Brexit: UK To Change Drug Import And Export Rules From 2021

Guidance Explains When Written Confirmations Will Be Needed For APIs

New guidance documents issued by the UK regarding medicines regulation after the end of the Brexit transition period cover the import of medicinal products from countries on an approved list, trade in APIs between the UK and third countries, and the acceptance of batch testing under existing mutual recognition agreements.

Export - Import — Brexit means new processes for trade in medicines and APIs • Source: Shutterstock

Companies with a wholesale dealer’s license that want to carry on importing medicines from countries on the UK’s “approved country for import” list next year have been told they must notify the Medicines and Healthcare products Regulatory Agency in writing of their intention to do so within six months of 1 January 2021.

Within two years of that date, wholesale dealers must also have nominated a Responsible Person for import (RPi) to carry...