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The National Health Service (Personal Medical Services Agreements) Regulations 2015

Type Statutory-Instrument

Publication 2015-11-06

Last updated 2026-07-10

State In force

Department Statute Law Database

Source legislation.gov.uk

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“the Scheme” means the National Health Service Pension Scheme established by the NHS Pension Scheme Regulations.

Out of hours services

22

(1) Subject to paragraphs (2) and (3), an agreement under which essential services are to be provided must provide for the provision of out of hours services throughout the out of hours period unless—

(a) NHS England has accepted in writing, prior to the signing of the agreement, a written request from the contractor that the agreement should not require the contractor to make such provision;

(b) the contractor has opted out of providing such services in the out of hours period in accordance with Part 6; or

(2) Except to the extent that the agreement otherwise provides, a contractor whose agreement includes the provision of out of hours services is only required to provide such services if, in the contractor's reasonable opinion having regard to the patient's medical condition, it would not be reasonable in all the circumstances for the patient to wait to obtain such services.

(3) Paragraph (4) applies to a contractor which—

(a) provides out of hours services to registered patients of another contractor or provider of essential services (or their equivalent); or

(b) has contracted to provide out of hours services to patients to whom it provides essential services.

(4) The contractor must, in the provision of those services—

(a) meet the quality requirements set out in the Integrated Urgent Care Key Performance Indicators published on 25th June 2018; and

(b) comply with any requests for information which it receives from, or on behalf of, NHS England about the provision by the contractor of out of hours services to its registered patients in such manner, and before the end of such period, as is specified in the request.

(5) Where a contractor is a provider of essential services but is not required to provide out of hours services under the agreement or, under Part 6, has opted out of the provision of such services under the agreement, the contractor must—

(a) monitor the quality of the out of hours services which are offered or provided to its registered patients having regard to the Integrated Urgent Care Key Performance Indicators referred to in sub-paragraph (4) and record, and act appropriately in relation to, any concerns arising;

(b) record any patient feedback received, including complaints; and

(c) report to NHS England, either at the request of NHS England or otherwise, any concerns arising about the quality of the out of hours services which are offered or provided to patients to its registered patients having regard to—

(i) any patient feedback received, including any complaints; and

(ii) the quality requirements set out in the Integrated Urgent Care Key Performance Indicators referred to in paragraph (4).

Sub-contracting

23

An agreement must contain terms which prevent a contractor from sub-contracting any of its obligations to provide clinical services under the agreement except in the circumstances provided for in Part 5 of Schedule 2.

Variation of agreements

24

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

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

(a) regulation 25;

(b) Part 6; and

Variation of agreements: integrated care provider contracts

24A

Schedule 2A has effect in relation to the variation of an agreement in circumstances where the contractor wishes to perform or provide primary medical services under an integrated care provider contract as described in paragraph 3 of that Schedule.

Variation of agreements: registered patients from outside practice area

25

(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 17 of Schedule 2.

(2) Subject to paragraphs (4) and (5), the terms of the contractor's agreement 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 agreement as if the person resided within the contractor's practice area.

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

(a) the terms under which the contractor is to provide essential services and any other service;

(b) the terms under which the contactor is required to provide out of hours services to patients to whom it provides essential services; and

(i) paragraph 1 (services to registered patients),

(ii) paragraph 5(1) (attendance at practice premises),

(iii) paragraph 6(2)(a) (attendance outside practice premises) , and

(iv) paragraph 20(2) (refusal of applications for inclusion 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 agreement must be varied so as to include a term which has the effect of modifying the application of paragraph 23 of Schedule 2 (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 agreement 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 agreement 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 services in accordance with those terms; or

(b) comply with those terms.

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

(a) essential services, and any other service in core hours, if, at the time the treatment is required, it is not clinically appropriate of practical to provide primary medical services given the particular circumstances of the patient; or

(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.

Termination of agreements

26

(1) An agreement may only be terminated in the circumstances provided for by Part 8 of Schedule 2.

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

Other required terms

27

(1) Subject to paragraph (2), an agreement must also contain provisions which are equivalent in their effect to the provisions set out in Parts 6 to 14 of, and Schedules 1 and 2 to, these Regulations, unless the agreement 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 76(5) to (14);

(b) regulation 77; and

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

Suspension of agreement terms or of enforcement of agreement terms while a disease is or in anticipation of a disease being imminently pandemic etc.

27A

(1) Any term that is part of an agreement as a consequence of action taken under this Part, by agreement between the parties or by virtue of regulation 47(2) of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (terms of service of dispensing doctors: general) is temporarily not part of that agreement, in the particular circumstances mentioned in sub-paragraph (c)(ii) and during the period mentioned in sub-paragraph (c)(iii), in the following circumstances—

(a) as a consequence of a disease being, or in anticipation of a disease being imminently—

(i) pandemic, and

(ii) a serious risk or potentially a serious risk to human health,

NHS England with the agreement of the Secretary of State has made an announcement in respect of the prioritisation of services to be provided in, or in any part of, England as part of the health service;

(b) the prioritisation is in order to assist in the management of the serious risk or potentially serious risk to human health;

(c) as part of the announcement, NHS England with the agreement of the Secretary of State has issued advice to the effect that contractors are not to comply with a specified type of term of personal medical services agreements—

(i) in the area to which the announcement relates,

(ii) in the circumstances specified in the announcement, and

(iii) during the period specified in the announcement; and

(d) the contractor is situated in the area to which the announcement relates and compliance with the term (it being of the specified type) would, but for the effect of this paragraph, be a requirement of the contractor’s agreement.

(2) NHS England must not take enforcement action, as provided for in an agreement, in respect of a breach of a term of the agreement in the following circumstances—

(a) as a consequence of a disease being, or in anticipation of a disease being imminently—

(i) pandemic, and

(ii) a serious risk or potentially a serious risk to human health,

(b) the prioritisation is in order to assist in the management of the serious risk or potentially serious risk to human health;

(c) as part of the announcement, NHS England with the agreement of the Secretary of State has issued advice to the effect that contractors need not comply with a specified type of term of personal medical services agreements—

(i) in the area to which the announcement relates

(ii) in the circumstances specified in the announcement, and

(iii) during the period specified in the announcement; and

(d) the contractor—

(i) is situated in the area to which the announcement relates, and

(ii) has not complied with the term (it being of the specified type) in the particular circumstances mentioned in sub-paragraph (c)(ii) and during the period mentioned in sub-paragraph (c)(iii).

PART 6 — Out of hours services: opt outs

Opt outs: interpretation

28

In this Part—

“out of hours opt out notice” means a notice given under regulation 30(1) to opt out permanently of the provision of out of hours services;

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

“B day” is the day six months after the date on which the out of hours opt out notice was given; and

“C day” is the day nine months after the date on which the out of hours opt out notice was given.

Opt outs: general

29

Where—

(a) an agreement requires the contractor to provide out of hours services in accordance with regulation 22; and

(b) the contractor has contracted to provide out of hours services only to patients to which it is required to provide essential services under the agreement,

the agreement must contain terms relating to the procedure for opting out of the provision of those services which have the same effect as those specified in the following provisions of this Part.

Opting out of out of hours service provision

30

(1) Where a contractor wants to terminate its obligation under the agreement 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 OOH day, which must be either three or six months after the date on which that notice was given.

(3) NHS England must approve the out of hours opt out notice and specify, in accordance with paragraph (5), the 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 in writing of its decision as soon as possible.

(5) 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.

(6) 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 the out of hours services from an alternative provider from OOH day.

(7) The contractor's duty to provide the out of hours services terminates on OOH day unless NHS England gives notice in writing to the contractor under paragraph (7) (extending OOH 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 the out of hours services from OOH day, NHS England must give notice in writing to the contractor of this fact no later than one month before OOH day, and—

(a) in a case where OOH day is three months after service of the opt out notice, the contractor must continue to provide the out of hours services until B day unless, at least one month before B day, it receives a notice in writing from NHS England under paragraph (8) that, despite using reasonable endeavours, it has failed to find an alternative provider to take on the provision of the out of hours services from B day;

(b) in a case where OOH day is six months after the date on which the opt out notice was served, the contractor must continue to provide the out of hours services until C day.

(9) Where, in accordance with paragraph (9)(a), the opt out is to commence on B day and NHS England, despite using reasonable endeavours, has failed to find an alternative provider to take on the provision of the out of hours services from that day, NHS England must give notice in writing to the contractor of this fact at least one month before B day, in which case the contractor must continue to provide the out of hours services until C day.

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

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

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

(11) As soon as reasonably practicable and, in any event, before the end of the period of seven days beginning with the date on which NHS England gives notice under paragraph (10), NHS England must enter into discussions with the contractor concerning the support that NHS England may give to the contractor or other changes which NHS England or the contractor may make in relation to the provision of out of hours services until C day.

Informing patients of opt outs

31

(1) Before any out of hours 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 the arrangements made for them to receive the out of hours services by—

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

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

PART 7 — Right to a general medical services contract

Right to a general medical services contract

32

(1) Where a contractor is providing essential services under the agreement and would like to enter into a general medical services contract by virtue of this regulation, the contractor must give notice in writing to NHS England to that effect at least three months before the date on which the contractor would like to enter into the general medical services contract.

(2) A notice given under paragraph (1) must—

(a) state that the contractor wants to terminate the agreement and the date on which the contractor would like the agreement to terminate, which must be at least three months after the date on which the notice was given;

(b) subject to paragraph (3), give the names of the person or persons with whom the contractor wants NHS England to enter into a general medical services contract; and

(c) confirm that the person or persons so named meet the conditions set out in section 86 of the Act (persons eligible to enter into GMS contracts) and regulations 5 (conditions relating solely to general medical practitioners) and 6 (general condition relating to all contracts) of the General Medical Services Contracts Regulations or, where the contractor is not able so to confirm, provide the reason why it is not able to do so together with confirmation that the person or persons will, immediately prior to entering into the general medical services contract, meet those conditions.

(3) A person's name may only be given in a notice referred to in paragraph (1) if that person is a party to the agreement.

(4) NHS England must acknowledge receipt of the notice given under paragraph (1) before the end of the period of seven days beginning with the date on which NHS England received the notice.

(5) Provided that the conditions set out in section 86 of the Act (persons eligible to enter into GMS contracts) and regulations 5 and 6 of the General Medical Services Contracts Regulations are met, NHS England must enter into a general medical services contract with the person or persons named in the notice given under paragraph (1).

(6) In addition to the terms required by the Act and the General Medical Services Contracts Regulations, a general medical services contract entered into by virtue of this regulation must provide for—

(a) the general medical services contract to commence immediately after the termination of the agreement;

(b) the names of the patients included in the contractor's list of patients immediately before the termination of the agreement to be included in the first list of patients to be prepared and maintained by NHS England under paragraph 17 of Schedule 3 to the General Medical Services Contracts Regulations;

(c) the same services to be provided under the general medical services contract as were provided under the agreement immediately before it was terminated unless the parties otherwise agree; and

(d) the opt out of the provision of out of hours services referred to in paragraph (7) in accordance with the terms specified in Part 6 of the General Medical Services Contracts Regulations (opt outs: additional and out of hours services).

(7) The out of hours services are the services which the contractor was providing under the agreement in accordance with regulation 22 immediately before its termination and which the general medical services contract continues to require the contractor to provide.

(8) An agreement is to terminate on the date stated in the notice given by the contractor under paragraph (1) unless a different date is agreed by the contractor and NHS England or no general medical services contract is entered into by NHS England by virtue of this regulation.

(9) Where there is a dispute as to whether or not a person satisfies the conditions set out in section 86 of the Act (persons eligible to enter into a GMS contract), or of regulations 5 and 6 of the General Medical Services Contracts Regulations, the contractor may appeal to the First-tier Tribunal under this regulation and NHS England is to be the respondent.

(10) Any other dispute relating to this regulation is to be determined by the Secretary of State in accordance with regulation 9(2) and (3) of the General Medical Services Contracts Regulations.

(11) The parties to a dispute referred to the Secretary of State in accordance with paragraph (10) are the contractor and NHS England.

PART 8 — Persons who perform services

Qualifications of performers: medical practitioners

33

A medical practitioner may only perform clinical services under the agreement 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

Qualifications of performers: health care professionals

34

(1) A health care professional (other than one to whom regulation 33 applies) may not perform clinical services under the agreement unless—

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

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

Conditional registration or inclusion in a primary care list

35

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 agreement.

Clinical experience

36

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

Conditions for employment and engagement: medical practitioners

37

(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 33; and

(b) regulation 36.

(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 36 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

38

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

(a) the contractor has checked that the health care professional meets the requirements of regulation 34; or

(b) the contractor has taken reasonable steps to satisfy itself that the health care professional meets the requirements of regulation 36.

(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 the matters referred to in regulation 36 in accordance with paragraph (1) before employing or engaging the healthcare 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 any—

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

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

Clinical references

39

(1) The contractor may not employ or engage a health care professional to perform clinical services under the agreement (other than a medical practitioner to whom regulation 33(2)(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

40

(1) The contractor must, before employing or engaging a person to assist it in the provision of services under the agreement, 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 37 to 39.

(3) When considering the competence and suitability of a 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

Training

41

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

(a) performing clinical services under the agreement, 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.

Arrangements for GP Specialty Registrars

42

(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 agreement or for which other staff assist those medical 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 to Postgraduate Specialty Training in the UK”.

Doctors with provisional registration

43

A contractor may not, by reason only of having employed or engaged a person who is—

(a) provisionally registered under section 15, 15A or 21 of the Medical Act 1983 ; and

(b) acting in the course of that person's employment in a resident medical capacity in a post-registration programme,

reduce the total number of hours in which other staff assist in the performance of medical services under the agreement.

Notice requirements in respect of relevant prescribers

44

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

(a) a chiropodist or podiatrist independent prescriber;

(b) an independent nurse 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 agreement 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 agreement (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 agreement;

(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;

(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 agreement (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;

(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 agreement,

(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

45

(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 15, 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

46

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

Appraisal and assessment

47

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

(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 is to provide services under the agreement 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 9 — Prescribing and dispensing

Prescribing: general

48

(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

complies as appropriate with the requirements in regulations 49, 50 and 52 to 55.

(2) In regulations 49, 50 and 52 to 56, a reference to “drugs” includes contraceptive substances and a reference to “appliances” includes contraceptive appliances.

Prescribing software and supply shortages etc. of medicines

48A

(1) This paragraph applies where—

(a) the Secretary of State, in the exercise of the Secretary of State’s obligations, duties or powers in respect of ensuring that adequate supplies of English health service medicines are available—

(i) has acquired information under Part 6 of the Health Service Products (Provision and Disclosure of Information) Regulations 2018 (information about price and availability of health service medicines) about a particular English health service medicine, and

(ii) authorises the disclosure of information derived from that information (“relevant communications information”) to contractors for the purpose of ensuring, by the appropriate and effective management of—

(aa) a supply shortage of that particular English health service medicine, or

(bb) the discontinuation of the production of that particular English health service medicine,

that adequate supplies of English health service medicines are available;

(b) the contractor wishes to receive relevant communications information via the prescribing software that it has to support the issuing of prescriptions for English health service medicines (in addition to the other ways in which it may access that information); and

(c) there is a software programme available to the contractor from its supplier of prescribing software (“SPS”) that would enable that.

(2) Where paragraph (1) applies, the contractor must ensure that the arrangements it makes with a SPS to support the issuing of prescriptions for English health service medicines—

(a) include appropriate provision requiring the updating of the software to take account of relevant communications information about supply shortages of, or the discontinuation of the production of, particular English health service medicines; and

(b) are, as regards that inclusion, consistent with the authorisation referred to in paragraph (1)(a)(ii).

(3) The disclosure of relevant communications information by the Secretary of State or a person acting on the Secretary of State’s behalf to a SPS, or by a SPS to a contractor in a manner that is consistent with the authorisation referred to in paragraph (1)(a)(ii), is not a disclosure of confidential or commercially sensitive information affected by section 264B(2)(b) of the Act, in a case where but for this paragraph it would be, if the disclosure is—

(a) for the purpose of ensuring, by the appropriate and effective management by the Secretary of State (and persons acting on the Secretary of State’s behalf) of—

(i) a supply shortage of the particular English health service medicine in question, or

(ii) the discontinuation of the production of the particular English health service medicine in question,

that adequate supplies of English health service medicines are available; and

(b) proportionate to that purpose.

(4) A disclosure of relevant communications information as mentioned in paragraph (3) may be by way of permitting access to that information rather than proactive disclosure.

(5) A disclosure of relevant communications information that is as mentioned in paragraph (3) is to be treated as neither constituting a breach of confidence nor prejudicing commercial interests in any case where, but for this paragraph, it would be so treated.

(6) Section 264B(3)(f) of the Act applies to the contractor in respect of relevant communications information received as part of the arrangements mentioned in paragraph (2) as it would if the Secretary of State had disclosed that information to the contractor directly instead of via an intermediary.

(7) A SPS must not disclose relevant communications information, other than as provided for in paragraph (3), if it is confidential or commercially sensitive information that, when disclosed to a contractor by the Secretary of State, is subject to the disclosure restriction in section 264B(2)(b) of the Act.

Orders for drugs, medicines or appliances

49

(1) Subject to paragraphs (1A), (2) and (3) and to the restrictions on prescribing in regulations 54 and 55, a prescriber must order any drugs, medicines or appliances which are needed for the treatment of a patient who is receiving treatment under the agreement by—

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

(b) creating and transmitting an electronic prescription in circumstances to which regulation 50(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 agreement 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 agreement,

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 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 or prophylaxis of, that disease;

(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 agreement; 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 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.

(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 54.

(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 Schedule 2 to the Misuse of Drugs Regulations 2001 (controlled drugs to which regulations 14 to 16, 18, 21, 23, 26 and 27 of those Regulations apply) for supply by instalments for treating addiction to any drug specified in that Schedule, that 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

(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 of importation, exportation and possession and subject to the requirements of regulations 24 and 26) to the Misuse of Drugs Regulations 2001 ; and

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

(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

50

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

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

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

(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 Schedule 4 (controlled drugs subject to the requirements of regulations 22, 23, 26 and 27) or 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, or

(ii) a bulk prescription issued for a school or institution under regulation 56.

(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Patient choice: pharmaceutical services

51

(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 operated 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;

(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.

(2A) The contractor must, where the patient has nominated a dispenser, consult the patient, or the patient’s authorised person, as to their choice of dispenser in respect of each order for drugs, medicines or appliances made by a prescriber under regulation 49.

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

(4) A contractor must not seek to persuade a patient, or a patient’s authorised person, to nominate a dispenser recommended by the prescriber or the contractor.

(5) The contractor must direct the patient, or the patient’s authorised person, to the relevant information made available by NHS England about all chemists who are available in the patient’s chosen area and who are able to provide the required service where—

(a) a patient does not have a nominated dispenser;

(b) a patient, or a patient’s authorised person, asks the contractor to recommend a chemist whom the patient or the patient’s authorised person might nominate as the patient’s dispenser; or

Repeatable prescribing services

52

(1) The contractor may only provide repeatable prescribing services to a person on its lists 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

(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 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 of its patients to whom a 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) a medical practitioner who is a party to the agreement;

(b) in the case of an agreement with a qualifying body, any medical practitioner who is both a legal and beneficial shareholder in that body; or

Repeatable prescriptions

53

(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 electronic repeatable 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 to the person as soon as possible to that effect.

(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 attention 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, the prescriber must, as soon as practicable, give notice to a person that the person's repeatable prescription should no longer be used to obtain repeat dispensing services.

Prescribing for electronic repeat dispensing

53A

(1) Subject to regulations 49, 50, 52 and 53(2)(b) to (4), where a prescriber orders a drug, medicine or appliance by means of an electronic repeatable prescription, the prescriber must issue the prescription in a format appropriate for electronic repeat dispensing where it is clinically appropriate to do so for that patient on that occasion.

(2) In this regulation, “electronic repeat dispensing” means dispensing as part of pharmaceutical services or local pharmaceutical services which involves the provision of drugs, medicines or appliances accordance with an electronic repeatable prescription.

Restrictions on prescribing by medical practitioners

54

(1) A medical practitioner, in the course of treating a patient to whom the practitioner is providing treatment under the agreement, 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 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 a general medical services 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 be ordered for specified patients and 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

(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 (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 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 .

(6) Subject to regulation 18(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 (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 Schedule 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 Schedule 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

55

(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

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 prescription only 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 may not be ordered for patients in the provision of medical services under a general medical services contract; and

(c) the prescription only medicine is not specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs) as being a prescription only 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) 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 at which 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 has 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 any 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 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;

(d) 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 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 a 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 a 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

Bulk prescribing

56

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

(a) a contractor is responsible under the agreement 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—

(a) in the case of a drug or medicine, is not a prescription only medicine; or

(b) in the case of an appliance, does not contain such a product.

Excessive prescribing

57

(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 may, if the contractor consents, seek the views of the Local Medical Committee (if any) for the area in which the contractor provides services under the agreement.

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

58

(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 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 any drug or medicine to a patient otherwise than in accordance with Part 12 of the Human Medicines Regulations 2012 .

PART 10 — Prescribing and dispensing: out of hours services

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

59

(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 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 agreement;

“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 agreement includes the provision of out of hours services has agreed with NHS England that its agreement should also include the supply of necessary drugs, medicines or 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

(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 Contracts) (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 sub-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 service 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 18 which relates to fees and charges apply in respect of the supply of necessary drugs, medicines and appliances under this regulation as they apply in respect of prescriptions for any drugs, medicines and appliances.

PART10A — Vaccines and immunisations

Part 10A: interpretation

59A

In this Part—

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

“vaccine and immunisations services” has the meaning given in regulation 3(7) of the General Medical Services Contracts Regulations.

Vaccines and immunisations: duty of co-operation

59B

(1) The contractor must co-operate, in so far as is reasonable, with relevant persons—

(a) to understand the current uptake, and barriers to uptake, of offers to provide or administer vaccines and immunisations of the type specified in the GMS Statement of Financial Entitlements (“relevant vaccines and immunisations”) to patients, and

(b) to develop (if necessary) a strategy for improving their immunisation programme.

(2) For the purposes of paragraph (1) “relevant persons” means—

(a) other persons who administer relevant vaccines and immunisations to patients;

(b) NHS England;

(d) local authorities.

(e) integrated care boards.

Vaccines and immunisations: standards

59C

(1) A contractor must ensure that they have in place a system for delivering appointments at which relevant vaccines or immunisations are administered to patients (“immunisation appointments”) which meets the Vaccines and Immunisations Standards.

(1A) A contractor must comply with the standards contained in the Vaccines and Immunisations Standards on the processing of data relating to patients.

(2) In this regulation—

“processing” has the meaning given by section 3(4) of the Data Protection Act 2018;

“relevant vaccine or immunisation” has the same meaning as in regulation 59B(1)(a) of these Regulations;

“the Vaccines and Immunisations Standards” means the standards determined by NHS England published on 15 April 2024 and which a contractor is required to meet in relation to the following matters—the invitation of patients for immunisation appointments when they first become eligible for relevant vaccines or immunisations (“newly eligible patients”);the steps to be taken if no response is received to an invitation falling within sub-paragraph (a);the provision of immunisation appointments to newly eligible patients;the steps to be taken if a newly eligible patient does not attend an immunisation appointment;requests for relevant vaccines or immunisations made by patients who are eligible for them but have not previously received them for any reason;the identification of gaps in the vaccination records of registered patients, and the offer, and provision of, immunisation appointments to those patients. the processing of records relating to patient vaccinations and immunisations, including records relating to the administration of vaccines and patient vaccination status.

Vaccines and immunisations: catch-up campaigns

59D

(1) The contractor must participate in a manner reasonably required by NHS England in one vaccines and immunisations catch-up campaign in each financial year.

(2) In this regulation “vaccines and immunisations catch-up campaign” means a campaign which is aimed at maximising the uptake of a particular vaccine or immunisation by patients who are eligible for it but have not received that vaccine or immunisation for any reason (other than a decision to refuse the vaccine or immunisation).

Vaccines and immunisations: additional staff training

59E

(1) The contractor must ensure that all staff involved in the administration of vaccines and immunisations are trained in the recognition and initial treatment of anaphylaxis.

(2) This regulation does not affect the contractor’s obligations under Part 8.

Vaccines and immunisations: nominated person

59F

(1) The contractor must nominate a person (a “V & I lead”) who is to have responsibility for—

(a) overseeing the provision of vaccine and immunisation services by the contractor,

(b) carrying out, on behalf of the contractor, any of the contractor’s functions under regulation 59B, and

(2) The contractor must ensure that the V & I lead—

(a) has regard to all guidance issued by NHS England which is relevant to that role, and

(b) if they are not a health care professional, is directly supervised in that role by a healthcare professional.

Vaccines and immunisations: exception for private arrangements

59G

Nothing in this Part applies in relation to the offer or administration of any vaccine or immunisation to a patient under a private arrangement.

PART 11 — Records and information

Patient records

60

(1) The contractor must keep adequate records of its attendance on and treatment of patients.

(2) A contractor which provides essential services must keep the records referred to in paragraph (1)—

(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.

(3) A contractor which provides essential services must include in the records referred to in paragraph (1), clinical reports sent in accordance with paragraph 7 of Schedule 2 or from any other health care professional who has provided clinical services to a person on the contractor's list of patients.

(4) The consent of NHS England required by paragraph (2)(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.

(5) 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 (4)(b) to the extent necessary for NHS England to confirm that the audit function is enabled and functioning correctly.

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

(6A) 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 62 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.

(6B) Where a patient on a contractor’s list of patients—

(a) is removed from that list at that patient’s request under paragraph 22 of Schedule 2, or by reason of the application of any of paragraphs 23 to 30 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.

(6C) Where a contractor’s responsibility for a patient terminates in accordance with paragraph 31 of Schedule 2, 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.

(6D) For the purposes of this regulation, “GP2GP facility” has the same meaning as in paragraph (2) of regulation 62.

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

(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(9) 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 (4)(b).

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

Record of ethnicity information

60A

(1) This regulation applies if a contractor, or a person acting on behalf of a contractor, makes a request to a patient (“P”) for P to disclose their ethnicity to the contractor so that information can be recorded in P’s medical record (a “relevant request”).

(2) If P, or where P is a person to whom paragraph (4) applies, an appropriate person acting on behalf of P, discloses P’s ethnicity in response to the relevant request, the contractor must record P’s ethnicity in P’s medical record.

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