Legalize / United Kingdom / Wales / Welsh-Statutory-Instrument

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

Type Welsh-Statutory-Instrument

Publication 2020-09-29

Last updated 2026-03-28

State In force

Jurisdiction Wales

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

PDF Download

articles Not indexed

Reform history JSON API

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

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

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

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

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

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

(5) The consultation that the Welsh Ministers undertake under section 89(1) of the 2006 Act (section 88: supplementary) prior to the inclusion of or a change to the price of a drug or appliance which is to form part of a calculation of remuneration must be by way of consultation on the process for determining the price to be included or changed, not on the proposed price itself (unless it is impossible to carry out an effective consultation in any other way).

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

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

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

Local Health Boards as determining authorities

56

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

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

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

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

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

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

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

Overpayments

57

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

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

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

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

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

Reward scheme

58

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

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

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

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

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

Payments to suspended NHS pharmacists and NHS appliance contractors

59

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

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

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

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

PART 11 — Miscellaneous

Home Local Health Board

60

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

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

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

(4) The applicant must either—

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

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

Publication of particulars

61

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

(a) its pharmaceutical needs assessment,

(b) its pharmaceutical list,

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

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

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

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

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

(i) the Drug Tariff.

(2) A Local Health Board may—

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

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

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

Exercise of choice in certain cases

62

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

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

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

(i) in the care of an authority to whose care the person has been committed under the provisions of the Children Act 1989[^f00035], by a person duly authorised by that authority, or

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

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

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

Transitional provisions

63

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Minor and consequential amendments

64

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

Revocation

65

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

(2) On 1 October 2020—

(a) Parts 1 to 3, and

(b) Parts 7 and 8.

(3) On 31 March 2021—

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

(b) in Part 5, regulation 20.

(4) On 1 October 2021—

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

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

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

SCHEDULE 1 — Information to be contained in pharmaceutical needs assessments

Current provision of pharmaceutical services

1

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

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

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

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

Other NHS services

2

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

Gaps in provision of pharmaceutical services

3

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

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

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

How the assessment was carried out

4

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

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

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

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

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

(aa) age,

(bb) gender,

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

(dd) disability,

(ee) race,

(ff) religion or belief, and

(gg) sexual orientation;

Map of provision

5

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

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

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

Information required from all applicants

Details of the application

1

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

2

Type of consent applied for (full or preliminary).

3

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

Details of the applicant

4

Name and address of the applicant.

5

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

6

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

Details of the premises and opening hours

7

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

8

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

9

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

Pharmaceutical services to be provided

10

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

11

Details of directed services that the applicant applies to provide.

12

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

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

13

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

Information relating to the prejudice test

14

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

Information relating to applications involving relocations

15

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

16

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

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

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

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

17

The applicant must provide details of whether—

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

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

18

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

Information relating to applications involving a change of ownership

19

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

20

The applicant must provide details of whether—

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

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

Applicant’s undertaking

21

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

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

Applicant’s details

22

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

(a) full name,

(b) gender,

(d) address and telephone number,

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

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

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

(a) full name,

(b) company registration number,

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

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

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

Investigation, proceedings and convictions

23

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

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

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

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

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

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

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

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

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

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

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

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

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

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

24

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

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

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

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

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

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

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

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

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

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

Pharmaceutical qualifications, referees etc.

25

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

26

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

27

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

28

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

29

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

Undertakings

30

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

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

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

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

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

PART 3 — Notification of commencement date

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

31

The applicant must provide the following information—

(a) name of the applicant,

(b) date of grant of application,

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

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

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

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

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

Details of the application

32

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

33

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

Details of the applicant

34

Name and address of the applicant.

35

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

36

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

37

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

Application for premises approval

38

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

39

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

40

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

41

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

42

If outline consent has already been granted a description and map of the area in respect of which consent has been granted.

43

Details of any other medical practice premises which have been granted premises approval or in respect of which an application has already been made but not yet determined by the Local Health Board.

Pharmaceutical services to be provided

44

The pharmaceutical services to be provided and the opening hours and days on which those services will be provided.

Prejudice test

45

The reasons why the applicant considers that granting the application will not prejudice the proper provision of primary medical services, dispensing services or pharmaceutical services in the controlled locality in which the premises specified in the application are situated.

Meeting identified needs

46

The reasons why the applicant considers it is necessary to grant the application in order to meet a need identified in a relevant pharmaceutical needs assessment.

Applicant’s undertaking

47

The applicant must give an undertaking that if the application is granted and outline consent and premises approval is in effect the applicant will provide the pharmaceutical services from the practice premises in respect of which the application is granted in accordance with the terms of service.

SCHEDULE 3 — Procedures to be followed by Local Health Boards to determine applications under the Regulations

PART 1 — Preliminary matters

General principles

1

(1) Except in so far as these Regulations provide to the contrary, a Local Health Board may determine an application submitted to it in such manner as it thinks fit.

(2) A Local Health Board must follow the procedure in regulation 15(4) in respect of an application submitted to it which does not contain all of the information that an applicant is required to provide in accordance with Schedule 2.

(3) A Local Health Board may if it thinks fit consider two or more applications together and in relation to each other but where it intends to do so it must give notice of that intention in writing to—

(a) the respective applicants, and

(b) where the application is one in respect of which notice must be given under paragraph 8, any other person that must be given notice of that application.

(4) Where in accordance with sub-paragraph (3) a Local Health Board considers two or more applications to which regulation 16(2) applies together and in relation to each other, it may refuse an application (notwithstanding the fact that it would if determining the application in isolation grant it) where the number of applications is such, or the circumstances in which they are made are such, that to grant all of them or more than one of them, would prejudice the proper provision of primary medical services, pharmaceutical services or dispensing services in the controlled locality within which the premises specified in the application are situated.

Timetable for determining applications

2

A Local Health Board must endeavour to determine an application as soon as is practicable after its receipt.

Persons prohibited from taking part in decision-making on applications

3

(1) No person is to take part in determining an application if they—

(a) are a person who is included in the pharmaceutical list or dispensing doctor list maintained by the Local Health Board, or are an employee of such a person,

(b) are a shareholder, director or company secretary of a company which runs a retail pharmacy business in the area of the Local Health Board,

(d) are an APMS contractor in the area of the Local Health Board, or is an officer, trustee or other person concerned with the management of a company, society or voluntary organisation or other body which is an APMS contractor, or is employed or engaged by such an APMS contractor, or

(e) are employed or engaged by the Local Health Board for the purposes of providing primary medical services within an LHBMS practice.

(2) No other person is to take part in determining an application if, because of an interest or an association they have, or because of a pressure to which they may be subject, their involvement would give rise to a reasonable suspicion of bias.

PART 2 — Determination of controlled localities

Notice of proposed determination in respect of controlled localities

4

(1) If a Local Health Board decides that an application by a Local Medical Committee or a Local Pharmaceutical Committee cannot be considered by virtue of regulation 13(3) (areas that are controlled localities), the Local Health Board must take no action in relation to that application other than to notify the applicant of that fact and of its right of appeal against that decision under regulation 14 (appeals).

(2) In all other cases, before making a determination under regulation 13(2) a Local Health Board must give a written notice of proposed determination to—

(a) the Local Medical Committee in its area,

(b) the Local Pharmaceutical Committee in its area,

(d) any person included in a pharmaceutical list maintained by the Local Health Board and any provider of local pharmaceutical services under a pilot scheme or any provider of primary medical services in the area for which the Local Health Board is established who, in the opinion of the Local Health Board, may be affected by the determination.

(3) A notice of proposed determination must inform the person notified of their right to make representations (or in the case of a Local Medical Committee or Local Pharmaceutical Committee being notified that applied for the determination any further representations) in writing on the proposed determination within 30 days of the date on which the notice was sent to them.

Deferral of applications

5

Where a Local Health Board has issued a notice of proposed determination it must defer consideration of any application submitted under Part 5 or Part 6 of these Regulations but not determined by it if the application could be affected by the proposed determination until—

(a) it has determined whether or not the locality is or is part of a controlled locality and the period for bringing an appeal relating to that determination has ended, or

(b) the date of the determination of any such appeal.

Imposition of conditions

6

Where a Local Health Board determines whether or not any particular area within the area for which it is established is, because it is rural in character, a controlled locality or part of a controlled locality it—

(a) must consider whether the provision of—

(i) primary medical services by a provider of such services (other than itself),

(ii) pharmaceutical services by an NHS pharmacist or NHS appliance contractor,

(iii) local pharmaceutical services provided under a pilot scheme, or

(iv) pharmaceutical services by a doctor,

is likely to be adversely affected as a consequence of that determination, and

(b) may, where it is of the opinion that any of those services are likely to be adversely affected, impose conditions to postpone, for such period as it thinks fit, the making or termination of arrangements under regulation 26 (arrangements for the provision of pharmaceutical services by doctors) or equivalent provision under the GMS Regulations for the provision by a doctor or GMS contractor of pharmaceutical services or dispensing services to patients on the relevant patient list.

Notification of determination and action following determination

7

(1) Once a Local Health Board has determined the question of whether or not any particular area within the area for which it is established is, because it is rural in character, a controlled locality or part of a controlled locality it must—

(a) as soon as practicable after reaching a determination give notice in writing to those notified under paragraph 4(2) informing them of—

(i) the determination and the reasons for it,

(ii) any conditions that it has imposed under paragraph 6, and

(iii) any rights of appeal under Schedule 4, and

(b) as soon as practicable after the relevant date—

(i) delineate precisely on a map the boundaries of the controlled locality or remove the delineated boundary of a locality that has ceased to be a controlled locality,

(ii) give a doctor that is affected reasonable notice of any conditions that have been imposed under paragraph 6 as a result of the determination, and

(iii) proceed to determine any applications that have been deferred under paragraph 5.

(2) For the purposes of this paragraph, “the relevant date” is the later of—

(a) the date on which the period for bringing an appeal relating to the determination ends, or

(b) the date of the determination of any such appeal.

PART 3 — Applications for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists

Notice of certain applications

8

(1) This paragraph applies to applications for—

(a) inclusion in, or to make an amendment to, a—

(i) pharmaceutical list made under Part 5 of these Regulations, except for applications under regulation 22 (applications involving a change of ownership), and

(ii) dispensing doctor list made under Part 6 of these Regulations,

(b) an extension of the relevant time period under regulation 24, and

(c) a further determination as to whether premises are, or a relevant location is, in a reserved location under regulation 17(2).

(2) The Local Health Board to which the application was submitted must give notice in writing of the application in accordance with paragraph 9.

(3) Those notified of an application may within 30 days of the date on which the notification was sent to them, make representations on the application, in writing, to the Local Health Board to which the application was submitted, except for applications made pursuant to regulation 21 (applications involving temporary relocation).

Persons and bodies to be notified

9

(1) The persons and bodies that must be notified by a Local Health Board are—

(a) the Local Pharmaceutical Committee,

(b) the Local Medical Committee,

(i) included in a pharmaceutical list maintained by it, or

(ii) who has been granted preliminary consent for inclusion in a pharmaceutical list, whose interests might, in the opinion of the Local Health Board, be significantly affected if the application is granted,

(d) any provider of local pharmaceutical services under a pilot scheme in the area for which the Local Health Board is established whose interests might, in the opinion of the Local Health Board, be significantly affected if the application is granted,

(e) the Citizen Voice Body,

(f) any patient group, consumer group or community group in the area of the Local Health Board that it considers has a significant interest in the provision of pharmaceutical services in the area,

(g) where the premises specified in the application are in a controlled locality, any person (except itself) who is a provider of primary medical services within the Local Health Board’s area or who is included in the dispensing doctor list maintained by the Local Health Board whose interests might, in the opinion of the Local Health Board, be significantly affected if the application is granted,

(h) any Local Health Board or equivalent body any part of whose area is within 2 kilometres of the premises or the location of the premises specified in the application, and

(i) in the case of an application made under regulation 20 (applications involving relocation between neighbouring Local Health Board areas), the Local Health Board from whose area the applicant wishes to relocate.

(2) A Local Health Board that provided the notification under sub-paragraph (1)(h) must—

(a) within 14 days of receiving the notification give notice in writing to the persons and bodies specified in sub-paragraph (1)(a) to (g) that are within or that serve the area for which the Local Health Board is established, and

(b) notify the Local Health Board that provided the notification under sub-paragraph (1) that it has provided the notification required by sub-paragraph (2)(a).

(3) An equivalent body notified under sub-paragraph (1)(h) may request the Local Health Board to give notification to such persons in the area for which the equivalent body is established whose interests might in the opinion of the equivalent body, be significantly affected if the application is granted and the Local Health Board must comply with any such request.

Content of notification

10

A notification of an application under paragraph 8 must—

(a) inform the person or body notified—

(i) of their right to make representations on the application under paragraph 8(3),

(ii) the circumstances in which the Local Health Board may require an oral hearing to be held under paragraph 11, and

(iii) if the Local Health Board intends to consider the application together with and in relation to any other application, of that intention,

(b) provide a copy of the application submitted by the applicant to enable the person or body notified to make informed representations with regard to whether or not the application should be granted, and

(c) where regulation 17(1) applies to an application under paragraph 8(1)(a) inform the person or body notified that the Local Health Board will be determining whether the premises or relevant location specified in the application that are in a controlled locality are also in a reserved location.

Oral hearings

11

(1) In the case of an application falling within paragraph 8, a Local Health Board may require an oral hearing to be held if it considers it is necessary to hear oral representations before determining such an application.

(2) If the Local Health Board does decide to hold an oral hearing, it must—

(a) give not less than 14 days’ notice of the time and place of the hearing to—

(i) the applicant, and

(ii) any person who has made representations on the application under paragraph 8(3),

(b) advise the applicant who has been given notice of the hearing, and

(3) Any person mentioned in sub-paragraph (2) wishing to make oral representations at the hearing may be assisted in the presentation of their representations by another person and may be represented by that other person at the hearing, including where the person notified under sub-paragraph (2) is unable to attend the hearing in person.

(4) A Local Health Board may determine the procedure to be followed at the oral hearing.

(5) A Local Health Board is not bound by any recommendations arising from an oral hearing.

Information to which a Local Health Board must have regard

12

In determining an application falling within paragraph 8, a Local Health Board must have regard, in particular, to—

(a) any representations received by the Local Health Board under paragraph 8(3),

(b) any recommendations arising from an oral hearing, if one is held under paragraph 11,

(d) any other information available to the Local Health Board which, in its opinion, is relevant to the consideration of the application.

Imposition of conditions

13

(1) This sub-paragraph applies where a Local Health Board decides to grant an application falling within—

(a) paragraph 8(1)(a)(i) where the premises specified in the application are in a controlled locality, or

(b) paragraph 8(1)(a)(ii).

(2) Where sub-paragraph (1) applies, a Local Health Board—

(a) must consider whether the provision of—

(i) primary medical services by a provider of such services (other than itself),

(ii) pharmaceutical services by an NHS pharmacist or NHS appliance contractor,

(iii) local pharmaceutical services provided under a pilot scheme, or

(iv) pharmaceutical services by a doctor,

is likely to be adversely affected as a consequence of its decision to grant the application, and

(b) may, where it is of the opinion that the provision of any of those services listed in sub-paragraph (2)(a) is likely to be adversely affected, impose conditions to postpone, for such period as it thinks fit, the making or termination of arrangements under regulation 26 (arrangements for the provision of pharmaceutical services by doctors) or equivalent provision by a doctor or GMS contractor of pharmaceutical services or dispensing services to patients on the relevant list.

Notification of decisions: applications for inclusion in or to make an amendment to a pharmaceutical list

14

(1) A Local Health Board must, as soon as is practicable after reaching a decision on an application falling within paragraph 8(1)(a)(i), give notice in writing of its decision (including the questions of the imposition of conditions under paragraph 13 and the determination of a reserved location under regulation 17(1)) to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) In the case of an application which is determined under regulation 22 (applications involving a change of ownership), a Local Health Board must as soon as practicable after reaching a decision give notice in writing in accordance with paragraph 9.

(3) A notification of a decision under this paragraph must include a statement of the reasons for the decision and of any rights of appeal.

Notification of decisions: applications for inclusion in or amendment to dispensing doctor lists

15

(1) A Local Health Board must, as soon as is practicable after reaching a decision on an application falling within paragraph 8(1)(a)(ii), give notice in writing of its decision (including the question of the imposition of conditions under paragraph 13) to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) A notification of a decision under this paragraph must include a statement of the reasons for the decision and of any rights of appeal.

Notification of decisions: applications under regulation 24 for extension of the relevant period

16

(1) A Local Health Board must, as soon as practicable after reaching a decision on an application falling within paragraph 8(1)(b), give notice in writing of its decision to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) Any notification of a decision under this paragraph must include a statement of the reasons for the decision.

Notification of decisions: applications under regulation 17(2)

17

(1) A Local Health Board must, as soon as practicable after reaching a decision on an application falling within paragraph 8(1)(c), give notice in writing of its decision to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) A notification of a decision under this paragraph must include a statement of the reasons for the decision and of any rights of appeal.

Action following determination in respect of reserved locations

18

(1) After determining an application under regulation 17(2) or making a determination in accordance with regulation 17(1), as soon as practicable after the relevant date, the Local Health Board must delineate precisely on a map the boundaries of any reserved location that it has determined, or remove the delineated boundary of a location that has ceased to be a reserved location, as the case may be.

(2) For the purposes of this paragraph, “the relevant date” is the later of—

(a) the date on which the period for bringing an appeal relating to the determination ends, or

(b) the date of the determination of any such appeal.

SCHEDULE 4 — Appeals to the Welsh Ministers

PART 1 — Preliminary matters

General principles

1

Except in so far as these Regulations provide to the contrary, the Welsh Ministers may determine an appeal submitted to them in such manner as they think fit and may, in particular—

(a) consider all information available to them which, in their opinion, is relevant to the determination of an appeal;

(b) consider two or more appeals together and in relation to each other (but they are not obliged to do so where the Local Health Board has determined two or more applications together and in relation to each other) but where they intend to do so they must give notice of that intention to each appellant and those given notice of each appeal in accordance with this Schedule;

(c) where in accordance with sub-paragraph (b) the Welsh Ministers consider two or more appeals to which regulation 15(2) applies together and in relation to each other, they may refuse an appeal (notwithstanding the fact that they would if determining the appeal in isolation grant it) where the number of appeals is such, or the circumstances in which they are made are such, that to grant all of them or more than one of them, would prejudice the proper provision of primary medical services, pharmaceutical services or dispensing services in the controlled locality within which the premises specified in the appeal are situated;

(d) remit an appeal submitted to them to a Local Health Board for re-determination in cases where the information that the applicant is required to provide in accordance with Schedule 2 was incomplete;

(e) dismiss an appeal if they are of the opinion that the notice of appeal—

(i) is not valid because it does not comply with the requirements of this Schedule,

(ii) does not disclose any reasonable grounds of appeal, or

(iii) is otherwise vexatious or frivolous.

Oral hearings

2

(1) The Welsh Ministers may require an oral hearing to be held if they consider that it is necessary to hear oral representations before determining an appeal submitted to them.

(2) If the Welsh Ministers decide to hold an oral hearing, they must—

(a) appoint one or more persons to hear and to report to them on the appeal,

(b) give not less than 14 days’ notice of the time and place of the hearing to the appellant and to any person sent a copy of the notice of appeal under paragraph 4 or 7,

(d) advise those notified that they may make oral representations relating to the appeal at the hearing.

(3) Any person mentioned in sub-paragraph (2) wishing to make oral representations at the hearing may be assisted in the presentation of their representations by another person and may be represented by that other person at the hearing, including where the person notified under sub-paragraph (2) is unable to attend the hearing in person.

(4) The person or persons appointed by the Welsh Ministers to hear the appeal may determine the procedure to be followed at the hearing.

(5) The Welsh Ministers are not bound by any recommendations arising from an oral hearing.

PART 2 — Appeals against decisions determining controlled localities

Right of appeal to the Welsh Ministers

3

(1) Where a Local Health Board has decided that an application by a Local Medical Committee or a Local Pharmaceutical Committee cannot be considered by virtue of regulation 13(3) (areas that are controlled localities), the applicant may submit a notice of appeal against that decision to the Welsh Ministers.

(2) Where a Local Health Board has determined under regulation 13(2) whether or not any particular area within the area for which it is established is, because it is rural in character, a controlled locality or part of a controlled locality, the persons entitled to submit a notice of appeal against that determination to the Welsh Ministers are—

(a) the Local Medical Committee,

(b) the Local Pharmaceutical Committee, and

(c) any person included in a pharmaceutical list maintained by the Local Health Board, any provider of local pharmaceutical services under a pilot scheme or any provider of primary medical services in the area for which the Local Health Board is established and who were given notice of the determination by the Local Health Board under paragraph 7(1) of Schedule 3.

(3) Where a Local Health Board has determined that it should or should not postpone the making or termination of arrangements, as mentioned in paragraph 6(b) of Schedule 3, those that may submit a notice of appeal against that determination to the Welsh Ministers are—

(a) the Local Medical Committee,

(b) the Local Pharmaceutical Committee, and

(c) any person included in a pharmaceutical list maintained by the Local Health Board, any provider of local pharmaceutical services under a pilot scheme or any provider of primary medical services in the area for which the Local Health Board is established and who were given notice of the determination by the Local Health Board under paragraph 7(1) of Schedule 3.

(4) A notice of appeal is valid if—

(a) it is submitted by a person with the right of appeal under sub-paragraph (1), (2) or (3),

(b) it is sent to the Welsh Ministers within 30 days of the date on which notice of the decision being appealed was sent by the Local Health Board to the person making the appeal, and

Notification of appeals

4

(1) The Welsh Ministers must on receipt of a notice of appeal submitted under paragraph 3(1) send a copy of the notice to the Local Health Board.

(2) The Welsh Ministers must on receipt of a notice of appeal submitted under paragraph 3(2) or 3(3) send a copy of the notice to—

(a) the Local Health Board, and

(b) those persons to whom the Local Health Board has given notice of its determination under paragraph 7(1) of Schedule 3.

(3) Those sent a copy of the notice of appeal under sub-paragraphs (1) to (3) must, at the same time, be informed by the Welsh Ministers—

(a) that they may within 30 days of the date on which the notice of appeal was sent to them, make representations on the appeal in writing to the Welsh Ministers, and

(b) of the circumstances in which the Welsh Ministers may require an oral hearing to be held.

Decision on appeals

5

(1) The Welsh Ministers must after reaching a decision on an appeal submitted under paragraph 3 give written notice of their decision together with the reasons for it to those persons sent a copy of the notice of appeal under paragraph 4.

(2) The Welsh Ministers—

(a) must, where they allow an appeal against a decision by a Local Health Board that an application cannot be considered by virtue of regulation 13(3), either—

(i) themselves determine the question of whether or not the particular locality is or is part of a controlled locality, or

(ii) remit the question to the Local Health Board for determination,

(b) may, where the Local Health Board, on determining the application, considered the imposition of conditions under paragraph 6 of Schedule 3, themselves consider whether to impose conditions,

(c) may, where the Local Health Board, on determining the application, has not considered the imposition of conditions under paragraph 6 of Schedule 3 either—

(i) themselves consider whether to impose conditions, or

(ii) remit the question to the Local Health Board for determination,

(d) may, where the Local Health Board, on determining the application, considered the question whether to postpone the making or termination of arrangements under regulation 26 (or equivalent provision under the GMS Regulations) for the provision by a doctor or a GMS contractor of pharmaceutical services or dispensing services to patients, themselves postpone, for such period as they think fit, the making or termination of such arrangements, or

(e) must, where the Local Health Board, did not consider the question whether to postpone the making or termination of arrangements under regulation 26 (or equivalent provision under the GMS Regulations) for the provision by a doctor or a GMS contractor of pharmaceutical services or dispensing services to patients, remit the question to the Local Health Board for determination.

PART 3 — Appeals against decisions for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists

Right of appeal to the Welsh Ministers

6

(1) For applications to which paragraph 8(1)(a) and (c) of Schedule 3 apply, the persons entitled to submit a notice of appeal against the decision of the Local Health Board to the Welsh Ministers are—

(a) the applicant;

(b) any of the following who made representations on the application to the Local Health Board under paragraph 8(3) of Schedule 3—

(i) any person included in a pharmaceutical list,

(ii) any person who has been granted preliminary consent for inclusion in a pharmaceutical list,

(iii) any provider of local pharmaceutical services under a pilot scheme, and

(iv) where the premises specified in an application are in a controlled locality, any person who is a provider of primary medical services or who is included in the dispensing doctor list.

(2) In the case of an application determined under regulation 22 (applications involving a change of ownership), the persons entitled to submit a notice of appeal to the Welsh Ministers are—

(a) the applicant, and

(b) any of the following who were, under paragraph 14(2) of Schedule 3, given notice of the Local Health Board’s decision on the application—

(i) any person included in a pharmaceutical list,

(ii) any person who has been granted preliminary consent for inclusion in a pharmaceutical list,

(iii) any provider of local pharmaceutical services under a pilot scheme, and

(iv) where the premises specified in the application are in a controlled locality, any person who is a provider of primary medical services or who is included in the dispensing doctor list.

(3) A notice of appeal is valid if—

(a) it is submitted by a person with the right of appeal under sub-paragraph (1) or (2),

(b) it is sent to the Welsh Ministers within 30 days of the date on which notice of the decision being appealed was sent by the Local Health Board to the person making the appeal, and

(c) it contains a statement of the grounds of appeal which do not amount to a challenge to the legality or reasonableness of a pharmaceutical needs assessment, or to the fairness of the process by which the Local Health Board undertook that assessment.

Notification of appeals

7

(1) The Welsh Ministers must, on receipt of a notice of appeal submitted under paragraph 6(1), send a copy of the notice to—

(a) the applicant, if the applicant has not submitted the notice of appeal,

(b) the Local Health Board, and

(2) The Welsh Ministers must, on receipt of a notice of appeal submitted under paragraph 6(2), send a copy of the notice to—

(a) the applicant, if the applicant has not submitted the notice of appeal,

(b) the Local Health Board, and

(3) The persons to whom a copy of the notice of appeal is sent under this paragraph must, at the same time, be informed by the Welsh Ministers—

(a) that they may, within 30 days of the date on which the notice of appeal was sent to them, make representations on the appeal in writing to the Welsh Ministers,

(b) of the circumstances in which the Welsh Ministers may require an oral hearing to be held, and

(c) where the Welsh Ministers intend to consider two or more appeals together and in relation to each other, of that intention.

Decision on appeals

8

(1) On determining an appeal made under paragraph 6, the Welsh Ministers must either—

(a) allow the appeal, or

(b) confirm the decision of the Local Health Board.

(2) In the case where the premises specified in an application that is subject to appeal are in a controlled locality, the Welsh Ministers—

(a) may, where the Local Health Board, on determining the application, considered whether to impose conditions under paragraph 13 of Schedule 3 or regulation 17(6)(b), themselves consider whether to impose conditions to postpone, for such period as they think fit, the making or termination of such arrangements, or

(b) must, where the Local Health Board on determining the application has not considered whether to impose conditions under paragraph 13 of Schedule 2 or regulation 17(6)(b) either—

(i) themselves consider whether to impose conditions, or

(ii) remit the question to the Local Health Board for determination.

(3) The Welsh Ministers must after reaching a decision on an appeal, including the imposition of conditions under sub-paragraph (2), give written notice of their decision together with the reasons for it to those persons sent a copy of the notice of appeal under paragraph 7.

Effect of decisions by the Welsh Ministers

9

For the purposes of these Regulations, the Welsh Ministers’ decision becomes the Local Health Board’s decision on the matter (but no further appeal to the Welsh Ministers on that decision is possible, unless the Welsh Ministers’ decision is overruled by a court).

SCHEDULE 5 — Terms of service for NHS pharmacists who provide pharmaceutical services in particular by the provisions of drugs

PART 1 — General

Interpretation

1

In this Schedule, drugs or appliances are to be taken to be requested or provided in accordance with a repeatable prescription even if the person who wishes to obtain pharmaceutical services does not present that prescription, as long as—

(a) the NHS pharmacist has that prescription in their possession, and

(b) that person presents, or the NHS pharmacist has in their possession, an associated batch issue.

Incorporation of provisions

2

Any provisions of the following affecting the rights and obligations of NHS pharmacists who provide pharmaceutical services form part of the terms of service—

(a) the Regulations,

(b) the Drug Tariff in so far as it lists drugs and appliances for the purposes of section 80 of the 2006 Act (arrangements for pharmaceutical services),

(i) investigations made by the pharmaceutical discipline committee and the joint discipline committee and action which may be taken by the Local Health Board as a result of such investigations, and,

(ii) appeals to the Welsh Ministers from decisions of the Local Health Board.

(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 — Essential services

Essential services

3

For the purposes of this Schedule, “essential services” means—

(a) the services described in this Part, and

(b) the activities described in this Part to be carried out in connection with those services.

Dispensing services

4

An NHS pharmacist must, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting a prescription for that drug or appliance signed by a prescriber in pursuance of their functions in the health service in Wales, England, Scotland or Northern Ireland and persons presenting an order for an ophthalmic listed appliance or an ophthalmic listed medicine signed by a qualifying optometrist in pursuance of their functions in the health service in Wales.

Dispensing of drugs and appliances

5

(1) Subject to the following provisions of this Part, where a person presents on a prescription form—

(a) an order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber,

(b) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs or medicines to be ordered only in certain circumstances), signed by, and endorsed on its face with the reference “SLS” by a prescriber, or

(c) an order for a restricted availability appliance, signed by and endorsed on its face with the reference “SLS” by a prescriber,

an NHS pharmacist must, with reasonable promptness and in accordance with any directions given by the prescriber in the prescription form, provide the drugs so ordered, and such of the appliances so ordered they supply in the normal course of business.

(2) Subject to the following provisions of this Part, where any person—

(a) presents a non-electronic repeatable prescription which contains—

(i) an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971[^f00037], other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001[^f00038] (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a repeatable prescriber,

(ii) an order for appliances, not being restricted availability appliances, signed by a repeatable prescriber, or

(iii) an order for a restricted availability appliance, signed by, and endorsed on its face with the reference “SLS” by a repeatable prescriber,

and also presents an associated batch issue, or

(b) requests the provision of drugs or appliances in accordance with an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) to (iii),

an NHS pharmacist must, with reasonable promptness and in accordance with any directions given by the repeatable prescriber in the repeatable prescription, provide the drugs so ordered, and such of the appliances so ordered as they supply in the normal course of their business.

(3) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances is to be taken to be presented even if the person who wishes to obtain the drugs or appliances does not present that prescription, where—

(a) the NHS pharmacist has that prescription in their possession, and

(b) that person presents, or the NHS pharmacist has in their possession, an associated batch issue.

Supply in accordance with a SSP

6

(1) This sub-paragraph applies where—

(a) a person requests a drug or appliance from an NHS pharmacist in accordance with a prescription form or repeatable prescription, and

(b) a SSP has effect in respect of—

(i) the requested drug or appliance, or

(ii) drugs or appliances of a specified description, and the requested drug or appliance is of that description.

(2) Where sub-paragraph (1) applies, the NHS pharmacist must consider whether it is reasonable and appropriate to supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

(3) Where sub-paragraph (1) applies, the NHS pharmacist may provide a different product or quantity of product to the product or quantity of product ordered on the prescription form or repeatable prescription, where—

(a) the NHS pharmacist is able to do so with reasonable promptness,

(b) to do so is in accordance with the SSP, and

(c) the supply of a different product or quantity of product to that ordered by the prescriber is by or under the direct supervision of a registered pharmacist who is of the opinion, in the exercise of their professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is reasonable and appropriate.

(4) Where an NHS pharmacist, in accordance with sub-paragraph (3), provides a different product or quantity of product to that ordered by the prescriber—

(a) the registered pharmacist mentioned in sub-paragraph (3)(c) must endorse the prescription or the associated batch issue accordingly (if the manner for making the endorsement is provided for in the Drug Tariff, in the manner provided for in the Drug Tariff), and the prescription or associated batch issue as so endorsed is treated as being the prescription for product reimbursement purposes (even though the supply is not in pursuance of that prescription), and

(b) if the patient to or for whom the product is provided is on a patient list, and the supply—

(i) by virtue of regulation 226A(5)(c)(iii) of the Human Medicines Regulations 2012 (sale etc. by a pharmacist in accordance with a serious shortage protocol), is of a prescription only medicine that is different to but has a similar therapeutic effect to the product ordered by the prescriber, or

(ii) is of any other type, and the Welsh Ministers and the person who is, for the time being, the person consulted under section 89(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists, acting jointly, have issued and publicised in such manner as they see fit a recommendation to the effect that, for clinical reasons, in the case of supplies of that type, providers of primary medical services should be notified of a supply to a patient on their patient list that is in accordance with a SSP instead of in accordance with a prescription form or repeatable prescription,

the NHS pharmacist must notify the provider of primary medical services on whose patient list the patient is, of the supply in accordance with the SSP instead of in accordance with the prescription form or repeatable prescription.

(5) Where—

(a) sub-paragraph (1) applies,

(b) a registered pharmacist is of the opinion, in the exercise of their professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate, and

(c) the NHS pharmacist is able to supply the product or quantity of product ordered by the prescriber within a reasonable timescale but not with reasonable promptness,

the requirements to act with reasonable promptness in paragraph 5(1) and (2) are to be read as requirements to act within a reasonable timescale.

Urgent supply without a prescription

7

(1) This paragraph applies where, in a case of urgency, a prescriber requests an NHS pharmacist to provide a drug or appliance.

(2) The NHS pharmacist may provide the drug or appliance requested before receiving a prescription form or repeatable prescription in respect of that drug or appliance, provided that—

(a) in the case of a request for a drug, the drug is neither—

(i) a Scheduled drug, nor

(ii) a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, and

(b) in the case of a request for a drug or an appliance, the prescriber undertakes to—

(i) give the NHS pharmacist a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug or appliance within 72 hours of the request being made, or

(ii) give the NHS pharmacist an electronic prescription form or electronic repeatable prescription complying with the ETP service within 72 hours of the request being made.

Preliminary matters before providing ordered drugs or appliances

8

(1) If the person presenting the prescription form or repeatable prescription, or requesting the provision of drugs or appliances in accordance with a repeatable prescription, asks the NHS pharmacist to do so—

(a) the NHS pharmacist must give an estimate of the time when the drugs or appliances will be ready, and

(b) if they are not ready by then, the NHS pharmacist must give a revised estimate of the time when they will be ready (and so on).

(2) Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription—

(a) the NHS pharmacist must ask any person who makes a declaration that the person named on the prescription form or the repeatable prescription does not have to pay the charges specified in regulation 3(1) of the Charges Regulations (supply of drugs and appliances by chemists) by virtue of either—

(i) entitlement to exemption under regulation 8(1) (exemptions) of the Charges Regulations, or

(ii) entitlement to remission of such charges under regulation 5 of the Remission of Charges Regulations (remissible NHS charges),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by regulation 8(1) of the Charges Regulations or in respect of entitlement to remission by virtue of sub-paragraphs (a) to (f) of regulation 5(2) of the Remission of Charges Regulations, and at the time of the declaration such evidence is already available to the NHS pharmacist, and

(b) if no satisfactory evidence, as required by paragraph (a), is produced to the NHS pharmacist, the NHS pharmacist must endorse the form on which the declaration is made to that effect.

(3) Sub-paragraph (2) applies to the provision of a drug or appliance in accordance with a SSP as it does to the provision of a drug or appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes, the prescription for product reimbursement purposes, as mentioned in paragraph 6(4)(a), is treated as being the prescription in accordance with which the drug or appliance is provided (even though the supply is not in pursuance of that prescription).

Providing ordered drugs or appliances

9

(1) Where an NHS pharmacist is presented with a prescription form or a repeatable prescription, the NHS pharmacist must only provide the drugs or appliances so ordered—

(a) if the prescription form or repeatable prescription is duly signed and endorsed as described in paragraph 5(1) or (2), and

(b) in accordance with the order and any directions given by the prescriber on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985[^f00039] and the following provisions of this Part.

(2) Drugs or appliances so ordered must be provided either by or under the ... supervision of a registered pharmacist.

(3) Where the pharmacist referred to in sub-paragraph (2) is employed by an NHS pharmacist, the registered pharmacist must not be someone—

(a) who is disqualified from inclusion in a relevant list, or

(b) who is suspended from the General Pharmaceutical Council Register.

(4) If the order is for, or a product to be provided in accordance with a SSP is, an appliance of a type requiring measuring and fitting (for example a truss), the NHS pharmacist must make all necessary arrangements—

(a) for measuring the person named on the prescription form or repeatable prescription for the appliance, and

(b) for fitting the appliance.

(5) If the order is for, or a product to be provided in accordance with a SSP is, a drug or appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner’s Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the drug or appliance provided must comply with the standard or formula specified therein.

(6) If the order—

(a) is an order for a drug, but

(b) is not an order for a controlled drug within the meaning of the Misuse of Drugs Act 1971 other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001,

and does not prescribe its quantity, strength or dosage, an NHS pharmacist may provide the drug in such strength and dosage as in the exercise of their professional skill, knowledge and care they consider to be appropriate and, subject to sub-paragraph (7), in such quantity as they consider to be appropriate for a course of treatment for a period not exceeding 5 days.

(7) Where an order to which sub-paragraph (6) applies is for—

(a) an oral contraceptive substance;

(b) a drug, which is available for supply as part of pharmaceutical services only together with one or more other drugs, or

(c) an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package,

which is not available for provision as part of pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, the NHS pharmacist may provide the minimum size available package.

(8) Where any drug to which this paragraph applies (that is, a drug that is not one to which the Misuse of Drugs Act 1971 applies, unless it is a drug for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by an NHS pharmacist in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is—

(a) sterile,

(b) effervescent or hygroscopic,

(d) a coal tar preparation,

(e) a viscous preparation, or

(f) packed at the time of its manufacture in a calendar pack or special container,

the NHS pharmacist must provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

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

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.