Additional 1st October Regulatory Changes

Requirement for practice leaflets

removed

The requirement to produce a practice leaflet has been removed for all pharmacies, including DSPs.

This change was agreed as part of the negotiated settlement with DHSC and NHSE earlier this year.

Pharmacy owners must still comply with the requirement to publicise the essential and any advanced services that are available at or from the pharmacy premises (but not emergency supply), and do so in a manner which makes clear the services are provided as part of the NHS (following the guidelines on use of the NHS logo).

The requirement to obtain references for all staff involved in the provision of NHS services (as part of a staff management programme) has been removed.

This change was agreed as part of the negotiated settlement with DHSC and NHSE earlier this year.

It remains open for pharmacy owners to seek references for new staff, if they want to do so.

Pharmacy owners must still check the qualifications of all staff involved in the provision of NHS services, have arrangements for appropriate induction of staff (including locums), and appropriate training for all staff for any role they carry out.

References to NHSmail are replaced with NHS.net Connect.

This follows the introduction of a new/revised platform for NHS communications.

The information that can be included in supplementary statements, which Health and Wellbeing Boards (HWBs) can publish to update their pharmaceutical needs assessments (PNAs), has been clarified.

Specifically, supplementary statements must not provide (and if they do provide, this must not be read as providing) a new analysis (assessment) of service provision. This needs to await a new PNA.

This means that supplementary statements must not identify gaps in the provision of services, and if they do, must be read on the basis that no gap has been identified (by, for example, an ICB deciding an application for a new NHS pharmacy). Supplementary statements should state facts on the availability of pharmaceutical services, and only if those changes are relevant to the granting of a new application.

One way of looking at a supplementary statement issued appropriately is that it flags up the possibility that a new pharmacy may be needed. But, there has been no assessment of patient needs in the area, so, for this and other reasons, an application for a new pharmacy may not be needed or appropriate and may not be granted.

There are two exceptions to this change:

First, this does not apply to 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).

Second, HWBs remain able to publish a supplementary statement, in appropriate cases, to state that a consolidation of two pharmacies does not create a gap in the provision of pharmaceutical services.

The term ‘at or from’ pharmacy premises replaces the terms ‘at’, ‘from’, or ‘on’ pharmacy premises.

This clarifies that activities starting at pharmacy premises may be completed elsewhere, for example, with the home delivery of dispensed medicines to patients.

The term ‘at or from’ is being aligned across the NHS Pharmaceutical Regulations, the Human Medicines Regulations 2012, and the Medicines Act 1968.

The supply of human papillomavirus (HPV) vaccine to community pharmacies from national stocks is permitted without purchase by the pharmacy (with zero or nominal reimbursement).

This vaccine is added to other vaccines that may be supplied to community pharmacies in this way.