The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025

Citation, commencement, extent, application and interpretation 1.

(1)

These Regulations may be cited as The National Health Service (Charges, Remission of Charges and Pharmaceutical Services etc.) (Amendment and Transitional Provisions) Regulations 2025.

(2)

These Regulations come into force on 23rd June 2025, subject to paragraph (3).

(3)

Regulation 9 comes into force on 1st October 2025.

(4)

These Regulations extend to England and Wales and apply in relation to England only.

(5)

In these Regulations—

“the Charges Regulations” means the National Health Service (Charges for Drugs and Appliances) Regulations 2015;

“the PLPS Regulations” means the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013;

“the TERCS Regulations” means the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003.

Amendment of the TERCS Regulations 2.

The TERCS Regulations are amended in accordance with regulations 3 to 5.

Amendments to regulation 2 of the TERCS Regulations 3.

(1)

Regulation 2 (interpretation) is amended as follows.

(2)

Omit the definitions of “child tax credit”, disability element”, “severe disability element” and “working tax credit”.

(3)

In the definition of “family”, omit paragraph (b) and add “and” at the end of paragraph (aa).

Amendment to regulation 5 of the TERCS Regulations 4.

In regulation 5 (entitlement to full remission and payment), in paragraph (1), omit sub-paragraph (e).

Amendments to regulation 8 of the TERCS Regulations 5.

(1)

Regulation 8 (notices of entitlement) is amended as follows.

(2)

Omit paragraphs (2) and (6).

(3)

In paragraph (4), omit “or paragraph (2)”.

Amendment of the PLPS Regulations 6.

The PLPS Regulations are amended in accordance with regulations 7 to 11.

Amendments to regulation 25 of the PLPS Regulations 7.

(1)

Regulation 25 (distance selling premises applications) is amended as follows.

(2)

In paragraph (1)—

(a) after “to an application” insert “to relocate to different premises”; and

(b) omit sub-paragraph (a).

(3)

In paragraph (2)(b)(ii)—

(a) for “essential services” substitute “pharmaceutical services”; and

(b) after “contact” insert “at the pharmacy premises”.

New regulation 25A of the PLPS Regulations 8.

After regulation 25 (distance selling premises applications) insert—

Transitional provision: distance selling premises applications for new inclusions made before 23rd June 2025 25A.

In the case of an application made before 23rd June 2025 to which regulation 25(1)(a) applied (applications for inclusion in a pharmaceutical list by a person not already included), notwithstanding the repeal of regulation 25(1)(a), that application is to be determined in accordance with regulation 25(1) as it had effect on 22nd June 2025.

Amendments to regulation 64 of the PLPS Regulations 9.

(1)

Regulation 64 (distance selling premises: specific conditions) is amended as follows.

(2)

In paragraph (3)(a) and (b), omit “, other than directed services,” in both places it occurs.

(3)

In paragraph (3)(d)(ii)—

(a) for “essential services” substitute “pharmaceutical services”; and

(b) after “contact” insert “at the pharmacy premises”.

(4)

After paragraph (3) insert —

(3A) Notwithstanding the amendments to paragraph (3) which come into force on 1st October 2025, until the end of 31st March 2026 paragraph (3) remains in force as it had effect before those amendments were made, but only in so far as is necessary to give effect to paragraph (3B).

(3B) At distance selling premises listed in relation to X before 1st October 2025, X may until the end of 31st March 2026 provide directed services that consist of the supply or administration of a prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus (but no other directed services).

Amendments to regulation 91A of the PLPS Regulations 10.

(1)

Regulation 91A (zero or nominal product reimbursement for vaccines and antivirals) is amended as follows.

(2)

In paragraph (2)—

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

(b) after sub-paragraph (ac) insert—

(ad) a drug or medicine which is used for vaccinating or immunising children against influenza, if the conditions set out in paragraph (3) are satisfied; or.

(3)

In paragraph (3)(c), for “an enhanced” substitute “a directed”.

(4)

In paragraph (3A), for “to (ac)” substitute “to (ad)”.

(5)

After paragraph (7) insert the following paragraph—

(8) For the purposes of paragraph (2)(ad), a drug or medicine is to be treated as a drug or medicine which is used for vaccinating or immunising children if (despite not being solely used for that purpose) it is mainly used for that purpose but it is also used for vaccinating or immunising people who have attained the age of 16 years.

Amendments to Schedule 4 of the PLPS Regulations 11.

(1)

Schedule 4 (terms of service of NHS pharmacists) is amended as follows.

(2)

In paragraph 24 (matters to be considered when issuing directions in respect of pharmacy premises core opening hours), in sub-paragraph (1), after “paragraph 26(2A)” insert “and except where paragraph 26(2ZB) applies”.

(3)

In paragraph 26 (determination of pharmacy premises core opening hours instigated by the NHS pharmacist)—

(a) after sub-paragraph (1), insert—

(1A) On or after 23rd June 2025, if P makes an application under paragraph (1)(b), P must state in the application whether P wishes the application to be determined on the basis of paragraph 24(1) or sub-paragraph (2ZB).

(b) in sub-paragraph (2), for “sub-paragraph (1)” substitute “sub-paragraph (1)(a)”;

(c) after sub-paragraph (2), insert—

(2ZA) Where P makes an application under sub-paragraph (1)(b), as part of that application P must provide NHS England with such information as NHS England may reasonably request in respect of the matters that NHS England must seek to ensure pursuant to sub-paragraph (2ZB) or paragraph or paragraph 24(1) (depending on the basis of the application).

(2ZB) In the case of an application under sub-paragraph (1)(b) which is based on the matters that NHS England must seek to ensure pursuant to this sub-paragraph, where NHS England—

(a) issues a direction under sub-paragraph (4) for setting any days or times for opening hours; or

(b) determines the application under sub-paragraph (4) without issuing a direction,

it must in doing so seek to ensure that the people who are accustomed to accessing pharmaceutical services at the pharmacy premises are likely to benefit from the changes because, overall, they would be more likely to access those services at those premises during the proposed core opening hours than during the existing core opening hours.

(d) in sub-paragraph (3), after “sub-paragraph (2)” insert “or (2ZA)”.

Amendments to regulation 17 of the Charges Regulations 12.

(1)

Regulation 17 of the Charges Regulations (pre-payment certificates: repayment) is amended as follows.

(2)

After paragraph (3), insert—

(3A) Where the issuing amount in respect of a pre-payment certificate has been paid and, not more than one month after the date when the pre-payment certificate became valid, the relevant person becomes entitled to exemption by virtue of regulation 10(1)(d) or 10(1)(e), the Secretary of State must—

(a) cancel the pre-payment certificate; and

(b) refund to the relevant person the entirety of the issuing amount (without an application for a refund needing to be made).

(3B) Where the issuing amount in respect of a pre-payment certificate has been paid, and during the period beginning one month after the date when the pre-payment certificate became valid and ending with the date of its expiry, the relevant person becomes entitled to exemption by virtue of regulation 10(1)(d) or 10(1)(e), the Secretary of State must—

(a) cancel the pre-payment certificate; and

(b) refund to the relevant person an amount that is to be calculated in accordance with paragraph (4) in respect of each complete month following the date on which the relevant person became entitled to an exemption (without an application for a refund needing to be made).

(3)

In paragraph (4)—

(a) for “paragraph (2) and (3)” substitute “paragraph (2), (3) and (3B)”;

(b) for “paragraph (2) or (3)” substitute “paragraph (2), (3) or (3B)”.

Signed by authority of the Secretary of State for Health and Social Care

Stephen Kinnock Minister of State Department of Health and Social Care at 12.12 p.m. on 2nd June 2025

Explanatory Note (This note is not part of the Regulations)

These Regulations make amendments to the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003 (the TERCS Regulations), the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (the PLPS Regulations) and the National Health Service (Charges for Drugs and Appliances) Regulations 2015 (the Charges Regulations).

As a consequence of tax credits ending on 5th April 2025, regulations 3, 4 and 5 make amendments to the TERCS Regulations to remove the NHS charge and NHS travel expenses exemption for those in receipt of tax credits where the individual (including their partner and dependent children) is in receipt of child tax credit, working tax credit and child tax credit paid together or working tax credit including a disability or severe disability element.

Currently Distance Selling Premises (DSPs) can enter into the NHS pharmaceutical services market on the basis of an exemption from the normal market entry test. They are not allowed to deliver essential services (including dispensing) on the pharmacy premises but they can deliver some clinical services face-to-face both there and elsewhere.

Regulations 7 and 8 amend the PLPS Regulations to require DSPs to deliver all NHS pharmaceutical services remotely and not face to face on the pharmacy premises and remove the exemption from the normal market entry test for new DSPs. DSP contractors already on the pharmaceutical list will continue to be able to apply to relocate or change ownership of their premises and in the situation where a DSP application for new inclusion on the pharmaceutical list is made before 23rd June 2025 such applications will be determined in accordance with the market entry test that was in effect before 23rd June 2025.

Regulation 9 amends regulation 64 of the PLPS Regulations to provide that DSP contractors will not be able to deliver directed services on pharmacy premises from 1st October 2025, but they will be able to continue delivering influenza and COVID-19 vaccinations on the premises until 31st March 2026.

Regulation 10 amends regulation 91A of the PLPS Regulations to enable pharmacies to access centrally procured influenza vaccine stock for children. Regulation 11 amends Schedule 4 of the PLPS Regulations to add a new basis, related to the level of use of a pharmacy, on which pharmacies will be able to apply for changes to their core opening hours, where the total number of hours for which they are open will stay the same.

Regulation 12 amends regulation 17 of the Charges Regulations to enable the automatic cancellation and refund of a pre-payment certificate to persons who become entitled to a maternity or medical exemption certificate.

A full impact assessment has not been produced 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.