Supply and administration of vaccines in Wales

Legal mechanisms for the supply and administration of vaccines in Wales

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Background

The Human Medicines Regulations 2012 (HMRs) underpin how vaccines are prepared, supplied and administered in the UK. During the COVID‑19 pandemic. National Protocols (regulations 247a) were introduced as temporary legal mechanisms to support rapid and safe vaccine deployment, allowing different trained staff to undertake different stages of vaccination.

Building on this experience, further amendments have come into force from 1st April 2026 aiming to make key flexibilities permanent and extend them to all national vaccination programmes. A new legal mechanism called a Vaccine Group Direction (VGD) was introduced into UK medicines legislation in April 2026 to support the administration of nationally commissioned vaccination programmes. Understanding Vaccine Group Directions (VGDs) – NHS SPS – Specialist Pharmacy Service

Because National Protocols automatically ended when the temporary COVID‑19 legislative amendments expired, VGDs were created to ensure that primary care and other vaccination providers retained a lawful, flexible, and scalable mechanism for delivering vaccination programmes without relying solely to Patient Group Directions (PGDs) or Patient Specific Directions (PSDs). Coronavirus Bill: What is the sunset clause provision?

Delivery of vaccination programmes in Wales is supported by a set of legal mechanisms that enable the supply, administration and governance of vaccines across NHS Wales settings. These mechanisms include Patient Group Directions (PGDs) and Patient Specific Directions (PSDs). From the 1st April 2026 Vaccine Group Directions (VGDs) are included. VGDs for use in Wales align with UK wide legislation but include governance structures and resources specific to Wales.

Patient Group Direction (PGD)

The legislation for PGDs remains unchanged. A PGD is a written instruction for the sale, supply and/or administration of medicines to groups of individuals who may not be individually identified before presenting for treatment.

This means an individual can be known to the service, have an appointment (for example, a baby immunisation clinic) or not be known in advance of presenting at a service, such as a walk-in centre.

PGDs can only be used by the registered health professionals listed in schedule 16, part 4 of the HMR 2012: The Human Medicines Regulations 2012

PGDs are not prescriptions

PGDs allow health care professionals specified within the legislation to supply and/or administer a medicine directly to an individual with an identified clinical condition without the need for a prescription or an instruction from a prescriber.

The health care professional working under the PGD is responsible for assessing that the individual meets the criteria set out in the PGD as no deviations from the PGD are permitted – the supply/administration must exactly follow the PGD for it to be legally undertaken. Therefore, criteria within the PGD must be clear and unambiguous and provide all the required information.

The supply and/or administration of medicines under a PGD cannot be delegated; the whole episode of care must be undertaken by the health care professional operating under the PGD.

Key features of a PGD

  • Applies to groups of patients who may not be individually identified before treatment.
  • Provides a legal framework enabling certain registered healthcare professionals to supply or administer medicines without a prescription.
  • Must be authorised for use within commissioned NHS services.
  • Only specific health professionals listed in legislation can operate under a PGD and no delegation of tasks is permitted.

For more information, see Introduction to PGDs – NHS SPS – Specialist Pharmacy Service

Patient Specific Direction (PSD)

The legislation on Patient Specific Directions (PSDs) remains unchanged. A PSD is a written instruction from an independent prescriber – such as a doctor, dentist, or non-medical prescriber – authorising another healthcare professional to supply and/or administer a medicine to a named individual. Unlike PGDs or VGDs, which apply to groups of patients, a PSD is patient‑specific. It can be issued for one named patient or several named patients, but each individual patient must be clearly identified and have been individually assessed by the prescriber prior to supply and/or administration.

Key features of a PSD

  • The prescriber carries out an individual clinical assessment, decides if the medicine is appropriate and gains informed consent.
  • The instruction is individualised for that specific patient. Therefore, administration of a vaccine to a single named individual or administration of a vaccine to multiple named individuals, each of whom has been individually clinically assessed and informed consent gained.
  • The vaccine may then be supplied or administered by another appropriately trained healthcare professional following the prescriber’s written direction.
  • Steps 1 (clinical assessment and informed consent) and 2 (preparation and administration) do not need to happen at the same time or in the same place. However, the vaccinator giving the vaccine must check that consent is still valid, and it was obtained by the prescriber and that it has been properly documented in the patient’s records before administering the vaccine.

Inappropriate mechanisms of vaccine programme delivery

The following are not PSDs and are not a legal authority for the administration or supply of medicines:

  • Written authorisation to administer a vaccine to multiple unnamed individuals.
  • A written instruction applying to a group of individuals where the individual(s) are not individually identified i.e. a PSD could not state ‘All persons attending the practice’s flu vaccine clinic on date dd/mm/yyyy’. To be a PSD it needs to be a list of all named individuals due to attend the clinic who have been individually clinically assessed and informed consent has been obtained by the prescriber as suitable for treatment and be signed (either by hand or electronically) and dated by a prescriber. Note this does not need to be completed for each entry but can be done once for the entire list. A PSD must be written; it is not a verbal instruction.

For more information, see Patient Specific Directions (PSD) – NHS SPS – Specialist Pharmacy Service

Vaccine Group Direction (VGD)

A VGD allows specified, registered healthcare professionals – listed in legislation – to clinically assess and administer vaccines without a prescription. Like PGDs, VGDs provide a structured, legally compliant framework for vaccine delivery, but with greater flexibility: certain operational tasks, e.g. vaccine preparation and administration (one step) and record‑keeping may be delegated to appropriately trained registered or non‑registered staff. However, clinical assessment and obtaining informed consent cannot be delegated and must be carried out by the registered healthcare professionals authorised under the VGD.

VGDs can be used to administer any licensed vaccine (for the prevention of disease) within a nationally commissioned vaccination programme. They were developed from the learning gained during the use of National Protocols in the COVID‑19 and influenza programmes.

How VGDs differ from PGDs

VGDs permit some tasks within them, such as preparation and administration or record keeping, to be delegated to suitably trained and competent registered and non-registered healthcare practitioners whereas PGDs do not allow any delegation. Each VGD will specifically state which tasks can be delegated and to whom.

The registered healthcare professional who carries out step 1 (clinical assessment and informed consent) under the VGD is accountable for the process and must oversee the delegated steps, step 2 (preparation and administration) and step 3 (record keeping). The registered healthcare professional must be available to step in if needed, see Understanding Vaccine Group Directions (VGDs) – NHS SPS – Specialist Pharmacy Service. The registered healthcare professional can operate all stages of the VGD in a similar manner to PGDs when appropriate. For example, where an individual is needle phobic, delegating the administration to another person may not be in the best interest of the individual.

Comparison table for PGDs, PSDs and VGDs

PGD

PSD

VGD

Who it applies to

Groups of patients who may not be individually identified before presenting for treatment.

A named individual (or a list of individually named people), each assessed by a prescriber.

Groups of patients receiving specific vaccines within nationally commissioned vaccination programmes.

Clinical assessment and informed consent

Must be carried out by the same registered healthcare professional delivering all steps under the PGD (no delegation).

Must be performed directly by a prescriber on a one-to-one basis. The person administering the vaccine is accountable for ensuring that the individual has not raised any new clinical concerns since the initial assessment and refer any issues back to the prescriber (consent to proceed).

Must be undertaken by a specific registered practitioner listed in legislation, who is able to work under a PGD or all steps of a VGD. Clinical assessment and obtaining informed consent cannot be delegated. The registered healthcare professional can operate all stages of the VGD when appropriate.

Delegation

❌ Not permitted — the registered healthcare professional using the PGD must perform all stages.

✅ Administration may be delegated to a trained non‑prescriber following the prescriber’s written instruction.

✅ Permitted for certain tasks (e.g., administration, preparation, record‑keeping), but not for clinical assessment or informed consent.

Supervision

Supervision is not required.

The prescriber must be satisfied that the person whom the administration is delegated to has the qualifications, experience and knowledge and skills to provide the treatment. The individual who carries out administration is accountable for their own practice and act according to their competence. Delegation can be to registrants or non-registrants.

Supervision is required. The registered healthcare professional who obtains informed consent must supervise (in the same clinical area) the individuals undertaking the delegated tasks. Delegation can be to registrants or non-registrants. The registered healthcare professional delegating tasks should ensure that the person they are delegating the tasks to are appropriately trained and competent.

Best used for

Routine immunisation where clear inclusion/exclusion criteria are defined and a consistent pathway is needed.

Individually tailored care.

Large-scale vaccination programmes requiring flexible workforce models and safe, controlled task delegation.

Legal basis

A legally authorised, written instruction signed by a doctor / dentist and pharmacist for use in NHS‑commissioned services.

Written instruction (not defined in legislation) but recognised as the traditional prescriber‑led mechanism for named individuals.

New statutory mechanism introduced April 2026 to replace National Protocols for vaccine administration. VGDs must be legally approved by Public Health Wales, however they also require local sign off.

Who it applies to

PGD:
Groups of patients who may not be individually identified before presenting for treatment.

PSD:
A named individual (or a list of individually named people), each assessed by a prescriber.

VGD:
Groups of patients receiving specific vaccines within nationally commissioned vaccination programmes.

Clinical assessment and informed consent

PGD:
Must be carried out by the same registered healthcare professional delivering all steps under the PGD (no delegation).

PSD:
Must be performed directly by a prescriber on a one-to-one basis. The person administering the vaccine is accountable for ensuring that the individual has not raised any new clinical concerns since the initial assessment and refer any issues back to the prescriber (consent to proceed).

VGD:
Must be undertaken by a specific registered practitioner listed in legislation, who is able to work under a PGD or all steps of a VGD. Clinical assessment and obtaining informed consent cannot be delegated. The registered healthcare professional can operate all stages of the VGD when appropriate.

Delegation

PGD:
❌ Not permitted — the registered healthcare professional using the PGD must perform all stages.

PSD:
✅ Administration may be delegated to a trained non‑prescriber following the prescriber’s written instruction.

VGD:
✅ Permitted for certain tasks (e.g., administration, preparation, record‑keeping), but not for clinical assessment or informed consent.

Supervision

PGD:
Supervision is not required.

PSD:
The prescriber must be satisfied that the person whom the administration is delegated to has the qualifications, experience and knowledge and skills to provide the treatment. The individual who carries out administration is accountable for their own practice and act according to their competence. Delegation can be to registrants or non-registrants.

VGD:
Supervision is required. The registered healthcare professional who obtains informed consent must supervise (in the same clinical area) the individuals undertaking the delegated tasks. Delegation can be to registrants or non-registrants. The registered healthcare professional delegating tasks should ensure that the person they are delegating the tasks to are appropriately trained and competent.

Best used for

PGD:
Routine immunisation where clear inclusion/exclusion criteria are defined and a consistent pathway is needed.

PSD:
Individually tailored care.

VGD:
Large-scale vaccination programmes requiring flexible workforce models and safe, controlled task delegation.

Legal basis

PGD:
A legally authorised, written instruction signed by a doctor / dentist and pharmacist for use in NHS‑commissioned services.

PSD:
Written instruction (not defined in legislation) but recognised as the traditional prescriber‑led mechanism for named individuals.

VGD:
New statutory mechanism introduced April 2026 to replace National Protocols for vaccine administration. VGDs must be legally approved by Public Health Wales, however they also require local sign off.

References

Additional resources

Welsh Medicines Advice Service
Patient Group Directions (PGDs) templates and guidance

Patient group Directions eLearning module
The aim of this course, which was developed by the NHS Specialist Pharmacy Service (SPS), is to support healthcare professionals and organisations who are considering, developing, authorising and using patient group directions (PGDs) to deliver healthcare services in line with legislation and NICE medicines practice guideline (MPG2).This module will be updated to include information on Vaccine Group Directions available to access here: Patient Group Directions (PGDs) – Public Health Wales

Specialist Pharmacy Service have a selection of explainer videos
PGDs in practice explainer videos – NHS SPS – Specialist Pharmacy Service

Specialist Pharmacy Service webinar
Amendments to HMR 2012 supporting vaccine supply and deployment – NHS SPS – Specialist Pharmacy Service

Change history

28 Apr 26

Published.

Cymraeg