Patient group directions

Published: 11 February 2013

Authorisation in new organisational structures

The Medicines and Healthcare Products Regulatory Agency (MRHA) and Department of Health are amending medicines legislation to:

These changes are consequential to the Health and Social Care Act 2012 and will enable the continued use of PGDs in new health system organisational structures.

Transitional arrangements

The legislation will also incorporate trasitional arrangements to ensure the continued availability of PGDs during the organisational change, and to ensure that staff and organisations are not acting outside the law. These arrangements will allow PGDs to remain legal after the original authorising body (for example a PCT) has been abolished and until expiry or authorisation by the new body responsible for the service in question. Responsibility for PGDs will transfer to these new bodies and organisations "inheriting" PGDs will need to put in place clear arrangements and a timetable for review and adoption/authorisation of all existing PGDs.

The National Prescribing Centre (NPC) is now called the Medicines and Prescribing Centre (MPC) at the National Institute for Health and Clinical Excellence (NICE) has published a practical guide and framework of competences for organisations and professionals developing and using PGDs available from their website.

The MPC are reviewing this document, including taking account of changes to legislation and organisational structures with the aim of republishing by April 2013. In advance of this updated edition, organisations delivering services under PGDs can still use the existing document to help guide them through the legal framework governing the development and authorisation of PGDs and to provide practical guidance on their use.