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Guidance

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Tissue Engineered Products - Pharmacy Institutional Readiness Guidance

21 July 2020This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Tissue Engineered Products.

Ex-Vivo (cell based) Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance

21 July 2020This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Ex-Vivo (cell based) Gene Therapy.

In-Vivo (virus based) Gene Therapy Medicinal Products - Pharmacy Institutional Readiness Guidance

21 July 2020This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing In-Vivo (virus based) Gene Therapy.

PGD use in services provided by multiple organisations

14 July 2020This article outlines the principles to be considered when PGDs are used in the provision of medicines/vaccines in services provided by multiple organisations.

Patient Specific Directions (PSD)

10 June 2020This article describes Patient Specific Directions and the requirements for their writing and use

Bank and agency staff and Patient Group Directions

25 February 2020The below summarises the advice on the use of PGDs by bank and agency staff working within organisations.

Out of Specification Advanced Therapy Medicinal Products - Guidance for Healthcare Organisations

24 February 2020This document clarifies the regulatory expectation regarding OOS ATMPs and advises hospitals on Governance in the event of an OOS ATMPs being offered for use.

Pharmacy Oversight and Supervision Requirements for Preparation of Licensed ATMPs

31 January 2020This guidance provides definitions of oversight and supervision it clarifies where each are required when implementing ATMPs.

Off-label or unlicensed product use under HMR 2012 exemptions

8 January 2020The below summary details the legal position regarding the sale, supply or administration of off-label/unlicensed products under Schedule 17 of the HMR 2012

Patient Group Direction use in Primary Care Networks

8 January 2020About PCNs Primary Care Networks (PCNs) are networks of GP practices collaboratively working together and with community, mental health, social care, pharmacy, hospital and voluntary…