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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

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Future improvements or better access: consequences of additional matters

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(1) If NHS England is satisfied as mentioned in regulation 20(2)(a), it may—

(a) defer determination of the application;

(b) invite applications from other persons to offer to secure the future improvements or better access mentioned in regulation 20(1) that the applicant is offering to secure; and

(i) as a consequence of the invitation issued in accordance with sub-paragraph (b), or

(ii) that, even if it was not received in response to that invitation, is in any event from another person offering to secure the future improvements or better access mentioned in regulation 20(1) that the applicant is offering to secure,

but it must not, pursuant to this paragraph, defer consideration of the application for longer than 6 months.

(2) If NHS England is satisfied as mentioned in regulation 20(2)(b), it may defer consideration of the application for such period as is reasonable in the circumstances, having regard to when the future circumstances specified in accordance with paragraph 4(b) of Schedule 1 are likely to arise.

(3) If NHS England is satisfied as mentioned in regulation 20(2)(c), it may defer consideration of the application until it can be considered at the same time as the other application.

(4) If NHS England is satisfied as mentioned in regulation 20(2)(d), it may defer consideration of the application until after the appeal has reached its final outcome.

(5) If NHS England is satisfied as mentioned in regulation 20(2)(e) to (i), it must refuse the application.

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

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(1) If NHS England receives a routine application to which regulation 19(6) does not apply, NHS England must refuse it unless granting it, or granting it in respect of some only of the services specified in it, would—

(a) meet a current or future need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB that has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 2 of Schedule 1; or

(b) secure (including in the future) improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB that have or has been included in the relevant pharmaceutical needs assessment in accordance with paragraph 4 of Schedule 1.

(2) For the purposes of paragraph (1), the relevant pharmaceutical needs assessment is—

(a) the pharmaceutical needs assessment of the relevant HWB that is current at the time that NHS England takes its decision to grant or refuse the application, unless in the opinion of NHS England (or on appeal the Secretary of State) the only way to determine the application justly is with regard to an earlier pharmaceutical needs assessment, in which case the relevant pharmaceutical needs assessment is that earlier assessment; or

(b) if the relevant HWB has not published a pharmaceutical needs assessment, the pharmaceutical needs assessment of a Primary Care Trust (as extended by regulation 7(1)) that relates to the locality in which the location or premises to which the application relates is or are situated.

PART 4 — Excepted applications

Applications from NHS chemists in respect of providing directed services

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Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application by a person already included in a pharmaceutical list for inclusion in that list also in respect of services that are directed services that are not already listed in relation to that person.

Relocations that do not result in significant change to pharmaceutical services provision

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(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application from a person already included in a pharmaceutical list to relocate to different premises in the area of the relevant HWB (HWB1) if—

(a) for the patient groups that are accustomed to accessing pharmaceutical services at or from the existing premises, the location of the new premises is not significantly less accessible;

(b) in the opinion of NHS England, granting the application would not result in a significant change to the arrangements that are in place for the provision of local pharmaceutical services or of pharmaceutical services other than those provided by a person on a dispensing doctor list—

(i) in any part of the area of HWB1, or

(ii) in a controlled locality in the area of a neighbouring HWB, where that controlled locality is within 1.6 kilometres of the premises to which the applicant is seeking to relocate;

(c) NHS England is not of the opinion that granting the application would cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of HWB1;

(d) the services the applicant undertakes to provide at or from the new premises are the same as the services the applicant has been providing at or from the existing premises (whether or not, in the case of enhanced services, NHS England chooses to commission them); and

(e) the provision of pharmaceutical services will not be interrupted (except for such period as NHS England may for good cause allow).

(2) Section 129(2A) of the 2006 Act does not apply to an application from a person already included in a pharmaceutical list for the area of a HWB (HWB2) for inclusion in the pharmaceutical list for the area of a neighbouring HWB (HWB3), or inclusion in the pharmaceutical list for the area of HWB3 also in respect of other premises than those already listed in relation to that person, if—

(a) the purpose of the application is to relocate to different premises;

(b) for the patient groups that are accustomed to accessing pharmaceutical services at or from the existing premises (P1), the location of the new premises (P2) is not significantly less accessible;

(c) in the opinion of NHS England, granting the application would not result in a significant change to the arrangements that are in place for the provision of local pharmaceutical services or of pharmaceutical services other than those provided by a person on a dispensing doctor list—

(i) in any part of HWB3's area; or

(ii) in a controlled locality in the area of a neighbouring HWB (including HWB2), where that controlled locality is within 1.6 kilometres of P2;

(d) NHS England is not of the opinion that granting the application would cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of HWB3;

(e) the services the applicant undertakes to provide at or from P2 are the same as the services the applicant has been providing at or from P1 (whether or not, in the case of enhanced services, NHS England chooses to commission them);

(f) the provision of pharmaceutical services will not be interrupted (except for such period as NHS England may for good cause allow); and

(g) the applicant consents to—

(i) where the applicant has only one set of listed chemist premises in the pharmaceutical list for the area of HWB2, the removal of the applicant's name from that pharmaceutical list, or

(ii) where the applicant has more than one set of listed chemist premises in the pharmaceutical list for the area of HWB2, the removal of P1 from being listed in relation to the applicant in that pharmaceutical list,

with effect from the date on which the applicant undertakes to provide pharmaceutical services from P2.

(3) An application pursuant to this regulation must be refused if the existing pharmacy premises from which the applicant is seeking to relocate (P3)—

(a) were listed in relation to an NHS pharmacist as a result of an application to which regulation 13(1)(a) of the 2005 Regulations (exemption from the necessary or expedient test) applied, and—

(i) P3 are located in an area that, immediately before the 2012 Regulations came into force, was an approved retail area (within the meaning given in regulation 15 of the 2005 Regulations (approved retail areas)), and

(ii) the applicant proposes to relocate from P3 to premises that are outside that area;

(b) were listed in relation to an NHS pharmacist as a result of an application to which regulation 13(1)(c) of the 2005 Regulations applied, unless—

(i) the provider, or where there is more than one provider all the providers, of primary medical services at the one-stop primary care centre (within the meaning given in regulation 16 of the 2005 Regulations (new one-stop primary care centres)) at which P3 are located are relocating with the applicant to a new discrete site or building,

(ii) at or from that new discrete site or building primary medical services are or are to be provided by one or more providers of primary medical services with a patient list of, or patient lists with a combined total of, 18,000 patients, and

(iii) at or from that site or building the services of a broad range of health care professionals are or will be regularly and frequently provided (together, where appropriate, with other health or social services); ...

(i) that listing arose out of the applicant relocating to P3 from other pharmacy premises,

(ii) that relocation arose out of the grant of an application—

(aa) that was an excepted application by virtue of this regulation or regulation 24 of the 2012 Regulations (relocations that do not result in significant change to pharmaceutical services provision), or

(bb) to which regulation 6 or 7 of the 2005 Regulations (which related to minor relocations) applied, and

(iii) the applicant is unable to satisfy NHS England that relocation from P3 is necessary for reasons that NHS England accepts are good cause ; or

(d) are distance selling premises, unless—

(i) the premises to which the applicant is seeking to relocate are also distance selling premises, and

(ii) if the application was one to which regulation 25(1) applied, it would not be refused pursuant to regulation 25(2).

Distance selling premises applications

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(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application to relocate to different premises—

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

(b) by a person already included in a pharmaceutical list for inclusion in that list ...in respect of premises other than those already listed in relation to that person,

in respect of pharmacy premises that are distance selling premises.

(2) NHS England must refuse an application to which paragraph (1) applies—

(a) if the premises in respect of which the application is made are on the same site or in the same building as the premises of a provider of primary medical services with a patient list; and

(b) unless NHS England is satisfied that the pharmacy procedures for the pharmacy premises are likely to secure—

(i) the uninterrupted provision of essential services, during the opening hours of the premises, to persons anywhere in England who request those services, and

(ii) the safe and effective provision of pharmaceutical services without face to face contact at the pharmacy premises between any person receiving the services, whether on their own or on someone else's behalf, and the applicant or the applicant's staff.

Change of ownership applications

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(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application from a person who is not included in a pharmaceutical list for inclusion in the list, or from a person included in a pharmaceutical list for inclusion in that list also in respect of other premises than those already listed in relation to that person, if—

(a) the applicant (X) is undertaking to provide pharmaceutical services at or from premises—

(i) that are already listed chemist premises, and

(ii) at or from which another person (Y) is providing pharmaceutical services;

(b) X is proposing to carry on at or from the listed chemist premises, in place of Y, the business in the course of which Y is providing pharmaceutical services at or from those premises;

(d) the provision of pharmaceutical services at or from the premises will not be interrupted (except for such period as NHS England may for good cause allow).

(2) Section 129(2A) of the 2006 Act does not apply to an application from a person who is not included in a pharmaceutical list for the area of a HWB (HWB1) for inclusion in that list, or from a person included in a pharmaceutical list for inclusion in that list also in respect of other premises than those already listed in relation to that person, if—

(a) the applicant (X) is undertaking to provide the pharmaceutical services that another person (Y)—

(i) is providing at or from listed chemist premises (“Y's premises”), whether in the area of HWB1 or a neighbouring HWB, or

(ii) has provided at or from Y's premises but Y is no longer able to provide pharmaceutical services at or from those premises for reasons that NHS England accepts are good cause;

(b) X is proposing to carry on, in place of Y, the business in the course of which Y is providing, or has provided, pharmaceutical services at or from Y's premises;

(c) X is undertaking to provide the same pharmaceutical services as Y is providing or has provided at or from Y's premises, but at or from different premises (“X's premises”);

(d) had Y applied to move to X's premises, that application would have been granted under regulation 24; and

(e) in a case where pharmaceutical services—

(i) are being provided at or from Y's premises, the provision of pharmaceutical services will not be interrupted (except for such period as NHS England may for good cause allow) by the move of the business from Y's premises to X's premises, or

(ii) are not being provided at or from Y's premises, the provision of pharmaceutical services will commence at or from X's premises within the period that NHS England considers is an acceptable period for the interruption of the provision of pharmaceutical services by the business that X is taking over.

(3) An application pursuant to paragraph (1) must be refused if it relates to distance selling premises, unless the application, if made pursuant to regulation 25(1), would not be refused pursuant to regulation 25(2).

(4) An application pursuant to paragraph (2) must be refused if the existing pharmacy premises from which the applicant is seeking to relocate are distance selling premises, unless the premises to which the applicant is seeking to relocate are also distance selling premises (and this is in addition to the requirement that arises by virtue of paragraph (2)(d) that the application, if made pursuant to regulation 25(1), would not be refused pursuant to regulation 25(2)).

Applications for temporary listings arising out of suspensions

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(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application—

(a) for temporary inclusion in a pharmaceutical list by a person not already included; or

(b) by a person already included in a pharmaceutical list for temporary inclusion in that list in respect of services, or services and premises, other than those already listed in relation to that person,

from a person (X) who proposes to provide pharmaceutical services which are not being provided because the person listed in relation to them (Y) is suspended from the pharmaceutical list.

(2) NHS England must refuse an application to which paragraph (1) applies—

(a) unless it is satisfied that—

(i) Y has nominated X as the person to provide those services for the duration of Y's suspension and consents to X doing so,

(ii) X will provide the same pharmaceutical services as those that Y provided or had undertaken to provide before the suspension, and

(iii) there is no direct or indirect connection between X and Y (including such a connection through a third party) the nature of which makes it unlikely that X will be able to exercise an appropriate degree of autonomy;

(b) if Y is a body corporate and X—

(i) is an employee of Y,

(ii) is, or was at the time of the suspension or of the originating events, a director or superintendent of Y,

(iii) is a body corporate in which Y or an employee of Y is a majority shareholder,

(iv) is a body corporate in which a majority shareholder of Y is, or was at the time of the suspension or of the originating events, a director or superintendent of X,

(v) is a body corporate which has a director or superintendent who is an employee of Y, or

(vi) is a body corporate which has as a director or superintendent someone who is, or was at the time of the suspension or of the originating events, a director or superintendent of Y;

(i) is an employee of Y,

(ii) is a body corporate of which Y or an employee of Y is a director or superintendent,

(iii) is a body corporate in which Y or an employee of Y is a majority shareholder, or

(iv) is a body corporate which has a director or superintendent who is an employee of Y; or

(d) if Y is a partnership and X—

(i) is or has been a member or employee of Y,

(ii) is a body corporate of which a member or employee of Y is or has been a director, superintendent or majority shareholder, or

(iii) is a partnership of which X, or a member or employee of X, is or has been a member.

(3) If an application to which—

(a) paragraph (1)(a) applies is granted, the applicant must only be included in the pharmaceutical list for a fixed period;

(b) paragraph (1)(b) applies is granted, the premises or services must only be listed in relation to the applicant for a fixed period.

(4) The fixed periods referred to in paragraph (3) must be no longer than—

(a) the period of Y's suspension; or

(b) until Y notifies NHS England, with effect from a specified date (which must be at least 2 working days after the date of the notification), that Y no longer consents to X providing the services that X is providing because of Y's suspension from the pharmaceutical list.

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

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(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application—

(a) for inclusion in a pharmaceutical list by a person not already included; or

(b) by a person already included in a pharmaceutical list for inclusion in that list also in respect of premises other than those already listed in relation to that person,

in the circumstances set out in paragraph (2).

(2) Those circumstances are—

(a) it has been determined in accordance with—

(i) regulation 4 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) (No. 2) Regulations 2002 (right of return to pharmaceutical lists),

(ii) regulation 15 of the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 (right of return to pharmaceutical lists), or

(iii) regulation 108,

that the applicant is to be given a right of return to a pharmaceutical list;

(b) the applicant is seeking to exercise that right after ceasing to provide local pharmaceutical services under the LPS scheme as a consequence of entering into which, or of the variation of which, the applicant was given the right of return; and

(c) the granting of the right of return arose out of the provision of the local pharmaceutical services which the applicant is ceasing to provide.

(3) NHS England must refuse an application to which paragraph (1) applies, unless—

(a) the change from providing local pharmaceutical services to providing pharmaceutical services will not give rise to any interruption in the receipt and dispensing of prescriptions by the applicant (except for such period as NHS England may for good cause allow); and

(b) any conditions in the relevant determination of the right of return are satisfied.

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

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(1) Section 129(2A) of the 2006 Act (regulations as to pharmaceutical services) does not apply to an application for a temporary amendment to a pharmaceutical list in the following circumstances—

(a) there is an emergency requiring the flexible provision of pharmaceutical services; or

(b) there is a temporary suspension in the provision of pharmaceutical services at or from listed chemist premises (P1) for a reason (for example, fire or flooding) that is beyond the control of the NHS chemist (C) listed in relation to P1.

(2) In the circumstances described in paragraph (1)(a), NHS England may make a temporary amendment to an entry in a pharmaceutical list, but—

(a) only for a specified period (which must not be longer than the specified period of the emergency given by the Secretary of State) which NHS England may extend or curtail in appropriate circumstances; and

(b) the applicant may revert to the applicant's overridden entry in the pharmaceutical list before the end of the period specified by NHS England, on giving NHS England at least 24 hours notice.

(3) In the circumstances described in paragraph (1)(b), NHS England may make a temporary amendment to the entry of C in the relevant pharmaceutical list in order to allow C to provide the services that C ordinarily provided at or from P1 at or from other premises nearby (P2), at the days on which and times at which those services were ordinarily provided at or from P1, for a period specified by NHS England.

(4) A period specified under paragraph (3) must not be longer (initially) than 6 months, and NHS England may under that paragraph—

(a) if it has good cause to do so, extend the period specified under that paragraph (but not beyond 12 months from the date on which C starts to provide the services in question from P2); or

(b) curtail the period specified,

in appropriate circumstances.

(5) For the period specified under paragraph (3), but subject to paragraph (6) and regulation 118, P2 instead of P1 are to be treated as listed in relation to C for the purposes of these Regulations (albeit that the premises actually listed in relation to C are P1).

(6) The applicant may revert to the applicant's overridden entry in the pharmaceutical list before the end of the period specified by under paragraph (3), on giving NHS England at least 24 hours notice.

(7) Planned refurbishment is not a “reason beyond the control” of C for the purposes of paragraph (1)(b).

(8) There is no right of appeal under these Regulations in respect of a decision of NHS England under this regulation.

PART 5 — Specific grounds for refusal or deferral of applications under Parts 3 and 4 which are not linked to fitness grounds

Refusal: language requirement for some NHS pharmacists

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An application for inclusion in a pharmaceutical list by a person not already included must be refused if the applicant is an individual (X) who qualified as a pharmacist in Switzerland or an EEA state other than the United Kingdom, unless X satisfies NHS England that X has the level of knowledge of English which, in the interests of X and the persons making use of the services to which the application relates, is necessary for the provision of those services in the area of the relevant HWB.

Refusal: same or adjacent premises

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(1) A routine or excepted application, other than a consolidation application, must be refused where paragraph (2) applies.

(2) This paragraph applies where—

(a) a person on the pharmaceutical list (which may or may not be the applicant) is providing or has undertaken to provide pharmaceutical services (“the existing services”) at or from—

(i) the premises to which the application relates, or

(ii) adjacent premises; and

(b) NHS England is satisfied that it is reasonable to treat the services that the applicant proposes to provide as part of the same service as the existing services (and so the premises to which the application relates and the existing listed chemist premises should be treated as the same site).

Deferrals arising out of LPS designations

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(1) A routine application may be deferred where paragraph (2) applies to the relevant premises.

(2) This paragraph applies where the relevant premises are premises or part of premises, or are located within an area, designated under—

(a) regulation 99; or

(b) regulation 4 of the 2006 Regulations (designation of priority neighbourhoods or premises),

and that designation has neither been varied so that it no longer applies to the relevant premises nor been cancelled.

(3) For the purposes of this regulation, “the relevant premises” are—

(a) the listed chemist premises or proposed listed chemist premises in the application; or

(b) as regards an application for inclusion in a pharmaceutical list by a person not already included, if no particular premises are proposed for listing in the application, premises located at the best estimate that NHS England is able to make as to where the proposed listed chemist premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2.

PART 6 — Refusal, deferral and conditional inclusion in pharmaceutical lists of chemists on fitness grounds

Refusal of applications for inclusion in a pharmaceutical list on fitness grounds

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(A1) In this regulation, “A” means, where an application for inclusion in a pharmaceutical list is made by a person who is—

(a) an individual, the individual making the application;

(b) a partnership, any partner in the partnership making the application; or

(i) except for the purposes of paragraphs (1)(a) and (b) and (3)(h)(i), the body corporate making the application, and

(ii) except for the purposes of paragraph (2)(b) and (e), any director or superintendent of the body corporate making the application.

(1) An application for inclusion in a pharmaceutical list by a person ... who is not already included in it must be refused if NHS England is satisfied that—

(a) A ...has been convicted in the United Kingdom of murder;

(b) A ...—

(i) has been convicted in the United Kingdom of a criminal offence, other than murder, which was committed after 1st April 2005, and

(ii) has been sentenced to a term of imprisonment of over 6 months;

(d) where, on appeal, the First-tier Tribunal determines A may be included in the pharmaceutical list subject to conditions, A has not within 30 days of that decision notified NHS England that A agrees to the imposition of the conditions.

(2) An application for inclusion in a pharmaceutical list by a person who is not already included may be refused if NHS England—

(a) having contacted the referees mentioned in paragraph 3(8) of Schedule 2, is not satisfied with the references given;

(b) considers that A is unsuitable to be included in the list;

(i) checked with the NHS CFA for any facts that it considers relevant relating to past or current fraud investigations involving or related to A ..., and

(ii) considered these and any other facts in its possession relating to fraud involving or relating to A ...,

considers the outcome of these enquiries justify such refusal;

(d) having—

(i) checked with the Secretary of State for any facts considered by the Secretary of State to be relevant relating to past or current investigations or proceedings involving or relating to A ..., and

(ii) considered these and any other facts in its possession involving or relating to A ...,

considers the outcome of these enquiries justify such refusal; or

(e) considers that granting the application would be prejudicial to the efficiency of the service which A has undertaken to provide.

(3) Where NHS England is considering refusal of an application under paragraph (2), it must consider all facts which appear to it to be relevant and must in particular take into consideration in relation to paragraph (2)(b) to (e)—

(a) the nature of any offence, investigation or incident;

(b) the length of time since any offence, incident, conviction or investigation;

(d) any action taken or penalty imposed by any licensing or regulatory body, the police or the courts as a result of any such offence, incident or investigation;

(e) the relevance of any offence, investigation or incident to the provision by A of pharmaceutical services and any likely risk to users of pharmaceutical services or to public finances;

(f) whether any offence was a sexual offence to which Part 1 of the Sexual Offences Act 2003 (sexual offences) or section 2 of the Modern Slavery Act 2015 in respect of sexual exploitation (human trafficking) applies, or if it had been committed in England and Wales, would have applied;

(g) whether A ... has been refused inclusion in, conditionally included in, removed, contingently removed or is currently suspended from a relevant list for a reason relating to unsuitability, fraud or efficiency of service provision, and if so, the facts relating to the matter which led to such action and the reasons given by NHS England or another primary care organisation for such action; or

(h) whether A ...was, at the time of the originating events, or has in the preceding 6 months been—

(i) a director or superintendent of a body corporate which has been refused inclusion in, conditionally included in, removed or contingently removed from a relevant list, or

(ii) is currently suspended from a relevant list,

for a reason relating to unsuitability, fraud or efficiency of service provision, and if so, what the facts were in each such case and the reasons given by NHS England or another primary care organisation in each case.

(4) When NHS England takes into consideration the matters set out in paragraph (3), it must consider the overall effect of all the matters being considered.

(5) If an application for inclusion in a pharmaceutical list by a person who is not already included in it is refused under paragraph (1) or (2), NHS England must notify the applicant of that decision and it must include with the notification an explanation of—

(a) the reasons for the decision;

(b) the applicant's right of appeal against the decision to the First-tier Tribunal, which must be exercised within 30 days of the date on which the applicant was notified of the decision.

Deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds

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(A1) In this regulation, “A” means, where an application for inclusion in a pharmaceutical list is made by a person who is—

(a) an individual, the individual making the application;

(b) a partnership, any partner in the partnership making the application; or

(i) except for the purposes of paragraph (1)(b), (c)(ii), (e), (g), (i) and (k), the body corporate making the application, and

(ii) any director or superintendent of the body corporate making the application.

(1) An application for inclusion in a pharmaceutical list by a person ...who is not already included in it may be deferred if NHS England is satisfied that—

(a) there are, in respect of A ...—

(i) criminal proceedings in the United Kingdom, or

(ii) proceedings elsewhere relating to conduct, which, if it had occurred in the United Kingdom, would constitute a criminal offence,

which, if they result in a conviction, or the equivalent of a conviction, would be likely to lead to the person’s removal from the pharmaceutical list, if the person were to be included in it;

(b) in respect of a body corporate of which A is, or has in the preceding 6 months been, or was at the time of the originating events, a director or superintendent, there are—

(i) criminal proceedings in the United Kingdom, or

(ii) proceedings elsewhere relating to conduct, which, if it had occurred in the United Kingdom, would constitute a criminal offence,

which, if they resulted in a conviction, or the equivalent of a conviction, would be likely to lead to the person’s removal from the pharmaceutical list, if the person were to be included in it;

(i) by A's ... licensing or regulatory body, or

(ii) relating to A ... in A's professional capacity (including one by NHS England or another primary care organisation),

which, if the outcome were adverse, would be likely to lead to the removal of the person from the pharmaceutical list if the person were to be included in it;

(d) A ...is suspended from a relevant list;

(e) a body corporate of which A ... was, at the time of the originating events, a director or superintendent, is suspended from a relevant list;

(f) the First-tier Tribunal is considering an appeal by A ... against a decision of NHS England or another primary care organisation—

(i) to refuse an application for inclusion in a relevant list, or

(ii) to include A conditionally in, or to remove or contingently remove A from, a relevant list,

and if that appeal were to be unsuccessful, NHS England would be likely to remove the person from the pharmaceutical list if the person were to be included in it;

(g) the First-tier Tribunal is considering an appeal by a body corporate of which A ... was, at the time of the originating events, or has in the preceding 6 months been, a director or superintendent, against a decision of NHS England or another primary care organisation—

(i) to refuse an application by that body corporate for inclusion in its list,

(ii) to include A conditionally in, or to remove or contingently remove A from, a relevant list,

and if that appeal were to be unsuccessful NHS England would be likely to remove the person from the pharmaceutical list if the person were to be included in it;

(h) A ... is being investigated by the NHS CFA in relation to any fraud, where the result, if adverse, would be likely to lead to the removal of the person from the pharmaceutical list if the person were to be included in it;

(i) a body corporate, of which A ...was, at the time of the originating events, a director or superintendent, is being investigated by the NHS CFA in relation to any fraud, where the result if adverse would be likely to lead to the removal of the person from the pharmaceutical list if the person were to be included in it;

(j) the First-tier Tribunal is considering an application from NHS England or a Local Health Board for a national disqualification of A ...;

(k) the First-tier Tribunal is considering an application from NHS England or a Local Health Board for a national disqualification of a body corporate of which A ... was, at the time of the originating events, a director or superintendent; or

(l) NHS England or another primary care organisation, for a reason relating to unsuitability, fraud or efficiency of service provision—

(i) is considering removal (other than voluntary removal) or contingent removal of the applicant from a relevant list, or

(ii) has taken a decision to remove (other than voluntary removal) or contingently remove the applicant from a relevant list but that decision has yet to take effect.

(2) NHS England may only defer a decision under paragraph (1) until—

(a) the outcome of the cause for the deferral is known; or

(b) the reason for the deferral no longer exists.

Granting applications for inclusion in a pharmaceutical list subject to efficiency conditions and conditions to combat fraud

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(1) An application for inclusion in a pharmaceutical list by a person (P) who is not already included may be granted subject to a condition of a type mentioned in paragraph (3), which is determined by NHS England and which NHS England decides to impose with regard to P.

(2) NHS England may vary the terms of service of an NHS chemist for the purpose of or in connection with the imposition of the condition.

(3) A condition imposed under paragraph (1) must be a condition with a view to—

(a) preventing any prejudice to the efficiency of the services, or any of the services, which P has undertaken to provide; or

(b) preventing any act or omission within section 151(3)(a) of the 2006 Act (disqualification of practitioners).

(4) If NHS England decides to grant an application subject to a condition imposed under paragraph (1), it must notify P of that decision and it must include with the notification an explanation of—

(a) the reasons for the decision;

(b) P's right of appeal against its decision to the First-tier Tribunal;

(c) the time limit within which, in accordance with the Tribunal Procedure (First-tier Tribunal) (Health, Education and Social Care Chamber) Rules 2008 , the application notice must be sent to the Tribunal if an appeal is to be brought; and

(d) the effect of paragraph (5).

(5) If P issues a notice of commencement before the First-tier Tribunal has determined an appeal against a condition imposed under paragraph (1), P is to be included in the pharmaceutical list subject to the condition, but only pending the outcome of the appeal if the appeal is successful.

(6) The appeal is to be by way of redetermination of—

(a) the decision of NHS England to impose the condition; and

(b) if P has, at the time the appeal is determined, been included in the pharmaceutical list, any decision under paragraph (2) to vary the terms of service of P for the purpose of or in connection with the imposition of the condition.

(7) If at the time the appeal is determined, P has not been included in the pharmaceutical list, and—

(a) the First-tier Tribunal confirms the decision of NHS England; or

(b) imposes a different condition,

P must, within 30 days of P being notified of the First-tier Tribunal's decision, notify NHS England as to whether or not P wishes to withdraw P's application

(8) If P fails, in the circumstances described in paragraph (7), to notify NHS England within that 30 days that P does not wish to withdraw P's application, the grant of P's application lapses.

PART 7 — Areas that are controlled localities or reserved locations, and new pharmacies within them

Determination that an area is a controlled locality

36

(1) Any area that was, or was part of, a controlled locality for the purposes of the 2012 Regulations immediately before these Regulations come into force continues to be, or to be part of, a controlled locality for the purposes of these Regulations (unless or until it is determined that the area is no longer, or no longer part of, a controlled locality).

(2) Subject to paragraph (3), NHS England may at any time consider and determine whether or not any locality, because it is rural in character, is to be, or to be part of, a controlled locality.

(3) Where the question of whether or not an area is to be, or to be part of, a controlled locality has been determined by NHS England, a Primary Care Trust or on appeal (whether under these Regulations, the 2012 Regulations or the 2005 Regulations), that question must not be considered again in relation to that area—

(a) for 5 years, beginning with the date of the determination of NHS England or the Primary Care Trust, or if that determination was appealed, the date of the decision on appeal;

(b) unless NHS England is satisfied (within that 5 years) that there has been a substantial change in circumstances in relation to that area since the question was last determined.

Process for determining controlled localities: preliminary matters

37

(1) A Local Medical Committee or Local Pharmaceutical Committee may apply in writing to NHS England for it to determine whether or not an area specified in the application (which must be all or part of the Committee's area) is to be, or is to be part of, a controlled locality.

(2) Before considering the application, NHS England must consider whether or not the application raises a question that it cannot consider by virtue of regulation 36(3).

(3) If NHS England decides that the application does raise a question that it cannot consider by virtue of regulation 36(3), it must take no further action in relation to that application other than informing the Committee making the application of that decision and its right of appeal against that decision under regulation 45(1)(b).

Process for determining controlled localities: local notification and deferment of routine applications

38

(1) If NHS England is considering making a determination that an area (A1) is or is not to be, or is or is not to be part of, a controlled locality (whether or not of its own motion), before making the proposed determination, it must give notice of the proposed determination to—

(a) any Local Pharmaceutical Committee whose area includes all or part of A1;

(b) any Local Medical Committee whose area includes all or part of A1;

(c) any person on a pharmaceutical list or dispensing doctors list who, in the opinion of NHS England, may be affected by the determination;

(d) any LPS chemist who, in the opinion of NHS England, may be affected by the determination;

(e) any provider of primary medical services who, in the opinion of NHS England, may be affected by the determination;

(f) where it is considering making a determination as a consequence of a routine application, the person making that application; and

(g) any HWB whose area includes all or part of A1.

(2) NHS England may also give notice of the proposed determination to such other persons as it considers appropriate to do so.

(3) A notice under paragraph (1) or (2) must inform the person notified—

(a) that they may make representations (or in the case of a Committee being notified that applied for the determination, any further representations) in writing within 30 days beginning on the day on which the notification was sent to them;

(b) of the date by which NHS England expects to make its determination, which must be no later than 6 months after the day on which NHS England first gives notice to any person in respect of the proposed determination under paragraph (1) or (2).

(4) Once NHS England has issued notice under paragraph (1), it must defer consideration of any routine application where the applicant is seeking the listing of pharmacy premises and the outcome of the application could (if the application is deferred) be affected as a result of the proposed determination, until—

(a) it has determined whether the area in question is or is not to be, or is or is not to be part of, a controlled locality; and

(b) the proceedings relating to that determination have reached their final outcome.

Process of determining controlled localities: formulation of NHS England’s decision

39

(1) When it is determining whether or not an area is or is part of a controlled locality, NHS England must have regard to whether the provision of—

(a) primary medical services by a provider of primary medical services;

(b) pharmaceutical services by a person on a pharmaceutical list; or

is likely to be adversely affected by the consequences of the determination.

(2) Once it has determined whether or not an area is or is part of a controlled locality, NHS England must—

(a) if it determines that the area is to become or become part of a controlled locality, or is to cease to be part of a controlled locality—

(i) delineate precisely the boundary of the resulting controlled locality on a map,

(ii) publish that map, and

(iii) make that map available as soon as is practicable to any HWB that has all or part of that controlled locality in its area;

(b) give notice of the determination to the persons mentioned in paragraph (3) informing them of—

(i) its determination and the reasons for it,

(ii) their right of appeal, if the person has a right of appeal under regulation 45(1)(a)(i), and

(iii) their right of appeal under regulation 45(1)(a)(ii), in the case of a person notified who is a Local Pharmaceutical Committee, a Local Medical Committee, a provider of primary medical services, an LPS chemist or a person on a pharmaceutical or dispensing doctors list.

(3) The persons mentioned in this paragraph are—

(a) if the determination resulted from an application from a Local Pharmaceutical Committee or Local Medical Committee pursuant to regulation 37(1), that Committee;

(b) if a routine application was deferred pursuant to regulation 38(4) until the proceedings relating to the determination reached their final outcome, the person making that application; and

(c) the persons notified in accordance with regulation 38(1) and (2) in relation to the proposal to make the determination.

(4) A HWB to which a map is made available under paragraph (2)(a)(iii) must—

(a) publish that map alongside its pharmaceutical needs assessment map (once it has one); or

(b) include the boundary of the controlled locality (in so far as it is in, or part of the boundary of, the HWB's area) in its pharmaceutical needs assessment map (once it has one).

Applications for new pharmacy premises in controlled localities: refusals because of preliminary matters

40

(1) This paragraph applies to all routine applications—

(a) for inclusion in a pharmaceutical list as an NHS pharmacist; or

(b) from an NHS pharmacist included in such a list—

(i) to relocate to different pharmacy premises in the area of the relevant HWB, or

(ii) to open, within the area of the relevant HWB, additional pharmacy premises at or from which to provide pharmaceutical services,

where the applicant is seeking the listing of pharmacy premises which are in a controlled locality.

(2) If NHS England receives an application (A1) to which paragraph (1) applies, it must refuse A1 (without needing to make any notification of that application under Part 3 of Schedule 2), where the applicant is seeking the listing of premises at a location which is—

(a) in an area in relation to which outline consent has been granted under these Regulations, the 2012 Regulations or under the 2005 Regulations within the 5 year period—

(i) starting on the date on which the proceedings relating to the grant of outline consent reached their final outcome, and

(ii) ending on the date on which A1 is made; or

(b) within 1.6 kilometres of the location of proposed pharmacy premises (other than proposed distance selling premises), in respect of which—

(i) a routine application under these Regulations or the 2012 Regulations, or

(ii) an application to which regulation 22(1) or (3) of the 2005 Regulations (relevant procedures for applications) applied,

was refused within the 5 year period starting on the date on which the proceedings relating to the refusal reached their final outcome and ending on the date on which A1 is made,

unless NHS England is satisfied that since the date on which the 5 year period started, there has been a substantial and relevant change of circumstances affecting the controlled locality.

(3) For the purposes of paragraphs (1) and (2), if no particular premises are proposed for listing in A1, the applicant is to be treated as seeking the listing of pharmacy premises at the location which is the best estimate that NHS England is able to make of where the proposed listed pharmacy premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2.

(4) Paragraph (2)(b) does not apply where NHS England is satisfied that there are reasonable grounds for believing the person making the refused application was motivated (wholly or partly) by a desire for that application to be refused.

(5) The refusal of an application pursuant to paragraph (2)(b), or regulation 40(2)(b) of the 2012 Regulations (applications for new pharmacy premises in controlled localities: refusals because of preliminary matters), is to be ignored for the purposes of the calculation of a 5 year period pursuant to paragraph (2)(b).

Applications for new pharmacy premises in controlled localities: reserved locations

41

(1) This paragraph applies to any routine application—

(a) for inclusion in a pharmaceutical list as an NHS pharmacist; or

(b) from an NHS pharmacist included in such a list—

(i) to relocate to different pharmacy premises in the area of the relevant HWB, or

(ii) to open, within the area of the relevant HWB, additional pharmacy premises at or from which to provide pharmaceutical services,

where the applicant is seeking the listing of pharmacy premises which are in a controlled locality and NHS England is required to notify the application under Part 3 of Schedule 2.

(2) If paragraph (1) applies to an application (referred to in this regulation and regulation 42 as “A1”), subject to paragraph (5), NHS England must determine whether or not the “relevant location”, that is—

(a) the location of the premises for which the applicant is seeking the listing; or

(b) if no particular premises are proposed for listing in A1, the location which is the best estimate that NHS England is able to make of where the proposed pharmacy premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2,

is, on basis of the circumstances that pertained on the day on which A1 was received by NHS England, in a reserved location.

(3) Subject to regulation 43(2), the area within a 1.6 kilometre radius of a relevant location is a “reserved location” if—

(a) the number of individuals residing in that area who are on a patient list (which may be an aggregate number of patients on more than one patient list) is less than 2,750; and

(b) NHS England is not satisfied that if pharmaceutical services were provided at or from the relevant location, the use of those services would be similar to, or greater than, the use that might be expected if the number of individuals residing in that area who are on a patient list were 2,750 or more.

(4) Before making a determination under paragraph (2) (referred to in this regulation and regulation 42 as “D1”), NHS England must—

(a) notify the persons notified under Part 3 of Schedule 2 about A1 that NHS England is required to make D1 (and it may make this notification at the same time as it notifies those persons about A1); and

(b) invite them, within a specified period of not less than 30 days, to make representations to NHS England with regard to D1 (and the period specified must end no earlier than the date by which the person notified needs to make any representations that they have with regard to A1).

(5) NHS England must not make a determination under paragraph (2) in respect of A1 in circumstances where an earlier application which was in respect of the relevant premises and to which paragraph (1), regulation 44(1) of the 2012 Regulations (prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location) or regulation 18ZA of the 2005 Regulations (refusal: premises which are in a controlled locality but not a reserved location) applied was refused—

(a) for the reasons relating to prejudice in—

(i) regulation 44(3),

(ii) regulation 44(3) of the 2012 Regulations, or

(iii) regulation 18ZA(2) of the 2005 Regulations; and

(b) within the 5 year period starting on the date on which the proceedings relating to the refusal reached their final outcome and ending on the date on which A1 is made,

unless NHS England is satisfied that since the date on which the 5 year period started, there has been a substantial and relevant change of circumstances affecting the controlled locality.

(6) For the purposes of paragraph (5), the “relevant premises” are—

(a) the premises which are proposed for listing; or

(b) if no particular premises are proposed for listing in A1, premises at the location which is the best estimate that NHS England is able to make of where the proposed listed pharmacy premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2.

Second and subsequent determinations of reserved location status

42

(1) Where NHS England has made D1, or a reserved location determination has been made in accordance with the 2012 Regulations or the 2005 Regulations, and the person in relation to whose proposed listing of premises that determination was made (or that person's successor as the owner of the relevant pharmacy business) requests a further determination (referred to in this regulation as “D2”), NHS England may determine (subject to paragraph (3) and regulation 43(2))—

(a) whether or not a location that has become the relevant location for the purposes of a listing application is in a reserved location, on the basis of the circumstances that pertained on the day on which the request for D2 was received by NHS England, in circumstances where the relevant location in relation to which the earlier determination was made has changed because—

(i) no particular premises were proposed for listing in the application, but

(ii) particular premises have since been identified; or

(b) that, on the basis of the circumstances that pertained on the day on which the request for D2 was received by NHS England, there is no longer—

(i) a reserved location, or

(ii) in the case of a determination of a reserved location that has not yet taken effect, a determination of a reserved location,

with regard to the premises proposed for listing (which may have become pharmacy premises) because the relevant location no longer meets (or does not meet) the criteria for being a reserved location in regulation 41(3).

(2) Before making D2, NHS England must—

(a) notify the persons that it would notify under Part 3 of Schedule 2, if the request for a determination were an application seeking the listing of pharmacy premises at the relevant location, that NHS England is required to make a determination under paragraph (1); and

(b) invite them, within a specified period of up to 3 months but not less than 30 days, to make representations to NHS England with regard to that determination.

(3) NHS England must only determine under paragraph (1) that the area, or any part of an area, that is within a 1.6 kilometre radius of a relevant location is no longer to be classed as a reserved location if it is satisfied that the change in classification of that area, or part of an area, will not prejudice the proper provision of relevant NHS services in the area of—

(a) the relevant HWB; or

(b) a neighbouring HWB of the relevant HWB.

(4) Where NHS England makes D2—

(a) D1 lapses as soon as D2 is made; and

(b) NHS England may (in accordance with regulation 50) postpone the termination of the arrangements that it has with the provider of primary medical services or dispensing doctor that would otherwise take place as a consequence of D2.

(5) Where—

(a) NHS England has made D2; and

(b) the person who sought the determination, or that person's successor as the person carrying on a pharmacy business at or from the relevant location, believes that the reserved location no longer meets the criteria for being a reserved location in regulation 41(3),

that person may request a further determination, under paragraph (1)(b), and if that person does, paragraphs (1) to (4) apply as if the references to D1 were to the most recent determination and the references to D2 were to the new further determination.

Determinations of reserved locations: supplemental matters

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(1) Once NHS England has determined whether or not an area is a reserved location under regulation 41(2) or 42(1), it must—

(a) give notice of the determination to the person in relation to whose pharmacy premises or proposed pharmacy premises the determination relates, and to the persons notified in accordance with regulation 41(4) or 42(2); and

(b) as part of that notice, inform them of—

(i) its determination and the reasons for it, and

(ii) in the case of any person notified who is a Local Pharmaceutical Committee, a Local Medical Committee, a provider of primary medical services, an LPS chemist or a person on a pharmaceutical or dispensing doctors list, their right of appeal under regulation 45(1)(c) or (d).

(2) Where—

(a) part of the area of what would otherwise be determined under regulation 41(2) or 42(1) to be a reserved location is within 1.6 kilometres of the location of other pharmacy premises (that is, pharmacy premises other than the pharmacy premises at the relevant location); and

(b) there is no reserved location arising out of the presence of those other pharmacy premises,

that part of that area is not to be part of the reserved location.

(3) A reserved location (as opposed to the determination of a reserved location) takes effect once the pharmacy premises to which it relates are listed in the pharmaceutical list.

(4) Once a reserved location takes effect, NHS England must—

(a) delineate precisely the boundary of the reserved location on a map;

(b) publish that map; and

(c) make that map available as soon as is practicable to any HWB that has all or part of that reserved location in its area.

Prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location

44

(1) This paragraph applies to all routine applications—

(a) for inclusion in a pharmaceutical list as an NHS pharmacist; or

(b) from an NHS pharmacist included in such a list—

(i) to relocate to different pharmacy premises in the area of the relevant HWB, or

(ii) to open, within the area of the relevant HWB, additional pharmacy premises at or from which to provide pharmaceutical services.

(2) As regards any application to which paragraph (1) applies, NHS England must have regard to whether or not the applicant is seeking the listing of pharmacy premises which are in a part of a controlled locality that is not a reserved location.

(3) If the applicant is seeking the listing of pharmacy premises which are in a part of a controlled locality that is not in a reserved location, NHS England must refuse the application if granting it would, in the opinion of NHS England, prejudice the proper provision of relevant NHS services in the area of—

(a) the relevant HWB; or

(b) a neighbouring HWB of the relevant HWB.

(4) For the purposes of paragraphs (2) and (3), if no particular premises are proposed for listing in the application, the applicant is to be treated as seeking the listing of pharmacy premises which are in a controlled locality if the best estimate that NHS England is able to make of where the proposed pharmacy premises would be is at a location which is in a controlled locality, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2.

Appeals against decisions under Part 7

45

(1) A person with appeal rights (as provided for in this regulation) may appeal to the Secretary of State against the following decisions by NHS England—

(a) a determination of whether or not an area is or is part of a controlled locality as mentioned in regulation 36(2), in respect of which the only people with appeal rights are—

(i) a person, as mentioned in regulation 38(4), who is making a routine application to which the determination relates, and

(ii) a person given notice of the determination who is mentioned in regulation 39(2)(b)(iii);

(b) a decision under regulation 37(3) that an application by a Local Pharmaceutical Committee or Local Medical Committee raises a question that it cannot consider by virtue of regulation 36(3), in respect of which only the Committee making the application to which the decision relates is a person with appeal rights;

(c) a determination as to whether or not a relevant location is in a reserved location under regulation 41(2), in respect of which the only people with appeal rights are—

(i) the person making the application to which the determination relates, and

(ii) a person given notice of the determination who is mentioned in regulation 43(1)(b)(ii); and

(d) a determination under regulation 42(1), in respect of which the only people with appeal rights are—

(i) the person making the application to which the determination relates, and

(ii) a person given notice of the determination who is mentioned in regulation 43(1)(b)(ii),

provided that, within 30 days of the date on which they were notified of the decision that is being appealed, they notify the Secretary of State with a valid notice of appeal.

(2) A notice of appeal under paragraph (1) is only valid if it includes a concise and reasoned statement of the grounds of appeal.

(3) Schedule 3 has effect in relation to appeals to the Secretary of State against decisions under this Part (as it does in relation to appeals against decisions under Parts 2 to 5, 8, 10 and 12 and Schedule 2).

PART 8 — Dispensing doctors

Dispensing doctor lists

46

(1) In respect of the area of each HWB, NHS England must prepare and publish a list (a “dispensing doctor list”) of the names of any “dispensing doctors” in that area, that is to say—

(a) providers of primary medical services who provide pharmaceutical services at or from medical practice premises in that area; and

(b) general practitioners who are not providers of primary medical services but who provide pharmaceutical services at or from medical practice premises in that area (not including general practitioners who are listed as part of the listing of a provider by virtue of paragraph (6)(b)).

(2) Each dispensing doctor list must include—

(a) the address of any premises in the area of the relevant HWB for which a listed dispensing doctor has premises approval (“the listed dispensing premises”) and any other medical practice premises of the dispensing doctor in that area; and

(b) any area in relation to which the dispensing doctor has outline consent (which may be in the area of a neighbouring HWB).

(3) NHS England must remove a dispensing doctor from a dispensing doctor list if—

(a) in the case of a listed provider of primary medical services, that person or partnership ceases to be a provider of primary medical services or ceases to be a provider of those services at or from (what were) the relevant listed dispensing premises;

(b) in the case of a listed general practitioner, that person is no longer on the medical performers list or no longer performs primary medical services within the area of the relevant HWB; or

(c) all the arrangements that the dispensing doctor has with NHS England to perform or provide pharmaceutical services at or from (what were) the relevant listed dispensing premises have been discontinued, or the permissions that the dispensing doctor requires in order to have such arrangements have lapsed, in accordance with this Part.

(4) If—

(a) a general practitioner who is the only member of a provider of primary medical services who is a dispensing doctor so elects; or

(b) all the general practitioners who are the members of a provider of primary medical services who are dispensing doctors so elect,

they may request that NHS England lists that provider instead of them as the dispensing doctor (or doctors) on a dispensing doctors list.

(5) In the circumstances described in paragraph (4)—

(a) NHS England must agree to that request;

(b) the arrangements that NHS England had with the individual dispensing doctor or doctors become arrangements with the provider of primary medical services; and

(c) the premises approvals and related outline consents of that individual general practitioner or those general practitioners become the premises approvals and outline consents of the provider of primary medical services.

(6) Where a provider of primary medical services is listed in a dispensing doctors list—

(a) the provider must notify NHS England—

(i) of any general practitioner who performs primary medical services on behalf of the provider who the provider anticipates will provide pharmaceutical services on behalf of the provider, and

(ii) if and when, in the case of a general practitioner who has been so notified, the provider no longer anticipates that the general practitioner will provide pharmaceutical services on behalf of the provider; and

(b) as part of the listing of the provider in its dispensing doctors list, NHS England must include the names of any general practitioner notified under sub-paragraph (a)(i), unless NHS England has received a further notification in respect of that general practitioner under sub-paragraph (a)(ii).

Terms of service of dispensing doctors: general

47

(1) The arrangements under which a dispensing doctor undertakes to provide pharmaceutical services (and so their terms of service) are to include any provisions affecting their rights or obligations that—

(a) are included in these Regulations, including—

(i) the terms of service set out in Schedule 6 (which accordingly has effect), and

(ii) any obligation that is only applicable in prescribed cases, if the dispensing doctor is a person to whom the obligation is applicable;

(b) were imposed, in relation to the dispensing doctor's ability to provide pharmaceutical services, by virtue of regulation 20(2) of the 2005 Regulations (imposition of conditions);

(c) are included in the arrangements for remuneration for services provided by dispensing doctors that give effect to regulation 92, in so far as those rights or obligations are applicable in the case of the dispensing doctor; and

(d) are—

(i) included in regulations under section 225 of the 2007 Act (duties of services-providers to allow entry by Local Healthwatch organisations or contractors), and

(ii) made for the purpose of imposing on a services-provider (within the meaning of that section) a duty to allow authorised representatives (within the meaning of that section) to enter and view, and observe the carrying-on of activities at or from, premises owned or controlled by the services-provider.

(2) NHS England must ensure that those terms of service—

(a) if the dispensing doctor has arrangements with NHS England for the provision of primary medical services to the patients to whom the dispensing doctor provides pharmaceutical services, are conditions of and so are enforceable under those arrangements; or

(b) if the dispensing doctor has no such arrangements, are terms of service of, and so are enforceable under, the arrangements that NHS England has with a provider of primary medical services for the provision of primary medical services to the patients to whom the dispensing doctor provides pharmaceutical services.

Arrangements for the provision of pharmaceutical services by doctors: applications by patients

48

(1) A patient (P) may at any time request in writing that a dispensing doctor (D) provides P with pharmaceutical services if—

(a) one or more of the Conditions specified in paragraphs (2) to (4) is satisfied in relation to P; and

(b) P is on either D's patient list or the patient list of a provider of primary medical services (E) by whom D is employed or engaged.

(2) Condition 1 is that P satisfies NHS England that P would have serious difficulty in obtaining any necessary drugs or appliances from pharmacy premises by reason of distance or inadequacy of means of communication.

(3) Condition 2 is that P is resident in a controlled locality at a distance of more than 1.6 kilometres from any pharmacy premises, other than distance selling premises, and—

(a) there is in effect—

(i) an outline consent that has been granted to D for the area in which P resides, and

(ii) a related premises approval for the premises at or from which D (or another general practitioner within the practice) would dispense to P; or

(b) the following—

(i) immediately before these Regulations came into force, there was a right (other than outline consent) in effect under the 2012 Regulations for D, E or another general practitioner employed or engaged by E to provide drugs or appliances to patients on D or E's patient list (a right which continues in effect under these Regulations, subject to regulation 60),

(ii) P either—

(aa) has not previously been included in a patient list whilst residing in the area of the relevant HWB,

(bb) has been so included but now resides at a different address in the area of the relevant HWB, or

(cc) has been so included and has not changed address, but immediately before P's acceptance by D or E onto their patient list, P was being provided with pharmaceutical services by another general practitioner or provider of primary medical services in the area of the relevant HWB under arrangements with NHS England, and

(iii) there is in effect premises approval in relation to the premises at or from which D would dispense to P.

(4) Condition 3 is that P is resident in a controlled locality and within a distance of 1.6 kilometres from pharmacy premises that are not distance selling premises, but—

(a) P is resident in a reserved location; and

(b) either paragraph (3)(a) or (b) is satisfied in relation to P.

(5) If D—

(a) in response to the request, applies in writing to NHS England, enclosing P's request, NHS England must make arrangements with D for the provision of pharmaceutical services to P—

(i) in a case to which Condition 1 applies, at or from D's medical practice premises, or

(ii) in a case to which Condition 2 or 3 applies, at or from D's listed dispensing premises; or

(b) does not respond to the request as mentioned in sub-paragraph (a) within 30 days, NHS England may, subject to paragraph (7), require D to undertake to provide pharmaceutical services to P—

(i) in a case to which Condition 1 applies, at or from D's medical practice premises, or

(ii) in a case to which Condition 2 or 3 applies, at or from D's listed dispensing premises,

by a notification to that effect which gives D reasonable notice of when the requirement is to take effect.

(6) NHS England must not, under paragraph (5)(b), require D to undertake to provide services to P, if D satisfies NHS England that—

(a) D does not normally provide pharmaceutical services; or

(b) P would not have serious difficulty in obtaining any necessary drugs or appliances from pharmacy premises by reason of distance or inadequacy of means of communication.

(7) Where arrangements have been made between D and NHS England for the provision of pharmaceutical services, those arrangements take effect—

(a) in a case to which paragraph (5)(a) applies, from the date of the patient's request in writing; or

(b) in a case to which paragraph (5)(b) applies, from the date which NHS England specifies in the notice under that paragraph as the date on which the arrangements are to take effect, or if D appeals the decision under paragraph (5)(b), the date on which that appeal reaches its final outcome.

(8) Under those arrangements, at or from the relevant medical practice premises or listed dispensing premises for those arrangements, the following may provide pharmaceutical services to the patient, for as long as the arrangements remain in effect—

(a) if the arrangements are with a provider of primary medical services (including an individual who is such a provider), any general practitioner performing primary medical services on behalf of that provider; or

(b) if the arrangements are with an individual general practitioner who performs primary medical services on behalf of a provider of primary medical services, the general practitioner or any other general practitioner who performs primary medical services on behalf of that provider.

(9) To be valid, a notification under paragraph (5)(b) by NHS England must include an explanation of—

(a) the reasons for the imposition of the requirement; and

(b) D's right of appeal under regulation 63(1)(a).

Necessary services for temporary patients

49

A dispensing doctor who provides pharmaceutical services to patients on a patient list may provide necessary pharmaceutical services to a person who has been accepted by the dispensing doctor as a temporary patient.

Discontinuation of arrangements for the provision of pharmaceutical services by doctors

50

(1) In circumstances where NHS England has arrangements (whether they were made under these Regulations or were made under or continued by virtue of the 2012 Regulations) with a dispensing doctor (D) to provide pharmaceutical services to a person (P), if—

(a) pharmaceutical services have been provided to P because of the circumstances described in Condition 1 in regulation 48(2), but NHS England determines that Condition 1 no longer applies in relation to P;

(b) the area in which P is resident was but ceases to be a controlled locality, and the provision of pharmaceutical services to P arose out of P's residence in a controlled locality;

(c) P was resident in but has moved out of a controlled locality, and the provision of pharmaceutical services to P arose out of P's residence in that controlled locality;

(d) P is resident in a controlled locality but is not (any longer) resident at a distance of more than 1.6 kilometres from any pharmacy premises, other than distance selling premises, at or from which pharmaceutical services are being provided, and—

(i) NHS England determines that Condition 3 in regulation 48(4) does not apply in respect of P, or

(ii) NHS England determines that Condition 3 in regulation 48(4) does apply in respect of P, but P informs NHS England that P wishes to be provided with pharmaceutical services by a person on a pharmaceutical list rather than by D (other than as permitted by paragraph 7 of Schedule 6);

(e) P is resident in a reserved location, and—

(i) had previously informed NHS England (or a Primary Care Trust) that P wished to be provided with pharmaceutical services by D, but

(ii) P has since informed NHS England that P wishes instead to be provided with pharmaceutical services by a person on a pharmaceutical list rather than by D (other than as permitted by paragraph 7 of Schedule 6); or

(f) P is resident in a location that ceases to be or be part of a reserved location as a consequence of a determination referred to in regulation 42 as D2,

D must terminate the provision of pharmaceutical services to P, subject to any postponement of the discontinuation by NHS England in accordance with paragraphs (2) to (6).

(2) NHS England may postpone the discontinuation—

(a) until any proceedings relating to the discontinuation, including proceedings arising out of the grant of a routine or excepted application that has led to the discontinuation, have reached their final outcome; or

(b) where paragraph (3) or (4) applies.

(3) This paragraph applies where—

(a) NHS England grants a routine or excepted application, the result of which is the inclusion in a pharmaceutical list of pharmacy premises that are not already listed in relation to an NHS pharmacist;

(b) the pharmacy premises to which that application relates are not distance selling premises but—

(i) are in a controlled locality, or

(ii) are within 1.6 kilometres of a part of a controlled locality in which patients of a dispensing doctor reside and those patients are being provided with pharmaceutical services by that dispensing doctor; and

(c) granting the routine or excepted application, in the opinion of NHS England, results in a significant change to the arrangements that are in place for the provision of pharmaceutical services (including by a person on a dispensing doctor list) or local pharmaceutical services in any part of a controlled locality.

(4) This paragraph applies where NHS England is required to terminate the provision of pharmaceutical services pursuant to paragraph (1)(f) but NHS England is satisfied that the determination that led to the decision to terminate has adversely affected D.

(5) Where paragraph (3) or (4) applies, NHS England may postpone the discontinuation for such period as it thinks fit.

(6) NHS England must postpone the discontinuation—

(a) while it is forming the opinion mentioned in paragraph (3)(c); or

(b) for such period as NHS England considers necessary in order to give the doctor reasonable notice (in any case to which paragraph (1) applies) of the discontinuation.

(7) NHS England must notify any decision under this regulation to terminate arrangements to provide pharmaceutical services, subject to any postponement of the discontinuation, to—

(a) D;

(b) if there is any postponement of the discontinuation, the NHS pharmacist listed in relation to any pharmacy premises, the presence of which, or the choice of a patient to obtain services at or from which, led to the determination of NHS England;

(c) any Local Pharmaceutical Committee whose area includes the listed dispensing premises at or from which D has been providing pharmaceutical services to P; and

(d) any Local Medical Committee whose area includes the listed dispensing premises at or from which D has been providing pharmaceutical services to P.

(8) Each notification under paragraph (7) must include—

(a) a statement of the reasons for the decision; and

(b) if the person notified is a person with rights of appeal under regulation 63(1)(b), an explanation of how those rights may be exercised.

51

(1) A person or partnership with a patient list, or a person who performs services on behalf of a provider of primary medical services, who wishes to be granted the right to provide pharmaceutical services to patients on their own list or the provider's list (if the patients apply under regulation 48(1) on the basis of Condition 2 or 3) may apply in writing to NHS England for—

(a) consent (“outline consent”) to the provision of pharmaceutical services to patients who request those services and who reside in the area specified in the application;

(b) approval of any medical practice premises at or from which D wishes to dispense (“premises approval”).

(2) Where D has outline consent that has taken effect and wishes to apply for premises approval in relation to—

(a) additional medical practice premises at or from which to provide pharmaceutical services to patients who reside in the area for which D has an outline consent; or

(b) medical practice premises at or from which D wishes to relocate to provide pharmaceutical services to patients who reside in the area for which D has an outline consent, but the move to new medical practice premises is not a relocation of the type provided for in regulation 55(2),

the premises approval application need not have a related outline consent application, but in all other cases a premises approval application under paragraph (1)(b) must have a related outline consent application.

(3) An application for premises approval must include details of the address of the premises and whether those premises are already listed in relation to a different area.

(4) Except in so far as these Regulations provide to the contrary, NHS England is to determine applications for outline consent and premises approval in such manner (including with regard to procedures) as it sees fit.

(5) NHS England must refuse an application under paragraph (1) (but not regulation 54, 55 or 58) for premises approval if the premises in respect of which approval is sought are within 1.6 kilometres of pharmacy premises that are not distance selling premises.

(6) NHS England must refuse an application for outline consent to the extent that any part of the area specified in the application—

(a) is not, or is not part of, a controlled locality; or

(b) is within 1.6 kilometres of pharmacy premises that are not distance selling premises.

(7) Where NHS England is minded to refuse an application for outline consent pursuant to paragraph (6)(a), it may defer that decision in order to make a determination under regulation 36(2).

(8) Subject to paragraph (9), NHS England must refuse an application under paragraph (1) (but not regulation 54, 55 or 58) if granting it would, in its opinion, prejudice the proper provision of relevant NHS services in the area of—

(a) the relevant HWB; or

(b) a neighbouring HWB of the relevant HWB.

(9) If NHS England determines that an application for outline consent would, if it had been made for a smaller area within the area specified in the application, not prejudice the proper provision of relevant NHS services in the area of—

(a) the relevant HWB; or

(b) a neighbouring HWB of the relevant HWB,

it may grant the application in respect of that smaller area.

(10) NHS England must refuse an application (A1) under paragraph (1)—

(a) for outline consent to the extent that any part of the area specified in A1 is the same as the area or any part of the area specified in an application for outline consent which was refused within the 5 year period starting on the date on which the proceedings relating to the refusal reached their final outcome and ending on the date on which A1 is made; or

(b) for premises approval (but not under regulation 54, 55 or 58) if the premises specified in A1 were specified in an application for premises approval, or relate to an application for outline consent where any part of the area specified in that application is the same as the area or any part of the area specified in an earlier application for outline consent, which was refused—

(i) under this regulation,

(ii) under regulation 51 of the 2012 Regulations (outline consent and premises approval: applications by doctors), or

(iii) by virtue of regulation 18(2) of the 2005 Regulations (refusal: outline consent and premises approval where patients are in a controlled locality),

within the 5 year period starting on the date on which the proceedings relating to the refusal reached their final outcome and ending on the date on which A1 is made,

unless NHS England is satisfied that there has been a substantial and relevant change of circumstances affecting the controlled locality to which the application relates since those proceedings reached their final outcome.

52

(1) Where NHS England receives an application for outline consent or premises approval (including an application for premises approval to which regulation 54 or 55 applies, but not an application for temporary premises approval to which regulation 58 or 61 applies), as soon as is practicable, it must give notice of that application to—

(a) any Local Pharmaceutical Committee—

(i) whose area includes the medical practice premises or all or part of the area to which the application relates, or

(ii) any part of whose area is within 2 kilometres of the medical practice premises to which the application relates;

(b) any Local Medical Committee—

(i) whose area includes the medical practice premises or all or part of the area to which the application relates, or

(ii) any part of whose area is within 2 kilometres of the medical practice premises to which the application relates;

(i) included in a pharmaceutical list for the area of the relevant HWB, or

(ii) who is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

whose interests might, in the opinion of NHS England, be significantly affected if the application were granted;

(d) any LPS chemist—

(i) with whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of the relevant HWB, and

(ii) whose interests might, in the opinion of NHS England, be significantly affected if the application were granted;

(e) any Local Healthwatch organisation for the area of the relevant HWB, and any other patient, consumer or community group in that area which, in the opinion of NHS England, has a significant interest in the outcome of the application;

(f) any provider of primary medical services, or any other person on the dispensing doctors list for the area of the relevant HWB if there is one (being a performer but not a provider of primary medical services), who in the opinion of NHS England has a significant interest in the outcome of the application;

(g) any Local Health Board any part of whose area is within 2 kilometres of the medical practice premises to which the application relates; and

(h) the relevant HWB and any other HWB (HWB2) any part of whose area—

(i) is within 2 kilometres of the medical practice premises to which the application relates, or

(ii) in the case of an application for outline consent, is part of the area specified in the application;

(2) NHS England may also give notice of the application to any other person who, in the opinion of NHS England, has a significant interest in the outcome of the application;

(3) If a HWB is notified under paragraph (1)(h), NHS England must also give notice of the application to—

(a) any person—

(i) included in a pharmaceutical list for the area of HWB2, or

(ii) who is entitled to be included in that pharmaceutical list because of the grant of a routine or excepted application but who is not (yet) included,

whose interests might, in the opinion of NHS England, be significantly affected if the application were granted;

(b) any LPS chemist—

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

Future improvements or better access: consequences of additional matters

21

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

22

PART 4 — Excepted applications

Applications from NHS chemists in respect of providing directed services

23

Relocations that do not result in significant change to pharmaceutical services provision

24

Distance selling premises applications

25

Change of ownership applications

26

Applications for temporary listings arising out of suspensions

27

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

28

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

29

PART 5 — Specific grounds for refusal or deferral of applications under Parts 3 and 4 which are not linked to fitness grounds

Refusal: language requirement for some NHS pharmacists

30

Refusal: same or adjacent premises

31

Deferrals arising out of LPS designations

32

PART 6 — Refusal, deferral and conditional inclusion in pharmaceutical lists of chemists on fitness grounds

Refusal of applications for inclusion in a pharmaceutical list on fitness grounds

33

Deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds

34

Granting applications for inclusion in a pharmaceutical list subject to efficiency conditions and conditions to combat fraud

35

PART 7 — Areas that are controlled localities or reserved locations, and new pharmacies within them

Determination that an area is a controlled locality

36

Process for determining controlled localities: preliminary matters

37

Process for determining controlled localities: local notification and deferment of routine applications

38

Process of determining controlled localities: formulation of NHS England’s decision

39

Applications for new pharmacy premises in controlled localities: refusals because of preliminary matters

40

Applications for new pharmacy premises in controlled localities: reserved locations

41

Second and subsequent determinations of reserved location status

42

Determinations of reserved locations: supplemental matters

43

Prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location

44

Appeals against decisions under Part 7

45

PART 8 — Dispensing doctors

Dispensing doctor lists

46

Terms of service of dispensing doctors: general

47

Arrangements for the provision of pharmaceutical services by doctors: applications by patients

48

Necessary services for temporary patients

49

Discontinuation of arrangements for the provision of pharmaceutical services by doctors

50

Outline consent and premises approval: applications by doctors

51

Notification of applications for outline consent and premises approval

52