Legalize / United Kingdom / Statutory-Instrument

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

Type Statutory-Instrument

Publication 2013-02-14

Last updated 2025-10-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

PDF Download

articles Not indexed

Reform history JSON API

(5) At the point at which P, in P’s clinical judgement is to, or would normally, discuss the prescription as mentioned in paragraph (3)(a)(i) or (b)(i) with X or Y, or where appropriate with a carer of X or Y, P must, as stage 3 of the service—

(a) engage in a discussion with X or Y, or where appropriate a carer of X or Y, in a manner which is in accordance with P’s duty of confidentiality to X or Y and which is—

(i) to assess their understanding of what medicinal products X or Y should be taking, and

(ii) to offer to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so advice, assistance and support in respect of X’s or Y’s medication regimen;

(b) draw to X’s or Y’s attention (where appropriate via a carer of X or Y)—

(i) P’s disposal service in respect of unwanted drugs, and

(ii) any other pharmaceutical services that P, in the exercise of P’s clinical judgement, considers X or Y may benefit from following X’s or Y’s stay in hospital or the transfer of X’s or Y’s care between different providers of NHS services;

(c) if any issues of concern are identified, raise these to the extent that P, in the exercise of P’s clinical judgement, considers it appropriate to do so with any provider of primary medical services on whose patient list X or Y is; and

(d) keep and maintain records, as appropriate—

(i) of the discussion pursuant to paragraphs (a) and (b), and of any raising of concerns and any actions taken, and

(ii) for service evaluation purposes.

(6) If the DMS referral requesting that P provides services under this paragraph includes circumstances in which P is not to provide, or is to cease to provide, services under this paragraph, P is not to, or is to cease to, provide services under this paragraph in those circumstances (for example, X’s or Y’s admission or re-admission to hospital).

Clinical governance and the promotion of healthy living

Premises requirements in respect of consultation rooms

28A

(1) An NHS pharmacist must ensure that at pharmacy premises, other than distance selling premises, there is a consultation room which is—

(a) clearly designated as a room for confidential conversations;

(b) distinct from the general public areas of the pharmacy premises; and

(c) a room where both a person accessing pharmaceutical services and a person performing pharmaceutical services are able to be seated together and communicate confidentially.

(2) Where, in the opinion of NHS England, pharmacy premises other than distance selling premises included on a pharmaceutical list on the relevant day are too small for a consultation room—

(a) the NHS pharmacist in respect of those premises may, with the agreement of NHS England, comply with paragraph 28B instead of sub-paragraph (1); and

(b) for these purposes, references to distance selling premises in paragraph 28B are to be treated as a reference to the premises about which NHS England has formed the opinion that they are too small for a consulting room.

(3) An NHS pharmacist in respect of premises that were on a pharmaceutical list on the relevant day but no advanced services were provided at or from those premises during the year before the relevant day need not comply with sub-paragraphs (1) or (2) in respect of those premises before 1st April 2023.

(4) In this paragraph, “the relevant day” means the day of the coming into force of regulation 15(1) of the National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020.

Consultations held from distance selling premises and some small pharmacy premises

28B

An NHS pharmacist in respect of distance selling premises must ensure that there are arrangements in place at those premises which enable a person performing pharmaceutical services to communicate confidentially with a person accessing pharmaceutical services—

(a) by telephone or another live audio link; and

(b) via a live video link.

Professional Standards

Accessing summary care records

Electronic Prescription Service access

Contact via NHSmail, pharmacy profiles and the Central Alerting System

Inducements etc.

Duty to provide information about fitness matters as they arise

Other information to be supplied

Facilitating remote access to pharmaceutical services

Co-operation with Health Education England

Complaints

Inspections and access to information

Supply in accordance with a PTP or a PTPGD

Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

22AA

(1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, a PTP or a PTPGD, an NHS pharmacist (P) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

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

is the subject of an announcement made by NHS England, with the agreement of the Secretary of State, to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, eligible patients are entitled to be provided with a home delivery option in respect of that item, if it is supplied to them as part of pharmaceutical services.

(3) Where P is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, a PTP or a PTPGD, P must ascertain from—

(a) an eligible patient—

(i) who has contacted P about the home delivery of a notified item, or

(ii) who is a person whom P considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted P about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which P must provide.

(4) Where paragraph (3) does not apply, the home delivery option that P must provide must comprise—

(a) P delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) P arranging for an item dispensed by P to be delivered by another NHS pharmacist or by an LPS contractor to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if P is unable to deliver the item or arrange for its delivery by another NHS pharmacist or by an LPS contractor, P arranging for the dispensing or supply of the item by another NHS pharmacist or by an LPS contractor who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at P’s pharmacy premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Part, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, P may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.

(7) Where arrangements are in place which enable an NHS pharmacist to make a delivery as mentioned in sub-paragraph (4)(a) or (b) as part of a directed service, the NHS pharmacist must deliver the item as part of that directed service.

(8) This paragraph does not apply to an NHS pharmacist in respect of distance selling premises.

Discharge medicines service

Service outline in respect of the discharge medicines service

Supply in accordance with a PTP or a PTPGD

Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

7AA

(1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, a PTP or a PTPGD, a dispensing doctor (D) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

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

(3) Where D is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, a PTP or a PTPGD, D must ascertain from—

(a) an eligible patient—

(i) who has contacted D about the home delivery of a notified item, or

(ii) who is a person whom D considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted D about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which D must provide.

(4) Where paragraph (3) does not apply, the home delivery option that D must provide must comprise—

(a) D delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) D arranging for an item dispensed by D to be delivered by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if D is unable to deliver the item or arrange for its delivery by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, D arranging for the dispensing or supply of the item by another dispensing doctor, or by an NHS pharmacist or an LPS contractor, who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at D’s listed dispensing premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, D may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.

Complaints procedures

Inspections and access to information

Voluntary closure of premises

Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

10AA

(1) Before dispensing a notified item on a prescription form or supplying it in accordance with a serious shortage protocol, an LPS contractor (C) must provide a home delivery option to eligible patients in respect of that item.

(2) For the purposes of this paragraph, a “notified item” is an item that, as a consequence of a disease being or in anticipation of a disease being imminently—

(a) pandemic; and

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

(3) Where C is to, or may be required to, dispense a notified item on a prescription form or supply it in accordance with a serious shortage protocol, C must ascertain from—

(a) an eligible patient—

(i) who has contacted C about the home delivery of a notified item, or

(ii) who is a person whom C considered, on the basis of an order or request for a notifiable item, might be an eligible person and accordingly, in the ordinary exercise of professional skill and judgement, made the appropriate checks and determined that they were; or

(b) a person who may make an application for pharmaceutical services on behalf of that eligible patient (a “duly authorised person”) who has contacted C about the home delivery of a notified item,

whether or not the item could be supplied via a duly authorised person, and if it could, then supplying the item via a duly authorised person is the home delivery option which C must provide.

(4) Where paragraph (3) does not apply, the home delivery option that C must provide must comprise—

(a) C delivering the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person (for example, a care home where the patient is temporarily residing);

(b) C arranging for an item dispensed by C to be delivered by another LPS contractor or by an NHS pharmacist to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person; or

(c) if C is unable to deliver the item or arrange for its delivery by another LPS contractor or by an NHS pharmacist, C arranging for the dispensing or supply of the item by another LPS contractor or by an NHS pharmacist who would be able to deliver the item to the eligible patient’s home or to an alternative address agreed with the patient or a duly authorised person.

(5) Paragraph (1) does not apply where the eligible patient or a duly authorised person is already at C’s chemist premises for the purposes of being supplied with the notifiable item.

(6) Notwithstanding the foregoing provisions of this Schedule, in any case of a supply in accordance with a home delivery option, if but for this sub-paragraph that supply would need to be made with reasonable promptness, C may instead, in the exercise of professional skill and judgment, make the supply within a reasonable timescale.

Information to be provided for the NHSCB's lists

Clinical governance

Professional Standards

Accessing summary care records

Electronic Prescription Service access

Contact via NHSmail and the Central Alerting System

Inducements etc

Duty to provide information about fitness to practise matters as they arise

Co-operation with Health Education England

Charges for drugs, appliances and containers, and ownership of containers

Refunds of prescription charges

Remuneration, overpayments etc

Local resolution of disputes

Dispute resolution: non-NHS contracts

NHS dispute resolution procedure

Determination of dispute

Disputes: supplemental

Complaints

Variation of LPS schemes

Termination by agreement

Termination by serving notice

Termination of arrangements by the NHSCB on grounds of suitability etc

Termination by the NHSCB: patient safety and material financial loss

Termination and the NHS dispute resolution procedure

Third party rights

Distance selling premises requirements in respect of websites and health promotion zones

28C

An NHS pharmacist (P) in respect of distance selling premises must ensure that P has a website for use by the public for the purpose of accessing pharmaceutical services from those premises, on which there is an interactive page, clearly promoted to any user of the website when they first access it, which provides public access to a reasonable range of up to date materials that promote healthy lifestyles by addressing a reasonable range of health issues.

Professional Standards

Accessing summary care records

Electronic Prescription Service access

Contact via NHSmail, pharmacy profiles and the Central Alerting System

Inducements etc.

Duty to provide information about fitness matters as they arise

Other information to be supplied

Facilitating remote access to pharmaceutical services

Co-operation with Health Education England

Complaints

Inspections and access to information

Supply in accordance with a LPIV

5C

(1) Subject to the following provisions of this Part, where—

(a) an NHS Pharmacist (P) receives a LPIV; and

(b) a person who is entitled to be supplied by P with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,

P must, with reasonable promptness, provide the prescription item so ordered.

(2) If a person who is entitled as mentioned in sub-paragraph (1)(b) asks P to do so—

(a) P must give an estimate of the time when the prescription item will be ready; and

(b) if they are not ready by then, P must give a revised estimate of the time when the item will be ready (until it is ready).

(3) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item (whether by P or otherwise) ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.

Urgent supply without a prescription

Preliminary matters before providing ordered drugs or appliances

Providing ordered drugs or appliances

Refusal to provide drugs or appliances ordered

Further activities to be carried out in connection with the provision of dispensing services

Additional requirements in relation to electronic prescribing

Additional requirements in relation to specified appliances

Disposal service in respect of unwanted drugs

Basic procedure in respect of unwanted drugs

Further activities to be carried out in connection with the disposal of unwanted drugs

Promotion of healthy lifestyles

Prescription linked intervention

... Health campaigns

Signposting

Service outline in respect of signposting

Support for self-care

Service outline in respect of support for self-care

Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.

Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

Discharge medicines service

Service outline in respect of the discharge medicines service

Supply in accordance with a LPIV

3C

(1) Subject to the following provisions of this Schedule, where—

(a) a dispensing doctor (D) receives a LPIV; and

(b) a person who is entitled to be supplied by D (Part 8 and this Schedule having that effect) with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,

D must, with reasonable promptness, provide the prescription item so ordered.

(2) If a person who is entitled as mentioned in sub-paragraph (1)(b) asks D to do so—

(a) D must give an estimate of the time when the prescription item will be ready; and

(b) if they are not ready by then, D must give a revised estimate of the time when the item will be ready (until it is ready).

(3) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.

Preliminary matters before providing ordered drugs or appliances

Charge exemption and remission of charges: declarations and checks

Checks and records in the case of supply in accordance with a SSP

Provision of Scheduled drugs

Refusal to provide drugs or appliances ordered

Dispensing doctors issuing prescription forms which may be presented to an NHS chemist

Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.

Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

Complaints procedures

Inspections and access to information

Voluntary closure of premises

Supply in accordance with a LPIV

3B

(1) Subject to the following provisions of this Schedule, where—

(a) a LPS Contractor (C) receives a LPIV; and

(b) a person who is entitled to be supplied by C with a prescription item ordered on the LPIV requests the provision of the item in accordance with that LPIV,

C must, with reasonable promptness, provide the prescription item so ordered.

(2) If a person who is entitled as mentioned in sub-paragraph (1)(b) asks C to do so—

(a) C must give an estimate of the time when the prescription item will be ready; and

(b) if they are not ready by then, C must give a revised estimate of the time when the item will be ready (until it is ready).

(3) Sub-paragraph (1) does not apply where arrangements are in place for the provision of the item ordered on the LPIV as part of a directed service which includes arrangements for the provision of such an item ordered on such a LPIV.

Urgent supply without a prescription

Preliminary matters before providing ordered drugs or appliances

Providing ordered drugs or appliances

Refusal to provide drugs or appliances ordered

Further activities to be carried out in connection with the provision of dispensing services

Additional requirements in relation to electronic prescribing

Further activities in connection with repeat dispensing

Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.

Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

Information to be provided for the NHSCB's lists

Clinical governance

Professional Standards

Accessing summary care records

Electronic Prescription Service access

Contact via NHSmail and the Central Alerting System

Inducements etc

Duty to provide information about fitness to practise matters as they arise

Co-operation with Health Education England

Charges for drugs, appliances and containers, and ownership of containers

Refunds of prescription charges

Remuneration, overpayments etc

Local resolution of disputes

Dispute resolution: non-NHS contracts

NHS dispute resolution procedure

Determination of dispute

Disputes: supplemental

Complaints

Variation of LPS schemes

Termination by agreement

Termination by serving notice

Termination of arrangements by the NHSCB on grounds of suitability etc

Termination by the NHSCB: patient safety and material financial loss

Termination and the NHS dispute resolution procedure

Third party rights

Temporary extension of earlier pharmaceutical needs assessments and access by NHS England and HWBs to pharmaceutical needs assessments

PNA based applications for new premises offering additional or different opening hours

21A

(1) Paragraph (2) applies where NHS England receives a routine application which is in respect of premises not already listed, where—

(a) the applicant’s stated intention (in accordance with paragraph 7(1)(a) of Schedule 2) is to meet a need, or secure improvements or better access, identified in the relevant pharmaceutical needs assessment (whether current or future gaps in provision); and

(b) the need is, or the improvements are or the better access is, in respect of the days on which or the times at which essential services are provided in the area of the relevant HWB.

(2) In determining whether or not it is satisfied as mentioned in section 129(2A) of the 2006 Act (regulations as to pharmaceutical services), NHS England must have regard to whether granting the application would result in an undesirable increase in the availability of essential services in the area of the relevant HWB.

(3) If NHS England is satisfied that granting the application would result in the undesirable increase in availability mentioned in paragraph (2), it must refuse the application.

Refusal of routine applications that are based on neither a pharmaceutical needs assessment nor unforeseen benefits

Pharmaceutical lists ...

Zero or nominal product reimbursement for ... vaccines and antivirals

91A

(1) In the case of the drugs or medicines to which paragraph (2) applies, determining authorities must ensure that determinations under section 164 of the 2006 Act (remuneration of persons providing pharmaceutical services) in respect of pharmaceutical remuneration that relates to the supply or administration of those drugs or medicines either—

(a) do not provide for or permit any reimbursement to be paid for the cost of the drug or medicine (and so the basic price of the drug or medicine, for Drug Tariff purposes, is zero); or

(b) only provide for or permit nominal reimbursement to be paid for the cost of the drug or medicine.

(2) This paragraph applies to—

(a) a drug or medicine which is used for vaccinating or immunising people against coronavirus ..., if the conditions set out in paragraph (3) are satisfied; ...

(aa) a drug or medicine which is used for vaccinating or immunising people against respiratory syncytial virus, if the conditions set out in paragraph (3) are satisfied;

(ab) a drug or medicine which is used for vaccinating or immunising people against measles, mumps and rubella, if the conditions set out in paragraph (3) are satisfied; ...

(ac) a drug or medicine which is used for vaccinating or immunising people against pertussis (whooping cough), if the conditions set out in paragraph (3) are satisfied; ...

(ad) a drug or medicine which is used for vaccinating or immunising children against influenza, if the conditions set out in paragraph (3) are satisfied; ...

(ae) a drug or medicine which is used for vaccinating or immunising people against human papillomavirus, if the conditions set out in paragraph (3) are satisfied; or

(b) an antiviral drug or medicine which is used for preventing or treating coronavirus (“a coronavirus antiviral”), if the conditions set out in paragraph (4) are satisfied.

(3) The conditions set out in this paragraph are—

(a) the Secretary of State (references to whom in this regulation encompass both the Secretary of State for Health and Social Care and other Secretaries of State) has purchased the vaccines for supply as part of the health service;

(b) the Secretary of State has made arrangements for all or part of the Secretary of State’s stock of the vaccines, purchased as mentioned in sub-paragraph (a), to be supplied to NHS pharmacists and LPS chemists, whether directly or via an intermediary, at no cost to the NHS pharmacists or LPS chemists;

(c) NHS England has made arrangements for the administration of the vaccines from the stock mentioned in sub-paragraph (b) as part of a directed service; and

(d) the ... vaccine in question is from that stock and administered as part of that service.

(3A) The references in paragraph (3) to vaccines or the vaccine in question are references to the drugs or medicines in respect of which the conditions set out in paragraph (3) are to be satisfied by virtue of paragraph (2)(a) to (ae).

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

(a) the Secretary of State has purchased coronavirus antivirals of a particular type for supply as part of the health service;

(b) the Secretary of State has made arrangements for all or part of the Secretary of State’s stock of that particular type of coronavirus antiviral, purchased as mentioned in sub-paragraph (a), to be supplied to NHS pharmacists and LPS chemists, whether directly or via an intermediary, at no cost to the NHS pharmacists or LPS chemists; and

(i) is from that stock, or

(ii) is not from that stock but is nevertheless of the particular type of coronavirus antiviral that is available at no cost to NHS pharmacists and LPS chemists under the arrangements mentioned in sub-paragraph (b).

(5) For the purposes of paragraph (4), the Secretary of State may characterise the particular type of coronavirus antivirals that are available at no cost to NHS pharmacists and LPS chemists solely by reference to the presentation of the drug or medicine (as well as by reference to its active ingredient, strength or any, or a combination of any, other distinguishing characteristics).

(6) For the avoidance of doubt, determinations under section 164 of the 2006 Act that, in accordance with this regulation—

(a) do not provide for or permit reimbursement to be paid for the cost of a drug or medicine (and so the basic price of the drug or medicine, for Drug Tariff purposes, is zero); or

(b) only provide for or permit nominal reimbursement to be paid for the cost of a drug or medicine,

may nevertheless provide for or permit remuneration to be paid for any service provided by a NHS pharmacist or LPS chemist, in the course of which the drug or medicine is supplied or administered.

(7) In this regulation, “nominal reimbursement” means, in the case of a drug or medicine that has been provided at no cost to a NHS pharmacist or LPS chemist, payment of an amount that is paid in place of the amount that the NHS pharmacist or LPS chemist would ordinarily make from the difference between—

(a) the amount that they paid for the drug or medicine when they purchased it; and

(b) the amount that they are paid by NHS England in respect of the cost of that drug or medicine (most commonly the basic price listed in the Drug Tariff), if they supply or administer that drug or medicine under arrangements for the provision of pharmaceutical or local pharmaceutical services.

(8) For the purposes of paragraph (2)(ad), a drug or medicine is to be treated as a drug or medicine which is used for vaccinating or immunising children if (despite not being solely used for that purpose) it is mainly used for that purpose but it is also used for vaccinating or immunising people who have attained the age of 16 years.

Dispensing doctor remuneration

The taking effect of determinations

Overpayments

Free supply of drugs, appliances and containers where the drug or appliance is supplied under pharmaceutical services

Refunds of prescription charges

Reward scheme

Payments to suspended chemists

Updating of information about or relating to a superintendent

5A

(1) Where, in the case of a body corporate making an application for inclusion in a pharmaceutical list, there is a change to the superintendent of the body corporate before the applicant is included in a pharmaceutical list or the application cannot be further proceeded with, the applicant must update the application as soon as is reasonably practicable with—

(a) the details about that superintendent that the applicant would have been required to submit under paragraph 3; and

(b) the details about any other body corporate that the applicant would have been required to submit under paragraph 4 because of that superintendent being that other body corporate’s superintendent,

had the superintendent been in post at the time the application was submitted.

(2) If—

(a) the application has been determined by NHS England but—

(i) there are proceedings relating to the application that have not yet reached their final outcome, or

(ii) in the case of an application that has been granted, there are no such proceedings but the applicant has not yet been included in a pharmaceutical list; and

(b) NHS England is satisfied, on the basis of the information provided or required to be provided under sub-paragraph (1), that there are grounds for refusing the application under regulation 33 or imposing a condition under regulation 35,

NHS England may redetermine the application, but only for the purpose of refusing it under regulation 33 or imposing a condition under regulation 35 (so there may still be a purpose to any proceedings that have not yet reached their final outcome).

Applications seeking the listing of premises that are already, or are in close proximity to, listed chemist premises

Additional information to be included with excepted applications

Undertakings

Nature of details to be supplied

Co-operation with NHS England

Continuity in respect of opening hours directions

65A

(1) In this regulation, “opening hours directions” means directions that have been given under regulation 65(4) or (5), or issued in accordance with paragraph 25 or 26 of Schedule 4 or paragraph 15 or 16 of Schedule 5, or given under or issued in accordance with earlier provisions which that regulation and those paragraphs have (at any distance in succession) replaced.

(2) Opening hours directions given or issued in respect of premises included in a pharmaceutical list apply to any NHS chemist listed in relation to those premises, not just to the NHS chemist to whom they were given or issued.

(3) Where, by virtue of regulation 24 or 26(2), an excepted application may be granted in circumstances where the applicant is undertaking to provide the same pharmaceutical services as those that are already being provided, but at or from premises that are not already included in a pharmaceutical list, that application must be refused where opening hours directions apply in respect of the premises from which the applicant is relocating the relevant business, unless—

(a) the applicant, as part of their undertaking, undertakes to provide pharmaceutical services for any total number of core opening hours, and on any set days and at any set times, specified in those opening hours directions, taking into account any variation in respect of a rest break in accordance with paragraph 23(7)(bd) of Schedule 4; and

(b) NHS England is, accordingly, required to give directions under regulation 65(4) in the same terms as those given in those opening hours directions, but in respect of the premises to which the applicant is relocating the relevant business and taking into account any variation in respect of a rest break in accordance with paragraph 23(7)(bd) of Schedule 4.

(4) In circumstances where, in respect of any premises, there are opening hours directions that have replaced (at any distance in succession) a 100 hours condition, whether that condition applied in respect of those premises or other premises, any routine application to relocate from those premises must be refused unless—

(a) the applicant undertakes to provide pharmaceutical services, at or from the premises to which the applicant is relocating the relevant business, for any total number of core opening hours, and on any set days and at any set times, specified in those opening hours directions; and

(b) NHS England is, accordingly, required to give directions under regulation 65(4) in the same terms as those given in those opening hours directions but in respect of the premises to which the applicant is relocating the relevant business.

Conditions relating to providing directed services

Conditions relating to voluntary closure of premises

Condition relating to entering administration

Conditions relating to local resolution of disputes over terms of service

Local hours plans

23A

(1) Where NHS England is satisfied that people in a particular area are experiencing, or are likely to experience, significant difficulty in accessing pharmaceutical services on a temporary basis for an identified period, NHS England may establish a local hours plan with the NHS pharmacists in that area that are willing to participate in a local hours plan for that area.

(2) NHS England must, prior to establishing a local hours plan, consult any local pharmaceutical committee for the area that comprises or includes the area of the plan, unless NHS England decides that it is not practicable to do so.

(3) NHS England must notify any local pharmaceutical committee for the area that comprises or includes the area of a local hours plan that it establishes of the contents of that plan and any changes to it, including where further NHS pharmacists join or any NHS pharmacists cease to participate in the plan.

(4) The local hours plan is to be of a specified duration, determined by NHS England, and is to contain the temporary opening hours agreed between NHS England and each of the participating NHS pharmacists (each participating NHS pharmacist agrees their own but not other participants’ temporary opening hours).

(5) NHS pharmacists that have agreed to participate in a local hours plan—

(a) must ensure that pharmaceutical services are provided at or from their pharmacy premises during the agreed temporary opening hours; and

(b) may cease to participate in the plan and return to their core and supplementary opening hours, provided that, subject to sub-paragraph (8), they have given the notice period for doing so that they have each agreed with NHS England as part of the plan.

(6) NHS England may revise a local hours plan from time to time, including by allowing further NHS pharmacists to join, but any change to the plan that is a change to the temporary opening hours of an NHS pharmacist that is participating in the plan, or of their notice period as referred to in sub-paragraph (5)(b), must be agreed with that NHS pharmacist.

(7) A local hours plan ceases to have effect on the expiry of its specified duration, determined by NHS England in accordance with sub-paragraph (4), unless NHS England revises the specified duration, in which case the new specified duration becomes the specified duration of the plan, and further revisions are then also permissible pursuant to this sub-paragraph.

(8) If NHS England revises the specified duration of a local hours plan, an NHS pharmacist may cease to participate in the plan on the date that was the plan’s expiry date, having given prior notice of their intention to do so, which may be of a shorter period than their agreed notice period where—

(a) the NHS pharmacist does not wish to participate in the plan beyond the expiry date that has been extended;

(b) the timing of the revision means it is not possible, or not reasonably practicable, for prior notice to be given for the agreed notice period; and

(c) the NHS pharmacist gives notice of their intention to cease to participate in the plan on the date that was the plan’s expiry date as soon as it is reasonably practicable for them to do so.

(9) While a local hours plan has effect, the core and supplementary opening hours that have temporarily been suspended may be changed in accordance with paragraphs 23(6) and (7), 25 and 26.

Matters to be considered when issuing directions in respect of pharmacy premises core opening hours

Determination of pharmacy premises core opening hours instigated by the NHS pharmacist

Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical services

Pharmacy opening hours: arrangements while a disease is or in anticipation of a disease being imminently pandemic etc.

Flexible provision of relevant immunisation services during a pandemic etc.

Business continuity plans to deal with temporary suspensions

29D

(1) An NHS Pharmacist (P) must have at all times an up to date business continuity plan for P’s pharmacy premises, which is available at those premises, to deal with the temporary suspension because of illness or another reason beyond the control of P of the provision of pharmaceutical services at or from those premises that—

(a) is proportionate to the needs of the people who are anticipating or are accustomed to receiving pharmaceutical services from P; and

(b) includes the components set out in sub-paragraph (2).

(2) The components are—

(a) arrangements for notifying NHS England, in the approved manner—

(i) about the prospect of a temporary suspension, whenever such a suspension becomes likely, and

(ii) about a temporary suspension and its anticipated duration, wherever possible before the start of the suspension;

(b) arrangements for updating the pharmacy profile mentioned in paragraph 29C(3) about the suspension, including in due course about the resumption of the provision of pharmaceutical services at or from the pharmacy premises;

(c) if P provides directed services that provide people with urgent care services, arrangements for ensuring, to the extent practicable, that people are not referred to P’s pharmacy premises for those services during the temporary suspension;

(d) arrangements, where practicable and to an extent that is reasonable having regard to the needs of the people who are anticipating or are accustomed to receiving pharmaceutical services from P, for notifying other providers of pharmaceutical and local pharmaceutical services and providers of primary medical services about the suspension and its anticipated duration;

(e) arrangements for displaying information about the suspension and its anticipated duration—

(i) in the case of distance selling pharmacies, on the website for the distance selling pharmacy, clearly promoted to any user of the website when they first access it, or

(ii) in any other case, on a notice at P’s pharmacy premises visible from outside the premises, which also provides information, where appropriate in the approved manner and to an extent that is reasonable having regard to the needs of the people who are anticipating or are accustomed to receiving pharmaceutical services from P, about the availability of pharmaceutical or local pharmaceutical services at or from other pharmacy premises nearby; and

(f) arrangements, where practicable, for the continuity of care for the people who are anticipating or are accustomed to receiving pharmaceutical services from P, including for any people who—

(i) have booked appointments, or

(ii) attend the pharmacy premises regularly for the supervised administration of medicines.

(3) For the purposes of sub-paragraph (2), “approved” means approved by NHS England.

(4) In the event of the temporary suspension, or the likely temporary suspension, of pharmaceutical services provision at or from P’s pharmacy premises, P must use all reasonable endeavours to implement P’s business continuity plan, and in the case of a likely temporary suspension, in a manner proportionate to that likelihood.

Inducements etc.

Duty to provide information about fitness matters as they arise

Other information to be supplied

Facilitating remote access to pharmaceutical services

Co-operation with NHS England

Complaints

Inspections and access to information

Notification by NHS England of changes to its lists

Functions of NHS England in relation to fitness information relevant to applications: aggregation of information

Information to be provided for NHS England’s lists

Termination of arrangements by NHS England on grounds of suitability etc

Termination by NHS England: patient safety and material financial loss

Transitional provision: distance selling premises applications for new inclusions made before 23rd June 2025

25A

In the case of an application made before 23rd June 2025 to which regulation 25(1)(a) applied (applications for inclusion in a pharmaceutical list by a person not already included), notwithstanding the repeal of regulation 25(1)(a), that application is to be determined in accordance with regulation 25(1) as it had effect on 22nd June 2025.

Change of ownership applications

Consolidation onto an existing site

Applications for temporary listings arising out of suspensions

Applications from persons exercising a right of return to a pharmaceutical list

Temporary arrangements during emergencies or because of circumstances beyond the control of NHS chemists

Sub-contracting aspects of dispensing under “hub and spoke” arrangements

7A

(1) Subject to sub-paragraph (3), an NHS pharmacist (P1) must not sub-contract the performance of any of its core dispensing functions.

(2) For the purposes of this paragraph and paragraph 7B, “core dispensing functions” means the assembly or part-assembly of any prescription item (including bagging and the application of dispensing labels) with a view to the supply of that prescription item in accordance with a prescription, a SSP, a LPIV, a PTP or a PTPGD.

(3) Sub-paragraph (1) does not apply to—

(a) a contract for services between P1 and—

(i) a health care professional (for example, a locum) or a provider of locums, or

(ii) a corporate body that is—

(aa) is a subsidiary undertaking of P1, or

(bb) a subsidiary undertaking of a parent undertaking of which P1 is also a subsidiary undertaking,

for the performance by that health care professional, a locum provided by the provider of locums, or the corporate body of core dispensing functions at P1’s pharmacy premises;

(b) arrangements whereby a retail pharmacy business that is not P1 is nevertheless carrying on a retail pharmacy business at P1’s premises as a temporary arrangement related to the purchase of those premises; or

(4) For the purposes of this paragraph and paragraphs 7B and 7C, “hub and spoke arrangements” are arrangements between P1 and another retail pharmacy business (P2) which—

(a) are for the purpose of P2 supporting P1with regard to the fulfilment of orders—

(i) submitted to P1 on prescription forms or LPIVs, or

(ii) for the provision of prescription items by P1 in accordance with PTPs or PTPGDs; and

(b) provide for the assembly or part-assembly of those orders (including in accordance with a SSP) at premises of P2 with a view to the supply of the prescription items at or from the pharmacy premises of P1 to or for the use of the patients for whom they were ordered.

(5) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 7B and 7C, P1 must—

(a) have given notice in writing to NHS England of P1’s intention to sub-contract core dispensing functions—

(i) not less than 28 days before the date on which the proposed arrangements are intended to commence, or

(ii) by a date agreed with NHS England before which the proposed arrangements are to commence; and

(b) have taken reasonable steps, before entering into the arrangements, to satisfy itself of P2’s fitness to carry out core dispensing functions on behalf of P1.

(6) A notice under sub-paragraph (5)(a) must include the particulars which have been approved by NHS England for the purposes of making such notifications.

(7) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 7B and 7C, they must have the following features—

(a) they must provide, and ensure, that any prescription item that is assembled or part-assembled under the arrangements is supplied to or for the use of the patient for whom it is dispensed at or from the pharmacy premises of P1 (and so the arrangements must not allow P2 to fulfil the order directly);

(b) in the case of an order for a medicine on a prescription form or LPIV, they must ensure that what is done, in the course of fulfilling the order, is done in a manner that ensures compliance with the requirements that are to be complied with for the supply from P2 to P1 of the medicine to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012 (assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses);

(c) in the case of orders for prescription items that are not orders for medicines on a prescription form or a LPIV (“non-regulation-222A orders”)—

(i) they must relate to fulfilling both orders for medicines on prescription forms and non-regulation-222A orders, and accordingly P1 cannot only sub-contract to P2 core dispensing functions in respect of non-regulation-222A orders, and

(ii) they must ensure that what is done, in the course of fulfilling the non-regulation-222A order, is done in a manner that would ensure compliance with the requirements that would need to be complied with for the supply from P2 to P1 of the prescription item, if it were instead of a medicine ordered on a prescription form or a LPIV, to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012;

(d) they must provide, and ensure, that P2 does not sub-contract any of the core dispensing functions that P2 performs on behalf of P1;

(e) they must provide for the discontinuation of the arrangements, as set out in paragraph 7B (in addition to any patient safety or commercial grounds P1 or P2 may have for discontinuing the arrangements); and

(f) they must not be or have become invalid by virtue of paragraph 7B.

(8) If P1 has hub and spoke arrangements in place, P1 must also have in place, as part of P1’s business continuity plan required by paragraph 29D, business continuity arrangements which ensure that P1 is able to meet all P1’s obligations to provide dispensing services in the event of any temporary or permanent discontinuation or disruption of the hub and spoke arrangements.

(9) P1 must give notice in writing to NHS England of any—

(a) temporary discontinuation of hub and spoke arrangements that amounts to a suspension of those arrangements; or

(b) permanent discontinuation of hub and spoke arrangements,

either before that discontinuation occurs or as soon as is reasonably practicable after it occurs, unless it is in response to a notice of objection from NHS England.

Objection to and discontinuation of hub and spoke arrangements

7B

(1) At any stage after receipt of a notice under paragraph 7A(5)(a), NHS England may request from P1 (as defined in paragraph 7A(1)) further information relating to the proposed or commenced hub and spoke arrangements that is relevant to one or more of the objection criteria, and if NHS England makes such a request, P1 must supply the requested information to NHS England promptly.

(2) For the purposes of this paragraph, the objection criteria are—

(a) the proposed or commenced hub and spoke arrangements do not have the features required by paragraph 7A(7), including where they have had them but they have lapsed;

(b) in the case of commenced hub and spoke arrangements, they have the features required by paragraph 7A(7) but there has been a breach of those requirements;

(c) the proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, the safety of any persons to whom P1 provides pharmaceutical services at serious risk;

(d) the proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, NHS England at risk of material financial loss;

(e) in the case of commenced hub and spoke arrangements, those arrangements have led to P1 repeatedly breaching P1’s terms of service, or to P1 breaching its terms of service in circumstances where P1 is likely to continue to do so repeatedly;

(f) P2’s (as defined in paragraph 7A(4)) fitness to carry out core dispensing functions is impaired; or

(g) in the opinion of NHS England, there are reasonable grounds for believing one or more of the objection criteria in paragraphs (a) to (f) are established.

(3) NHS England may, before the commencement of proposed hub and spoke arrangements, issue a notice of objection to the proposed arrangements, based on one or more of the objection criteria and if it does so—

(a) P1 must not commence the arrangements unless or until the notice of objection is withdrawn by NHS England; and

(b) any arrangements that are commenced, in breach of this sub-paragraph, are invalid.

(4) NHS England may, after the commencement of hub and spoke arrangements, issue a notice of objection to the arrangements, based on one or more of the objection criteria, and if it does so—

(a) those arrangements become invalid; and

(b) P1 must discontinue the arrangements promptly.

(5) NHS England may withdraw a notice of objection issued under sub-paragraph (4), which has the effect of the arrangements to which the notice related no longer being invalid.

(6) NHS England must, in a notice of objection, give its reasons for issuing the notice.

(7) Subject to sub-paragraph (9), before issuing a notice under sub-paragraph (4), NHS England must make every reasonable effort to communicate and co-operate with P1 with a view to resolving the matter without the notice being issued.

(8) Where P1 invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (7), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.

(9) Sub-paragraphs (7) and (8) do not apply where NHS England is satisfied—

(a) its concerns relate to a matter that has already been the subject of dispute resolution between NHS England and P1 and there are no new issues of substance to delay issuing the notice; or

(b) that it is appropriate to proceed immediately to issuing a notice—

(i) to protect the safety of any persons to whom P1 may provide pharmaceutical services, or

(ii) to protect NHS England from material financial loss.

(10) After issuing a notice of objection under sub-paragraph (3), or issuing a notice of objection under sub-paragraph (4) which was not delayed by virtue of sub-paragraph (7) or (8), NHS England must, where requested to do so by P1, make every reasonable effort to communicate and co-operate with P1 with a view to resolving the matter in a manner that may lead to the notice of objection being withdrawn.

(11) Where P1 invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (10), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.

(12) Sub-paragraphs (10) and (11) do not apply where NHS England is satisfied its concerns that led to the notice of objection being issued relate to a matter that has already been the subject of dispute resolution between NHS England and P1 and there are no new issues of substance to be resolved.

7C

(1) This paragraph applies to “relevant data”, which is data that relates to a patient and which is shared for the purpose of fulfilling an order under hub and spoke arrangements (as defined in paragraph 7A(4)) which is a non-regulation-222A order (as defined in paragraph 7A(7)(c)).

(2) For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc – health or social care purpose) to, the Data Protection Act 2018, sub-paragraph (3) applies to the processing of any relevant data—

(a) by P1 or P2 (as defined in paragraph 7A(1) and (4)) which relates to a patient; and

(b) which is necessary for the purposes of—

(i) fulfilling an order of a type mentioned in paragraph 7A(4)(a) under valid hub and spoke arrangements, or

(ii) discharging any related professional obligations to the patient (including obligations relating to the keeping of records).

(3) That processing is—

(a) necessary for the performance of a task carried out in the public interest; and

(b) if the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.

(4) Any person (P3) who—

(a) is employed or engaged by P1 or P2; and

(b) in the course of being so employed or engaged is required to undertake the processing of data described in sub-paragraph (2),

owes a duty of confidentiality in respect of that data (whether or not they would do so but for this sub-paragraph).

(5) The duty in paragraph (4)—

(a) is a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); and

(b) is such that, if the processing is necessary for the purposes described in sub-paragraph (2)(b), P3 is able, lawfully, to process that data by virtue of this paragraph.

(6) For the purposes of sub-paragraph (2)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—

(a) also be an obligation that arises in some other way (for example, arising from a duty of care); or

(b) be done by a person who is not a health care professional.

(7) Sub-paragraphs (2) and (3) do not apply where, in reliance or purported reliance on valid hub and spoke arrangements, a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—

(a) the requirements to be fulfilled if what is done is to be treated as part of valid hub and spoke arrangements; or

(b) a duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in sub-paragraph (5)(a).

(8) Words and expressions used in both—

(a) sub-paragraphs (1) to (7); and

(b) Parts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,

bear the meanings they bear in those provisions of the Data Protection Act 2018.

Providing ordered drugs or appliances

Refusal to provide drugs or appliances ordered

Additional requirements in relation to electronic prescribing

Additional requirements in relation to specified appliances

Disposal service in respect of unwanted drugs

Basic procedure in respect of unwanted drugs

Further activities to be carried out in connection with the disposal of unwanted drugs

Promotion of healthy lifestyles

Prescription linked intervention

... Health campaigns

Signposting

Service outline in respect of signposting

Support for self-care

Service outline in respect of support for self-care

Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.

Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

Discharge medicines service

Service outline in respect of the discharge medicines service

Contact via NHS.net Connect, pharmacy profiles and the Central Alerting System

Sub-contracting aspects of dispensing under “hub and spoke” arrangements

4ZA

(1) For the purposes of—

(a) Part 5 of Schedule 3 to the GMS Regulations (other contractual terms – sub-contracting);

(b) Part 5 of Schedule 2 to the PMS Regulations (other required terms – subcontracting); and

(c) any contractual arrangements with an APMS practice that restrict the sub-contracting of rights or duties under the arrangements in relation to clinical matters,

core dispensing functions are clinical matters (whether or not they would be considered as such but for this sub-paragraph) and accordingly, the specific requirements in this Schedule in respect of sub-contracting those functions are in addition to the general requirements in those Schedules in respect of sub-contracting them.

(2) For the purposes of this paragraph and paragraph 4ZB, “core dispensing functions” means the assembly or part-assembly of any prescription item (including bagging and the application of dispensing labels) with a view to the supply of that prescription item in accordance with a prescription, an SSP, a LPIV, a PTP or a PTPGD.

(3) A dispensing doctor (and by extension a provider of primary medical services as mentioned in regulation 47(2)(b), referred to together for the purposes of this paragraph and paragraphs 4ZB and 4ZC as (D)) must not sub-contract the performance of any of its core dispensing functions, but this does not apply to—

(a) a contract for services between D and a health care professional (for example, a locum), or a provider of locums, for performance by that professional, or by locums provided by that provider of locums, personally of core dispensing functions at D’s listed dispensing premises; or

(b) the performance of any of D’s core dispensing functions under valid hub and spoke arrangements.

(4) For the purposes of this paragraph and paragraphs 4ZB and 4ZC, “hub and spoke arrangements” are arrangements between D and a retail pharmacy business (P) which—

(a) are for the purpose of P supporting D with regard to the fulfilment of orders—

(i) submitted to D on prescription forms or LPIVs, or

(ii) for the provision of prescription items by D in accordance with PTPs or PTPGDs; and

(b) provide for the assembly or part-assembly of those orders (including in accordance with an SSP) at premises of P with a view to the supply of the prescription items at or from the listed dispensing premises of D to or for the use of the patients for whom they were ordered.

(5) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 4ZB and 4ZC, any prior notification that D is required to give to NHS England or an ICB before the commencement of arrangements by virtue of which D sub-contracts the core dispensing functions must include the following particulars—

(a) the name, pharmacy premises address and General Pharmaceutical Council premises registration number of P;

(b) the duration of the proposed arrangements;

(d) a description of the manner in which P proposes to meet D’s obligations under the terms of service in respect of the core dispensing functions to be covered by the arrangements.

(6) For the hub and spoke arrangements to be valid for purposes of this paragraph and paragraphs 4ZB and 4ZC, if D is not otherwise (apart from by virtue of this sub-paragraph) required to give prior notification to NHS England or an ICB before the commencement of the sub-contracting of clinical services such as core dispensing functions—

(a) it must give that prior notice in the case of hub and spoke arrangements, and in a manner that puts NHS England or the ICB for its location on reasonable notice of the commencement of the arrangements; and

(b) the notification that it does give must include the particulars specified in sub-paragraph (5)((a) to (d).

(7) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 4ZB and 4ZC, they must have the following features—

(a) they must provide, and ensure, that any prescription item that is assembled or part-assembled under the arrangements is supplied to or for the use of the patient for whom it is dispensed at or from the listed dispensing premises of D (and so the arrangements must not allow P to fulfil the order directly);

(b) in the case of an order for a medicine on a prescription form or LPIV, they must ensure that what is done, in the course of fulfilling the order, is done in a manner that ensures compliance with the requirements that are to be complied with for the supply from P to D of the medicine to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012 (assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses);

(c) in the case of orders for prescription items that are not orders for medicines on a prescription form or a LPIV (“non-regulation-222A orders”)—

(i) they must relate to fulfilling both orders for medicines on prescription forms and non-regulation-222A orders, and accordingly D cannot only sub-contract to P core dispensing functions in respect of non-regulation-222A orders, and

(ii) they must ensure that what is done, in the course of fulfilling the non-regulation-222A order, is done in a manner that would ensure compliance with the requirements that would need to be complied with for the supply from P to D of the prescription item, if it were instead of a medicine ordered on a prescription form or a LPIV, to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012;

(d) they must provide, and ensure, that P does not sub-contract any of the core dispensing functions that P performs on behalf of D;

(e) they must provide for the discontinuation of the arrangements, as set out in paragraph 4ZB (in addition to any patient safety or commercial grounds D or P may have for discontinuing the arrangements); and

(f) they must not be or have become invalid by virtue of paragraph 4ZB.

(8) If D has hub and spoke arrangements in place, D must also have in place business continuity arrangements which ensure that D is able to meet all D’s obligations to provide dispensing services in the event of any temporary or permanent discontinuation or disruption of the hub and spoke arrangements.

(9) D must give notice in writing to NHS England of any—

(a) temporary discontinuation of hub and spoke arrangements that amounts to a suspension of those arrangements; or

(b) permanent discontinuation of hub and spoke arrangements,

either before that discontinuation occurs or as soon as is reasonably practicable after it occurs, unless it is in response to a notice of objection from NHS England.

Objection to and termination of hub and spoke arrangements

4ZB

(1) NHS England may at any time request from D (as defined in paragraph 4ZA(3)) information relating to hub and spoke arrangements that is relevant to the termination criteria (whether or not the arrangements have commenced), and if NHS England makes such a request, D must supply the requested information to NHS England promptly.

(2) For the purposes of this paragraph, the termination criteria are—

(a) the hub and spoke arrangements do not have the features required by paragraph 4ZA(7), including where they have had them but they have lapsed;

(b) the hub and spoke arrangements have the features required by paragraph 4ZA(7) but there has been a breach of those requirements;

(c) the hub and spoke arrangements put the safety of any persons to whom D provides pharmaceutical services at serious risk;

(d) the hub and spoke arrangements put NHS England at risk of material financial loss;

(e) the hub and spoke arrangements have led to D repeatedly breaching D’s terms of service, or to D breaching its terms of service in circumstances where D is likely to continue to do so repeatedly;

(f) P’s (as defined in paragraph 4ZA(4)) fitness to carry out core dispensing functions is impaired; or

(g) in the opinion of NHS England, there are reasonable grounds for believing one or more of the termination criteria in paragraphs (a) to (f) are established.

(3) NHS England may, after the commencement of hub and spoke arrangements, issue a notice of objection to the arrangements, based on one or more of the termination criteria, and if it does so—

(a) those arrangements become invalid on the termination date specified in the notice of objection; and

(b) D must discontinue the arrangements on or by the date specified in the notice for their termination.

(4) NHS England may withdraw a notice of objection issued under sub-paragraph (3), which has the effect of the arrangements to which the notice related no longer being invalid.

(5) NHS England must, in a notice of objection, give its reasons for issuing the notice.

(6) Subject to sub-paragraph (7), before issuing a notice of objection, NHS England must make every reasonable effort to communicate and co-operate with D with a view to resolving the matter without the notice being issued.

(7) Sub-paragraph (6) does not apply where NHS England is satisfied—

(a) its concerns relate to a matter that has already been the subject of dispute resolution between NHS England and D and there are no new issues of substance to delay issuing the notice; or

(b) that it is appropriate to proceed immediately to issuing a notice—

(i) to protect the safety of any persons to whom D may provide pharmaceutical services, or

(ii) to protect NHS England from material financial loss.

(8) After issuing a notice of objection, unless—

(a) it was delayed by virtue of sub-paragraph (6); or

(b) NHS England is satisfied its concerns related to a matter that has already been the subject of dispute resolution between NHS England and D and there are no new issues of substance to be resolved,

NHS England must, where requested to do so by D, make every reasonable effort to communicate and co-operate with D with a view to resolving the matter in a manner that may lead to the notice of objection being withdrawn.

4ZC

(1) This paragraph applies to “relevant data”, which is data that relates to a patient and which is shared for the purpose of fulfilling an order under hub and spoke arrangements (as defined in paragraph 4ZA(4)) which is a non-regulation-222A order (as defined in paragraph 4ZA(7)(c)).

(2) For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc – health or social care purpose) to, the Data Protection Act 2018, sub-paragraph (3) applies to the processing of any relevant data—

(a) by D or P (as defined in paragraph 4ZA(3) and (4)) which relates to a patient; and

(b) which is necessary for the purposes of—

(i) fulfilling an order of a type mentioned in paragraph 4ZA(4)(a) under valid hub and spoke arrangements, or

(ii) discharging any related professional obligations to the patient (including obligations relating to the keeping of records).

(3) That processing is—

(a) necessary for the performance of a task carried out in the public interest; and

(b) if the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.

(4) Any person (X) who—

(a) is employed or engaged by D or P; and

(b) in the course of being so employed or engaged is required to undertake the processing of data described in sub-paragraph (2),

owes a duty of confidentiality in respect of that data (whether or not they would do so but for this sub-paragraph).

(5) The duty under paragraph (4)—

(a) is a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); and

(b) is such that, if the processing is necessary for the purposes described in sub-paragraph (2)(b), X is able, lawfully, to process that data by virtue of this paragraph.

(6) For the purposes of sub-paragraph (2)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—

(a) also be an obligation that arises in some other way (for example, arising from a duty of care); or

(b) be done by a person who is not a health care professional.

(7) Sub-paragraphs (2) and (3) do not apply where, in reliance or purported reliance on valid hub and spoke arrangements, a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—

(a) the requirements to be fulfilled if what is done is to be treated as part of valid hub and spoke arrangements; or

(b) a duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in sub-paragraph (5)(a).

(8) Words and expressions used in both—

(a) sub-paragraphs (1) to (7); and

(b) Parts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,

bear the meanings they bear in those provisions of the Data Protection Act 2018.

Charge exemption and remission of charges: declarations and checks

Checks and records in the case of supply in accordance with a SSP

Provision of Scheduled drugs

Refusal to provide drugs or appliances ordered

Dispensing doctors issuing prescription forms which may be presented to an NHS chemist

Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.

Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

Complaints procedures

Inspections and access to information

Voluntary closure of premises

Sub-contracting aspects of dispensing under “hub and spoke” arrangements

5A

(1) Subject to sub-paragraph (3), an LPS contractor (C) must not sub-contract the performance of any of its core dispensing functions.

(2) For the purposes of this paragraph and paragraph 5B, “core dispensing functions” means the assembly or part-assembly of any prescription item (including bagging and the application of dispensing labels) with a view to the supply of that prescription item in accordance with a prescription, a SSP, a LPIV, a PTP or a PTPGD.

(3) Sub-paragraph (1) does not apply to—

(a) a contract for services between C and—

(i) a health care professional (for example, a locum) or a provider of locums, or

(ii) a corporate body that is—

(aa) a subsidiary undertaking of C, or

(bb) a subsidiary undertaking of a parent undertaking of which C is also a subsidiary undertaking,

for the performance by that health care professional, a locum provided by that provider of locums or the corporate body of core dispensing functions at C’s pharmacy premises;

(b) arrangements whereby a retail pharmacy business that is not C is nevertheless carrying on a retail pharmacy business at C’s premises as a temporary arrangement related to the purchase of those premises; or

(4) For the purposes of this paragraph and paragraphs 5B and 5C, “hub and spoke arrangements” are arrangements between C and a retail pharmacy business (P) which—

(a) are for the purpose of P supporting C with regard to the fulfilment of orders—

(i) submitted to C on prescription forms or LPIVs, or

(ii) for the provision of prescription items by C in accordance with PTPs or PTPGDs;

(b) provide for the assembly or part-assembly of those orders (including in accordance with an SSP) at premises of P with a view to the supply of the prescription items at or from the scheme premises of C to or for the use of the patients for whom they were ordered.

(5) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 5B and 5C, C must—

(a) have given notice in writing to NHS England of C’s intention to sub-contract core dispensing functions—

(i) not less than 28 days before the date on which the proposed arrangements are intended to commence, or

(ii) by a date agreed with NHS England on which the proposed arrangements are to commence; and

(b) have taken reasonable steps, before entering into the arrangements, to satisfy itself of P’s fitness to carry out core dispensing functions on behalf of C.

(6) A notice under sub-paragraph (5)(a) must include the particulars which have been approved by NHS England for the purposes of making such notifications.

(7) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 5B and 5C, they must have the following features—

(a) they must provide, and ensure, that any prescription item that is assembled or part-assembled under the arrangements is supplied to or for the use of the patient for whom it is dispensed at or from the scheme premises of C (and so the arrangements must not allow P to fulfil the order directly);

(b) in the case of an order for a medicine on a prescription form or LPIV, they must ensure that what is done, in the course of fulfilling the order, is done in a manner that ensures compliance with the requirements that are to be complied with for the supply from P to C of the medicine to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012 (assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses);

(c) in the case of orders for prescription items that are not orders for medicines on a prescription form or a LPIV (“non-regulation-222A orders”)—

(i) they must relate to fulfilling both orders for medicines on prescription forms and non-regulation-222A orders, and accordingly C cannot only sub-contract to P core dispensing functions in respect of non-regulation-222A orders, and

(ii) they must ensure that what is done, in the course of fulfilling the non-regulation-222A order, is done in a manner that would ensure compliance with the requirements that would need to be complied with for the supply from P to C of the prescription item, if it were instead of a medicine ordered on a prescription form or a LPIV, to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012;

(d) they must provide, and ensure, that P does not sub-contract any of the core dispensing functions that P performs on behalf of C;

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.