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).

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

(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

(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));

(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—

“(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.”.