Update: Group Directions – PSD (Patient Specific Direction), PGD (Patient Group Direction) and VGD (Vaccine Group Direction)
I am writing to highlight a change in the legal framework for delivering UK licensed vaccines within a nationally commissioned vaccination programme. Vaccine Group Directions (VGD) were introduced (under Regulation 235A of the Human Medicines Regulations (HMR)) from 01April 2026, replacing the National Protocols (under Regulation 247A of the HMA), which were used during the pandemic.
Vaccines may still be delivered under Patient Specific Direction (PSD) and Patient Group Direction (PGD).
As a reminder:
- Patient Specific Direction (PSD) relates to a specific patient and authorises administration of a specific medicine (including a vaccine). Many current GP practice vaccination services continue to use this arrangement.
- Patient Group Direction (PGD) allows a suitable registered healthcare professional to assess and deliver medicines (including vaccines) to groups of patients who all share the same specified characteristics, in terms of eligibility and appropriateness of the treatment.
VGDs incorporate many of the features of PSDs and PGDs, but they allow certain activities during the vaccine process to be delegated, including vaccine administration, documentation and record keeping, all under appropriate supervision. GP practices are not required to adopt VGDs in preference to PSDs or PGDs, but in certain settings the flexibility in terms of staffing arrangements may make a VGD a more suitable operational model. VGDs within England are developed by the UKHSA and cannot be amended locally.
Under a VGD, the clinical assessment consent must be obtained by a registered healthcare profession (RHCP); however, vaccine administration, documentation and record keeping can be delegated to a suitability trained and competent person, including non-registered healthcare workers, with the RHCP supervising and retaining overall responsibility. The responsible RHCP must remain on-site.
The preparation of vaccines (reconstitution and dilution, if required) should be carried out together and by the same person who is administering the vaccine.
The same registered healthcare professionals who work under a PGD can work under a VGD to:
- Assess the patient;
- Obtain consent; and
- Supervise non-registered staff undertaking delegated tasks.
Colleagues will recall the concerns raised several months ago about the role of non-registered healthcare workers (often described as Healthcare Support Workers (HCSW)) in the vaccination delivery arrangements, following updated guidance from the UKHSA. In particular, UKHSA advised that HSCWs should not undertake a clinical assessment for vaccination or take informed consent. VGDs specify the same advice. The UKHSA advised HSCWs should not work under a PGD, but could undertake, when suitably trained and supervised, tasks including vaccine administration under a PSD.
VGDs may been seen as a hybrid route, in terms of staff working responsibilities, applicable to UK-licensed vaccines only, delivered under a nationally commissioned immunisation programme.
VGDs place more emphasis on supervision, as they authorise delegation. Colleagues are reminded that under their Primary Medical Services Contracts (GMS, PMS and APMS), any staff to whom work is delegated should be appropriately trained, competent and supported and/or supervised where this is relevant. It is also important this is documented and CQC are likely to request evidence of appropriate training. UKHSA advise HCSWs involved in vaccination delivery should have Level Three of the Qualifications and Credit Framework or equivalent and working at Level Three or above of the NHS Career Framework.
I hope this background is helpful and the SSLMC website will be updated to include this and any further information.
Dr Julius Parker, Chief Executive