1. Introduction

The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (the 2013 regulations) set the legal framework for the commissioning of pharmaceutical services in England by (integrated care boards (ICBs)). In particular they set out:

• the requirements for the publication of pharmaceutical needs assessments by health and wellbeing boards,
• the maintenance of lists of contractors who provide pharmaceutical services or local pharmaceutical services (LPS) namely pharmacies, dispensing appliance contractors and dispensing doctors,
• how applications for inclusion in pharmaceutical lists, maintained by ICBs and published by NHS England, are made and determined,
• specific matters relating to the provision of services in rural areas,
• the terms of service for those contractors who provide pharmaceutical services, and
• other miscellaneous provisions.

The 2013 regulations have been amended several times since they came into force on 1 April 2013, and this document provides information on the latest set of amendments contained within The NHS (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 (the 2023 regulations).

The 2023 regulations amend a number of provisions within the 2013 regulations and for the most part these amendments came into force on 25 May 2023. The one exception to this date is the amendments made to the terms of service relating to the temporary suspension in the provision of pharmaceutical services by pharmacy contractors (paragraph 23(10), Schedule 4 of the 2013 regulations) and the requirement for contractors to have a business continuity plan for each of their pharmacy premises (paragraph 29D, Schedule 4 of the 2013 regulations). Those requirements came into force on 31 July 2023.

The amendments within the 2023 regulations cover the following areas.

• The ability for integrated care boards (ICBs) to remove the “100 hours condition” from those pharmacies that applied under regulation 13(1)(b) of The NHS (Pharmaceutical Services) Regulations 2005 (referred to as 100 hour pharmacies) following submission of a valid application (chapter 2).
• The ability for pharmacy contractors to apply to reduce the core opening hours of their 100 hour pharmacy to between 72 and 100 hours where certain requirements are met (chapter 2).
• Confirmation that if a contractor successfully applies to reduce the core opening hours of their 100 hour pharmacy they are still required to give six months’ notice if they wish to withdraw those premises from the relevant pharmaceutical list (chapter 2).
• Confirmation that directions issued in relation to the opening hours of pharmacy premises transfer to any subsequent owner of those premises and continue to apply to any premises that the pharmacy may subsequently relocate to.
• Where an opening hours direction is in place for pharmacy premises that are the subject of a change of ownership (or a combined change of ownership and relocation) application the applicant must undertake to provide pharmaceutical services for the same total number of core opening hours on the same days and at the same times as the current owner. If they fail to do so the application is to be refused (chapters 2 and 3).
• A change to the requirement for applicants to provide the full work history for pharmacists, reducing it to providing their personal work history for the seven years ending on the date that the application for inclusion in a pharmaceutical list is submitted (chapter 7).
• A requirement for applicants to make a declaration on certain fitness matters as part of an application for inclusion in a pharmaceutical list (chapter 7).
• Changes to the requirements for notices of commencement in relation to the date service provision is to commence which can now be no longer than 60 days after the end of the “grant period”. Where an applicant notifies the ICB of a change to that commencement date, the new date must also fall within 60 days of the end of the “grant period” (chapter 8).
• Introduction of a notification process for pharmacy contractors who wish to include a rest break into their core opening hours where certain requirements are met, as opposed to having to apply to do so. However, pharmacy contractors who wish to introduce a rest break into the core opening hours of their 100 hour pharmacy must apply to do so and their application will be assessed against the new ‘test’ in paragraph 24(1), Schedule 4 (chapter 4).
• Pharmacy contractors who increase the number of supplementary opening hours of their pharmacy premises must now notify the relevant ICB in advance, but there is no minimum amount of notice that must be given (chapter 4).
• Pharmacy contractors who wish to reduce, or amend the timing of their supplementary opening hours are still required to give at least five weeks’ notice, however they may now ask the ICB to agree to a shorter notice period (chapter 4).
• Amendments to the requirements on pharmacy contractors where there is a temporary suspension in the provision of pharmaceutical services at their pharmacy premises because of illness or another reason beyond the control of the contractor. The requirement to make arrangements with one or more other pharmacy contractors has been removed and instead pharmacy contractors are required to have a business continuity plan for their pharmacy premises which is implemented when there is a temporary suspension of the provision of pharmaceutical services at the premises. In addition, pharmacy contractors are required to notify the relevant ICB of the temporary suspension in an approved manner (chapter 5).
• A change to the ‘test’ in paragraph 24(1), Schedule 4 against which:
  • applications to change core opening hours are assessed; and
  • decisions are made by an ICB to issue a direction to a pharmacy contractor to open their pharmacy premises on set days and/or at set times (chapter 3).
• The ability for ICBs to put in place a local hours plan where they are satisfied that people in a particular area are experiencing, or are likely to experience, significant difficulty in accessing pharmaceutical services on a temporary basis for an identified period of time (chapter 6).

The following points should be noted when reading this guidance:

• All references to regulations, paragraphs and schedules in this document are to the 2013 regulations as in force as of 25 May 2023 unless otherwise specified.
• This document is intended to complement the 2013 regulations and should be read alongside them (and not in place of them).
• The term “‘pharmacy premises” has the same definition as in regulation 2 namely premises that are included in a pharmaceutical list.
• The amendments relating to opening hours and temporary suspensions do not automatically apply to contractors providing services under a LPS contract. Where an ICB wishes to include one or all of these provisions within a LPS contract it can only do so with the agreement of the contractor and both parties are required to sign a contract variation notice to effect the variations.
• The term “40 hour pharmacy” is used to describe any pharmacy that is not, or has never been, subject to the 100 hours condition, irrespective of the total number of core opening hours they may have. The term “100 hour pharmacy” is used to describe any pharmacy that is, or has ever been, subject to the 100 hours condition irrespective of whether they have subsequently successfully applied to reduce their total number of core opening hours.
• Chapter 8 supersedes chapter 17 of NHS England’s ‘Guidance on the National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020’ published on 22 December 2020. It also supersedes paragraphs 32 to 42, chapter 3 of NHS England’s pharmacy manual (version 2 published 10 February 2023).

2. 100 hour pharmacies

2.1 Background

With effect from 1 April 2005, primary care trusts were required to grant applications for inclusion in a pharmaceutical list where the applicant undertook to provide pharmaceutical services for at least 100 hours per week (regulation 13(1)(b), The NHS (Pharmaceutical Services) Regulations 2005, the “2005 regulations”). The applicant’s subsequent inclusion in the relevant pharmaceutical list (and so a term of service) was subject to the condition that the premises are kept open for at least 100 hours per week for the provision of pharmaceutical services (regulation 13(2)(a) of the 2005 regulations). Primary care trusts were not able to vary or remove that condition. Such pharmacies have become known as “100 hour pharmacies”.

Whilst the ability to apply to open a new 100 hour pharmacy was removed from the regulations with effect from 1 September 2012, the requirement on these pharmacies to continue to be open for 100 hours per week was carried into the NHS (Pharmaceutical Services) Regulations 2012 and 2013 regulations. NHS England could not vary or remove this “100 hours condition” (regulation 65(3)).

2.2 Amendment to the 100 hours condition

With effect from 25 May 2023, the 2013 regulations were amended so that:

• A pharmacy contractor can apply to the relevant ICB to reduce the total core opening hours of their 100 hour pharmacy, and
• The ICB may agree to remove the 100 hours condition in respect of those premises and replace it with a direction which specifies a lower number of total core opening hours.

However, ICBs and contractors must note that the direction, and any subsequent direction that may be issued in respect of these pharmacy premises, must specify a total number of core opening hours of not less than 72 (regulation 65(3A)). In addition:

• any core opening hours must be maintained on a Monday to Saturday between 17.00 and 21.00;
• any core opening hours on a Sunday between 11.00 and 16.00 cannot be changed, other than by way of the inclusion of, or a change to, a rest break which:
  • is no longer than one hour, and
  • starts at least three hours after the start of the pharmacy’s opening hours and ends at least three hours before the end of the pharmacy’s opening hours on that day; and
• the total number of core opening hours on a Sunday cannot be reduced (paragraph 26(2A), Schedule 4).

It is to be noted that where a contractor has successfully applied to reduce the total core opening hours of their 100 hour pharmacy, the contractor will still be required to give six months’ notice if they wish to withdraw the pharmacy from the relevant pharmaceutical list (regulation 67(2)(b)(i)).

Where a contractor successfully applies to reduce the total number of core opening hours of their 100 hour pharmacy, paragraph 24(5), Schedule 4 confirms that paragraph 25(4), Schedule 4 does not apply. This means that the ICB does not need to be satisfied that the contractor will receive reasonable remuneration in respect of those opening hours that are in excess of 40.

Directions that reduce the total number of core opening hours of a 100 hour pharmacy continue to apply whilst the pharmacy is included in the relevant pharmaceutical list, even if the pharmacy relocates to different premises (which may be in a neighbouring health and wellbeing board’s area) or if the ownership of the pharmacy changes (regulation 65(3A)).

2.3 First applications to reduce core opening hours of 100 hour pharmacies

Where a contractor operating a 100 hour pharmacy wishes to reduce the total core opening hours of their pharmacy they must apply under paragraph 24, Schedule 4 to the relevant ICB and should use the application form in annex 1. ICB posts that are the equivalent of the former NHS England (NHSE) pharmacy contracts managers are delegated to consider such applications. Decisions will then be reported on a monthly basis to the ICB’s pharmaceutical services regulations committee, or equivalent committee.

Where a contractor believes that their current 100 hours are at different times to those held on file by the ICB, both parties will need to seek to resolve this discrepancy before the application can be determined unless the proposed hours fall within the opening times that both agree on. If neither party can provide evidence to support their claim, or the proposed hours do not fall within agreed opening times, then agreement will need to be reached as to when the current 100 hours are, once agreed the application can be considered.

The application must be granted as long as the following criteria of paragraph 26(2A), Schedule 4 are met:

• the pharmacy will still have 72 or more core opening hours per week;
• the pharmacy will have the same core opening hours on a Monday to Saturday between 17.00 and 21.00;
• there are no changes to any core opening hours that the pharmacy may have on a Sunday between 11.00 and 16.00 other than by way of the inclusion of, or a change to, a rest break which:
  • is no longer than one hour, and
  • starts at least three hours after the start of the pharmacy’s opening hours and ends at least three hours before the end of the pharmacy’s opening hours; and
• the total number of core opening hours on a Sunday will remain the same (but could start and finish at different times).

Normally, where a pharmacy contractor applies to vary their core opening hours, the ICB must consider the application against paragraph 24(1), Schedule 4. However, paragraph 26(2A), Schedule 4 states that where an application to reduce the core opening hours of a 100 hour pharmacy is made, paragraph 24(1), Schedule 4 does not apply.

Where the application is granted, the direction in annex 2 must be sent to the contractor. ICBs are to note that unlike directions that require a 40 hour pharmacy to be open for more than 40 core opening hours a week, directions to 100 hour pharmacies are required to set out the times and days of all of the core opening hours (paragraph 26(5)(a), Schedule 4).

If the application does not meet the requirements of the regulations, it is not a valid application and no direction can be issued (paragraph 26(4A), Schedule 4). The applicant is to be advised:

• that their application is not valid,
• the reasons why it is not valid, and
• that they have a right to appeal the decision to NHS Resolution.

2.4 Implementing a reduction in the core opening hours of 100 hour pharmacies

As decisions to consider applications to reduce the core opening hours of 100 hour pharmacies are delegated to an officer of the ICB, it is expected that such applications will be considered on a timely basis.

However, ICBs are to note that:

• where a pharmacy contractor submits a valid application to reduce the core opening hours of their 100 hour pharmacy, and
• the date included in the application as the date the contractor wishes to change the core opening hours is five weeks or more after the day the application is received by the ICB, and
• the ICB’s officer has not determined the application by that date,

then, whilst the application is being considered, the contractor may change their core opening hours with effect from the date given in the application (paragraph 26(2A), Schedule 4) whilst they await the ICB’s decision.

2.5 Applications received under paragraph 26, Schedule 4 before 25 May 2023

ICBs may have received an application from a contractor wishing to change the core opening hours of their 100 hour pharmacy before 25 May 2023. In that instance, ICBs are to note the provisions of paragraph 26(4B), Schedule 4.

This paragraph states that where applications were received in relation to a 100 hour pharmacy under paragraph 26(1), Schedule 4 but had not been determined before 25 May 2023, then a direction could not be issued in relation to that application if the direction would reduce any of the following:

• core opening hours on a Monday to Saturday at times between 17.00 and 21.00;
• core opening hours on a Sunday at times between 11.00 and 16.00 other than by way of the inclusion of, or a change to, a rest break which
  • is no longer than one hour, and
  • starts at least three hours after the start of the pharmacy’s opening hours and ends at least three hours before the end of the pharmacy’s opening hours, and
• the total number of core opening hours on a Sunday.

2.6 Subsequent applications to change core opening hours of 100 hour pharmacies 

It is possible for a contractor to submit more than one application under paragraph 26(1), Schedule 4 to change the core opening hours of their 100 hour pharmacy. This could, for example, be to initially change their core opening hours to 90 per week, and then a later application could seek to further reduce them.

ICBs will need to consider each application against the requirements of the regulations and only revoke an existing direction and replace it with a new direction where the application meets the requirements of paragraph 26(4A), Schedule 4.

2.7 Continuity in respect of opening hours directions for 100 hour pharmacies and pharmacies that have ever been subject to the 100 hours condition

2.7.1 Relocations of pharmacy premises that are subject to the 100 hours condition

A contractor may apply to relocate their 100 hour pharmacy as:

• a routine application in order to meet a current or future need, or secure improvements or better access, identified in a pharmaceutical needs assessment, or
• an excepted application under regulation 24 or 26(2).

If the application is granted and a valid notice of commencement is received, the applicant and their new pharmacy premises remain subject to the 100 hours condition set out in regulation 65(1).

2.7.2 Relocations under regulation 24 of pharmacy premises that were previously subject to the 100 hours condition

A contractor successfully applied to reduce the core opening hours of their 100 hour pharmacy to, for example, 85 per week. Once implemented the contractor subsequently applies to relocate to new premises under regulation 24. As part of the application the applicant will need to provide pharmaceutical services for 85 core opening hours per week, at the same times and on the same days as set out in the opening hours direction issued in respect of the current premises. If they do not, then the application must be refused (regulation 65A(3)).

If the application is granted and a valid notice of commencement is received, when the ICB amends the relevant pharmaceutical list to give effect to the notice of commencement it will need to issue a new direction that confirms the pharmacy has 85 core opening hours and sets out the times and days, pharmaceutical services are to be provided (regulation 65A(3)(b)).

2.7.3 Relocations under regulation 26(2) of pharmacy premises that were previously subject to the 100 hours condition

A contractor successfully applied to reduce the core opening hours of their 100 hour pharmacy to, for example, 85 per week. Some months later an application is made under regulation 26(2) to change the ownership of the pharmacy and to relocate it to new premises. As part of the application the applicant will need to provide pharmaceutical services for 85 core opening hours per week, at the same times and on the same days as set out in the opening hours direction issued in respect of the current premises. If they do not, then the application must be refused (regulation 65A(3)).

If the application is granted and a valid notice of commencement is received, when the ICB amends the relevant pharmaceutical list to give effect to the notice of commencement it will need to issue a new direction to the new owner that confirms the pharmacy has 85 core opening hours and sets out the times and days pharmaceutical services are to be provided (regulation 65A(3)(b)).

2.7.4 Relocations of pharmacy premises that were previously subject to the 100 hours condition as a routine application

A contractor successfully applied to reduce the core opening hours of their 100 hour pharmacy to, for example, 80 per week. Some months later the contractor applies to relocate to new premises in order to meet a current need identified in the pharmaceutical needs assessment. As part of the application the applicant will need to provide pharmaceutical services for 80 core opening hours per week, at the same times and on the same days as set out in the opening hours direction issued in respect of the current premises. If they do not, then the application must be refused (regulation 65A(4)).

If the application is granted and a valid notice of commencement is received, when the ICB amends the relevant pharmaceutical list to give effect to the notice of commencement it will need to issue a new direction that confirms the pharmacy has 80 core opening hours and sets out the times and days pharmaceutical services are to be provided at the new premises (regulation 65(4)(b)).

2.8 Continuity in respect of opening hours directions for 100 hour pharmacies

 “Opening hours directions” are defined in regulation 65A as directions that have been:

• given under either regulation 65(4) or (5), or
• issued in accordance with paragraph 25 or 26, Schedule 4, or
• given under, or issued in accordance with, earlier versions of that regulation and those paragraphs (no matter how much time may have since passed).

Such “opening hours directions” apply to any person included in the relevant pharmaceutical list in respect of those pharmacy premises, not just to the person to whom they were given or issued (regulation 65A(2)). This makes it clearer that these directions will then apply to the contractor should they then successfully apply to relocate the premises of their pharmacy; or to the new contractor should there be a successful change of ownership application. 

2.9 Rest breaks and 100 hour pharmacies

Under paragraphs 23(7)(ba) and (bd), Schedule 4 a contractor may notify the relevant ICB of a rest break where certain requirements are met (see chapter 4). However, paragraph 23(7A), Schedule 4 states that they do not apply to 100 hour pharmacies, or pharmacies that have ever been subject to a 100 hours condition.

Pharmacies that are, or were ever, subject to the 100 hours condition may introduce rest breaks as follows.

• A contractor wishes to introduce rest breaks into the core opening hours of their 100 hour pharmacy but still have 100 core opening hours per week – by virtue of paragraph 23(7A), Schedule 4 the contractor cannot notify of a rest break under paragraph 23(7)(ba), Schedule 4. The core opening hours of the pharmacy can only be changed to introduce a rest break via an application under paragraph 26(1)(b), Schedule 4 (a form to use for such application can be found in annex 3).
• A contractor has previously successfully applied to reduce the 100 core opening hours of their pharmacy and now wishes to introduce rest breaks – by virtue of paragraph 23(7A), Schedule 4 the contractor cannot notify of a rest break under paragraph 23(7)(ba), Schedule 4. The core opening hours of the pharmacy can only be changed to introduce a rest break via an application under paragraph 26(1)(b), Schedule 4 (a form to use for such application can be found in annex 3).
• A contractor wishes to reduce the core opening hours of their 100 hour pharmacy and also introduce rest breaks. They would need to apply under paragraph 26(1)(a), Schedule 4. However, rest breaks cannot be introduced into the hours of 17.00 to 21.00 Monday to Saturday and if the contractor wishes to introduce a rest break into the pharmacy’s Sunday opening times between 11.00 and 16.00 they can only do if:
  • the rest break is no longer than one hour,
  • it starts at least three hours after the pharmacy opens,
  • it ends at least three hours before the pharmacy closes, and
  • the total number of core opening hours on that day remains the same.

3. Changes to core opening hours

3.1 Introduction

This chapter looks at the amendments that were made to paragraphs 24 and 26, Schedule 4 of the 2013 regulations, which came into effect from 25 May 2023 in relation to applications from contractors who wish to change the core opening hours of their 40 hour pharmacies.

Where a pharmacy contractor wishes to change the core opening hours of their pharmacy, they must first apply to the relevant ICB to make this change. The regulation that allows this application is paragraph 26(1), Schedule 4. To enable the ICB to make its decision on the application, the contractor must provide such information as ICB may reasonably request to enable it to make its decision, this is detailed in paragraph 24(1), Schedule 4.

However, there are two exceptions to this:

The first is in relation to pharmacy premises that are, or have ever been, subject to the 100 hours condition where the contractor is seeking to reduce the total number of core opening hours of those premises. In this situation the application must meet the requirements of paragraph 26(2A), Schedule 4, (see chapter 2 for further information).

The second is for those pharmacies providing services under a LPS contract. Their opening hours are set out in those contracts. Where a LPS contractor or an ICB wishes to vary the opening hours set out in a LPS contract, they are to refer to the process set out in the LPS contract. The provisions described in this chapter and set out in paragraphs 24 to 26, Schedule 4 do not apply to the provision of services under a LPS contract.

3.2 Matters to be considered when issuing directions in respect of core opening hours

The matters that an ICB must consider before it issues a direction to a pharmacy contractor within its area regarding the core opening hours of their pharmacy premises are set out in paragraph 24, Schedule 4. The rationale for issuing such a direction changed with effect from 25 May 2023.

There are two grounds for a direction to be issued in relation to core opening hours:

• Firstly, as a result of an application from a pharmacy contractor to change their core opening hours (paragraph 26, Schedule 4).
• Secondly, where it appears to an ICB that the days or times pharmacy premises are, or are to be, open for the provision of pharmaceutical services during core opening hours will not meet, or no longer meets, the needs of people in its area, or other likely users of the pharmacy premises (paragraph 25, Schedule 4).

From 25 May 2023, in issuing a such a direction, the ICB is seeking to ensure that for people in the area, or other likely users, of the pharmacy premises, the days and times pharmacy premises are open for the provision of pharmaceutical services maintain:

• as necessary the existing level of service provision; or
• a sustainable level of adequate service provision in circumstances where maintaining the existing level of service provision is either unnecessary or not a realistically achievable outcome (paragraph 24(1), Schedule 4).

This is a different test to the one that was previously set out in paragraph 24(1), Schedule 4.

When considering whether a direction is to be issued under paragraph 24 or 26, Schedule 4, the ICB:

• must take into consideration any provision of LPS in its area, and
• may take supplementary opening hours into account (paragraph 24(2), Schedule 2).

An ICB may only direct pharmacy premises to be open for less than 40 core opening hours per week if it is satisfied that the provision of pharmaceutical services by other pharmacies in its area is likely to be adequate to meet the need for such services when the pharmacy premises that would be subject to the direction would be closed (paragraph 24(3), Schedule 4).

Where an ICB directs pharmacy premises to be open for more than 40 core opening hours per week, it must be satisfied that the contractor will receive reasonable remuneration in respect of those opening hours that are over and above the usual 40 (referred to as ‘additional opening hours’). There are three exceptions to this:

• as part of the application for inclusion in the relevant pharmaceutical list, the contractor offered more than 40 core opening hours and the application was granted partly on the basis of this greater number of core opening hours (regulation 65); or
• an ICB (or previously, NHS England) invited the contractor to increase their total number of core opening hours, and subsequently agreed that total with the contractor (paragraph 24(4), Schedule 4); or
• With effect from 25 May 2023 the contractor is, or has ever been, subject to the 100 hours condition set out in regulation 65(1) that the contractor must be kept open for at least 100 hours per week for the provision of pharmaceutical services. (paragraph 24(5), Schedule 4)

With effect from 25 May 2023 those pharmacies subject to the 100 hours condition can apply to reduce their core opening hours in line with paragraph 26(2A), Schedule 4. Where such an application is granted, a direction must be issued to confirm this. However, there is no requirement on the ICB to ensure that reasonable remuneration is paid for those core opening hours that are over and above 40. This new provision applies to the current owner of such pharmacies, and any future owner of such pharmacies (paragraph 24(5), Schedule 4).

3.3 Changes to core opening hours instigated by an ICB

No changes have been made to paragraph 25, Schedule 4. However, an ICB will need to take into consideration the new test set out in paragraph 24(1), Schedule 4 when considering whether or not the days or times pharmacy premises are, or are to be, open will not, or no longer meet the needs of:

• people in its area, or
• other likely users of the pharmacy premises.

3.4 Changes to core opening hours instigated by a pharmacy contractor – 40 hour pharmacies

Where a contractor wishes to change the core opening hours of a 40 hour pharmacy, either to reduce the total number of them or to change the times they are provided (other than by way of introducing a rest break – see chapter 4), they are required to apply under paragraph 26(1), Schedule 4 and should use the form in annex 3.

As part of such applications, NHS England may request information in relation to the matters set out in paragraph 24(1), Schedule 4. To expedite the application process NHS England has determined, that the contractor is to provide this information as part of applications to change core opening hours. The ICB will then need to decide whether the days and times the contractor’s premises would be open, if the application was granted, would maintain:

• as necessary, the existing level of service provision for the people in the area, or other likely users of the contractor’s premises, or
• a sustainable level of adequate service provision for the people in the area or other likely users of the pharmacy premises, in circumstances where maintaining the existing level of service provision is either unnecessary or not a realistically achievable outcome (paragraph 26(2), Schedule 4).

These are now the two tests that a contractor will need to meet for an ICB to be able to decide that a change in hours can be granted.

 ICBs and pharmacy contractors are to note that the information to be provided as part of such applications changed with effect from 25 May 2023. Therefore, where an application received prior to 25 May 2023, is determined on or after that date, there will be a need to go back to the contractor and ask them to provide the new information outlined above.

Applications are to be determined within 60 days of receipt, with the clock stopping on the date that any further information is requested from the contractor, and restarting on the date when it is provided (paragraph 26(3), Schedule 4).

When considering an application from a contractor who wishes to change the days or times they are obliged to provide pharmaceutical services during core opening hours, ICBs will need to establish the current level of pharmaceutical service provision in the area in which the contractor’s premises are located for it to be able to decide if the two tests have then been met in the application. This will include identifying:

• the location of pharmacy premises in the area noting that such premises may be in the area of neighbouring ICBs,
• the provision of pharmaceutical services to those in the area of the contractor’s premises, both by contractors located in that area, and by contractors who are not, for example distance selling premises, pharmacies elsewhere in the country, and dispensing appliance contractors,
• any local hours plans that may be in place for the area,
• the level of temporary suspensions in the provision of pharmaceutical services in the area, and
• the findings of the pharmaceutical needs assessment for the area in which the contractor’s premises are located, noting that pharmacy opening times may have changed since it was published.

Once the location of other providers of pharmaceutical services has been identified, ICBs will then need to identify when their core opening hours are and what advanced and enhanced services they provide. Whilst those providers may have supplementary opening hours it is anticipated that little or no weight will be placed on those as they can be reduced or changed with five weeks’ notice.

Once the existing level of service provision has been established, the ICB will be in a position to assess whether the core opening hours set out in the contractor’s application will maintain the existing level of service provision for the people in the area of the contractor’s premises or other likely users of those premises. It will also need to take into account any information provided by the applicant on this point. Where it is satisfied that the proposed core opening hours will maintain the existing level of service provision in the area, it may grant the application.

Where it is satisfied that the application will not maintain the existing level of service provision and so fails the test of paragraph 24(1)(a), Schedule 4, the ICB will need to consider whether it is satisfied in relation to the second strand of the new test. For paragraph 24(1)(b), Schedule 4 the ICB will need to consider whether the proposed core opening hours would maintain a sustainable level of adequate service provision for the people in the area, or other likely users of the pharmacy premises, in circumstances where maintaining the existing level of service provision is either unnecessary or not a realistically achievable outcome. In coming to a decision on this matter the ICB will again need to take into account any information provided by the applicant. The application must only be granted if that information satisfies the ICB with regard to paragraph 24(1)(b), Schedule 4.

3.5 Changes to core opening hours instigated by a pharmacy contractor – 100 hour pharmacies

There are two routes by which a contractor may apply to change the core opening hours of a 100 hour pharmacy. The first is to reduce those hours under paragraph 26(2A), Schedule 4, and as discussed in detail in chapter 2 applications under that provision are to be granted where they meet all the requirements of that paragraph.

The second route is for the 100 hour contractor to apply under paragraph 26(1), Schedule 4 in the same way that a 40 hour pharmacy would as described in section 3.4. The applicant would need to provide the information required to satisfy the test set out in paragraph 24(1), Schedule 4. This could be, for example, to maintain the 100 core opening hours but to change the timing or distribution of them over the week.

3.6 Continuity in respect of opening hours directions

 “Opening hours directions” are defined in regulation 65A as directions that have been:

• given under either regulation 65(4) or (5), or
• issued in accordance with paragraph 25 or 26, Schedule 4, or
• given under, or issued in accordance with, earlier versions of that regulation and those paragraphs (no matter how much time may have since passed).

3.6.1 Changes of ownership – 40 hour pharmacies

Opening hours directions given or issued in respect of premises included in a pharmaceutical list apply to any contractor listed in relation to those premises, not just to the contractor to whom they were given or issued (regulation 65A(2)).

3.6.2 Relocations of 40 hour pharmacies under regulation 24

Where a 40 hour pharmacy, with a direction in place for additional opening hours, applies to relocate then as part of the application, the applicant must undertake to provide pharmaceutical services for the same total number of core opening hours, and at the same times and on the same days. If they do not then the application must be refused (regulation 65A(3)).

If the application is granted and a valid notice of commencement is received, when the ICB amends the relevant pharmaceutical list to give effect to the notice of commencement it will need to issue a new direction that confirms the total number of core opening hours and sets out the times at, and days on, which pharmaceutical services are to be provided (regulation 65A(3)(b)).

3.6.3 Relocations of 40 hour pharmacies under regulation 26(2)

Where a combined change of ownership and relocation application is received for a 40 hour pharmacy that has a direction in place for additional opening hours, the applicant must undertake to provide pharmaceutical services for the same total number of core opening hours, and at the same times and on the same days. If they do not then the application must be refused (regulation 65A(3)).

If the application is granted and a valid notice of commencement is received, when the ICB amends the relevant pharmaceutical list to give effect to the notice of commencement it will need to issue a new direction that confirms the total number of core opening hours and sets out the days and times pharmaceutical services are to be provided (regulation 65A(3)(b)).

3.6.4 Relocations of 40 hour pharmacies as a routine application

Where a 40 hour pharmacy, with a direction in place for additional opening hours, applies to relocate in order to meet a current or future need, or secure improvements or better access, in a pharmaceutical needs assessment, then as part of the application, the applicant must undertake to provide pharmaceutical services for the same total number of core opening hours, and at the same times and on the same days. If they do not, then the application must be refused (regulation 65A (3)).

If the application is granted and a valid notice of commencement is received, when the ICB amends the relevant pharmaceutical list to give effect to the notice of commencement it will need to issue a new direction that confirms the total number of core opening hours and sets out the days and times pharmaceutical services are to be provided (regulation 65A(3)(b)).

3.6.5 Relocations of 100 hour pharmacies, or pharmacies that were subject to the 100 hours conditions

Please see chapter 2 which covers the continuity of opening hours directions in respect of 100 hour pharmacies.

4. Supplementary opening hours and rest breaks

4.1 Introduction

Part 3 of Schedule 4 of the 2013 regulations sets out the terms of service for pharmacy premises included in a pharmaceutical list in relation to their opening hours. With effect from 25 May 2023 they were amended in relation to a number of matters. This chapter focuses on the following amendments that have been made to paragraph 23, Schedule 4 of the 2013 regulations:

• the ability for contractors to be able to notify ICBs of the introduction of a rest break into the core opening hours of 40 hour pharmacies, or amend the timing of an existing rest break, where certain requirements are met;
• notifications of changes to supplementary opening hours; and
• temporary suspensions in the provision of pharmaceutical services.

The amendments that have been made to Part 3 of Schedule 4 do not apply to LPS contracts. Opening hours for those providing services under a LPS contract are set out in that contract. Where a LPS contractor wishes to amend their opening hours to, for example, introduce a rest break this can be only done with the agreement of the relevant ICB and once a variation notice has been signed by both parties. Contractors and ICBs will also need to refer to the contract should there be a failure to provide services during the opening hours set out in the contract.

4.2 Background

Some of the terms of service for pharmacy contractors in relation to their core and supplementary opening hours are set out in paragraph 23, Schedule 4. In summary, a contractor must ensure that pharmaceutical services are provided at their pharmacy premises:

• for 40 hours each week,
• in the case of 100 hour pharmacies, for not less than 100 hours each week (please see chapter 2 for information on the changes that have been made to the regulations in respect of 100 hour pharmacies),
• where an ICB, NHS England, a primary care trust, or on appeal NHS Resolution has issued a direction that pharmaceutical services are to be provided for fewer than 40 hours each week, at the times and on the days set out in that direction,
• where a direction has been issued under previous regulations by a primary care trust or on appeal NHS Resolution, requiring pharmaceutical services to be provided for more than 40 hours each week, at the times and on the days set out in that direction, or
• where a direction has been issued under the 2013 regulations by an ICB, NHS England or on appeal NHS Resolution requiring pharmaceutical services to be provided for more than 40 hours each week, at the times and on the days set out in that direction (paragraph 23(1), Schedule 4).

These hours are referred to as ‘core opening hours’. Core opening hours were set by the contractor either by the return that was required to be submitted to the relevant primary care trust in 2005, or in an application for inclusion in the relevant pharmaceutical list made on or after 1 April 2005. Core opening hours can only be changed on application to the relevant ICB (previously NHS England or the relevant primary care trust).

An ICB may, in appropriate circumstances, agree a temporary suspension of services during core opening hours for a set period where it has received three months’ notice of the proposed suspension (paragraph 23(1), Schedule 4).

Any opening hours over and above core opening hours are referred to as ‘supplementary opening hours’. Where a contractor chooses to have supplementary opening hours, they must ensure that pharmaceutical services are provided at their pharmacy premises during these hours as well as their core opening hours.

Supplementary opening hours are set by the contractor either:

• as part of their application for inclusion in the relevant pharmaceutical list, or
• in the return required by paragraph 23(4), Schedule 1 of the 2005 regulations, or
• in a return notifying of a change of supplementary opening hours submitted under paragraph 23(6)(a), Schedule 4 or a preceding regulatory provision.

Pharmacies are not required to open on Christmas Day, Good Friday, Easter Sunday or a bank holiday (paragraph 23(12), Schedule 4) but may choose to do so, either for their normal core and supplementary opening hours or for different hours.

With the exception of distance selling premises, contractors are required to exhibit, at their pharmacy premises, a notice which sets out the days on, and times at, which the premises are open for the provision of drugs and appliances (both core and supplementary opening hours). In addition, they are required to exhibit, when the pharmacy is closed, a notice based on information provided by the relevant ICB specifying the addresses of:

• other pharmacies included in a pharmaceutical list and their core and supplementary opening hours, and
• pharmacies providing services under a LPS contract, the type of LPS they provide and their opening hours (paragraph 23(4), Schedule 4).

Where requested to do so by an ICB, a contractor must submit a return which sets out:

• the days and times pharmaceutical services are provided at their pharmacy premises (both core and supplementary opening hours), and
• the pharmaceutical services which they ordinarily provide at their premises (paragraph 23(5), Schedule 4).

The terms of service relating to the requirements:

• on contractors who wish to change their supplementary opening hours or
• introduce or change a rest break;

and what contractors are required to do in relation to a temporary suspension in the provision of pharmaceutical services because of illness or another reason beyond the control of the contractor, are also set out in paragraph 23, Schedule 4.

4.3 Rest breaks

Applicants, when drafting their application for inclusion in a pharmaceutical list, and contractors, when they notified their primary care trust of their core and supplementary opening hours in 2005, were free to decide whether or not they wished to close their pharmacy premises for a period of time, either for lunch or to provide their staff with a rest break. Of the 11,051 pharmacies included in a pharmaceutical list as at 31 December 2022, 8,146 chose, either deliberately or unintentionally, not to include a rest break in their opening hours.

Prior to 25 May 2023, if a contractor wished to include a rest break within their core opening hours they were required to apply to change their core opening hours, and as part of the application demonstrate a change to the needs of people in the area or other likely users, such as to warrant the change of core opening hours.

The 2013 regulations were amended with effect from 25 May 2023 to allow contractors to introduce rest breaks into the core opening hours of their 40 hour pharmacies, or amend an existing rest break, subject to certain requirements being met as set out in paragraph 23(7), Schedule 4.

It is to be noted that there is no provision within paragraph 23, Schedule 4 to remove an existing rest break from core opening hours. Where a contractor wishes to do that, they are required to apply to change their core opening hours under paragraph 26, Schedule 4.

Where a contractor successfully notifies of the introduction of a rest break, or of a change to an existing rest break, within the core opening hours of their 40 hour pharmacy, the ICB must notify NHS Prescription Services using the ‘Change of NHS pharmacy contractor details’ form on the NHSBSA Website[4]. This form can be found under the heading ‘Notify us about changes’. The email address to send the completed form to can also be found on this page.

It’s important to note that any changes to core or supplementary hours must be submitted to NHS Prescription Services with the change of contractor details form on the NHSBSA website.

4.3.1 Introducing a rest break during core opening hours – 40 hour pharmacies

Under paragraph 23(7)(ba), Schedule 4 a contractor may introduce a rest break into the core opening hours of their 40 hour pharmacy that is up to one hour in length, as long as, on a Monday to Saturday:

• the rest break starts at least three hours after the pharmacy opens, and
• ends at least three hours before the pharmacy closes, and
• the total core opening hours on any one day does not change.

There are no restrictions as to when rest breaks on a Sunday may start or finish but the total number of core opening hours on that day must not be changed.

Where a contractor wishes to introduce a rest break into the core opening hours of their 40 hour pharmacy, they must notify the relevant ICB in writing and should use the form in annex 4. They may then implement the change no earlier than five weeks after the date that notification is received by the relevant ICB (assuming the notification is valid), although the ICB could agree to the rest break being implemented within a shorter timescale (paragraph 23(7)(bd), Schedule 4).

If a contractor wishes to introduce a rest break into the core opening hours of their 40 hour pharmacy, the timing of which does not meet the requirements of paragraph 23(7)(ba), Schedule 4 the ICB will advise them of that fact and the contractor can choose whether or not to amend their notification so that it does comply or apply to vary their core opening hours under paragraph 26, Schedule 4 in order to introduce a rest break.

Upon receipt of a notification of the introduction of a rest break within core opening hours, the relevant ICB must check that it complies with the requirements of paragraph 23(7), Schedule 4.

ICB officers who are the equivalent of the former NHS England pharmacy contract managers are to determine whether notifications meet the requirements of the regulations.

Decisions as to whether a shorter notice period are to be agreed are to be made by the ICB’s pharmaceutical services regulations committee, or equivalent committee. Such committees may delegate these decisions to an officer who is the equivalent of the former NHS England pharmacy contract managers if they so wish. There is no right of appeal against a refusal to allow a shorter notice period.

Where a contractor wishes to introduce a rest break into core opening hours that are specified in a direction, the ICB will need to amend the direction and reissue it to the contractor.

4.3.2 Amending the times of an existing rest break during core opening hours

Under paragraph 23(7)(ba), Schedule 4 a contractor may change the timing of an existing rest break that is within the core opening hours of their 40 hour pharmacy. However, if the pharmacy is applying under this paragraph, then the application for the revised rest break will be treated in the same way as an application for a new rest break under this paragraph, i.e. it can be no longer than one hour in length and:

• must start at least three hours after the pharmacy opens, and
• end at least three hours before the pharmacy closes, and
• the total core opening hours on any one day does not change.

Again, there are no restrictions as to when amended rest breaks on a Sunday may start or finish but the total number of core opening hours on that day may not be changed (paragraph 23(7)(ba), Schedule 4).

The process for these applications and who can make these decisions are the same as described in section 4.3.1.

4.4 Changing supplementary opening hours

The requirements relating to the ability of a contractor to change the supplementary opening hours of their pharmacy premises are also set out in paragraph 23, Schedule 4. They were amended in October 2022 as follows.

• The amount of notice that a contractor had to give to reduce the total number of supplementary opening hours of a pharmacy was reduced from at least three months to at least five weeks.
• The ability for NHS England or a delegated ICB to agree to a shorter notice period was removed.
• Where a contractor wishes to increase the total number of supplementary opening hours of their pharmacy, no notice was required to be given.

Further changes have been made with effect from 25 May 2023.

Where a contractor intends to change the supplementary opening hours of their pharmacy premises, they must notify the relevant ICB before the change takes place (paragraph 23(6), Schedule 4). How long a period of notice is to be given will depend on how the contractor wishes to change their supplementary opening hours (see the sections below).

If a contractor wishes to amend the supplementary opening hours in a way that reduces the time between a rest break and the pharmacy opening or closing to less than three hours then they would also need to notify a change to the timing of the rest break under paragraph 23(7)(ba), Schedule 4 to maintain the three hours between the rest break and the pharmacy opening or closing.

Where a contractor wishes to reduce the total number of supplementary opening hours of their pharmacy premises, or to maintain the total number but change their distribution, sooner than the regulatory five-week period they may ask for the ICB’s approval to do so. Such requests are to be considered by the ICB’s committee that is the equivalent of the former NHS England pharmaceutical services regulations committees and determined accordingly. Such committees may delegate these decisions to an officer who is the equivalent of the former NHS England pharmacy contract managers. It is to be noted that there is no right of appeal against a decision to refuse to agree to a shorter notice period.

ICBs and contractors are to note that paragraph 23(7)(bb) and (bd), Schedule 4 place some restrictions on the ability to change supplementary opening hours. A contractor cannot change the supplementary opening hours of their pharmacy premises in such a way that reduces the time for which the pharmacy will be open before or after a rest break on a Monday to Saturday to less than three hours.

Changes to supplementary opening hours are to be notified to NHS Prescription Services by ICBs using the ‘Change of NHS pharmacy contractor details’ form5

4.4.1 Increasing the total number of supplementary opening hours

Where a contractor wishes to increase the total number of supplementary opening hours for their pharmacy premises they must notify the relevant ICB in writing in advance of the change (paragraph 23(6) and 23(7)(bc), Schedule 4) and should use the form in annex 6. There is no minimum amount of notice that is to be given, simply that the contractor must notify the relevant ICB in advance of the change.

If the notification is not submitted before the change took place, then this is a potential breach of the terms of service and the ICB will need to consider what action is to be taken.

4.4.2 Reducing the total number of supplementary opening hours

Where a contractor wishes to reduce the total number of supplementary opening hours for their pharmacy premises they must notify the relevant ICB in writing at least five weeks in advance of the change (paragraph 23(6) and 23(7)(bc), Schedule 4) and should use the form in annex 7. As noted in section 4.4 above, the contractor can ask to give a shorter notice period.

4.4.3 Redistributing supplementary opening hours without either increasing or reducing the total number of them

Where a contractor wishes to maintain the total number of supplementary opening hours, but to change the days or times, they must notify the relevant ICB in writing at least five weeks in advance of the change (paragraph 23(6) and 23(7)(bc), Schedule 4) and should use the form in annex 8. As noted in section 4.4 above, the contractor can ask to give a shorter notice period.

Where any changes are made to a contractor’s opening hours, whether core or supplementary or both, then the contractor must update their NHS website and DoS profile. See section 5.4.2 Arrangements for updating the pharmacy profile.

It’s important to note that any changes to core or supplementary hours must be submitted to NHS Prescription Services with the change of contractor details form on the NHSBSA website.

5. Regulatory requirements relating to temporary suspensions and business continuity plans

5.1 Introduction

There may be occasions where a contractor needs to temporarily suspend the provision of pharmaceutical services at their pharmacy premises because of illness or another reason beyond their control. The contractor will not be in breach of their opening hours terms of service as long as they complete certain actions set out paragraph 23, Schedule 4. These actions were amended with effect from 31 July 2023 and this chapter explains what amendments have been made.

5.2 Temporary suspensions in the provision of pharmaceutical services

Prior to 31 July 2023, where a contractor was prevented by illness or other reasonable cause from complying with their obligations to open for their core opening hours they were required, where practicable, to make arrangements with one or more other contractors with premises in the same area for the provision of pharmaceutical services during the temporary suspension (paragraph 23(8), Schedule 4).

In addition, where there was a temporary suspension for a reason beyond the control of the contractor they were required to:

• Notify NHS England of the suspension as soon as practical, and
• Use all reasonable endeavours to resume the provision of pharmaceutical services as soon as practicable (paragraph 23(10), Schedule 4).

By virtue of paragraph 23(11), Schedule 4, planned refurbishment of the pharmacy was not deemed to be “reasonable cause”.

As long as the contractor complied with these requirements they were not in breach of their terms of service.

With effect from 31 July 2023, where there is a temporary suspension in the provision of pharmaceutical services because of illness or another reason beyond the contractor’s control, they are not in breach of their terms of service provided they:

• notify the ICB of that suspension as soon as practicable, in the manner required by paragraph 29D(2)(a), Schedule 4 and wherever possible before the start of the suspension;
• use all reasonable endeavours to implement the business continuity plan that they are required by paragraph 29D, Schedule 4 to have for the pharmacy premises; and
• use all reasonable endeavours to resume the provision of pharmaceutical services as soon as practicable (paragraph 23(10), Schedule 4).

The requirement in paragraph 23(8), Schedule 4 to make arrangements with one or more other contractors with premises in the same area for the provision of pharmaceutical services during the temporary suspension was removed from the regulations with effect from 31 July 2023.

5.3 Business continuity plans

Whilst the need to have business continuity plans has been a requirement of the pharmacy quality scheme and data and security protection toolkit, until 31 July 2023 it has never been a mandatory requirement for all pharmacies included in a pharmaceutical list in relation to opening hours.

With effect from 31 July 2023 pharmacy contractors will need to ensure that, in relation to each of their pharmacy premises, they have an up-to-date business continuity plan which is available at those premises at all times (paragraph 29D, Schedule 4). The purpose of the requirement is to ensure that each pharmacy contractor has a plan to deal with the temporary suspension in the provision of pharmaceutical services at or from their pharmacy premises, due to illness or another reason that is beyond the control of the contractor.

In line with paragraph 29D(1), Schedule 4 the plan must:

• be proportionate to the needs of those people who anticipate receiving pharmaceutical services from the pharmacy premises or who are accustomed to doing so, and
• include the components set out in paragraph 29D(2), Schedule 4 which are set out below.

The requirement to have a business continuity plan does not automatically apply to those contractors solely providing services under a LPS contract as Schedule 5 of the 2013 regulations has not been amended to include this requirement. Where an ICB wishes to vary an LPS contract to include a requirement for a business continuity plan to be put in place for the premises listed in the LPS contract, it can only do this with the agreement of the contractor. Such a variation must be in writing and signed by both parties.

5.4 Components of a business continuity plan

As a minimum, each pharmacy premises’ business continuity plan must cover the following requirements (paragraph 29D(1)(b), Schedule 4). Contractors may also wish to refer to information regarding business continuity plans on Community Pharmacy England’s website.

5.4.1 Notifying the relevant ICB of a temporary suspension

The plan must clearly set out how staff at the pharmacy premises are to notify the relevant ICB about:

• the prospect of a temporary suspension, whenever such a suspension becomes likely, and
• a temporary suspension and its anticipated duration, wherever possible before the start of the temporary suspension.

Such notifications must be in the “approved manner”. For the purposes of paragraph 29D(2)(a), Schedule 4 the “approved manner” is as detailed on the NHS England website.

The plan must, therefore, ensure that staff at the pharmacy premises are aware that the relevant ICB is to be notified, in the approved manner:

• that the pharmacy premises may have to temporarily close, and
• where possible before the pharmacy premises actually close, that there will be a temporary suspension and how long it is expected to last.

5.4.2 Arrangements for updating the pharmacy profile

Since 29 November 2020, pharmacy contractors have been required to ensure that there is a comprehensive and accurate profile for their pharmacy premises on both NHS England’s directory of services and the NHS website (paragraph 29C(3) and (4), Schedule 4). Each profile must be verified at least once each quarter of the financial year, and also updated each quarter as required. This is undertaken via the NHS Profile Manager.

The plan for each pharmacy premises will need to include the arrangements for updating the pharmacy’s profile on the directory of services and NHS website regarding:

• any temporary suspension, and
• the subsequent re-opening of the pharmacy premises for the provision of pharmaceutical services (paragraph 29D(2)(b), Schedule 4).

Contractors can find more information on the NHS Profile Manager on the NHS Profile Manager webpage.

DSPs do not have an NHS website profile but can update their DoS profile using NHS Profile Manager.

5.4.3 Arrangements for reducing the likelihood of referrals

Where the pharmacy provides urgent care enhanced or advanced services to people who are referred by another healthcare professional or service the plan will need to set out how the contractor will endeavour to ensure such people are not referred for those services during the temporary suspension (paragraph 29D(2)(c), Schedule 4).

The community pharmacist consultation service is, as of June 2023, the only advanced service of this kind. A pharmacy may provide this service to people referred by the NHS 111 service, an integrated urgent care clinical assessment service, GP practice, 999 services and authorised providers of urgent and emergency care.

The enhanced services that may be commissioned by an ICB that would fall within the definition of ‘urgent care services’ include:

• the on demand of availability of specialist drugs service, for example palliative care drugs,
• the out of hours service, the underlying purpose of which is for pharmacy contractors to dispense drugs and appliances for all or part of the out of hours period, and
• an emergency supply service which, in certain specified circumstances, ensures prompt access to drugs and appliances which have been previously prescribed to a patient in an NHS prescription, but the patient does not have such a prescription, and where the requirements of regulation 225 or 226 of The Human Medicines Regulations 2012 are satisfied.

The contractor must therefore set out in the plan what steps are to be taken to minimise such referrals being made, for example by ensuring the directory of services is updated with details of the temporary suspension and notifying local GP practices of the temporary suspension. It is, however, recognised that it may not be possible for the plan to completely reduce the likelihood of all referrals. For example, it would not be practicable to notify all GP practices in England of the temporary suspension on the off chance that one may refer someone under the community pharmacist consultation service. It would, however, be reasonable to expect those GP practices that routinely make referrals under this service to the pharmacy to be notified.

5.4.4 Arrangements for notifying other providers of pharmaceutical services, local pharmaceutical services, and primary medical services of the temporary suspension

Within the plan the contractor will need to set out how other pharmacies and GP practices will be notified of the temporary suspension and its anticipated duration, where this is practicable and to the extent it is reasonable to do so (paragraph 29D(2)(d), Schedule 4). When assessing whether this is practicable and reasonable, the contractor will need to have regard to the needs of those people who:

• anticipate receiving services from the pharmacy premises, or
• are accustomed to receiving services from the pharmacy premises.

For example, it would not be practicable to notify all GP practices who have written prescriptions dispensed by the pharmacy in the last 12 months of a temporary suspension. It would, however, be deemed practicable to notify those GP practices whose prescriptions form the majority of the prescriptions that are dispensed by the pharmacy.

Similarly, it would not be practicable to notify every other pharmacy in the town or city of the temporary suspension. The contractor should seek to identify those pharmacies to whom they believe people are most likely to go to whilst the pharmacy has temporarily suspended the provision of pharmaceutical services.

5.4.5 Arrangements for displaying information regarding the temporary suspension

As well as updating the pharmacy’s directory of services profile, other pharmacies and GP practices of the temporary suspension, the plan must include ensuring people who anticipate or are accustomed to receiving pharmaceutical services from the pharmacy premises are aware of the temporary suspension.

Since 1 April 2021, every distance selling premises is required to have a website for use by the public for the purpose of accessing pharmaceutical services from the pharmacy (paragraph 28C, Schedule 4). The plan must set out how this website is to be updated about the temporary suspension and its anticipated duration so that this information is clearly promoted to any user of the website when they first access it (paragraph 29D(2)(e)(i), Schedule 4).

All other pharmacies are required by paragraph 23(4), Schedule 4 to exhibit:

• a notice specifying the days and times the premises are open for the provision of drugs and appliances, and
• when the pharmacy is closed, a notice based on information provided by the ICB, legible from outside the pharmacy, specifying the address and opening hours of other pharmacies from whom people can obtain drugs and appliances.

As part of the business continuity plans such pharmacies will need to set out the arrangements for a notice to be displayed at the pharmacy premises, which is visible from the outside of the premises, which confirms:

• the pharmacy is temporarily closed,
• how long it will be closed, and
• the availability of pharmaceutical services at or from other nearby pharmacies.

It would not be appropriate for the notice to merely signpost people to other pharmacies operated by the contractor. Details of all the other nearby pharmacies are to be provided.

The information on the availability of pharmaceutical services at or from other nearby pharmacies is to be provided in the approved manner (paragraph 29D(2)(e)(ii), Schedule 4), as detailed on the NHS England website.

5.4.6 Arrangements for the continuity of care

The final matter that the plan must include are the arrangements, where practicable, for the continuity of care for those people who are accustomed to, or who anticipate, receiving pharmaceutical services from the contractor, whether face to face at the pharmacy premises or virtually, (paragraph 29D(2)(f), Schedule 4).

This includes people who have a booked appointment, e.g. for vaccination services, or those who attend the pharmacy premises regularly for the supervised administration of medicines. It will also include those who are expecting to collect dispensed drugs and/or appliances.

Where a person has a booked appointment, it is anticipated that the pharmacy will have contact details for them and therefore the plan would set out how they are to be contacted so that their appointment can be re-arranged. However, it would not be practicable, for example, for the plan to require every person who may attend the pharmacy during the temporary suspension to collect dispensed drugs and/or appliances or to access a service that does not require a pre-booked appointment to be contacted about the temporary suspension.

Contractors should ensure their business continuity plans also meet the requirements of any services that they have signed up to provide. For example, the service specification for the COVID-19 vaccination service requires providers to have a business continuity plan that includes how any temporary suspension of the administration of COVID-19 vaccinations will be agreed with the commissioner and relevant changes are made to the National Booking Service as soon as practicably possible.

5.5 Implementing business continuity plans

By virtue of paragraph 29D(4), Schedule 4 contractors are required to use all reasonable endeavours to implement their business continuity plan in the event of any temporary suspension, or likely temporary suspension, of pharmaceutical services at or from the pharmacy premises. This includes temporary suspensions under:

• paragraph 23(1), Schedule 4, where an ICB has agreed to a temporary suspension of services having first received three months’ notice of a proposed temporary suspension; or
• paragraph 23(10), Schedule 4, temporary suspensions because of illness or another reason that is beyond the control of the contractor.

It would be reasonable to expect a contractor to fully implement their business continuity plan if, for example, a temporary suspension has been agreed under paragraph 23(1), Schedule 4 because the contractor must have given at least three months’ notice of such a suspension. It would also be reasonable to expect a contractor to fully implement their business plan if it identifies a reason to temporarily suspend services several days before the suspension itself.

However, if a pharmacy member of staff arrives to open the pharmacy premises in the morning and finds them flooded, it is unlikely to be possible to immediately instigate the full implementation of the business continuity plan. Similarly, if staff cannot access the pharmacy premises because, for example, the road is closed by an emergency service it is unlikely to be possible that all elements of the business continuity plan can be completed.

6. Local hours plans

6.1 Introduction

A new provision has been inserted into schedule 4 of the 2013 regulations which allows an ICB to establish a ‘local hours plan’ with contractors (paragraph 23A, schedule 4). A plan may be put in place where the level of temporary suspensions in the provision of pharmaceutical services is such that people in a particular area are experiencing, or are likely to experience, significant difficulty in accessing pharmaceutical services. Plans are expected to be put in place on a temporary basis and for an identified period of time (paragraph 23A(1), schedule 4).

The decision as to whether or not a local hours plan is to be established is to be made by the ICB’s pharmaceutical services regulations committee, or equivalent committee. As with the committee’s other decisions, these must be fully documented within the relevant meeting minutes.

Contractors who provide services under a local pharmaceutical services contract (LPS) are not automatically able to participate in a local hours plan because the terms of service set out in schedule 5 of the 2013 regulations have not been amended to include such plans. Should a LPS contractor wish to participate in a local hours plan, or where an ICB wishes to include a LPS pharmacy in a local hours plan, both will need to agree to a variation to the LPS contract. Such a variation must be in writing and signed by both parties before the LPS contractor’s premises can be included in the plan.

6.2 What is a local hours plan?

A local hours plan is a plan agreed between an ICB and the pharmacy contractors in a specified area that suspends the participating pharmacies’ usual core and supplementary opening hours at either specified times or on specified days or both, and instead sets out when and at what times the participating pharmacies will open in order to ensure that people in the area are still able to access pharmaceutical services during the period of significant difficulty. They therefore provide flexibility to ICBs to put in place, with the agreement of the participating pharmacies, alternative opening hours that will meet the needs of people in a specified area for a specified period of time.

Local hours plans could, therefore, mean that pharmacy premises have fewer core opening hours than usual. For example, a pharmacy with 40 core opening hours could have 35 as part of a local hours plan, and a 100 hour pharmacy could have 70 core opening hours.

Whilst participating in a local hours plan, a pharmacy contractor can still notify of a temporary suspension in the provision of pharmaceutical services in line with paragraph 23(10), Schedule 4 for example where their pharmacy premises are flooded or have been damaged in a fire.

ICBs should note that the opening hours agreed as part of a local hours plan do not have to be within a pharmacy’s normal core and supplementary opening hours. This may be relevant where a pharmacy with extended opening hours has closed, or where there are temporary suspensions in the provision of pharmaceutical services in the evening or at the weekends. The aim of a local hours plan is to ensure people in a particular area are able to access pharmaceutical services during the times that pharmacies would normally be open if it were not for the temporary suspensions.

Pharmacy premises that are not included in a local hours plan are required to open in line with their core and supplementary opening hours.

6.3 Establishing a local hours plan

NHS England is under a duty to ensure that people in England are able to access their dispensed drugs and appliances and such other services as may be prescribed in regulations. ICBs will therefore need to monitor the level of temporary suspensions in pharmaceutical services provision across their area (recognising they may not have a complete record of all temporary suspensions) with a view to identifying any areas where people are experiencing, or are likely to experience, significant difficulty in accessing pharmaceutical services.

‘Significant difficulty’ may be identified at certain times of the day and/or days of the week, and ICBs are to note the test is one of ‘significant’ difficulty for people in accessing pharmaceutical services across an area, rather than just difficulty. The regulations do not provide a definition for ‘significant’ difficulty and therefore ICBs will need to take into account the facts of each case when deciding whether or not to implement a local hours plan.

It is also to be noted that the test is not in relation to contractors who may be having difficulty in opening in line with their core and supplementary opening hours. It is, however, recognised that contractors and/or their local pharmaceutical committee may approach the ICB expressing their concerns that the inability of contractors to open as required is affecting the ability of people to access pharmaceutical services. In that instance, the ICB would need to consider this information alongside other relevant information in the ICB’s possession, for example the reporting of temporary suspensions when deciding whether or not a local hours plan is required, or whether people are still able to access pharmaceutical services at or from those pharmacy premises that are open.

The regulations do not define the maximum size of the area that a local hours plan may cover, although as they are to be implemented by ICBs it is expected that the area covered by such a plan would be no larger than the ICB’s area (and in reality is likely to cover a much smaller area) and cannot include a neighbouring ICB’s area. Similarly, there is no minimum size for the area covered by a local hours plan. Due to the amount of time it may take to agree temporary opening hours with the participating pharmacies, ICBs may wish to consider establishing a local hours plan for a small area covering a couple of pharmacies and then increasing the area that it covers.

Where an ICB is considering establishing a local hours plan along the boundary with a neighbouring ICB, it may wish to liaise with that ICB to ensure there is no destabilisation of cross-border provision of pharmaceutical services, thereby taking into account that people will access pharmaceutical services from locations that are convenient for them and do not observe NHS organisational boundaries.

ICBs will need to take into account provision of pharmaceutical services in neighbouring ICBs’ areas, including the arrangement in any local hours plans that have been agreed, when assessing whether or not people are having significant difficulties in accessing pharmaceutical services. Where an ICB (ICB1) is considering implementing a local hours plan which will or may impact on the ability of people living in a neighbouring ICB’s area (ICB2) to access pharmaceutical services, it is expected that ICB1 will liaise with ICB2 at an early stage and throughout its consideration as to whether or not a local hours plan needs to be implemented and how. An ICB can only include pharmacies that are in its area within its local hours plan; for example, it is not possible for ICB1 to include a pharmacy in a ICB2’s area in a local hours plan that covers part of ICB1’s area.

ICBs are to note that local hours plans are to be for a specified duration and are to be temporary in nature.

Having monitored the level of temporary suspensions in pharmaceutical services provision in its area, an ICB may identify an area where people are having significant difficulty in accessing pharmaceutical services. The ICB will need to identify the days and/or times   pharmaceutical services should be provided in order to meet the need for such services by people in the area. Having established those times and/or days it would then approach the pharmacies in the area to be covered by the plan with a view to agreeing the opening hours of each pharmacy. Initial approaches could be made by email, via a phone call to, or meeting with, the relevant pharmacies.

ICBs are to note that contractors do not need to agree to participate in a local hours plan. However, in not participating contractors must ensure that pharmaceutical services are provided at their pharmacy premises throughout their existing core opening hours and supplementary opening hours. A failure to comply with their terms of service will lead to consideration of the use of the performance related sanctions by the ICB.

If insufficient pharmacies agree to be part of a local hours plan, then the plan cannot be put in place and pharmacies will be required to open in line with their core and supplementary opening hours. ICBs will be expected to monitor this and where pharmacies are not opening when they should consider whether there has been a breach of the terms of service and what action is to be taken.

Local hours plans cannot take effect until all the pharmacies required for the plan to ensure adequate service provision have signed up. Until that happens all pharmacies will be required to open in line with their core and supplementary opening hours. ICBs will be expected to monitor this and where pharmacies are not opening when they should consider whether there has been a breach of the terms of service and what action is to be taken.

Each participating pharmacy agrees the temporary opening hours that they will provide throughout the life of the local hours plan with the ICB. They do not agree the temporary opening hours of other participating pharmacies (paragraph 23A(4), Schedule 4).

Prior to coming to a decision as to whether or not a local hours plan is to be established, the ICB must consult with the local pharmaceutical committee, or committees, for the area covered by the plan (paragraph 23A(2), Schedule 4). The purpose of the consultation is to seek views on:

• whether the difficulties that people are facing in an area are so significant that a local hours plan is necessary,
• the contents of the plan, including the area it covers and the hours that will be secured,
• any changes to it that may occur, for example how pharmacies may join or leave the plan,
• the notice period to be given by pharmacies who wish to leave the plan, and
• the duration of the plan.

The regulations do not set out a timescale for that consultation. ICBs will need to balance the need to consult meaningfully with the local pharmaceutical committee or committees with the need to establish the local hours plan timeously.

Where the ICB is of the opinion that it is not practicable to consult with the relevant local pharmaceutical committee or committees, this is to be formally minuted (paragraph 23A(2)). This could, for example, be where a local hours plan needs to be implemented in an emergency.

Once the consultation has concluded the ICB will then consider what, if any, changes are to be made before the plan is implemented. If changes to the previously agreed opening hours need to be made, then these must first be discussed and agreed with the affected pharmacy or pharmacies. Until this has happened the local hours plan cannot take effect.

The relevant local pharmaceutical committee or committees are to be notified once the plan is finalised. In addition it is, or they are, to be notified of any changes to the plan, for example where pharmacies join or leave (paragraph 23A(3), Schedule 4). ICBs will need to consider whether details of the revised opening hours should be published on their website. In coming to this decision, they will wish to note that the participating pharmacies will be required to update their opening hours on both their directory of services and NHS website profiles via Profile Manager. Where an ICB publishes the local hours plan or plans on its website it should remove the annexes to it (see annex 9 for a template plan).

ICBs are to note that where a pharmacy participates in a local hours plan their usual core and supplementary opening hours are temporarily suspended, and the pharmacy will instead have “temporary opening hours” during the period of their participation.

6.4 Contents of a local hours plan

The following information must be included in a local hours plan.

• The area that it covers,
• The duration of the plan,
• The name and address of each participating pharmacy,
• The temporary opening hours of each participating pharmacy,
• The notice period to be given where a participating pharmacy wishes to leave the plan, and
• Confirmation that participating pharmacies will update their opening hours in their NHS website and directory of services profiles via Profile Manager.

A template plan can be found in annex 9.

ICBs will also need to consider the action to be taken should any of the following matters arise during the lifetime of a local hours plan. This is not an exhaustive list.

• The steps to be taken where a participating pharmacy gives notice to withdraw from the relevant pharmaceutical list.
• The ownership of a participating pharmacy changes during the lifetime of the plan.
• A participating pharmacy successfully applies to relocate and completes that relocation during the lifetime of the plan and either remains in the area covered by the plan or has moved outside of it.
• The process to be followed where a pharmacy asks to join the plan, and how this will then be managed.
• How temporary opening hours will be renegotiated with participating pharmacies if a pharmacy joins or leaves.
• How the plan is to be terminated if insufficient pharmacies remain in it.
• How the plan will be reviewed should a new pharmacy open within the area that it covers.
• How frequently the plan will be reviewed to see if:
  • it is addressing the significant difficulties that people in the area are or were facing in accessing pharmaceutical services,
  • the plan needs to be amended or extended, and
  • if the plan has fulfilled its objectives and the serious difficulties have now been resolved and the plan therefore is no longer necessary.

6.5 Implementation of a local hours plan

Once a local hours plan has been finalised, each participating pharmacy must ensure that pharmaceutical services are provided at their pharmacy premises during the agreed temporary opening hours paragraph 23A(5)(a), Schedule 4. ICBs will be expected to monitor this and consider what action to take where pharmacies are not opening when they should.

A pharmacy may cease to participate in the plan and return to their usual core and supplementary opening hours by giving the required notice period (paragraph 23A(5)(b), Schedule 4).

6.6 Cessation of a local hours plan

A local hours plan ceases to have effect on the expiry of the duration specified in the plan. At that point all participating pharmacies will return to their usual core and supplementary opening hours. The only exception to this is where the ICB revises the duration of the plan (paragraph 23A(7), Schedule 4). In that instance the participation of each pharmacy that agrees to remain in the extended plan continues until such time as the pharmacy gives the required notice period to leave the plan or the plan ends on the new expiry date.

If a pharmacy or pharmacies withdraw from a local hours plan the ICB will need to review whether or not the plan is still addressing the significant difficulties that people were experiencing in accessing pharmaceutical services. Where it isn’t, then the ICB will need to either renegotiate the opening hours of the remaining pharmacies, approach other pharmacies with a view to joining the plan or terminate the plan. Where the plan is terminated, all pharmacies will return to their usual core and supplementary opening hours.

6.7 Revising a local hours plan

Local hours plans can be revised by the ICB, from time to time, to allow:

• further pharmacies to join,
• agreement of different temporary opening hours for one or more participating pharmacies,
• agreement to change the notice period to be given by a participating pharmacy, or
• an extension to, or reduction of, the duration of the plan (paragraph 23A(6)).

If an ICB revises the duration of a local hours plan, a participating pharmacy may give the required notice to cease to participate in the plan. A participating pharmacy may give a shorter notice period where:

• it no longer wishes to participate in the plan beyond the original expiry date,
• the timing of the decision by the ICB means it is not possible to give the required notice period, or it isn’t reasonably practicable for the required period of notice to be given, and
• the pharmacy gives notice of its intention to cease participation on the original expiry date as soon as it is reasonably practicable for it to do so (paragraph 23A(8)).

6.8 Failure to comply with a local hours plan

Where a participating pharmacy fails to ensure that pharmaceutical services are provided at the agreed temporary opening hours, this will be considered a breach of the pharmacy’s terms of service. ICBs will therefore consider whether use of the performance related sanctions is appropriate, based on the facts of the case.

6.9 Implications of local hours plans on applications to change core opening hours or notifications of changes to supplementary opening hours

Whilst a local hours plan is in place, a participating pharmacy may:

• notify the ICB of a change of supplementary opening hours under paragraph 23(6) and (7), Schedule 4,
• notify the ICB of the inclusion of, or change to, a rest break under paragraph 23(7), Schedule 4, or
• apply to vary its core opening hours under paragraph 26. Schedule 4.
•  

In addition, an ICB may make a determination in relation to a participating pharmacy’s core opening hours under paragraph 25, Schedule 4 (paragraph 23A(9), Schedule 4).

Where a participating pharmacy’s core and/or supplementary opening hours were due to change prior to the implementation of a local hours plan, those hours will become the pharmacy’s usual core and/or supplementary opening hours when the local hours plan expires or when the pharmacy has served the required notice period and ceases to participate in the plan.

7. Fitness information to be provided alongside an application for inclusion in a pharmaceutical list

7.1 Introduction

The information that must be provided in an application for inclusion in a pharmaceutical list is set out in paragraphs 1 to 10, Schedule 2. There are two elements:

• information in support of the application required by paragraph 1, Schedule 2, for example the name of the health and wellbeing board, the type of application, the name and address of the applicant etc, and
• fitness information on the applicant required by paragraphs 2 to 4, Schedule 2.
•  

If the applicant’s fitness information required by paragraphs 3 and 4, Schedule 2 has already been provided to NHS England or an ICB (or, prior to 1 April 2013, to a body corporate’s home primary care trust) then it does not need to be provided again as long as the applicant:

• confirms that NHS England already has all of the required fitness information, or
• if there is any missing information, confirm the information that NHS England already has, and provide the missing information (paragraph 5, Schedule 2).
•  

ICBs should note that applicants may therefore rely upon previously provided fitness information and that information may now be held by another ICB. The pharmacy manual confirms that if, after using reasonable endeavours, the previously provided fitness information cannot be found it is to be treated as missing information and the applicant is to be asked to provide it again. Where the applicant fails or refuses to comply with the request, the application will be treated as withdrawn in accordance with paragraph 11, Schedule 2 (paragraph 28, chapter 4 of the pharmacy manual).

If the applicant has not previously provided the required fitness information, then it must do so as part of the application for inclusion in a pharmaceutical list.

Changes have been made to both paragraphs 3 and 5, Schedule 2 which came into effect on 25 May 2023.

7.2 Personal work history – providing fitness information for the first time

Applications for inclusion in a pharmaceutical list in relation to pharmacy premises may only be made by:

• a sole trader who is a registered pharmacist,
• a partnership where each partner is a registered pharmacist, or
• a body corporate with a superintendent who is a registered pharmacist.
•  

There are no such requirements relating to who can apply for inclusion in a pharmaceutical list as a dispensing appliance contractor.

Prior to 25 May 2023, sole traders, partners, superintendents and any directors who are a registered pharmacist were required to provide, amongst other things, 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 (paragraph 3(7)(b), Schedule 2). This applied equally to applications for pharmacy premises and dispensing appliance contractor premises.

With effect from 25 May 2023 this requirement has been amended so that sole traders, partners, superintendents and any directors who are a registered pharmacist need to provide:

• information on their personal work history for the seven years ending on the date the application is submitted (previously it was details of all of their professional experience), and
• a declaration that:
  • the details provided are a complete and accurate account of their personal work history,
  • they have not been dismissed in that time, and if they cannot make that declaration, the reasons for that are to be provided,
  • they have not had a break of more than six months from work in that seven-year period, and if they cannot make that declaration, the reasons for that are to be provided, and
  • if they are already included in a pharmaceutical list (either as the applicant or as a different entity) they have complied with the requirements of paragraph 31, Schedule 4 (pharmacy contractors) or paragraph 21, Schedule 5 (dispensing appliance contractors) as applicable.

Once a contractor is included in a pharmaceutical list they are required by paragraph 31, Schedule 4 or paragraph 21, Schedule 5 to provide to their ICB information about fitness matters as they arise. This includes, for example, the requirement to notify the relevant ICB of investigations into professional conduct by any licensing, regulatory or other body.

7.3 Personal work history – fitness information that has previously been provided

Where an applicant is relying on previously provided fitness information, they will need to be aware of the changes that have been made to paragraphs 3 and 5, Schedule 2.

The template application for inclusion in a pharmaceutical list forms contain a section entitled “Provision of fitness information required by Part 1, Schedule 2 of the Regulations”. Applicants choose one of three options:

1. they have previously provided the required fitness information and there is no missing information;
2. they have previously provided the required fitness information but there is missing information (which is then provided); or
3. the required fitness information has been provided alongside the application form.

In order to tick option 1, applicants will need to check that they (and where the applicant is a partnership that means each partner, or where they are a body corporate that means each director or superintendent) have previously provided:

• information on their personal work history for the seven years ending on the date the application is submitted, and
• a declaration that:
  • the details provided are a complete and accurate account of their personal work history,
  • they have not been dismissed in that time, and if they cannot make that declaration, the reasons for that are to be provided,
  • they have not had a break of more than six months from work in that seven-year period, and if they cannot make that declaration, the reasons for that are to be provided, and
  • if they are already included in a pharmaceutical list (either as the applicant or as a different entity) they have complied with the requirements of paragraph 31, Schedule 4 (pharmacy contractors) or paragraph 21, Schedule 5 (dispensing appliance contractors) as applicable.

Where they have not done that, they will need to tick option 2 and provide the missing information. Fitness information is to be considered as missing if it has previously been provided to NHS England more than seven years prior to the date the application is submitted (paragraph 5(4), Schedule 2).

Where the declaration required by paragraph 3(7)(b), Schedule 2 has never previously been made by the application, or has been provided but is no longer up-to-date, then this is to be treated as missing information and the applicant must:

• provide an up-to-date declaration, together with any information required to support that declaration; or
• where the applicant cannot make the declaration, provide any information that needs to be provided (paragraph 5(5), Schedule 2).
•  

8. Notices of commencement

8.1 Introduction

Where a person wishes to:

• open a pharmacy or dispensing appliance contractor premises and provide pharmaceutical services,
• apply to relocate existing premises, or
• buy an existing business,
•  

they must first apply to the relevant ICB to be included in the pharmaceutical list in respect of the health and wellbeing board in whose area the premises are or are to be located.

Where such an application is granted, the applicant will then have a specified period of time within which to submit a ‘notice of commencement’. The notice of commencement advises the ICB of the date the applicant intends to start to provide services, and it is on this date that the applicant and their premises are included in the relevant pharmaceutical list and the contractual relationship between the two parties commences.

Notices of commencement must be “in the correct form” (paragraph 34(2), Schedule 2). A notice of commencement is in the correct form if it:

• includes the information required under paragraph 29, Schedule 2, and
• is in the same format as the version sent with the decision letter (paragraph 34(3), Schedule 2).
•  

They must also be “valid” and paragraphs 34(3A), (3C) and (4), Schedule 2 set out what makes a notice of commencement invalid. These predominantly relate to:

• the date the notice of commencement is given to PCSE in relation to the date service provision will commence (paragraph 34(3A), Schedule 2),
• the date service provision will commence in relation to the time period within which the notice of commencement must be submitted (paragraph 34(3C), Schedule 2), and
• the time period within which the notice of commencement must be sent to PCSE (paragraph 34(4), Schedule 2).
•  

The regulatory requirements relating to the submission and content of notices of commencement are set out in paragraph 34, Schedule 2. A number of changes have previously been made to this paragraph and two further changes were made with effect from 25 May 2023.

This chapter supersedes chapter 17 of NHS England’s ‘Guidance on the National Health Service (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2020’ published on 22 December 2020 on the NHS England website. It also supersedes paragraph 32 to 42, chapter 3 of NHS England’s pharmacy manual (version 2 published 10 February 2023).

It should be noted that none of the changes to paragraph 34, Schedule 2 apply to the submission of notices of consolidation which are dealt with in line with paragraph 34A, Schedule 2.

8.2 Period of time within which to submit a notice of commencement

Since 14 September 2020 applicants have had 12 months within which to submit a valid notice of commencement (paragraph 34(4)(b), Schedule 2). Prior to that date it was six months. ICBs can increase this 12-month period up to an overall total of 15 months, following a request from the applicant, where there are valid grounds to do so (paragraph 34(4)(c)(i), Schedule 2).

Table 1 sets out when the 12-month period starts for the most common scenarios. For all other scenarios reference should be made to paragraph 34(4), Schedule 2; it is to be noted that no changes have been made to the provisions within this paragraph since September 2020.

Table 1 – Submission of notices of commencement

It should be noted that the timescale for the submission of notices of consolidation under paragraph 34A, Schedule 2 is six months.

8.3 Date services are to commence

Since 9 November 2020, notices of commencement must be submitted no fewer than 30 days prior to the date the applicant intends to commence service provision (paragraph 34(3A), Schedule 2). Prior to that date it was up to 14 days in advance.

There is one exception to this rule and that is where the relevant ICB agrees to a shorter notice period. The form to be used for this purpose can be found on PCSE’s website.

With effect from 25 May 2023, paragraph 34(3C), Schedule 2 has been inserted into the 2013 regulations and the provision it brings in will limit how far into the future the date service commencement can be. This amendment will apply to all notices of commencement received on or after 25 May 2023. Where a notice of commencement has been given to PCSE on or before 24 May 2023, paragraph 23(3C), Schedule 2 will also have implications should the applicant wish to change the date service provision will commence (see 8.4).

8.3.1 Notices of commencement given to PCSE on or after 25 May 2023

Where a notice of commencement is given to PCSE on or after 25 May 2023, the date service provision is to commence must be within either:

• the 12-month grant period (or such extended period as the ICB may allow up to an overall maximum of 15 months), or
• up to 60 days after the end of that period (paragraph 34(3C), Schedule 2).
•  

Where the date service provision will commence is more than 60 days after the end of the grant period the notice of commencement is not valid and the applicant will, if there is time, need to submit a new notice of commencement.

8.3.2 Notices of commencement given to PCSE on or before 24 May 2023

Where a notice of commencement was given to PCSE on or before 24 May 2023 it will be assessed against the wording of paragraph 34, Schedule 2 as it was drafted on the date the notice of commencement was received.

8.4 Changing the date service provision is to commence

Where a valid notice of commencement that is in the correct form is received, the ICB is required to amend the relevant pharmaceutical list to include the applicant and their premises. This is done on the date given in the notice of commencement (paragraph 34(2), Schedule 2).

Since 9 November 2020, where the applicant has submitted a valid notice of commencement, they may change the date service provision is to commence (paragraph 34(3B), Schedule 2) where certain requirements are met. The form to use for this purpose can be found on PCSE’s website. Two changes have been made to paragraph 34, Schedule 2 in relation to changing the date of commencement given in a notice of commencement.

In line with paragraph 34(3B), Schedule 2, once a valid notice of commencement has been accepted by the ICB, if the applicant wishes to change the date the provision of services will commence, they are required to notify the ICB, via PCSE, of the change as soon as is reasonably practicable. From 25 May 2023 they must notify of the change in advance of the date the provision of services is now to commence (previously it was in advance of the original and new date).

The second change that has been made is the number of times that the date can be changed; it has now been limited by virtue of paragraph 34(3C), Schedule 2. With effect from 25 May 2023, where an applicant whose notice of commencement has been accepted by the ICB wishes to change the date service provision will commence, the new date can be no later than 60 days after the end of the 12-month (or such extended period as the ICB may allow up to an overall maximum of 15 months) grant period. It is to be noted that the timescale is 60 days and not two calendar months.

It should be noted once a valid notice of consolidation has been submitted the date the consolidation will be affected cannot be unilaterally changed by the applicant.

9. Glossary

• 40 hour pharmacy – any pharmacy that is not, or has never been, subject to the 100 hours condition, irrespective of the total number of core opening hours they may have.
• 100 hour pharmacy – any pharmacy that is, or has ever been, subject to the 100 hours condition irrespective of whether they have subsequently successfully applied to reduce their total number of core opening hours.
• 2005 regulations – The NHS (Pharmaceutical Services) Regulations 2005
• 2013 regulations – The NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013
• 2023 regulations – The NHS (Charges and Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023
• LPS – local pharmaceutical services
• Pharmacy premises – has the same definition as in regulation 2 of the 2013 regulations, namely premises that are included in a pharmaceutical list.

Annex 1 – application to reduce the total core opening hours of a 100 hour pharmacy

Download annexes 1 -9 in Word document format.

This is an application to reduce the total core opening hours of a 100 hour pharmacy in line with paragraph 26(2A), Schedule 4 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.

Please insert below the current core opening hours for the premises.

Please insert below the proposed core opening hours for the premises. Please note that the revised total core opening hours cannot be less than 72 per week; the change cannot lead to a loss of core opening hours between 17.00 and 21.00, Monday to Saturday; there can be no change to the core opening hours on Sundays between 11.00 and 16.00, other than by way of the inclusion of, or a change to, a rest break which is no longer than one hour, and starts at least three hours after the start of the pharmacy’s opening hours and ends at least three hours before the end of the pharmacy’s opening hours; and there can be no change to the total number of core opening hours on Sundays. Applications that do not meet the requirements of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, as amended, must be refused.

Please state in the box below the date from which you would like the change to take effect.

Name ……………………………………………………………………………………….

Position …………………………………………………………………………………….

Date ………………………………………………………………………………………………………

On behalf of …………………………………………………………………………………

(insert name of contractor)

Contact email address in case of queries …………………………………………………

Contact phone number in case of queries …………………………………………………

NHS England’s Privacy Notice describes how certain services are provided on behalf of ICBs and how personal data is used. It also explains how you can invoke your rights as a data subject. We will protect your information in line with the requirements of the Data Protection Act 2018.

Annex 2 – direction in relation to a 100 hour pharmacy seeking to reduce its total core opening hours

Download annexes 1 -9 in Word document format.

This direction is in respect of the core opening hours of the above pharmacy premises and is issued under paragraph 26(4) of Schedule 4 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (the 2013 regulations).

The total number of core opening hours a week during which pharmaceutical services must be provided at the above pharmacy premises is [insert number].

With effect from [insert date], the core opening hours during which pharmaceutical services are to be provided at the above premises are as follows:

[insert days and times for all core opening hours]

By virtue of the 2013 regulations this direction applies:

• in relation to the abovementioned pharmacy premises. It also applies to any premises to which the pharmacy may successfully apply to relocate to under the 2013 regulations (regulation 65A(3) and (4)); and
• to the abovementioned owner of the pharmacy premises. It also applies to any future owner who may be included in the relevant pharmaceutical list in respect of these pharmacy premises (or any premises to which the pharmacy may successfully apply to relocate to (regulation 65A(2)).

NHS England’s Privacy Notice describes how certain services are provided on behalf of Integrated Care Boards and how personal data is used. It also explains how you can invoke your rights as a data subject. We will protect your information in line with the requirements of the Data Protection Act 2018.

Annex 3 – application to change core opening hours – pharmacy premises 

Download annexes 1 -9 in Word document format.

This is an application to:

• • permanently change core opening hours                            ☐
  • make a one-off change                                                        ☐

(Please tick as relevant).

Please insert below the current core opening hours for these premises.

Please insert below the proposed core opening hours for these premises. Please note that this form is not to be used by 100 hour pharmacies seeking to reduce their total core opening hours in line with paragraph 26(2A), Schedule 4.

If this is a permanent change, please state in the box below the date from which you would like the change to take effect.

If this is a one-off change, please enter the dates for the change below.

Please provide information that demonstrates that your proposed core opening hours will:

• either maintain as necessary the existing level of service provision for people in the area of the pharmacy, or other likely users of the pharmacy premises; or
• maintain a sustainable level of adequate service provision for the people in the area of the pharmacy, in circumstances where maintaining the existing level of service provision is either unnecessary or not a realistically achievable outcome.

Name ……………………………………………………………………………………….

Position …………………………………………………………………………………….

Date ………………………………………………………………………………………………………

On behalf of …………………………………………………………………………………

(insert name of contractor)

Contact email address in case of queries …………………………………………………

Contact phone number in case of queries …………………………………………………

NHS England’s Privacy Notice describes how certain services are provided on behalf of Integrated Care Boards and how personal data is used. It also explains how you can invoke your rights as a data subject. We will protect your information in line with the requirements of the Data Protection Act 2018.

Annex 4 – notification of the introduction of a rest break into core opening hours of a 40 hour pharmacy

Download annexes 1 – 9 in Word document format.

This is a notification for the introduction of a rest break into the core opening hours of the above pharmacy premises. Pharmacies that are subject to, or have ever been subject to, the 100 hours condition cannot notify of the introduction of a rest break into the core opening hours.

Please insert the total opening hours for these premises.

Please insert the current core opening hours for these premises.

Please insert the total opening hours for these premises once the rest break is introduced.

Please insert the core opening hours for these premises once the rest break is introduced.

As long as this notification complies with the requirements of paragraph 23(7)(ba), Schedule 4 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, you may introduce the rest break no earlier than five weeks after this notification is received by the relevant delegated integrated care board.

I confirm that the timing of this rest break meets the requirements of paragraph 23(7)(ba), Schedule 4.          Yes ☐

Please state the date on which the rest break will be introduced ……………………………….

If you would like the relevant delegated integrated care board to agree to the rest break being introduced sooner, please set out your reasons for this in the box below.

Name ……………………………………………………………………………………….

Position …………………………………………………………………………………….

Date ………………………………………………………………………………………………………

On behalf of …………………………………………………………………………………

(insert name of contractor)

Contact email address in case of queries …………………………………………………

Contact phone number in case of queries …………………………………………………

NHS England’s Privacy Notice[20] describes how certain services are provided on behalf of Integrated Care Boards and how personal data is used. It also explains how you can invoke your rights as a data subject. We will protect your information in line with the requirements of the Data Protection Act 2018.

Annex 5 – notification of the amendment of an existing rest break within core opening hours of a 40 hour pharmacy

Download annexes 1 – 9 in Word document format.

This is a notification for the amendment of an existing rest break within the core opening hours of the above pharmacy premises. Pharmacies that are subject to, or have ever been subject to, the 100 hours condition cannot notify of the introduction of a rest break into the core opening hours.

Please insert the total opening hours for these premises.

Please insert the current core opening hours for these premises.

Please insert the total opening hours for these premises once the rest break is amended.

Please insert the core opening hours for these premises once the rest break is amended.

As long as this notification complies with the requirements of paragraph 23(7)(ba), Schedule 4 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, you may amend the rest break no earlier than five weeks after this notification is received by the relevant delegated integrated care board.

I confirm that the timing of this rest break meets the requirements of paragraph 23(7)(ba), Schedule 4.      Yes ☐

Please state the date on which the rest break will be amended ……………………………….

If you would like the relevant delegated integrated care board to agree to the rest break being amended sooner, please set out your reasons for this in the box below.

Name ……………………………………………………………………………………….

Position …………………………………………………………………………………….

Date ………………………………………………………………………………………………………

On behalf of …………………………………………………………………………………

(insert name of contractor)

Contact email address in case of queries …………………………………………………

Contact phone number in case of queries …………………………………………………

NHS England’s Privacy Notice describes how certain services are provided on behalf of Integrated Care Boards and how personal data is used. It also explains how you can invoke your rights as a data subject. We will protect your information in line with the requirements of the Data Protection Act 2018.

Annex 6 – notification of an increase to the total number of supplementary opening hours

Download annexes 1 – 9 in Word document format.

This is a notification to increase the total number of supplementary opening hours of the above premises:

• • Permanently                                                   ☐
  • On a one-off basis                                           ☐

(Please tick as relevant)

Please insert the current supplementary opening hours for these premises.

Please insert the proposed supplementary opening hours for these premises.

If this is a permanent change, please state in the box below the date from which the change will take effect.

If this is a one-off change, please enter the dates for the change below.

Dispensing appliance contractors

At least three months’ notice must be given by dispensing appliance contractors. If you are seeking to increase the total number of supplementary opening hours within a shorter timescale, please set out your reasons below and the relevant delegated integrated care board will consider whether it can agree to a shorter notice period.

Pharmacy contractors

Where a pharmacy contractor wishes to increase its total supplementary opening hours they must notify the relevant delegated integrated care board in advance of the change.

I confirm that:

• I am/we are notifying you of this increase in the total number of supplementary opening hours in advance of the change being made                                                                                             ☐
• the pharmacy’s NHS website and Directory of Services profiles will be updated accordingly                                                                                              ☐

Name ……………………………………………………………………………………….

Position …………………………………………………………………………………….

Date ………………………………………………………………………………………………………

On behalf of …………………………………………………………………………………

(insert name of contractor)

Contact email address in case of queries …………………………………………………

Contact phone number in case of queries …………………………………………………

NHS England’s Privacy Notice describes how certain services are provided on behalf of Integrated Care Boards and how personal data is used. It also explains how you can invoke your rights as a data subject. We will protect your information in line with the requirements of the Data Protection Act 2018.

Annex 7 – notification of a decrease in the total number of supplementary opening hours

Download annexes 1 – 9 in Word document format.

This is a notification to decrease the total number of supplementary opening hours of the above premises:

• Permanently                                                   ☐
• On a one-off basis                                           ☐

(Please tick as relevant)

Please insert the current supplementary opening hours for these premises.

Please insert the proposed supplementary opening hours for these premises.

If this is a permanent change, please state in the box below the date from which the change will take effect.

If this is a one-off change, please enter the dates for the change below.

Dispensing appliance contractors

At least three months’ notice must be given by dispensing appliance contractors. If you are seeking to reduce the total number of supplementary opening hours within a shorter timescale, please set out your reasons below and the relevant delegated integrated care board will consider whether it can agree to a shorter notice period.

Pharmacy contractors

At least five weeks’ notice must be given by pharmacy contractors. If you are seeking to reduce the total number of supplementary opening hours within a shorter timescale, please set out your reasons below and the relevant delegated integrated care board will consider whether it can agree to a shorter notice period.

I confirm that the pharmacy’s NHS website and Directory of Services profiles will be updated accordingly                                                                                                    □

Name ……………………………………………………………………………………….

Position …………………………………………………………………………………….

Date ………………………………………………………………………………………………………

On behalf of …………………………………………………………………………………

(insert name of contractor)

Contact email address in case of queries …………………………………………………

Contact phone number in case of queries …………………………………………………

NHS England’s Privacy Notice describes how certain services are provided on behalf of Integrated Care Boards and how personal data is used. It also explains how you can invoke your rights as a data subject. We will protect your information in line with the requirements of the Data Protection Act 2018.

Annex 8 – notification of a redistribution of supplementary opening hours

Download annexes 1 – 9 in Word document format.

This is a notification to redistribute the supplementary opening hours of the above premises:

• Permanently                                                   ☐
• On a one-off basis                                           ☐

(Please tick as relevant)

Please insert the current supplementary opening hours for these premises.

Please insert the proposed supplementary opening hours for these premises.

If this is a permanent change, please state in the box below the date from which the change will take effect.

If this is a one-off change, please enter the dates for the change below.

Dispensing appliance contractors

At least three months’ notice must be given by dispensing appliance contractors. If you are seeking to change the supplementary opening hours within a shorter timescale, please set out your reasons below and the relevant delegated integrated care board will consider whether it can agree to a shorter notice period.

Pharmacy contractors

At least five weeks’ notice must be given by pharmacy contractors. If you are seeking to change the supplementary opening hours within a shorter timescale, please set out your reasons below and the relevant delegated integrated care board will consider whether it can agree to a shorter notice period.

I confirm that the pharmacy’s NHS website and Directory of Services profiles will be updated accordingly 

Name ……………………………………………………………………………………….

Position …………………………………………………………………………………….

Date ………………………………………………………………………………………………………

On behalf of …………………………………………………………………………………

(Insert name of contractor)

Contact email address in case of queries …………………………………………………

Contact phone number in case of queries …………………………………………………

NHS England’s Privacy Notice describes how certain services are provided on behalf of Integrated Care Boards and how personal data is used. It also explains how you can invoke your rights as a data subject. We will protect your information in line with the requirements of the Data Protection Act 2018.

Annex 9 – template local hours plan

Download annexes 1 – 9 in Word document format.

NHS [insert name] Integrated Care Board has identified the need for a local hours plan due to the significant difficulties that are being experienced, or are likely to be experienced, in accessing pharmaceutical services. The plan covers [insert description or map of the area].

The plan will commence at 00.01 on [insert date] and will terminate at 23.59 on [insert date] after which the participating pharmacies will return to their usual core and supplementary opening hours.

Where a participating pharmacy wishes to cease participating in the plan it is required to give [insert period] prior notice.

The plan will be reviewed during its lifetime to ensure that it continues to address the significant difficulties that have been identified in accessing pharmaceutical services. Such reviews may be triggered by, but are not limited to, the following events.

• A participating pharmacy gives (or pharmacies give) notice to withdraw from the plan.
• The ownership of a participating pharmacy changes during the lifetime of the plan.
• A participating pharmacy successfully applies to relocate to new premises, or a non-participating successfully applies to relocate into the area covered by the plan.
• New pharmacy premises open within the area covered by the plan.
• One or more participating pharmacies give notice to withdraw from the relevant pharmaceutical list.
• A non-participating pharmacy asks to participate in the plan.
• There is a change to the needs for pharmaceutical services in the area covered by the plan.

The pharmacies participating in this local hours plan are shown in the table below along with their temporary opening hours.

Annex 1 – Agreement of temporary opening hours (delete or add annexes as required. Delete footnote once completed)

The pharmacy’s usual core opening hours are as follows:

The pharmacy’s usual supplementary opening hours are as follows:

During the lifetime of this local hours plan the pharmacy’s temporary opening hours are as follows:

I confirm that the pharmacy’s profiles on the directory of services and NHS website will be amended to reflect the agreed temporary opening hours for the lifetime of the local hours plan.

Signed:

On behalf of [insert name of contractor, not the trading name]

Name:

Date:

Annex 2 – Agreement of temporary opening hours

The pharmacy’s usual core opening hours are as follows:

The pharmacy’s usual supplementary opening hours are as follows:

During the lifetime of this local hours plan the pharmacy’s temporary opening hours are as follows:

I confirm that the pharmacy’s profiles on the directory of services and NHS website will be amended to reflect the agreed temporary opening hours for the lifetime of the local hours plan.

Signed:

On behalf of [insert name of contractor, not the trading name]

Name:

Date:

Annex 3 – Agreement of temporary opening hours

The pharmacy’s usual core opening hours are as follows:

The pharmacy’s usual supplementary opening hours are as follows:

During the lifetime of this local hours plan the pharmacy’s temporary opening hours are as follows:

I confirm that the pharmacy’s profiles on the directory of services and NHS website will be amended to reflect the agreed temporary opening hours for the lifetime of the local hours plan.

Signed:

On behalf of [insert name of contractor, not the trading name]

Name:

Date:

Annex 4 – Agreement of temporary opening hours

The pharmacy’s usual core opening hours are as follows:

The pharmacy’s usual supplementary opening hours are as follows:

During the lifetime of this local hours plan the pharmacy’s temporary opening hours are as follows:

I confirm that the pharmacy’s profiles on the directory of services and NHS website will be amended to reflect the agreed temporary opening hours for the lifetime of the local hours plan.

Signed:

On behalf of [insert name of contractor, not the trading name]

Name:

Date:

Publication reference:  PRN00278