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

• (a) refuse to grant an application from a person under regulation 37,

• (b) impose conditions under regulation 38,

• (c) remove a person from its pharmaceutical list under regulation 39 or 40,

• (d) suspend a person from its pharmaceutical list under regulation 41,

• (e) impose or vary a condition under regulation 43, or

• (f) impose or vary a condition under regulation 44,

it must notify the persons and bodies specified in paragraph (2) and additionally notify those specified in paragraph (3), if requested to do so by those persons or bodies in writing (including electronically), of the matters set out in paragraph (4).

• (2) The persons to be notified are—

• (a) the Welsh Ministers,

• (b) any other Local Health Board or equivalent body that to the knowledge of the notifying Local Health Board has the applicant included in a relevant list,

• (c) the Scottish Ministers,

• (d) the Secretary of State,

• (e) the Northern Ireland Executive,

• (f) the General Pharmaceutical Council, the Pharmaceutical Society of Northern Ireland or any other appropriate regulatory body,

• (g) the Local Pharmaceutical Committee for the Local Health Board’s area,

• (h) NHS England, and

• (i) in the case of fraud, the NHS Business Services Authority.

• (3) The persons or bodies who may request to be additionally notified in accordance with paragraph (1) are—

• (a) persons or bodies that can establish that they—

• (i) are or were employing the person, are using or have used their services (or where the person is a body corporate, have used the services of any director or superintendent of that body corporate) in a professional capacity, or

• (ii) are considering employing or using the services of the person (or where the person is a body corporate, using the services of any director or superintendent of that body corporate) in a professional capacity, and

• (b) a partnership any of whose members provide or assist in the provision of pharmaceutical services and can establish that the person is or was a member of the partnership or that it is considering inviting the person to become a member.

• (4) The matters referred to in paragraph (1) are—

• (a) where the person is an individual or a partnership—

• (i) the person’s, or each member of the partnership’s name, address and date of birth,

• (ii) the person’s or each member of the partnership’s, professional registration number,

• (iii) the date and copy of the decision of the Local Health Board, and

• (iv) a contact name of a person in the Local Health Board for further enquiries;

• (b) where the person is a body corporate—

• (i) the body corporate’s name, company registration number and the address of the registered office,

• (ii) the professional registration number of body corporate’s superintendent and of any director of the body corporate who is a registered pharmacist,

• (iii) the date and copy of the decision of the Local Health Board, and

• (iv) a contact name of a person in the Local Health Board for further enquiries.

• (5) The Local Health Board must send to the person a copy of any information about them provided to the persons or bodies specified in paragraphs (2) and (3) and any correspondence with those persons or bodies relating to that information.

• (6) Where the Local Health Board has notified any of the persons or bodies specified in paragraph (2) or (3) of the matters set out in paragraph (4), it may in addition, if so requested by that person or body, notify that person or body of any evidence that was considered, including representations made by the person.

• (7) Where a Local Health Board is notified by the Tribunal that it has imposed a national disqualification on a person whom the Local Health Board has removed from its pharmaceutical list, the Local Health Board must notify the persons or bodies specified in paragraph (2)(b), (g), (h) and (i) and paragraph (3).

• (8) Where a decision is changed on review or appeal, or a suspension lapses, the Local Health Board must notify any person or body that was notified of the original decision of the later decision, or of the fact that the suspension has lapsed.

Review of decision to impose a suspension under section 110 of the 2006 Act or a contingent removal under section 108 of the 2006 Act

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• (1) Where in accordance with section 113 (review of decisions) of the 2006 Act, a Local Health Board must review its decision to contingently remove a person from the pharmaceutical list or suspend a person from the pharmaceutical list under section 110 (suspension) of the 2006 Act, or where it decides to review such a decision, it must give that person—

• (a) notice that it intends to review its decision,

• (b) notice of the decision that it is minded to take upon review, and the reasons for it,

• (c) the opportunity to make written representations to the Local Health Board within the period of 30 days beginning with the date of notification under sub-paragraph (a), 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).

• (2) On such a review, the Local Health Board may—

• (a) confirm the contingent removal or suspension,

• (b) in the case of a suspension terminate it, or

• (c) in the case of a contingent removal, vary the conditions, impose different conditions, revoke the contingent removal, or remove the person from the list.

• (3) A person who has been suspended from a pharmaceutical list under section 110 of the 2006 Act or contingently removed from a pharmaceutical list under section 108 of the 2006 Act cannot request a review until the expiry of—

• (a) 3 months beginning with the date of the decision of the Local Health Board to contingently remove, or

• (b) 6 months beginning with the date of the decision on the previous review.

• (4) If the Local Health Board receives representations or a request for an oral hearing within the period specified in paragraph (1)(c), it must take the representations into account or hold the oral hearing, as the case may be, before reaching its decision.

• (5) Once the Local Health Board has made a decision under section 113(3) of the 2006 Act, it must notify the person of its decision and it must include with the notification of its decision an explanation of—

• (a) the reasons for the decision;

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

• (i) the right of appeal that the person has in relation to that decision under section 114 of the 2006 Act (appeals)³², 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 the person has been or remains suspended or contingently removed, the arrangements for review of the suspension or the conditions under section 113(1) of the 2006 Act.

Review of a decision to impose conditions

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• (1) Where a Local Health Board has made a decision to impose conditions in accordance with regulation 38, it may review such a decision either of its own volition or at the request of the person whose application has been granted subject to conditions.

• (2) A person whose application has been granted subject to conditions may not request a review of a Local Health Board’s decision until the expiry of a 3 month period beginning with the date the Local Health Board—

• (a) includes the person’s name on its pharmaceutical list, or

• (b) grants the person preliminary consent,

and cannot request a review within 6 months of a decision on a previous review.

• (3) A Local Health Board must give the person whose application has been granted subject to conditions—

• (a) notice that it intends to review its decision,

• (b) notice of the decision that it is minded to take upon review, and the reasons for it,

• (c) the opportunity to make written representations to the Local Health Board within the period of 30 days beginning with the date of notification under sub-paragraph (a), 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).

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

• (5) Upon review the Local Health Board may—

• (a) maintain the current conditions,

• (b) impose new conditions,

• (c) vary the person’s terms of service,

• (d) vary the conditions, or

• (e) where the person has breached a condition, remove the person from the pharmaceutical list.

• (6) As soon as practicable after reaching a decision, the Local Health Board must notify the person of its decision, and it must include with the notification of its decision an explanation of—

• (a) the reasons for the decision,

• (b) the right of appeal that the person has 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.

Appeals

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• (1) A person, other than a person notified under regulation 42, who has been notified by a Local Health Board of its decision that—

• (a) intends to—

• (i) refuse to grant an application to which regulation 37 (refusal of applications on fitness grounds) applies under grounds contained in paragraph (2) or (3) of that regulation,

• (ii) impose conditions on the person by virtue of regulation 38 (conditional inclusion relating to fitness grounds), or vary the person’s terms of service pursuant to that regulation,

• (iii) in accordance with regulation 39 (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)—

• (aa) remove the person’s name from the pharmaceutical list under section 107 (disqualification of practitioners) of the 2006 Act;

• (bb) contingently remove the person’s name from the pharmaceutical list under section 108 (contingent removal) of the 2006 Act;

• (cc) remove the person’s name from the pharmaceutical list for breach of a condition imposed under section 108 of the 2006 Act;

• (dd) impose any particular condition under section 108 of the 2006 Act, vary any condition, impose a different condition or vary the person’s terms of service under that section;

• (ee) remove the person’s name from the pharmaceutical list for breach of a condition imposed under regulation 38, or

• (iv) remove the person from the pharmaceutical list on grounds contained in regulation 40(1), or

• (b) has reviewed a decision to impose conditions under regulation 44 (review of a decision to impose conditions) and has decided to take any of the actions in regulation 44(5), or

• (c) has reviewed a decision to contingently remove the person from a pharmaceutical list by virtue of regulation 43 (review of decision to impose a suspension under section 110 of the 2006 Act or a contingent removal under section 108 of the 2006 Act) and has—

• (i) confirmed the contingent removal,

• (ii) varied the conditions attached to the contingent removal or imposed different conditions, or

• (iii) has removed the person from the pharmaceutical list,

may appeal that decision to the Tribunal.

• (2) An appeal under paragraph (1) must be made in writing, setting out the grounds on which the appeal is made and must be submitted to the Tribunal within 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.

• (3) The Tribunal, on determining an appeal, may make any decision that the Local Health Board could make under this Part.

PART 8 — Conditional inclusion in pharmaceutical lists: certain specific conditions that do not relate to fitness or performance

Core opening hours conditions

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• (1) Where, in the course of making an application to which regulation 15, 19, 20 or 22 applies—

• (a) for inclusion in a pharmaceutical list as mentioned in regulation 10(1)(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 Local Health Board, additional pharmacy premises—

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

• (ii) the NHS pharmacist and the Local Health Board agreed that pharmaceutical services are to be provided at the proposed pharmacy premises during the additional opening hours specified (that is, the hours which are the difference between the total number of hours specified and 40) 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, the Local Health Board must direct that the person listed in relation to the premises is to provide pharmaceutical services at 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;

• (b) for inclusion in a pharmaceutical list as mentioned in regulation 10(1)(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 Local Health Board, additional appliance contractor premises—

• (i) an NHS appliance contractor undertook to provide pharmaceutical services at proposed appliance contractor premises for a specified number of core opening hours each week which is more than 30,

• (ii) the NHS appliance contractor and the Local Health Board agreed that pharmaceutical services are to be provided at 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, the Local Health Board must direct that the person listed in relation to the premises is to provide pharmaceutical services at 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.

• (2) Where the Local Health Board has—

• (a) invited an NHS pharmacist or NHS appliance contractor to increase the total number of core opening hours during which the NHS pharmacist or NHS appliance contractor is to provide pharmaceutical services at listed premises, and

• (b) thereafter agreed with the NHS pharmacist or NHS appliance contractor—

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

• (ii) in the case of an NHS pharmacist, that pharmaceutical services are to be provided at the pharmacy premises during any additional opening hours (that is, the hours which are the difference between the total number of hours specified and 40) at set times and on set days, or

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

the Local Health Board must direct that the person listed in relation to the premises is to provide pharmaceutical services at those premises for the specified number of core opening hours so undertaken, and during any additional opening hours at the set times and on the set days so agreed.

• (3) Except as so provided for under paragraph (2) and subject to paragraph (4), the Local Health Board may only vary a direction given under paragraph (1) or (2) in accordance with paragraph 25 or 26 of Schedule 5 or paragraph 15 or 16 of Schedule 6.

• (4) A direction given under paragraph (1) or (2) must not be varied within 3 years of the direction having been given.

Conditions relating to providing directed services

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• (1) Where in the course of making an application under these Regulations or the 2013 Regulations, an NHS pharmacist or an NHS appliance contractor undertook—

• (a) to provide the directed services mentioned in the application, if a Local Health Board 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

• (c) not to withhold agreement to a service specification unreasonably,

the inclusion in the pharmaceutical list of the person listed in relation to the premises that were listed as a consequence of that application is subject to the condition set out in paragraph (2).

• (2) The condition is that the person listed in relation to the premises must—

• (a) provide the directed services mentioned in the application (whether or not the person listed was the applicant), and

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

if the Local Health Board commissions the services from the person listed in relation to the premises 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 the Local Health Board ceases to commission the services (if it has commissioned them).

• (3) Where a Local Health Board 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.

• (4) The Local Health Board may not vary or remove the condition imposed by virtue of paragraph (2).

Conditions relating to local resolution of disputes over terms of service

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• (1) It is a condition of the inclusion of each NHS pharmacist or NHS appliance contractor in a pharmaceutical list by the Local Health Board that the NHS pharmacist or NHS appliance contractor will make every reasonable effort to communicate with the Local Health Board with a view to resolving any dispute between either the NHS pharmacist or NHS appliance contractor and the Local Health Board relating to compliance with the terms of service under which pharmaceutical services are provided.

• (2) The Local Health Board may not vary or remove the condition imposed by virtue of paragraph (1).

PART 9 — Performance related sanctions and Market Exit

Local dispute resolution before serving remedial notices or breach notices

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• (1) Subject to paragraph (3), before issuing a notice under regulation 50 or 51, the Local Health Board must make every reasonable effort to communicate and co-operate with an NHS pharmacist or NHS appliance contractor with a view to resolving any dispute between the NHS pharmacist or NHS appliance contractor and the Local Health Board relating to compliance by the NHS pharmacist or NHS appliance contractor with the terms of service.

• (2) Where an NHS pharmacist or NHS appliance contractor invites a Local Pharmaceutical Committee to participate in the attempts to resolve the dispute, the Local Health Board 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 the Local Health Board is satisfied—

• (a) the dispute relates to a matter that has already been the subject of dispute resolution between the Local Health Board and the NHS pharmacist or NHS appliance contractor and there are no new issues of substance that justify delay in issuing a notice under regulation 50 or 51, or

• (b) that it is appropriate to proceed immediately to issuing a notice under regulation 50 or 51—

• (i) because listed premises are not, or have not been, open during core opening hours or supplementary opening hours without good cause,

• (ii) to protect the safety of any persons to whom an NHS pharmacist or NHS appliance contractor may provide pharmaceutical services, or

• (iii) to protect the Local Health Board from material financial loss.

Breaches of terms of service: remedial notices

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• (1) Where an NHS pharmacist or NHS appliance contractor breaches a term of service and the breach is capable of remedy, the Local Health Board may by a notice (“a remedial notice”) require the NHS pharmacist or NHS appliance contractor to remedy the breach.

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

• (a) the nature of the breach,

• (b) the steps the NHS pharmacist or NHS appliance contractor must take, to the satisfaction of the Local Health Board, in order to remedy the breach,

• (c) the period (“the notice period”) during which the steps must be taken, and

• (d) an explanation of how the NHS pharmacist or NHS appliance contractor’s rights of appeal under regulation 54(1)(a) may be exercised.

• (3) The notice period must be not less than 30 days, unless the Local Health Board is satisfied that a shorter period is appropriate—

• (a) to protect the safety of any persons to whom the NHS pharmacist or NHS appliance contractor may provide pharmaceutical services, or

• (b) to protect the Local Health Board from material financial loss.

• (4) If the breach relates to a failure to provide, or a failure to provide to a reasonable standard, a pharmaceutical service that an NHS pharmacist or NHS appliance contractor 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, the Local Health Board is to withhold all or part of the remuneration due to the NHS pharmacist or NHS appliance contractor in respect of that period under the Drug Tariff or a determination as mentioned in regulation 56(2)(b);

• (b) pending the NHS pharmacist or NHS appliance contractor taking the steps that either must take, to the satisfaction of the Local Health Board, in order to remedy the breach, the Local Health Board is to withhold all or part of the remuneration due to the NHS pharmacist or NHS appliance contractor under the Drug Tariff or a determination as mentioned in regulation 56(2)(b), and in these circumstances—

• (i) as regards any period for which the NHS pharmacist or NHS appliance contractor remains in breach, any withholding that is attributable to that period is to be permanent, and

• (ii) once the NHS pharmacist or NHS appliance contractor has taken the steps required, to the satisfaction of the Local Health Board, any withholding that has taken place which is attributable to a period when the NHS pharmacist or NHS appliance contractor is no longer in breach is to be restored, provided that the NHS pharmacist or NHS appliance contractor submits a claim, in accordance with the Drug Tariff or a determination as mentioned in regulation 56(2)(b), 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 56(2)(b) where the breach relates to a failure to provide, or a failure to provide to a reasonable standard, a pharmaceutical service.

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

• (7) If the Local Health Board refuses to restore all or part of any withheld remuneration which is claimed under paragraph (4)(b)(ii), it must notify the NHS pharmacist or NHS appliance contractor 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 the NHS pharmacist or NHS appliance contractor’s rights of appeal under regulation 54(1)(b) may be exercised.

• (8) A Local Health Board may vary or revoke a remedial notice issued in accordance with this regulation at any time after it has been issued.

Breaches of terms of service: breach notices

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• (1) Where an NHS pharmacist or NHS appliance contractor breaches a term of service and the breach is not capable of remedy, the Local Health Board may by a notice (“a breach notice”) require the NHS pharmacist or NHS appliance contractor 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 the NHS pharmacist or NHS appliance contractor’s rights of appeal under regulation 54(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 pharmaceutical service that an NHS pharmacist or NHS appliance contractor 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, the Local Health Board is to withhold all or part of the remuneration due to the NHS pharmacist or NHS appliance contractor under the Drug Tariff or a determination as mentioned in regulation 56(2)(b) 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 56(2)(b) where the breach relates to a failure to provide, or a failure to provide to a reasonable standard, a pharmaceutical service.

• (5) A Local Health Board may vary or revoke a breach notice issued in accordance with this regulation at any time after is has been issued.

Payment withholdings: supplementary matters

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• (1) A remedial notice or breach notice may only provide for the withholding of all or any part of the remuneration of an NHS pharmacist or NHS appliance contractor if—

• (a) the Local Health Board 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) the Local Health Board 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) The Local Health Board 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 the NHS pharmacist or NHS appliance contractor 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 57 and the Drug Tariff.

• (4) For the purposes of regulations 50(4) and 51(3), remuneration determined by the Welsh Ministers, or by the Local Health Board acting as determining authority pursuant to regulation 56(2)(b), is remuneration due to the NHS pharmacist or NHS appliance contractor under the Drug Tariff.

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

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• (1) The Local Health Board may remove an NHS pharmacist or NHS appliance contractor from a pharmaceutical list, or remove the listing of a particular listed premises in relation to the NHS pharmacist or NHS appliance contractor, if the NHS pharmacist or NHS appliance contractor—

• (a) fails to take the steps set out in a remedial notice, to the satisfaction of the Local Health Board, in order to remedy the breach, and the Local Health Board is satisfied that it is necessary to remove the NHS pharmacist or NHS appliance contractor from the pharmaceutical list, or remove the listing of a particular listed premises in relation to the NHS pharmacist or NHS appliance contractor—

• (i) to protect the safety of any persons to whom the NHS pharmacist or NHS appliance contractor may provide pharmaceutical services, or

• (ii) to protect the Local Health Board from material financial loss, or

• (b) has breached terms of service for NHS pharmacists and NHS appliance contractors, and—

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

• (ii) been previously issued with a remedial notice or breach notice in relation to the relevant term of service, and the Local Health Board is satisfied that the NHS pharmacist or NHS appliance contractor is likely to persist in breaching the term of service without good cause, or

• (iii) has repeatedly been issued with remedial notices or breach notices (or both) in relation to different terms of service, and the Local Health Board is satisfied that the NHS pharmacist or NHS appliance contractor is likely to persist in breaching their terms of service without good cause.

• (2) For the purpose of paragraph (1), the Local Health Board may only remove—

• (a) particular premises from a NHS pharmacist or NHS appliance contractor’s listing in a pharmaceutical list if the relevant breaches all relate to those particular premises, or

• (b) an NHS pharmacist or NHS appliance contractor from a particular pharmaceutical list if the relevant breaches all relate to listed premises which are the only premises listed in that pharmaceutical list in relation to the NHS pharmacist or NHS appliance contractor.

• (3) The Local Health Board may only remove an NHS pharmacist or NHS appliance contractor, or a premises listed in relation to an NHS pharmacist or NHS appliance contractor, 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) the Local Health Board, when it notifies the NHS pharmacist or NHS appliance contractor of the decision, includes in the notice its duly justified reasons for the decision.

• (4) The Local Health Board 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 the NHS pharmacist or NHS appliance contractor to discover the reasons but has been unable to discover them.

• (5) Where the Local Health Board is considering removing an NHS pharmacist or NHS appliance contractor, or removing the listing of particular premises listed in relation to an NHS pharmacist or NHS appliance contractor, from a pharmaceutical list under paragraph (1), it must—

• (a) give notice to the NHS pharmacist or NHS appliance contractor, at least 30 days in advance of taking the decision, that the Local Health Board is minded to remove the NHS pharmacist, NHS appliance contractor or the premises from a pharmaceutical list,

• (b) as part of that notification, advise the NHS pharmacist or NHS appliance contractor that they may make—

• (i) written representations to the Local Health Board with regard to that action, provided the NHS pharmacist or NHS appliance contractor notifies the Local Health Board with those representations within 30 days beginning with the date of the notification by the Local Health Board, and

• (ii) oral representations to the Local Health Board with regard to that action, provided—

• (aa) the NHS pharmacist or NHS appliance contractor notifies the Local Health Board of the NHS pharmacist or NHS appliance contractor’s wish to do so within 30 days beginning with the date of the notification by the Local Health Board, and

• (bb) the NHS pharmacist or NHS appliance contractor (or a representative) attends the hearing that the Local Health Board arranges for the purpose of hearing those representations, which the Local Health Board must give the NHS pharmacist or NHS appliance contractor reasonable notice of, and

• (c) consult any Local Pharmaceutical Committee whose area includes the particular listed premises or the only premises of the NHS pharmacist or NHS appliance contractor on that pharmaceutical list.

• (6) If the Local Health Board does decide to remove a NHS pharmacist or NHS appliance contractor, or to remove the listing of particular premises listed in relation to the NHS pharmacist or NHS appliance contractor, from a pharmaceutical list under paragraph (1), it must, when it notifies the NHS pharmacist or NHS appliance contractor of that decision, include in that notification—

• (a) a statement of the reasons for the decision, and

• (b) an explanation of how the NHS pharmacist or NHS appliance contractor’s rights of appeal under regulation 54(1)(d) may be exercised.

Appeals against decisions under Part 9

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• (1) An NHS pharmacist or NHS appliance contractor may appeal against the following decisions by the Local Health Board—

• (a) the issuing of a remedial notice under regulation 50, including—

• (i) the specified steps that an NHS pharmacist or NHS appliance contractor 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 the NHS pharmacist or NHS appliance contractor, as provided for in a remedial notice in accordance with regulation 50(4)(b)(ii), or to restore a smaller amount than the amount that the NHS pharmacist or NHS appliance contractor considers should be restored;

• (c) the issuing of a breach notice under regulation 51, including—

• (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 an NHS pharmacist or NHS appliance contractor from a pharmaceutical list, or remove the listing of particular listed premises in relation to the NHS pharmacist or NHS appliance contractor, under regulation 53(1);

provided that an NHS pharmacist or NHS appliance contractor notifies the Welsh Ministers with a valid notice of appeal within 30 days of the date on which the NHS pharmacist or NHS appliance contractor 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) The Local Health Board must not remove an NHS pharmacist, NHS appliance contractor or the listing of particular listed premises in relation to an NHS pharmacist or NHS appliance contractor (as the case may be) from a pharmaceutical list under regulation 53(1)—

• (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 Welsh Ministers.

• (4) Schedule 4 has effect in relation to appeals to the Welsh Ministers against decisions under this Part.

PART 10 — Payments to NHS pharmacists and NHS appliance contractors

The Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors

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• (1) The Drug Tariff referred to in section 81(4) of the 2006 Act (arrangements for additional pharmaceutical services) is the aggregate of—

• (a) the determinations of remuneration made by the Welsh Ministers, acting as a determining authority, under section 88 of the 2006 Act (remuneration for persons providing pharmaceutical services), and

• (b) any other instruments that the Welsh Ministers are required by virtue of these Regulations or the 2006 Act to publish, or which they do publish, together with those determinations,

in the publication known as the Drug Tariff published by the Welsh Ministers in such format as they think fit.

• (2) Determinations under section 88 of the 2006 Act by the Welsh Ministers—

• (a) may be made by reference to scales, indices or formulae of any kind, and where a determination falls to be made by reference to any such scale, index or formula, the determination may provide that the relevant price calculation is to be made by reference to the scale, index or formula which is—

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

• (ii) in any subsequent form taking effect after that time, and

• (b) may take effect in relation to remuneration in respect of a period beginning on or after the date specified in the determination, which may be the date of the determination or an earlier or later date, but it may be an earlier date only if, taking the determination as a whole, it is not detrimental to the persons to whose remuneration it relates.

• (3) Where a determination included in the Drug Tariff does not specify a date as mentioned in paragraph (2)(b), it will have effect in relation to remuneration in respect of the period beginning on the date on which the change to the Drug Tariff is published in accordance with paragraph (4).

• (4) Amendments that may be made to the Drug Tariff at such intervals as the Welsh Ministers think fit must be published by the Welsh Ministers in a consolidated version of the Drug Tariff that has the amendments included in it.

• (5) The consultation that the Welsh Ministers undertake under section 89(1) of the 2006 Act (section 88: supplementary) prior to the inclusion of or a change to the price of a drug or appliance which is to form part of a calculation of remuneration must 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).

• (6) Payments under the Drug Tariff must be made—

• (a) by the Local Health Board responsible for making the payment, and

• (b) in accordance with arrangements for claiming and making payments which are to be set out in the Drug Tariff but subject, as appropriate, to any deduction that may or must be made from the remuneration of an NHS pharmacist or NHS appliance contractor under these Regulations or any other regulations under the 2006 Act.

Local Health Boards as determining authorities

56

• (1) The Welsh Ministers may state in the Drug Tariff that the determining authority for a particular fee, allowance or other remuneration is to be the Local Health Board of the NHS pharmacist or NHS appliance contractor to whom the remuneration relates.

• (2) Where a Local Health Board is authorised to be a determining authority, the Local Health Board must—

• (a) consult the relevant Local Pharmaceutical Committee before making any determination,

• (b) publish the determination in such manner as it thinks appropriate for bringing it to the attention of persons included in its pharmaceutical lists, and

• (c) make the determination available for inspection.

• (3) A determination made by a Local Health Board must include the arrangements for claiming and paying the remuneration and—

• (a) claims by NHS pharmacists and NHS appliance contractors must be made in accordance with the arrangements, and

• (b) payments of remuneration must be made in accordance with the arrangements subject, as appropriate, to any deduction that may or must be made from the remuneration under these Regulations or any other regulations under the 2006 Act.

Overpayments

57

• (1) Where a Local Health Board considers that a payment has been made to an NHS pharmacist or NHS appliance contractor as mentioned in regulation 55(6) or 56(3) in circumstances where it was not due, the Local Health Board must draw the overpayment to the attention of the NHS pharmacist or NHS appliance contractor and—

• (a) where the overpayment is admitted by the NHS pharmacist or NHS appliance contractor, or

• (b) where the NHS pharmacist or NHS appliance contractor does not admit there has been an overpayment but the Local Health Board or, on appeal, the Welsh Ministers under regulation 9(1)(c) of the National Health Service (Service Committees and Tribunal) Regulations 1992, decides that there has been an overpayment,

the amount overpaid will be recoverable either by deduction from the remuneration of the NHS pharmacist or NHS appliance contractor or in some other manner.

• (2) Recovery of an overpayment under this regulation is without prejudice to the investigation of an alleged breach of the terms of service.

Reward scheme

58

• (1) An NHS pharmacist who is presented with an order under paragraph 5 of Schedule 5 or an NHS appliance contractor who is presented with an order under paragraph 4 of Schedule 6 will be eligible to claim a payment from the Local Health Board, in accordance with the Drug Tariff, if—

• (a) in accordance with paragraph 10 of Schedule 5 or paragraph 9 of Schedule 6 the NHS pharmacist or the NHS appliance contractor refused to provide the drugs or medicines or listed appliances ordered and informed the Local Health Board of this action as soon as practicable, or

• (b) the NHS pharmacist or the NHS appliance contractor provided the drugs or listed appliances but had reason to believe at that time or subsequently came to have reason to believe that the order was not a genuine order for the person named on the prescription form or repeatable prescription form and informed the Local Health Board of this belief as soon as practicable and in either case the NHS pharmacist or the NHS appliance contractor has sent the order referred to in this paragraph to the Local Health Board and the Local Health Board has established that the order referred to in this paragraph was not a genuine order for the person named on the prescription form or repeatable prescription form.

• (2) The Local Health Board must in respect of any claim under paragraph (1) make such payment as is due to the NHS pharmacist or the NHS appliance contractor calculated in the manner specified in the Drug Tariff.

• (3) In this regulation, “order” includes a purported order.

Payments to suspended NHS pharmacists and NHS appliance contractors

59

• (1) The Local Health Board must make payments to any NHS pharmacist or NHS appliance contractor who is suspended from a pharmaceutical list, in accordance with the Welsh Ministers’ determination in relation to such payments.

• (2) The Welsh Ministers must make the determination in accordance with paragraph (3) after consultation with such organisations as they may recognise as representing NHS pharmacists and NHS appliance contractors with whom arrangements for the provision of pharmaceutical services exist, and must publish it in the Drug Tariff.

• (3) The determination may be amended from time to time by the Welsh Ministers after consultation with the organisations referred to in paragraph (2), and any amendments must also be published with the Drug Tariff.

• (4) The Welsh Ministers’ determination may include provision that payments in accordance with the determination are not to exceed a specified amount in any specified period.

PART 11 — Miscellaneous

Home Local Health Board

60

• (1) An applicant which is a body corporate that is required to provide the information specified in Part 2 of Schedule 2 may make a request to a Local Health Board for that Local Health Board to act as its home Local Health Board.

• (2) Where a Local Health Board has agreed to a request made under paragraph (1), an applicant required to provide as part of an application the information specified in Part 2 of Schedule 2 may instead provide that information to its home Local Health Board and inform the Local Health Board to which the application is made that the home Local Health Board already has the information.

• (3) The home Local Health Board must pass the information it has received from an applicant under this regulation to any Local Health Board to which the applicant makes a subsequent application and must do so within 30 days of a request for that information from the other Local Health Board.

• (4) The applicant must either—

• (a) confirm to the Local Health Board to which the application is made that the information is up to date, or

• (b) update the information by sending it to the home Local Health Board.

Publication of particulars

61

• (1) A Local Health Board must publish in such manner as it sees fit and make available for inspection at its offices copies of—

• (a) its pharmaceutical needs assessment,

• (b) its pharmaceutical list,

• (c) its dispensing doctor list,

• (d) a map delineating the boundaries of any controlled localities and reserved locations that have been determined,

• (e) details of any determinations made by the Local Health Board under these Regulations in the previous 3 years,

• (f) the terms of service for NHS pharmacists in Schedule 5,

• (g) the terms of service for NHS appliance contractors in Schedule 6,

• (h) the terms of service for doctors providing pharmaceutical services in Schedule 7, and

• (i) the Drug Tariff.

• (2) A Local Health Board may—

• (a) make such of the documents referred to in paragraph (1) available for inspection at such other places in the area for which it is established as appear to it convenient for informing all persons interested, or

• (b) publish at such places in the area for which it is established a notice of the places and times at which copies of such documents may be seen.

• (3) A Local Health Board must send a copy of its pharmaceutical needs assessment, pharmaceutical lists and of its dispensing doctor list to the Welsh Ministers, the Local Medical Committee and the Local Pharmaceutical Committee, and must, within 14 days of any alteration to those lists, inform them in writing of those alterations.

Exercise of choice in certain cases

62

An application to an NHS pharmacist or an NHS appliance contractor for pharmaceutical services may be made—

• (a) on behalf of any child by either parent, or in the absence of both parents, the guardian or other person who has the care of the child,

• (b) on behalf of any person under 18 years of age who is—

• (i) in the care of an authority to whose care the person has been committed under the provisions of the Children Act 1989³³, by a person duly authorised by that authority, or

• (ii) in the care of a voluntary organisation, by that organisation or a person duly authorised by them,

• (c) on behalf of any adult who is incapable of making such an application or authorising such an application to be made on their behalf, by a relative or the primary carer of that person, or

• (d) on behalf of any other person by any duly authorised person.

Transitional provisions

63

• (1) Any application made under the 2013 Regulations that has been received by a Local Health Board on or before 30 September 2021 must be determined in accordance with the provisions of the 2013 Regulations until that application is finally determined.

• (2) Any proposed determination by a Local Health Board under regulation 6(2) of the 2013 Regulations (areas that are controlled localities) on or before 30 September 2020, must be determined in accordance with the provisions of the 2013 Regulations until that application has been finally determined.

• (3) Any appeal under the 2013 Regulations that is—

• (a) received by the Welsh Ministers on or before 30 September 2020, or

• (b) made after the coming into force of these Regulations in respect of an application determined in accordance with paragraph (1) or a determination made under paragraph (2),

must be determined in accordance with the provisions of the 2013 Regulations.

• (4) Where, before 30 September 2020 or as a consequence of paragraph (1) or (3), a person is entitled on the basis of a decision (whether by a Local Health Board or on appeal)—

• (a) to be included in a pharmaceutical list or a dispensing doctor list but has not been included in that list, or

• (b) to have listed in relation to their entry in a pharmaceutical list or dispensing doctor list premises that have not been listed in relation to them,

the arrangements for the listing of that person or those premises, and the circumstances in which that decision lapses, are as set out in the 2013 Regulations.

• (5) In respect of a determination made under paragraph (2), the procedure that must be followed is that in regulation 6(4) of, and Parts 1 and 2 of Schedule 2 to, the 2013 Regulations.

• (6) Where preliminary consent was granted under regulation 12 of the 2013 Regulations (applications for preliminary consent and effect of preliminary consent) and no application had been made under regulation 12(6) of the 2013 Regulations before 30 September 2020, regulation 18 (applications for preliminary consent and effect of preliminary consent) will apply as if the preliminary consent had been granted under that regulation.

• (7) Where paragraph (6) applies, regulation 12(6) of the 2013 Regulations is substituted for regulation 18(5).

• (8) If a determination under regulation 6 of the 2013 Regulations has not been finally determined before 30 September 2020 (“an outstanding determination”) a Local Health Board must defer consideration of any application submitted to it under Parts 5 and 6 of these Regulations if the application could be affected by an outstanding determination until such time as the outstanding determination is finally determined.

• (9) For the purposes of this regulation, an application or a determination is not to be treated as finally determined until the end of the period for bringing an appeal against that application or determination, or until the determination of any such appeal, whichever is later.

Minor and consequential amendments

64

The Regulations listed in Schedule 8 are amended as set out in that Schedule.

Revocation

65

• (1) The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 are revoked in accordance with paragraphs (2) to (5).

• (2) On 1 October 2020—

• (a) Parts 1 to 3, and

• (b) Parts 7 and 8.

• (3) On 31 March 2021—

• (a) in Part 4, regulation 8(1)(a), and

• (b) in Part 5, regulation 20.

• (4) On 1 October 2021—

• (a) in Part 4, regulation 8(1)(b) to (7), and regulations 9 to 19,

• (b) in Part 5, regulations 21 to 30, and

• (c) Part 6.

• (5) So far as they have not been revoked by paragraphs (2) to (4), the 2013 Regulations are revoked on 1 October 2021.

SCHEDULE 1 — Information to be contained in pharmaceutical needs assessments

Current provision of pharmaceutical services

1

A statement of the pharmaceutical services that the Local Health Board has identified as services that are provided—

• (a) in the area of the Local Health Board and which are necessary to meet the need for pharmaceutical services in its area,

• (b) outside the area of the Local Health Board but which nevertheless contribute towards meeting the need for pharmaceutical services in its area (if the Local Health Board has identified such services), or

• (c) in or outside the area of the Local Health Board and, whilst not being services of the types described in sub-paragraph (a) or (b), they nevertheless affect the assessment by the Local Health Board of the need for pharmaceutical services in its area.

Other NHS services

2

A statement of any NHS services provided or arranged by the Local Health Board, another Local Health Board, a dispensing doctor or NHS Trust to which the Local Health Board has had regard in its assessment, which affect the need for pharmaceutical services, or pharmaceutical services of a specified type, in its area.

Gaps in provision of pharmaceutical services

3

A statement of the pharmaceutical services that the Local Health Board has identified (if it has) as services that are not provided in the area of the Local Health Board but which the Local Health Board is satisfied—

• (a) need to be provided (whether or not they are located in the area of the Local Health Board) in order to meet a current need for pharmaceutical services, or pharmaceutical services of a specified type, in its area;

• (b) will, in specified future circumstances, need to be provided (whether or not they are located in the area of the Local Health Board) in order to meet a future need for pharmaceutical services, or pharmaceutical services of a specified type, in its area.

How the assessment was carried out

4

An explanation of how the assessment has been carried out, and in particular—

• (a) how it has determined what are the localities in its area,

• (b) how it has taken into account (where applicable)—

• (i) the different needs of different localities in its area, and

• (ii) the different needs of members of different groups in its area who share a common attribute in respect of one, or more than one, of the following characteristics—

• (aa) age,

• (bb) gender,

• (cc) proposed, commenced or completed reassignment of gender,

• (dd) disability,

• (ee) race,

• (ff) religion or belief, and

• (gg) sexual orientation;

• (c) a report on the consultation that it has undertaken.

Map of provision

5

A map that identifies the premises at which pharmaceutical services and dispensing services are provided in the area of the Local Health Board.

SCHEDULE 2 — Information to be included in applications to provide pharmaceutical services

PART 1 — Application for inclusion in or for amendment to a pharmaceutical list

Information required from all applicants

Details of the application

1

Name of the Local Health Board to which the application is made.

2

Type of consent applied for (full or preliminary).

3

Type of application (for example: new inclusion; relocation within a Local Health Board’s area; relocation between neighbouring Local Health Board areas; relocation; change of ownership; preliminary consent).

Details of the applicant

4

Name and address of the applicant.

5

If the applicant is an individual or a partnership carrying on a retail pharmacy business, the applicant’s or each partner’s registration number in the General Pharmaceutical Council register.

6

If the applicant is a body corporate carrying on a retail pharmacy business, the name and registration number of the applicant’s superintendent in the General Pharmaceutical Council register.

Details of the premises and opening hours

7

The address of the premises from which the applicant applies to provide pharmaceutical services; or the location of the premises from which the applicant intends to provide pharmaceutical services if the application is for preliminary consent.

8

Whether the applicant is currently in possession of the premises or whether, for example, the premises are under construction or negotiation.

9

The days on which the pharmacy will be open for the provision of pharmaceutical services and the opening hours on those days.

Pharmaceutical services to be provided

10

Confirmation that all essential services will be provided and, if applicable, which appliances the applicant undertakes to supply.

11

Details of directed services that the applicant applies to provide.

12

If the application is to provide pharmaceutical services of a different description to those currently provided at the listed premises, details of those services.

Information relating to applications to be included in, or amend, a pharmaceutical list

13

Where regulation 16 applies to the determination of an application, the applicant must state the reasons why the applicant considers the application will meet a need identified in the relevant pharmaceutical needs assessment of the Local Health Board in which the premises specified in the application are situated.

Information relating to the prejudice test

14

Where the prejudice test in regulation 16 applies to the determination of an application, the applicant must state the reasons why they consider that granting the application will not prejudice the proper provision of primary medical services, dispensing services or pharmaceutical services in the controlled locality in which the premises specified in the application are situated.

Information relating to applications involving relocations

15

Where the applicant applies to relocate (whether within the Local Health Board’s area under regulation 19, between neighbouring Local Health Board areas under regulation 20 or on a temporary relocation basis under regulation 21) the applicant must provide details of the proposed relocation including the address of the applicant’s existing listed premises.

16

Where the application involves a relocation between neighbouring Local Health Board area under regulation 20 the applicant must state—

• (a) the name of the Local Health Board where the existing premises are located,

• (b) that the applicant consents to the removal of their name from the pharmaceutical list maintained by the Local Health Board in whose area the existing premises are located and in respect of those existing listed premises with effect from the date on which the provision of pharmaceutical services from the new premises will commence, and

• (c) how the applicant intends to meet a need identified in the pharmaceutical needs assessment of the neighbouring Local Health Board, if the application involves a relocation to meet such a need.

17

The applicant must provide details of whether—

• (a) for the patients who are accustomed to accessing pharmaceutical services at the existing premises, the location of the new premises is significantly less accessible,

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

• (c) the provision of pharmaceutical services will be continuous or interrupted and the reasons for any interruption.

18

If the application is for a temporary relocation, the applicant must state the circumstances that require a temporary relocation.

Information relating to applications involving a change of ownership

19

Name of the person included in the pharmaceutical list currently providing pharmaceutical services from the premises.

20

The applicant must provide details of whether—

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

• (b) the provision of pharmaceutical services will be continuous or interrupted and the reasons for any interruption.

Applicant’s undertaking

21

The applicant must give an undertaking that if the application is granted the applicant will provide the pharmaceutical services, and if applicable supply the appliances, at the premises in respect of which the application is granted in accordance with the applicable terms of service.

PART 2 — Information and undertakings for applications for inclusion in a pharmaceutical list

Applicant’s details

22

• (1) An applicant (other than an applicant which is a body corporate) must provide the following information—

• (a) full name,

• (b) gender,

• (c) date of birth,

• (d) address and telephone number,

• (e) a declaration that they are a registered pharmacist, and

• (f) professional registration number and date of first registration in the register.

• (2) An applicant which is a body corporate must provide the following information—

• (a) full name,

• (b) company registration number,

• (c) registered office and telephone number relating to that office,

• (d) a declaration that it is a person who is or who will be lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968,

• (e) registration number in the Register of Premises maintained by the General Pharmaceutical Council, and

• (f) details of any relevant list from which it has been removed or contingently removed, or to which it has been refused admission or in which it has been conditionally included, on fitness grounds, with an explanation as to why.

Investigation, proceedings and convictions

23

An applicant must supply in writing information as to whether they, or where the applicant is a body corporate any of its directors or its superintendent—

• (a) has any criminal convictions in the United Kingdom,

• (b) has been bound over following a criminal conviction in the United Kingdom,

• (c) has accepted a police caution in the United Kingdom,

• (d) has in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging them absolutely (without proceeding to conviction),

• (e) has accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal) or agreed to pay a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution),

• (f) has been convicted elsewhere of an offence, or what would constitute a criminal offence if committed in England and Wales, or is subject to a penalty which would be the equivalent of being bound over or cautioned,

• (g) is currently the subject of any proceedings which might lead to such a conviction, which have not yet been notified to the Local Health Board,

• (h) has been subject to any investigation into their professional conduct by any licensing, regulatory or other body, where the outcome was adverse,

• (i) is currently subject to any investigation into their professional conduct by any licensing, regulatory or other body,

• (j) is or has been where the outcome was adverse, the subject of any investigation into their professional conduct in respect of any current or previous employment,

• (k) is the subject of any investigation by another Local Health Board or equivalent body, which might lead to removal from any relevant list,

• (l) is, or has been where the outcome was adverse, the subject of any investigation by the NHS Business Services Authority in relation to fraud,

• (m) has been removed or contingently removed from, refused admission to, or conditionally included in, any relevant list kept by another Local Health Board or equivalent body, or has been or is currently suspended from such a list, on fitness grounds, and if so, why and the name of that Local Health Board or equivalent body, or

• (n) is, or ever has been, subject to a national disqualification, and, if so, the applicant must give details including approximate dates, or where any investigation or proceedings were or are to be brought, the nature of that investigation or proceedings, and any outcome.

24

If the applicant (and where the applicant is a body corporate, any director or superintendent of the applicant) is, has been in the preceding 6 months, or was at the time of the originating events, a director or superintendent of a body corporate, they must in addition supply information in writing to the Local Health Board as to whether the body corporate—

• (a) has any criminal convictions in the United Kingdom,

• (b) has been convicted elsewhere of an offence, or what would constitute a criminal offence if committed in England and Wales,

• (c) is currently the subject of any proceedings which might lead to such a conviction, which have not yet been notified to the Local Health Board,

• (d) has been subject to any investigation into its provision of professional services by any licensing, regulatory or other body, where the outcome was adverse,

• (e) is currently subject to any investigation into its provision of professional services by any licensing, regulatory or other body,

• (f) is the subject of any investigation by another Local Health Board or equivalent body, which might lead to its removal from any relevant list,

• (g) is, or has been where the outcome was adverse, the subject of any investigation by the NHS Business Services Authority in relation to fraud,

• (h) has been removed or contingently removed from, refused admission to, or conditionally included in, any relevant list, or has been or is currently suspended from such a list, on fitness grounds, or

• (i) is or ever has been, subject to a national disqualification, and if so, the applicant must give the name and registered office of the body corporate and details, including approximate dates, or where any investigation or proceedings were or are to be brought, the nature of that investigation or proceedings and any outcome.

Pharmaceutical qualifications, referees etc.

25

Where the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) is a registered pharmacist, the applicant must supply details of their pharmaceutical qualifications (including where obtained) and chronological details of their professional experience (including starting and finishing dates of each appointment), with an explanation of any gaps between appointments and of why they were dismissed from any post.

26

Where the applicant (or where the applicant is a body corporate, any director or superintendent of the applicant) is a registered pharmacist, the applicant must supply names and addresses of two referees who are willing to provide references in respect of two recent posts (which may include any current post) as a pharmacist which lasted at least 3 months without a significant break, or where this is not possible, a full explanation and alternative referees.

27

Where the applicant is a body corporate, the name and address of each director and superintendent of the body corporate must be supplied.

28

The applicant must supply the name of any Local Health Board (or equivalent body) in whose pharmaceutical list the applicant, and where the applicant is a body corporate, any director or superintendent of the applicant, is included, and particulars of any outstanding applications (including deferred applications) for inclusion in, or preliminary consent to be included in, any pharmaceutical list of a Local Health Board (or equivalent body) with the name of the Local Health Board (or body) in question.

29

If the applicant is the director or superintendent of a body corporate that is included in any relevant list, or which has an outstanding application (including a deferred application) for inclusion in any relevant list, the applicant must supply the name of the Local Health Board or equivalent body in question, and the name and registered office of any such body corporate.

Undertakings

30

• (1) The applicant must give a written undertaking to notify the Local Health Board within 7 days of any material changes to the information provided in the application until—

• (a) their name is entered on the pharmaceutical list,

• (b) the period specified in regulation 23(2) for them to notify the Local Health Board that they will commence the provision of the pharmaceutical services in respect of which the application was made has expired,

• (c) they withdraw the application, or

• (d) in the case of an applicant who has been granted preliminary consent under regulation 18, the period during which the preliminary consent has effect in accordance with regulation 18(5) has expired.

• (2) The applicant must give a written undertaking to notify the Local Health Board if they are included or apply to be included in a relevant list.

PART 3 — Notification of commencement date

Information to be provided prior to the commencement of the provision of pharmaceutical services

31

The applicant must provide the following information—

• (a) name of the applicant,

• (b) date of grant of application,

• (c) premises specified in the application from which the pharmaceutical services will be provided,

• (d) confirmation that the premises are registered with the General Pharmaceutical Council (including reference number),

• (e) details of the pharmaceutical services to be provided,

• (f) date on which the provision of pharmaceutical services will commence,

• (g) name and registration number of the registered pharmacist in charge at the premises, and

• (h) an undertaking that the applicant will, in accordance with the application granted by the Local Health Board, provide the pharmaceutical services from the premises in accordance with the terms of services.

PART 4 — Applications for outline consent and premises approval

Details of the application

32

Name of the Local Health Board to which the application is made.

33

Type of application (outline consent, premises approval or both).

Details of the applicant

34

Name and address of the applicant.

35

The General Medical Council reference number under which the applicant is included in the List of Registered Medical Practitioners maintained by the General Medical Council.

Application for outline consent

36

Description and map of the area within which the applicant wishes to provide pharmaceutical services.

37

Address of any pharmacy within the area described and delineated under paragraph 36.

Application for premises approval

38

The address of the practice premises from which the applicant applies to provide pharmaceutical services and whether those practice premises are listed premises in relation to a different area.

39

Distance between those premises and the nearest pharmacy (and the address of that pharmacy).

40

Whether the application is for premises approval for additional premises or to relocate to new premises (and if the latter the distance from the new premises to the premises in respect of which the applicant currently has premises approval).

41

Whether the application arises because a practice amalgamation has taken place or will be taking place and, if so, the names of the doctors or contractors participating in the amalgamation.

42