The requirements and procedures for clinical trials in the UK are set out in the Medicines for Human Use (Clinical Trials) Regulations 2004. They also include requirements for the application and assessment of each trial, the supply of investigational medicinal products (IMPs) and the conduct of clinical trials.
There will be a one-year transition period from 1 January 2021 to implement this guidance. IMPs coming to Great Britain from Northern Ireland do not require this additional oversight.
This should be used to confirm the site responsible for final certification of the finished IMP. details of each shipment of IMP to Great Britain including the addressees' information. This is not an exclusive or exhaustive list because information requirements may vary depending on the responsibilities of each organisation in the supply chain.
Evidence that each batch of IMP imported from a listed country has been QP certified for use in the specified UK trial. This should be verified prior to the first shipment of IMP from each batch to the Great Britain trial site(s).
You may use a distribution facility to store IMPs imported from a listed country before supply to Great Britain clinical trial sites. Great Britain storage and distribution facilities should be named on the UK MIA(IMP) of the company responsible for oversight of the import.
Obtaining non-investigational medicinal products from Northern Ireland will require a WDA(H) Unless you are the Sponsor of the clinical trial.
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