or appliances in respect of which the patient has a repeat prescription,

in a manner which is capable of being electronically integrated with the computerised clinical systems of the contractor's practice using appropriate systems authorised by NHS England .

• (2) The requirements in paragraph (1) do not apply where the contractor does not have access to computer systems and software which would enable it to offer the online services described in that paragraph to its registered patients.

• (3) A contractor must when complying with the requirements in paragraph (1)(a)—

• (a) ensure that all of its directly bookable appointments are made available for online booking, whether or not those appointments are booked online, by telephone or in person, to include all appointments which must be made available for direct booking by NHS 111 in accordance with paragraph 11B of Part 1 of Schedule 3 to these Regulations; and

• (b) consider whether it is necessary, in order to meet the needs of its registered patients, to increase the proportion of appointments which are available for its registered patients to book online and, if so, increase that number.

• (3A) In the case of appointments required to be made available for direct booking by NHS 111, in accordance with paragraph 11B of Part 1 of Schedule 3 to these Regulations, those appointments can be released to be booked by a contractor’s registered patients by any means in the two hour period within core hours prior to the appointment time, or such other period agreed pursuant to a local arrangement, if they have not been booked by NHS 111 prior to this time.

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (8) ... The contractor must also promote and offer to its registered patients the facility referred to in paragraph (1)(a) and (b) on the home page (or equivalent) of its practice website or online practice profile.

• (9) In this regulation—

• (a) “local arrangement” means an arrangement between the contractor and NHS England as to the timeframe within which appointments not booked by NHS 111 can be released for booking by the contractor’s registered patients; and

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Confidentiality of personal data: nominated person

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The contractor must nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it.

Provision of information on practice website

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• (1) A contractor must have—

• (a) a practice website, or

• (b) an online practice profile.

• (2) The contractor must publish on its practice website or profile (as the case may be) all the information which is required to be included in its practice leaflet.

• (3) The contractor must publish that information otherwise than by making its practice leaflet available for viewing or downloading.

• (4) The contractor must review the information available on its practice website or profile at least once in every period of 12 months.

• (5) The contractor must make any amendments necessary to maintain the accuracy of the information on its website or profile following—

• (a) a review under paragraph (4);

• (b) a change to—

• (i) the address of any of the contractor’s practice premises,

• (ii) the contractor’s telephone number,

• (iii) the contractor’s electronic-mail address (if made available on its website or profile), or

• (iv) any other stated means by which a patient may contact the contractor to book or amend an appointment, or to order repeat prescriptions for drugs, medicines or appliances.

• (5A) The contractor must also ensure there are links on its website or profile which direct people to—

• (a) its online consultation tool, ...

• (b) the symptom checker and self-care information available on the NHS website , and

• (c) the General Practice Patient Guidance published on the NHS England website.

• (5B) The links mentioned in paragraph (5A) must be displayed prominently on the home page (or equivalent) of its website or profile (as the case may be).

• (6) The requirements in this regulation are in addition to those in regulation 27 and paragraph 8(8) of Schedule 3.

• (7) In these Regulations, “online practice profile” means a profile—

• (a) which is on a website (other than the NHS website), or an online platform, provided by another person for use by the contractor, and

• (b) through which the contractor advertises the primary medical services it provides.

Provision of information

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• (1) Subject to paragraph (2), the contractor must, at the request of NHS England, produce to NHS England, or to a person authorised in writing by NHS England, or allow NHS England , or a person authorised in writing by it, to access—

• (a) any information which is reasonably required by NHS England for the purposes of or in connection with the contract; and

• (b) any other information which is reasonably required in connection with NHS England’s functions.

• (2) The contractor is not required to comply with any request made under paragraph (1) unless it has been made by NHS England in accordance with directions relating to the provision of information by contractors given to NHS England by the Secretary of State under section 98A of the Act (exercise of functions).

• (3) The contractor must produce the information requested, or, as the case may be, allow NHS England access to such information—

• (a) by such date as has been agreed as reasonable between the contractor and NHS England; or

• (b) in the absence of such agreement, before the end of the period of 28 days beginning with the date on which the request is made.

Inquiries about prescriptions and referrals

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• (1) The contractor must, subject to paragraphs (2) and (3), sufficiently answer any inquiries whether oral or in writing from NHS England concerning—

• (a) any prescription form or repeatable prescription form issued or created by a prescriber;

• (b) the considerations by reference to which prescribers issue such forms;

• (c) the referral by or on behalf of the contractor of any patient to any other services provided under the Act; or

• (d) the considerations by which the contractor makes such referrals or provides for them to be made on its behalf.

• (2) An inquiry referred to in paragraph (1) may only be made for the purpose of obtaining information to assist NHS England to discharge its functions, or of assisting the contractor in the discharge of its obligations under the contract.

• (3) The contractor is not obliged to answer any inquiry referred to in paragraph (1) unless it is made—

• (a) in the case of paragraph (1)(a) or (b), by an appropriately qualified health care professional; or

• (b) in the case of paragraph (1)(c) or (d), by an appropriately qualified medical practitioner.

• (4) The appropriately qualified person referred to in paragraph (3)(a) or (b) must—

• (a) be appointed by NHS England in either case to assist it in the exercise of its functions under this regulation; and

• (b) produce, on request, written evidence of that person's authority from NHS England to make such an inquiry on the NHS England’s behalf.

Provision of information to a medical officer etc.

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• (1) The contractor must, if satisfied that the patient consents—