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The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

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PART 3U.K.Hours of opening

Pharmacy opening hours: generalU.K.

23.—(1) [F1Subject to paragraph 23A,] an NHS pharmacist (P) must ensure that pharmaceutical services are provided at P's pharmacy premises—

(a)for 40 hours each week;

(b)for not less than 100 hours each week, in the case of premises in respect of which a 100 hours condition applies;

(c)if [F2NHS England] or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at the premises for fewer than 40 hours per week, provided that the person listed in relation to them provides those services at set times and on set days, at the times and on the days so set;

(d)if a Primary Care Trust, or on appeal the Secretary of State, has (under previous Regulations) directed that pharmaceutical services are to be provided at the premises for more than 40 hours per week, and at set times and on set days, at the times and on the days so set [F3, subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd)]; or

(e)if [F2NHS England] or a Primary Care Trust, or on appeal the Secretary of State, has directed that pharmaceutical services are to be provided at the premises for more than 40 hours each week, but only on set times and on set days as regards the additional opening hours [F4, or the core opening hours where paragraph 26(4A) applied to the issuing of the direction]

(i)for the total number of hours each week required by virtue of that direction, and

(ii)as regards the additional opening hours for which the person listed in relation to the premises is required to provide pharmaceutical services by virtue of that direction, at the days on which and times at which that person is required to provide pharmaceutical services during those additional opening hours, as set out in that direction [F5, subject to any variation in respect of a rest break in accordance with sub-paragraph (7)(bd)],

but [F2NHS England] may, in appropriate circumstances, agree a temporary suspension of services for a set period, where it has received 3 months notice of the proposed suspension.

(2) The hours during which pharmacy premises must be open by virtue of sub-paragraph (1) are referred to in these Regulations as “core opening hours”.

(3) P must notify [F2NHS England] of other hours during which P's pharmacy premises are to be open, which are hours in addition to P's core opening hours (and which are referred to in these Regulations as “supplementary opening hours”).

(4) Unless P is a distance selling chemist, at P's pharmacy premises P must exhibit—

(a)a notice specifying the days on which and times at which the premises are open for the provision of drugs and appliances (including times at which P is providing pharmaceutical services during supplementary opening hours); and

(b)at times when the premises are not open, a notice based on information provided by [F2NHS England], where practicable legible from outside the premises, specifying—

(i)the addresses of other NHS pharmacists and the days on which and times at which drugs and appliances may be obtained from those addresses, and

(ii)the addresses of LPS chemists in the area, the type of local pharmaceutical services which those LPS chemists provide, and the days on which and times at which their premises are open.

(5) P must, on request, submit a return to [F2NHS England] setting out—

(a)the days on which and times at which pharmaceutical services are provided at P's pharmacy premises (including times at which P is providing pharmaceutical services during supplementary opening hours); and

(b)the pharmaceutical services which P ordinarily provides at those premises.

(6) Where P changes—

(a)the supplementary opening hours of P's pharmacy premises; or

(b)the pharmaceutical services which P ordinarily provides at those premises,

P must supply [F2NHS England] with a return informing it of the change [F6before the change takes place].

(7) Where P has notified to [F2NHS England] (or, before the appointed day, a Primary Care Trust) the days on which and times at which pharmaceutical services are to be provided at P's pharmacy premises (for example, in a return under sub-paragraph (5) or (6) or in an application for inclusion in a pharmaceutical list)—

(a)P must ensure that pharmaceutical services are provided at the premises to which the notification relates on the days and at the times set out in the notification (unless the notification has been superseded by a return, or a further return, under sub-paragraph (6)); F7...

[F8(ba)P must not change the days on which or the times at which pharmaceutical services are to be provided at those premises during core opening hours, except for making a change that—

(i)amounts to the inclusion of a rest break which is no longer than one hour, or a change to such a rest break—

(aa)on a Monday to Saturday, which starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours, or

(bb)on a Sunday, and

(ii)does not change the total number of P’s core opening hours on a particular day,

otherwise than as provided for, and in accordance with the procedures set out in, paragraphs 25 and 26;

(bb)P must not change P’s supplementary opening hours in a way that reduces the time for which P’s pharmacy is open before or after a rest break on a Monday to Saturday to less than 3 hours (if P wants to change the supplementary opening hours affected by this requirement, P must also change the time of the rest break);

(bc)P must not change—

(i)the total number of P’s supplementary opening hours in a way that either reduces or leaves the same the total number of P’s supplementary opening hours, or

(ii)unless the change relates to an increase of the total number of supplementary opening hours, the days on which or the times at which pharmaceutical services are to be provided at P’s premises during supplementary opening hours,

for a period of at least 5 weeks after the day on which that notification was received by NHS England, unless NHS England agrees otherwise; and

(bd)P must not change the days on which or the times at which pharmaceutical services are to be provided at those premises during core opening hours, in the case of making a change that—

(i)amounts to the inclusion of a rest break which is no longer than one hour, or a change to such a rest break—

(aa)on a Monday to Saturday, which starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours, or

(bb)on a Sunday, and

(ii)does not change the total number of P’s core opening hours on a particular day,

for a period of at least 5 weeks after the day on which that notification was received by NHS England, unless NHS England agrees otherwise.]

[F9(7A) Paragraphs (ba) and (bd) of sub-paragraph (7) do not apply to changes to core opening hours of premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, and accordingly the core opening hours of such premises may only be changed in accordance with paragraph 25 or 26.]

F10(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F11(9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(10) Where there is a temporary suspension in the provision of pharmaceutical services by P [F12because of illness or another reason] beyond the control of P, P is not in breach of sub-paragraphs (1) and (7), [F13or of paragraph 23A(5)(a),] provided that—

(a)P notifies [F2NHS England] of that suspension as soon [F14as practicable, in the manner required by paragraph 29D(2)(a) and wherever possible before the start of the suspension;]

[F15(aa)P uses all reasonable endeavours to implement the business continuity plan that P is required to have by virtue of paragraph 29D; and]

(b)P uses all reasonable endeavours to resume provision of pharmaceutical services as soon as is practicable.

(11) Planned refurbishment of pharmacy premises is [F16not] a “reason beyond the control of P” for the purposes of sub-paragraph (10).

(12) For the purposes of calculating the number of hours that pharmacy premises are open during a week that includes Christmas Day, Good Friday, Easter Sunday or a bank holiday, it is to be deemed that the pharmacy premises were open on that day at the times at which they would ordinarily have been open on that day of the week.

(13) For the purposes of this Part, “additional opening hours”, where they are required, are hours during which P is required to provide pharmaceutical services pursuant to sub-paragraph (1)(e) which are in addition to the hours during which P would be required to provide pharmaceutical services, if P were subject instead to the condition set out in sub-paragraph (1)(a).

Textual Amendments

[F17Local hours plansU.K.

23A.(1) Where NHS England is 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, NHS England may establish a local hours plan with the NHS pharmacists in that area that are willing to participate in a local hours plan for that area.

(2) NHS England must, prior to establishing a local hours plan, consult any local pharmaceutical committee for the area that comprises or includes the area of the plan, unless NHS England decides that it is not practicable to do so.

(3) NHS England must notify any local pharmaceutical committee for the area that comprises or includes the area of a local hours plan that it establishes of the contents of that plan and any changes to it, including where further NHS pharmacists join or any NHS pharmacists cease to participate in the plan.

(4) The local hours plan is to be of a specified duration, determined by NHS England, and is to contain the temporary opening hours agreed between NHS England and each of the participating NHS pharmacists (each participating NHS pharmacist agrees their own but not other participants’ temporary opening hours).

(5) NHS pharmacists that have agreed to participate in a local hours plan—

(a)must ensure that pharmaceutical services are provided at their pharmacy premises during the agreed temporary opening hours; and

(b)may cease to participate in the plan and return to their core and supplementary opening hours, provided that, subject to sub-paragraph (8), they have given the notice period for doing so that they have each agreed with NHS England as part of the plan.

(6) NHS England may revise a local hours plan from time to time, including by allowing further NHS pharmacists to join, but any change to the plan that is a change to the temporary opening hours of an NHS pharmacist that is participating in the plan, or of their notice period as referred to in sub-paragraph (5)(b), must be agreed with that NHS pharmacist.

(7) A local hours plan ceases to have effect on the expiry of its specified duration, determined by NHS England in accordance with sub-paragraph (4), unless NHS England revises the specified duration, in which case the new specified duration becomes the specified duration of the plan, and further revisions are then also permissible pursuant to this sub-paragraph.

(8) If NHS England revises the specified duration of a local hours plan, an NHS pharmacist may cease to participate in the plan on the date that was the plan’s expiry date, having given prior notice of their intention to do so, which may be of a shorter period than their agreed notice period where—

(a)the NHS pharmacist does not wish to participate in the plan beyond the expiry date that has been extended;

(b)the timing of the revision means it is not possible, or not reasonably practicable, for prior notice to be given for the agreed notice period; and

(c)the NHS pharmacist gives notice of their intention to cease to participate in the plan on the date that was the plan’s expiry date as soon as it is reasonably practicable for them to do so.

(9) While a local hours plan has effect, the core and supplementary opening hours that have temporarily been suspended may be changed in accordance with paragraphs 23(6) and (7), 25 and 26.]

Matters to be considered when issuing directions in respect of pharmacy premises core opening hoursU.K.

24.[F18(1) Subject to paragraph 26(2A), where NHS England issues a direction for setting any days or times for opening hours under this Part, or determines them without issuing a direction, it must in doing so seek to ensure that the days and times at which pharmacy premises are open for the provision of pharmaceutical services in the area in which the premises that are the subject of the direction are located are such as—

(a)to maintain as necessary the existing level of service provision for the people in that area or other likely users of the pharmacy premises; or

(b)to maintain a sustainable level of adequate service provision for the people in that 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.]

(2) In considering the matters mentioned in sub-paragraph (1), [F2NHS England]

(a)must treat any local pharmaceutical services being provided in its area as if they were pharmaceutical services being so provided; and

(b)may have regard to any pharmaceutical services that are being provided in its area during supplementary opening hours.

(3) [F2NHS England] may only direct that an NHS pharmacist (P) may provide pharmaceutical services at premises for less than 40 hours in any week if it is satisfied that the provision of pharmaceutical services in its area is likely to be adequate to meet the need for such services at times when P is not providing pharmaceutical services.

(4) Except in the case of premises that have (at any time) been subject to a direction under regulation 65 or regulation 65 of the 2012 Regulations (core opening hours conditions), [F2NHS England] may only direct that P must provide pharmaceutical services at premises for more than 40 hours in any week where it is satisfied that P is to receive reasonable remuneration in respect of the additional opening hours for which P is required to provide pharmaceutical services (and any additional remuneration payable in accordance with a determination made as mentioned in regulation 91(6) in respect of those hours is “reasonable remuneration” for these purposes).

[F19(5) Sub-paragraph (4) does not apply in circumstances where the direction is in respect of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies.]

Determination of pharmacy premises core opening hours instigated by [F2NHS England]U.K.

25.—(1) Where it appears to [F2NHS England], after consultation with or having considered the matter at the request of the Local Pharmaceutical Committee for the area in which the premises are situated, that the days on which or times at which pharmacy premises are or are to be open for the provision of pharmaceutical services will not, or no longer, meet the needs of—

(a)people in its area; or

(b)other likely users of the pharmacy premises,

for the pharmaceutical services available at or from those premises, it must carry out an assessment as to whether to issue a direction requiring the NHS pharmacist (P) whose premises they are to provide pharmaceutical services at the pharmacy premises at set times and on set days (which may include Christmas Day, Good Friday and bank holidays).

(2) Before concluding the assessment under sub-paragraph (1) [F2NHS England] must—

(a)give notice to P of any proposed changes to the days on which or times at which the pharmacy premises are to be open; and

(b)allow P 30 days within which to make written representations to [F2NHS England] about the proposed changes.

(3) When it determines the outcome of its assessment, [F2NHS England] must—

(a)issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs (4) and (5);

(b)confirm any existing direction in respect of the times at which P must provide pharmaceutical services at the pharmacy premises, provided that the existing direction (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (4) and (5); or

(c)either—

(i)revoke, without replacing it, any existing direction in respect of the times at which P must provide pharmaceutical services at the pharmacy premises (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), or

(ii)in a case where there is no existing direction, issue no direction,

in which case, by virtue of whichever of paragraph 23(1)(a) or (b) applies, the pharmacy will need to be open for 40 hours each week or for at least 100 hours each week.

(4) Where [F2NHS England] issues a direction under sub-paragraph (3) in respect of pharmacy premises that are to be required to be open—

(a)for more than 40 hours each week, it must set out in that direction—

(i)the total number of hours each week for which P must provide pharmaceutical services at the pharmacy, and

(ii)as regards the additional opening hours, the days on which and the times at which P is required to provide those services during those hours,

but it must not set out in that direction the days on which or times at which P is to provide pharmaceutical services during hours which are not additional opening hours; or

(b)for less than 40 hours each week, it shall set out in that direction the days on which and times at which pharmaceutical services are to be provided at the pharmacy premises.

(5) [F2NHS England] must not issue a direction under sub-paragraph (3) that has the effect simply of requiring pharmacy premises to be open for 40 hours each week on set days and at set times (that is, the direction must have the effect of requiring pharmacy premises to be open for either more or less than 40 hours each week).

(6) [F2NHS England] must notify P of any direction issued or any other action taken under sub-paragraph (3), and where it sets new days on which or times at which P is to provide pharmaceutical services at pharmacy premises, it must include with the notification a statement of—

(a)the reasons for the change; and

(b)P's right of appeal under paragraph (7).

(7) P may, within 30 days of receiving notification under sub-paragraph (6), appeal in writing to the Secretary of State against any direction issued or any other action taken under sub-paragraph (3) which sets new days on which or times at which P is to provide pharmaceutical services.

(8) The Secretary of State may, when determining an appeal, either confirm the action taken by [F2NHS England] or take any action that [F2NHS England] could have taken under paragraph (3).

(9) The Secretary of State shall notify P of the determination and shall in every case include with the notification a statement of the reasons for the determination.

(10) If the days on which or times at which P is to provide pharmaceutical services at pharmacy premises have been changed in accordance with this paragraph, P must introduce the changes—

(a)if P has not appealed under sub-paragraph (7), not later than 8 weeks after the date on which P receives notification under sub-paragraph (6); or

(b)if P has appealed under sub-paragraph (7), not later than 8 weeks after the date on which P receives notification under sub-paragraph (9).

(11) This paragraph does not apply where regulation 65(5) to (7) applies.

Determination of pharmacy premises core opening hours instigated by the NHS pharmacistU.K.

26.—(1) An NHS pharmacist (P) may apply to [F2NHS England] for it to change the days on which or times at which P is obliged to provide pharmaceutical services [F20during core opening hours] at P's pharmacy premises in a way that—

(a)reduces the total number of hours for which P is obliged to provide pharmaceutical services at those premises each week F21...; or

(b)keeps that total number of hours the same.

(2) [F22Except where sub-paragraph (2A) applies,] where P makes an application under sub-paragraph (1), as part of that application P must provide [F2NHS England] with such information as [F2NHS England] may reasonably request in respect of [F23the matters that NHS England must seek to ensure pursuant to paragraph 24(1)].

[F24(2A) In the case of an application for a direction under sub-paragraph (4) that has the effect of reducing, in the case of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, the total number of core opening hours to 72 or above, but without changing any or all of the following—

(a)the core opening hours on a Monday to Saturday at times between 5pm and 9pm;

(b)the core opening hours on a Sunday at times between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which—

(i)is no longer than one hour, and

(ii)starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours; and

(c)the total number of core opening hours on a Sunday,

NHS England must grant that application, and paragraph 24(1) does not apply to such an application.

(2B) In the case of a valid application for a direction under sub-paragraph (4) to which sub-paragraph (2A) applies, if—

(a)the date included in the application as the date on which P wishes to change P’s core opening hours is five weeks or more after the day on which the application is received by NHS England; and

(b)NHS England has not determined the application by that date,

pending the determination of the application, P’s core opening hours are the core opening hours that P requested in the application.]

(3) [F2NHS England] must determine the application within 60 days of receiving it (including any information required of P in accordance with sub-paragraph (2)).

(4) When it determines the application, [F2NHS England] must—

(a)issue a direction (which replaces any existing direction) which meets the requirements of sub-paragraphs [F25(4A),] (5) and (6) and which has the effect of either granting the application under this paragraph or granting it only in part;

(b)confirm any existing direction in respect of the times at which P must provide pharmaceutical services at the pharmacy premises, provided that the existing direction (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations) would meet the requirements of sub-paragraphs (5) and (6); or

(c)either—

(i)revoke, without replacing it, any existing direction in respect of the times at which P must provide pharmaceutical services at the pharmacy premises (whether issued under regulation 65, this Part, the 2012 Regulations, the 2005 Regulations or the 1992 Regulations), where this has the effect of granting the application under this paragraph or granting it only in part, or

(ii)in a case where there is no existing direction, issue no direction.

F26...

[F27(4A) NHS England must not issue a direction under sub-paragraph (4), or revoke without replacing it an existing direction under that sub-paragraph, if doing so would have the effect of reducing, in the case of any premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, any or all of the following—

(a)the total number of core opening hours to below 72;

(b)the core opening hours on a Monday to Saturday at times between 5pm and 9pm;

(c)the core opening hours on a Sunday at times between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which—

(i)is no longer than one hour, and

(ii)starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours; and

(d)the total number of core opening hours on a Sunday,

and an application seeking such a change is not a valid application for the purposes of sub-paragraph (2B).

(4B) On and after 25th May 2023, NHS England must not issue a direction under sub-paragraph (4), or revoke without replacing it an existing direction under that sub-paragraph, pursuant to an application made before 25th May 2023 for a direction pursuant to this paragraph as it had effect before 25th May 2023, if doing so would have the effect of reducing, in the case of any premises in respect of which a 100 hours condition applies, any or all of the following—

(a)the core opening hours on a Monday to Saturday at times between 5pm and 9pm;

(b)the core opening hours on a Sunday at times between 11am and 4pm, other than by way of the inclusion of, or a change to, a rest break which—

(i)is no longer than one hour, and

(ii)starts at least 3 hours after the start of the pharmacy’s opening hours and ends at least 3 hours before the end of the pharmacy’s opening hours; and

(c)the total number of core opening hours on a Sunday.]

(5) Where [F2NHS England] issues a direction under sub-paragraph (4) in respect of pharmacy premises that are to be required to be open—

(a)for more than 40 hours each week, it must set out in that direction—

(i)the total number of hours each week for which P must provide pharmaceutical services at the pharmacy premises, and

(ii)as regards any additional opening hours, the days on which and the times at which P is required to provide those services during those hours,

but [F28except in a case to which sub-paragraph (4A) applies,] it must not set out in that direction days on which or times at which P is to provide pharmaceutical services during hours which are not additional opening hours; or

(b)for less than 40 hours each week, it shall set out in that direction the days on which and times at which pharmaceutical services are to be provided at the pharmacy premises.

(6) [F2NHS England] must not issue a direction under sub-paragraph (4) that has the effect simply of requiring pharmacy premises to be open for 40 hours each week on set days and at set times (that is, the direction must have the effect of requiring pharmacy premises to be open for either more or less than 40 hours each week).

(7) Where [F2NHS England] is considering taking action under sub-paragraph (4)(a) or (c)(i), it shall consult the Local Pharmaceutical Committee for the area in which the pharmacy premises are situated before determining the application.

(8) [F2NHS England] must notify P of any direction issued or any other action taken under sub-paragraph (4), and where this has the effect of refusing an application under this paragraph or granting it in part, it must send P a statement setting out—

(a)the reasons for the refusal or, as the case may be, for granting the application only in part; and

(b)P's right of appeal under sub-paragraph (9).

(9) P may, within 30 days of receiving a notification pursuant to sub-paragraph (8), appeal in writing to the Secretary of State against any action under sub-paragraph (4) which has the effect of refusing an application under this paragraph or granting it only in part.

(10) The Secretary of State may, when determining an appeal, either confirm the action taken by [F2NHS England] or take any action that [F2NHS England] could have taken under sub-paragraph (4).

(11) The Secretary of State must notify the pharmacist of the determination and must include with the notification a statement of the reasons for the determination.

(12) If the days on which or times at which P is to provide pharmaceutical services at pharmacy premises have been changed in accordance with this paragraph, P must introduce the changes—

(a)if P has not appealed under sub-paragraph (9), not earlier than 30 days after the date on which P receives notification under sub-paragraph (4); or

(b)if P has appealed under sub-paragraph (9), not earlier than 30 days after the date on which P receives notification under sub-paragraph (11).

(13) This paragraph does not apply where regulation 65(5) to (7) applies.

Textual Amendments

Temporary opening hours and closures during an emergency requiring the flexible provision of pharmaceutical servicesU.K.

27.—(1) Notwithstanding the provisions of this Part, during an emergency requiring the flexible provision of pharmaceutical services, [F2NHS England] may, on application from an NHS pharmacist (“P”), permit P a temporary change to the days on which or times at which P is obliged to provide pharmaceutical services at pharmacy premises, or permit temporary closure of those premises, if—

(a)P gives at least 24 hours notice of the change or closure; and

(b)the reasons given by P for the request are, in the opinion of [F2NHS England], adequate reasons.

(2) [F2NHS England] need not approve the request in advance of the change or closure, but if it does not do so and decides subsequently that P's reasons are not, in its opinion, adequate reasons, then the days on which or times at which P is obliged to provide pharmaceutical services at the premises are to revert to the overridden days or times, from the day after the date on which that decision is given to P.

[F29Pharmacy opening hours: arrangements while a disease is or in anticipation of a disease being imminently pandemic etc.U.K.

27A.(1) Notwithstanding the foregoing provisions of this Part, the core or supplementary opening hours of an NHS pharmacist (P) may be changed by [F2NHS England] where, as a consequence of a disease being, or in anticipation of a disease being imminently—

(a)pandemic; and

(b)a serious risk or potentially a serious risk to human health,

[F2NHS England] with the agreement of the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, [F2NHS England] may, in the area to which the announcement relates and in the circumstances specified in the announcement, notify NHS pharmacists of changes to core and supplementary opening hours for the period specified in the announcement.

(2) Where paragraph (1) applies, where [F2NHS England] notifies P of changes to P’s core or supplementary hours at P’s pharmacy premises, those are P’s core and supplementary opening hours for the period that [F2NHS England] specifies in the notification (unless [F2NHS England] notifies P of further changes to P’s opening hours).]

[F30Flexible provision of relevant immunisation services during a pandemic etc.U.K.

27B.(1) Notwithstanding the forgoing provisions of this Part, in order to assist in the management of a serious risk or potentially serious risk to human health which arises as a consequence of a disease being, or in anticipation of a disease being imminently, pandemic, an NHS pharmacist (P) may, with the agreement of [F2NHS England], limit for a specified period (within P’s core and supplementary opening hours) the pharmaceutical services provided at or from P’s pharmacy premises to relevant immunisation services.

(2) If [F2NHS England] has made an announcement to the effect that there are particular arrangements under this paragraph that it is prepared to agree, and P limits P’s provision of pharmaceutical services to relevant immunisation services in a manner that is consistent with that announcement, it is to be assumed (in the absence of a contrary notification from [F2NHS England] to P) that P has the agreement of [F2NHS England] to those arrangements.

(3) In this paragraph, “relevant immunisation services” means directed services that provide for the administration of a medicinal product for vaccination or immunisation against coronavirus or influenza virus in accordance with—

(a)a patient group direction that meets the conditions of regulation 233 of the Human Medicines Regulations 2012 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business); or

(b)a protocol that meets the conditions of regulation 247A of the Human Medicines Regulations 2012 (protocols relating to coronavirus and influenza vaccinations and immunisations),

and for these purposes, “coronavirus” has the meaning given in section 1(1) of the Coronavirus Act 2020.]

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