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

11 November 2019This document has been developed by the NHS Quality Assurance Committee and National Pharmacy Clinical Trials Advisory Group with input provided by the MHRA Clinical…

Operational Implications of UK Exit from the EU for NHS Clinical Trial Sites

16 September 2022A summary of the implications of the UKs exit from the EU for clinical trial sites for both IMP and ATIMPs, including supply to and from Northern Ireland

Outsourcing of Storage or Preparation of ATIMPs Across Legal Boundaries

15 November 2022Guidance on the considerations for Pharmacy Clinical Trial Sites outsourcing activities involved in the delivery of ATIMPs

Acute settings and transcribing

22 February 2022Consideration needs to be given to the risk factors particularly associated with transcribing in acute settings

Off-label or unlicensed product use under HMR 2012 exemptions

8 January 2020A legal position summary regarding the sale, supply or administration of off-label/unlicensed products under Schedule 17 of the Human Medicines Regulations 2012

Prescribing available HRT products

28 April 2022Hormone Replacement Therapy availability varies currently. Check for available products and keep up-to-date. Supply content is maintained regularly by DHSC.

Patient Group Direction use in End of Life Care

10 August 2020Considerations required before implementing Patient Group Directions (PGDs) in End of Life Care.

Worked example of assessing the risk of transcribing

22 February 2022Example where medicines are prescribed by both the patient’s GP and specialist clinicians, and are administered in a patient’s home.

Supply and administration of medicines by staff group (P to Z)

2 April 2024Different staff groups have different permissions with respect to medicines supply and administration and it is important to ensure legislation is followed.

Legal mechanisms to supply and administer medicines to individuals

24 January 2022The main legal mechanisms used to supply and/or administer medicines are explained and considerations suggested for the most appropriate option(s)