SI 2026/961 - The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2026

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STATUTORY INSTRUMENTS 2026 No. 961 NATIONAL HEALTH SERVICE, ENGLAND The National Health Service (Pharmaceutical and Local Pharmaceutical Services)

(Amendment) (No. 2) Regulations 2026 Made - - - - 2nd September 2026 Laid before Parliament 3rd September 2026 Coming into force in accordance with regulation 1(2) and (3) The Secretary of State makes these Regulations in exercise of the powers conferred by sections 126(2), 129(1), (2)(c), (2A), (2C), (6)(f), (g), (h) and (l), 132, 160, 162, 272(7) and (8) of, and paragraphs 3(1) and 3(3)(d) of Schedule 12 to, the National Health Service Act 2006(1).

Citation, commencement, extent and application

1.—(1) These Regulations may be cited as The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2026.

(2) Subject to paragraph (3), these Regulations come into force on 1st October 2026.

(3) Regulations 10(4) and 11(3) come into force on 1st January 2027.

(4) These Regulations extend to England and Wales and apply in relation to England only(2).

(1) 2006. c. 41. Section 126 has been amended by: the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”), sections 213(7)(k) and 220(7), and Schedule 4, paragraph 63; the Children and Social Work Act 2017 (c. 16), Schedule 5, paragraph 30 and 47(j);

and the Health and Care Act 2022 (c. 31) (“the 2022 Act”), Schedule 1, paragraph 1. Section 129 has been amended by: the Health Act 2009 (c. 21), sections 26, 27 and 38, and Schedule 6; the 2012 Act, section 207(1) to (9), and Schedule 4, paragraph 66; the Protection of Freedoms Act 2012 (c. 9), Schedule 9, paragraphs 120 and 121; the 2022 Act, Schedule 1, paragraph 1; and S.I. 2010/231. Section 132 has been amended by: the Protection of Freedoms Act 2012, Schedule 9, paragraph 122;

the 2012 Act, Schedule 4, paragraph 69(4); the 2022 Act, Schedule 1, paragraph 1; and S.I. 2007/289, 2010/22 and 231 and 2025/989. Section 160 has been amended by the 2022 Act, Schedule 1, paragraph 1. Section 162 has been amended by the 2022 Act, Schedule 1, paragraph 1. See section 275(1) of the National Health Service Act 2006 for the meanings given to “prescribed” and “regulations”, which are relevant to the powers being exercised.

(2) See section 271(1) of the National Health Service Act 2006, by virtue of which the functions of the Secretary of State being exercised in the making of these Regulations are exercisable only in relation to England.Document Generated: 2026-09-03

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

Amendment of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 2 The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013(3) are amended in accordance with regulations 3 to 11.

Amendment to regulation 31

3.—(1) Regulation 31 (refusal: same or adjacent premises)(4) is amended as follows.

(2) In paragraph (1), after “consolidated application” insert “or a change of ownership application pursuant to regulation 26(1)”.

Amendments to regulation 52

4.—(1) Regulation 52 (notification of applications for outline consent and premises approval)(5) is amended as follows.

(2) In paragraph (1), at the beginning, for “Where” substitute “Subject to paragraph (12), where”.

(3) After paragraph (11) insert— “(12) Where NHS England is required to refuse an application pursuant to regulation 51(5) or (6), NHS England need not give notice of that application to any person under this regulation before refusing that application.”.

Amendment to regulation 53

5.—(1) Regulation 53 (decisions on outline consent and premises approval applications and the taking effect of grants)(6) is amended as follows.

(2) In paragraph (1) in sub-paragraph (b) after “the application” insert “, or any person who would have been so notified but for regulation 52(12)”.

New regulation 66A 6 After regulation 66 (conditions relating to providing directed services), insert— “Conditions relating to independent prescribing 66A.—.—(1) It is a condition of the inclusion of each NHS pharmacist in a pharmaceutical list that the NHS pharmacist must not provide a drug or appliance that is ordered on a prescription form by a prescriber who is or who is employed or engaged by the NHS pharmacist, except as provided for by this regulation.

(2) An NHS pharmacist may provide a drug or appliance that is ordered on a prescription form by a prescriber who is or who is employed or engaged by the NHS pharmacist where—

(a) the drug or appliance is provided as part of a directed service;

(b) the terms on which the arrangements are made for the provision of the directed service allow for the provision, by the NHS pharmacist, of a drug or appliance ordered on a prescription form by a prescriber who is or who is employed or engaged by the NHS pharmacist; and

(3) S.I. 2013/349, as amended.

(4) Regulation 31 was amended by S.I. 2014/417, 2016/1077, 2023/1071 and 2025/989.

(5) Regulation 52 was amended by S.I. 2023/1071.

(6) Regulation 53 was amended by S.I. 2023/1071 and 2025/989.

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Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

(c) any conditions that are part of those arrangements and that relate to the ordering on a prescription form of a drug or appliance by a prescriber who is or who is employed or engaged by the NHS pharmacist, or to the provision of a drug or appliance in accordance with a prescription of such a prescriber, are met.

(3) An NHS pharmacist may, as part of an essential service, provide a drug or appliance that is ordered on a prescription form by a prescriber (P) who is or who is employed or engaged by the NHS pharmacist only if—

(a) the NHS pharmacist is also the provider of a directed service as part of which P is entitled to order drugs or appliances on a prescription form;

(b) the NHS pharmacist has in place standard operating procedures that relate to prescribing and dispensing drugs or appliances on the same pharmacy premises and to carrying out best interests assessments prior to prescribing at those premises;

(c) the order by P replaces an order by a prescriber who is or who is employed or engaged by a provider of primary medical services and it replaces that order with the agreement of the provider of primary medical services (the agreement may relate to the replacement of a specific order or to replacement of a pre-arranged category of orders, where the specific order is within that category);

(d) the order by P is on an electronic prescription form and is for a prescription only medicine, the ordering of which is not restricted under the Prescription of Drugs Regulations(7); and

(e) before placing the order, P carries out a best interests assessment, and the placing of the order is in accordance with that best interests assessment.

(4) For the purposes of paragraph (3), a best interests assessment is an assessment that an order for a drug or appliance is—

(a) clinically appropriate and in the best interests of the patient for whom the drug or appliance is ordered;

(b) consistent with best practice within the health service with regard to obtaining value for money for the health service; and

(c) in all other respects professionally appropriate.

(5) No pharmaceutical remuneration is payable in respect of the provision of a drug or appliance that is ordered on a prescription form by a prescriber who is or who is employed or engaged by the NHS pharmacist who claims the pharmaceutical remuneration, where such provision is, in the opinion of NHS England, otherwise than as provided for by this regulation.”.

Amendment to regulation 68

7.—(1) Regulation 68 (conditions relating to local resolution of disputes over terms of service)(8) is amended as follows.

(2) After paragraph (2) insert— “(3) For the purposes of paragraph (1), co-operation includes—

(a) answering any questions which are reasonably put to C by NHS England within the timescales NHS England reasonably notifies; and

(7) “The Prescription of Drugs Regulations” is defined in regulation 2 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, and means the National Health Service (General Medical Services) (Prescription of Drugs etc.) Regulations 2004 (S.I. 2004/629).

(8) Regulation 68 was amended by S.I. 2023/1071.

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(b) providing any information relating to the dispute which is reasonably required by NHS England within the timescales NHS England reasonably notifies.”.

Amendments to regulation 69

8.—(1) Regulation 69 (local dispute resolution before serving remedial notices or breach notices)(9) is amended as follows.

(2) In paragraph (3)—

(a) omit “or” at the end of sub-paragraph (a); and

(b) after sub-paragraph (a), insert— “(aa) C is in breach of C’s obligation under regulation 68(1) in relation to the dispute; or”.

Amendments to Schedule 2

9.—(1) Schedule 2 (applications in respect of pharmaceutical lists and the procedures to be followed) is amended as follows.

(2) In paragraph 1 (information to be included in all routine and excepted applications)(10), in sub-paragraph (8) omit paragraphs (b) to (d).

(3) In paragraph 2 (information to be included in all routine and excepted applications for inclusion in a pharmaceutical list), in sub-paragraph (2) omit paragraph (b).

Amendments to Schedule 4

10.—(1) Schedule 4 (NHS England’s terms of service of NHS pharmacists) is amended as follows.

(2) In paragraph 11 (additional requirements in relation to electronic prescribing)(11), after sub- paragraph (6) insert— “(7) P must not enter a dispensing contractor into, or change a dispensing contractor in, a person’s PDS patient details(12) without that person’s, or that person’s duly authorised representative’s, explicit consent.”.

(3) After paragraph 23A (local hours plans)(13) insert— “Closure for learning and development 23B.—.—(1) For the purposes of this Part, for up to four hours in each calendar month, pharmacy premises are treated as open at times when they are closed for learning and development, provided the following conditions are met in respect of the closure—

(a) the NHS pharmacist (P) listed in respect of the pharmacy premises has notified NHS England of the closure for learning and development, as a proposed closure, at least 30 days in advance of the closure;

(b) NHS England has not objected to the closure (as to the valid grounds for objection, see sub-paragraph (2));

(9) Regulation 69 was amended by S.I. 2018/1114 and 2023/1071.

(10) Schedule 2, paragraph 1 was amended by S.I. 2023/1071.

(11) Schedule 4, paragraph 11 was amended by S.I. 2018/1114, 2020/1126 and 2025/989.

(12) “PDS patient details” is defined in regulation 2 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, and means the information held about a patient in the Patient Demographics Service managed by NHS England.

(13) Schedule 4, paragraph 23A was inserted by S.I. 2023/479 and amended by S.I. 2025/989.

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(c) no part of the period of closure is—

(i)within three hours of the start of the pharmacy premises opening hours on the first week-day of opening,

(ii)within three hours of the end of the pharmacy premises opening hours on the last week-day of opening,

(iii)on a Saturday,

(iv)on a Sunday, or

(v)in the case of pharmacy premises in respect of which a 100 hours condition(14) applies or has ever applied, from 5pm to 9pm on any week-day of opening;

(d) in advance of the closure, P has notified the providers of primary medical services that are accustomed to sending patients to the pharmacy premises for the dispensing of emergency prescriptions, or for treatment as part of a directed service, of the closure;

(e) in advance of the closure, P amended the pharmacy profile in respect of the pharmacy premises in the NHS England directory of services and on the NHS.uk website so that it shows the day and times of the closure;

(f) unless the premises of P are distance selling premises, P has exhibited a notice, where practicable legible from outside the premises, which specifies the days on which and times at which the premises are closed for learning and development; and

(g) if P’s premises are distance selling premises, any website that P has for use by the public for the purposes of accessing pharmaceutical services from the premises, on which the opening hours of the premises are displayed, has as part of that display a notice containing the same information as provided for in paragraph (f).

(2) NHS England may object to a closure for learning and development if the closure, taken with other closures for learning and development and any gaps in availability of pharmaceutical services in the area in which the pharmacy premises are located, would lead to avoidable disruption to the provision of pharmaceutical services in that area.”.

(4) In paragraph 28 (clinical governance and the promotion of healthy living)(15), in sub- paragraph (2)(e), after sub-paragraph (i) insert— “(ia)arrangements for ensuring that all professional staff and locums who are involved in the provision of pharmaceutical services have either a valid certificate for an enhanced Disclosure and Barring Service (DBS) check (certificates are to be treated as valid for three years from the date of issue by the DBS) or evidence to demonstrate that an enhanced DBS status check has been undertaken using the DBS Update Service,”.

Amendments to Schedule 7

11.—(1) Schedule 7 (mandatory terms for LPS schemes) is amended as follows.

(2) In paragraph 9 (additional requirements in relation to electronic prescribing)(16), after sub- paragraph (5) insert—

(14) “100 hours condition” is defined in regulation 2 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 and is to be construed in accordance with regulation 65(1).

(15) Schedule 4, paragraph 28 was amended by S.I. 2015/58, 2016/1077, 2020/1126, 2021/1346, 2022/930, 2023/1071 and 2025/989.

(16) Schedule 7, paragraph 9 was amended by S.I. 2018/1114 and 2020/1126.

5Document Generated: 2026-09-03

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format. “(6) C must not enter a dispensing contractor into, or change a dispensing contractor in, a person’s PDS patient details(17) without that person’s, or a duly authorised person representing that person’s, explicit consent.”.

(3) In paragraph 12 (clinical governance)(18) after sub-paragraph (2) insert— “(3) The LPS contractor must have arrangements for ensuring that all professional staff and locums who are involved in the provision of local pharmaceutical services have either a valid certificate for an enhanced Disclosure and Barring Service (DBS) check (certificates are to be treated as valid for three years from the date of issue by the DBS) or evidence to demonstrate that an enhanced DBS status check has been undertaken using the DBS Update Service.”.

Signed by authority of the Secretary of State for Health and Social Care Diana Johnson Minister of State 2nd September 2026 Department of Health and Social Care

(17) “PDS patient details” is defined in regulation 2 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, and means the information held about a patient in the Patient’s Demographics Service managed by NHS England.

(18) Schedule 7, paragraph 12 was amended by S.I. 2023/1071.

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EXPLANATORY NOTE (This note is not part of the Regulations) These Regulations make amendments to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (the PLPS Regulations). The PLPS Regulations govern arrangements, in England, for the provision of pharmaceutical services and local pharmaceutical services under Part 7 of the National Health Service Act 2006.

Regulation 3 amends regulation 31 of the PLPS Regulations to exclude change of ownership applications that do not involve relocation from the requirement to refuse a pharmaceutical list application if the proposed premises are part of the same site as the premises of an existing provider of pharmaceutical services.

Regulation 4 amends regulation 52 of the PLPS Regulations to provide that NHS England does not need to give notice of the application having been made in certain instances where the regulations require the application to be refused. The applications in question relate to the provision of services by dispensing doctors.

Regulation 5 amends regulation 53 of the PLPS Regulations to provide for notification of NHS England’s decision to the people who would have been notified of the application but for the amendment made to regulation 52 of the PLPS Regulations by regulation 4.

Regulation 6 inserts new regulation 66A which limits the occasions on which an authorised prescriber who works at pharmacy premises may act as an independent prescriber for the owner of the pharmacy.

Regulations 7 and 8 amend regulations 68 and 69 to clarify the co-operation by providers on pharmaceutical lists which is required before the commissioner is obliged to undertake or continue dispute resolution before making a decision.

Regulation 9 amends Schedule 2 of the PLPS by removing the requirement to provide additional information where an application relates to directed services; and removing the requirement for an applicant’s sex to be included in all routine or excepted applications for inclusion in a pharmaceutical list.

Regulation 10 amends Schedule 4 of the PLPS Regulations to provide a framework for treating the closure of pharmacy premises for up to four hours each calendar month as open at times when they are closed for learning and development purposes; by adding the requirement for professional staff to hold a valid certificate for an enhanced DBS check to an NHS pharmacist’s terms of service; and preventing a pharmacy changing a patient’s preferred dispensing contractor without the patient’s or their representative’s explicit consent.

Regulation 11 similarly amends Schedule 7 of the PLPS Regulations to prevent a LPS pharmacy changing a patient’s preferred dispensing contractor without the patient’s or their representative’s consent and adding the requirement for a valid certificate for an enhanced DBS check as a term of their NHS service.

A full impact assessment has not been prepared for this instrument as no, or no significant, impact on the public sector is foreseen, and only a limited impact on the private sector, below the threshold for producing a full impact assessment.

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