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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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(i) with whom NHS England has made arrangements for the provision of any local pharmaceutical services in the area of HWB2, and

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

(c) any Local Healthwatch organisation for the area of HWB2, 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; and

(d) any provider of primary medical services, or any other person on the dispensing doctors list for the area of HWB2 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.

(4) A person (P) notified under paragraphs (1) to (3) may make representations in writing about the application that is the subject of the notification to NHS England, provided P does so within 45 days of the date on which notice of the application was given to them.

(5) If NHS England is considering, as a consequence of an application for outline consent or premises approval, making (including revising) a determination as to whether or not an area is or is not to be part of controlled locality, it must give notice under paragraph (1) at the same time that it gives notice under regulation 38(1).

(6) A person (P) notified under paragraphs (1) to (3)—

(a) must be informed of P's right to make representations under paragraph (4); and

(b) need not be given the same information as other persons notified under paragraphs (1) to (3) but, subject to sub-paragraphs (7) to (9), P must be provided with sufficient information, from the information supplied by the applicant, to enable P to make informed representations with regard to whether or not the application should be granted, having regard to P's interest in the matter.

(7) P need not be provided with any information that is published as part of the relevant pharmaceutical needs assessment.

(8) P must not be provided with any private addresses, private telephone numbers or dates of birth supplied by the applicant (A).

(9) If A advises NHS England that—

(a) information supplied by A is considered by A to be confidential to A; and

(b) A does not consent to the information being disclosed as part of the notification,

NHS England must withhold that information from P if it considers that the full disclosure principle does not require it to provide that information to P.

(10) The “full disclosure principle” is that information that is relevant to the determination of an application should be available to any individual who has a significant interest in the outcome of the application, unless it is fair and proper for that information to be withheld from that individual.

(11) If information is being withheld from P under paragraph (9), P must be informed of the nature of the information that is being withheld from P.

53

(1) Once NHS England has determined an application for outline consent or premises approval, as soon as is practicable, it must give notice of that decision to—

(a) the applicant; and

(b) any person notified by it under regulation 52(1) to (3) in relation to the application.

(2) Each notification under paragraph (1) must include a statement of the reasons for the decision and, if the person notified is a person with rights of appeal in relation to the decision under regulation 63(1)(c) or (d), an explanation of how those rights may be exercised.

(3) When outline consent is granted, subject to paragraphs (11) and (13)(b), NHS England must determine when the outline consent is to take effect.

(4) Subject to regulation 54, premises approval takes effect, if the application for it had a related outline consent application, when the related outline consent takes effect (but otherwise it does so in accordance with regulation 56).

(5) Outline consent takes effect on the day the proceedings relating to the grant of it have reached their final outcome, unless on the day before that day within 1.6 kilometres of the relevant practice premises there are premises which are the subject of an outstanding pharmacy application.

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

(a) which are the subject of a related premises approval application; or

(b) if there is no related premises approval application, that are the medical practice premises of the dispensing doctor from which the dispensing doctor wishes to dispense to patients in the area in relation to which outline consent is sought.

(7) In these Regulations, “outstanding pharmacy application” means—

(a) an application which has not yet reached its final outcome—

(i) for inclusion in a pharmaceutical list (not necessarily that of the relevant HWB), or

(ii) from a person included in a pharmaceutical list—

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

(bb) to open, within the area of that HWB, additional premises at or from which to provide pharmaceutical services,

where the applicant is seeking the listing of pharmacy premises other than distance selling premises; or

(b) circumstances where an application of the type mentioned in paragraph (a) has been granted, and—

(i) the provision of pharmaceutical services at or from the premises for which listing was sought has not yet commenced, and

(ii) the grant has not yet lapsed.

(8) In a case where outline consent is not to take effect on the date on which it is granted, NHS England must give the dispensing doctor to whom outline consent was granted (D) written details of—

(a) the outstanding pharmacy application; and

(b) the earliest date (referred to in this Part as the “provisional date”) on which an application can be made by D for a determination of when the outline consent is to come into effect.

(9) That provisional date, subject to paragraph (10), is the day after the end of the period of one year beginning on the day of—

(a) the determination by NHS England of D's application of outline consent; or

(b) where that determination is the subject of an appeal, the day on which the appeal reaches its final outcome.

(10) NHS England may at any time before the provisional date determine that the provisional date be changed to a later date, but only to a date which is not more than 3 months after the date originally determined in accordance with paragraph (8).

(11) Outline consent lapses if, before the provisional date, pharmaceutical services are provided at or from the pharmacy premises to which the outstanding pharmacy application relates.

(12) On or as soon as is reasonably practicable after the provisional date, NHS England must notify D that D may within 3 months of the provisional date request in writing that NHS England determine whether the outline consent is to come into effect.

(13) Where NHS England receives a request under paragraph (12), it must, as soon as is reasonably practicable determine—

(a) unless paragraph (b) applies, that the outline consent is to come into immediate effect; or

(b) that the outline consent has lapsed—

(i) where on the date of the determination (which must be a day from Monday to Friday, except Good Friday, Christmas Day or a bank holiday) primary medical services are not being provided at or from the relevant practice premises, or

(ii) by virtue of paragraph (11),

and it must inform D accordingly.

(14) NHS England must notify the applicant for outline consent of its determination under paragraph (10) or (13) and must include with the notification of its determination an explanation of—

(a) the reasons for the determination; and

(b) the applicant's rights of appeal in relation to it under regulation 63(1)(e).

54

(1) If outline consent has been granted but has not yet taken effect, before the provisional date the person or partnership (D) to whom it was granted may apply to NHS England to change the premises at or from which D wishes to dispense to other premises in the area of the relevant HWB.

(2) NHS England may agree to the change (and so, where appropriate, grant premises approval to the new premises) if it is satisfied that the relocation is of the type provided for in regulation 55(2).

(3) Where NHS England agrees to a change pursuant to paragraph (2), the premises approval takes effect when the related outline consent takes effect or, if later, on the date on which the change is agreed by NHS England.

(4) NHS England must notify its decision in relation to the application under paragraph (1) to the persons to whom it notified the application who made representations in relation to it under regulation 52(4), and it must include with the notification of its decision an explanation of—

(a) the reasons for the decision; and

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

55

(1) A dispensing doctor (D) who—

(a) is providing pharmaceutical services at or from listed dispensing premises; and

(b) wishes to relocate and dispense from new medical practice premises in relation to the area for which D has outline consent,

may apply in writing to NHS England for premises approval for the new medical practice premises at or from which D wishes to dispense.

(2) Subject to paragraph (3), NHS England must grant that application if it is of the type described in this paragraph, that is to say if NHS England is satisfied that—

(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) granting the application would not result 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 of local pharmaceutical services—

(i) in any part of the area of the relevant HWB, 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; and

(c) NHS England is satisfied that granting the application would not cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area of the relevant HWB.

(3) NHS England must, unless it has good cause not to do so, refuse an application under paragraph (1) if an application under—

(a) that paragraph;

(b) regulation 55(1) of the 2012 Regulations (premises approval: relocations of practice premises which are not significant after outline consent has taken effect); or

(c) regulation 65(4)(a) of the 2005 Regulations (premises approval: additional and new premises after outline consent has taken effect),

has been granted to D during the 12 months before the application was submitted under paragraph (1).

(4) NHS England must notify its decision in relation to the application under paragraph (1) to the persons to whom it notified the application who made representations in relation to it under regulation 52(4), and it must include with the notification of its decision an explanation of—

(a) the reasons for the decision; and

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

56

(1) Where—

(a) premises approval is granted in relation to additional medical practice premises, or in relation to medical practice premises to which a dispensing doctor (D) is relocating; and

(b) the application for premises approval had no related application for outline consent,

paragraph (2) applies.

(2) In the circumstances described in paragraph (1), the approval takes effect—

(a) on the date the determination of the application takes effect, and that date is—

(i) if no appeal is made against the decision within the period for bringing an appeal, the date on which that period expires, or

(ii) if the decision is appealed within that period, the date on which the appeal reaches its final outcome; or

(b) if on the day before that day within 1.6 kilometres of the relevant medical practice premises there are premises which are the subject of an outstanding pharmacy application, on the date which is—

(i) the day after the end of a period of one year from the date on which that outstanding pharmacy application reaches its final outcome, or

(ii) such longer period (not exceeding 3 months) as NHS England may for good cause allow before the expiry of that year.

(3) Premises approval to which paragraph (1) applies lapses if before the date on which it would otherwise take effect by virtue of paragraph (2), pharmaceutical services are provided at or from the pharmacy premises to which the outstanding pharmacy application relates.

Gradual introduction of premises approval

57

(1) Where a dispensing doctor (D) has outline consent but NHS England considers that the provision of pharmaceutical services by any NHS pharmacist, or of LP services by any LPS chemist, is likely to be adversely affected if D provides pharmaceutical services at or from medical practice premises which have been subject to a related application for premises approval (whether under regulation 51, 54 or 55), NHS England may by conditions—

(a) postpone the taking effect of the related premises approval for such period as it thinks fit; or

(b) limit the patients to whom D (or any successor to D) is able to provide pharmaceutical services at or from the medical practice premises in such manner, and for such periods, as it thinks fit.

(2) NHS England must decide whether or not to impose conditions under paragraph (1)—

(a) if there was a delay in the related outline consent taking effect because of an outstanding pharmacy application, when it determines that the outline consent is to come into effect; or

(b) in any other case, when it determines the application for premises approval.

(3) NHS England must notify any decision to impose, or not to impose, conditions under paragraph (1) to—

(a) D;

(b) any person with third party appeal rights in relation to the related application for premises approval;

(c) any Local Pharmaceutical Committee whose area includes the medical practice premises to which the decision relates; and

(d) any Local Medical Committee whose area includes the medical practice premises to which the decision relates.

(4) A notification under paragraph (3) 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)(f), an explanation of how those rights may be exercised.

Temporary provision in cases of relocations or additional premises where premises approval has not taken effect

58

(1) In the circumstances described in regulation 56(1), if the premises approval has not taken effect because of an outstanding pharmacy application which has not lapsed, NHS England may grant the applicant (D) temporary premises approval—

(a) if it considers it is desirable to do so in order to secure the adequate provision of pharmaceutical services in the area for which D has outline consent;

(b) for a period of not exceeding 12 months, but which may be renewed for a further period not exceeding 3 months (and if the first period granted is less than 12 months, it may be renewed more than once for up to a total aggregate period of 15 months).

(2) If NHS England grants temporary premises approval under paragraph (1), it must notify—

(a) D;

(b) the applicant who made the outstanding pharmacy application;

(c) any Local Pharmaceutical Committee whose area includes the medical practice premises for which temporary premises approval has been granted; and

(d) any Local Medical Committee whose area includes the medical practice premises for which temporary premises approval has been granted;

(3) A notification under paragraph (2) must include—

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

(b) a statement of the duration of the temporary premises approval and any circumstances in which it might be extended.

(4) If NHS England refuses an application to grant temporary premises approval under paragraph (1), NHS England must notify that decision to the applicant and include with that notification—

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

(b) an explanation of how D's rights of appeal under regulation 63(1)(c)(iii) may be exercised.

Practice amalgamations

59

(1) A “practice amalgamation” occurs where 2 or more patient lists are combined as a result of the coming together, as a single provider of primary medical services (SP), of 2 or more providers of primary medical services.

(2) If, following a practice amalgamation, the medical practice premises of SP are all premises that immediately prior to the amalgamation were listed dispensing premises, the premises approvals for those premises and the related outline consents become the premises approvals and outline consents of SP.

(3) If, following practice amalgamation, paragraph (2) does not apply but one or more of the providers of primary medical services coming together as SP had, immediately prior to amalgamation, listed dispensing premises—

(a) if any listed dispensing premises become medical practice premises of SP—

(i) the premises approvals for those premises, and the related outline consents, become approvals and consents of SP, and

(ii) any applications for premises approval in respect of other medical practice premises of SP are to be treated under this Part as applications for additional premises;

(b) if none of the listed dispensing premises become medical practice premises of SP—

(i) SP may nominate one of its medical practice premises as premises in respect of which it may apply for premises approval and have that application treated as a relocation from listed dispensing premises of a dispensing doctor who was part of the coming together to form SP, and

(ii) any applications for premises approval in respect of other medical practice premises of SP are to be treated under this Part as applications for additional premises.

(4) Where a practice amalgamation is proposed, a dispensing doctor who intends to be part of the practice amalgamation may make an application on the basis of paragraph (3)(b) in anticipation of circumstances that are expected to arise following the practice amalgamation, and if the dispensing doctor does so—

(a) any premises approval granted as a consequence becomes, when the practice amalgamates, a premises approval granted to SP; or

(b) if the proposed amalgamation does not take place, or if the dispensing doctor who makes the application does not become party to a practice amalgamation that does take place, any premises approval granted on the basis of that application lapses.

(5) If an application for premises approval arises because a practice amalgamation has taken or is due to take place, it must include the names of all the medical practitioners and any other providers of primary medical services who are participating in the amalgamation.

60

(1) Outline consent lapses (in addition to as mentioned in regulation 53(11) and (13)(b)) if—

(a) no arrangement has been made under regulation 48 with a patient pursuant to that outline consent within 6 months of the date on which it takes effect;

(b) 6 months have elapsed since any drug or appliance was dispensed under the arrangements made pursuant to that outline consent; or

(c) following a practice amalgamation, the amalgamated practice has no medical practice premises with premises approval and there are no outstanding applications to which regulation 59(3)(b) applies in respect of premises approval from the amalgamated practice.

(2) If an area, or part of an area, for which a dispensing doctor (D) has outline consent becomes a location in relation to which it is no longer possible for D to provide pharmaceutical services to patients on a patient list, D ceases to have outline consent in relation to that location.

(3) Premises approval lapses (in addition to as mentioned in regulation 56(3) and 59(4)(b)) if—

(a) the premises are no longer medical practice premises of a dispensing doctor with outline consent;

(b) 6 months have elapsed, or such longer period as NHS England may for good cause allow, since any drug or appliance was dispensed under the arrangements made pursuant to regulation 48 at or from those premises;

(c) the provider of primary medical services whose premises, or (if different) the dispensing doctor in relation to whom they are listed, notifies NHS England on whose dispensing doctors list the premises are listed that all the medical practitioners with authority to dispense at or from those premises have ceased to do so;

(d) the dispensing doctor in relation to whom the premises are listed in the dispensing doctors list is no longer listed in that list; or

(e) the related outline consent lapses.

(4) A right which continues in effect by virtue of regulation 48(3)(b)(i) is to be treated as outline consent for the purposes of paragraphs (1) and (3).

(5) For the purposes of—

(a) paragraph (1)(a), no account is to be taken of a period when D is unable to make arrangements to provide pharmaceutical services; or

(b) paragraph (1)(b) or (3)(b), no account is to be taken of a period when D is unable to provide pharmaceutical services,

because of a condition imposed by virtue of one of the provisions mentioned in paragraph (6).

(6) Those provisions are—

(a) regulation 57;

(b) regulation 57 of the 2012 Regulations (gradual introduction of premises approval); and

Temporary arrangements during emergencies or circumstances beyond the control of a dispensing doctor

61

(1) During an emergency requiring the flexible provision of pharmaceutical services, NHS England may require a dispensing doctor to provide pharmaceutical services (“temporary services”) to patients to whom the dispensing doctor is not otherwise entitled to provide pharmaceutical services—

(a) where, as a result of the temporary closure of pharmacy premises in the area of the relevant HWB, NHS England considers that, in order to secure continuing adequate provision of pharmaceutical services in that area during the emergency, it is necessary for it to require provision of those temporary services; and

(b) 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.

(2) NHS England must terminate arrangements to provide temporary services if the doctor notifies it that the doctor is unwilling to provide those services (and so wishes to revert to the doctor's overridden arrangements for the provision of pharmaceutical services).

(3) NHS England may grant temporary premises approval—

(a) in relation to additional premises that are not listed dispensing premises; or

(b) to premises to which a doctor wishes to relocate temporarily from listed dispensing premises,

because there is an emergency requiring the flexible provision of pharmaceutical services.

(4) In the circumstances described in paragraph (3)—

(a) the temporary premises approval must be 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 dispensing doctor may revert to the overridden premises approval before the end of the period specified by NHS England, on giving NHS England at least 24 hours notice.

(5) NHS England may grant temporary premises approval if there is a temporary suspension in the provision of dispensing services at or from listed dispensing premises (P1) for a reason (for example, fire or flooding) that is beyond the control of the dispensing doctor (D) listed in relation to P1.

(6) In the circumstances described in paragraph (5), NHS England may make a temporary amendment to the entry of D in the relevant dispensing list in order to allow D to provide the services that D 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.

(7) A period specified under paragraph (6) 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 D starts to provide the services in question from P2); or

(b) curtail the period specified,

in appropriate circumstances.

(8) For the period specified under paragraph (6), but subject to paragraph (9) and regulation 118, P2 instead of P1 are to be treated as listed in relation to D for the purposes of these Regulations (albeit that the premises actually listed in relation to D are P1).

(9) D may revert to the overridden premises approval before the end of the period specified under paragraph (6), on giving NHS England at least 24 hours notice.

(10) Planned refurbishment is not a “reason beyond the control” of D for the purposes of paragraph (5).

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

(12) If NHS England grants an application for temporary premises approval under this regulation, it must notify that decision to the persons who would have been notified about the application had the application been an application to which regulation 55 applies.

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(1) No person is to take part in determining any application for outline consent (including determining when it is to come into effect), premises approval or temporary premises approval, or in taking decisions under regulation 50, 53 or 57, who—

(a) is a person who is included in a pharmaceutical list or is an employee of such a person;

(b) assists in the provision of pharmaceutical services under Chapter 1 of Part 7 of the 2006 Act (pharmaceutical services and local pharmaceutical services – provision of pharmaceutical services);

(d) is a provider of primary medical services;

(e) is a member of a provider of primary medical services that is a partnership or a shareholder in a provider of primary medical services that is a company limited by shares;

(f) is employed or engaged by a primary medical services provider; or

(g) is employed or engaged by an APMS contractor in any capacity relating to the provision of primary medical services,

whether or not their involvement would give rise to a reasonable suspicion of bias.

(2) No other person is to take part in determining any application, or taking any decision, referred to in paragraph (1) if because of an interest or association they have, or because of a pressure to which they may be subject, their involvement would give rise to a reasonable suspicion of bias.

Appeals against decisions under Part 8

63

(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 decision under regulation 48(5)(b) to require a dispensing doctor to undertake to provide pharmaceutical services, in respect of which the only person with appeal rights is the dispensing doctor;

(b) a decision under regulation 50 requiring the termination of arrangements to provide pharmaceutical services, subject to any postponement of the discontinuation, in respect of which the only people with appeal rights are—

(i) the dispensing doctor who is being required to terminate arrangements, subject to any postponement of the discontinuation, and

(ii) 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 by NHS England;

(i) outline consent under regulation 51,

(ii) premises approval under regulation 51, 54 or 55, or

(iii) temporary premises approval under regulation 58,

in respect of which the only person with appeal rights is the applicant;

(d) a decision to grant an application for—

(i) outline consent under regulation 51, or

(ii) premises approval under regulation 51, 54 or 55,

in respect of which the only person with appeal rights is a person who has third party appeal rights;

(e) a determination of—

(i) a change to a provisional date under regulation 53(10), or

(ii) whether outline consent is to come into effect under regulation 53(13),

in respect of which the only person with appeal rights is the person to whom the relevant outline consent was granted; and

(f) a decision to impose, or a failure to impose, conditions under regulation 57, in respect of which the only people with appeal rights are—

(i) the dispensing doctor, and

(ii) an NHS pharmacist or LPS chemist who has third party appeal rights in relation to the related application for premises approval,

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

(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) For the purposes of paragraph (1)(d) or (f), a person (P1) has third party appeal rights if—

(a) P1 was a person whom NHS England was required to notify about the relevant application for outline consent or premises approval by virtue of P1 being—

(i) included in a pharmaceutical list,

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

(iii) an LPS chemist with whom NHS England has made arrangements for the provision of any local pharmaceutical services, or

(iv) (except in relation to paragraph (1)(f)), a 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),

and a person whose interests might, in the opinion of NHS England, be significantly affected by the decision;

(b) P1 made representations in writing about the application under regulation 52(4); and

(c) subject to sub-paragraph (5), NHS England is satisfied, having regard to those representations in writing and any oral representations made at any oral hearing, that P1—

(i) made a reasonable attempt to express P1's grounds for opposing the application adequately in P1's representations, and

(ii) has grounds for opposing the application, which—

(aa) do not amount to a challenge to the legality or reasonableness of the relevant pharmaceutical needs assessment, or to the fairness of the process by which that assessment was undertaken, and

(bb) are not vexatious or frivolous.

(4) If NHS England considers that a person notified under regulation 52(1) to (3) is a person with third party appeal rights, it must notify that person of that fact when it notifies that person of a decision (D1) in respect of which that person may be able to exercise those rights.

(5) A person to whom paragraph (3)(a) and (b) applies (P2) who is not notified by NHS England that they are person with third party appeal rights may appeal to the Secretary of State against the determination (D2) by NHS England that it is not satisfied as mentioned in sub-paragraph (3)(c), provided that P2—

(a) notifies the Secretary of State within 30 days of the date on which that person was notified of NHS England’s decision that P2 wishes to appeal against both D1 and D2; and

(b) includes within that notification concise and reasoned statements of P2's grounds of appeal against both D1 and D2,

and if the appeal against D2 is successful, P2 is a person with third party appeal rights in relation to D1 for the purposes of this regulation.

(6) 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, 7, 10 and 12 and Schedule 2).

PART 9 — Conditional inclusion in pharmaceutical lists: certain specific conditions that do not relate to fitness or performance

Distance selling premises: specific conditions

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(1) Paragraph (2) applies where—

(a) an application in respect of distance selling premises is granted under these Regulations; or

(b) an application was granted under the 2005 Regulations or 2012 Regulations in respect of premises which were, for the purposes of the Regulations under which the application was granted, distance selling premises.

(2) The inclusion in the pharmaceutical list of the person (X) listed in relation to—

(a) those distance selling premises; or

(b) if there has been a relocation of the retail pharmacy business or appliance contractor business at those distance selling premises to other premises, those other premises,

is subject to the conditions set out in paragraph (3).

(3) Those conditions are—

(a) X must not offer to provide pharmaceutical services ... to persons who are present at (which includes in the vicinity of) the listed chemist premises;

(b) the means by which X provides pharmaceutical services ... must be such that any person receiving those services does so otherwise than at the listed chemist premises;

(c) the listed chemist premises must not be on the same site or in the same building as the premises of a provider of primary medical services with a patient list;

(d) in the case of pharmacy premises, the pharmacy procedures for the premises must be such as 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 X or X's staff; and

(e) nothing ... in X's publicity material in respect of the listed chemist premises, in material published on behalf of X publicising services provided at or from the listed chemist premises or in any communication (written or oral) from X or X's staff to any person seeking the provision of essential services from X must represent, either expressly or impliedly, that—

(i) the essential services provided at or from the premises are only available to persons in particular areas of England, or

(ii) X is likely to refuse, for reasons other than those provided for in X's terms of service, to provide drugs or appliances ordered on prescription forms or repeatable prescription forms which are presented by particular categories of patients (for example, because the availability of essential services from X is limited to other categories of patients).

(3A) Notwithstanding the amendments to paragraph (3) which come into force on 1st October 2025, until the end of 31st March 2026 paragraph (3) remains in force as it had effect before those amendments were made, but only in so far as is necessary to give effect to paragraph (3B).

(3B) At distance selling premises listed in relation to X before 1st October 2025, X may until the end of 31st March 2026 provide directed services that consist of the supply or administration of a prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (but no other directed services).

(4) NHS England may not vary or remove the conditions set out in paragraph (3).

Core opening hours conditions

65

(1) If an application to which regulation 13(1)(b) of the 2005 Regulations (exemption from the necessary or expedient test) applied was granted, the inclusion in the pharmaceutical list of the person listed in relation to—

(a) the premises that were listed as a consequence of that application; or

(b) if there has been a relocation of the retail pharmacy business or appliance contractor business at those premises to other premises, those other premises,

is subject to the condition set out in paragraph (2) (“the 100 hours condition”).

(2) The condition is that the premises must be kept open for at least 100 hours per week for the provision of pharmaceutical services.

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

(3A) NHS England may remove a 100 hours condition in respect of premises of an NHS pharmacist and replace it with a direction under paragraph (4) or (5) or paragraph 25 or 26 of Schedule 4, but that direction, and any subsequent direction which replaces that direction (whether it is in respect of those premises or any premises to which that NHS pharmacist, or any NHS pharmacist that is in succession to that NHS pharmacist, relocates), must specify a total number of core opening hours of not less than 72.

(4) Where, in the course of making a routine application or an excepted application to which regulation 24 or 26(2) applies—

(a) for inclusion in a pharmaceutical list as mentioned in regulation 10(2)(a), or from a person already included in such a list to relocate to different pharmacy premises or to open, within the area of the relevant HWB, additional pharmacy premises—

(i) an NHS pharmacist undertook to provide pharmaceutical services at or from the proposed pharmacy premises for a specified number of core opening hours each week which is more than 40 ...,

(ii) the NHS pharmacist and NHS England agreed , or the NHS pharmacist undertook, that pharmaceutical services are to be provided at or from the proposed pharmacy premises during any additional opening hours specified , or any core hours specified that replace (at any distance in succession) a 100 hours condition, at set times and on set days, and

(iii) the application was granted having regard to any such undertaking or agreement,

when it includes the premises in a pharmaceutical list, NHS England must direct that the person listed in relation to the premises is to provide pharmaceutical services at or from those premises for the specified number of core opening hours so undertaken, and ... at the set times and on the set days so agreed or undertaken; or

(b) for inclusion in a pharmaceutical list as mentioned in regulation 10(2)(b), or from a person already included in such a list to relocate to different appliance contractor premises or to open, within the area of the relevant HWB, additional appliance contractor premises—

(i) an NHS appliance contractor undertook to provide pharmaceutical services at or from proposed appliance contractor premises for a specified number of core opening hours each week which is more than 30 (other than as a consequence of a 100 hours condition),

(ii) the NHS appliance contractor and NHS England agreed that pharmaceutical services are to be provided at or from the appliance contractor premises during the additional opening hours specified (that is, the hours which are the difference between the total number of hours specified and 30) at set times and on set days, and

(iii) the application was granted having regard to that undertaking and that agreement,

when it includes the premises in a pharmaceutical list, NHS England must direct that the person listed in relation to the premises is to provide pharmaceutical services at or from those premises for the specified number of core opening hours so undertaken, and during the additional opening hours at the set times and on the set days so agreed.

(5) Where NHS England has—

(a) invited an NHS chemist to increase the total number of core opening hours during which the NHS chemist is to provide pharmaceutical services at or from listed chemist premises; and

(b) thereafter agreed with the NHS chemist—

(i) an increased number of core opening hours, and

(ii) if the NHS chemist—

(aa) is an NHS pharmacist, that pharmaceutical services are to be provided at or from the pharmacy premises during any additional opening hours , or any core hours specified that replace (at any distance in succession) a 100 hours condition, at set times and on set days, and

(bb) is an NHS appliance contractor, that pharmaceutical services are to be provided at or from the appliance contractor premises during any additional opening hours (that is, the hours which are the difference between the total number of hours specified and 30) at set times and on set days,

NHS England must direct that the person listed in relation to the premises is to provide pharmaceutical services at or from those premises for the specified number of core opening hours so undertaken, and ... at the set times and on the set days so agreed or undertaken.

(6) Except as provided for under paragraph (5) and subject to paragraph (7), NHS England may only vary a direction given under paragraph (4) or (5), or regulation 65(4) or (5) of the 2012 Regulations (core opening hours conditions), in accordance with paragraph 25 or 26 of Schedule 4 or paragraph 15 or 16 of Schedule 5.

(7) A direction given under paragraph (4) or (5), or regulation 65(4) or (5) of the 2012 Regulations, must not be varied within 3 years of the direction being given.

Conditions relating to providing directed services

66

(1) Where, immediately before these Regulations came into force, the inclusion in the pharmaceutical list of an NHS chemist (C1) was subject to a condition imposed in relation to listed chemist premises by virtue of regulation 13(3)(b) of the 2005 Regulations (exemption from the necessary or expedient test), including such a condition as varied in accordance with regulation 14 of the 2005 Regulations (variation of directed services in respect of exempted premises) or regulation 66(2) and (3) of the 2012 Regulations (conditions relating to providing directed services), it is a condition of the inclusion in the pharmaceutical list of the person listed in relation to those premises—

(a) if, before these Regulations came into force, C1 had not been requested by a Primary Care Trust to provide the directed services specified as regards C1 for the purposes of that condition, that they must provide those directed services at or from those premises, where requested to do so by NHS England unless thereafter NHS England ceases to commission those services; or

(b) if, before these Regulations came into force, C1 was providing, or had been requested by a Primary Care Trust to provide, the directed services specified as regards C1 for purposes of that condition, that they must provide those directed services at or from those premises unless NHS England does not continue to commission those services.

(2) The person listed in relation to the premises may apply to NHS England to vary the directed services specified for the purposes of the condition imposed by virtue of paragraph (1), or to remove the condition, but only if at least 3 years have elapsed—

(a) since the condition was imposed by virtue of the 2005 Regulations; and

(b) during that period neither a Primary Care Trust nor NHS England has requested that the services be provided at or from the premises in respect of which the condition was imposed,

but otherwise NHS England may not vary or remove the condition imposed by virtue of paragraph (1).

(3) If, pursuant to an application under paragraph (2), NHS England does vary the directed services specified for the purposes of the condition imposed by virtue of paragraph (1) in respect of any premises, it is a condition of the inclusion in the pharmaceutical list of the person listed in relation to those premises that they must—

(a) provide the directed services specified as regards C1 as a consequence of the application—

(i) if NHS England commissions the services within 3 years of the date on which the condition is imposed by virtue of these Regulations, and

(ii) unless thereafter NHS England ceases to commission the services; and

(b) not withhold agreement to a service specification for those services unreasonably.

(4) Where, in the course of making a routine or excepted application under these Regulations or the 2012 Regulations, an NHS chemist undertook—

(a) to provide the directed services mentioned in the application, if a Primary Care Trust or NHS England commissioned the services within 3 years of the date of either the grant of the application or, if later, the listing in relation to the applicant of the premises to which the application relates;

(b) if the directed services were commissioned, to provide the services in accordance with an agreed service specification; and

the inclusion in the pharmaceutical list of the person (C2) listed in relation to the premises that were listed as a consequence of that application is subject to the condition set out in paragraph (5).

(5) The condition is that, at or from those premises, C2 must—

(a) provide the directed services mentioned in the application (whether or not C2 was the applicant); and

(b) not withhold agreement to a service specification for those services unreasonably,

if the Primary Care Trust or NHS England commissions the services from C2 within 3 years of the date of either the grant of the application or, if later, the listing in relation to the applicant of the premises to which the application relates, unless thereafter NHS England ceases to commission the services (if it has commissioned them) or does not continue to commission services (that is, if only the Primary Care Trust, and not NHS England, has commissioned them).

(6) Where a Primary Care Trust or NHS England specifies that a requirement to provide directed services arising out of a condition imposed by virtue of this regulation is to take effect by a specified date, the requirement takes effect—

(a) on that date; or

(b) on the date on which provision of the directed service is commenced,

whichever is the sooner.

(7) NHS England may not vary or remove the condition imposed by virtue of paragraphs (3) to (5).

Conditions relating to voluntary closure of premises

67

(1) Except in the circumstances described in paragraph (3) or (5), where an NHS chemist (C) wishes, other than as a consequence of a change of ownership application or a consolidation application—

(a) to withdraw from a pharmaceutical list, or

(b) for particular listed chemist premises no longer to be listed in relation to C,

C must comply with paragraph (2).

(2) C must notify NHS England of C's wish—

(a) unless sub-paragraph (b) applies, at least 3 months in advance of the date on which pharmaceutical services are no longer to be provided;

(b) at least—

(i) 6 months in advance of that date, in the case of premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, or

(ii) 30 days in advance of that date, if—

(aa) a condition is imposed under regulation 35,

(bb) C appeals that condition to the First-tier Tribunal,

(cc) on appeal, the First-tier Tribunal confirms the imposition of that condition or imposes another condition, and

(dd) within 30 days of being informed of the decision of the First-tier Tribunal, C notifies NHS England that C wishes to withdraw from the pharmaceutical list within a shorter period of not less than 30 days,

unless either it is impracticable for C to do so, in which case C must notify NHS England as soon as it is practicable for C to do so, or NHS England agrees to a shorter notification period.

(3) If C has consented to—

(a) particular listed chemist premises no longer being listed in relation to C by NHS England; or

(b) being removed from the pharmaceutical list for the area of a HWB,

in the context of a relocation application, which is not part of a consolidation application, paragraph (4) applies.

(4) In the circumstances described in paragraph (3), C must, where the relocation application is granted, when C gives notice to NHS England of C's intention to commence the provision of pharmaceutical services at or from the new premises (in accordance with paragraph 34 of Schedule 2), give notice to NHS England of when, before C commences the provision of pharmaceutical services at or from the new premises, C is to cease to provide pharmaceutical services at or from the existing premises.

(5) If C has consented to—

(a) particular listed chemist premises no longer being listed by NHS England; or

(b) being removed from a pharmaceutical list for the area of a HWB,

in the context of a consolidation application, paragraph (6) applies.

(6) In the circumstances described in paragraph (5), in the context of an application—

(a) to which regulation 26A(3) applies, if it is granted—

(i) C who is the person listed in relation to S2 for the purposes of regulation 26A(3)(b) must give notice of C’s intention to cease the provision of pharmaceutical services at the same time as C who is P1 for the purposes of regulation 26A(3) issues a notice in accordance with paragraph 34A of Schedule 2; but

(ii) C who is P1 for the purposes of regulation 26A(3) need not issue a notice under this regulation;

(b) to which regulation 26A(4) applies, if it is granted—

(i) C who is the person listed in relation to S1 for the purposes of regulation 26A(4) must give notice of C’s intention to cease the provision of pharmaceutical services at the same time as C who is P2 for the purposes of regulation 26A(4) issues a notice in accordance with paragraph 34A of Schedule 2; but

(ii) C who is P2 for the purposes of regulation 26A(4) need not issue a notice under this regulation.

Conditions relating to local resolution of disputes over terms of service

68

(1) It is a condition of the inclusion of each NHS chemist (C) in a pharmaceutical list by NHS England that C makes every reasonable effort to communicate and co-operate with NHS England with a view to resolving any dispute between C and NHS England relating to C's compliance with the terms of service under which C provides pharmaceutical services for NHS England.

(2) NHS England may not vary or remove the condition imposed by virtue of paragraph (1).

Local dispute resolution before serving remedial notices or breach notices

69

(1) Subject to paragraph (3), before issuing a notice under regulation 70 or 71, NHS England must make every reasonable effort to communicate and co-operate with an NHS chemist (C) with a view to resolving any dispute between C and NHS England relating to C's compliance with C's terms of service.

(2) Where an NHS pharmacist invites a Local Pharmaceutical Committee to participate in the attempts to resolve the dispute, NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the dispute.

(3) Paragraphs (1) and (2) do not apply where NHS England is satisfied—

(a) the dispute relates to a matter that has already been the subject of dispute resolution between NHS England (or a Primary Care Trust) and C and there are no new issues of substance that justify delay in issuing a notice under regulation 70 or 71; or

(b) that it is appropriate to proceed immediately to issuing a notice under regulation 70 or 71—

(i) because listed chemist premises are not, or have not been, open during core opening hours or supplementary opening hours without good cause, NHS England having made reasonable efforts to communicate with C with a view to establishing what the cause was,

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

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

Breaches of terms of service: remedial notices

70

(1) Where an NHS chemist (C) breaches a term of service and the breach is capable of remedy, NHS England may by a notice (“a remedial notice”) require C to remedy the breach.

(2) To be valid, the remedial notice must include—

(a) the nature of the breach;

(b) the steps C must take, to the satisfaction of NHS England, in order to remedy the breach;

(d) an explanation of how C's rights of appeal under regulation 77(1)(a) may be exercised.

(3) The notice period must be not less than 30 days, unless NHS England is satisfied that a shorter period is appropriate—

(a) to protect the safety of any persons to whom C may provide pharmaceutical services; or

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

(4) If the breach relates to a failure to provide, or a failure to provide to a reasonable standard, a service that C is required to provide, the remedial notice may provide that—

(a) as regards the period during which there was a failure to provide, or a failure to provide to a reasonable standard, that service, NHS England is to withhold all or part of the remuneration due to C in respect of that period under the Drug Tariff or a determination as mentioned in regulation 91(6);

(b) pending C taking the steps that C must take, to the satisfaction of NHS England, in order to remedy the breach, NHS England is to withhold all or part of the remuneration due to C under the Drug Tariff or a determination as mentioned in regulation 91(6), and in these circumstances—

(i) as regards any period for which C remains in breach, any withholding that is attributable to that period is to be permanent, and

(ii) once C has taken the steps that C must take, to the satisfaction of NHS England, any withholding that has taken place which is attributable to a period when C is no longer in breach is to be restored to C, provided that C submits a claim, in accordance with the Drug Tariff or a determination as mentioned in regulation 91(6), for restoration of the withheld remuneration attributable to that period.

(5) The remedial notice may only provide for the withholding of all or part of the remuneration payable under a determination as mentioned in regulation 91(6) where the breach relates to a failure to provide, or a failure to provide to a reasonable standard, an enhanced service.

(6) The period referred to in paragraph (4)(b)(i) may be a longer period than the notice period.

(7) If NHS England refuses to restore all or part of any withheld remuneration which is claimed under paragraph (4)(b)(ii), it must notify C of that decision as soon as is practicable, and that notification must include—

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

(b) an explanation of how C's rights of appeal under regulation 77(1)(b) may be exercised.

(8) NHS England may rescind a remedial notice at any time.

Breaches of terms of service: breach notices

71

(1) Where an NHS chemist (C) breaches a term of service and the breach is not capable of remedy, NHS England may by a notice (“a breach notice”) require C not to repeat the breach.

(2) To be valid, the breach notice must include—

(a) the nature of the breach; and

(b) an explanation of how C's rights of appeal under regulation 77(1)(c) may be exercised.

(3) If the breach relates to a failure to provide, or a failure to provide to a reasonable standard, a service that C is required to provide, the breach notice may provide that, as regards the period during which there was a failure to provide, or a failure to provide to a reasonable standard, that service, NHS England is to withhold all or part of the remuneration due to C under the Drug Tariff or a determination as mentioned in regulation 91(6) in respect of that period.

(4) The breach notice may only provide for the withholding of all or part of the remuneration payable under a determination as mentioned in regulation 91(6) where the breach relates to a failure to provide, or a failure to provide to a reasonable standard, an enhanced service.

(5) NHS England may rescind a breach notice at any time.

Payment withholdings: supplementary matters

72

(1) A remedial notice or breach notice may only provide for the withholding of all or any part of the remuneration of an NHS chemist (C) if—

(a) NHS England is satisfied that the breach to which the withholding relates is, or was, without good cause;

(b) the amount withheld is justifiable and proportionate, having regard to the nature and seriousness of the breach and the reasons for it;

(c) NHS England includes in the notice its duly justified reasons for both the decision to withhold remuneration and the amounts that are, and (where applicable) are to be, withheld.

(2) NHS England need not take into account the reasons for the breach, pursuant to paragraph (1)(b), if it has made every reasonable effort to communicate with C to discover the reasons but it has been unable to discover them.

(3) Withholdings of payments provided for in remedial notices and breach notices are without prejudice to the arrangements in place for recovering overpayments under regulation 94 and the Drug Tariff.

(4) For the purposes of regulations 70(4) and 71(3), remuneration determined by the Secretary of State, or by NHS England acting as determining authority pursuant to regulation 91(1), is remuneration due to C under the Drug Tariff.

Removal of listings: cases relating to remedial notices and breach notices

73

(1) NHS England may remove an NHS chemist (C) from a pharmaceutical list, or remove the listing of particular listed chemist premises in relation to C, if C—

(a) fails to take the steps set out in a remedial notice that C must take, to the satisfaction of NHS England, in order to remedy the breach, and NHS England is satisfied that it is necessary to remove C from the pharmaceutical list, or remove the listing of particular listed chemist premises in relation to C—

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

(ii) to protect NHS England from material financial loss; or

(b) has breached C's terms of service, and—

(i) C has repeatedly been issued with remedial notices or breach notices (or both) in relation to the relevant term of service,

(ii) previously been issued with a remedial notice or breach notice in relation to the relevant term of service, and NHS England is satisfied that C is likely to persist in breaching the term of service without good cause, or

(iii) C has repeatedly been issued with remedial notices or breach notices (or both) in relation to different terms of service, and NHS England is satisfied that C is likely to persist in breaching C's terms of service without good cause.

(2) For the purpose of paragraph (1), NHS England may only remove—

(a) particular chemist premises from C's listing in a pharmaceutical list if the relevant breaches all relate to those particular chemist premises; or

(b) C from a particular pharmaceutical list if the relevant breaches all relate to listed chemist premises which are the only chemist premises listed in that pharmaceutical list in relation to C.

(3) NHS England may only remove C, or chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1) if—

(a) the removal is justifiable and proportionate, having regard to the nature and seriousness of the breaches (or likely breaches) and the reasons for them; and

(b) NHS England, when it notifies C of the decision, includes in the notice its duly justified reasons for the decision.

(4) NHS England need not take into account the reasons for the breaches (or likely breaches), pursuant to paragraph (3)(a), if it has made every reasonable effort to communicate with C to discover the reasons but has been unable to discover them.

(5) NHS England must not remove C, or chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1) because—

(a) C has simply ceased to provide pharmaceutical services at or from particular listed chemist premises (regulation 74 applies in those circumstances); or

(b) of failure to provide, or to provide to a reasonable standard, a directed service, unless C is required to provide that service pursuant to a condition imposed by virtue of regulation 66(1) or (3) to (5) (and the removal is justifiable and proportionate etc.).

(6) Where NHS England is considering removing C, or removing the listing of particular chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1), it must—

(a) give notice to C, at least 30 days in advance of taking the decision, that NHS England is minded to remove C or the premises from a pharmaceutical list;

(b) as part of that notification, advise C that C may make—

(i) written representations to NHS England with regard to that action, provided C notifies NHS England with those representations within 30 days beginning with the date of the notification by NHS England, and

(ii) oral representations to NHS England with regard to that action, provided—

(aa) C notifies NHS England of C's wish to do so within 30 days beginning with the date of the notification by NHS England, and

(bb) C (or a representative of C) attends the hearing that NHS England arranges for the purpose of hearing those representations, which NHS England must give C reasonable notice of; and

(c) consult any Local Pharmaceutical Committee whose area includes the particular listed chemist premises or C's only chemist premises on that pharmaceutical list.

(7) If NHS England does decide to remove C, or to remove the listing of particular chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1), it must, when it notifies C of that decision, include in that notification—

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

(b) an explanation of how C's rights of appeal under regulation 77(1)(d) may be exercised.

Removal of listings: cases relating to death, incapacity or cessation of service

74

(1) Subject to paragraphs (2) and (4), if an NHS chemist (C)—

(a) dies;

(b) in the case of an NHS pharmacist, ceases to carry on a retail pharmacy business; or

(c) in the case of an NHS appliance contractor, ceases to carry on a business in the course of which C supplies appliances either by retail sale or in circumstances corresponding to retail sale,

NHS England must remove C from the relevant pharmaceutical lists.

(2) Paragraph (1)(a) or (b) shall not apply in the case of an NHS pharmacist, if—

(a) a representative of C (as defined in section 72 of the 1968 Act (representative of pharmacist in case of death or disability)) is carrying on the retail pharmacy business of C that is included in the relevant pharmaceutical list (“the business”);

(b) the conditions specified in section 72(2) of the 1968 Act are fulfilled in relation to the representative and the business;

(d) the representative has agreed to be bound by, and continues to agree to be bound by, C's terms of service.

(3) If NHS England determines that C has not, during the preceding 6 months, provided pharmaceutical services at or from chemist premises (“the particular premises”) listed in a particular pharmaceutical list—

(a) if there are other chemist premises listed in that pharmaceutical list in relation to C, NHS England must remove the listing of the particular premises from that list; or

(b) if there are no other chemist premises listed in that pharmaceutical list in relation to C, NHS England must remove C from that list.

(4) When determining, for the purposes of paragraph (1) or (3), whether C has ceased to carry on a business or ceased to provide pharmaceutical services, no account is to be taken of any time spent by C—

(a) suspended from a relevant pharmaceutical list;

(b) in whole-time service in the armed forces of the Crown in a national emergency;

(c) in compulsory whole-time service in the armed forces of the Crown (including service resulting from reserve liability); or

(d) where C is liable for compulsory whole-time service in the armed forces of the Crown, in any equivalent service,

and in a case of C ceasing to carry on a business, no account is to be taken of the first 6 months after C completes that whole-time service in the armed forces of the Crown or equivalent service.

(5) Before taking a decision to remove C, or chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1) or (3), NHS England must—

(a) give notice to C (or, in appropriate circumstances, a person whom NHS England reasonably believes is representing C or is an executor of C) of the decision that NHS England is minded to take;

(b) as part of that notification, advise C (or the representative or executor) that they may make—

(i) written representations to NHS England with regard to that action, provided they notify NHS England with those representations within 30 days beginning with the date of the notification by NHS England, and

(ii) oral representations to NHS England with regard to that action, provided—

(aa) they notify NHS England of their wish to do so within 30 days beginning with the date of the notification by NHS England, and

(bb) C (or the representative or executor, or someone representing the representative or executor) attends the hearing that NHS England arranges for the purpose of hearing those representations, which NHS England must give C reasonable notice of; and

(c) consult any Local Pharmaceutical Committee whose area includes the chemist premises that NHS England is minded to remove from the pharmaceutical list.

(6) If NHS England does decide to remove C, or chemist premises listed in relation to C, from a pharmaceutical list under paragraph (1) or (3), it must, when it notifies C of that decision, include in that notification—

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

(b) an explanation of how C's rights of appeal under regulation 77(1)(d) may be exercised.

Voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure

75

(1) If, as a consequence of a change of ownership application or a consolidation application, an NHS chemist (C) is no longer to be the person listed in a pharmaceutical list in relation to particular pharmacy premises—

(a) if there are other chemist premises listed in that pharmaceutical list in relation to C, NHS England must remove the listing of the particular premises in relation to C from that list; or

(b) if there are no other chemist premises listed in that pharmaceutical list in relation to C, subject to regulation 76, NHS England must remove C from that pharmaceutical list.

(2) If C is relocating from existing chemist premises listed in a particular pharmaceutical list to new chemist premises other than as a consequence of a consolidation application—

(a) if—

(i) there are other chemist premises listed in that pharmaceutical list in relation to C, or

(ii) there are no other chemist premises so listed, but the existing chemist premises and the new chemist premises are in the area of the same HWB,

NHS England must remove the listing of the existing premises in relation to C from that pharmaceutical list with effect from the date that C is required to notify to NHS England under regulation 67(4); or

(b) if—

(i) there are no other premises listed in that pharmaceutical list in relation to C, and

(ii) the new chemist premises are in the area of another HWB,

subject to regulation 76, NHS England must remove C from that pharmaceutical list with effect from the date that C is required to notify to NHS England under regulation 67(4).

(3) If C has been providing pharmaceutical services on behalf of a suspended NHS chemist at or from chemist premises listed in a particular pharmaceutical list (“the temporary provision premises”), once the fixed period referred to in regulation 27(3) expires, if—

(a) other chemist premises are listed by NHS England in that pharmaceutical list in relation to C, NHS England must remove the listing of the temporary provision premises in relation to C; or

(b) apart from the temporary provision premises, there are no other chemist premises listed by NHS England in that pharmaceutical list in relation to C, NHS England must remove C from that pharmaceutical list.

(4) Paragraph (5) applies if C—

(a) wishes, other than as provided for in paragraphs (1) to (3), to close particular listed chemist premises and so—

(i) to withdraw from a pharmaceutical list, or

(ii) for particular listed chemist premises no longer to be listed in relation to C; and

(b) has complied with regulation 67(2).

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

(a) if there are other chemist premises listed in the relevant pharmaceutical list in relation to C, NHS England must remove the listing of the particular premises in relation to C from that list; or

(b) if there are no other chemist premises listed in the relevant pharmaceutical list in relation to C, subject to regulation 76, NHS England must remove C from that list.

(6) If NHS England decides not to remove C from a pharmaceutical list under paragraph (5), it must, when it notifies C of that decision, include in that notification—

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

(b) where appropriate, an explanation of how any rights of appeal that C has under regulation 77(1)(e) may be exercised.

Limitation on withdrawal from pharmaceutical lists while fitness investigations or proceedings are ongoing

76

(1) If NHS England would otherwise remove an NHS chemist (C) from a pharmaceutical list under regulation 75, but—

(a) is investigating C in order to see whether there are grounds for exercising its powers in relation to C under section 151, 152 or 154 of the 2006 Act (which relate to disqualification of practitioners, contingent removal and suspension), or regulation 80;

(b) has decided to—

(i) remove C from a pharmaceutical list under section 151 or 152 of the 2006 Act or regulation 80, or

(ii) contingently remove C under section 152 of the 2006 Act,

but C has not yet been removed or contingently removed; or

it must not, without the consent of the Secretary of State, remove C from that pharmaceutical list under regulation 75 until the relevant investigation or proceedings have been concluded.

(2) If C's name is kept on a pharmaceutical list pursuant to paragraph (1)—

(a) as regards C, NHS England may exercise its functions under—

(i) Part 11 of these Regulations, and

(ii) Chapter 6 of Part 7 of the 2006 Act (pharmaceutical services and local pharmaceutical services – disqualification); but

(b) for all other purposes, C is to be treated as having been removed from that pharmaceutical list under regulation 75.

Appeals against decisions under Part 10

77

(1) An NHS chemist (C) may appeal against the following decisions by NHS England—

(a) the issuing of a remedial notice under regulation 70, including—

(i) the specified steps that C must take that are in the notice,

(ii) the duration of the notice period in the notice,

(iii) any decision to provide for a withholding of remuneration that is included in the notice, and

(iv) the amount of any withholding;

(b) a decision not to restore remuneration to C, as provided for in a remedial notice in accordance with regulation 70(4)(b)(ii), or to restore a smaller amount than the amount that C considers should be restored;

(i) any decision to provide for a withholding of remuneration that is included in the notice, and

(ii) the amount of any withholding;

(d) a decision to remove C from a pharmaceutical list, or remove the listing of particular listed chemist premises in relation to C, under regulation 73(1) or 74(1) or (3);

(e) a refusal to remove C from a pharmaceutical list under regulation 75(5), other than a decision to keep C on the pharmaceutical list for limited purposes pursuant to regulation 76,

provided that C notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which C was notified of the decision that is being appealed.

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

(3) NHS England must not remove C or the listing of particular listed chemist premises in relation to C (as the case may be) from a pharmaceutical list under regulation 73(1) or 74(1) or (3)—

(a) if no appeal is brought against the decision to remove, until the period for bringing the appeal has elapsed; or

(b) if an appeal is brought against the decision to remove but it is unsuccessful, before the appeal is determined by the Secretary of State.

(4) 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, 7, 8 and 12 and Schedule 2).

PART 11 — Enforcement, reviews and appeals relating to fitness matters

Extended meaning of “health scheme” in fraud cases

78

The schemes prescribed under section 151(7)(b) of the 2006 Act (disqualification of practitioners) are schemes in the course of which health or medical services are paid for out of public funds and provided—

(a) other than as part of the health services referred to in section 151(7)(a)—

(i) by port health authorities,

(ii) by the armed forces of the Crown, or

(iii) to persons in accommodation in which they are required in accordance with law to be detained (but not naval, military and air force prisons, which are covered by sub-paragraph (ii)); or

(b) by or on behalf of the government of a country or territory outside the United Kingdom.

Review of decisions to impose fitness conditions originally imposed on grants of applications

79

(1) Where NHS England has imposed a condition on an NHS chemist (C) under regulation 35 (or thereafter under this regulation), or a Primary Care Trust has imposed a condition on C under regulation 35 or 79 of the 2012 Regulations (which relate to fitness conditions and conditions to combat fraud), NHS England may review the decision to impose the condition—

(a) at its own volition; or

(b) where requested to do so by C, but C may not make such a request—

(i) in the case of the first such request, until at least 3 months have elapsed since C was included in the relevant pharmaceutical list, or

(ii) thereafter, until at least 6 months have elapsed since NHS England (or a Primary Care Trust) determined the outcome of the previous review.

(2) If NHS England is undertaking the review of its own volition, it must inform C that it is doing so.

(3) As part of any review under paragraph (1), NHS England must afford C an opportunity to make representations to it in writing.

(4) As a result of the review, NHS England may remove the condition, leave the condition unchanged, vary the condition or impose a different condition, but any varied or different condition must be a condition with a view to—

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

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

(5) NHS England must notify C of a decision under paragraph (4), and it must include with the notification an explanation of—

(a) the reasons for the decision;

(b) C's right of appeal against its decision on the review to the First-tier Tribunal (which C has by virtue of this sub-paragraph);

(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 continuing application of the condition that applied prior to the review, if there is an appeal, pending the outcome of the appeal.

(6) If the outcome of the review is that the condition is to be varied or a different decision is to be imposed, that decision is to take effect—

(a) if no appeal is brought against the decision, once the period for bringing an appeal has elapsed; or

(b) if an appeal is brought against the decision, and the decision of NHS England is not changed by the First-tier Tribunal, once the First-tier Tribunal has determined the appeal (if the First-tier Tribunal takes a different decision to the decision taken by NHS England, that decision takes effect upon the taking of that decision, unless the First-tier Tribunal directs otherwise).

Removal for breach of fitness conditions imposed under regulation 35 or 79

80

If, in the course of a review under regulation 79 or otherwise, NHS England determines that an NHS chemist has failed to comply with a condition imposed under—

(a) regulation 35 or 79, or as varied under regulation 79; or

(b) regulation 35 or 79 of the 2012 Regulations (which relate to fitness conditions and conditions to combat fraud), or as varied under regulation 79 of those Regulations,

it may remove that NHS chemist from the relevant pharmaceutical list.

Mandatory removal in suitability cases

81

In unsuitability cases, NHS England must remove an NHS chemist (C) from a pharmaceutical list if—

(a) C (or where C is a body corporate, any director or superintendent of C) has been convicted in the United Kingdom of murder;

(b) C (or where C is a body corporate, any director or superintendent of C)—

(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; or

Fitness cases: procedures for removal or contingent removal from pharmaceutical lists

82

(1) This paragraph applies where NHS England is considering—

(a) removing an NHS chemist (C) from a pharmaceutical list under section 151 or 152(3)(b) of the 2006 Act (which relate to disqualification of practitioners and contingent removal);

(b) removing C from a pharmaceutical list under regulation 80; or

(2) Where paragraph (1) applies, before reaching its decision, NHS England must—

(a) notify C of the action NHS England is considering taking and its grounds for considering taking that action; and

(b) as part of that notification—

(i) inform C of any allegation against C, and

(ii) advise C that C may make—

(aa) written representations to NHS England with regard to that action, provided C notifies NHS England with those representations within 30 days beginning with the date of the notification by NHS England, and

(bb) oral representations to NHS England with regard to that action, provided C notifies NHS England of C's wish to do so within 30 days beginning with the date of the notification by NHS England and C (or a representative of C) attends the hearing that NHS England arranges for the purpose of hearing those representations, which NHS England must give C reasonable notice of; and

(c) in an unsuitability case to which regulation 81(a) or (b) applies, if C is a body corporate, advise C that NHS England will not remove C from the relevant pharmaceutical list as a consequence of that regulation (without prejudice to any other action it may take), provided that—

(i) the director or superintendent ceases to be a director or superintendent of C within the period of 30 days that begins on the date of the notification by NHS England, and

(ii) within that period, C notifies NHS England of the date on which the director or superintendent has ceased or is to cease to be a director or superintendent of C.

(3) Once NHS England has taken its decision, it must notify C of its decision, and it must include with the notification (which may be combined, in appropriate cases, with a notification under regulation 79(5)) an explanation of—

(a) the reasons for the decision;

(b) if NHS England has decided to remove or contingently remove C from a pharmaceutical list—

(i) C's rights of appeal in relation to that decision under section 158 of the 2006 Act (appeals), and

(ii) 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

(c) if NHS England has decided to contingently remove C, the arrangements for review of the conditions under section 157(1) of the 2006 Act (review of decisions).

(4) If NHS England has decided to remove or contingently remove C from a pharmaceutical list in accordance with this regulation, that decision is not to take effect—

(a) if C does not appeal against the decision, until the period for bringing an appeal against the decision has elapsed; or

(b) if C does appeal against the decision, unless the First-tier Tribunal has determined the appeal and confirmed the decision of NHS England (if the First-tier Tribunal takes a different decision to the decision taken by NHS England, that decision takes effect upon the taking of that decision, unless the First-tier Tribunal directs otherwise).

Procedure for suspensions in fitness cases

83

(1) Where NHS England is considering suspending an NHS chemist (C) from a pharmaceutical list under section 154(1) or section 155(2) of the 2006 Act (which relate to suspension and suspension pending appeal), before reaching its decision, it must—

(a) notify C of the action NHS England is considering taking and its grounds for considering taking that action; and

(b) as part of that notification—

(i) where NHS England is considering taking action under section 154(1), inform C of any allegation against C, and

(ii) advise C that C may make oral representations to NHS England with regard to the possible suspension on a specified day, provided C notifies NHS England of C's wish to do so within a specified period (of not less than 24 hours).

(2) If, within the specified period—

(a) C does not advise NHS England that C wishes to make oral representations to NHS England on the specified day, thereafter NHS England may suspend C with immediate effect; or

(b) C does advise NHS England that C wishes to make oral representations to NHS England on the specified day, NHS England must not suspend C until after the oral hearing, but may then do so with immediate effect.

(3) Once NHS England has taken its decision, it must notify C of its decision as soon as is practicable, and it must include with the notification of its decision an explanation of—

(a) the reasons for the decision;

(b) if NHS England has decided to suspend C under section 154(1), the arrangements for review of the suspension under section 157(1) of the 2006 Act (review of decisions).

Procedure for reviewing some suspensions and contingent removal conditions

84

(1) This paragraph applies where NHS England—

(a) is required to review a contingent removal or a suspension under section 157(1) of the 2006 Act (review of decisions); or

(b) decides to review a contingent removal or a suspension that it could be required to review under that section (if section 157(2) were satisfied).

(2) Where paragraph (1) applies, as part of the review, NHS England must afford the NHS chemist who has been contingently removed or is suspended (C) the opportunity to make—

(a) written representations to NHS England, provided C notifies NHS England with those representations within 30 days beginning with the date of the notification by NHS England; and

(b) oral representations to NHS England with regard to that action, provided—

(i) C notifies NHS England of C's wish to do so within 30 days beginning with the date of the notification by NHS England, and

(ii) C (or a representative of C) attends the hearing that NHS England arranges for the purpose of hearing those representations, which NHS England must give C reasonable notice of.

(3) Once NHS England has taken its decision under section 157(3) of the 2006 Act, it must notify C of its decision, and it must include with the notification of its decision an explanation of—

(a) the reasons for the decision;

(b) if C has a right of appeal in relation to the decision—

(i) the right of appeal that C has in relation to that decision under section 158 of the 2006 Act (appeals), and

(ii) 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

(c) if C has been or remains suspended or contingently removed, the arrangements for review of the suspension or the conditions under section 157(1) of the 2006 Act.

General power to revoke suspensions in appropriate circumstances

85

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