ABPI asks MHRA for more detail on Brexit

2 September 2020

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published information for drugmakers trying to prepare for the end of the Brexit transition period.

This guidance provides some information on how to operate from the beginning of January 2021, including on licensing of drugs and devices, clinical trials, exporting active substances for medicines, importing products and investigational medicinal products, pharmacovigilance procedures and new IT systems.

The guidance is largely similar to the Brexit no deal guidelines published in 2019, unnecessarily in that instance, though the UK now again looks set to leave without an agreement amid tortured negotiations between the two parties.

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