The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013

F1 PART 1 E+W Introduction

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Pt. 1 revoked (1.10.2020) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (S.I. 2020/1073), reg. 65(2)(a) (with reg. 63)

F2 PART 2 E+W Pharmaceutical lists and dispensing doctor lists

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2 Pt. 2 revoked (1.10.2020) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (S.I. 2020/1073), reg. 65(2)(a) (with reg. 63)

F3 PART 3 E+W Determination of controlled localities

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F3 Pt. 3 revoked (1.10.2020) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (S.I. 2020/1073), reg. 65(2)(a) (with reg. 63)

PART 4 E+W Applications by NHS pharmacists and NHS appliance contractors for inclusion in or amendment to pharmaceutical lists

Applications to be included in or for amendment to a pharmaceutical list E+W

8.—(1) A person may submit an application to a Local Health Board where that person—

(a) wishes to be included in a pharmaceutical list maintained by the Local Health Board;

(b) is already included in a pharmaceutical list maintained by the Local Health Board but wishes, within the Board’s area, to—

(i) open additional premises from which to provide the same or different pharmaceutical services;

(ii) relocate to different premises, and at those premises to provide the same or different pharmaceutical services; or

(iii) provide from the listed premises pharmaceutical services that are of a different description to those services already listed in relation to that person; or

(c) is already included in a pharmaceutical list maintained by a neighbouring Local Health Board but wishes to relocate to different premises in the area of the Local Health Board to which the application is made, and at those premises to provide the same pharmaceutical services.

(2) 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 1 of Schedule 1.

(3) Subject to regulation 46 (home Local Health Board), a person making an application under paragraph (1)(a) must provide the information and undertakings specified in Part 2 of Schedule 1.

(4) A Local Health Board must return an application if it does not contain all of the information required under paragraphs (2) and (3).

(5) An application to be included in a pharmaceutical list by a person not already included must be refused if the applicant is an individual who qualified as a pharmacist in Switzerland or an EEA state other than the United Kingdom, unless that individual satisfies the Local Health Board that he or she has the level of knowledge of English which, in the interests of that individual and the persons making use of the services to which the application relates, is necessary for the provision of those services in the area of the Local Health Board.

(6) All applications made under regulation 8(1) will be determined under regulation 9 (determination of applications to be included in or for amendment to a pharmaceutical list) except for applications to which—

(a) regulation 13 (applications involving minor relocation within a Local Health Board’s area);

(b) regulation 14 (applications involving minor relocation between neighbouring Local Health Board areas);

(c) regulation 15 (applications involving temporary relocation); or

(d) regulation 16 (applications involving a change of ownership),

applies and which are determined under those regulations.

(7) Parts 1 and 3 of Schedule 2 specify the procedures to be followed by a Local Health Board when determining applications made under this Part.

Commencement Information

I1 Reg. 8 in force at 10.5.2013, see reg. 1(2)

Determination of applications to be included in or for amendment to a pharmaceutical list E+W

9.—(1) Subject to regulation 10 (determination of applications to be included in or for amendment to a pharmaceutical list: effect of earlier determinations), where the premises specified in an application are not in a controlled locality, the Local Health Board must grant the application only if it is satisfied that it is necessary or expedient to do so in order to secure in the neighbourhood in which the premises are located the adequate provision, by persons included in a pharmaceutical list, of the services, or some of the services, specified in the application (the “necessary or expedient test”).

(2) Subject to regulation 10, where the premises specified in an application are in a controlled locality but not in a reserved location (as defined in regulation 11(4)) the Local Health Board—

(a) must refuse the 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”); and

(b) must, where the application has not been refused under the prejudice test, grant the application only if it is satisfied that it is necessary or expedient to do so to secure in the neighbourhood in which the premises are located the adequate provision, by persons included in a pharmaceutical list, of the services, or some of the services, specified in the application (the “necessary or expedient test”).

(3) The prejudice test does not apply to the Local Health Board’s determination of an application where the premises specified in an application are situated in a reserved location.

(4) A Local Health Board must refuse an application in which the applicant does not offer to provide all of the essential services but may grant an application in respect of all or some only of the directed services specified in it.

(5) In determining an application under this regulation which has been made under regulation 8(1)(a), (except where the application is made by a person who has been granted preliminary consent under regulation 12 which is valid in accordance with regulation 12(5)); or under regulation 12 where the applicant is not already included in that Local Health Board’s pharmaceutical list a Local Health Board may—

(a) defer consideration of the application on fitness grounds under regulation 31 (deferral of applications on fitness grounds);

(b) refuse the application on fitness grounds under regulation 32 (refusal of applications on fitness grounds); or

(c) impose conditions on the grant of the application under regulation 33 (conditional inclusion relating to fitness grounds).

Commencement Information

I2 Reg. 9 in force at 10.5.2013, see reg. 1(2)

Determination of applications to be included in or for amendment to a pharmaceutical list: effect of earlier determinations E+W

10.  Where in determining an earlier application for inclusion in or amendment to a pharmaceutical list the necessary or expedient test under regulation 9 was considered in relation to the neighbourhood in which the Local Health Board is satisfied the premises specified in the application under consideration are located and it was decided that it was not necessary or expedient to grant the earlier application to secure in the neighbourhood the adequate provision of pharmaceutical services, the necessary or expedient test must not be considered again in relation to that neighbourhood—

(a) for three years, beginning on the date on which the earlier application was determined by the Local Health Board or, if that determination was appealed, the date of the decision on the appeal; unless

(b) the Local Health Board is satisfied that there has been a substantial change of circumstances in relation to the neighbourhood since the necessary or expedient test was last considered.

Commencement Information

I3 Reg. 10 in force at 10.5.2013, see reg. 1(2)

Locations in controlled localities that are reserved locations E+W

11.—(1) A Local Health Board must determine whether premises specified in an application submitted to it under regulation 8 (applications to be included in or for amendment to a pharmaceutical list) or premises or the relevant location from which the applicant wishes to provide pharmaceutical services, specified in an application submitted to it under regulation 12 (applications for preliminary consent and effect of preliminary consent) that are in a controlled locality are also in a reserved location.

(2) Where it has been determined by the Local Health Board, or on appeal the Welsh Ministers (under paragraph (1) and Schedule 3 respectively) or pursuant to regulation 11ZA or 13 of the 1992 Regulations, in relation to premises or a relevant location, from which pharmaceutical services are to be or are being provided, that those premises are or the relevant location is in a reserved location, the person included in the pharmaceutical list in relation to those premises, or that relevant location, may make an application in writing to the Local Health Board to make a further determination as to whether, on the date of the application, those premises are, or that relevant location is, in a reserved location.

(3) For the purposes of this regulation the “relevant location” (“lleoliad perthnasol”) means, where the location of the premises from which the pharmaceutical services are to be provided, is specified in writing by the applicant before the Local Health Board makes its determination, that location, and where that location is not so specified, the best estimate the Local Health Board is able to make of where those premises may be

(4) Subject to paragraph (5), a reserved location is a location in a controlled locality in respect of which the number of individuals on the patient lists for the area within 1.6 kilometres of the premises or the location of the premises is less than 2,750 persons.

(5) A location is not a reserved location under paragraph (4) if the Local Health Board considers that if a pharmacy were to operate from the location the extent to which it would be used would be similar to or greater than might be expected if the number of individuals on the patient lists for the area within 1.6 kilometres of the premises or the location were equal to or more than 2,750 persons.

(6) Where in making a further determination applied for in accordance with paragraph (2) the Local Health Board determines that those premises are, or the relevant location is, not in a reserved location, or there is an appeal against a determination by the Local Health Board and it is determined on appeal that the premises are not, or that the relevant location is not, in a reserved location—

(a) the Local Health Board may determine that the premises are, or the relevant location is to be treated for the purposes of these Regulations as if they were in a reserved location, where it is of the opinion that not to do so would prejudice the proper provision of primary medical services (other than those provided by the Local Health Board itself), dispensing services or pharmaceutical services in any controlled locality; or

(b) if the Local Health Board considers that the provision of primary medical services by a provider of primary medical services (other than one employed by the Local Health Board), pharmaceutical services by a NHS pharmacist or NHS appliance contractor, local pharmaceutical services provided under a pilot scheme or pharmaceutical services provided by a doctor is likely to be adversely affected by a determination that the premises are not in a reserved location, it may make such determination but may impose conditions to postpone, for such period as it thinks fit, the making or termination of arrangements under regulation 20 (or equivalent under the GMS Regulations) for the provision by a doctor or a GMS contractor of pharmaceutical services or dispensing services to patients.

Commencement Information

I4 Reg. 11 in force at 10.5.2013, see reg. 1(2)

Applications for preliminary consent and effect of preliminary consent E+W

12.—(1) A person who wishes to be granted the right to be included in a pharmaceutical list maintained by the Local Health Board on a subsequent application under regulation 8(1)(a) or 8(1)(b)(i) (applications to be included in or for amendment to a pharmaceutical list) may submit an application to a Local Health Board for preliminary consent under this regulation.

(2) An application made under this regulation must be made in writing and must provide the information and undertakings set out in—

(a) Part 1 of Schedule 1; and

(b) subject to regulation 46, Part 2 of Schedule 1.

(3) A Local Health Board must return an application if it does not contain all of the information required under paragraph (2).

(4) A Local Health Board must determine an application for preliminary consent as if it were an application made under regulation 8(1)(a) or 8(1)(b)(i).

(5) A preliminary consent will be valid for a period of six months from the date on which it is granted, which is the later of either—

(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 14 of Schedule 2; or

(b) where an appeal is made against the decision of the Local Health Board, the date on which the Welsh Ministers give notice of their decision on the appeal under paragraph 8 of Schedule 3.

(6) A Local Health Board must grant a subsequent application made under regulation 8(1)(a) or 8(1)(b)(i) by a person who has been granted preliminary consent if—

(a) the date on which the application was received by the Local Health Board is within the period specified in paragraph (5);

(b) the services specified in the application are the same as those that were specified in the application for preliminary consent; and

(c) the premises specified in the application are in the same location as the premises or the locality of the premises specified in the application for preliminary consent.

(7) Where sub-paragraphs (a) and (b) of paragraph (6) are satisfied but the premises specified in the application have a different location from that in respect of which preliminary consent was granted, the Local Health Board must treat the application as though it were an application under regulation 8(1)(b)(ii).

(8) The grant of an application under paragraph (6) must be subject to any conditions that were imposed by the Local Health Board, or the Welsh Ministers on appeal, in relation to the final grant of the corresponding preliminary consent.

(9) In determining an application under this regulation from a person who is not already included in the Local Health Board’s pharmaceutical list (apart from an application from a person who has a valid preliminary consent in accordance with paragraph (5)), a Local Health Board may—

(a) defer consideration of the application on fitness grounds under regulation 31 (deferral of applications on fitness grounds);

(b) refuse the application on fitness grounds under regulation 32 (refusal of applications on fitness grounds); or

(c) impose conditions on the grant of the application under regulation 33 (conditional inclusion relating to fitness grounds).

Commencement Information

I5 Reg. 12 in force at 10.5.2013, see reg. 1(2)

Applications involving minor relocation within a Local Health Board’s area E+W

13.—(1) A person who has made an application under regulation 8(1)(a) (applications to be included in or for amendment to a pharmaceutical list) may at any time after making the application but before the end of the relevant period (as defined in regulation 17(3)(b) (procedure following grant of an application)) notify the Local Health Board that he or she wishes to change the premises from which he or she intends to provide the pharmaceutical services specified in the application and the Local Health Board may amend the premises specified in the original application if it is satisfied that—

(a) the change is a minor relocation;

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

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

(2) A Local Health Board must grant an application made by a person under regulation 8(1)(b)(ii) to relocate from listed premises to new premises at which the person intends to provide the same pharmaceutical services if it is satisfied that—

(a) the change is a minor relocation;

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

(c) the same pharmaceutical services will be provided at the new premises as are provided at the listed premises;

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

(e) the premises specified in the application from which the person wishes to relocate are not premises to which the person has temporarily relocated under regulation 15 (applications involving temporary relocation).

(3) A person who has had an application granted under this regulation may not, within twelve months of the date of the grant of the application (as defined in regulation 17(3)(a)) submit another application for determination under this regulation or under regulation 14.

Commencement Information

I6 Reg. 13 in force at 10.5.2013, see reg. 1(2)

Applications involving minor relocation between neighbouring Local Health Board areas E+W

14.—(1) A Local Health Board must grant an application made by a person under regulation 8(1)(c) (applications to be included in or for amendment to a pharmaceutical list) to relocate from listed premises in the area of a neighbouring Local Health Board to new premises in the area of the Local Health Board to which the application is made, and at those premises the person intends to provide the same pharmaceutical services, if—

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

(i) the change is a minor relocation,

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

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

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

(v) the premises specified in the application from which the person wishes to relocate are not premises to which the person has temporarily relocated under regulation 15 (applications involving temporary relocation); and

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

(2) A person who has had an application granted under this regulation may not, within twelve months of the date of the grant of the application (as defined in regulation 17(3)(a)) submit another application for determination under this regulation or under regulation 13.

Commencement Information

I7 Reg. 14 in force at 10.5.2013, see reg. 1(2)

Applications involving temporary relocation E+W

15.—(1) A Local Health Board may make a temporary amendment to an entry in a pharmaceutical list by granting an application made by a person under regulation 8(1)(b)(ii) (applications to be included in or for amendment to a pharmaceutical list) to relocate to different premises on a temporary basis if it is satisfied that—

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

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

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

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

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

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

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

Commencement Information

I8 Reg. 15 in force at 10.5.2013, see reg. 1(2)

Applications involving a change of ownership E+W

16.—(1) A Local Health Board must grant an application made by a person under regulation 8(1)(a), (b)(i) or (ii) (applications to be included in or for amendment to a pharmaceutical list) who intends to provide pharmaceutical services at premises from which those services are, at the time of the application, provided by another person who is included in a pharmaceutical list maintained by the Local Health Board under regulation 3 (preparation and maintenance of pharmaceutical lists) if the Local Health Board is satisfied that—

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

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

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

(2) In determining an application under this regulation which has been made under regulation 8(1)(a) (except where the application has been made by a person who has been granted preliminary consent under regulation 12 which is valid in accordance with regulation 12(5)), or under regulation 12 where the applicant is not already included in that Local Health Board’s pharmaceutical list a Local Health Board may—

(a) defer consideration of the application on fitness grounds under regulation 31 (deferral of applications on fitness grounds);

(b) refuse the application on fitness grounds under regulation 32 (refusal of applications on fitness grounds); or

(c) impose conditions on the grant of the application under regulation 33 (conditional inclusion relating to fitness grounds).

Commencement Information

I9 Reg. 16 in force at 10.5.2013, see reg. 1(2)

Procedure following grant of an application E+W

17.—(1) Following the date of the grant of an application made under regulation 8 (applications to be included in or for amendment to a pharmaceutical list), a Local Health Board must not include a person in a pharmaceutical list or amend a pharmaceutical list unless—

(a) the condition in paragraph (2) is satisfied; and

(b) the requirements of regulation 33 (conditional inclusion relating to fitness grounds), if any, are met as regards the imposition of conditions on any person.

(2) A person will be included in the relevant pharmaceutical list or the relevant pharmaceutical list will be amended as appropriate if, not less than 14 days before the end of the relevant period, he or she notifies the Local Health Board in writing, providing the information specified in Part 3 of Schedule 1, that he or she will within the next 14 days commence the provision at the premises of the services that were specified in the application.

(3) For the purposes of this regulation and, where relevant, regulation 18—

(a) “the date of the grant of an application” (“y dyddiad y caniateir cais”) is the date which is the later of either—

(i) 30 days after notice of the Local Health Board’s decision on the application was sent by the Local Health Board in accordance with paragraph 14 of Schedule 2; or

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

and “granted” (“caniatawyd”) is to be construed accordingly; and

(b) “the relevant period” (“cyfnod perthnasol”) is—

(i) the period of six months from the date an application is granted; or

(ii) such further period in addition to that specified in sub-paragraph (a) not exceeding three months that the Local Health Board may for good cause allow.

Commencement Information

I10 Reg. 17 in force at 10.5.2013, see reg. 1(2)

Application to extend the relevant period E+W

18.—(1) Before the expiry of the relevant period, a person may make an application to the Local Health Board to extend the relevant period.

(2) In accordance with regulation 17(3)(b)(ii) the person may apply for an extension of up to three months.

(3) An application to the Local Health Board under this regulation must be in writing and must set out in full why an extension of the relevant period is sought.

(4) Parts 1 and 3 of Schedule 2 specify the procedures to be followed by a Local Health Board when determining applications made under this regulation.

(5) For the purposes of this regulation, “person” (“person”) means the person who would be entitled to provide notification to a Local Health Board in accordance with regulation 17(2) of commencement of provision of pharmaceutical services.

Commencement Information

I11 Reg. 18 in force at 10.5.2013, see reg. 1(2)

Appeals E+W

19.—(1) Schedule 3 makes provision for appeals to the Welsh Ministers in respect of decisions of Local Health Boards made under this Part.

(2) There is no right of appeal under these Regulations in respect of a decision of a Local Health Board to make or not to make, or to extend a temporary amendment to a pharmaceutical list under regulation 15 (applications involving temporary relocation).

Commencement Information

I12 Reg. 19 in force at 10.5.2013, see reg. 1(2)

PART 5 E+W Applications by doctors for inclusion in or amendment to dispensing doctor lists

Arrangements for the provision of pharmaceutical services by doctors E+W

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

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

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

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

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

(a) the patient has made a request in writing to the Local Health Board for the doctor to provide him or her with pharmaceutical services for the reasons specified in paragraph (1)(a); and

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

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

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

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

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

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

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

(c) the outline consent and premises approval has taken effect under regulation 25 (taking effect of outline consent and premises approval); and

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

(5) References in paragraph (4) to outline consent, premises approval and conditions imposed include references to those in effect under the 1992 Regulations.

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

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

(8) A doctor falls within this paragraph if he or she is—

(a) a GMS contractor or an APMS contractor;

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

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

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

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

(11) The Welsh Ministers may determine an appeal pursuant to paragraph (9) in such manner as they see fit, taking into consideration the preliminary matters in Part 1 of Schedule 3.

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

Commencement Information

I13 Reg. 20 in force at 10.5.2013, see reg. 1(2)

Necessary services for temporary patients E+W

21.  A doctor who provides pharmaceutical services to patients on a patient list by arrangement made with a Local Health Board under regulation 20 (arrangements for the provision of pharmaceutical services by doctors) may provide necessary pharmaceutical services to a person who has been accepted by the doctor as a temporary patient.

Commencement Information

I14 Reg. 21 in force at 10.5.2013, see reg. 1(2)

Provision of pharmaceutical services for immediate treatment or personal administration E+W

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

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

(b) provide to a patient any appliance or drug, not being a Scheduled drug, which he or she personally administers or applies to that patient.

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

Commencement Information

I15 Reg. 22 in force at 10.5.2013, see reg. 1(2)

Discontinuation of arrangements for the provision of pharmaceutical services by doctors E+W

23.—(1) A Local Health Board must give reasonable notice in writing to a doctor that he or she must discontinue the provision of pharmaceutical services to a patient under an arrangement pursuant to regulation 20 where the patient no longer falls within regulation 20(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 2, paragraph 13 of Schedule 2 or regulation 11(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 2 applies.

Commencement Information

I16 Reg. 23 in force at 10.5.2013, see reg. 1(2)

Outline consent and premises approval E+W

24.—(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 20(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 25 (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 1.

(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) subject to paragraph (7) and where an application has not been refused under the prejudice test, must refuse the application unless it is satisfied that it is necessary or expedient to grant the application in order to secure in the area in respect of which the doctor has applied for outline consent the adequate provision, by persons included in a list, of the services, or some of the services, specified in the application; and

(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 subparagraphs (a) to (e) above 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) Where in determining an earlier application made under this regulation that application was refused under paragraph (5)(d), the question under paragraph (5)(d) must not be considered again in relation to the same area as was specified in the earlier application—

(a) for three years, beginning on the date on which the earlier application was determined by the Local Health Board or, if that determination was appealed, the date of the decision on the appeal; unless

(b) the Local Health Board is satisfied that there has been a substantial change of circumstances in relation to the area in respect of which the doctor has applied for outline consent since the question under paragraph (5)(d) was last considered.

(8) Subject to any specific requirements that are contained within this Part, Parts 1 and 3 of Schedule 2 specify the procedures to be followed by a Local Health Board when determining applications under this Part.

(9) 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 2; 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 3.

Modifications etc. (not altering text)

C1 Reg. 24 applied (with modifications) (10.5.2013) by S.I. 2004/478, Sch. 6 para. 48 (as amended by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013 (S.I. 2013/898), reg. 1(2), Sch. 7 para. 4(3)(b))

Commencement Information

I17 Reg. 24 in force at 10.5.2013, see reg. 1(2)

Taking effect of outline consent and premises approval E+W

25.—(1) When granting an application made under regulation 24 (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 24 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 24, 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 24 that—

(a) the doctor may within three 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 24 was required to be given under paragraph 8 of Schedule 2.

(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 24 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 I of Schedule 3 and the following paragraphs of Schedule 3 will apply:

(a) 6(4)(b) and (c);

(b) 7(2) and (4); and

(c) 8,

as if the notice of appeal were submitted under paragraph 6(2) of Schedule 3.

(11) In this regulation—

“outstanding pharmacy application” (“cais am fferyllfa yn yr arfaeth”) means an application made under regulation 8 (applications to be included in or for amendment to a pharmaceutical list) or regulation 12 (applications for preliminary consent and effect of preliminary consent)—

(a)

where the premises specified in that application are within 1.6 kilometres of the premises for which premises approval has been sought; and

(b)

which has either—

(i)

been made but not yet determined, including on appeal, or

(ii)

has been granted as defined in regulation 17 (procedure following grant of an application) but the provision of pharmaceutical services from those premises has not been commenced; and

(c)

“provisional date” (“dyddiad dros dro”) means the day after the end of a period of one year or such further period not exceeding three months as the Local Health Board may determine (and it must notify the doctor who made the application under regulation 24 of any extension) beginning with the date on which the application is granted in accordance with regulation 24(9).

Commencement Information

I18 Reg. 25 in force at 10.5.2013, see reg. 1(2)

Lapse of outline consent and premises approval E+W

26.—(1) Outline consent will cease to have effect—

(a) where the provision of dispensing services has not commenced within twelve months of outline consent or premises approval taking effect under regulation 25 (taking effect of outline consent and premises approval);

(b) where more than twelve 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 25.

(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 six 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 29(3), where no practice amalgamation takes place within the period specified in regulation 29(7).

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

Commencement Information

I19 Reg. 26 in force at 10.5.2013, see reg. 1(2)

Premises approval: change of premises before outline consent takes effect E+W

27.—(1) Where—

(a) outline consent has been granted but has not yet taken effect under regulation 25 (taking effect of outline consent and premises approval); and

(b) before the provisional date defined in regulation 25(11) the doctor intends to change the practice premises from which he or she wishes to provide pharmaceutical services,

he or she may apply in writing to the Local Health Board providing the information set out in Part 4 of Schedule 1 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 those new premises must be refused.

(3) The Local Health Board must notify those persons to whom notice of the application made under regulation 24 (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 I of Schedule 3 and the following paragraphs of Schedule 3 will apply:

(a) 6(4)(b) and (c);

(b) 7(2) and (4); and

(c) 8,

as if the notice of appeal were submitted under paragraph 6(2) of Schedule 3.

Commencement Information

I20 Reg. 27 in force at 10.5.2013, see reg. 1(2)

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

28.—(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 1 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 24 (outline consent and premises approval) and regulation 25 (taking effect of outline consent and premises approval).

(3) For the purpose of this regulation—

(a) the “appropriate Local Health Boards” (“Byrddau Iechyd Lleol priodol”) are those who hold the dispensing doctor lists on which the doctor making the application is included; and

(b) the “relevant Local Health Board” (“Bwrdd Iechyd Lleol perthnasol”) 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 he or she wishes 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 1 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 2 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 other case determine the application as an application for premises approval made under regulation 24(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 twelve 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 24 and paragraph 8 of Schedule 2.

(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 2.

(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(2) of Schedule 3.

(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 were, at the date of the grant, outstanding pharmacy applications (as defined in regulation 25(11)),

the premises approval will take effect on the date which is the day after the end of a period of one year, or such further period (not exceeding three 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 it considers it is necessary or expedient to do so to secure the adequate provision of pharmaceutical services in the area served by the additional or new premises, and renew any such temporary approval granted, to secure such adequate provision, and where it does so it must—

(a) notify those persons to whom notice of the application under regulation 24 (outline consent and premises approval) was required to be given under paragraph 8 of Schedule 2 and the applicants in relation to the outstanding pharmacy applications;

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

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

(14) Temporary premises approval may be granted for a period not exceeding twelve months, and may be renewed for a further period not exceeding three 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 I of Schedule 3 and the following paragraphs of Schedule 3 will apply:

(a) 6(4)(b) and (c);

(b) 7(2) and (4); and

(c) 8,

as if the notice of appeal were submitted under paragraph 6(2) of Schedule 3.

Commencement Information

I21 Reg. 28 in force at 10.5.2013, see reg. 1(2)

Premises approval: practice amalgamations E+W

29.—(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 28 (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 24 (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 28.

(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 28(13) for a period stated by the Local Health Board not exceeding one 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 one 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 one 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” (“cymeradwyaeth mangre weddilliol”) means premises approval to provide pharmaceutical services—

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

(b) to a patient falling within regulation 20(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 20(1)(b) or (c).

(10) For the purposes of paragraph (9), regulation 20(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 28 in respect of an application under paragraph (3)(a)(ii) or (b)(ii); or

(b) regulation 24 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 I of Schedule 3 and the following paragraphs of Schedule 3 will apply:

(a) 6(4)(b);

(b) 7(2) and (4); and

(c) 8,

as if the notice of appeal were submitted under paragraph 6(2) of Schedule 3.

Commencement Information

I22 Reg. 29 in force at 10.5.2013, see reg. 1(2)

Appeals E+W

30.  Subject to any specific provisions that are contained within this Part, Schedule 3 makes provision for appeals to the Welsh Ministers in respect of determinations of Local Health Boards made under this Part.

Commencement Information

I23 Reg. 30 in force at 10.5.2013, see reg. 1(2)

PART 6 E+W Fitness grounds and inclusion in and removal from pharmaceutical lists

Deferral of applications on fitness grounds E+W

31.—(1) This regulation applies to applications made under—

(a) regulation 8(1)(a) (applications to be included in or for amendment to a pharmaceutical list), except where the application is made by a person who has a valid preliminary consent in accordance with regulation 12(5); and

(b) regulation 12 (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 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 six 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 he or she 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 six 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 corporate body 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 he or she 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; or

(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 he or she within 30 days of the date of the notification (or such longer period as it may agree)—

(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 he or she wishes to proceed in accordance with paragraph (5), the Local Health Board must deem the application as having been withdrawn by the applicant.

Commencement Information

I24 Reg. 31 in force at 10.5.2013, see reg. 1(2)

Refusal of applications on fitness grounds E+W

32.—(1) This regulation applies to applications made under—

(a) regulation 8(1)(a) (applications to be included in or for amendment to a pharmaceutical list), except where the application is made by a person who has a valid preliminary consent in accordance with regulation 12(5); and

(b) regulation 12 (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 1 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 1, 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 service which he or she 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 six months;

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

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

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

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

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

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

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

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

(f) whether any offence was a sexual offence to which Part 2 of the Sexual Offences Act 2003(1) 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 six 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(2), the application notice must be sent to the Tribunal if an appeal is to be brought.

Commencement Information

I25 Reg. 32 in force at 10.5.2013, see reg. 1(2)

Conditional inclusion relating to fitness grounds E+W

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

(a) under regulation 8(1)(a) (applications to be included in or for amendment to a pharmaceutical list), except where the application is made by a person who has been granted preliminary consent under regulation 12 (applications for preliminary consent and effect of preliminary consent) and which is valid in accordance with regulation 12(5); or

(b) under regulation 12 where the applicant is not already included in that Local Health Board’s pharmaceutical list,

may determine that the person, whilst he or she is included in the pharmaceutical list or whilst his or her 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 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 17(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

(a) the Tribunal 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 his or her application.

(8) If the person fails, in the circumstances described in paragraph (7), to notify the Local Health Board within that 30 days that he or she does not wish to withdraw his or her application, the grant of that person’s application lapses.

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

(a) a condition is imposed under paragraph (1);

(b) the person appeals that condition to the Tribunal;

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

(d) within 30 days of being informed of the decision of the Tribunal the person notifies the Local Health Board that he or she wishes 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.

Commencement Information

I26 Reg. 33 in force at 10.5.2013, see reg. 1(2)

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 E+W

34.—(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 35 (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 33 (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 him or her;

(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 33 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.

Commencement Information

I27 Reg. 34 in force at 10.5.2013, see reg. 1(2)

Removal from a pharmaceutical list for other reasons E+W

35.—(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 six months; or

(c) is subject to a national disqualification.

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

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

(b) as part of that notification—

(i) inform the person of any allegation made against him or her; and

(ii) advise the person that he or she 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 his or her 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 six 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 six month period); or

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

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

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

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

(b) give the person or the person’s representative mentioned under paragraph (3)(b) the opportunity to make representations in writing or, if he or she so desires, in person, during that period; and

(c) consult the Local Pharmaceutical Committee.

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

(a) the reasons for the decision;

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

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

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

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

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

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

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

(a) confirm the decision of the Local Health Board; or

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

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

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

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

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

Commencement Information

I28 Reg. 35 in force at 10.5.2013, see reg. 1(2)

Suspension from a pharmaceutical list E+W

36.—(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 him or her;

(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 he or she wishes 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 his or her 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.

Commencement Information

I29 Reg. 36 in force at 10.5.2013, see reg. 1(2)

Notification of decision to impose conditions E+W

37.—(1) Where a Local Health Board decides to—

(a) refuse to grant an application from a person under regulation 32;

(b) impose conditions on a person under regulation 33;

(c) remove a person from its pharmaceutical list under regulation 34 or 35;

(d) suspend a person from its pharmaceutical list under regulation 36,

(e) impose or vary a condition under regulation 38; or

(f) impose or vary a condition under regulation 39

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) the National Health Service Commissioning Board; 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 his or her 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 him or her 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.

Commencement Information

I30 Reg. 37 in force at 10.5.2013, see reg. 1(2)

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 E+W

38.—(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;

(c) in the case of a contingent removal, vary the conditions, impose different conditions, revoke the contingent removal, or remove the practitioner 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) three months beginning with the date of the decision of the Local Health Board to contingently remove; or

(b) six 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)(3), 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.

Commencement Information

I31 Reg. 38 in force at 10.5.2013, see reg. 1(2)

Review of a decision to impose conditions E+W

39.—(1) Where a Local Health Board has made a decision to impose conditions in accordance with regulation 33, 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 three 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 six 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.

Commencement Information

I32 Reg. 39 in force at 10.5.2013, see reg. 1(2)

Appeals E+W

40.—(1) A person, other than a person notified under regulation 37, who has been notified by a Local Health Board of its decision that it—

(a) intends to—

(i) refuse to grant an application to which regulation 32 (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 33 (conditional inclusion relating to fitness grounds), or vary the person’s terms of service pursuant to that regulation;

(iii) in accordance with regulation 34 (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 33; or

(iv) remove the person from the pharmaceutical list on grounds contained in regulation 35(1); or

(b) has reviewed a decision to impose conditions under regulation 39 (review of a decision to impose conditions) and has decided to take any of the actions in regulation 39(5); or

(c) has reviewed a decision to contingently remove the person from a pharmaceutical list by virtue of regulation 38 (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.

Commencement Information

I33 Reg. 40 in force at 10.5.2013, see reg. 1(2)

F4 PART 7 E+W Payments to NHS pharmacists and NHS appliance contractors

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F4 Pt. 7 revoked (1.10.2020) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (S.I. 2020/1073), reg. 65(2)(b) (with reg. 63)

F5 PART 8 E+W Miscellaneous

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F5 Pt. 8 revoked (1.10.2020) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (S.I. 2020/1073), reg. 65(2)(b) (with reg. 63)

Mark Drakeford

Minister for Health and Social Services, one of the Welsh Ministers

17 April 2013