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

Type Welsh-Statutory-Instrument

Publication 2020-09-29

Last updated 2026-03-28

State In force

Jurisdiction Wales

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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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.

30

(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.

31

(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

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).

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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.

33

(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

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.

34

(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

(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

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

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,

(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,

(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 2003[^f00032] 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 2008[^f00033], 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,

(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

39

(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

40

(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

(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

(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

(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

41

(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

42

(1) Where a Local Health Board decides to—

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

(b) impose conditions under regulation 38,

(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,

(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

43

(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)[^f00034], 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

44

(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,

(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

45

(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

46

(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,

(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

47

(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

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

48

(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).

Local dispute resolution before serving remedial notices or breach notices

49

(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

50

(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,

(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

51

(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

52

(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

53

(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

54

(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;

(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

55

(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—

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

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

Discontinuation of arrangements for the provision of pharmaceutical services by doctors

29

Outline consent and premises approval

30

Taking effect of outline consent and premises approval

31

Lapse of outline consent and premises approval

32

Premises approval: change of premises before outline consent takes effect

33

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

34

Premises approval: practice amalgamations

35

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

Deferral of applications on fitness grounds

36

Refusal of applications on fitness grounds

37

Conditional inclusion on fitness grounds

38

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

39

Removal from a pharmaceutical list for other reasons

40

Suspension from a pharmaceutical list

41

Notification of a decision to impose conditions

42

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

43

Review of a decision to impose conditions

44

Appeals

45

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

Core opening hours conditions

46

Conditions relating to providing directed services

47

Conditions relating to local resolution of disputes over terms of service

48

PART 9 — Performance related sanctions and Market Exit

Local dispute resolution before serving remedial notices or breach notices

49

Breaches of terms of service: remedial notices

50

Breaches of terms of service: breach notices

51

Payment withholdings: supplementary matters

52

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

53

Appeals against decisions under Part 9

54

PART 10 — Payments to NHS pharmacists and NHS appliance contractors

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

55