The landscape of clinical trials has evolved significantly with the pandemic and interest in utilization of decentralized clinical trial (DCT) designs as a mitigation and the need for remote data collection. In response to this shift, the US Food and Drug Administration (US FDA) has released draft guidelines to try to provide clarity on the use of DCT models in clinical trials. While the...
The main change can be seen on the imports of IMPs from EU/EEA to Great Britain starting 01 January 2022. Sponsors of United Kingdom Clinical trials will need to appoint a United Kingdom Manufacture & Importation Authorization (MIA) (IMP) holder who will be responsible for implementing an oversight process to confirm each batch has been certified by a Qualified Person before its release to...
Customs procedures also imply having an Importer of Record liable at destination as well as having each party, exporter, and importer, registered, and identified with its own EORI (from the Country it is based at). An XI EORI number is required to move goods between NI and non-EU Countries (which comprise Great...
The United Kingdom (UK) (England, Northern Ireland, Scotland and Whales) is no longer part of the European Union (EU) Customs Union. Simply put, it means movement of goods between the UK and the EU are now to be an import and export trade transaction. Multiple industries have been impacted, including...
