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Can patients receive medicines under PGD when they are used outside their licenced uses?

20th May 2020 · Licenced medicines can be used under PGDs outside the terms of their Summary of Product Characteristics (SPC).  This is also called off-label or off-licence use.…

The supply of unlicensed medicinal products ("specials") MHRA Guidance Note 14

2nd March 2020 · The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines and medical devices work, are safe and of appropriate quality. The…

Supply of Aseptically Prepared Doses of IMPs Across Legal Boundaries, Version 2, October 2019

28th February 2020 · Supply of Aseptically Prepared Doses of IMPs Across Legal Boundaries Version 2 Oct 19 This document has been developed by the NHS Quality Assurance Committee…

Supply of aseptically Prepared Doses of IMPs Across Legal Boundaries Version 2 October 2019

27th February 2020 · This document has been developed by the NHS Quality Assurance Committee and National Pharmacy Clinical Trials Advisory Group with input provided by the MHRA Clinical…

Content page for Yellow Cover Documents (Yellow Cover)

27th February 2020 · A list of Yellow Cover Documents is provided below. Please note to access any of the links below you need to be registered with, and…

Can off label or unlicensed products be sold, supplied or administered under Schedule 17 of the Human Medicines Regulations 2012 exemptions?

7th January 2020 · Exceptions to the general rule for which certain healthcare professionals can sell, supply, and/or administer medicines to patients under Schedule 17 of the Human Medicines…

Questions about Patient Specific Directions (PSD)

2nd January 2020 · A Patient Specific Direction (PSD) is the traditional written instruction, signed by a doctor, dentist, or non-medical prescriber for medicines to be supplied and/or administered…

Can appliances and dressings be supplied and/or administered under a PGD?

2nd January 2020 · No. Appliances and dressings are not licensed medicines – PGDs apply only to licensed medicines. For dressings and appliances, consider using a locally approved protocol…

Can registered health professionals who are trainee injectors , administer injections under PGD whilst being supervised?

2nd January 2020 · It is not specified in legislation that only trained and competent professionals should be authorised to practice under PGDs.  However, members of the PGD Service…

What are the legal requirements for labelling a Prescription Only Medicine (POM) issued via a PGD before supply to the patient?

2nd January 2020 · The MHRA have advised that medicines supplied under a PGD would usually be considered to be “dispensed medicines” but that the definition in the legislation…

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