The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020

• (b) the pharmaceutical services specified in the application that would have been provided at the premises specified in the original application will be provided at the new premises, and

• (c) the relocation still meets the need for pharmaceutical services, or pharmaceutical services of a specified type, identified in the relevant pharmaceutical needs assessment.

• (2) A Local Health Board may grant an application made by a person under regulation 15(1)(b)(ii) to relocate from listed premises to new premises at which the person intends to provide pharmaceutical services, if it is satisfied that—

• (a) the relocation is to meet a need for pharmaceutical services, or pharmaceutical services of a specified type, identified in the relevant pharmaceutical needs assessment and—

• (i) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good reason permit),

• (ii) the premises specified in the application from which the person wishes to relocate are not premises to which the person has temporarily relocated under regulation 21 (applications involving temporary relocation), and

• (iii) would not, if granted, result in a significant change to the arrangements that are in place for the provision of pharmaceutical services (other than those provided by a person on a dispensing doctor list) in any part of the Local Health Board’s area, or in a controlled locality in the area of a neighbouring Local Health Board where that controlled locality is within 1.6 kilometres of the new premises, or

• (b) the relocation is not to meet a need for pharmaceutical services, or pharmaceutical services of a specified type, identified in the relevant pharmaceutical needs assessment but—

• (i) for the patients who are accustomed to accessing pharmaceutical services at the existing premises, the location of the new premises is not significantly less accessible,

• (ii) the same pharmaceutical services will be provided at the new premises as are provided at the listed premises,

• (iii) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good reason permit),

• (iv) the premises specified in the application from which the person wishes to relocate are not premises to which the person has temporarily relocated under regulation 21 (applications involving temporary relocation), and

• (v) would not, if granted, result in a significant change to the arrangements that are in place for the provision of pharmaceutical services (other than those provided by a person on a dispensing doctor list) in any part of the Local Health Board’s area, or in a controlled locality in the area of a neighbouring Local Health Board where that controlled locality is within 1.6 kilometres of the new premises.

• (3) A person who has had an application granted under this regulation may not, within 12 months of the date of the grant of the application (as defined in regulation 23(3)(a)), submit another application for determination pursuant to this regulation or regulation 20.

Applications involving relocation between neighbouring Local Health Board areas

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• (1) A Local Health Board may grant an application made by a person under regulation 15(1)(c) (applications to be included in or make amendment to a pharmaceutical list) to relocate from listed premises in the area of neighbouring Local Health Board to new premises in the area of the Local Health Board to which the application is made, and at those premises the person intends to provide pharmaceutical services, if—

• (a) the Local Health Board, to which the application is made, is satisfied that—

• (i) the change is a relocation to meet a need identified in the relevant pharmaceutical needs assessment of the Local Health Board,

• (ii) for the patients who are accustomed to accessing pharmaceutical services at the existing premises, the location of the new premises is not significantly less accessible,

• (iii) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good reason permit),

• (iv) the premises specified in the application from which the person wishes to relocate are not premises to which the person has temporarily relocated under regulation 21 (applications involving temporary relocation),

• (v) the application would not, if granted, result in a significant change in the arrangements that are in place for the provision of pharmaceutical services (other than those provided by a person on a dispensing doctor list) in any part of the Local Health Board’s area, or in a controlled locality in the area of a neighbouring Local Health Board where that controlled locality is within 1.6 kilometres of the new premises, and

• (b) the person consents to the removal of the premises from the pharmaceutical list maintained by the Local Health Board in whose area the current listed premises are located with effect from the date on which the provision of pharmaceutical services from the new premises commences.

• (2) A person who has had an application granted pursuant to this regulation may not, within 12 months of the date of the grant of the application (as defined in regulation 23(3)(a)), submit another application for determination under this regulation or regulation 19.

Applications involving temporary relocation

21

• (1) A Local Health Board may make a temporary amendment to an entry in a pharmaceutical list by granting an application made by a person under regulation 15(1)(b)(ii) (applications to be included in or make amendment to a pharmaceutical list) to relocate to different premises on a temporary basis if it is satisfied that—

• (a) the circumstances in which the application is made require the flexible provision of pharmaceutical services,

• (b) for the patients who are accustomed to accessing pharmaceutical services at the existing premises, the location of the temporary premises is not significantly less accessible,

• (c) the same pharmaceutical services will be provided at the temporary premises as are provided at the listed premises, and

• (d) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good cause allow).

• (2) A temporary amendment to an entry in the pharmaceutical list will have effect from the date on which the Local Health Board approved the application made to it and will be valid for such period of up to 6 months and any further periods of up to 3 months each that the Local Health Board considers necessary.

• (3) A person may revert to the overridden entry in the pharmaceutical list maintained by the Local Health Board before the end of the period determined by the Local Health Board under paragraph (2) on giving the Local Health Board at least 7 days’ notice in writing.

• (4) Where, in accordance with this regulation, an entry in a pharmaceutical list is overridden by a temporary amendment, any proceedings with regard to the overridden arrangements are unaffected by that overriding (although they may need to be stayed for other reasons) and if, as a result of those proceedings the overridden arrangements require amendment before the end of the temporary amendment, the reversion to the overridden arrangements is to be to the original overridden amendments as amended as a result of those proceedings.

Applications involving a change of ownership

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• (1) A Local Health Board must grant an application made by a person under regulation 15(1)(a), (b)(i) or (ii) (applications to be included in or make amendment to a pharmaceutical list) who intends to provide pharmaceutical services at premises from which those services are, at the time of the application, provided by another person who is included in a pharmaceutical list maintained by the Local Health Board under regulation 10 (preparation and maintenance of pharmaceutical lists) if the Local Health Board is satisfied that—

• (a) the premises are already included in a pharmaceutical list maintained by the Local Health Board,

• (b) the same pharmaceutical services will continue to be provided from the premises, and

• (c) the provision of pharmaceutical services will not be interrupted (except for such period as the Local Health Board may for good cause allow).

• (2) In determining an application under this regulation which has been made under regulation 15(1)(a) (except where the application has been made by a person who has been granted preliminary consent under regulation 18 which is valid in accordance with regulation 18(5)), or under regulation 18 where the applicant is not already included in that Local Health Board’s pharmaceutical list a Local Health Board may—

• (a) defer consideration of the application on fitness grounds under regulation 36 (deferral of applications on fitness grounds),

• (b) refuse the application on fitness grounds under regulation 37 (refusal of applications on fitness grounds), or

• (c) impose conditions on the grant of the application under regulation 38 (conditional inclusion on fitness grounds).

Procedure following grant of an application

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• (1) Following the date of the grant of an application made under regulation 15 (applications to be included in or make amendment to a pharmaceutical list), a Local Health Board must not include a person in a pharmaceutical list or amend a pharmaceutical list unless—

• (a) the condition in paragraph (2) is satisfied, and

• (b) the requirements of regulation 38 (conditional inclusion on fitness grounds), if any, are met as regards the imposition of conditions on any person.

• (2) A person will be included in the relevant pharmaceutical list or the relevant pharmaceutical list will be amended as appropriate if, not less than 14 days before the end of the relevant period, that person notifies the Local Health Board in writing, providing the information specified in Part 3 of Schedule 2, that they will within the next 14 days commence the provision at the premises of the pharmaceutical services that were specified in the application.

• (3) For the purposes of this regulation and, where relevant, regulation 24—

• (a) “the date of the grant of an application” is the date which is the later of either—

• (i) 30 days after notice of the Local Health Board’s decision on the application was sent by the Local Health Board in accordance with paragraph 14 of Schedule 3, or

• (ii) the date of the determination of any appeal that is brought against the decision of the Local Health Board, and

• (b) “the relevant period” is—

• (i) the period of 6 months from the date of the grant of an application, or

• (ii) such further period in addition to that specified in paragraph (i) not exceeding 3 months that the Local Health Board may for good reason allow.

Application to extend the relevant period

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• (1) A person may make an application to the Local Health Board to extend the relevant period no later than 5 months after the date of the grant of an application.

• (2) In accordance with regulation 23(3)(b)(ii) a person may apply for an extension of up to 3 months.

• (3) An application to the Local Health Board under this regulation must be made in writing and must provide reasons why an extension of the relevant period is sought.

• (4) Parts 1 and 3 of Schedule 3 specify the procedures to be followed by a Local Health Board when determining applications made under this regulation.

• (5) For the purposes of this regulation, “person” means the person who would be entitled to provide notification to a Local Health Board in accordance with regulation 23(2) of commencement of provision of pharmaceutical services.

Appeals

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• (1) Schedule 4 makes provision for appeals to the Welsh Ministers in respect of decisions of Local Health Boards made under this Part, save for those regulations listed in paragraph (2).

• (2) There is no right of appeal in respect of a decision of a Local Health Board—

• (a) to make or not to make, or to extend, a temporary amendment to a pharmaceutical list under regulation 21 (applications involving temporary relocation), or

• (b) to extend or not to extend the relevant period under regulation 24 (application to extend the relevant period).

PART 6 — Applications by doctors for inclusion in or amendment to dispensing doctors lists

Arrangements for the provision of pharmaceutical services by doctors

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• (1) A Local Health Board may make an arrangement with a doctor who falls within paragraph (8) for the doctor to provide pharmaceutical services to a patient included on the doctor’s patient list or the patient list of a provider of primary medical services by whom the doctor is employed or engaged, if the patient—

• (a) would have serious difficulty in obtaining any necessary drugs or appliances from a pharmacy because of distance or inadequacy of means of communication, and the conditions in paragraph (2) are satisfied,

• (b) is resident in a controlled locality, at a distance of more than 1.6 kilometres from any pharmacy, and the conditions specified in paragraph (4) are satisfied, or

• (c) is resident in a controlled locality and any pharmacy within a distance of 1.6 kilometres from where the patient lives has been determined to be in a reserved location, and that determination has not been altered on appeal or by way of a further determination and the conditions specified in paragraph (4) are satisfied.

• (2) The conditions referred to in paragraph (1)(a) are—

• (a) the patient has made a request in writing to the Local Health Board for the doctor to provide them with pharmaceutical services for the reasons specified in paragraph (1)(a), and

• (b) the Local Health Board is satisfied that the patient would have serious difficulty in obtaining any necessary drugs or appliances for those reasons.

• (3) In making an arrangement with a doctor for the doctor to provide a patient under paragraph (1)(a) with pharmaceutical services from practice premises, the Local Health Board must give reasonable notice in writing to the doctor of when the arrangement is to take effect unless the doctor satisfies the Local Health Board that—

• (a) the doctor does not normally provide pharmaceutical services to patients, or

• (b) the patient would not have serious difficulty in obtaining drugs and appliances from a pharmacy because of distance or inadequacy of means of communication.

• (4) The conditions referred to in paragraph (1)(b) and (c) are that—

• (a) outline consent has been granted to the doctor or the provider of primary medical services by whom the doctor is employed or engaged,

• (b) premises approval has been granted in relation to the premises from which the doctor will provide pharmaceutical services to that patient,

• (c) the outline consent and premises approval has taken effect under regulation 31 (taking effect of outline consent and premises approval), and

• (d) any conditions imposed under these Regulations in connection with the grant of outline consent or premises approval are such as to permit arrangements to be made under this regulation for the provision of pharmaceutical services by that doctor to patients under paragraph (1)(b) or (c).

• (5) References in paragraph (4) to outline consent, premises approval and conditions imposed include references to those in effect under the 2013 Regulations.

• (6) A doctor with whom an arrangement has been made to provide pharmaceutical services to a patient under this regulation may, with the consent of the patient, instead of providing the drugs or appliances order them by issuing a prescription to the patient.

• (7) Where an arrangement for a doctor to provide pharmaceutical services to a patient was in effect immediately before these Regulations came into force, that arrangement will have effect as though made under this regulation notwithstanding that the conditions in paragraph (4) are not satisfied.

• (8) A doctor falls within this paragraph if they are—

• (a) a GMS contractor or an APMS contractor,

• (b) engaged or employed by a GMS contractor or an APMS contractor, or

• (c) is engaged by a Local Health Board for the purposes of providing primary medical services to a LHBMS practice.

• (9) A doctor may appeal to the Welsh Ministers against a decision of a Local Health Board under paragraph (3). The appeal must be made in writing within 30 days beginning with the date on which notice of the decision was sent to the doctor and must contain a concise statement of the grounds of appeal.

• (10) The Welsh Ministers must, on receipt of any notice of appeal under paragraph (9), send a copy of that notice to the Local Health Board and the relevant GMS contractor or APMS contractor, and the Local Health Board and the relevant GMS contractor or APMS contractor may, within 30 days from the date on which the Welsh Ministers sent a copy of the notice of appeal, make representations in writing to the Welsh Ministers.

• (11) The Welsh Ministers may determine an appeal pursuant to paragraph (9) in such manner as they see fit, taking into consideration the preliminary matters in Part 1 of Schedule 4.

• (12) The Welsh Ministers must, upon determination by them of any appeal under paragraph (9), give notice of their decision in writing, together with the reasons for it, to the appellant, to the Local Health Board, and to the relevant GMS contractor or APMS contractor.

Necessary services for temporary patients

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A doctor who provides pharmaceutical services to patients on a patient list by arrangement made with a Local Health Board under regulation 26 (arrangements for the provision of pharmaceutical services by doctors) may provide necessary pharmaceutical services to a person who has been accepted by the doctor as a temporary patient.

Provision of pharmaceutical services for immediate treatment or personal administration

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• (1) Subject to paragraph (2), a doctor whose name is included in a medical performers list may—

• (a) provide to a patient any appliance or drug, not being a Scheduled drug, where such provision is needed for the immediate treatment of that patient before a provision can otherwise be obtained, and

• (b) provide to a patient any appliance or drug, not being a Scheduled drug, which the doctor personally administers or applies to the patient.

• (2) A doctor may only provide a restricted availability appliance if it is for a person or a purpose specified in the Drug Tariff.

Discontinuation of arrangements for the provision of pharmaceutical services by doctors

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• (1) A Local Health Board must give reasonable notice in writing to a doctor that they must discontinue the provision of pharmaceutical services to a patient under an arrangement pursuant to regulation 26 where the patient no longer falls within regulation 26(1)(a), (b) or (c).

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

• (a) is subject to any postponement or termination of arrangements for the provision of pharmaceutical services to that person by that doctor made under paragraph 6 of Schedule 3, paragraph 13 of Schedule 3 or regulation 17(6), and

• (b) must not be given—

• (i) pending any appeal against a decision of the Local Health Board to postpone the making of or the termination of the arrangement, or

• (ii) where paragraph 5 of Schedule 3 applies.

Outline consent and premises approval

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• (1) A doctor who is a provider of primary medical services or who is engaged or employed by a provider of primary medical services and who wishes to make an arrangement with a Local Health Board to provide pharmaceutical services to patients under regulation 26(1)(b) or (c) (arrangements for the provision of pharmaceutical services by doctors) must submit an application in writing to the Local Health Board for—

• (a) consent, specifying the area in which the doctor wishes to provide pharmaceutical services (“outline consent”), and

• (b) approval of any practice premises from which the doctor wishes to dispense (“premises approval”).

• (2) A doctor who has outline consent which has taken effect under regulation 31 (taking effect of outline consent and premises approval) may submit an application for premises approval only in relation to—

• (a) additional practice premises from which to provide pharmaceutical services, or

• (b) practice premises to which the doctor wishes to relocate from listed premises.

• (3) An application to a Local Health Board made under this regulation must be made in writing and must provide the information set out in Part 4 of Schedule 2

• (4) A Local Health Board must return an application if it does not contain all of the information required under paragraph (3).

• (5) The Local Health Board—

• (a) must refuse outline consent in relation to any part of the area specified in the application which is not in a controlled locality or which is within 1.6 kilometres of any pharmacy;

• (b) must refuse premises approval in relation to any premises specified in the application which are within 1.6 kilometres of any pharmacy;

• (c) must refuse an application where it is of the opinion that to grant it would prejudice the proper provision of primary medical services, dispensing services or pharmaceutical services in the controlled locality within which the premises specified in the application are situated (“the prejudice test”);

• (d) where an application has not been refused under the prejudice test, must refuse the application unless it is satisfied that it would meet a need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant locality and which has been included in the relevant pharmaceutical needs assessment and which the doctor has applied for outline consent;

• (e) may, where the Local Health Board has considered two or more applications together and in relation to each other, refuse one or more of them (notwithstanding that it would, if determining the applications in isolation, grant them) where the number of applications is such that to grant all of them or more than one of them would prejudice the proper provision of primary medical services, dispensing services or pharmaceutical services in any controlled locality.

• (6) Any refusal of an application outlined at paragraph (5)(a) to (e) may relate to all or any part of the area within the controlled locality, or, as the case may be, all or some of the premises for which approval is sought.

• (7) Subject to any specific requirements that are contained within this Part, Parts 1 and 3 of Schedule 3 specify the procedures to be followed by a Local Health Board when determining applications under this Part.

• (8) An application under this regulation is granted on the date which is the later of—

• (a) 30 days after notice of the Local Health Board’s decision on the application was sent by the Local Health Board in accordance with paragraph 15 of Schedule 3, or

• (b) where an appeal is made against the decision of the Local Health Board, the date on which the Welsh Ministers gave notice of their decision on the appeal under paragraph 8 of Schedule 4.

Taking effect of outline consent and premises approval

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• (1) When granting an application made under regulation 30 (outline consent and premises approval), the Local Health Board must determine the date on which outline consent and premises approval are to take effect.

• (2) Where there are no outstanding pharmacy applications (as defined in paragraph (11)) outline consent and premises approval take effect on the date on which the application is granted.

• (3) Where there are outstanding pharmacy applications on the day before the application under regulation 30 is granted, the date on which outline consent and premises approval take effect is to be determined in accordance with paragraphs (4) to (9).

• (4) The Local Health Board must in respect of an application to which paragraph (3) applies notify the doctor who made the application under regulation 30, and the Welsh Ministers if the application is subject to appeal, of—

• (a) any outstanding pharmacy applications,

• (b) the withdrawal of outstanding pharmacy applications,

• (c) the provisional date (as defined in paragraph (11)) on which the doctor can request the Local Health Board to determine that outline consent and premises approval should come into effect, and

• (d) the lapse of the doctor’s application for outline consent and premises approval if, before the provisional date, the provision of pharmaceutical services is commenced from the premises which were the subject of an outstanding pharmacy application which has been granted.

• (5) On, or as soon as reasonably practicable after, the provisional date, the Local Health Board must notify the doctor who made the application under regulation 30 that—

• (a) the doctor may within 3 months of the Local Health Board’s notification submit a request in writing to the Local Health Board asking it to determine whether the outline consent and premises approval should come into effect, and

• (b) the Local Health Board must determine the request as soon as practicable and in accordance with paragraphs (6) and (7).

• (6) Where on the date of the determination under paragraph (5), the premises in respect of which premises approval is sought are practice premises, the Local Health Board must determine that the outline consent and premises approval in respect of those premises will come into effect on that date.

• (7) Where on the date of the determination under paragraph (5), the premises in respect of which premises approval is sought are not practice premises outline consent and premises approval will lapse.

• (8) The Local Health Board must notify its determination under paragraph (5) to the applicant and those persons to whom notice of the application under regulation 30 was required to be given under paragraph 8 of Schedule 3.

• (9) Where the Local Health Board has determined that outline consent and premises approval will lapse by virtue of paragraph (7) or that the provisional date is to be extended under paragraph (11), the doctor who made the application under regulation 30 may appeal to the Welsh Ministers.

• (10) If, in the circumstances outlined in paragraph (9), a notice of appeal is submitted to the Welsh Ministers, Part 1 of Schedule 4 and the following paragraphs of Schedule 4 will apply—

• (a) 6(3)(b) and (c),

• (b) 7(1) and (3), and

• (c) 8,

as if the notice of appeal were submitted under paragraph 6(1) of Schedule 4.

• (11) In this regulation—

• “outstanding pharmacy application” (“cais am fferyllfa yn yr arfaeth”) means an application made under regulation 15 (applications to be included in or make amendment to a pharmaceutical list) or regulation 18 (applications for preliminary consent and effect of preliminary consent)—where the premises specified in that application are within 1.6 kilometres of the premises for which premises approval has been sought, andwhich has either—been made but not yet determined, including on appeal, orhas been granted as defined in regulation 23 (procedure following grant of an application) but the provision of pharmaceutical services from those premises has not been commenced;

• “provisional date” (“dyddiad dros dro”) means the day after the end of a period of 1 year or such further period not exceeding 3 months as the Local Health Board may determine (and it must notify the doctor who made the application under regulation 30 of any extension) beginning with the date on which the application is granted in accordance with regulation 30(9).

Lapse of outline consent and premises approval

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• (1) Outline consent will cease to have effect—

• (a) where the provision of dispensing services has not commenced within 12 months of outline consent or premises approval taking effect under regulation 31 (taking effect of outline consent and premises approval),

• (b) where more than 12 months have elapsed since the last provision of dispensing services,

• (c) where there is a practice amalgamation and following the amalgamation there are no practice premises which have premises approval, or

• (d) where outline consent has lapsed under regulation 31.

• (2) Premises approval will cease to have effect in relation to—

• (a) listed premises which have permanently ceased to be practice premises,

• (b) listed premises which have not been used for dispensing by any doctor authorised to dispense from those premises for 6 months or such longer period as the Local Health Board may for good cause allow,

• (c) listed premises where the doctor under whose name those premises are listed in the dispensing doctors list has notified the Local Health Board that all the doctors who have authority to dispense from those premises have ceased to do so,

• (d) listed premises where there is no doctor with premises approval in respect of them remaining on the dispensing doctor list, or

• (e) listed premises which were granted premises approval under regulation 35(3), where no practice amalgamation takes place within the period specified in regulation 35(7).

• (3) Premises approval will cease to have effect where the related outline consent ceases to have effect.

Premises approval: change of premises before outline consent takes effect

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• (1) Where—

• (a) outline consent has been granted but has not yet taken effect under regulation 31 (taking effect of outline consent and premises approval), and

• (b) before the provisional date defined in regulation 31(11) the doctor intends to change the practice premises from which they wish to provide pharmaceutical services,

the doctor may apply in writing to the Local Health Board providing the information set out in Part 4 of Schedule 2 for the Local Health Board to determine whether premises approval should be given in relation to the new premises, and the Local Health Board must make the determination in accordance with paragraph (2).

• (2) If the Local Health Board is satisfied that the change of premises is a minor relocation it may grant the premises approval for those new premises, but if it is not so satisfied, premises approval for the new premises must be refused.

• (3) The Local Health Board must notify those persons to whom notice of the application made under regulation 30 (outline consent and premises approval) was required to be given of its determination under paragraph (2).

• (4) The determination by the Local Health Board under paragraph (2) may be appealed by the applicant to the Welsh Ministers.

• (5) If, in the circumstances outlined in paragraph (4), a notice of appeal is submitted to the Welsh Ministers, Part 1 of Schedule 4 and the following paragraphs of Schedule 4 will apply—

• (a) 6(3)(b) and (c),

• (b) 7(1) and (3), and

• (c) 8,

as if the notice of appeal were submitted under paragraph 6(1) of Schedule 4.

• (6) In this regulation—

• “minor relocation” means a relocation of practice premises where—the pharmaceutical services specified in the application that would have been provided at the practice premises specified in the original application will be provided at the new practice premises, andthe location of the new practice premises would not be significantly less accessible for the patients who access the practice premises specified in the original application.

Premises approval: additional and new premises after outline consent has taken effect

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• (1) A doctor who has outline consent which has taken effect and who wishes to be granted premises approval for premises in addition to those premises in respect of which premises approval has been given (“additional premises”) may apply in writing providing the information set out in Part 4 of Schedule 2 to all of the appropriate Local Health Boards and the application will be determined by the relevant Local Health Board in accordance with paragraph (2).

• (2) An application for additional premises must be determined by the relevant Local Health Board in accordance with regulation 30 (outline consent and premises approval) and regulation 31 (taking effect of outline consent and premises approval).

• (3) For the purposes of this regulation—

• (a) the “appropriate Local Health Boards” are those Local Health Boards that hold the dispensing doctor lists on which the doctor making the application is included, and

• (b) the “relevant Local Health Board” is the Local Health Board in whose area the additional premises are situated.

• (4) A doctor wishing to be granted premises approval in relation to premises (“new premises”) where they wish to dispense instead of listed premises may apply to all the appropriate Local Health Boards providing the information set out in Part 4 of Schedule 2 and the application will be determined by the relevant Local Health Board in accordance with paragraphs (5) and (6).

• (5) In the case of an application for new premises, the relevant Local Health Board must give notice of the application in accordance with paragraph 9 of Schedule 3 and the content of the notification must comply with paragraph 10 of that Schedule.

• (6) In the case of an application for new premises the relevant Local Health Board must—

• (a) grant an application, where it is satisfied that—

• (i) for the patients that are accustomed to accessing pharmaceutical services at the existing premises, the location of the new premises is not significantly less accessible, and

• (ii) granting the application would not result in a significant change in the arrangements for the provision of pharmaceutical or dispensing services to any part of the controlled locality in which the new premises are located, or

• (b) in any case, determine the application as if it were an application for premises approval made under regulation 30(1)(b).

• (7) A Local Health Board must, unless it has good cause not to do so, refuse an application under paragraph (1) or (4) if an application made by the doctor has been granted under paragraph (6)(a) during the 12 months before the application was submitted under paragraph (1) or (4).

• (8) The Local Health Board must notify its determination under paragraph (2) or paragraph (6)(b) to the persons to whom notice of the application is required to be given in accordance with regulation 30 and paragraph 8 of Schedule 3.

• (9) The Local Health Board must notify its determination under paragraph (6)(a) to those persons to whom notification is required to be given in accordance with paragraph 15 of Schedule 3.

• (10) A determination by the Local Health Board under paragraph (2), (6)(a) or (6)(b) may be appealed to the Welsh Ministers by the persons listed in paragraph 6(1) of Schedule 4.

• (11) Subject to paragraph (12), the premises approval for the additional or new premises will take effect from the date of notification of the grant of premises approval, which is—

• (a) where no appeal is made against the decision of the Local Health Board, the date after the expiry of 30 days beginning with the date on which notice of that decision is given under paragraph (8) or paragraph (9), or

• (b) where such an appeal is made, the date on which the Welsh Ministers give notice of their decision on that appeal.

• (12) Where—

• (a) the premises approval is granted in relation to additional premises, and

• (b) in relation to the premises for which the approval is granted there, at the date of the grant, outstanding pharmacy applications (as defined in regulation 31(11)),

the premises approval will take effect on the date which is the day after the end of a period of 1 year, or such further period (not exceeding 3 months) as the Local Health Board may for good cause allow, from the final resolution of any outstanding pharmacy application.

• (13) The Local Health Board may grant temporary premises approval to a doctor who has outline consent and premises approval in relation to additional or new premises where the Local Health Board considers it would meet a need for pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant locality and which has been included in the relevant pharmaceutical needs assessment and in respect of which the doctor has applied for outline consent, and renew any such temporary approval granted, and where it does so it must—

• (a) notify those persons to whom notice of the application under regulation 30 (outline consent and premises approval) was required to be given under paragraph 8 of Schedule 3 and the applicants in relation to the outstanding pharmacy applications,

• (b) state the period during which the temporary premises approval is to apply, and

• (c) include those premises in the dispensing doctor list in relation to that doctor.

• (14) Temporary premises approval may be granted for a period not exceeding 12 months, and may be renewed for a further period not exceeding 3 months.

• (15) The determination by the Local Health Board under paragraph (13) may be appealed by the applicant to the Welsh Ministers.

• (16) If, in the circumstances outlined in paragraph (15), a notice of appeal is submitted to the Welsh Ministers, Part 1 of Schedule 4 and the following paragraphs of Schedule 4 will apply—

• (a) 6(3)(b) and (c),

• (b) 7(1) and (3), and

• (c) 8,

as if the notice of appeal were submitted under paragraph 6(1) of Schedule 4.

Premises approval: practice amalgamations

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• (1) A practice amalgamation occurs where two or more providers of primary medical services amalgamate as a single provider of primary medical services as a result of which two or more patient lists are combined.

• (2) Following a practice amalgamation, if the practice premises of the single provider of primary medical services are all premises that immediately prior to the practice amalgamation were listed premises, the premises approvals for those premises and the related outline consents will continue to have effect.

• (3) Following a practice amalgamation, if paragraph (2) does not apply but one or more of the doctors coming together as the single provider of primary medical services had, immediately prior to amalgamation, premises approval for premises—

• (a) if any of those premises become practice premises of the single provider of primary medical services—

• (i) the premises approvals for the premises and the related outline consents will continue to have effect, and

• (ii) any applications for premises approvals for other practice premises must be treated as applications for additional premises under regulation 34 (premises approval: additional and new premises after outline consent has taken effect);

• (b) if none of those premises become practice premises of the single provider of primary medical services—

• (i) a doctor may submit an application for premises approval for premises under regulation 30 (outline consent and premises approval) and have that application treated as a relocation from listed premises of a doctor who was part of the practice amalgamation, and

• (ii) any applications for premises approval in respect of other practice premises of the single provider of primary medical services are to be treated as applications for additional premises under regulation 34.

• (4) An application mentioned in paragraph (3) may be made before or after the practice amalgamation takes place, and where the practice amalgamation takes effect before the application has been finally determined—

• (a) any premises approval in effect at the date of the practice amalgamation will have effect from the date of the amalgamation as if it were a temporary premises approval under regulation 34(13) for a period stated by the Local Health Board not exceeding 1 year, and

• (b) the new practice will have temporary premises approval from the date of the practice amalgamation to dispense from any premises mentioned in the application for a period stated by the Local Health Board not exceeding 1 year.

• (5) When the practice amalgamation takes effect the doctors must notify all Local Health Boards in whose area the amalgamated practice is situated that the practice amalgamation has taken place.

• (6) Subject to paragraph (7), where an application made under paragraph (3) was granted before the practice amalgamation takes place, premises approval will take effect from the date of the practice amalgamation.

• (7) Where an application was made under paragraph (3) before the practice amalgamation takes place and the practice amalgamation has not taken place before the end of a period of 1 year beginning with the date that premises approval was granted under that paragraph, that grant will lapse.

• (8) Where an application under paragraph (3) for premises approval is refused either for all or any of the premises specified in the application, whether before or after the practice amalgamation takes place, the doctors who had premises approval prior to making the application, and any other doctor in the new practice after that date will have residual premises approval.

• (9) For the purposes of this regulation, “residual premises approval” means premises approval to provide pharmaceutical services—

• (a) from premises in respect of which the doctor or another doctor in the practice had premises approval at the time of the application in relation to the practice amalgamation, and

• (b) to a patient falling within regulation 26(1) to whom the doctor making the application provides pharmaceutical services, but excluding any such patient who ceases to be a patient mentioned in regulation 26(1)(b) or (c).

• (10) For the purposes of paragraph (9), regulation 26(1)(b) or (c) is to be read as if the words “and the conditions specified in paragraph (4) are satisfied” were omitted.

• (11) Where a Local Health Board has determined an application for premises approval under paragraph (3), the persons who may make an appeal to the Welsh Ministers will be determined in accordance with—

• (a) regulation 34 in respect of an application under paragraph (3)(a)(ii) or (b)(ii), or

• (b) regulation 30 in respect of an application under paragraph (3)(b)(i).

• (12) Where a Local Health Board has determined an application under paragraph (4), the applicant may make an appeal to the Welsh Ministers.

• (13) If, in the circumstances outlined in paragraph (12), a notice of appeal is submitted to the Welsh Ministers, Part 1 of Schedule 4 and the following paragraphs of Schedule 4 will apply—

• (a) 6(3)(b),

• (b) 7(1) and (3), and

• (c) 8,

as if the notice of appeal were submitted under paragraph 6(1) of Schedule 4.

PART 7 — Fitness grounds and inclusion in and removal from pharmaceutical lists

Deferral of applications on fitness grounds

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• (1) This regulation applies to applications made under—

• (a) regulation 15(1)(a) (applications to be included in or make amendment to a pharmaceutical list), except where the application is made by a person who has a valid preliminary consent in accordance with regulation 18(5), and

• (b) regulation 18 (applications for preliminary consent) where the applicant is not already included in that Local Health Board’s pharmaceutical list.

• (2) A Local Health Board may defer consideration or determination of an application where—

• (a) there are criminal proceedings in the United Kingdom or proceedings elsewhere in the world relating to conduct which in the United Kingdom would constitute a criminal offence in respect of—

• (i) the applicant (and where the applicant is a body corporate, in respect of the applicant or a director or superintendent of the applicant), or

• (ii) a body corporate of which the applicant is, or has in the preceding 6 months been, or was at the time of the originating events, a director or superintendent, which, if they resulted in a conviction or the equivalent of a conviction, would be likely to lead to the applicant’s removal from the Local Health Board’s pharmaceutical list, if the applicant had been included in it;

• (b) there is an investigation anywhere in the world by the applicant’s (or where the applicant is a body corporate, any director or superintendent of the applicant) licensing or regulatory body or any other investigation (including one by another Local Health Board or equivalent body) relating to the applicant’s professional capacity, that if the outcome of which was adverse would be likely to lead to the removal of the applicant from the Local Health Board’s pharmaceutical list, if the applicant had been included in it;

• (c) the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) is suspended from a relevant list;

• (d) a body corporate of which the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) was, at the time of the originating events, a director or superintendent, is suspended from a relevant list;

• (e) the Tribunal is considering an appeal by the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) against a decision of a Local Health Board or an equivalent body—

• (i) to refuse an application by the applicant for inclusion in a relevant list,

• (ii) to conditionally include or remove or contingently remove the applicant from a relevant list, or

• (iii) to refuse an application from the applicant for preliminary consent to be included in a pharmaceutical list held by a Local Health Board or an equivalent body,

and if that appeal were to be unsuccessful the Local Health Board would be likely to remove the applicant from the pharmaceutical list if they were to be included in it;

• (f) the Tribunal is considering an appeal by a body corporate of which the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) was, at the time of the originating events, or has in the preceding 6 months been, a director or superintendent, against a decision of a Local Health Board or equivalent body—

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

• (ii) to refuse an application by that body corporate for preliminary consent to be included in a pharmaceutical list held by a Local Health Board or an equivalent body, or

• (iii) to conditionally include it in, or to remove or contingently remove it from any relevant list,

and if that appeal were to be unsuccessful the Local Health Board would be likely to remove the applicant from the pharmaceutical list if they were to be included in it;

• (g) the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) is being investigated in relation to any fraud, where the outcome, if adverse, would be likely to lead to the removal of the applicant from the pharmaceutical list if the applicant had been included in it;

• (h) a body corporate, of which the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) was, at the time of the originating events, a director or superintendent, is being investigated in relation to fraud, where the outcome if adverse would be likely to lead to the removal of the applicant from the pharmaceutical list if the body corporate had been included in it;

• (i) the Tribunal is considering an application from a Local Health Board or equivalent body for a national disqualification of the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) or of a body corporate of which the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) was, at the time of the originating events, a director or superintendent;

• (j) a Local Health Board or equivalent body, for a reason relating to fraud, unsuitability or efficiency of service provision—

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

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

• (3) A Local Health Board may only defer a decision under paragraph (2) until the proceedings, investigations or applications mentioned in that paragraph are concluded or the reason for the deferral no longer exists.

• (4) A Local Health Board must, as soon as is practicable, notify the applicant in writing of a decision to defer consideration or determination of the application, and the reasons for this.

• (5) Once the proceedings, investigations or applications mentioned in paragraph (2) are concluded, the Local Health Board must notify the applicant that within 30 days of the date of the notification (or such longer period as it may agree) the applicant—

• (a) must confirm in writing that the applicant wishes to proceed with the application, and

• (b) may update the application if the applicant wishes.

• (6) If the applicant fails to confirm that they wish to proceed in accordance with paragraph (5), the Local Health Board must deem the application as having been withdrawn by the applicant.

Refusal of applications on fitness grounds

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• (1) This regulation applies to applications made under—

• (a) regulation 15(1)(a) (applications to be included in or make amendment to a pharmaceutical list), except where the application is made by a person who has a valid preliminary consent in accordance with regulation 18(5), and

• (b) regulation 18 (applications for preliminary consent and effect of preliminary consent) where the applicant is not already included in that Local Health Board’s pharmaceutical list.

• (2) A Local Health Board may refuse to grant an application where—

• (a) having considered the information and undertakings required by Part 2 of Schedule 2 and any other information in its possession in relation to the application, the Local Health Board considers that the applicant is unsuitable to be included in its pharmaceutical list,

• (b) having contacted the referees nominated by the applicant in accordance with Part 2 of Schedule 2, it is not satisfied with the references given,

• (c) having checked with the NHS Business Services Authority for any facts that it considers relevant relating to past or current fraud investigations involving or related to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant), and having considered these and any other facts in its possession relating to fraud involving or relating to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant), it considers these justify such refusal,

• (d) having checked with the Welsh Ministers for any facts that they consider relevant relating to past or current investigations or proceedings involving or relating to the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) and having considered these and any other facts in its possession involving or relating to the applicant (and where the applicant is a body corporate any director or superintendent of the applicant), it considers that these justify such a refusal, or

• (e) it considers that admitting the applicant to the list would be prejudicial to the efficiency of the pharmaceutical service which they would undertake to provide.

• (3) A Local Health Board must refuse to grant an application where—

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

• (b) the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) has been convicted in the United Kingdom of a criminal offence, other than murder, which was committed after the date on which these Regulations come into force and has been sentenced to a term of imprisonment of over 6 months,

• (c) the applicant is the subject of a national disqualification, or

• (d) on appeal the Tribunal determines that the applicant may be included in the pharmaceutical list subject to conditions but the applicant has not, within 30 days of that decision notified the Local Health Board that they agree to the imposition of conditions.

• (4) Where the Local Health Board is considering a refusal of an application under paragraph (2), it must consider all facts which appear to it to be relevant and must, in particular, take into consideration in relation to paragraph (2)(a), (c) and (d)—

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

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

• (c) whether there are other offences, incidents or investigations to be considered;

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

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

• (f) whether any offence was a sexual offence to which Part 2 of the Sexual Offences Act 2003³⁰ applies, or if it had been committed in England and Wales would have applied,

• (g) whether the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) has been refused admittance to, conditionally included in, removed, contingently removed or is currently suspended from any list or equivalent list on fitness to practise grounds, and if so, the facts relating to the matter which led to such action and the reasons given by the Local Health Board or equivalent body for such action, or

• (h) whether the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) was, at the time of the originating events, or has in the preceding 6 months been, a director or superintendent of a body corporate which has been refused admittance to, conditionally included in, removed or contingently removed from any list or equivalent list, or is currently suspended from any such list on fitness to practise grounds, and if so, what the facts were in each such case and the reasons given by the Local Health Board or equivalent body in each case.

• (5) When the Local Health Board takes into account the matters set out in paragraph (4), it must consider the overall effect of the matters being considered.

• (6) If a Local Health Board refuses an application to which this regulation applies under grounds in paragraph (2) or (3), the Local Health Board must notify the applicant of that decision and it must include with the notification an explanation of—

• (a) the reasons for the decision;

• (b) the applicant’s right of appeal against the decision to the Tribunal, and

• (c) the time limit within which, in accordance with the Tribunal Procedure (First-tier Tribunal) (Health, Education and Social Care Chamber) Rules 2008³¹, the application notice must be sent to the Tribunal if an appeal is to be brought.

Conditional inclusion on fitness grounds

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• (1) A Local Health Board that receives an application from a person—

• (a) under regulation 15(1)(a) (applications to be included in or make amendment to a pharmaceutical list), except where the application is made by a person who has been granted preliminary consent under regulation 18 (applications for preliminary consent and effect of preliminary consent) and which is valid in accordance with regulation 18(5), or

• (b) under regulation 18 where the applicant is not already included in that Local Health Board’s pharmaceutical list,

may determine that the person, whilst they are included in the pharmaceutical list or whilst their preliminary consent is valid, is to be subject to the imposition of conditions having regard to the requirements of section 104 (conditional inclusion in ophthalmic and pharmaceutical lists) of the 2006 Act.

• (2) A Local Health Board may vary the terms of service on which a person is included in the pharmaceutical list for the purpose of paragraph (1).

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

• (a) preventing any prejudice to the efficiency of the pharmaceutical services, or any of the services, which the person has undertaken to provide, or

• (b) preventing any act or omission within section 107(3)(a) of the 2006 Act (disqualification of practitioners).

• (4) If a Local Health Board decides to grant an application subject to a condition imposed under paragraph (1), it must notify the person of that decision and it must include with the notification an explanation of—

• (a) the reasons for the decision,

• (b) the person’s right of appeal against its decision to the Tribunal,

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

• (d) the effect of paragraph (5).

• (5) If the person, in accordance with regulation 23(2), provides a notice of commencement before the Tribunal has determined an appeal against a condition imposed under paragraph (1), that person is to be included in the pharmaceutical list subject to the condition, but only until the outcome of the appeal if the appeal is successful.

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

• (a) the decision of the Local Health Board to impose the condition, and

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

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

• (a) confirms the decision of the Local Health Board, or

• (b) imposes a different condition,

the person must, within 30 days of being notified of the Tribunal’s decision, notify the Local Health Board as to whether or not the person wishes to withdraw their application.

• (8) If the person fails, in the circumstances described in paragraph (7), to notify the Local Health Board within that 30 days that they do not wish to withdraw their application, the grant of that person’s application lapses.

• (9) Where a person wishes to withdraw from a pharmaceutical list, that person must notify the Local Health Board at least 30 days in advance of that date, if—

• (a) a condition is imposed under paragraph (1),

• (b) the person appeals that condition to the Tribunal,

• (c) on appeal, the Tribunal confirms the imposition of that condition or imposes another condition, and

• (d) within 30 days of being informed of the decision of the Tribunal the person notifies the Local Health Board that they wish to withdraw from its pharmaceutical list,

unless it is impracticable for the person to do so in which case the person must notify the Local Health Board as soon as it is practicable to do so.

Removal from a pharmaceutical list for breach of conditions on fitness grounds or imposition or variation or imposition of new conditions under section 108 of the 2006 Act

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• (1) Where a Local Health Board is considering—

• (a) removing a person’s name from the pharmaceutical list under section 107 (disqualification of practitioners) of the 2006 Act, other than in cases specified in regulation 40 (removal from a pharmaceutical list for other reasons),

• (b) contingently removing a person’s name from the pharmaceutical list under section 108 (contingent removal) of the 2006 Act,

• (c) removing a person’s name from the pharmaceutical list for breach of a condition imposed under section 108 of the 2006 Act,

• (d) imposing any particular condition under section 108 of the 2006 Act, or varying any condition or imposing a different condition under that section, or varying a person’s terms of service under section 108(4) of the 2006 Act, or

• (e) removing a person’s name from the pharmaceutical list for breach of a condition under regulation 38 (conditional inclusion relating to fitness grounds),

on fitness grounds, it must follow the procedure set out in this regulation.

• (2) Before taking an action specified in paragraph (1), the Local Health Board must give the person—

• (a) notice of any allegation against that person;

• (b) notice of what action the Local Health Board is considering and on what grounds,

• (c) the opportunity to make written representations within 30 days beginning on the date on which the notification is given under this paragraph, and

• (d) the opportunity to put the person’s case at an oral hearing before the Local Health Board, if the person so requests within the 30 day period mentioned in sub-paragraph (c).

• (3) If the Local Health Board receives representations or a request for an oral hearing within the period specified in paragraph (2)(c), it must take the representations into account, or hold the hearing, as the case may be, before reaching its decision.

• (4) Once the Local Health Board has reached a decision it must notify the person of that decision and it must include with that notification an explanation of—

• (a) the reasons for the decision,

• (b) the person’s right of appeal against its decision to the Tribunal, and

• (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.

• (5) Where the Local Health Board has decided to impose a contingent removal, it must inform the person of their right to have the decision reviewed in accordance with section 113 (review of decisions) of the 2006 Act.

• (6) The Local Health Board must not remove a person’s name from the pharmaceutical list, or impose a contingent removal, until the time for bringing an appeal has expired or, where an appeal is made, it has been determined by the Tribunal.

• (7) Where a Local Health Board is notified by the Tribunal that it has considered—

• (a) an appeal by a person against a contingent removal and the Tribunal has decided to remove the person from the pharmaceutical list instead, or

• (b) an appeal by a person who is subject to conditions under regulation 38 and the Tribunal has decided not to include the person in that pharmaceutical list,

the Local Health Board must remove the person from its pharmaceutical list and must notify the person immediately that it has done so.

Removal from a pharmaceutical list for other reasons

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• (1) Subject to paragraph (2), a Local Health Board must remove a person from a pharmaceutical list that it maintains where it becomes aware that the person (and where the person is a body corporate, any director or superintendent of that body)—

• (a) has been convicted in the United Kingdom of murder,

• (b) has been convicted in the United Kingdom of a criminal offence which was committed after the date on which these Regulations come into force and has been sentenced to a term of imprisonment of over 6 months, or

• (c) is subject to a national disqualification.

• (2) Where a Local Health Board is considering removing a person from its pharmaceutical list under grounds contained in paragraph (1), the Local Health Board must, before reaching its decision—

• (a) notify the person of the action that it is considering taking and the grounds for considering taking that action, and

• (b) as part of that notification—

• (i) inform the person of any allegation made against them, and

• (ii) advise the person that they may make—

• (aa) written representations to the Local Health Board with regard to that action provided such representations are received by the Local Health Board within 30 days beginning with the date of notification by the Local Health Board, and

• (bb) oral representations to the Local Health Board with regard to that action, provided the person notifies the Local Health Board of their wish to make oral representations within 30 days beginning with the date of the notification by the Local Health Board and the person (or a representative) attends the hearing that the Local Health Board arranges for the purposes of hearing those representations, and

• (c) in a case to which paragraph (1)(a) or (b) applies, if the person is a body corporate, advise the person that the Local Health Board will not remove the body corporate from its pharmaceutical list as a consequence of paragraph (1)(a) or (b) (without prejudice to any other action that it may take), provided that—

• (i) the director or superintendent concerned ceases to be a director or superintendent of the body corporate within the period of 30 days commencing with the date of the notice, and

• (ii) within that period, the body corporate notifies the Local Health Board of the date on which the director or superintendent has ceased or is to cease to be a director or superintendent of the body corporate.

• (3) A Local Health Board must remove a person from a pharmaceutical list—

• (a) if the person has not, in the preceding 6 months, provided pharmaceutical services from the premises in respect of which the person is included in the pharmaceutical list (but a period during which the person has been suspended does not count towards calculating the 6 month period), or

• (b) if the person has died, but not if that person’s business is carried on after their death by a representative under section 72 of the Medicines Act 1968 (representative of pharmacist in case of death or disability) so long as the business is carried on by the representative in accordance with the provisions of that Act, and the representative agrees to be bound by the terms of service, or

• (c) if the person is no longer a registered pharmacist.

• (4) Before removing a person from a pharmaceutical list under paragraph (3) the Local Health Board must—

• (a) give the person or the person’s representative mentioned under paragraph (3)(b) 30 days’ notice of its intention to remove the person from the pharmaceutical list,

• (b) give the person or the person’s representative mentioned under paragraph (3)(b) the opportunity to make representations in writing or, if they so desire, in person, during that period, and

• (c) consult the Local Pharmaceutical Committee.

• (5) Once the Local Health Board has taken a decision to remove the person from the pharmaceutical list on grounds contained in paragraph (1), it must notify the person of that decision and it must include with the notification an explanation of—

• (a) the reasons for the decision,

• (b) the person’s right of appeal against its decision to the Tribunal, and

• (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.

• (6) The Local Health Board must notify the person immediately in writing of its decision under paragraph (3) to remove the person from the pharmaceutical list and of the person’s right of appeal under paragraph (7).

• (7) A person notified under paragraph (6) may, within 30 days of receiving the notice appeal the decision by notice in writing to the Welsh Ministers setting out the grounds of appeal.

• (8) Upon receipt of an appeal under paragraph (7) the Welsh Ministers must notify the Local Health Board that an appeal has been received.

• (9) The Welsh Ministers may determine the appeal in respect of which a valid notice of appeal has been given in accordance with paragraph (7) in such manner (including with regard to procedures) as the Welsh Ministers think fit.

• (10) On determining an appeal under paragraph (9), the Welsh Ministers may—

• (a) confirm the decision of the Local Health Board, or

• (b) substitute for that decision any decision that the Local Health Board could have taken when it took that decision.

• (11) A Local Health Board must not remove the person’s name from the pharmaceutical list until—

• (a) if no appeal is made, the period for bringing an appeal against the decision has elapsed, or

• (b) if an appeal is made, the appeal is determined.

• (12) Where an appeal is upheld, the Local Health Board must not remove the person’s name from the pharmaceutical list.

Suspension from a pharmaceutical list

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• (1) Before making a decision under section 110(1) (suspension) or section 111(2) (suspension pending appeal) of the 2006 Act, the Local Health Board must give the person—

• (a) notice of any allegation against that person,

• (b) notice of the action the Local Health Board is considering and on what grounds,

• (c) the opportunity to make written representations within 30 days beginning with the date the notification is given under this paragraph, and

• (d) the opportunity to make representations at an oral hearing before the Local Health Board, provided the person notifies the Local Health Board that they wish to make representations within a specified period (of not less than 24 hours).

• (2) The Local Health Board must take into account any representations made by the person before it reaches its decision.

• (3) Once the Local Health Board has reached a decision it must as soon as is reasonable practicable notify the person in writing of its decision and the reasons for it (including any facts relied upon).

• (4) Where the Local Health Board has suspended a person from the pharmaceutical list, it must inform the person of the reasons for the decision and, in the case of a suspension under section 110(1) of the 2006 Act, of that person’s right to have the decision reviewed in accordance with section 113 (review of decisions) of the 2006 Act.

• (5) The Local Health Board may at any time revoke the suspension and notify the person of its decision.

Notification of a decision to impose conditions

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• (1) Where a Local Health Board decides to—