Vaccine Group Direction (VGD) Policy – NHS Borders

A Vaccine Group Direction (VGD) is a legal mechanism (Regulation 235A of the Human Medicines Regulations 2012, as amended in April 2026) to support the administration of UK licensed vaccines within nationally commissioned vaccination programmes approved by Scottish Ministers. It allows vaccination to be delivered without an individual prescription, where the requirements of the VGD are met.

Under a VGD, an appropriate registered healthcare practitioner must clinically assess the person’s eligibility and obtain and record informed consent. These activities must not be delegated.

VGDs may allow some tasks within the vaccination process (such as vaccine preparation, administration and record keeping) to be delegated to suitably trained registered and non-registered staff at the same location as, and under the supervision of, an appropriate registered healthcare practitioner, but only where this is explicitly permitted by the individual VGD. The supervising registered healthcare practitioner must be available to provide immediate support and escalation in line with the VGD and local SOPs. Each VGD will state which tasks can be delegated and to whom, and this may vary between VGDs, so it is essential to check each VGD carefully before implementation.

VGDs replace pandemic National Protocols (formerly Regulation 247A) and apply only to national vaccination programmes approved by Scottish Ministers.

Key legal characteristics of VGDs

• VGDs are authored nationally by Public Health Scotland (PHS).
  
  
• NHS Boards must not amend the clinical or legal content of a VGD.
  
  
• VGDs must be authorised locally by NHS Boards before use.
  
  
• Any local amendment causes the document to revert legally to a Patient Group Direction (PGD) and must then meet PGD legal and governance requirements.

What can they be used for?

This policy applies to:

• All vaccination and immunisation services delivered by or on behalf of NHS Borders using VGDs.
  
  
• All staff involved in VGD consideration, authorisation, implementation, supervision, training, and governance.

What can’t they be used for?

This policy does not apply to:

• Private vaccination services not commissioned by NHS Borders.
  
  
• Vaccinations outside nationally approved programmes (e.g. private travel vaccinations).

Relationship between VGDs and PGDs

NHS Borders recognises that both VGDs and PGDs are lawful mechanisms for vaccine delivery. The decision on which mechanism to use is a local governance decision, informed by service design, workforce capacity, and risk.

Key distinctions:

• VGDs: nationally authored; vaccines only; some tasks may be delegated where explicitly permitted by the VGD; locally authorised.
  
  
• PGDs: locally developed; locally amended; may cover non-vaccine medicines; delegation is not permitted.

NHS Borders may continue to use PGDs instead of VGDs where this is clinically or operationally preferred.

Public Health Scotland

• Commissioning and authorship of VGDs.
  
  
• National peer review and assurance of VGD content.

NHS Borders

NHS Borders is responsible for:

• Determining whether adoption of a nationally authored VGD is appropriate locally.
  
  
• Ensuring governance, workforce readiness, SOPs and systems are in place prior to authorisation.
  
  
• Monitoring safe and effective use of VGDs, including incident reporting and audit.

Authorising signatories

In line with Regulation 235A, VGDs must be authorised by a senior manager.

NHS Borders will normally mirror existing PGD assurance arrangements, typically including:

• Medical Director (or delegated senior medical representative)
  
  
• Director of Pharmacy
  
  
• Senior Nursing / Vaccination Professional Lead

VGDs are only lawful for use in NHS Borders once they have been locally authorised (signed on behalf of the service by a senior manager) and are the current, authorised version in effect at the time of administration. The role of the senior manager will fulfilled by the Director of Pharmacy

NHS Borders authorisation relates to the use of the Public Health Scotland (PHS) authored VGD without amendment. Any local change to the VGD’s clinical or legal content means it is no longer a VGD and must be managed via the PGD governance process.

This provides continuity of clinical and medicines governance assurance.

Immunisation Co-ordinators and clinical leads

• Advising on local suitability of VGDs.
  
  
• Supporting implementation, SOP development and workforce planning.
  
  
• Acting as the primary route for feedback or requests to Public Health Scotland.
  
  
• Signing.

Registered healthcare practitioner responsible for assessment and consent

For vaccination delivered under a VGD, an appropriate registered healthcare practitioner (as listed in legislation and the relevant VGD) must:

• Clinically assess and determine eligibility to receive the vaccine.
  
  
• Obtain and record informed consent.

These activities must not be delegated. The registered healthcare practitioner must also ensure that any delegated tasks are only delegated where explicitly permitted by the individual VGD.

Line managers and supervising registered professionals

Responsible for ensuring:

• Staff operating under VGDs are trained, competent, and supervised in line with the relevant VGD and local SOPs.
  
  
• Where a VGD permits delegation of tasks (e.g., administration and/or record keeping), the supervising registered healthcare practitioner is at the same location and available for supervision, support and escalation as required by the VGD and local governance arrangements.
  
  
• Compliance with the requirement that where vaccine reconstitution/dilution is required, the same individual must prepare and administer the vaccine dose (Regulation 3A amendment effective from 1 April 2026).
  
  
• Adherence to professional codes and NHS Borders policies.

1^st review is by the local clinical team with a recommendation that they want to use the VGD in NHS Borders. This should be sent to PGD admin at bor.pgdadmin@borders.scot.nhs.uk.

2^nd review is by the Area Drugs and Therapeutic Committee followed by a   recommend approval sent to the authorised signatories.

Can Boards request amendment of authored VGDs/suggest new VGDs?

Yes. It is recommended that such requests are via local Immunisation Co-ordinators in the first instance but requests can be raised through the Vaccination Delivery Board or directly with Public Health Scotland. Please note that Public Health Scotland, as the organisation with authoring responsibility, will consider all requests in a Scottish context.

NHS Boards cannot amend the content of VGDs authored by Public Health Scotland. Should this occur, the legal status of an amended VGD reverts to a PGD.

• All staff operating under a VGD must complete the training and competency assessment required for the tasks they will undertake.
  
  
• Clinical assessment for suitability and obtaining/recording informed consent must only be undertaken by appropriate registered healthcare practitioners listed in legislation and the relevant VGD, and must not be delegated.
  
  
• Where a VGD permits delegation of tasks (e.g., vaccine preparation, administration and/or record keeping), delegation must only be to staff who are trained and assessed as competent for those specific tasks, and the delegation/supervision arrangements must follow the individual VGD.
  
  
• From 1 April 2026, where vaccine reconstitution/dilution is required, this must be carried out by the same person who administers the vaccine dose; services must reflect this in SOPs, training and competency sign-off.
  
  
• NES national education materials and competency frameworks will be used where available, supplemented by local SOPs.
  
  
• Local services must maintain records of staff competence and authorisation for VGD roles/tasks, and ensure arrangements are in place for ongoing supervision, refresher training, and performance monitoring.

Vaccines administered under a VGD do not require full ‘dispensed’ labelling provided the product remains in the original manufacturer’s packaging and is not supplied to the patient to take away. Where local processes involve drawing up doses (e.g., from multi-dose vials) or moving doses within a clinic, labelling/traceability arrangements must follow the vaccine’s Summary of Product Characteristics (SmPC), the relevant VGD and local SOPs.

Patient information leaflets / patient information

Patients (or their carers) must be provided with appropriate vaccine information (e.g., manufacturer’s patient information leaflet or national programme information) in line with the relevant VGD and national vaccination programme requirements. Where possible, availability of information in different languages and accessible formats (e.g., large print/Braille) should be considered.

Provision of patient information and any advice/counselling given should be recorded as required by the VGD and local vaccination record processes.

It is essential that due consideration is given to the arrangements for the supply, security, storage, and stock rotation of all medicines.

Record keeping

Proper audit trails must be in place to demonstrate whether the VGD has been followed. This requires a robust system for recording vaccination activity on an individual patient-by-patient basis in line with the specific VGD and local vaccination SOPs.

Stock balances must be reconcilable with receipts, administrations, records, and disposals. Any non-administration leading to wastage of vaccine must be documented. From this it should be possible to identify which patient received which vaccine, including batch number and expiry date.

The names (and role) of staff undertaking each permitted task under the VGD (e.g., assessment/consent by registered healthcare practitioner; administration/recording by delegated staff where permitted must be recorded.

What should be recorded?

Details of assessment, consent, vaccine preparation (where applicable), administration and recording must be documented in line with the relevant VGD and national vaccination programme requirements. This includes, as a minimum: patient identifiers; vaccine name, brand (if applicable), dose, route, site; date; batch number and expiry; the registered healthcare practitioner who undertook assessment and consent; the individual who prepared and administered the vaccine (noting that where reconstitution/dilution is required, this must be undertaken by the same person who administers the vaccine); advice given and patient information leaflet provision; and any adverse reactions or incidents.

Legal requirements for VGDs under the Human Medicines Regulations (HMR) 2012 (as amended)

Records of vaccine preparation (where applicable), administration, consent, batch number, and expiry date must be accurately maintained. Clinical assessment for suitability and obtaining informed consent cannot be delegated and must be undertaken by an appropriate registered healthcare practitioner.

Patients’ clinical records

To ensure all members of the multidisciplinary team are aware that the patient has received a vaccine under a VGD, details must be recorded in the patient record/approved vaccination record system.

The provision of the manufacturer’s patient information leaflet (or other approved patient information), action taken, and any counselling/advice given must be recorded.

Any failed attempt to administer a vaccine under a VGD and any vaccine wastage must be documented and managed in accordance with local incident reporting procedures.

Records must be kept by the vaccination team to allow the process to be audited internally (by Local Clinical Team) and externally.  

Record Keeping

A simple audit would be to look at the records and ascertain whether they have been completed properly.  Incomplete record keeping could lead to NHS Borders removing the approval for an individual healthcare professional to supply / administer against VGDs.

Inclusion/exclusion criteria

A check on whether healthcare professionals are following the inclusion/exclusion criteria in all cases. A simple review of the records will demonstrate whether this is being followed.

Counselling

If the VGD does not specify the content and quantity of counselling that should be given, then each healthcare professional must decide how much counselling they think is appropriate for each patient. It is good practice to make a formal decision about how much counselling and what areas the healthcare professional would wish to cover with each supply/administration.  It would be useful to produce a counselling checklist.

To audit counselling, the healthcare professional could review the actual counselling noted in the records against their decision about how much counselling was required.  The healthcare professional may then want to reflect on whether they are delivering all the counselling that they thought necessary and decide whether to change their practice.

Significant Events

An important form of auditing practice is to note any significant events that have happened during supply/administration of a medicine under a VGD.  A significant event could be a supply/administration which was particularly difficult or went particularly well. 

Significant events are important in highlighting learning experiences.  If possible, share your experiences, either good or bad, with colleagues and staff so that they can also learn.  If appropriate, complete an Inphase Adverse event report for Medication Events (including “Near-Misses”).

After a supply/administration that you did not handle particularly well, try to reflect on why you had a problem:

• What could you do differently next time?
• How could you have dealt with the client better?
• Could your peers give you some insight into how to improve your techniques?

Similarly, after a supply/administration that you were particularly happy about:

• What did you do particularly well?
• Is there something you could incorporate into future supplies/administrations?

Formal Audit Reporting

To ensure safe and effective mechanisms the use of VGDs will be monitored through routine vaccination governance and medicines assurance processes.

Can NHS Borders amend a VGD?

No. VGDs must be implemented exactly as authored by Public Health Scotland. If local changes are made to the clinical or legal content, the document reverts legally to a PGD and must then meet PGD requirements.

Can tasks be delegated under a VGD?

Some tasks may be delegated, but only where the individual VGD explicitly permits it and only to staff who are trained and assessed as competent. Each VGD states which tasks can be delegated and to whom, and this may vary between VGDs. Clinical assessment for eligibility and obtaining/recording informed consent must not be delegated.

Can one person prepare and another administer the vaccine?

Where vaccine reconstitution/dilution is required, this must be carried out by the same person who administers the vaccine dose (Regulation 3A amendment effective from 1 April 2026). Services must reflect this in clinic workflow and SOPs.

What if the patient does not meet the VGD inclusion criteria?

If an individual does not meet the VGD criteria, vaccination must be provided via another lawful mechanism (e.g., PSD) in line with local clinical governance arrangements.

STOCK RECORD FOR MEDICATION ORDERED & SUPPLIED UNDER A VGD

This could be a form or a specific record book.