Vaccine Group Directions (VGDs), consent and the role of non-registered staff in vaccination programmes

In April 2026, regulation 235A of the Human Medicines Regulations introduced Vaccine Group Directions (VGDs). 

VGDs provide a new legal mechanism for approved vaccination programmes and replace the National Protocol arrangements previously used in some settings. 

The introduction of VGDs has prompted questions from practices, PCNs and provider organisations regarding: 

• the role of healthcare assistants and other non-registered staff; 
• consent arrangements; 
• supervision requirements; 
• workforce models; and 
• how VGDs differ from Patient Specific Directions (PSDs) and Patient Group Directions (PGDs). 

This updated guidance explains the practical implications for primary care. 

What has changed?

The introduction of VGDs provides a more structured legal framework for vaccination programmes and explicitly defines: 

• which activities can be delegated; 
• which activities remain the responsibility of registered healthcare professionals; 
• supervision requirements; and 
• documentation requirements. 

What has not changed? 

Many of the principles discussed in previous national guidance remain unchanged. In particular: 

• consent remains a process rather than a single event; 
• a PSD is not the same as consent; 
• clinical assessment remains distinct from vaccine administration; 
• staff must work within their competence; 
• providers remain responsible for ensuring staff are appropriately trained and supported; and 
• governance and accountability remain essential. 

If anything, current VGDs reinforce many of these existing principles. 

Patient Specific Direction (PSD) 

A PSD relates to an individual patient and provides the legal authority for a specified medicine to be supplied or administered to that patient. 

Many traditional practice vaccination services continue to operate using PSD-based arrangements. 

A PSD does not itself constitute informed consent. 

Patient Group Direction (PGD) 

A PGD allows specified registered healthcare professionals to assess and administer medicines to groups of patients meeting defined criteria. 

Delegation is not permitted under a PGD. 

Vaccine Group Direction (VGD) 

A VGD is a nationally developed legal framework supporting specified vaccination programmes. 

Unlike a PGD, a VGD allows certain vaccination activities to be delegated where the VGD specifically permits this and appropriate supervision arrangements are in place. 

The existence of a VGD does not require providers to adopt a VGD-based model if another lawful mechanism is more appropriate. 

Read LMC advice letter from Dr Julius Parker >

No. 

A PSD provides legal authority for a named patient to receive a specified medicine, including a vaccine. It does not in itself constitute consent. 

Informed consent remains a separate requirement. 

Where a vaccine is administered under a PSD, responsibility for obtaining informed consent rests with the prescribing clinician. 

Informed consent and agreement to proceed do not need to occur at the same time or in the same location. 

Where informed consent has already been obtained by an appropriately authorised registered healthcare professional permitted to undertake Step 1 activities under the relevant VGD, it is entirely reasonable for the person administering the vaccine to confirm immediately before administration that the individual remains happy to proceed. 

National guidance continues to emphasise that informed consent should not be regarded as a single event. 

Consent is a process that includes: 

• provision of appropriate information; 
• opportunity to ask questions; 
• support to enable decision-making; 
• consideration of individual circumstances; and 
• confirmation that the individual wishes to proceed. 

Current VGDs reinforce this principle by treating assessment, information-giving, consent and supervision as part of a single clinical process rather than separate administrative tasks. 

There is no universal requirement for written consent forms. 

Practices should continue to document significant discussions or concerns where clinically appropriate. 

The overarching principles of consent remain set out within Chapter 2 of the Green Book.

Current UKHSA VGDs describe vaccination as a series of distinct activities. 

Step 1 

• Clinical assessment 
• Assessment of eligibility 
• Provision of information 
• Obtaining informed consent 
• Clinical supervision 

Step 2 

• Vaccine preparation 

Step 3 

• Vaccine administration 

Step 4 

• Record keeping 

Current VGDs allow delegation of certain activities within Steps 2, 3 and 4 where specified. 

Step 1 activities remain the responsibility of an appropriately authorised registered healthcare professional. 

One of the most important messages from the VGD framework is that assessment, consent and supervision are treated as distinct professional responsibilities and are not simply administrative tasks that can be separated from clinical decision-making. 

Healthcare assistants and other healthcare support workers continue to play an important role within vaccination programmes. 

Where appropriate legal authority exists and where staff are trained, competent and supported, non-registered staff may contribute to vaccination delivery, including administration of vaccines under appropriate arrangements. 

National guidance continues to distinguish between: 

• clinical assessment and decision-making; and 
• vaccine administration and supporting activities. 

Healthcare support workers should not undertake activities that fall outside their competence or authorised scope of practice. 

Practices should ensure that training, competence assessment, supervision and governance arrangements are clearly documented. 

Nursing associates are registered professionals regulated by the Nursing and Midwifery Council and should not be regarded as healthcare support workers.

However, current UKHSA Vaccine Group Directions place specific limits on the role of nursing associates. Nursing associates are not authorised to undertake Step 1 activities under a VGD, which include clinical assessment, eligibility checks and obtaining informed consent.

Current VGDs allow nursing associates to undertake delegated activities within Steps 2-4, including vaccine administration where appropriately trained, competent and supervised by a registered healthcare professional who has already undertaken the assessment and consent process.

Practices employing nursing associates should ensure their local protocols clearly define responsibilities, supervision arrangements and the legal mechanism being used for vaccination delivery.

Note: read FAQ entitled ‘How do VGDs divide the vaccination process?’ to review the steps mentioned above.

The current VGD framework places greater emphasis on supervision than many organisations may historically have been accustomed to. 

Where activities are delegated: 

• supervision arrangements should be clearly defined; 
• delegated staff should be appropriately trained and assessed as competent; 
• responsibilities should be documented; and 
• providers should be able to demonstrate appropriate governance arrangements. 

Practices, PCNs and provider organisations should ensure that local protocols clearly identify: 

• who assesses eligibility; 
• who provides information and obtains consent; 
• who supervises; 
• who administers the vaccine; and 
• how responsibility is documented. 

Different providers are using different workforce models depending on staffing, local workflows and the legal mechanism being used. 

Examples may include: 

Practice-based clinics 

A registered healthcare professional undertakes assessment and consent. 

Other activities may be delegated where this is compatible with the legal framework being used. 

Nurse-led vaccination clinics 

The nurse undertakes assessment, consent and supervision while other team members undertake delegated activities where appropriate. 

PCN vaccination services 

One or more registered practitioners undertake assessment and consent while a wider vaccination team supports delivery. 

Federation or large-scale vaccination services 

Larger provider organisations may utilise centralised governance, competency assessment and supervision arrangements to support delivery at scale. 

These examples are illustrative rather than prescriptive. 

The appropriate model will depend on staffing, governance arrangements and the legal framework being used. 

This guidance is not saying that: 

• every provider must adopt a VGD model; 
• new consent forms are required; 
• additional appointments are needed purely for consent; 
• every vaccination programme must operate in the same way; 
• healthcare assistants can never administer vaccines; or 
• practices must redesign existing services solely because VGDs now exist. 

Its purpose is to help practices understand the available legal frameworks and their practical implications, rather than prescribe a single operational model.