The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025

• (b) in sub-paragraph (2), after “is obliged to provide pharmaceutical services at” insert “or from”.

Amendments to Schedule 6

58

• (1) Schedule 6 (terms of service of dispensing doctors) is amended as follows.

• (2) In paragraph 7 (dispensing doctors issuing prescription forms which may be presented to an NHS chemist), after “available on prescription” insert “at or”.

• (3) In paragraph 10 (voluntary closure of premises)⁸², in sub-paragraph (2)—

• (a) after “provision of pharmaceutical services at” insert “or from”; and

• (b) after “cease to provide pharmaceutical services at” insert “or from”.

Amendments to Schedule 7

59

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

• (2) In paragraph 1, (general provisions)⁸³, in sub-paragraph (1)(b)(ii), for “activities on” substitute “activities at or from”.

• (3) In paragraph 26 (variation of LPS schemes)⁸⁴—

• (a) in sub-paragraph (3)(a), after “provide local pharmaceutical services at” insert “or from”; and

• (b) in sub-paragraph (4), after “provide local pharmaceutical services at” insert “or from”.

PART 5 — Other miscellaneous amendments

Amendments to regulation 2

60

In regulation 2 (interpretation)⁸⁵, in paragraph (1)—

• (a) omit the definition of “NHSmail”; and

• (b) at the appropriate place insert—

• “NHS.net Connect” means the secure e-mail service of that name for the sharing of patient identifiable and patient sensitive information, for which NHS England is responsible;

Amendment to regulation 6

61

In regulation 6 (subsequent assessments and later first assessments)⁸⁶, after paragraph (3) insert—

(3ZA) Except in the circumstances provided for in paragraph (4), a supplementary statement must not provide (and if it does, it must not be read as providing) a new analysis of service provision (for example, by identifying gaps in service provision). (3ZB) Paragraph (3ZA) does not apply in the case of a routine application submitted before 1st October 2025 based on a need, an improvement or better access identified in a supplementary statement as part of the provision of a new analysis of service provision (but does apply to consideration after that date of an unforeseen benefits application submitted before that date).

Amendment to regulation 64

62

In Regulation 64 (distance selling premises: specific conditions)⁸⁷, in paragraph (3)(e), omit “in X’s practice leaflet,”.

Amendments to regulation 91A

63

• (1) Regulation 91A (zero or nominal product reimbursement for vaccines and antivirals)⁸⁸ is amended as follows.

• (2) In paragraph (2)—

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

• (b) after sub-paragraph (ad) insert—

(ae) a drug or medicine which is used for vaccinating or immunising people against human papillomavirus, if the conditions set out in paragraph (3) are satisfied; or

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

Amendments to Part 4 of Schedule 4

64

• (1) Schedule 4 (terms of service of NHS pharmacists), Part 4 (other terms of service) is amended as follows.

• (2) In paragraph 28 (clinical governance and the promotion of healthy living)⁸⁹, in sub-paragraph (2)—

• (a) omit paragraph (a)(i); and

• (b) in paragraph (e)(iii), omit “and references”.

• (3) In paragraph 29C (contact via NHSmail, pharmacy profiles and the Central Alerting System)⁹⁰—

• (a) in the title, for “NHS mail” substitute “NHS.net Connect”;

• (b) in sub-paragraph (1)—

• (i) for “NHSmail” at the first place it occurs, substitute “messages via NHS.net Connect”, and

• (ii) for “NHSmail”, at the second place it occurs, substitute “NHS.net Connect”;

• (c) in sub-paragraph (2), at both places that it occurs, for “NHSmail” substitute “NHS.net Connect”; and

• (d) in sub-paragraph (5)—

• (i) in paragraph (a), for “NHSmail” substitute “NHS.net Connect”,

• (ii) in paragraph (b), at both places that it occurs, for “NHSmail” substitute “NHS.net Connect”, and

• (iii) in paragraph (c), for “NHSmail” substitute “NHS.net Connect”.

Amendments to Schedule 5

65

In Schedule 5 (terms of service of NHS appliance contractors), in paragraph 18 (clinical governance)⁹¹, in sub-paragraph (2)—

• (a) omit paragraph (a)(i); and

• (b) in paragraph (e)(iii), omit “and references”.

Amendments to Schedule 7

66

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

• (2) In paragraph 13C (contact via NHSmail and the Central Alerting System)⁹²—

• (a) in the title, for “NHSmail” substitute “NHS.net Connect”;

• (b) in sub-paragraph (1)—

• (i) for “NHSmail” at the first place it occurs, substitute “messages via NHS.net Connect”, and

• (ii) for “NHSmail”, at the second place it occurs, substitute “NHS.net Connect”;

• (c) in sub-paragraph (2), at both places that it occurs, for “NHSmail” substitute “NHS.net Connect”; and

• (d) in sub-paragraph (3)—

• (i) in paragraph (a), for “NHSmail” substitute “NHS.net Connect”,

• (ii) in paragraph (b), at both places that it occurs, for “NHSmail” substitute “NHS.net Connect”, and

• (iii) in paragraph (c), for “NHSmail” substitute “NHS.net Connect”.

Signed

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

Stephen Kinnock — Minister of State — Department of Health and Social Care — 1st September 2025

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (S.I. 2013/349, as amended – “the PLPS Regulations”). The PLPS Regulations govern the arrangements in England, under Part 7 of the National Health Service Act 2006 (“the 2006 Act”), for the provision of pharmaceutical and local pharmaceutical services.

These Regulations place a restriction on community pharmacies and the GP practices that dispense medicines in some rural areas (known as “dispensing doctors”) from sub-contracting any of their core dispensing functions under the PLPS Regulations, subject to exceptions. These include an exception for so-called “hub and spoke” dispensing arrangements, which are provided for in most cases by regulation 222A of the Human Medicines Regulations 2012 (S.I. 2012/1916, as amended by S.I. 2025/758) (“the 2012 Regulations”). Under “hub and spoke” arrangements, a “spoke” (either a community pharmacy or a dispensing doctor) submits the information contained in a prescription to a “hub” pharmacy, which sends the prescribed item back to the “spoke” for final supply to or for the patient. Part 3 of these Regulations sets out the NHS terms of service being inserted into the PLPS Regulations for such supply.

In the case of community pharmacies, these terms of service include the community pharmacy needing to give notice to NHS England of their intention to enter into hub and spoke arrangements and what features those arrangements must have. NHS England are also granted a power to ask for information at any time in relation to specific objection criteria. In appropriate circumstances, NHS England can issue a notice of objection to the hub and spoke arrangements and the community pharmacy must then end the arrangements, subject to dispute resolution arrangements. An information gateway is also created for products on prescription, and some pandemic supplies, that are not covered by the arrangements in regulation 222B of the 2012 Regulations, most notably prescription foods, cosmetics and medical devices such as dressings. A shortened version of the arrangements for community pharmacies – to accommodate the existing arrangements for sub-contracting under GP contracts – is applied to dispensing doctors.

Partly as a result of amendments introduced to the 2012 Regulations by S.I. 2025/758, consequential amendments are made to the PLPS Regulations so that references to “on”, “at” or “from” premises are now to be read as “at or from” premises. This brings the PLPS Regulations into line with the Medicines Act 1968 and the 2012 Regulations on this issue. This clarifies that transactions starting at pharmacy premises may be completed elsewhere (Part 4).

A number of miscellaneous other amendments are also made. References to the NHS Business Services Authority that were related to fraudulent activity have been replaced by references to the NHS Counter Fraud Agency to reflect an operational reorganisation (Part 2). Vaccines for human papillovirus are added to the list of vaccines suppliable to community pharmacies as part of what are, in practice, NHS central purchasing arrangements, so are supplied at no cost to the pharmacy (regulation 63). The requirements for community pharmacies to produce practice leaflets are removed (regulations 62, 64(2)(a) and 65(a)), as are the requirements that references are necessary for all staff involved in the provision of NHS services (regulations 64(2)(b) and 65(b)). What can be included in supplementary statements for local plans for the provision of pharmaceutical services known as pharmaceutical needs assessments is clarified (regulation 60). References to “NHSmail” are replaced with “NHSnet. Connect” to reflect current practice (60, 64(3) to (5) and 66).

An assessment of the effect of this instrument was undertaken and it was deemed that a full impact assessment would not be proportionate. These Regulations are not expected to have a significant impact on the public and voluntary sectors, and only a limited impact on the private sector, below the threshold for undertaking a full impact assessment.

Footnotes