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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

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

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)

Administration of contrast agents under a PGD by multiple HCPs

15 July 2024Whether a healthcare professional (HCP) can prepare and/or administer contrast supplied by another HCP under a PGD will depend on a range of factors.

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.

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.

Transcribing in the patient's home with healthcare input

22 February 2022Consideration needs to be given to the risk factors particularly associated with transcribing in the patient's home with healthcare input

Acute settings and transcribing

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

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.