Legalize / United Kingdom / Statutory-Instrument

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

Type Statutory-Instrument

Publication 2013-02-14

Last updated 2025-10-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(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

(1) If an NHS chemist is suspended from a pharmaceutical list, in addition to NHS England’s powers to terminate suspensions under section 157(3)(b) of the 2006 Act (review of decisions) on a review, NHS England may terminate the suspension at any time, in appropriate circumstances.

(2) If NHS England terminates a suspension under paragraph (1), it must notify the NHS chemist that it has done so.

Internal handling of fitness information by NHS England or an agent of NHS England

86

(1) NHS England must ensure that the records it maintains relating to the fitness of NHS chemists and LPS chemists to be NHS chemists or LPS chemists are only accessible to persons whom NHS England employs in circumstances where NHS England is satisfied that they—

(a) should have access to the information on a need-to-know basis; and

(b) fully understand the confidential nature of the information and the purposes for which they are being permitted access to it.

(2) Where functions of NHS England relating to the fitness of NHS chemists or LPS chemists are carried out on behalf of NHS England by an agent of NHS England—

(a) the reference in paragraph (1) to persons whom NHS England employs includes reference to persons whom the agent employs to perform functions under the agency arrangement (about whom the agent must be satisfied on NHS England’s behalf as mentioned in sub-paragraphs (a) and (b) of paragraph (1)); and

(b) NHS England must ensure that the terms of the agency arrangement are such that the information the agent holds relating to the fitness of NHS chemists and LPS chemists to be NHS chemists or LPS chemists as a consequence of the arrangement is not further processed by the agent in a manner which is incompatible with the confidential nature of the information and the purposes for which it has been obtained.

Review periods for national disqualifications

87

(1) Section 159(8)(a) of the 2006 Act (national disqualification) is to have effect as if the reference to “two years” were a reference to “five years”, if the First-tier Tribunal determines, when it imposes the national disqualification, that the conduct of the person on whom the national disqualification has been imposed has been such that there is no realistic prospect of a review being successful if held within five years.

(2) Section 159(8)(b) of the 2006 Act is to have effect as if the reference to “one year” were a reference to “three years”, if the First-tier Tribunal determines, on a review, that the conduct of the person on whom the national disqualification has been imposed has been such that there is no realistic prospect of a further review being successful if held within three years.

(3) Section 159(8) of the 2006 Act is to have effect as if the references to “two years” and “one year”—

(a) in a case where—

(i) a national disqualification has been imposed as a consequence of a criminal conviction, and

(ii) on appeal, the conviction has been quashed or the penalty imposed by the court has been reduced; or

(b) in a case where—

(i) a national disqualification has been imposed as a consequence of an adverse decision of a licensing body, and

(ii) on appeal, the decision of the licensing body has been quashed or the penalty imposed by it has been reduced,

were a reference to a period equal to the period between the date on which that appeal was determined and the date on which the national disqualification was imposed or last reviewed.

Wider notifications of fitness decisions

88

(1) Where NHS England—

(a) refuses an application from a person (P) by virtue of regulation 33;

(b) grants an application subject to conditions imposed on P by virtue of regulation 35;

(d) removes P from a pharmaceutical list by virtue of section 151 or 152(3)(b) of the 2006 Act (which relate to disqualification of practitioners and contingent removal);

(e) contingently removes P from a pharmaceutical list by virtue of section 152 of the 2006 Act, or varies or imposes a different condition on P by virtue of that section; or

(f) suspends P under section 154 or 155 of the 2006 Act (which relate to suspension and suspension pending appeal),

NHS England must notify the persons listed in paragraph (2) that it has done so.

(2) Those persons are—

(a) the Secretary of State;

(b) where known to NHS England, any other primary care organisation that—

(i) has included P, or a body corporate of which P is a director or superintendent, in a relevant list, or

(ii) is considering including P, or a body corporate of which P is a director or superintendent, in a relevant list;

(d) the Welsh Ministers;

(e) the Northern Ireland Executive;

(f) the General Pharmaceutical Council;

(g) any Local Pharmaceutical Committee for the area of the relevant HWB (including any Local Pharmaceutical Committee for part of its area or for its area and that of all or part of the area of one or more other HWBs);

(h) in a case that is or may be a fraud case, the NHS CFA; and

(i) any person who may and does request to be notified of an adverse fitness decision as regards P.

(3) A person (Q) comes within paragraph (2)(i) if Q establishes to the satisfaction of NHS England (or before the appointed day the relevant Primary Care Trust) that Q—

(a) has employed or engaged, is employing or engaging or is considering employing or engaging P, or a director or superintendent of P, in a professional capacity; or

(b) is a member of a partnership of which P has been or is a member, or which is considering inviting P to be a member.

(4) A notification under paragraph (1) must include—

(a) where P is an individual or a partnership—

(i) P's, or each member of the partnership's, name, address and date of birth, and

(ii) P's, or each member of the partnership's, registration number in the Register of Pharmacists; and

(b) where P is a body corporate—

(i) P's name, company registration number and the address of P's registered office, and

(ii) the registration number in the Register of Pharmacists of P's superintendent and of any director of P who is a registered pharmacist;

(d) the name of and contact details for a person at NHS England who is in a position to respond to further enquiries.

(5) NHS England must notify P of whom it has notified under paragraph (1) and include, when it does so, the content of that notification.

(6) If, in response to an enquiry from a person notified under paragraph (1), NHS England notifies that person with further documentation (including documentation in an electronic form) that relates to P, NHS England must also notify P with—

(a) that documentation; and

(b) details of the person to whom it has been sent.

(7) If NHS England is notified by the First-tier Tribunal of a national disqualification, or the outcome of the review of a national disqualification, it must notify that information to the persons it notified about its own decision in relation to P under paragraph (2)(b) and (g) to (i).

(8) If—

(a) having notified a person under paragraph (1) of a suspension or a condition (including a condition imposed on contingent removal); or

(b) after a Primary Care Trust notified a person under regulation 88(1) of the 2012 Regulations (wider notifications of fitness decisions) of a suspension or a condition (including a condition imposed on contingent removal),

NHS England terminates the suspension or removes the condition, NHS England must notify that person with the notification given to P of the decision to terminate the suspension or remove the condition.

PART 12 — Remuneration, charges and refunds

The Drug Tariff and section 164: general provisions

89

(1) The Drug Tariff referred to in section 127(4) of the 2006 Act (arrangements for additional pharmaceutical services) is the aggregate of—

(a) the determinations of remuneration made by the Secretary of State, acting as a determining authority, under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services), but not of the remuneration of dispensing doctors;

(b) the determinations of remuneration made by NHS England, acting as a determining authority, pursuant to regulation 91(1); and

(c) any other instruments that the Secretary of State is required by virtue of these Regulations or the 2006 Act to publish, or does publish, together with those determinations,

in the publication known as the Drug Tariff, which the Secretary of State shall publish in such format as the Secretary of State thinks fit.

(2) Determinations under section 164 of the 2006 Act by the Secretary of State or NHS England may be made by reference to—

(a) the drugs and appliances dispensed or expected to be dispensed in accordance with NHS prescriptions during a reference period determined by the Secretary of State;

(b) lists of published prices produced by suppliers of the drugs or appliances that are available from them on NHS prescription;

(c) scales, indices or other data that relate to volume and price that are produced by suppliers of the drugs or appliances that are available from them on NHS prescription; and

(d) any other scales, indices or other data (including formulae) by reference to which the Secretary of State considers it appropriate to make such a determination, and in these circumstances, the Secretary of State may provide that remuneration is to be determined by reference to data which is—

(i) in the form current at the time of the determination; and

(ii) in any subsequent form taking effect after that time.

(3) Amendments may be made to the Drug Tariff at such intervals as the Secretary of State thinks fit, but must be published in a consolidated version of the Drug Tariff that has the amendments included in it.

(4) The consultation that the Secretary of State must undertake under section 165(1) of the 2006 Act (section 164: supplementary) prior to the inclusion of, or change to, a price of a drug or appliance which is to form part of a calculation of remuneration shall be by way of consultation on the process for determining the price to be included or changed, not on the proposed price itself (unless it is impossible to carry out an effective consultation in any other way).

(5) The Drug Tariff is to include the arrangements for the claiming of payments by NHS chemists and the making of payments to NHS chemists under it (whether the amounts are determined by the Secretary of State or NHS England), and—

(a) claims by NHS chemists for payments under the Drug Tariff must be made in accordance with those arrangements;

(b) payments under the Drug Tariff must be made—

(i) by NHS England (or a person exercising its functions), and

(ii) in accordance with those arrangements, subject as appropriate to any deduction that may or must be made in accordance either with those arrangements or with any provision of, or made under, the 2006 Act (including the Drug Tariff); and

Data to be provided to assist Drug Tariff determinations

90

(1) The data which the Secretary of State and NHS England may take into account prior to making a determination under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services) may include information obtained pursuant to paragraph (3) by—

(a) the Secretary of State or a person appointed by the Secretary of State under this paragraph; or

(b) NHS England or a person appointed by NHS England under this paragraph,

and a person appointed under this paragraph is referred to in this regulation as “a nominee”.

(2) Before appointing a person to be a nominee, the Secretary of State or NHS England must consult, as they consider appropriate, organisations representative of the NHS chemists to whose remuneration the possible determination arising out of the data would relate.

(3) An NHS chemist must, within 30 days of a request to do so, provide—

(a) the Secretary of State or a nominee of the Secretary of State with information (for example invoices) which the Secretary of State considers to be relevant to the matters the Secretary of State may take into account prior to making a determination under section 164 of the 2006 Act; or

(b) NHS England or a nominee of NHS England with information (for example invoices) which NHS England considers to be relevant to the matters NHS England may take into account prior to making a determination under section 164 of the 2006 Act.

(4) A nominee may handle and process information obtained under paragraph (3).

(5) The Secretary of State may require—

(a) information obtained by a nominee of the Secretary of State under paragraph (3)(a) to be obtained; and

(b) information processed or handled by a nominee of the Secretary of State under paragraph (4) to be processed or handled,

in such manner as the Secretary of State may reasonably specify.

(6) NHS England may require—

(a) information obtained by a nominee of NHS England under paragraph (3)(b) to be obtained; and

(b) information processed or handled by a nominee of NHS England under paragraph (4) to be processed or handled,

in such manner as NHS England may reasonably specify.

(7) The Secretary of State and NHS England may share with each other information which they or their nominees have obtained under this regulation (for purposes related to the determination of pharmaceutical remuneration).

Remuneration of NHS chemists: instruments of appointment of NHS England

91

(1) NHS England is appointed by the Secretary of State as a determining authority in relation to the following remuneration to be paid to NHS chemists for providing pharmaceutical services—

(a) the remuneration listed in Schedule 8 (which has effect); and

(b) remuneration in respect of advanced services.

(2) Before making determinations as provided for by paragraph (1), NHS England must consult—

(a) the Secretary of State in such manner as the Secretary of State may reasonably request; and

(b) a body appearing to it to be representative of persons to whose remuneration the determination would relate.

(3) In making determinations as provided for by paragraph (1), NHS England must—

(a) co-operate with the Secretary of State over seeking to ensure that resource use in respect of pharmaceutical remuneration is compatible with any objectives agreed between the Secretary of State and NHS England in respect of the total resource to be available for pharmaceutical remuneration;

(b) ensure that those determinations are compatible with the Secretary of State's arrangements for the claiming and making of payments, and making deductions from payments, that are included in the Drug Tariff (which may relate to pharmaceutical remuneration determined by NHS England as well as to pharmaceutical remuneration determined by the Secretary of State);

(c) ensure that those determinations are signed by a member of the senior management of NHS England, and for these purposes a person is a member of the senior management of NHS England if that person plays a significant role in—

(i) the making of decisions about how the whole or a substantial part of its activities are to be managed or organised, or

(ii) the actual managing or organising of the whole or a substantial part of those activities; and

(d) act in a manner that ensures that any amendments which, as a consequence, need to be made to the Drug Tariff, are made in a manner that is compatible with the Secretary of State's arrangements for the publication of the Drug Tariff (or the arrangements of a person publishing the Drug Tariff on the Secretary of State's behalf).

(4) The Secretary of State must, before making a determination which could by virtue of paragraph (1) be made by NHS England, notify NHS England of the Secretary of State's intention to make the determination.

(5) Before determining any remuneration payable in respect of an enhanced service, NHS England must consult—

(a) if the service is to be provided on the basis of a service specification that sets standard conditions nationally (including with regard to remuneration), the body that is, for the time being, the body consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists; or

(b) otherwise, any Local Pharmaceutical Committee for the area in which the service is to be provided.

(6) Where NHS England makes a determination of the remuneration payable in respect of an enhanced service, it must publish the determination in such manner as it thinks appropriate for bringing it to the attention of persons included in the relevant pharmaceutical lists.

(7) The arrangements for claiming and paying any remuneration in respect of an enhanced service thus determined must allow for the making for any deduction that may or must be made from that remuneration by virtue of any provision of, or made under, the 2006 Act (for example, a deduction that may or must be made by virtue of regulations 70 to 72).

Dispensing doctor remuneration

92

(1) As regards the pharmaceutical services provided by dispensing doctors—

(a) if a drug, appliance or related additional service is provided by a dispensing doctor in circumstances where the dispensing doctor could provide it under pharmaceutical services or related arrangements for the provision of primary medical services, the remuneration in respect of providing that drug, appliance or service is to be the remuneration payable in respect of that drug, appliance or service under the related arrangements; and

(b) in all other cases, the remuneration payable to a dispensing doctor in respect of those pharmaceutical services is to be the remuneration payable under a GMS contract to a GMS practice in respect of those services by virtue of directions under section 87 of the 2006 Act (GMS contracts: payments), whether or not the dispensing doctor is a GMS practice.

(2) Claims for remuneration in respect of pharmaceutical services by or on behalf of a dispensing doctor are to be made to the NHS BSA (which calculates the amount of the payment on behalf of NHS England) in such manner as the NHS BSA determines.

(3) The making of payments by NHS England pursuant to a claim made in accordance with paragraph (2) is to be in accordance with the arrangements—

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