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

Regulations 15, 18, 23, 30, 33 and 34

SCHEDULE 2 E+W Information to be included in applications to provide pharmaceutical services

PART 1 E+W Application for inclusion in or for amendment to a pharmaceutical list

Information required from all applicants E+W

Details of the application E+W

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

Commencement Information

I1 Sch. 2 para. 1 in force at 1.10.2020, see reg. 1(2)(b)

2.  Type of consent applied for (full or preliminary). E+W

Commencement Information

I2 Sch. 2 para. 2 in force at 1.10.2020, see reg. 1(2)(b)

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). E+W

Commencement Information

I3 Sch. 2 para. 3 in force at 1.10.2020, see reg. 1(2)(b)

Details of the applicant E+W

4.  Name and address of the applicant.

Commencement Information

I4 Sch. 2 para. 4 in force at 1.10.2020, see reg. 1(2)(b)

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. E+W

Commencement Information

I5 Sch. 2 para. 5 in force at 1.10.2020, see reg. 1(2)(b)

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. E+W

Commencement Information

I6 Sch. 2 para. 6 in force at 1.10.2020, see reg. 1(2)(b)

Details of the premises and opening hours E+W

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.

Commencement Information

I7 Sch. 2 para. 7 in force at 1.10.2020, see reg. 1(2)(b)

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

Commencement Information

I8 Sch. 2 para. 8 in force at 1.10.2020, see reg. 1(2)(b)

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

Commencement Information

I9 Sch. 2 para. 9 in force at 1.10.2020, see reg. 1(2)(b)

Pharmaceutical services to be provided E+W

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

Commencement Information

I10 Sch. 2 para. 10 in force at 1.10.2020, see reg. 1(2)(b)

11.  Details of directed services that the applicant applies to provide. E+W

Commencement Information

I11 Sch. 2 para. 11 in force at 1.10.2020, see reg. 1(2)(b)

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. E+W

Commencement Information

I12 Sch. 2 para. 12 in force at 1.10.2020, see reg. 1(2)(b)

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

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. E+W

Commencement Information

I13 Sch. 2 para. 13 in force at 1.10.2020, see reg. 1(2)(b)

Information relating to the prejudice test E+W

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. E+W

Commencement Information

I14 Sch. 2 para. 14 in force at 1.10.2020, see reg. 1(2)(b)

Information relating to applications involving relocations E+W

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. E+W

Commencement Information

I15 Sch. 2 para. 15 in force at 1.10.2020, see reg. 1(2)(b)

16.  Where the application involves a relocation between neighbouring Local Health Board area under regulation 20 the applicant must state— E+W

(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.

Commencement Information

I16 Sch. 2 para. 16 in force at 1.10.2020, see reg. 1(2)(b)

17.  The applicant must provide details of whether— E+W

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

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

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

Commencement Information

I17 Sch. 2 para. 17 in force at 1.10.2020, see reg. 1(2)(b)

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

Commencement Information

I18 Sch. 2 para. 18 in force at 1.10.2020, see reg. 1(2)(b)

Information relating to applications involving a change of ownership E+W

19.  Name of the person included in the pharmaceutical list currently providing pharmaceutical services from the premises. E+W

Commencement Information

I19 Sch. 2 para. 19 in force at 1.10.2020, see reg. 1(2)(b)

20.  The applicant must provide details of whether— E+W

(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.

Commencement Information

I20 Sch. 2 para. 20 in force at 1.10.2020, see reg. 1(2)(b)

Applicant’s undertaking E+W

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. E+W

Commencement Information

I21 Sch. 2 para. 21 in force at 1.10.2020, see reg. 1(2)(b)

PART 2 E+W Information and undertakings for applications for inclusion in a pharmaceutical list

Applicant’s details E+W

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

(a) full name,

(b) gender,

(c) date of birth,

(d) address and telephone number,

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

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

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

(a) full name,

(b) company registration number,

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

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

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

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

Commencement Information

I22 Sch. 2 para. 22 in force at 1.10.2020, see reg. 1(2)(b)

Investigation, proceedings and convictions E+W

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Commencement Information

I23 Sch. 2 para. 23 in force at 1.10.2020, see reg. 1(2)(b)

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— E+W

(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.

Commencement Information

I24 Sch. 2 para. 24 in force at 1.10.2020, see reg. 1(2)(b)

Pharmaceutical qualifications, referees etc. E+W

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.

Commencement Information

I25 Sch. 2 para. 25 in force at 1.10.2020, see reg. 1(2)(b)

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. E+W

Commencement Information

I26 Sch. 2 para. 26 in force at 1.10.2020, see reg. 1(2)(b)

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

Commencement Information

I27 Sch. 2 para. 27 in force at 1.10.2020, see reg. 1(2)(b)

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. E+W

Commencement Information

I28 Sch. 2 para. 28 in force at 1.10.2020, see reg. 1(2)(b)

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. E+W

Commencement Information

I29 Sch. 2 para. 29 in force at 1.10.2020, see reg. 1(2)(b)

Undertakings E+W

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

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

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

(c) they withdraw the application, or

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

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

Commencement Information

I30 Sch. 2 para. 30 in force at 1.10.2020, see reg. 1(2)(b)

PART 3 E+W Notification of commencement date

Information to be provided prior to the commencement of the provision of pharmaceutical services E+W

31.  The applicant must provide the following information—

(a) name of the applicant,

(b) date of grant of application,

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

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

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

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

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

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

Commencement Information

I31 Sch. 2 para. 31 in force at 1.10.2020, see reg. 1(2)(b)

PART 4 E+W Applications for outline consent and premises approval

Details of the application E+W

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

Commencement Information

I32 Sch. 2 para. 32 in force at 1.10.2020, see reg. 1(2)(b)

33.  Type of application (outline consent, premises approval or both). E+W

Commencement Information

I33 Sch. 2 para. 33 in force at 1.10.2020, see reg. 1(2)(b)

Details of the applicant E+W

34.  Name and address of the applicant.

Commencement Information

I34 Sch. 2 para. 34 in force at 1.10.2020, see reg. 1(2)(b)

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. E+W

Commencement Information

I35 Sch. 2 para. 35 in force at 1.10.2020, see reg. 1(2)(b)

Application for outline consent E+W

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

Commencement Information

I36 Sch. 2 para. 36 in force at 1.10.2020, see reg. 1(2)(b)

37.  Address of any pharmacy within the area described and delineated under paragraph 36. E+W

Commencement Information

I37 Sch. 2 para. 37 in force at 1.10.2020, see reg. 1(2)(b)

Application for premises approval E+W

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.

Commencement Information

I38 Sch. 2 para. 38 in force at 1.10.2020, see reg. 1(2)(b)

39.  Distance between those premises and the nearest pharmacy (and the address of that pharmacy). E+W

Commencement Information

I39 Sch. 2 para. 39 in force at 1.10.2020, see reg. 1(2)(b)

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). E+W

Commencement Information

I40 Sch. 2 para. 40 in force at 1.10.2020, see reg. 1(2)(b)

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. E+W

Commencement Information

I41 Sch. 2 para. 41 in force at 1.10.2020, see reg. 1(2)(b)

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

Commencement Information

I42 Sch. 2 para. 42 in force at 1.10.2020, see reg. 1(2)(b)

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. E+W

Commencement Information

I43 Sch. 2 para. 43 in force at 1.10.2020, see reg. 1(2)(b)

Pharmaceutical services to be provided E+W

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

Commencement Information

I44 Sch. 2 para. 44 in force at 1.10.2020, see reg. 1(2)(b)

Prejudice test E+W

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.

Commencement Information

I45 Sch. 2 para. 45 in force at 1.10.2020, see reg. 1(2)(b)

Meeting identified needs E+W

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.

Commencement Information

I46 Sch. 2 para. 46 in force at 1.10.2020, see reg. 1(2)(b)

Applicant’s undertaking E+W

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.

Commencement Information

I47 Sch. 2 para. 47 in force at 1.10.2020, see reg. 1(2)(b)