About
Following the UK exit from the EU, the regulatory requirements for moving medicines between the EEA and EU member states has changed. Since the 1st January 2021 clinical trial sponsors have been required to begin implementing systems to support the continued supply of Investigational Medicinal Products (IMPs) taking into consideration the new legislative requirements. A one-year transition period for this implementation ended on the 1st January 2022.
As a result, supply chains for all IMPs, including Advanced Therapy Investigational Medicinal Products (ATIMPs), must comply with the new requirements. This requires a UK MIA(IMP) holder to be part of the supply chain and complete checks on any IMPs imported for use in a UK clinical trial.
There are additional arrangements in place for trials conducted in Northern Ireland, and for IMPs supplied to, or from, NI.
Purpose
This guidance document is intended to be used by NHS trial sites to determine what evidence should be available on receipt of IMPs supplied via different routes. There are additional considerations where IMPs may have extremely short shelf lives (e.g. ATIMPs or Radiopharmaceuticals), and need to be supplied directly from the EEA/EU manufacturer to the clinical trial site. Appropriate arrangements must be in place to ensure the IMP is not made available until the required checks are complete.
The information provided will help NHS trial sites to understand their individual responsibilities, those of the trial Sponsor, and where necessary the importer. This can be used to develop internal procedures to ensure due diligence is applied to received IMP stock.
The guidance includes a number of supply chain examples with detail on what the expectations of each member of the supply chain.