Legal position

The Medicines and Healthcare Products Regulatory Agency (MHRA) has sought legal advice and has confirmed that local authorities cannot delegate responsibility for organisational authorisation of PGDs to an ICB or other relevant NHS organisation under a Section 75 agreement.

Authorisation of Local Authority commissioned PGDs

Organisational authorisation of PGDs by a local authority should be carried out by the Chief Executive or Director of Public Health of the Local Authority (LA). However, this responsibility may be delegated to a clinical governance lead such as a Medical or other Clinical Director in the local authority. The Chief Executive or Director of Public Health would need to determine and note formally which individual would have the authority and responsibility to be the signatory in order to state that PGDs are fit for purpose.

For further information about PGD signatories refer to Understanding roles and responsibilities of PGD signatories.

Developing and maintaining Local Authority PGDs

An ICS or other relevant organisation can support the development, maintenance and clinical authorisation of PGDs by doctor/pharmacist signatories who are employed by them.

This should be a formal arrangement between the local authority (LA) and the ICS/other relevant organisation with agreed processes and policies to support this arrangement and to comply with NICE PGD guidance. For further information refer to Patient Group Directions in Complex Commissioning Scenarios.

The medicines decision-making committee of the ICS/other relevant organisation such as the Medicines Management Committee cannot extend the expiry dates of PGDs for services commissioned by the LA. The committee may provide clinical opinion or guidance to the LA as to whether this is safe or appropriate. For further information refer to Extension of expiry date of a Patient Group Direction.

Any changes made to the PGDs during their valid use period requires the reauthorisation of the PGDs by the LA. For further information refer to Managing Patient Group Directions following amendments or changes.

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